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Found 6,988 cases where Vaccine is HPV4 and Serious

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VAERS ID: 305606 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2008-02-20
Onset:2008-02-22
   Days after vaccination:2
Submitted: 2008-02-25
   Days after onset:3
Entered: 2008-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1968U / 3 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2008-02-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin daily birth control
Current Illness:
Preexisting Conditions: No known drug allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden unattended death. Autopsy results pending (inconclusive 2/25/08). 2/26/08 Reviewed pcp medical records & vax records which reveal patient received HPV#1 0469U 7/16/07 & HPV#2 09300 9/17/07. In 11/20/07, noted to have left sided head pain intermittently along with lightheadedness; dx w/tension HA. HPV#3 was scheduled for 1/16/2008 but postponed due to no parental signature. Returned to office 1/24/08 for left wrist pain from cheerleading injury s/p ER vs for same on 1/19/08. Patient last seen in office by nurse only on 2/20 for HPV #3, no notes for visit. PMH: kicked in face by horse in past (undated) & had contusion on cheek; acne vulgaris, started Yasmin & topicals 4/07 w/improvement after multiple other drug failures; 1/19/08 wrist contusion from cheerleading. 5/2/08 Autopsy report states COD as undetermined. Autopsy states patient had intermittent HAs x 2 mo & had been on BCP x 1 year for acne. Found w/small facial laceration from striking flower pot when fell. The autopsy was neg for all findings. Scene indicated sudden death from collapse & fall. Suspected long QT interval syndrome w/fatal arrhythmia rather than new onset seizure in patient w/no history of either. Suggested testing family members.


VAERS ID: 305693 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2007-08-13
Onset:2007-09-02
   Days after vaccination:20
Submitted: 2008-02-26
   Days after onset:177
Entered: 2008-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0245U / 1 LA / UN
TD: TD ADSORBED (DITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B016BA / UNK LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Anterior spinal artery syndrome, Laboratory test abnormal, Leukoencephalomyelitis, Monoplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None. PMH: none. Allergic to PCN and Septra.
Allergies:
Diagnostic Lab Data: Tests confirmed acute disseminated encephalomyelitis (ADEM). Labs and Diagnostics: Spinal Arteriogram revealed no AV malformations. MR of spine c/w inflammatory process /demyelination. UC (+) for E. coli and Enterobacter. CSF WNL.
CDC Split Type:

Write-up: On September 2, 2007, patient''s left leg became paralyzed. She was taken to the emergency room and hospitalized for 13 days. The doctors at hospital diagnosed her with non-infectious A.D.E.M. 04/11/2008 MR received from hospital for DOS 9/6-10/2008 where pt was sent for diagnostic testing to r/o AVM. D/C DX: was Spinal cord anterior spinal artery infarct. Pt was transfered to another facility where Final DX was made. Pt initially had presented to local facility with sudden onset L lower extremity plegia. 04/28/2008 MR received for DOS 9/10-15/2007 with D/C DX: Acute Demyelinating Encephalomyelitis (ADEM). Urinary Tract infection. Pt admitted after transfer from above admission. Pt initially presented with Left leg weakness/paralysis and upper back pain. Upon admission pt was unable to void and later had urinary incontinence. Tx with solumedrol and abx for UTI. At D/C pt still with decreased strength of LLE, depressed reflexes and unable to bear weight independantly. Using a walker. Will continue with Outpt rehab. 1/20/2010 Patient stil has not been able to walk or run normal. She is still receiving physical therapy 2x a week. Follow-up Information 06-MAY-2008:


VAERS ID: 305823 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2007-10-12
Onset:2007-10-26
   Days after vaccination:14
Submitted: 2008-02-26
   Days after onset:123
Entered: 2008-02-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1062U / 2 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Joint swelling, Parvovirus B19 serology positive
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: parvovirus B19 PCR - positive
CDC Split Type: WAES0802USA04191

Write-up: Information has been received from a health professional concerning a 20 year old female with no illness at the time of vaccination and no pertinent medical history or drug reactions/allergies who on 12-OCT-2007 was vaccinated with a second dose of GARDASIL (lot# 658560/1062U) in the left arm at 9:15 AM. On 26-OCT-2007 the mother described patient had joint pain and swelling. An evaluation by a rheumatologist was performed and reported negative findings. On 12-FEB-2008 the mother reported that the patient was positive for parvovirus. At the time of reporting it was unknown if the patient had recovered from the events. Additional information is not expected. The health care professional considered arthralgia, positive for papovirus and swelling to be disabling.


VAERS ID: 306198 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2008-01-16
Onset:2008-01-28
   Days after vaccination:12
Submitted: 2008-02-29
   Days after onset:32
Entered: 2008-02-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAUB225BC / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1448U / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2864AA / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF protein increased, CSF virus no organisms observed, CSF white blood cell count increased, Meningitis aseptic, Viral test negative
SMQs:, Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Not currently available. In summary, high CSF WBC, High CSF Protein, Negative Viral and Bacterial CSF Cultures. LABS: Flu test neg. CSF: WBC 60, segs 86%, lymphs 8%, RBC 36, glucose 69, protein 96, c/s neg. Sodium 129 (L). Sed rate 40. CRP 14.3 (H). Blood & urine c/s neg.
CDC Split Type:

Write-up: Aseptic Meningitis - Bacterial and Viral Cultures negative. Hospitalized for 5 days, received antibiotics for 48 hrs. until cultures confirmed negative. 3/19/08 Reviewed hospital medical records of 1/28-2/1/2008 admission. FINAL DX: Aseptic meningitis & SIADH. Records reveal patient experienced HA x 5 days, fever & nausea/vomiting x 2 days. Seen by pcp & also noted to have photophobia, meningismus, dehydration & gen myalgias. LP done. Tx w/IVF, IV antibiotics. Discussed w/ID. Continued to be febrile through d/c but clinically improved. D/C to home w/pcp f/u.


VAERS ID: 306242 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2007-12-01
Onset:2007-12-01
   Days after vaccination:0
Submitted: 2008-02-29
   Days after onset:90
Entered: 2008-03-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cough, Drug exposure during pregnancy, Kidney infection, Laboratory test, Pyrexia, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: KEFLEX; iron (unspecified); vitamins (unspecified)
Current Illness:
Preexisting Conditions: Urinary tract infection; kidney infection
Allergies:
Diagnostic Lab Data: laboratory test - Unspecified. Labs and Diagnostics: UA (+) for large nitrite, large leukocyte esterase, WBCs TNTC. UC (+) for E.coli. Blood cx (+) for E. coli. Na+ 129. K+ 2.6. Cl- 95. Ca++ 8.3. CBC with WBCs 30.2 on admit, down to 7.0 by 2/5/08. Hct, Hgb, and RBCs all low. Pregnancy test (+). CXR WNL. OB US (+) for IUP at 19 wks 5 days with shortened cervix. Renal US (+) for hydronephrosis.
CDC Split Type: WAES0802USA05316

Write-up: Information has been received from a consumer from Merck Pregnancy Registry for Gardasil concerning her 15 year old daughter with a history of urinary tract infection and kidney infection who in December 2007, was vaccinated with a first dose 0.5 mL of Gardasil (lot # unknown). Concomitant therapy included prenatal vitamins (unspecified), KEFLEX and iron (unspecified). On 31-JAN-2008 the patient developed coughing, severe high fevers, urinary tract infection and kidney infection. On 31-JAN-2008, she was hospitalized for five days. It was reported that she was pregnant for five months. Laboratory tests were performed but not specified. She was recovering. Additional information has been requested. 03/05/2008 MR received for DOS 1/31/2008 to 2/6/2008 with DX: Intrauterine Pregnancy at 18wks 5 days. R Acute Pyelonephritis. Shortened cervix with mild funneling, r/o cervical insufficiency/incompetance. Teen pregnancy with no prenatal care. Possible URI. Electrolyte disturbances (hyponatremia and hypokalemia). Incidental spina bifida occulta C7. Non-specific anemia, r/o sickle cell anemia. Pt presented to ER with c/o R flank pain and fever/chills x 3 days. Temp 101.6''F. Pt found to be pregnant on exam. Consult for bacteremia. Improved on IV Rocephin. Cervical cerclage performed on 2/6/08.


VAERS ID: 306555 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-03-05
Entered: 2008-03-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA06378

Write-up: Information has been received from a certified nurse midwife who reported that a patient of his mentioned that her 16 year old female cousin was vaccinated with her third dose of Gardasil. Her cousin subsequently experienced grand mal seizures and was hospitalized. Her cousin did not have any prior history of seizures, and her cousin''s twin and older sister received the Gardasil vaccine series and had no adverse effects post vaccination. The nurse stated he did not have any additional information regarding his patient''s cousin''s experience. At the time of reporting, the patient was still hospitalized. Additional information is not expected.


VAERS ID: 306624 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2007-09-21
Onset:2007-10-03
   Days after vaccination:12
Submitted: 2008-03-06
   Days after onset:155
Entered: 2008-03-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Transfusion
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: URI 10/7 w/rhinorrhea, cough, diarrhea & upset stomach. 10/11 vomited drk brown blood & HA. Lactose intolerance. Family HX: multiple people w/IBS. Grandparents w/colon cancer, melanoma & other unknown cancers.
Allergies:
Diagnostic Lab Data: Unknown LABS: CXR c/e pneumonia or aspiration. Hgb 4.1 on admit; 8.7 at d/c. Hgb 9.4 on clinic visit 10/30/07. O2 sat 93% on RA. EGD revealed gastric ulcer near pylorus w/overlying clot; pathology revealed min gastritis & (-) H. pylori; hemoccult (+) stools. Capsule colonoscopy WNL.
CDC Split Type: WAES0802USA06323

Write-up: Information has been received from a nurse practitioner (NP), via a company representative, concerning a 17 year old female patient, who on 12-SEP-2007 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot # not reported). On 03-OCT-2007, "3 weeks after vaccine," the patient required a blood transfusion (no details provided). She was hospitalized for an unknown period of time. At the time of this report, the patient had recovered from the event (date and duration not reported). The NP considered the event to be serious as an other important medical event. Additional information has been requested. 3/25/08 Reviewed hospital medical records of 10/18-10/20/2007. FINAL DX: severe anemia; dizziness/weakness; transfused 3U PRBCs; hematemesis, presumed UGI bleed; melena, improved; pertussis, improving; pulmonary edema, improved. Records reveal patient experienced fatigue, dizziness, weakness, upper abdominal pain. Seen in student health clinic for pmh on 10/12. Dx at health clinic: whooping cough. Tx w/antibiotics. 10/13 post-tussive HA, felt faint, DOE, muscle aches, heart pounding, difficult ambulation. 10/15 developed black hard, tarry stool. Vomiting again on 10/17, but no blood noted. Gastric lavage in ER was clear. Tx w/O2, IVF, antiulcer meds & #U PRBCs. Improved & d/c to home w/peds GI f/u. Seen in GI clinic 10/30 & was stable; antiulcer med d/c; hemoccult cards provided to collect; consider enteroscopy for any further GI bleeding.


VAERS ID: 306713 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-07-02
Onset:2007-08-27
   Days after vaccination:56
Submitted: 2008-03-07
   Days after onset:193
Entered: 2008-03-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Hypotonia
Preexisting Conditions: 4/7/08-records received-PMH:Childhood hypotonia (resolved), GERD, Hyperlipidemia. Short stature on growth hormone2 years of hypothyroidism, migraines, depression and obsessive-compulsive disorder.
Allergies:
Diagnostic Lab Data: Unknown 4/7/08-records received-CSF normal. Negative Lyme disease and Welt Nile. MRI brain normal. MRI spine unremarkable. EMG and nerve conduction study unremarkable. Elevated ANA.
CDC Split Type: WAES0802USA06113

Write-up: Information has been received from a physician, concerning a 15 year old female patient with "some baseline hypotonia," who on 02-JUL-2007 was vaccinated with the third dose of Gardasil (route, site and lot # not reported). Concomitant vaccine therapy at the visit included a dose of MENACTRA. In October 2007, "the patient experienced an adverse reaction," described as Guillain Barre syndrome (GBS)-type symptoms. She was hospitalized in an intensive care unit for 3 weeks though no diagnosis was made during that time. The patient was then transferred to an inpatient rehabilitation center for "about 3 months." The reporting physician stated the patient just became her patient within the past week and a half. She stated that the patient had not yet fully recovered, and was currently undergoing outpatient rehabilitation. Additional information has been requested. 04/07/08-records received for DOS 10/27-11/6/07- DX DC: Weakness, elevated ANA. Presented with 1-2 months of neurological symptoms which began as diffuse mild back pain for 2 months, aching, then 2-3 weeks ago experienced heaviness of limbs, particularly her upper arms and upper legs, non-painful tingling but no numbness. Muslces feel achy all over. Diffuse headache. Mild nausea. Neck pain and siffness times 1 week. General feeling of fatigue and malaise. Weakness progressing from proximal to distal extremities. Unable to walk independently. Short of breath with mild exertion. Lightheaded when standing up. Diplopia. Poor appetite. Constipated for 1 week. Thought to have a significant psychiatric component to current presentation. Tensilon test no improvement in strength.


VAERS ID: 306714 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2007-09-21
Onset:2007-09-21
   Days after vaccination:0
Submitted: 2008-03-07
   Days after onset:168
Entered: 2008-03-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP=Unknown)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0803USA00160

Write-up: Information has been received from a physician''s assistant concerning a 16 year old female with pertinent medical history and drug reaction/allergies reported as none who on 21-SEP-2007 was vaccinated with the first dose of Gardasil (lot#658222/0927U), 0.5 ml, IM in the left deltoid. Concomitant medication was not reported. On 08-OCT-2007, the patient told the physician''s assistant that she was 7 1/2 months pregnant. In approximately October 2007 (date unspecified), the patient was hospitalized and delivered the baby. The patient reported that the delivery was preterm, but no problems were reported. The physician''s assistant reported that there were no known problems with the baby or mother. On 04-DEC-2007 (about 6 to 8 weeks) after the patient delivered the baby, the patient received the second dose of Gardasil (lot#657868/0523U) and a dose of MENACTRA. The physician''s assistant was not following the pregnancy, only providing the vaccinations. Subsequently on an unspecified date, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 306720 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2007-06-01
Onset:2007-06-01
   Days after vaccination:0
Submitted: 2008-03-07
   Days after onset:280
Entered: 2008-03-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Postpartum depression, Pregnancy test
SMQs:, Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol; AMOXIL; ZYRTEC; ADVAIR; HISTUSSIN D; SINGULAIR; prednisone
Current Illness: Pregnancy NOS (LMP = 2/1/2007)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: beta-human chorionic
CDC Split Type: WAES0802USA06245

Write-up: Information has been received from a medical assistant concerning a 16 year old female, who on 01-JUN-2007 was vaccinated IM with a 0.5mL first dose of Gardasil. Concomitant suspect therapy included motelukast sodium. Other concomitant therapies included ZYRTEC, albuterol, ADVAIR, HISTUSSIN D, AMOXIL and prednisone. On 19-AUG-2007 the patient was vaccinated with a second dose of Gardasil. On 01-SEP-2007 the patient found out that she was thirty weeks pregnant. The patient was seen at the office. A pregnancy test was performed at home and in the office. The patient''s last menstrual period was approximately in February 2007 and her estimated delivery date was in November 2007. The patient gave birth in November 2007. On 08-NOV-2007 the patient was hospitalized due to postpartum depression. At the time of the report, the outcomes of the patient and the baby were unknown. Additional information has been requested.


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