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From the 1/14/2022 release of VAERS data:

This is VAERS ID 631323

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Case Details

VAERS ID: 631323 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-12
Entered: 2016-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Lethargy
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypoglycaemia (broad)

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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016046410

Write-up: This case was reported by a other health professional via sales rep and described the occurrence of lethargy in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced lethargy, tiredness and injection site pain. On an unknown date, the outcome of the lethargy, tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the lethargy, tiredness and injection site pain to be related to BEXSERO. Additional details were received as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days. After two days the symptoms resolved. Office manager then mentioned that another patient (see case US2016GSK049200) who received BEXSERO and experienced a softball-like swelling at the injection site. Also mentioned about some other patients (see case US2016GSK049201) who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days, then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.


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