Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Fatigue, Headache, Illness
Clinical narrative: exhausted; headache; nauseous; sore arm; COVID-19 positive; COVID-19 positive; sick off and on; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4318662-00.  A 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "recovered" (2021) and all described as "COVID-19 positive"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "sick off and on"; FATIGUE (non-serious) with onset Mar2022, outcome "recovering", described as "exhausted"; HEADACHE (non-serious) with onset Mar2022, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset Mar2022, outcome "recovering", described as "nauseous"; PAIN IN EXTREMITY (non-serious) with onset Mar2022, outcome "recovering", described as "sore arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) negative; (Oct2021) positive; (Dec2021) positive. The action taken for adalimumab was unknown. Clinical course In 2021, the patient experienced sick off and on. In Oct2021, the patient experienced Covid-19 positive. In Dec2021, the patient experienced Covid-19 Positive. In 2021, the Covid-19 Positive and Covid-19 Positive resolved. In Mar2022, the patient experienced exhausted, headache, nauseous and sore arm. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of Covid-19 Positive onset in Oct2021, Covid-19 Positive onset in Dec2021, sick off and on, exhausted, headache, nauseous and sore arm with Humira (Adalimumab) was no reasonable possibility. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran): Causality 1) COVID-19 virus test positive (SARS-CoV-2 test positive), Causality as per reporter (Drug/Vaccine) : Not Reported, Dechallenge : N/A, 2) COVID-19 virus test positive (SARS-CoV-2 test positive) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge : N/A, 3) Sickness (Illness), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge : N/A, 4) Exhaustion (Fatigue), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A, 5) Headache (Headache), Action(s) taken with drug: Unknown, Causality as per reporter, Drug/Vaccine): Possible, Dechallenge : N/A, 6) Nauseous (Nausea), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A, 7) Pain in arm (Pain in extremity), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events and "BNT162B2" cannot be completely excluded.