Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hypersomnia, Immunisation reaction, Liver injury
Clinical narrative: plaque psoriasis flare; body aches; Fatigue; Vaccination site pain; In Feb2022, the patient experienced COVID; In Feb2022, the patient experienced COVID; Liver damage; Sleep excessive; Vaccination adverse reaction; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4283709-00 (Agency).  A 28 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and intramuscular, administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administration date 19Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2022, outcome "unknown" and all described as "In Feb2022, the patient experienced COVID"; LIVER INJURY (non-serious) with onset 2022, outcome "unknown", described as "Liver damage"; PSORIASIS (non-serious), outcome "unknown", described as "plaque psoriasis flare"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "unknown", described as "Vaccination adverse reaction"; HYPERSOMNIA (non-serious) with onset 2022, outcome "recovering", described as "Sleep excessive". The action taken for adalimumab was unknown.  Additional information: Drug Moderna Covid-19 Vaccine, for event Fatigue, Generalized aching causality as per reporter (Drug/Vaccine) was Possible and for Pfizer BioNTech Covid-19 Vaccine: Event Fatigue, Vaccination adverse reaction causality as per reporter (Drug/Vaccine) was Possible.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (28Mar2022): This is a follow-up Solicited report based on information received by Pfizer from Agency (Manufacturer Control Number#: 22K-163-4283709-00). A contactable consumer (patient) reported that:  Updated Information Included: Market Authorization Holder (Moderna Covid-19 Vaccine). Dose Description. Dechallenge Results (Humira). Outcome of Event (Generalized aching and Fatigue). New event.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events.