Age: 35.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Headache, Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: COVID-19 recurrent; drug ineffective; Maternal exposure during pregnancy; Vaccination site pain; Headache; 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-163-4292780-00.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single, intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease, psoriasis. The patient was 10 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), outcome "recovered", described as "COVID-19 recurrent"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "drug ineffective"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Maternal exposure during pregnancy"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache". The action taken for adalimumab was unknown.  The reporter considered "vaccination site pain" and "headache" not related to bnt162b2.  Additional information: On unknown dates, the patient experienced maternal exposure during pregnancy, Covid three times, headaches after vaccine and sore arm after vaccines. On an unknown date, Covid three times resolved. The fetus was exposed to maternal use of Humira in utero. She was ten weeks pregnant. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of maternal exposure during pregnancy and Covid three times with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of headaches after vaccine and sore arm after vaccines was not provided.  Causality for Humira (Solution for injection in pre-filled pen) (Adalimumab) for the events Maternal exposure during pregnancy, Covid-19 recurrent was No Reasonable possibility and for the events Headache and Vaccination site pain was Not reported.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) for the events Maternal exposure during pregnancy and Covid-19 recurrent was not reported and for the events headache and vaccination site pain was not related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.