Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache, Malaise, Maternal exposure during pregnancy
Clinical narrative: Headaches; Chills; 6 months pregnant; Pregnant patient was administered with expired booster dose of Pfizer Covid Vaccine; Pain in the vaccination injection site: left arm; patient really does not feel fine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 38 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 11:00 (Lot number: 3302689, Expiration Date: 13Dec2021) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 22Jul2021. The patient was 20 weeks pregnant at the time of exposure to bnt162b2. The patient was 20 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Apr2022. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Lot No: EW0150) muscular injection, left arm), administration date: 08Apr2021, when the patient was 37 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE (Lot No: EW0164) muscular injection, left arm), administration date: 29Apr2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Dec2021, outcome "recovered" (Dec2021), described as "Pain in the vaccination injection site: left arm"; CHILLS (non-serious) with onset 15Dec2021, outcome "recovered" (15Dec2021), described as "Chills"; HEADACHE (non-serious) with onset 24Dec2021, outcome "not recovered", described as "Headaches"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "patient really does not feel fine"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 14Dec2021 11:00, outcome "unknown", described as "6 months pregnant"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 14Dec2021 11:00, outcome "unknown", described as "Pregnant patient was administered with expired booster dose of Pfizer Covid Vaccine". Therapeutic measures were not taken as a result of vaccination site pain, chills, malaise. Therapeutic measures were taken as a result of headache. Verbatim event relatedness were reported as follows: Pain in the vaccination injection site: left arm - Related; Chills - Related; Headaches - Unrelated. Additional information: The patient on the line mentioned that she received the Pfizer Covid Vaccine booster dose on 14Dec2021 and wanted to know if it's ok, or if she can get another booster dose of Pfizer Covid Vaccine because the first booster dose of Pfizer Covid Vaccine she was adminsitered with was expired. Patient thought that the booster dose of Pfizer Covid Vaccine she was administered was effective because she experienced pain in the vaccination site and had chills. The patient was a nurse, has no relevant family history, and was concomitantly taking unspecified vitamins. The patient did not receive any other vaccines administered on same date with BNT162B2 and within 4 weeks prior to the COVID vaccine. Onset time of event Vaccination site pain was at night (14Dec2021), recovery date was until 17Dec2021 or 18Dec2021 (as reported). Onset time of event Chills was in the morning (15Dec2021), and by the afternoon of 15Dec2021, patient felt okay, event was gone. The patient took paracetamol (TYLENOL) for 2 days as treatment for headaches. Outcome persistent; but the patient really does not feel fine, still has headaches. Headaches are always the same, especially if she put some pressure or if she suddenly move or after waking up. The patient has this headache always now. The patient verified that she has not had any physician's office visit, emergency room visit or hospitalization related to all the events. There has been no testing, any other treatment aside from the Tylenol she has been taking, and no medical interventions performed relative to these events. The patient has an appointment scheduled on 12Jan2022 to perform her glucose test. The patient's OB advised her not to get another vaccine in replacement with the expired one.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101871673 Same reporter/suspect drug, similar event, different patient.