Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Urticaria, Vaccination site pain
Clinical narrative: Booster; recurrence of hives on legs and shoulder; mild headaches; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Nov2021 16:30 (Lot number: EW0165) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lower than normal amniotic fluid" (unspecified if ongoing), notes: during 15-week pregnancy antenatal visit; "Chronic ideopathic hives" (unspecified if ongoing); "Subclinical hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Urticaria" (unspecified if ongoing); "Shellfish" (unspecified if ongoing), notes: shellfish allergy (cause itchiness). Date of last menstrual period: 05Jul2021. The patient was 18 weeks pregnant at the time of exposure to bnt162b2. The patient was 18 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 11Apr2022. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism, start date: Jul2021 (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0182, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11May2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 20Apr2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; URTICARIA (non-serious) with onset 11Nov2021 20:30, outcome "recovered" (2021), described as "recurrence of hives on legs and shoulder"; HEADACHE (non-serious) with onset 11Nov2021 20:30, outcome "not recovered", described as "mild headaches"; VACCINATION SITE PAIN (non-serious) with onset 11Nov2021 20:30, outcome "not recovered", described as "injection site pain". Therapeutic measures were not taken as a result of urticaria, headache, vaccination site pain.  Additional information: Facility type vaccine: Health Clinic. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product bad a causal effect to the adverse event? Yes. Please describe all the signs and symptoms of the anaphylactic reaction (Please include information on vital signs, e.g. blood pressure, oximetry): Details: There was no anaphylactic reaction. Only local hives on shoulder/legs, symptom was mild and self limited. Did the patient require medical intervention? No. Please provide information on organ involvement: Multiorgan involvement? No. Localized injection site urticaria: Yes, If Yes, please provide details: Shoulder and Legs. Did the event require the initiation of new medication or other treatment or procedure? No. If there is a previous history of any allergies, does the patient take (or have readily available) any specific medication related to this: For asthma: Albuterol inhaler PRN, For urticaria: no treatment. Did the patient receive any recent vaccines for any other conditions prior to the event being reported? No. Did the patient receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported? No. Has the patient received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination? No. Mother's Information: Education level: Doctorate. Pregnancy. First day of last menstrual period Date: 05Jul2021. Estimated date of conception: 26Jul2021 (Frozen embryo transfer). Gestational period at time of initial exposure: 4th Months 2nd Trimester. Did the mother smoke during this pregnancy? No. Did the mother drink alcohol during this pregnancy? No. Did the mother use illicit drugs during this pregnancy: No. Mother's Information - Obstetrical History: Not Applicable: No previous pregnancy. Mother's Information - Relevant History: Treatment for infertility (specify): IVF. Neonatal Information - Outcome of Pregnancy: N/A not yet delivered. Neonatal Information - Infant Details: Gender (sex): Male. Paternal Information (Check the box if not applicable): Age (years): 36 years; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101572412 mother/baby case