Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, HEP, HPV4, MMR, VARCEL
Symptoms: Maternal exposure during pregnancy, Off label use, Pain in extremity, Product use issue, Serology test
Clinical narrative: Arm soreness; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; Dose/Frequency: 0.3mcg IM X 1; This is a spontaneous report from a contactable Pharmacist. A 33-year-old pregnant female pharmacist reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE also reported as Covid-19 Vaccine) intramuscular left deltoid on 19Dec2020 09:10 (lot number: EJ1685; expiration date: Mar2021) at 0.3 mcg [ug] single dose and second dose was via intramuscular 09Jan2021 (unknown lot number and expiration date) at 0.3 mcg [ug] single dose for COVID-19 immunization. Medical history included ongoing seasonal allergies since 01Jan1991, ongoing pregnancy and ongoing GI health (gastrointestinal disorder). The patient reported that her last menstrual period was 10Sep2020 and estimated date of conception was 29Sep2020 and estimated delivery date is 17Jun2021. The patient's gestational period at time of initial exposure was 3 months (14 weeks, 17 weeks). The patient does not smoke, drink alcohol and use illicit drugs during this pregnancy. The patient had two live births and two C-sections with no complications. The patient has no maternal medical history and no family history of genetic abnormalities on either maternal or paternal. The patient did not have treatment for infertility. The results of serology tests (e.g., rubella, toxoplasmosis, etc) was negative. Ante-natal check-up included ultrasound at 8 weeks and at 14 weeks with both normal results. Since the patient has not delivered the baby yet, no information about the neonatal information, delivery information and baby details. There is no paternal medical history and history of genetic abnormalities. The father does not take any drugs during the wife's pregnancy. The father does not smoke or use illicit drugs during the mother's pregnancy but drinks alcohol 1 drink per week during the wife's pregnancy. History of all previous immunization with the Pfizer vaccine included MMR [Measles, Mumps, and Rubella vaccine], Tdap (Tetanus, Diphtheria, Pertussis vaccine), Varicella (Varicella vaccine), Hepatitis B (Hepatitis B vaccine) and Gardasil. Ongoing concomitant medication included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE), both since 01Jan2010 for seasonal allergies; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) since 09Jan2020 for pregnancy; and probiotics since 01Jan2015 for GI health. The patient 14 weeks pregnant at the report time. The patient volunteer to have any information collected from her be used to inform recommendations on pregnant patients receiving the covid vaccine. As of 08Jan2021, the patient reported that she did not report adverse events with the use of the product as there was no adverse event that occurred. The patient had arm soreness at 17:00. The patient did not visit the emergency room or the physician's office. The patient did not have any vaccination within 4 weeks prior to vaccination. The patient did not have lack of efficacy or a primary infection site. No antipyretic was used. The patient mentioned that she does consider the Pfizer product had a causal effect to the adverse events. The outcome of the events was unknown.   The information on the lot/batch number has been requested.   Amendment: This follow-up is being submitted to amend previously reported information: the coding of event 'The patient 14 weeks pregnant' was recoded from 'Exposure during pregnancy' to 'Maternal exposure during pregnancy'.   Follow up (08Jan2021): New information received from a contactable pharmacist (patient) reported in response to HCP letter sent via email included: patient details, medical history, partner medical history, product details, lab data, new events (0.3 mcg single, arm soreness) and clinical course of the events.