Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Poor quality product administered, Product temperature excursion issue, Vaccination site pain
Clinical narrative: The patient receive the vaccine on 03Feb2022 at 2:13 pm, 26 hours after the vial had been punctured.  The pre filled vaccine was stored in the refrigerator at 40 degrees during the entire time after; a 37 year old pregnant female that received a Pfizer Covid 19 vaccine; The patient receive the vaccine on 03Feb2022 at 2:13 pm, 26 hours after the vial had been punctured.  The pre filled vaccine was stored in the refrigerator at 40 degrees during the entire time after; mild soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 37 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 03Feb2022 14:13 (Lot number: FJ6369, Expiration Date: 30Jun2022) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low grade squamous ASCUS" (ongoing); "Over weight" (ongoing). Date of last menstrual period: 24Jun2021. The patient was 32 weeks pregnant at the time of exposure to bnt162b2; 30 weeks pregnant to influenza vaccine. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Mar2022. Concomitant medication(s) included: INFLUENZA VACCINE, start date: 20Jan2022. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 03Feb2022, outcome "unknown", POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 03Feb2022 14:13, outcome "unknown" and all described as "The patient receive the vaccine on 03Feb2022 at 2:13 pm, 26 hours after the vial had been punctured.  The pre filled vaccine was stored in the refrigerator at 40 degrees during the entire time after"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 03Feb2022, outcome "unknown", described as "a 37 year old pregnant female that received a Pfizer Covid 19 vaccine"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "recovered" (Feb2022), described as "mild soreness at injection site".  Additional information: Patient received a Pfizer Covid 19 vaccine LOT FJ6369 expiration date 30Jun2022 that had been drawn up on 02Feb2022 at 11:44am. The patient received the vaccine on 03Feb2022 at 2:13 pm, 26 hours after the vial had been punctured. The pre filled vaccine was stored in the refrigerator at 40 degrees during the entire time after it was drawn up. The reporter wanted to have some guidance in regards to re-vaccination for the patient or any other guidance in regards to this incidence. Other products, patient history and investigation assessment was reported as no. Anatomical location of vaccine administration was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect was reported as no. Did not require Emergency Room or physician office visit. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. No prior Vaccinations (within 4 weeks). Medical History (including any illness at time of vaccination) was reported as no. No Relevant Tests done. Patient Medical History (including any illness at time of vaccination) was reported as none. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  Follow-up (08Feb2022): This is a follow-up spontaneous report from a contactable other-HCP. This other-HCP reported for a 37-year-old female patient that:   Updated information included: Vaccine facility information, Other Products, Patient History, Vaccination Details.  Follow up (21Mar2022): This is a follow-up spontaneous report from a same contactable nurse. This nurse reported for the patient in response to the HCP letter sent via follow-up letter which included that: New information included: New event added ''mild soreness at injection site''. For suspect product route of administration added. Facility name and phone number added.