Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 57-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, start date: 05Oct2021, stop date: 05Oct2021. Vaccination history included: BNT162b2 (Dose 1, First Dose of the Pfizer Covid-19 Vaccine: Received by the caller on 06Mar2021; Lot Number: Reported by the caller as looking like EN6198, States it is handwritten. NDC and Expiry date are unknown, Administered in the caller's left arm), administration date: 06Mar2021, for Covid-19 immunization, reaction(s): "Vaccination site pain"; BNT162b2 (Dose 2, Second Dose of the Pfizer Covid-19 Vaccine: Received by the caller, on 27Mar2021; Lot Number: ER8727. NDC and Expiry date are unknown.  Administered in the caller's left arm), administration date: 27Mar2021, for Covid-19 immunization; BNT162b2 (Dose 3, Third Dose of the Pfizer Covid 19 Vaccine: Received by the caller on 02Nov2021; Lot Number: 320308D. NDC and Expiry date are unknown. Administered in the caller's left arm), administration date: 02Nov2021, for Covid-19 immunization; flu vaccine (Flu Vaccine 2020: Received by the caller on 05Oct2020), administration date: 05Oct2020. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Apr2022, outcome "recovered" (28Apr2022), described as "It stung and burned the entire time the caller was receiving the injection"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Additional Information: No PQC Present. The person administering the vaccine told her that she was holding the syringe in her hand to warm it up because it was still a little cold. The caller states, the shot burned the whole time she was giving it, it was placed very well into the muscle because some of my other shots that I have received have been too high on the shoulder but this one was in the right spot and was right in the muscle". Patient states that she didn't receive her vaccine until "about 30 minutes later". The caller also states that the person who administered the vaccine told her there was a subdermal needle on the syringe and this was noticed prior to the patient receiving the dose and the needle was changed out to an appropriate needle for the IM administration. Reason for no lot number: of Pfizer Covid Vaccine was other that Caller states that the Lot Number is hard to read due to the label being cut off at the bottom; first letter is E or F, second is I or a 1, and then 4991. Reaction / Event as Reported by the Primary Source for Translation: Sore arm. Outcome of reaction/event RECOVERING/RESOLVING). NDC number of Pfizer Covid Vaccine: Unknown. Caller states that the stinging and burning with the fourth injection went away quickly the same day, soon as the provider was finished giving the caller the vaccine. Caller states that she also has experienced arm soreness, which is almost gone. Caller states that with the second dose of the vaccine she barely felt it. She had no soreness in her arm. She told the person administering that second dose that the person who gave the caller her first dose had given it way high up on the shoulder bone and it hurt like crazy. Caller states that she let the person giving her the second dose know about that so they could get it in her deltoid. Caller says she didn't feel any soreness or anything at all with that second dose. States she had no soreness afterwards. Facility Type was Pharmacy Facility. No prior Vaccinations within four weeks prior to the first administration date. Caller states no prior vaccinations at first. Then she states that she has had other vaccines that were given high up like with her Shingles shot, and that hurt. Caller states that it was given way too high. Says that some of her flu shots have been given too high. NDC, Lot Number, Expiry Date for Shingles Vaccine unknown by the caller. Is there a product complaint to report. Yes. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.