Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Poor quality product administered, Product storage error
Clinical narrative: Headache; Nausea; Second dose was invalid; There were storage issues; Second dose was invalid; There were storage issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.   The reporter is the patient. A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 19Mar2021, for COVID-19 immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT STORAGE ERROR (non-serious) all with onset 09Apr2021, outcome "unknown" and all described as "Second dose was invalid; There were storage issues"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Call was transferred from Support by person (not spelled) Transferring agent stated, "I have a caller on hold to transfer that has some concern about the second dose that they received. So, they received the first dose on March 19 and the second dose on April 9, however they received a notification stating that the second dose was invalid and I asked her if they mention the reason and they were told that it was a storage issue, that is basically the concern that the second dose was invalid. So, she is calling to report her case and she is calling on her behalf and also her boyfriend's behalf (further clarification about boyfriend was unknown)." Consumer stated, "We recently got our second Covid-19 vaccination and we got it at the clinic and we were just notified from the department of health that there was an investigation at the clinic and I was notified and there were storage issues and instructed everybody who has got the shot at that clinic to get revaccinatedbecause the shot was invalid. So, we got our first dose which was valid in March and we wanted to know kind of, in the mail that we got from department of health, they were just instructing people who gotthe first dose at the clinic but we got our second dose there, so we were wondering what do you think we should do in terms of when to get our second dose because like should we be waiting 21 days from the invalid dose or should we wait 21 days from our first valid dose or can we get our second shot somewhere else today? Also, we did have side effects from the invalid dose just like kind of typical side effects like headache, nausea and so, I was just wondering if there is a risk of getting like a third dose or if there was some sort of efficacy in the invalid dose." When paraphrased the concern, consumer stated, "We don't have to report it, it is just pretty common side effect but just I think that even if the shot wasconsidered invalid we still felt an immune response, so with getting a third dose will be kind of overdose or too much vaccine I think (consumer was not sure), so I am concerned safety wise." Product details: LOT#: Consumer stated, "EW0161, there is two numbers on here, it says Pfizer and then, I think that is it." (not clarified further) NDC# and UPC#: Consumer stated, "I don't see anything like that on my card."