Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Poor quality product administered, Product temperature excursion issue, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "ended up getting COVID"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "it isn't stored properly". Clinical Course: This is the Second case out of the 2 split cases. Reporter stated that he had a very speaking disorder. He had adverse side effect. He saw something, He was not sure, where they got at because the vaccine was not cold. He had a horrible reaction along with the person. I did not see it cold (Covid-19 vaccine). He saw something but it was not cold, it might not be effective. He got it prior COVID, also he thought it was recognized in the US. There was no tag, there was nothing and afterwards, both of us ended up getting COVID (hence, split made). He doesn't know if it was the vaccine or if it is the way it was dispensed and stored and given because it literally then in and it was, they there free sales. He doesn't know if it was the vaccine. Reporter know he had an adverse effect and so did he, but he won't, Reporter was calling for himself. He doesn't want him getting involved and he need because I was sick prior with rare diseases (history), out of it being, you know people who their perfectly healthy are taking it. He was not sure what to do but the CDC told him to call us, if it was needed to be stored in the cold area. So, he was not sure what to do."  On paraphrasing the concern: Reporter stated, "Yes, afterwards and they think he had prior to it. He had the vaccine in 2021, both doses but he had not had his booster. He got the vaccine a year back." On confirming the medical enquiry, Reporter stated, "No, he did it because CDC told him. He saw something on the news, saying that the people, the places that you get it done at, it isn't stored properly, like cold. It was out on the table ma'am, it wasn't cold. He might have had an adverse reaction because of him, because he was just one of the ones or it might be because it wasn't stored properly. He don't know. So, what He was trying to say that it was not cold. So, he was not sure that is the issue. He ended up, as did he, getting COVID and in 2022. So, was it ineffective or did it cause adverse reaction, he was not sure what to do but yes, his doctors had known that I had an adverse reaction, extreme one (not clarified) and he can barely speak? He was not a tech. He would do this on a computer and if it sounds like He was crying or he was baby, he was not. He was not able to control his tone. So, he was not yelling if it sounds like, he was doing his best towards it." Description of Product Complaint: Reporter stated, "What is your name please. I have a question. I am sorry. I have a very, I have speaking disorder please. My name is (Name withheld) (further not clarified hence, not captured in tab). Before they recorded, I have had adverse side effect. I saw something, I am not sure, where they got at because the vaccine was not cold. I have had a horrible reaction along with the person. I did not see it cold (Covid-19 vaccine). I saw something but it was not cold, it might not be effective. I got it prior COVID, also I thought it was recognized. There was no tag, there was nothing and afterwards, both of us ended up getting COVID (hence, split made). I don't know if it was the the vaccine or if it is the way it was dispensed and stored and given because it literally went in and it was, they were free sales. I don't know if it was the vaccine. I know I have had an adverse effect and so did he, but he won't, I am calling for me. He doesn't want me getting him involved and I need (Voice not clear) because I was sick prior with rare diseases (history), out of it being, you know people who they were perfectly healthy were taking it. I am not sure what to do but the CDC told me to call you guys, if it was needed to be stored in the cold area. So, I am not sure what to do." Reporter hung up the call abruptly.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.