Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypertonia, Poor quality product administered, Product temperature excursion issue
Clinical narrative: I have speaking disorder please; I can barely speak; I am not able to control my tone/ if it sounds like I am crying or I am baby, I am not; I ended up, as did he, getting COVID and in 2022; I ended up, as did he, getting COVID and in 2022; it isn't stored properly; it isn't stored properly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 immunization. The patient's relevant medical history included: "sick" (unspecified if ongoing), notes: I was sick prior with rare diseases. The patient's concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 2021, outcome "unknown" and all described as "it isn't stored properly"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I ended up, as did he, getting COVID and in 2022"; SPEECH DISORDER (medically significant), outcome "unknown", described as "I have speaking disorder please; I can barely speak"; HYPERTONIA (medically significant), outcome "unknown", described as "I am not able to control my tone/ if it sounds like I am crying or I am baby, I am not". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: getting COVID and in 2022. The description of product complaint included that, the patient had speaking disorder. Stated that, the patient name was (Name withheld) (further not clarified hence, not captured in tab). Stated that, before they recorded, the patient have had adverse side effect. Stated that, the patient saw something, not sure, where they got at because the vaccine was not cold. Stated that, the patient have had a horrible reaction along with the person. The patient did not saw it cold (Covid-19 vaccine). Stated that, the patient saw something but it was not cold, it might not be effective. Stated that, the patient got it prior COVID, also the patient thought it was recognized in the privacy. There was no tag, there was nothing and afterwards, both of them ended up getting COVID (hence, split made). Stated that, the patient didn't know if it was the vaccine or if it was the way it was dispensed and stored and given because it literally went in and it was, they were free sales. Stated that, the patient didn't know if it was the vaccine. Stated that, the patient knew that have had an adverse effect and so did he, but he won't. Stated that, the patient was called for self. Stated that, didn't want getting him involved and the patient need (Voice not clear) because the patient was sick prior with rare diseases (history), out of it being, you know people who were perfectly healthy are taking it. Stated that, the patient was not sure what to do but the CDC told to call you guys, if it was needed to be stored in the cold area. So, the patient was not sure what to do. On paraphrasing the concern: Reporter stated, yes, afterwards and they think the patient had prior to it. Stated that, the patient had the vaccine in 2021, both doses but the patient have not had booster. Stated that, the patient got the vaccine a year back. On confirming the medical enquiry, the reporter stated, no, the patient did it because CDC told me. Stated that, the patient saw something on the news, saying that the people, the places that you get it done at, it wasn't stored properly, like cold. It was out on the table ma'am, it wasn't cold. Stated that, the patient might have had an adverse reaction because of me, because the patient was just one of the ones or it might be because it wasn't stored properly. The patient didn't know. So, what the patient was trying to say was, it wasn't cold. So, the patient was not sure that was the issue. Stated that, the patient ended up, as did he, getting COVID and in 2022. So was it ineffective or did it cause adverse reaction, not sure what to do but yes, but doctors have known that the patient have had an adverse reaction, extreme one (not clarified) and the patient could barely speak. Stated that, the patient was not a tech. Stated that, the patient would do this on a computer and if it sounds like the patient crying or the patient was baby, the patient was not. Stated that, the patient was not able to control tone. Stated that, so, not yelling if it sounds like, the patient was doing the best towards it. Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information Department for the concern. Reporter hung up the call abruptly. Further probing could not be done. Hence, limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.