Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye oedema, Hypotrichosis, Interchange of vaccine products, Throat irritation
Clinical narrative: his facial hair is not growing the same; Since AE in Dec2020 he had COVID vaccine Janssen in Apr2021; experienced eye puffiness; light headed ness; scratchy throat; This case has been considered invalid due to a reporter with no first-hand knowledge regarding the events. Upon receipt of follow-up information on (05Dec2022), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP). Other Case identifier(s): 2021006760 (nullified case).  A 43-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EK5730, Expiration Date: 06Jan2021) at the age of 43 years intramuscular, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: EYE OEDEMA (medically significant) with onset 16Dec2020, outcome "recovered" (16Dec2020), described as "experienced eye puffiness"; DIZZINESS (medically significant) with onset 16Dec2020, outcome "recovered" (16Dec2020), described as "light headed ness"; THROAT IRRITATION (medically significant) with onset 16Dec2020, outcome "recovered" (16Dec2020), described as "scratchy throat"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Apr2021, outcome "unknown", described as "Since AE in Dec2020 he had COVID vaccine Janssen in Apr2021"; HYPOTRICHOSIS (non-serious) with onset Jun2022, outcome "unknown", described as "his facial hair is not growing the same". The events "experienced eye puffiness", "light headed ness" and "scratchy throat" required emergency room visit. Therapeutic measures were taken as a result of eye oedema, dizziness, throat irritation.   Clinical information: Clinical course: Our Pfizer colleague got below information from the hospital (social media), could you please help provide this letter to the male health care worker. Below information posted on (social media) around Dec2020. Male Health care worker experienced eye puffiness, light headedness and scratchy throat 10 minutes after vaccination. Reaction was not considered anaphylaxis. Optional Information: Patient received epinephrine, Pepcid and Benadryl in the ED, felt completely back to normal within an hour and was released. Family medical history relevant to ae (s) was smoker. Reported in Jun2022-his facial hair not graving the same. Since AE in Dec2022. He had Covid vaccine Janssen in Apr2021 then unknown if experience info or symptoms of covid since then. Vaccination facility type was hospital. Query: It was communicated to Pfizer that the reason for delay in forwarding the adverse event (AE) information within 24 hours, was due to an oversight in not reporting the information within timelines. You confirm that you received this information on Wednesday, 16Dec2020 but was initially unclear about information on social media and after a discussion with a colleague you submitted the report on Tuesday, 05Jan2021 although it was late. You confirm completion of AE Reporting training and understanding of the compliance timelines and AE reporting obligations. Since the first Pfizer awareness date was Wednesday, 16Dec2020, and the information was not received in safety until Tuesday 05Jan2021, this resulted in a delay in reporting. As a reminder - "All product safety monitoring reports, including all complaints associated with a drug product or medical device, must be forwarded to the appropriate Pfizer group as soon as practical, but within 24 hours, irrespective of the seriousness of the report or whether or not you think a causal relationship with the use of the product is involved." (Monitoring the Safety, Performance and Quality of Pfizer Products Training Guide and Reference Card). Part of the responsibility of the Agency is to follow-up on reports that are received outside the timeline outlined above with an explanation as to why there was a delay in receipt of a report. Information concerning the delay must be provided to the Agency no later than the following day. Please ensure corrective measures are put in place to ensure future reports are sent within 24 hours of awareness. Information for you to review which will serve as a refresher on adverse event reporting can be found on the following link: (Link withheld). Response: Thanks for the follow up. I have reviewed the training since your initial contact and understand the reporting situations and timelines. I have been having more interactions with customers since completing my orientation, and I should have reviewed the training earlier when the COVID vaccine was authorized to review my responsibilities for clarity. I am a field medical director, however in vaccines we are listed as Vaccines Medical directors. Thanks, and hope you have a good day. Query: Thanks so much for your information. I have one question to ensure we are capturing your title correctly in our safety system regarding the AE report. When you say you are a filed medical director are you considered a sales rep? We have to differentiate in database between sales reps and colleagues. Although sales reps are colleagues also, they have a differentiation in our safety system for metrics, etc. I wanted to ensure we captured your title accurately as either a "Colleague" or a "Sales rep". Sorry for so many questions but we need to be accurate. Response: Thanks (name withheld). My position is with Medical Affairs, work in the field, but I am not a sales rep. I don't know all the details, but I think I would be a colleague. Does that help. The information I reported was from a (social media withheld) post from the hospital, which was shared by the (State name withheld) Dept of Health (which I follow on (social media withheld)). The hospital had released the details on their (social media withheld) page which was then shared by the state on their (social media withheld) page. I did not have any firsthand Knowledge of the situation, the information I reported was directly from the (social media withheld) post. I have since reviewed the Agency training again and it was helpful for (name withheld) and (name withheld) to clarify the firsthand knowledge info. Feel free to contact me if you have additional questions or if there is anything else I need to do.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.