Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Pain in extremity, Swelling, Swelling face
Clinical narrative: allergic reaction; He had numbness and swelling up the side of his neck and face around his eye; He had numbness and swelling up the side of his neck and face around his eye; He had numbness and swelling up the side of his neck and face around his eye; Experienced a reaction around the injection site which was a little bit numb; Pain around the injection site; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. This consumer (patient's wife) reported for a 36-year-old male patient (reporters' husband).  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 (Lot number: FC3180) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Tetanus vaccine (Route, Anatomical Location: unknown, No. of Previous Doses: n/a, Date: 3 weeks ago), when the patient was 36 years old, for Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 04Aug2021, outcome "recovered" (Aug2021), described as "allergic reaction"; SWELLING FACE (non-serious), SWELLING (non-serious), HYPOAESTHESIA (non-serious) all with onset 04Aug2021, outcome "recovered" (Aug2021) and all described as "He had numbness and swelling up the side of his neck and face around his eye"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 04Aug2021, outcome "recovered" (Aug2021), described as "Experienced a reaction around the injection site which was a little bit numb"; VACCINATION SITE PAIN (non-serious) with onset 04Aug2021, outcome "not recovered", described as "Pain around the injection site"; PAIN IN EXTREMITY (non-serious) with onset 04Aug2021, outcome "unknown", described as "arm soreness".  Additional information: The consumer wanted any information on whether he should receive the second dose of the vaccine, or the booster or if he should be avoiding this vaccine completely. Is report related to a study or programme was reported as No; Is the patient also the reporter was reported No. experienced a reaction around the injection site which was a little bit numb. reporter states she is calling about the Pfizer covid vaccine and her question is about her fiance who got the vaccine 1st dose about 2 weeks ago and the day he got it. The consumer experienced events. Reporter also States she wanted him to go get checked out and he did not, and the symptoms went away on their own in a couple of hours and he did not use an antihistamine and he did have arm soreness that was expected and she wanted to know the recommendation and if he should be getting the booster in another week or if due to his allergic reaction should he avoid the MRNA vaccine. At the time of the call, the agent was unsure of reporter type and caller was asked seriousness criteria which she stated as medically significant and stated yes for causality; due to resources stating that the reporter is not an HCP, this report filed as non-serious. States she took a photo of his face that day and the date the caller had the 1st dose of the Pfizer COVID Vaccine was 04Aug2021 and his patient card has no expiry date or NDC written on it. the patient has not had the 2nd dose or booster vaccine of the Pfizer Covid vaccine and she is calling to find out if she should let him do it or not; states his reaction began the same day on 04Aug2021 and started about 20 minutes after the vaccine was administered; states the patient sat there for 15 minutes and after the drive home he felt the numbing sensation and probably within like 15 minutes of that his face felt swollen and it got a little worse before it got better but it was fairly mild or he would've rushed him in and in like 2-4 hours it had resolved regarding the swelling and the numbness also; states the only thing left behind is more pain around the injection site but nothing major. States the patient did get the Tetanus vaccine probably three weeks prior to the Pfizer covid vaccine because he cut himself and it was kind of deep and she looked at the contents of the tetanus vaccine and the Pfizer COVID Vaccine and all the additives of the tetanus vaccine versus the covid vaccine she saw nothing that overlapped so it seems less likely like it was a built up reaction; states she has no name of the tetanus vaccine, no lot, expiry date or NDC to provide and it was at the urgent care that day. States the patient does not take any medication. Time the Vaccination Was Given as between 12-1:00pm. Vaccine Administered at private Facility was reported as No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): This was the patient's first dose of the Pfizer COVID Vaccine. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency Room and Physician Office. the patient was not hospitalized. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s):States the patient did get the Tetanus vaccine probably three weeks prior to the Pfizer covid vaccine because he cut himself and it was kind of deep and she looked at the contents of the tetanus vaccine and the Pfizer COVID Vaccine and all the additives of the tetanus vaccine versus the covid vaccine she saw nothing that overlapped so it seems less likely like it was a built up reaction; states she has no name of the tetanus vaccine, no lot, expiry date or NDC to provide and it was at the urgent care that day. Vaccine Name: Tetanus vaccine, unknown name.  Relevant Tests was None. Is there a Product Complaint was reported as Yes.   Description of Product Complaint: Description of complaint: Vaccine Supplemental form completed in additional context. States the patient did get the Tetanus vaccine probably three weeks prior to the Pfizer covid vaccine because he cut himself and it was kind of deep and she looked at the contents of the tetanus vaccine and the Pfizer COVID Vaccine and all the additives of the tetanus vaccine versus the covid vaccine she saw nothing that overlapped so it seems less likely like it was a built up reaction; states she has no name of the tetanus vaccine, no lot, expiry date or NDC to provide and it was at the urgent care that day.  Follow-up attempts are completed. No further information is expected.