Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: headache; nausea; tired; diarrhea; rash on his head; He had a temperature; This is a spontaneous report from a contactable consumer (Mother). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN0196, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Deltoid Left on 27Jun2021 (at the age of 41-years-old) as a DOSE 1, SINGLE for covid-19 immunisation at Pharmacy/Drug Store. The patient medical history was none. There were no concomitant medications. 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) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) or list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and event following prior vaccinations were none. Patient's Medical History (including any illness at time of vaccination) was none. Family medical history relevant to AEs was not provided. On 28Jul2021, the patient experienced headache, nausea, tired, diarrhea, rash on his head and he had a temperature. It was reported that, her son experienced some AE. He received first shot in Jun and had side effect only on 28Jul2021. She was asking if her son should get the second dose. He experienced headache, nausea, tired, diarrhea, rash on his head. She was questioning if that could be related to the vaccine as it has been far out after receiving the first dose and should the patient receive the second shot. Referred her to their HCP for a proper diagnosis and medical guidance and she was not happy with the response. She mentioned that they already went to an epidemiologist and a dermatologist saying that it may be cause by the vaccine, but no one really gave them an answer. No one had been helpful. She also said that the information provided was unhelpful as it did not answer her question. Reporter reported in regard to the Covid shot, the first shot. The Reporter stated she reported to VAERS for her son. She was told she could do that. Her son possibly could have had an adverse reaction. She was wondering if she has the Lot number from the vaccine certificate, if Pfizer can see if there have been any issues with that particular Lot number or vaccine? Reporter stated the possible reaction happened on 28Jul2021 and lasted for a few days. The actual first shot was administered on 27Jun2021. She spoke to a viral epidemiologist who said it could have been a reaction that many weeks out, but the doctors around where she lives were telling her that it would be too long to tie it to the vaccine. She clarified her patient had a headache; he was tired. He had nausea a few times during a 24-hour period. He had diarrhea. He had a temperature and a rash on his head. She stated by about 02Aug2021, he was better. He went to a dermatologist in regard to his rash because he still had the rash. At that point he was still feeling tired, he wasn't 100% but was feeling better. no symptoms are still ongoing at the time of reporting and, she stated patient seems good. Reporter said patient has not yet received his second dose. She was going to ask that question as well. If this was a possible reaction from the first shot, is he supposed to get the second shot? The dermatologist's response to her son was that they'll never know if it was a reaction or not? So how are they supposed to know what to do? Should he get the second shot? Reporter said she knows she can't be advised but she wanted to know what is she supposed to do? It's like they are shooting darts blind. It's upsetting because she felt like she was getting the run around. It's like she was in a rowboat with no paddle. Event did not require a visit to the emergency Room. Reporter stated her son was close to going, but he started feeling a little bit better, so he didn't go. Physician office visit was required as, she made an appointment with the dermatologist for her son regarding the rash. Relevant tests done were none. There was a Product Complaint. Reporter reported in regard to patient first dose of the Pfizer COVID shot. Her son possibly could have had an adverse reaction. The reporter stated the possible reaction happened on 28Jul2021 and lasted for a few days. The actual first shot was administered on 27Jun2021. She clarified her son had a headache he was tired. He had nausea for a few times during the 24-hour period. He had diarrhea. He had a temperature and a rash on his head. She was wondering if she has the Lot number from the vaccine certificate, if Pfizer can see if there have been any issues with that particular Lot number or vaccine. Lot was reported as EN0196, no further details were provided or obtained. Case was reported as non-serious. Outcome of the rash on his head was not resolved whereas, rest of the events were resolving.  Follow-Up (09Sep2021): Follow-up attempts are completed. No further information is expected.