Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: rash; photo sensitivity; over 101 fever; nausea; fatigue; headache; This is a spontaneous report from a contactable Nurse.  A 72-year-old male patient (reporter's Husband) received the third dose (booster) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0186), on 27Sep2021 (at the age of 72-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot number: EK923) on 12Jan2021 and the second dose of  BNT162B2 l(ot number: EL9261) on 29Jan2021. The patient was a veteran and Caller volunteers at the clinic there. She was able to get their shots early because of working with patients. They were one of the first ones to get Pfizer Vaccine. She didn't want to abuse it and go since they are not immune compromised, but the clinic approved the booster dose. Medical history included Insulin Dependent Diabetes and high blood pressure, Cholesterol. Concomitant drugs included Statin 10  for Cholesterol, Lantus on it probably a year and a half at the maximum dose of 50 daily for Insulin Dependent Diabetes. Prior to that he was on NPH and regular insulin, this has been really good for him. He took Losartan for his blood pressure has been really good. He has been on it probably six or seven months. He was on something else before, but he had angioedema after many years. That was a crisis during COVID. Because of the mask caller didn't see his lips swelling. He had to change his medication due to that.  The caller reporte that the patient  had received his flu vaccine as well as the 1st dose of the shingles vaccine 2 weeks prior to the COVID booster vaccine and questioned if his symptoms may be possibly related to this. On 27Sep2021 the patient experienced  headache and fatigue and on 28Sep2021 he had fever and nausea. He had over 101 fever, headache at 3 point, and nausea. Caller has been medicating him for symptoms. She gave him Dramamine  ( lot number: 2O1495, Expiration: May2023) Strength: 25mg and gave him 2000mg of Extra Strength Tylenol over 24 hours (Manufacturer: Tylenol Gelcaps,lot number: AFA091, Expiry: Apr2023).  When he woke up  the day of reporting he still felt fatigue. The headache is 3 on a 10 point scale. Caller gave him Extra Strength Tylenol. She was not sure if it is within the normal side effects. She called hosptial in and they said if he is not any better to go to the hospital. He was breathing and fine. Caller didn't want to make her husband anxious. When she took fever last night it was 101.6 but she told him it was 101.1 because it would freak him out. Her husband is a diabetic and it hasn't been quite 48 hours post vaccination and he has been quite incapacitated. Headache the day before reporting it was a 10. He also had nausea like a severe migraine. Seriousness Criteria: He has some photo sensitivity. It is a little disabling. The nausea was normal for the headache that he had. Fatigue was still present, but has improved.  The caller stated he remained fatigued and was currently laying down with a headache that was rated as a "3." The wife, also the caller, is and has been giving Tylenol to help manage his symptoms. She states she "cleared up right away. He is "getting better." Caller states with his high fevers he was "incapacitated" and notes his symptoms to have been "quite debilitating" and was "out yesterday" although today he is better. The husband also received his flu vaccine and 1st shingles vaccine 2 weeks ago. The caller is not sure if this could have precipitated the fevers he is experiencing. Caller says her husband got like a shingle type rash on the arm where his shingles vaccine was given. The event nausea was recovered on 28Sep2021, fever recovered on 29Sep2021, the outcome event shingle type rash on the arm  and photo sensitivity was unknown and the outcome of other events were recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pyrexia and the suspect drug BNT162B2. 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.,Linked Report(s) : US-PFIZER INC-202101289286 same drug, different AE/patient