Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness, Off label use
Clinical narrative: First injection given on 12Jan2021/Second injection given on 29Jan2021; First injection given on 12Jan2021/Second injection given on 29Jan2021; She is a little tired today; Flu like symptoms; Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administration date 29Jan2021 (Lot number: EL9261) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B12 [VITAMIN B12 NOS]. Vaccination history included: Bnt162b2 (First injection given on 12Jan2021 and lot: EW0186. Expiry: unknown. NDC: unknown., She was able to get her shots early because of working with patients. They were one of the first ones to get Pfizer Vaccine on 12Jan on day two. They went where the first were given. administration date: 12Jan2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "First injection given on 12Jan2021/Second injection given on 29Jan2021"; HEADACHE (non-serious) with onset 27Sep2021, outcome "recovered" (28Sep2021), described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "She is a little tired today"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". Therapeutic measures were taken as a result of fatigue.  Clinical Course: She was calling about her husband. Caller was a retired nurse practitioner, but she kept an active RN license. Caller was 71 and her husband was 72 years old. They got their booster on 27Sep2021 where they got the first two shots. Minor side effects after injection. For caller it was headache, fatigue, and flu like symptoms. Her husband was a diabetic and it hasn't been quite 48 hours and he has been quite incapacitated. He had over 101 fever, headache at a three, and nausea. She is not sure if it is within the normal side effects. What would it be considered. She was able to get her shots early because of working with patients. They were one of the first ones to get Pfizer Vaccine on 12Jan on day two. They went where the first were given. Caller states that she had a headache when she woke up yesterday. She felt it in the occipital area. She has a masters in mental health and felt like the top would blow off. It was 10 out of 10. It dissipated throughout the day. She is a little tired today. She took Tylenol. The nurse who was giving the injections couldn't find caller in the computer. HCP Information: She doesnt have the address and phone number to provide at the time of the call. Headache: started on 27Sep2021 about 25 minutes after the injection. That happened when she had the second vaccine before, but it dissipated. She didn't think much about it because it started after. She took Extra Strength Tylenol when she got home. During the night and wee hours of the morning around 4:30AM on 28Sep2021 it was 100 out of 10. It just felt like a really horrifically bad headache.  Pfizer COVID shot: First injection given on 12Jan2021 and lot: EK9231. Expiry: unknown. NDC: unknown. It was given in the wing of the hospital. Second injection given on 29Jan2021 and lot: EL9261. Expiry: unknown. NDC: unknown. Booster: given on 27Sep2021 and lot: EW0186. NDC: unknown. Expiry: unknown. They are working with computers. Caller was speculating that the rest of the information was in the computer. This nurse came over after the injection and asked caller if she could see her card because she couldn't find caller in the computer. That was distressing to caller. Caller was ashamed that their state vaccination rate is low and they have had to throw out a lot of medication. Investigations: None, but she has annual bloodwork next week. Extra Strength Tylenol: lot number: AFA091, Expiry: Apr2023, NDC: 30043739. She doesn't have the box. Usually they bike everyday, but yesterday nothing. Is there a Product Complaint: Yes  Description of Product Complaint: Description of complaint: Caller reporting adverse event with Pfizer COVID shot. It started on 27Sep2021 about 25 minutes after the injection. She took Extra Strength Tylenol when she got home. During the night and wee hours of the morning around 4:30AM on 28Sep2021 it was 100 out of 10. It just felt like a really horrifically bad headache. She felt it in the occipital area. It felt like the top would blow off.  She took Tylenol. Extra Strength Tylenol: lot number: AFA091, Expiry: Apr2023, NDC: 30043739. She doesn't have the box. Manufacturer: Tylenol Gelcaps. Count size: 100. Packaging Sealed and Intact: Yes. Was a sample of the product available to be returned, if requested (Y/N): Not Provided.  No follow-up attempts are possible. No further information is expected.