Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Echocardiogram, Fatigue, Headache, Weight
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. An 82-year-old female patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, 0.3 ml single (Lot number: EL0264, Expiration Date: 30Apr2021), in right arm and on 14Feb2021 as dose 2, 0.3 ml single (Lot number: EL0264, Expiration Date: 31May2021) at the age of 82 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Illness/AE: Recurrent breast cancer-she has ongoing follow up for 3rd bout of breast cancer. She should lose a little bit of weight, but that is impossible because the treatment for the breast cancer prevents her from ever losing any weight; "Dust allergy" (unspecified if ongoing), notes: Illness/AE: Dust allergy; "Fibromyalgia" (unspecified if ongoing), notes: Illness/AE: Fibromyalgia; "arthritis" (unspecified if ongoing), notes: Illness/AE: arthritis; "Exercise" (unspecified if ongoing), notes: She could go into Diabetes if she neglected what she eats; but she controls everything with diet and exercise. There were no concomitant medications. The following information was reported: CHRONIC FATIGUE SYNDROME (disability) with onset 15Feb2021, outcome "not recovered", described as "Really bad chronic fatigue syndrome"; HEADACHE (disability) with onset 15Feb2021, outcome "not recovered", described as "Severe headaches, chronic, they never go away"; FATIGUE (non-serious), outcome "unknown", described as "exhaustion". The patient underwent the following laboratory tests and procedures: Echocardiogram: (Aug2021) Did not show anything, notes: Result: Did not show anything; Unit: Not Provided; Weight: (unspecified date) She should lose a little bit of weight, notes: She should lose a little bit of weight, but that is impossible because the treatment for the breast cancer prevents her from ever losing any weight. Clinical information: No other Conditions and other products reported. This caller initially reported being a consumer who is the patient who called regarding Pfizer product: Covid Pfizer CV. Later in the report she mentioned that she is a Retired Nurse who is also the patient. She has been told if you have side effects they generally go away after about a week. For her, she has had side effects since 15Feb2021. Something has got to be done. She is having a tough time. How does she know what kind of help can be provided? She can't continue to live with these side effects and does not know what to do. She has been seeing doctors about these side effects and they don't know what to do. She clarified the side effects as being severe headaches, chronic, they never go away and bad chronic fatigue syndrome. She was not foolish enough to think she is the only one who has gotten those injections and have those side effects. She does not know if Pfizer is even interested in keeping track of this kind of side effect to try to do something about it in the future. These events have left her capable of doing nothing, it has taken away her life. Initially events were persistent, but events worsened after the 3rd dose was administered 12Oct2021. She is down on the bed like 24/7 and only gets up for the bathroom and get up to quickly fix something to eat that's all she can do. The fatigue is so bad, at times the headaches keep her flat for 2 solid days. She's always been superwoman, and this has ruined her life. She has no family in (State name withheld) and it is vitally important that she be able to live by herself. Caller said to let her get a magnifying glass to read the CDC vaccine record card; she will never understand why something is made so small when someone later must read them. Regarding testing, treatment, or other medical interventions relative to these events because of her exhaustion with the chronic fatigue syndrome it was questioned whether there were heart problems, so they did the echocardiogram, but it didn't show anything in Aug2021. No additional vaccines. Time of Onset of events (24-hour clock) was unknown initially didn't pay too much attention, kind of assumed there would be aftereffects for a while. No visit to emergency room or physician office. Caller as she has just infrequently gone to the doctor to see if there has been any change. No prior vaccinations within 4 weeks. About history caller reported from Jul2020 to Dec2020 she went back to help out with a family crisis and when she was there her family will verify that she was functioning at top capacity from 8am until 10pm with no complaint of headache or fatigue. She didn't have the flu or anything like that. No family history reported. Relatedness of drug to reaction(s)/event(s). Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Result of Assessment: Yes. Follow up attempts are completed. No further information is expected. Sender's Comments: As per limited available information, the causal relationship between the events Headache and Chronic fatigue syndrome the suspected drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.