Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Emotional disorder, Fatigue, Rash, Vaccination site pain
Clinical narrative: Doesn't feel real energetic; It is upsetting to her; Full blown body rash/Total body RASH/rashed out like crazy; Very tired/ feeling tired; Injection arm tender for 2 days; This is a spontaneous report from a contactable other HCP. A 69-years-old non-pregnant female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 19Mar2021 08:15 (at the age of 69-years-old) (Batch/Lot Number: EN6208) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient took COVID-19 vaccine because of Pandemic to be safe for herself and community. The patient did not have Covid prior vaccination. The vaccine was not administered at Military facility and the vaccination facility type is clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not Covid tested post vaccination. Medical history included 9 weeks post OP Open Heart surgery (on new heart medications with that. Listed heart medications in online report. Didn't know if those medications were going to react with COVID-19 Vaccine), langerhans' cell histiocytosis (diagnosed a couple of years) which is a blood thing. First was diagnosed with an itchy skin spot on her back. Has been to Stanford and all-around town. Has not had trouble with it. Half of medical professionals state it is cancer and can metastasize, and others say it is just an immune thing and will go away. Is trying to eat healthy, but maybe her immune system is compromised, which may be why she is having his reaction, asthma and allergy to latex. The patient did not have family medical history. Concomitant medications included HCTZ; POTASSIUM; METOPROLOL; acetylsalicylic acid (ASPIRIN 81); warfarin sodium (COUMADIN); amiodarone hydrochloride (AMIOD). The patient previously took vicodin for drug hypersensitivity and experienced abdominal discomfort. The patient experienced full blown body rash/Total body rash/rashed out like crazy, very tired/ feeling tired, injection arm tender for 2 days on 19Mar2021. Doesn't feel real energetic and It is upsetting to her on an unspecified date. It was reported that, full blown body rash was worsened. The patient did not undergo relevant tests. The patient did not receive treatment for the events full blown body rash/Total body rash/rashed out like crazy, very tired/ I am also feeling tired, injection arm tender for 2 days. The patient was rashed out like crazy, is very hesitant to have anything reinforced or be stronger and is upsetting to her. The patient started getting very tired and went to bed. In morning around 8:00AM, she got into shower and noticed rash. It was shocking. Rash was down her legs and tummy. Today, rash has spread to her upper arms. Every time she looks the rash is going to a different area. Doesn't know if rash is going to progress to other complications. It is not normal. Stated she is sitting on eggshells. Spoke to physician on-call at the hospital. Was told if it gets worse to go to the ER. Injection arm looks fine. It was a little tender for two days at least. The patient just felt more tired as the day went on and evening was approaching. Reiterated is nine weeks out from open heart surgery and does take naps. She did feel a little more tired than usual. Hard to tell if it is ongoing. Doesn't feel real energetic. The patient has total body rash and this is day six and continues to spread. Does not itch or burn presently. Some areas are raised skin rash she feeling tired. The patient is kind of scary where she is sitting right now. Doesn't know if rash is going to progress or not. Doesn't know where she would be in the next few days. The seriousness of the events full blown body rash/Total body rash/rashed out like crazy was reported as medically significant and other events was reported as non-serious. Outcome of the events Full blown body rash/Total body rash/rashed out like crazy, very tired/ feeling tired and Injection arm tender for 2 days was not recovered and other events was reported as unknown. It was reported that, full blown body rash is related to Covid-19 vaccination.  Follow-up attempts are needed. additional information is requested.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded.  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 RAs, Ethics Committees, and Investigators, as appropriate.