Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Aphonia, Chills, Headache, Injection site pain
Clinical narrative: She confirms the rash started after receiving the covid vaccine/terrible rash is up and down both arms, the crown of her head, and on her scalp; Pfizer covid vaccine: nausea; Pfizer covid vaccine: chills; Pfizer covid vaccine: hurting at the injection site; Pfizer covid vaccine: headaches/on and off headaches; She cannot speak this morning; Pfizer covid vaccine: vomiting; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL8982, expiry date: 31May2021) intramuscular injection in right upper arm on 19Jan2021 10:00 at single dose for COVID-19 immunisation. Her second dose is scheduled on 10Feb2021. Medical history included stage 4 metastatic breast cancer. There were no concomitant medications. The patient previously took Ibrance for stage 4 metastatic breast cancer and experienced broken out in terrible rash. She is taking Ibrance for cancer, she has been taking it for a while. The past few weeks she has broken out in terrible rash. She went to a dermatologist that stated the rash was from Ibrance. She cannot speak this morning (Jan2021). Her doctors are speaking to each other and she is being told not take Ibrance by the dermatologist and to continue taking from her oncologist. Reports she had a pathology report and it showed her skin eruptions she is having is from Ibrance. She clarifies that her terrible rash is up and down both arms, the crown of her head, and on her scalp. She took the first dose of the COVID-19 vaccine a couple of weeks ago. She is having quite a bunch of side effects from the injection. The side effects she is experiencing after the COVID vaccine are nausea, vomiting, chills, hurting at the injection site which is not terrible, and on and off headaches. Events did not require a visit to emergency room or physician office. Nausea started 3 days after the receiving the vaccine on 22Jan2021. Vomiting is still ongoing on and off and started about a week and half after receiving the vaccine (Jan2021). Chills started right away and she still has the chills. It has not changed. The chills started maybe a day after receiving the vaccine (20Jan2021). Hurting at the injection site started the day after (20Jan2021) and lasted for two or three days and is still ongoing, reports it goes on and off. Reports the hurting at the injection site is not terrible. Headaches started a day or so after receiving the vaccine (20Jan2021) and is still ongoing, on and off. Reporter seriousness for events nausea, vomiting, chills, hurting at the injection site, headaches were reported as medically significant. She is currently taking Ibrance since her oncologist told her not to stop taking Ibrance. The dermatologist said her rash is related to Ibrance. When querying causality she reported that she is not sure because she has been taking Ibrance for a while. She confirms the rash started after receiving the COVID vaccine. Events outcome of nausea, vomiting, chills, hurting at the injection site, headaches was not recovered (nausea and vomiting was reported as worsened), while for others was unknown. Relatedness of drug Pfizer COVID vaccine to events for nausea, vomiting, chills, hurting at the injection site, headaches were reported as related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  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.