Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Somnolence
Clinical narrative: Tingling on top of her head; Sleepiness; Nosebleeds; Nausea; migraines; Diarrhea; Body aches; Headaches; getting cold; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Right on 14Apr2021 09:00 (Batch/Lot Number: EN6208) (at the age of 63 years old) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included arthritis from an unknown date. The patient's concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/Batch :EN6205), via unspecified route of administration in right arm on 24Mar2021 09:00AM for COVID-19 Immunization. She thinks the vaccine would protect her from going to the hospital and not to get COVID. Stated none of her offspring her husband got Johnson and Johnson and her son got Pfizer and had no effect relevant to adverse effect (AE). Her second dose of the Pfizer vaccine was 14Apr2021, she had nausea, diarrhea, body aches and headaches, sleepiness. She read these were things that could happen. On 22Apr2021, she started with nose bleeds and they had been recurring every day, once a day, twice a day and haven't stopped. It was reported that nausea went away stated that she recovered completely 4 or 5 days after the second day, she could say she recovered and she get migraines so she doesn't associate it with the vaccine. No treatment medication as she wanted her body to go through what it needed. Stated that she could not remember the time for nausea. On 14Apr2021 (day of the vaccine), diarrhea started in the afternoon. Vaccine at 9 am then after 2pm she had diarrhea, went away recovered completely. She did not seek treatment or medication as she let her body go through what it needed to go through. Stated that these things were bound to happen and not everyone was the same. Body aches started on 14Apr2021 the same day at night early evening. Reported that it's ongoing, stated that she suffered from arthritis so she didn't attribute the body aches to the vaccine, it just exacerbated. Not a lasting affect. She didn't attribute to the vaccine. Stated that it's persisting since she suffered from arthritis. She did not take treatment or anything. Headaches started the same day on 14Apr2021 in the morning (reported time was around 1 or 2). It's ongoing and even though she said she suffered from migraines. Her headaches were different from her migraines, they worsened, especially after the nose bleeds, she got a sense of tingling on the top of her head. The migraine headaches cluster on one side. Acetaminophen with caffeine tension headache aide over the counter did not take for a week or maybe more she read the body needs to go through all of those things to create the proteins so she didn't take anything at the beginning. Tingling on top her head started 3 weeks ago, stated at 630-7AM from the top of her head to her cerebellum. It went away after the acetaminophen with caffeine she's not a coffee drinker. She didn't drink or smoke. It's worsened after her nose bleeds the day before the report, she had 2 or 3 nosebleeds and the latest at night, then she had tingling at 11 at night. She clarified after nose bleeds on 22Apr2021 and then she gets either a headache or tingling. She did not took medication as she thought she had to go to the emergency but she didn't go. That morning she woke up at 6:30AM with the tingling, had breakfast at 8 then took two acetaminophen with caffeine, and the headache was mild, but the tingling was still there. Tension relief: 500 mg acetaminophen/caffeine 65 mg aspirin free (NDC: 11673-839-01, LOT B018H , EXP: Dec2022). Further reported that she usually doesn't sleep or take naps, but since the first dose and the second dose on both times she had sleepiness in the morning around 11 or 1030. After 14Apr2021, it was for a week she could not remember. She recovered completely, the usual with no treatment. Nosebleeds started in the afternoon around 4 pm. She was going to notify the doctor, the ENT has no appointments, but she did not want to go to the ER, but it needed to be taken care of. Right after the vaccine she took regular TYLENOL, clarified as acetaminophen, 500mg. Not on a daily basis. Took acetaminophen, she started on 20Apr2021 or 22Apr2021, before the nose bleeds. She is only currently taking the one for the headaches. She took acetaminophen maybe two times, it wasn't necessarily daily. She felt like she was irritated and getting cold on unspecified date and then she just took it. No additional vaccines were administered on same date of the Pfizer suspect, stated she hasn't went to the doctor. Did not require a visit to the Emergency Room and physician office. No prior vaccinations (within 4 weeks) within four weeks prior to the first. Described headaches after getting COVID vaccine, and said she has tingling on the top of her head. That morning she woke up at 6:30 with the tingling, had breakfast at 8 then took two acetaminophen with caffeine, the headache is mild, but tingling still there. Therapeutic measures were taken as a result of headaches and getting cold. The outcome of the events nosebleeds, body aches and headaches were not recovered, while nausea, diarrhea and sleepiness was recovered on unspecified date and unknown outcome for the other events.  Batch/Lot number has been obtained. Further information has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.