Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Somnolence, Vaccination site pain, Vaccination site swelling
Clinical narrative: Last night of insomnia, never slept all night. Coincided with brain fog. Did not remember dogs vet visit. Did not check calendar. Did not notice telephone or text reminders. Missed appointment.; Soreness and swelling at injection site.; Soreness and swelling at injection site.; Headache and nausea; Headache and nausea; Extreme fatigue and need to sleep.; Extreme fatigue and need to sleep.; Feeling hot and cold.; Feeling hot and cold.; insomnia; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 74-year-old), as a single dose for COVID-19 immunisation. Medical history included restless leg syndrome, raynaud's syndrome, polio, malaria, gastro oesophageal reflux disease (GERD), removed thyroid, removed pituitary tumor (ended migraine headaches of 30 years), known allergy to penicillin, concord grapes and must not take NSAIDs.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), pramipexole dihydrochloride monohydrate (MIRAPEX) and colecalciferol (VITAMIN D3) and Al (as reported); for unknown indication from an unknown date and unknown if ongoing. The patient previously received metronidazole(FLAGYL) and prochlorperazine edisylate(COMPAZINE) both for unknown indication from an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 15:15 (at the age of 74-year-old), as a single dose for COVID-19 immunisation. On 31Mar2021 at 17:30, the patient experienced soreness and swelling at injection site, headache, nausea and extreme fatigue and need to sleep, felt hot and cold. The patient had early reactions in first few days. The patient then got better and then extreme fatigue returned and was unable to do more than 3 tasks in a day. It was reported that if the patient did more, had to rest 2 days. On an unknown date in 2021, most recently the patient had insomnia, for 5 of 7 nights unable to sleep except for 2 hours at end of usual sleep time. The patient never had insomnia in her life before. On unknown date of Apr2021 (reported as last night) patient had insomnia, never slept all night, coincided with brain fog and did not remember dog's vet visit, did not check calendar, did not notice telephone or text reminders and missed appointment. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness and swelling at injection site, headache, nausea and extreme fatigue and need to sleep, felt hot and cold, brain fog, insomnia, was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.