Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypersomnia, Impaired work ability, Injection site pain
Clinical narrative: sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself).  A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation.  Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting".  The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea  and other events due to temporal relationship.   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.