Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Somnolence, Weight
Clinical narrative: she was extremely groggy; She wanted to sleep & rest. She said she woke up at almost 10:00AM today, and at noon, she laid back down for 2 hours.; She wanted to sleep & rest. She said she woke up at almost 10:00AM today, and at noon, she laid back down for 2 hours.; had no appetite; had diarrhea; heavy dreams; she was afraid she might fall; she had really heavy dreams; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 92-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 16:00 (at the age of 92 years) (Batch/Lot Number: ET0202) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included bad legs, hard of hearing, uses canes to get around from an unknown date and unknown if ongoing (She said she takes a Quinine 200mg capsule every night for her legs). Concomitant medication included quinine sulfate (QUININE-ODAN) taken for limb discomfort, start and stop date were not reported. Patient had the first dose of the Pfizer COVID-19 vaccine on Tuesday (02Mar2021) in the afternoon. Yesterday (07Mar2021), she was extremely groggy, wanted to rest, had diarrhea, and had no appetite. She reported those as adverse events associated with the Pfizer COVID-19 vaccine. She also said that she normally takes quinine for her legs, but her pharmacist recommended her not to take it for 2 weeks before having the COVID-19 vaccine. She has not taken the quinine 4 weeks before taking the vaccine and she has stopped taking it for 5 weeks now. She has not restarted taking this medication. She wanted to know if there is an interaction between quinine and the Pfizer COVID-19 vaccine. Reported she got her first COVID-19 Vaccine on Tuesday, 02Mar2021, at about 4:00PM in her left arm. She said since receiving her COVID-19 Vaccine on Tuesday, she was feeling fine. She said she had no problems until yesterday, 07Mar2021. She said yesterday she was extremely groggy. She said she wanted to sleep, and rest, saying she had a terrible time. She clarified she still feels the same right now. She said she woke up at almost 10:00AM today, and at noon, she laid back down for 2 hours. She clarified she had really heavy dreams, as well. She said she had diarrhea yesterday and took Pepto Bismol. She said the Pepto Bismol seemed to help her diarrhea. She said because she was 92 years old, she uses canes to get around. She said she was being very cautious now because she was afraid, she might fall. She said she has had no appetite since yesterday (07Mar2021). Reported she had a new doctor and doesn't remember the doctor's name. She said she doesn't have the doctor's business card to provide any further contact information. Reported she was taking a product that she gets in Canada, Quinine 200mg. She said she takes a Quinine 200mg capsule every night for her legs. She said she had bad legs. She said her doctor, at the time, gave her a number in Canada to get the Quinine because the Quinine is not available in the United States. She said she had heard through her iPhone that people that take Quinine may have an interaction with the COVID-19 Vaccine. She said a month ago, she called the pharmacy she gets the Quinine 200mg from and talked to a  pharmacist. She said she told the  pharmacist that she had been taking Quinine for a number of years, and asked the  pharmacist what she should do, since she was planning to get the COVID-19 Vaccine. She said the  pharmacist initially told her to discontinue taking the Quinine 200mg 4 weeks prior to getting the COVID-19 Vaccine. She said the  Pharmacist then told her she could discontinue the Quinine 2 weeks prior to getting the COVID-19 Vaccine. The caller said she decided on her own she would discontinue the Quinine 4 weeks prior to getting her first COVID-19 Vaccine dose. The caller stated she had an unopened Quinine 200mg white manufacturer's bottle, providing: Quinine-ODAN 200mg capsules (100 capsules/bottle). She stated a prescription label with a date of 04Sep2020 was placed over the Quinine-ODAN 200mg white manufacturer's bottle. She said (withheld) was listed on the prescription label. She said her previous Quinine 200mg prescriptions were dispensed in a pharmacy bottle from the  pharmacy. She stated it was almost 5 weeks since she had taken the Quinine 200mg capsule, clarifying she did not restart the Quinine 200mg after she received her COVID-19 Vaccine on 02Mar2021. Reported she had called the CDC to ask about a possible interaction between the Quinine and the COVID-19 Vaccine. She said the CDC didn't give her a specific answer and connected her to different people. She said she did not know if those people were also from the CDC. She said she then spoke with a woman that she believed was with her Healthcare plan. She said  Healthcare couldn't tell her if the Quinine would interact with the COVID-19 Vaccine but sent her a necklace to use around her neck if she gets in trouble and needs help. She said she then contacted the  pharmacy where she gets the Quinine 200mg from. Reported she saw from the COVID-19 Vaccine paperwork she received that she had an option to call V-SAFE to report side effects from the COVID-19 Vaccine. The caller asked if the Pfizer  agent could file her V-SAFE report. The caller was advised that she would need to contact the CDC to use the V-SAFE reporting. The caller asked if the Pfizer  agent had a telephone number for V-SAFE. Wanted to know if she should take the second dose of the vaccine considering her adverse reactions with the first dose of the Pfizer COVID-19 vaccine. The patient received treatment as Pepto Bismol for her diarrhea. The patient underwent lab tests and procedures which included weight: gone below 130 lbs on an unspecified date. The clinical outcome of the event had diarrhea was recovering and remaining all other events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.