Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Fatigue; intermittent bowels of severe Diarrhea since she had the initial COVID and each time she had vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Indication for concomitant drug: Levothyroxine; "she had the initial COVID" (unspecified if ongoing); "intermittent bowels of severe diarrhea" (unspecified if ongoing), notes: Since she had the initial COVID. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder. Vaccination history included: moderna (DOSE 1, SINGLE), administration date: 10Feb2021, for Covid-19 immunization, reaction(s): "intermittent bowels of severe Diarrhea since she had the initial COVID and each time she had vaccination"; moderna (DOSE 2, SINGLE), administration date: 10Mar2021, for Covid-19 immunization, reaction(s): "intermittent bowels of severe Diarrhea since she had the initial COVID and each time she had vaccination"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), administration date: 13Oct2021, for Covid-19 immunization, reaction(s): "intermittent bowels of severe Diarrhea since she had the initial COVID and each time she had vaccination"; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE; Lot number: unknown), administration date: 26Nov2022, for Covid-19 immunization, reaction(s): "intermittent bowels of severe Diarrhea since she had the initial COVID and each time she had vaccination". The following information was reported: FATIGUE (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "intermittent bowels of severe Diarrhea since she had the initial COVID and each time she had vaccination". Therapeutic measures were taken as a result of fatigue, diarrhoea.  Additional information: The caller was actually the patient. She received two forms regarding lack of efficacy for COVID-19 vaccines and for the follow-up questions. She had two shots with Moderna (COVID-19 Vaccine) before and two Pfizer (COVID-19) Boosters and the last booster that the patient had was on 27Sep2023 that came along with the flu vaccine (unspecified flu vaccine). After the shot, the caller experienced fatigue and caller wanted to know what the form that she received was for and also provided an AER reference number. The flu shot on 27Sep2023 was actually the last booster shot that the patient had. The patient stated that most of the information appeared to her were needed to be filled up by a Physician not the patient. So, she was curious just to why she had received two different sets of it and was being asked to follow up by filling out these forms, which she said she could not fill out. It was asking her for batch numbers and lot numbers and so forth and so on, which she cannot provide. Her height and weight were 5 feet 175 and recently in the last since 2016, she was about 145 pounds. When height and weight were confirmed, she stated "Approximately" (Not clarified further, hence not captured in tab). When probed for name Initials, (name withheld) (Not appropriately clarified hence, not captured in tab). When probed for LOT#, expiration date, NDC# and UPC# of Pfizer COVID-19 Shot: She stated that the last booster shot she got they did not give her. They did not enter on the card. They said the pharmacy had the information that was done on 27Sep2023. It was a Pfizer booster at (withheld). The one prior to that was done, she had the number for that, but she doesn't know if it was 0 or O 446, that was done on 26Nov2022 (withheld) 9266 that was in 2022. Before that she had a Moderna shot done and the number was 023C, she can't tell if it was a Z or 2, 1A as an (withheld) that was done on 13Oct2021 and that was done in (withheld). The one before that was also Moderna that looked like 0030A21A that was on 10Mar2021 and that was done at (withheld). The first one that she gave was on 07Sep2023, they did not fill out the card. They said they had the information at the Pharmacy. When probed for LOT# of Moderna shot, she stated 023CZ OR 2 but she can't tell 1A and that was given on (withheld). It looked like 0030 may or A or H 21A that was 10Mar2021 and that was done in (withheld). When probed for medical conditions and concomitant medications, she stated that she had another Moderna shot or booster, they call it. She doesn't know whether booster or a shot. The first one she had was in (withheld) also and the number was 031L, it's 208 OR V08 and that was done 10Feb2021 in (withheld). Those were all the boosters and the vaccine she got. When again probed for medical conditions and concomitant medications, she stated that she takes Levothyroxine which was for her Thyroid at 88 microgram once a day. She hasn't had any lab test in recent two weeks. For treatment, she took B12, Iron that was called gentle Iron, D3 supplements and B-Complex. She added that the supplements she took for Fatigue were over-the-counter supplements that she purchased. She had nothing to do with the medication that the doctor prescribed. She further stated that the biggest issue she was still experiencing was intermittent bowels of severe diarrhea. Since she had the initial COVID. It comes and goes, whenever it wanted to. It would last all day long. Diapers do not contain them. It was uncontrollable, that was her biggest issue. That has happened after she initially had Covid and after for each time she had vaccination within 10 days later usually, although have about a diarrhea. This was not something she had before. This was why the doctor had her on Atropine Sulphate Diphenoxylate (Intent: Treatment).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.