Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Gastrooesophageal reflux disease, Headache, Insomnia, Mood altered
Clinical narrative: headaches; acid reflux; issues sleeping; weird chilling at the injection site; uncomfortably warm--doesn't have a fever; lactose intolerance is still bad; has lost desire to eat; chilling effects at the injection site; Feels like his core body temperature has increased; his mood has changed, he is moodier; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 (Lot number: FC3182) at the age of 42 years as dose 2, single for covid-19 immunisation; metformin (METFORMIN), oral (Batch/Lot number: unknown) at 500 mg 2x/day for diabetes mellitus; tilactase (LACTAID), oral (Batch/Lot number: unknown) at 1 DF daily for lactose intolerance. Relevant medical history included: "endocrine abnormalities (including diabetes)" (ongoing); "Pre-diabetic" (unspecified if ongoing); "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01), when the patient was 42 years old, for Covid-19 immunization, reaction(s): "he still has dairy issues and they are now worse after getting the vaccine", "call in sick to work one morning", "His lactose intolerance has increased in severity"; Bnt162b2 (Dose: 01), administration date: Aug2021, when the patient was 42 years old, for Covid-19 immunization, reaction(s): "severe reaction to dairy". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 2021, outcome "not recovered", described as "acid reflux"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "issues sleeping"; VACCINATION SITE DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "weird chilling at the injection site"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "uncomfortably warm--doesn't have a fever"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "lactose intolerance is still bad"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "has lost desire to eat"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chilling effects at the injection site"; BODY TEMPERATURE INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "Feels like his core body temperature has increased"; MOOD ALTERED (non-serious) with onset 2021, outcome "not recovered", described as "his mood has changed, he is moodier". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for metformin and tilactase was unknown.  Additional information: NDC number of Covid vaccine: Unknown, Expiry Date of Covid vaccine: Unknown. Unable to provide UPC, Lot, expiry for the Lactaid tablets, patient had a brand-new box and it was not sitting around. He had to go buy some and they are single serve tablets. Family Medical History Relevant was none. Vaccination Facility Type was not Pharmacy/Drug Store nor it was Administered at a Facility. The patient took no other vaccines given the same day, had no problems with vaccines in past. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. Caller (reporter) was a consumer calling on behalf of her husband (Patient, currently 43 years old, was 42 years old at time of vaccination, male) inquiring about side effect information for the Pfizer Covid-19 vaccine. Caller stated "my husband was having some side effects from his Pfizer Covid-19 vaccine, I wasn't sure if they are common or if you any remedies for them. Since his second dose, he (patient) had frequent headaches, acid reflux, issues sleeping, but I'm not sure if that's due to acid reflux. His lactose intolerance was still bad. He has had less and less of a desire to eat as time goes on--he is pre-diabetic so she needed to make sure he's eating, he's having some weird chilling at the injection site like putting bengay on it but that's intermittent. He's feeling uncomfortably warm--doesn't have a fever, just feeling uncomfortable hot. He's moodier than before but I don't know if that's symptoms of vaccine or consequence of the acid reflux and lack of sleep, more disengaged than before, withdrawn. We're about a month out from his second dose now. He got his second dose 03Sep2021. He's able to sleep a little bit, but we're not sure if it's because of the acid reflux.Usually does not have to take Lactaid tablets unless he chugs a whole gallon of milk. After the first dose, he had a much more severe reaction to dairy. It was so much he had to call in sick the day following. Had a little bit of cheese on his taco and a dollop of sour cream and it put him out of work. Now he was taking Lactaid tablets at every meal, but he still has dairy issues and they are now worse after getting the vaccine. Product strength and count size dispensed: unable to provide Additional lot numbers: n/a Is a sample of the product available to be returned, if requested (Y/N): not provided Packaging sealed and intact was not provided. Does not know if it's something heard of and since they haven't and the other side effects he has had, a couple of things. Did not know rather to call you guys about what he experienced but wants to know if they are common. Clarifies product husband given as Pfizer Covid vaccine. After the second dose he has had an increase instance of headaches and now experiences acid reflux, which he has not had before. Having trouble sleeping and not sure if it's related to the acid reflux or if just something on its own, does not know for sure. As time progresses, he has lost desire to eat. Is at 250 pounds and usually loves to eat. He ate half of his dinner last night and the night before he didn't feel like eating. Does take Metformin for diabetes and she asks him if he has eaten. Unable to provide NDC, Lot, or expiry for Metformin. Has been on it a couple of years, not good about taking it for probably the last year but was taking it more regularly now. Later provides he had 3 other symptoms after the second dose. Reporter questioned Is getting chilling effects at the injection site, it's random and pops up, almost like he was rubbing Bengay on it. Felt like his core body temperature has increased, just feels uncomfortably warm all the time now. It may not really be symptoms of vaccine but could be response to all the other symptoms he has, but his mood has changed, he was moodier. Does not know if it's not being able to sleep, feeling hot, those symptoms, but he just doesn't want to do things. No further details provided. AE required no emergency room or physician visit. Patient contacted a primary care physician and not been seen yet. Relevant tests were none.  No follow-up attempts are possible. No further information is expected.