Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Gastrointestinal disorder, Gastrooesophageal reflux disease, Heart valve incompetence, Oropharyngeal pain
Clinical narrative: Echocardiogram showed leaky valve; has had breakthrough tachycardia episodes; Since receiving both doses of the vaccine, caller states she has developed an gastrointestinal intolerance to Miralax (polyethylene glycol).; she started feeling a lot of bloating in her upper GI; acid reflux in her throat; throat was hurting; impairing her breathing; panic attack; Testosterone level as high as a male's /Her level was like 300 which is like a teen male; This is a spontaneous report from a contactable pharmacist (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at vaccination age of 58-year-old via an unspecified route of administration in the left deltoid on 18Feb2021 [late in the morning] (Lot Number: EN6200; Expiration Date: Jun2021) as dose 2, single for covid-19 immunization. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 (Lot Number E, I or L, 9265; Expiry Date: May2021 [also reported as Jun2021]) for Covid-19 immunisation. Medical history included allergy, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity and ectopic atrial tachycardia. Family history for as gastrointestinal there is none but for the cardiac, she has a history of stroke and heart attack in her family. Concomitant medications included aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) for little reflux; omeprazole (PROTONIX) for an unspecified indication; macrogol 3350 (MIRALAX) [for years] for constipation; testosterone taken for an unspecified indication; and metoprolol [been on that for years] for ectopic atrial tachycardia, all therapy dates were not reported. Historical vaccination included Zostrix vaccine (That was right before the Shingrix came out) at the beginning of 2017 for shingles immunization but had big large welt on her arm with a raised red area for a month. The patient reported that she got the two Pfizer covid 19 vaccine doses and since receiving both doses of the vaccine, caller states she has developed a gastrointestinal intolerance to Miralax (polyethylene glycol). She mentioned that she has had breakthrough tachycardia episodes in which she has a history of ectopic atrial tachycardia with no change and has taken metoprolol for years. After the second vaccine, she noticed that she would be sitting and all of a sudden, she would have a tachycardia attack. She was on her beta blocker and it was quite frightening. She took a second dose of her beta blocker and tried to breathe deep and eventually within a half hour it would resolve. She was getting a panic attack and thought what's going on. She saw her cardiologist. Her cardiologist recommended increasing her dose of metoprolol. Cardiologist also said she has noticed in her practice that after receiving the Covid Vaccine patients had a little exacerbation of cardiac conditions. Her cardiologist thought it could be due to the vaccine. The breakthrough episodes the caller experienced would happen suddenly during periods of inactivity like while watching TV. She increased her dosing for two or three months after her second dose and it has resolved. The patient has resumed taking her normal dose of metoprolol. Occasionally her heart rate increases more with activity or if she had an alcoholic drink which she knows that can happen or if dehydrated. She is comfortable and feels like she did before the vaccine. She feels more stable. The patient inquired if there were any reports of patients who received the Covid Vaccine and subsequently developed gastrointestinal intolerance to Miralax or Polyethylene Glycol. She was taking Miralax for years, and then 2 weeks after the second vaccine (01Mar2021), she started feeling a lot of bloating in her upper GI and acid reflux in her throat. She didn't know if it was a coincidence or if she developed an intolerance. The patient reported that she was seeing a gastroenterologist wherein she asked him about it, and he said he has no data. She searched herself and she couldn't find anything about it. She did report it with the CDC through texting, but she hasn't received any texts from them. Around 01Mar2021, she noticed that her throat was hurting, and it felt like a lot of gas was stuck in her throat. She mentioned that she could only tolerate small meals. She usually has the symptoms at night when she is laying down. She would get up and then started to make sure she waited 4 hours after eating before she went to bed and raise the bed. Now, she was on a PPI twice a day plus Pepcid at bedtime. She never had this before. She started thinking what if her body was reacting to something. She stopped the Miralax for a while and it seemed to get better, but her constipation got worse. She just started taking the Miralax again a week ago and now she feels like something is stuck in her throat, it is the same acid reflux as before. She is thinking she will stop the Miralax again. With regards to the seriousness of the event, her gastroenterologist and ENT both think that it is not serious, but to her it is very disturbing because it feels like something is stuck in her throat. There is air stuck in her throat until she can finally belch it out. In the meantime, it is disturbing, and it feels like it is impairing her breathing. For her it is very significant. She doesn't like getting vaccines and she doesn't get the flu vaccine, but this is different. She is also older and could get complications. When asked causality, she stated she is just wondering because she knows that there are vaccines people can develop allergies to. She thought maybe because her body is very reactive, it was her body thinking it was the same Covid protein when it was introduced to the Polyethylene Glycol and went into defense mode. She has been searching the internet and can't find anything with regard to the Covid vaccine. The only thing she could see was GI distress with Covid. On another side note, she was on a topical testosterone therapy. She didn't know this, but she got her testosterone level taken and it was as high as a male's level. She stopped using it after that. Her gynecologist changed her to estrogen on preparation. She found on the internet hat a high testosterone level can cause tachycardia, but she doesn't know. It has since resolved. It was a compound that was prepared by the pharmacy. She doesn't know whether they made a mistake or what happened. They use a powder and put in almond oil. She doesn't know if it was weighed properly. Her level was like 300 which is like a teen male. She had the test probably 2 months ago (2021), and that's the only test she had while on the medication so who knows how long that was going on. Investigations: She had an echocardiogram on May2021 which showed a leaky valve which happens with age. Her doctor is not too worried at this point. She mentioned she thought it could have something to do with the vaccine and maybe things will calm down, which it appears they have. She thinks she had the echocardiogram done in May. For the reflux, she had a nasal endoscopy done from the ENT. They did not see any damage to the lining of her throat. All of her symptoms are in her throat, not her esophagus. She doesn't have a burning chest or anything. She had it done in the beginning of June. The patient reported that she did not visit the emergency room. She thought about it and wanted to when she had a panicky feeling like her airway was compromised, but she never went. She tried to calm herself down and breathe deep. She measured her oxygen saturation and told herself she was getting oxygen. She added the she went to physician's office. The patient underwent lab tests and procedures which included echocardiogram showed leaky valve on May2021 which happens with age and nasal endoscopy which showed no damage to lining of throat on Jun2021 for the reflux she had a nasal endoscopy done from the ENT which they did not see any damage to the lining of her throat. The outcome of the events tachycardia and testosterone high were recovered on an unspecified date in 2021, as for the events gastrointestinal disorder and acid reflux were not recovered while the outcome of the other events was unknown.; Sender's Comments: Based on a the vailable data a contributory role of BNT162B2 to the events, cannot be fully excluded.  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