Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal swelling, Swollen tongue
Clinical narrative: stomach cramps and diarrhea that lasted for a day and a half; stomach cramps and diarrhea that lasted for a day and a half; tiredness; nausea; feeling sick to my stomach that is still waking me up at 3 AM every morning/not achy feeling but feeling unwell; a slightly swollen tongue and throat for about an hour; a slightly swollen tongue and throat for about an hour; allergic to poly glycol which is in the first dose of the vaccine, and she had a reaction to; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US support. A 70-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: was not reported) via an unspecified route of administration, on 13Jun2021 (past Sunday) as 1st dose, single dose for COVID-19 immunization. Medical history included irritable bowel syndrome, fibromyalgia, food allergy, hypersensitivity, hormone therapy, herpes zoster all from an unknown date and unknown if ongoing. Concomitant medication(s) included valaciclovir hydrochloride (VALTREX) taken for herpes zoster, start and stop date were not reported. Patient received first dose of the Pfizer COVID-19 vaccine this past Sunday 13Jun2021 and she reports experiencing the following side effects: stomach cramps and diarrhea that lasted for a day and a half, tiredness that was starting to go away today, and nausea/feeling sick to my stomach that was still waking me up at 3 AM every morning. Patient reports that she has a pre existing history of irritable bowel syndrome and fibromyalgia. Patient also stated that she did experience a slightly swollen tongue and throat for about an hour. She states that the same thing happens if she drinks any sort of diet drinks because of the artificial sweeteners that contain poly-glycol. Patient states that she has heard from many people that they did not experience side effects with the first dose but they did with the second dose. Since she experienced side effects with the first dose she was concerned that she will experience more side effects with the second dose if the second dose stronger. Patient would like to know if the second dose is a different strength or if the two doses are the same and Do most side effects go away within a few days. Patient states that she also takes hormone therapy and that her pharmacist said that there should be no interactions with the Pfizer COVID-19 vaccine but would like to know if there was any additional information available. she takes Valtrex as needed for herpes zoster outbreaks on her legs and ribs. She does not currently has an outbreak but would like to know if this would cause an interaction with the Pfizer COVID-19 vaccine if she did have to take Valtrex. She has spoken with her pharmacist about it but wanted to check with Pfizer as well. Patient asks why there is poly-glycol in the Pfizer COVID-19 vaccine. Patient was concerned she may have worse side effects after the second dose of the Pfizer COVID-19 vaccine especially since most of the people she has spoken with have told her they did not have any side effects after their first dose. She would like to know if her side effects could be worse after the second dose. Patient wants to know if the second dose was the same or a stronger dose. Everyone the caller knows they have had no reactions to the first dose but have had bad reactions with the second dose. The caller cannot drink artificial sweeteners and the reaction was not severe but her tongue and throat feels like its closing up. Patient also has to stay away from foods with preservatives, like hot dogs and cold cuts. These things can sometimes give the caller a migraine too so she stays away from them. She saw that poly glycol was on the ingredient list of the vaccine but she decided to get the vaccine. After the vaccine, the caller had cramping, diarrhea, tiredness, she has been in bed since Sunday, and not achy feeling but feeling unwell. The second dose, from what the she hears, that people react to the second dose instead off the first. Asking the second dose going to be stronger because then the she may feel twice as bad. She was contemplating on getting the second dose. Asking it the same shot or a different dose. The outcome of the tiredness, nausea, feeling sick to my stomach that is still waking me up at 3 am every morning/ not achy feeling but feeling unwell, a slightly swollen tongue and throat for about an hour and allergic to poly glycol which is in the first dose of the vaccine, and she had a reaction to was unknown and stomach cramps and diarrhea that lasted for a day and a half was recovered on Jun2021.   Information on the lot/batch number has been requested.