Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Dysgeusia, Nausea
Clinical narrative: Stomach upset; Mid back hurting; Metallic taste mouth; Nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm left on 09Mar2021 at 07:58 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing gastrooesophageal reflux disease (GERD) and ongoing allergies from an unknown date. Concomitant medications included lansoprazole (PREVACID) taken for gastrooesophageal reflux disease, start and stop date were not reported. The patient got her first dose of the vaccine yesterday (09Mar2021) and immediately when she was given the injection, she had a metallic taste in her mouth. This lasted 10-15 minutes. She added, she has allergies and she told them that when getting the vaccine. She was told to sit for 30 minutes. She actually sat for 45 minutes instead, but that went away. She later clarified she was referring to the metallic taste that went away. She also had nausea throughout the day. Last night, she took medicine for acid reflux because she has GERD and had stomach upset from the nausea. She clarified she took PEPCID. Then after that, she noticed her mid back was hurting. She is not sure if this is considered a muscle ache, did not really feel like a muscle ache, but it was like a burning type of pain. This was in her mid-back area. It would like to start on one side and rotate to the other and go back and forth. She sent an email to the doctor. She is the one who suggested she get the vaccine because at first, she was not going to get it. The doctor talked her into it. Metallic taste in mouth she did not have after leaving the area. It was a different taste. She was unable to clarify outcome. It was just something she noticed. Nausea: Commented she also take lansoprazole (PREVACID) every day. Last night, she took PEPCID. From what she can tell this morning she has not had nausea. However, she has not gone through the full day yet so would say it's still ongoing, but better. PEPCID (Lot: MHF063, Exp: Mar2021) at 20mg tablet, as needed, for stomach upset. She commented she does not know if she will take the second dose. Stomach upset seriousness criteria was confirmed as medically significant. It has gone away, but medically significant because she did not feel it until after the shot. Mid back hurting seriousness criteria was confirmed as medically significant as it is significant to her even though she is not currently getting treated for it. She still feels the ache. Yesterday, it was like a burning ache. Today it is just an ache on her right side, but still mid back. She does not know if it is a muscle ache. The outcome of the events was stomach upset was recovered on 10Mar2021, Mid back hurting and nausea was recovering, while of metallic taste mouth was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of stomach upset and back hurting due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.