Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Electrocardiogram, Gastritis, Influenza virus test, Polymerase chain reaction
Clinical narrative: gastritis; abdominal pain radiating to her back and had it on the side of her left breast and that continued; abdominal pain radiating to her back and had it on the side of her left breast and that continued; She was not able to sleep; having discomfort; chondrocostal junction syndrome; severe pain on the side where they gave it; tenderness on the left side of her breast and back; tenderness on the left side of her breast and back; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Lot number: HG2282) at the age of 72 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: She is taking Amlodipine and Losartan; "prediabetic" (ongoing), notes: prediabetic began many years ago, maybe 4-5 years ago and she takes Metformin for that. Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: EL3248, Expiry date: Apr2021), administration date: 18Jan2021, for COVID-19 immunisation, reaction(s): "Injection site pain", "Arm discomfort"; bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Expiry date: 30May2021, Route of administration: intramuscular, Anatomical location: left deltoid), administration date: 08Feb2021, for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 16Oct2023, outcome "recovering", described as "severe pain on the side where they gave it"; BACK PAIN (medically significant), BREAST TENDERNESS (medically significant) all with onset 16Oct2023, outcome "not recovered" and all described as "tenderness on the left side of her breast and back"; COSTOCHONDRITIS (medically significant) with onset 22Oct2023, outcome "unknown", described as "chondrocostal junction syndrome"; GASTRITIS (medically significant), outcome "unknown"; ABDOMINAL PAIN (medically significant), BREAST PAIN (medically significant), outcome "unknown" and all described as "abdominal pain radiating to her back and had it on the side of her left breast and that continued"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious), outcome "recovered", described as "She was not able to sleep"; DISCOMFORT (non-serious), outcome "unknown", described as "having discomfort". The events "severe pain on the side where they gave it", "tenderness on the left side of her breast and back", "chondrocostal junction syndrome", "gastritis", "abdominal pain radiating to her back and had it on the side of her left breast and that continued", "she was not able to sleep" and "having discomfort" required physician office visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (unspecified date) normal; Influenza virus test: (22Oct2023) negative for influenza A and influenza B; Polymerase chain reaction: (22Oct2023) it was influenza negative and covid negative; SARS-CoV-2 test: (unspecified date) Negative; (16Oct2023) Negative; (22Oct2023) Negative; (24Oct2023) remain covid negative today; Ultrasound chest: (22Oct2023) diagnosed with costochondritis; X-ray: (unspecified date) normal; (22Oct2023) diagnosed with costochondritis. Therapeutic measures were taken as a result of vaccination site pain, back pain, breast tenderness, costochondritis, gastritis, abdominal pain, breast pain, sleep disorder due to a general medical condition, discomfort. Clinical course: Hypertension She was taking Amlodipine and Losartan but could not recall the date the hypertension began and it was all prior to receiving the Pfizer covid vaccine back in 2021 and prior to this booster vaccine that she got for 2023. On 16Oct2023, she developed severe pain on the side where they gave it in her left arm and the right side and she started to experience tenderness on the left side of her breast and back and did not know what it was and she thought it was because she had eaten southern cuisine. It started with abdominal pain radiating to her back and had it was on the side of her left breast and that continued and then she went to see her doctor and on Thursday and she told the doctor that she had gotten the vaccine and he attributed it. This was not the first Pfizer vaccine she had and it was the last one the booster that is now. The doctor said she had gastritis and increased her Omeprazole from 20mg to 40mg and advised her if the symptoms worsened to go to the emergency room and that was on Thursday. On Friday she continued to have discomfort and called them and they ordered a chest xray and ultrasound and she was diagnosed with costochondritis due to this injection and it was the first side effect she had and she sees that arm pain was normal but not this type of pain that developed with this shot. This was the first time she experienced a reaction to the shot that she had to seek medical care for and all of her other vaccines that she received were Pfizer shots and they have been within the normal experience except for an arm reaction that was back in 2021 and clarified later in the report it was injection site pain. Both the caller's mother and she both had the same shot on same day but the caller's mother was ok except for arm and body discomfort at the injection site and the caller was not concerned about that. The reporter's mother and the reporter both experienced that pain at the injection site but the reporter had to seek medical attention for the other issues the caller experienced which the doctor diagnosed the caller with chondrocostal junction syndrome when she went to see the physician on 22Oct2023. She was not able to sleep and was up all night on Saturday due to discomfort so at 8:00am in the morning she went to Patient First on 22Oct2023 as the doctor's office was closed. She had a chest xray, covid test, and EKG that were all normal except for this pain and she was prescribed an anti-inflammatory. The caller and her mother both took a covid test prior to the vaccine on 16Oct2023 which was negative and both the caller's mother and the caller wanted to make sure they were negative before they got the booster shots and they were both negative on 16Oct2023 and were able to schedule to get their shots and they wanted to make sure they were fine and were negative. The caller had a PCR test that was negative on 22Oct2023 and it was influenza negative and covid negative and it was a Flu combo lab test and was negative for influenza A and influenza B and negative for covid. The caller's pain and tenderness got worse as the days went by and she had to seek medical attention on two occasions. For the arm pain at the injection site that she and her mother experienced, states it was with each time and it was just had the arm discomfort and she did not call it in because she expected that for the initial covid shots and that was what the package says. The caller did not take Tylenol. The caller was just concerned because she does not think she read that costochondritis is one of the side effects and that was what compelled her to call; she had been taking what the doctor prescribed that was Naprosyn and it allowed her to sleep for the past two days and today as she was speaking the pain was subsiding and that was a great relief. She was feeling much better and they remain covid negative today although the caller did get covid post her shot and had covid post injection but they said that was due to an expected thing and she was with infection of covid but that date was not available as it was not in front of her at this time and she did not remember which prior dose of her covid vaccines this was associated with but she did got two infections of covid and was treated successfully and did not required hospitalization.; Sender's Comments: Based on known drug safety profile and close temporal association, the events of vaccination site pain are assessed as related to suspect product. Based on the information provided and close temporal relationship there is a reasonable possibility of causal association between the events Back pain, Breast tenderness with the suspect product. Based on the current available limited information in the case provided, the causal association between the events Costochondritis , Abdominal pain, Gastritis , Breast pain and the use of suspect product cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-202300347233 same patient, vaccine, different dose and event;US-PFIZER INC-202300347242 same reporter, vaccine, different patient and event;