Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | — | SYR / LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | — | LA |
Tachycardia; had a low TSH level, but normal T3 and T4; swelling in her neck; Biopsy; blood pressure spiked; Angina; Subclinical hyperthyroidism; Subacute thyroiditis; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Sep2024 as dose 5, single (Batch/Lot number: unknown) at the age of 67 years, in left deltoid for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 13Sep2024 as dose number unknown, single for immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing), notes: She had tachycardia and had to get off of her exercise bike and said that she had to get off of it because she was palpitating so bad.; "High blood pressure" (ongoing); "High cholesterol" (ongoing); "Supplementation therapy" (ongoing). Concomitant medication(s) included: VALSARTAN taken for hypertension (ongoing); ATORVASTATIN CALCIUM taken for blood cholesterol increased (ongoing); VITAMIN C [ASCORBIC ACID] taken for supplementation therapy (ongoing); VITAMIN D [COLECALCIFEROL] taken for supplementation therapy (ongoing). Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset Oct2024, outcome "unknown", described as "Angina"; THYROIDITIS SUBACUTE (non-serious) with onset Oct2024, outcome "unknown", described as "Subacute thyroiditis"; HYPERTHYROIDISM (medically significant) with onset Oct2024, outcome "unknown", described as "Subclinical hyperthyroidism"; BLOOD PRESSURE INCREASED (non-serious) with onset Oct2024, outcome "unknown", described as "blood pressure spiked"; BIOPSY (non-serious) with onset 11Dec2024, outcome "unknown"; TACHYCARDIA (non-serious), outcome "unknown"; BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious), outcome "unknown", described as "had a low TSH level, but normal T3 and T4"; SWELLING (non-serious), outcome "recovered", described as "swelling in her neck". The patient underwent the following laboratory tests and procedures: Biopsy: (11Dec2024) Adenomatoid, notes: Result: adenomatoid with a background of thyroiditis; Unit: Not Provided; Blood pressure diastolic: (Oct2024) Low, notes: Her diastolic was so low and her body was not normal and nothing was controlled; Blood pressure measurement: (Oct2024) High, notes: blood pressure spiked, like 200 systolic at one point; Blood pressure systolic: (Oct2024) 200, notes: 200 systolic; Blood thyroid stimulating hormone: (Oct2024) Low; Thyroxine: (Oct2024) Normal; Tri-iodothyronine: (Oct2024) Normal; Ultrasound scan: (unspecified date) Unknown results. Therapeutic measures were taken as a result of blood pressure increased. Clinical course: Dosage text : Dose unknown, injection in the Left arm/upper shoulder Additional Information for Other medicines Atorvastatin Calcium: Well controlled. Her body makes too much cholesterol on its own Additional Information for Other medicines Vitamin C: Been taking it for some time. Additional Information for Other medicines Vitamin D: This was doctor recommended. Narrative case summary and further information: Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Additional Context: Caller was a consumer calling about the Covid-19 Vaccine and reported that she just filed a report with VAERS and it was slightly labor intensive and she had to provide them with all kinds of documentation. She had a biopsy, though it was not necessary, but it was suggested by her doctor and radiologist and said that it would have gone away on it's own. Right before her vaccine on 12-13Sep2024. Clarified she had the Covid-19 vaccine on 12Sep2024. The vaccine formulation had been changed in Aug2024. She said that it was the Bivalent in previous years and the new formulation was the monovalent. She had received 4 Covid-19 vaccines on different occasions in the previous years. After doing research the vaccine changed from the original vaccine. She sent the info to her primary care and to her pharmacy. The pharmacist said that the Covid-19 vaccine formulation had never changed. She said that she had to educate the pharmacist. For the first 4 vaccines she had, the original and the boosters, she had no reactions. With the 5th one, with the monovalent in 2024, she did not think anything of it, but had weird feeling about getting it. Around Oct2024 she started having symptoms that she did not relate to the covid vaccine until recently. She did some research and saw that someone else had been diagnosed with subacute thyroiditis, clarified that it is unknown if it was someone or other individuals, and stated that online the adverse event had been reported and had resulted from covid vaccine. She was diagnosed with Subacute thyroiditis. The ordeal was awful. It was like subclinical hyperthyroidism with 3 different phases. They are comparable, the initial biopsy saw what was thyroiditis, but was actually subacute thyroiditis. She was not sick prior to this. Prior to to her diagnosis, her symptoms came out of nowhere. Caller said that her symptoms were that her blood pressure spiked, like 200 systolic at one point and she called 911. Her diastolic was so low and her body was not normal and nothing was controlled. She had tachycardia and had to get off of her exercise bike and said that she had to get off of it because she was palpitating so bad. She felt angina and around this time they increased her blood pressure medications by 2.5mg. She had never experienced anything like these events happening to her. Weight: She is a little overweight. She spoke to her doctor and they said that another patient contacted the manufacturer and reported and that is what prompted her to contact Pfizer. No further details provided. Did not know why her endocrinologist has subacute thyroiditis and subclinical hyperthyroidism in her chart, but she had a low TSH level, but normal T3 and T4. She reported that she had the flu vaccine like a day later after her 5th Covid vaccine dose. Caller doesn't have the NDC , lot, or expiry date for her previous doses of the Pfizer Covid-19 vaccine. Clarified that she was placed on Amlodipine Besylate 2.5mg once a day after her blood pressure spike. Biopsy showed a nodule, clarified it was 2 nodules, that they thought were suspicious, but was a adenomatoid with a background of thyroiditis. She also had a ultrasound prior to the biopsy. She said that none of it was necessary as the subacute thyroiditis does resolve on it's own. The swelling in her neck would have subsided and gone away. She wass better now, but she is not getting a covid vaccine ever again. She understands peoples concerns now. Her body said enough is enough and said that her body was telling her that if she continued she would die. Her pharmacist also told her to never get another covid vaccine. Caller notified that it was up to her to file a report online if she wanted to complete a separate report through the online portal and she said that she was not going to do that. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Blood pressure high; High cholesterol; Supplementation therapy
Medical History/Concurrent Conditions: Tachycardia (She had tachycardia and had to get off of her exercise bike and said that she had to get off of it because she was palpitating so bad.)
VALSARTAN; ATORVASTATIN CALCIUM; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]
Test Date: 20241211; Test Name: Biopsy; Result Unstructured Data: Test Result:Adenomatoid; Comments: Result: adenomatoid with a background of thyroiditis; Unit: Not Provided; Test Date: 202410; Test Name: diastolic; Result Unstructured Data: Test Result:Low; Comments: Her diastolic was so low and her body was not normal and nothing was controlled; Test Date: 202410; Test Name: blood pressure; Result Unstructured Data: Test Result:High; Comments: blood pressure spiked, like 200 systolic at one point; Test Date: 202410; Test Name: Systolic; Result Unstructured Data: Test Result:200; Comments: 200 systolic; Test Date: 202410; Test Name: TSH level; Result Unstructured Data: Test Result:Low; Test Date: 202410; Test Name: T4 Level; Result Unstructured Data: Test Result:Normal; Test Date: 202410; Test Name: T3 Level; Result Unstructured Data: Test Result:Normal; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown results