Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Discomfort, Dyspnoea
Clinical narrative: Itchy; became extremely hot; could not get comfortable; Headache more like a migraine; Headache more like a migraine; could not sleep all night; Felt like she could not breathe; Had really bad fatigue; Really blurry vision; Increased symptoms of vertigo and had balance issues; Increased symptoms of vertigo and had balance issues; Sweaty and then chilly; Sweaty and then chilly; soreness in shoulder area and neck area; soreness in shoulder area and neck area; felt like a heavy brick was on top of her head; Sjogren's; This is a spontaneous report. A contactable consumer (patient mother) reported for a 49-year-old female patient (reporters daughter). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Apr2021 at 12:00 (at the age of 49-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Reason for no lot number: of Pfizer COVID vaccine: Complainant does not have the product with them at the time of call. Medical history included, obesity (Patient was trying to work on it and is not doing so well. Obesity started after high school) from an unknown date and unknown if ongoing. Vertigo (Patient did confirm that she had vertigo prior to getting the vaccine) from an unknown date and unknown if ongoing. Thyroid disorder (Patient did take medication for thyroid) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported) as dose 1, single on an unspecified date for COVID-19 immunization. Other products, patient history and investigation assessment: no. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available). Previous doses was unknown. Additional vaccines administered on same date of the pfizer suspect: none. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Adverse events following prior vaccinations: None. Patient never had any kind of reactions. Family medical history relevant to adverse events: none. Relevant tests: none or unknown. Vaccination facility type clinic. Caller wanted to speak with someone in medical research. We may be entrusted to know how the vaccine has affected patient (her daughter). Patient had both doses of the Pfizer COVID vaccine. Did not say what the side effects were. On 28Apr2021, the patient experienced, within 15 minutes after receiving 2nd vaccine, event the nurse kept patient for a longer time because patient was having a reaction. Patient became itchy, extremely hot, could not get comfortable at 12:00, and had a headache. That night, patient could not sleep all night when patient went to bed. Patient felt like could not breathe unknown time. Patient had really bad fatigue felt that way all the rest of the afternoon. Unknown time of start also, started really blurry vision. Patient could not even see with prescription glasses on. Patient felt like a very heavy brick was laying on top of head unknown time it started. It felt like patient had a migraine. Patient was very sweaty and then chilly unknown time. Also, doctor noticed it increased symptoms of the vertigo also had balance issues started that evening. Patient had vertigo and something that starts with an S. Patient later remembered it was called Sjogren's. Patient had soreness in shoulder area and neck area and this was already there and was part of Sjogren's. Patient had to report out of work the next day because of all of these Symptoms. Headaches were more like a migraine and improved at times at 12:00, but comes back periodically. Patient was treated for the vertigo and balance issues and did not know the outcome. She did confirm that patient had Vertigo prior to getting the vaccine. Patient does take medication for thyroid and for Sjogren's and Vertigo. Did not know the names, doses, or any other information about them. Ophthalmologist recommended she see a neurologist because of blurry vision. He said he did not think baby cataracts were an issue but recommended patient see Neurologist. They were there before the vaccine. Went to Neurologist and he did 3 special MRI's and did not know what they were. The results were all normal. Brain activity was normal. He did prescribe a medication for the vertigo, but patient did not have any information on the medication name, dose, lot or expiration. She felt it might be useful and wanted Pfizer to be aware, because obviously this and COVID was so new and we did not know a lot about it yet. List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI). The patient underwent lab tests and procedures which included magnetic resonance imaging: the results were all normal (Brain activity was normal). Magnetic resonance imaging: the results were all normal. (Brain activity was normal). Magnetic resonance imaging: the results were all normal (Brain activity was normal). Caller just wanted to let us know her neurologist and ENT doctor both agree second vaccine very well may have a negative reaction to some of her other medical issues. If the patient was hospitalized, how many days was the hospital stay reported as none. Adverse events require a visit to not to emergency room, but visited to physician office. Neurologist was giving medication to help sleep and it was helping. Going off of symptoms until got results from 3 specific MRI's that did. He did give medication because he did not have anything to go on other than symptoms. She did say it kind of helps patient sleep. She did not know the name of the medication and had no lot or expiration. He just renewed the prescription around 18Aug2021. The outcome of the event vision blurred was not recovered and pruritus, feeling hot, vertigo and balance disorder were unknown while other events were recovering.   The lot number was not provided. Information on lot number has been requested during follow up.