Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Tinnitus
Clinical narrative: She had buzzing in her ear or tinnitus; lost her balance; The dizziness started on the morning of 14Feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient; This is a spontaneous report from a contactable consumer. This consumer reported for an 83-ear-old female patient that received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's thyroiditis and She says she has had this since the 1970's, she was diagnosed in the 1970's but she had it long before that, they finally figured out what it was, ongoing tremor and she says she has had this for about 10 years, her brother has it, her sister has it, her mom has it, it is called familiar tremors. Concomitant medication(s) included ongoing levothyroxine sodium (LEVOTHYROXINE SODIUM) at 125 mcg once a day for Hashimoto's thyroiditis She says this is Synthroid, she has been taking it for years, She was diagnosed with Hashimoto's thyroiditis in 1970, but she's had it all her life; ongoing metoprolol tartrate (METOPROLOL TARTRATE) at 25 mg, once a day for tremor and She says its a heart medication but she takes for tremors, she has been taking it for a long time; ongoing nitroglycerin (NITROGLYCERIN) precautionary because she was having chest pain from 22Nov2019 and she says she has never had to use it, ongoing cobamamide  (VITAMIN B12 [COBAMAMIDE]) and she says she has been taking this for a long time, it has green tea, coQ10, B vitamins in it for energy and ongoing Vitamin D3 and she says she has been taking this for a long time for energy. The patient previously took first dose of bnt162b2 for covid-19 immunisation. The patient experienced the dizziness started on the morning of 14feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient on 14Feb2021 with outcome of not recovered , lost her balance on 15Feb2021 with outcome of unknown, she had buzzing in her ear or tinnitus on an unspecified date with outcome of unknown.   The clinical course was reported as follows: Dizziness - is this normal and how long will it last?  Upon further discussion, patient stated that she got her second dose of the Pfizer Covid 19 vaccine on 13Feb2021.  The dizziness started on the morning of 14Feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient.  The other day, she lost her balance when going down the steps and almost fell.  Her doctor suggested the Epley maneuver which she has been using for the past 2 weeks and it is not helping at all.  She had buzzing in her ear or tinnitus (onset not reported).  Her doctor has referred her to an ENT specialist for further evaluation. Discussed per Pfizer-BioNTech COVID-19 Vaccine EUA PI (LAB-1457-7.0, Revised: 06 April 2021) Adverse Reactions section (nothing found on dizziness, vertigo, tinnitus) and per attached CONS documents and VR re: 'dizziness and weakness' as part of possible allergic reaction, noting no specific information on duration as it may vary by individual.  Referred to HCP for further discussion/guidance, based on medical history.  Investigation Assessment: No Additional Context: The caller is calling about the COVID vaccine, Pfizer. She says she had her last vaccine on 13FEB2021 and got dizzy and it's not going away. She says she has seen her doctor, he suggested using the Epley maneuver but it its not helping any. She said that she is ondering if the Pfizer Vaccine is causing the dizziness? She is wondering if this is something she should be worried about it. Contact Details: She says she was a medical transcriptionist for many many years and a medical secretary. She does not have an email address. HCP: Caller does not have a full address or email to provide. Products: She reads EN6201, Pfizer EN6201. She says her first dose was on 23JAN2021 and reads EL8982 for that one. No expiry date for the first dose. History: She says it is hard for her to get around, she is so dizzy. She says she has nitroglycerin because she had chest pain back in  2019. She says her doctor is sending her to an ear specialist. VACCINE SUPPLEMENTAL FORM Pfizer Suspect Vaccine and Vaccination Details Time the Vaccination Was Given: 10:15 in the morning Anatomical Location of Administration of Pfizer vaccine considered as suspect: left arm Vaccination Facility Type hospital. No Vaccine Administered at Military Facility. No additional Vaccines Administered on Same Date of the Pfizer Suspect. AE(s) require a visit to no Emergency Room but Physician Office. Saw her primary doctor, she called and told him about it, her appointment was for this past Friday but he had her come in that day. She does not remember which day. She says she put up with the dizziness, it got worse. Prior Vaccinations (within 4 weeks): No. She says she needs to get a lot of vaccines, she is behind in a lot of this, she just hasn't done it yet. AE(s) following prior vaccinations: No She says she has had reaction to 3 medications. Sulfa, she says the reaction was low blood pressure. Celebrex, she says the reaction was severe chest pain, she thought she was having a heart attack, she went to the ER they thought she was having a heart attack. Codeine, she says the reaction was an extremely low blood pressure, all her vitals dropped really low, dangerously low. She says there was another one she can't remember, her reaction was she broke out in real bright red hives. Family Medical History Relevant to AE(s) She says her mother had cancer and died of cancer and her husband died of cancer. She is wondering if this is something she should be worried about it, if this is a normal side effect and is it  going to last much longer because it is terrible.   No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.