Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Investigation, Magnetic resonance imaging, Presyncope, Vertigo
Clinical narrative: he had a very lightheaded episode that was much more vertigo-like where things were spinning; I had almost a very light headache where I almost fainted; he had a very lightheaded episode that was much more vertigo-like where things were spinning; he had a very lightheaded episode that was much more vertigo-like where things were spinning; This is a spontaneous report from a contactable consumer. This 67-year-old male consumer reported that:  Patient characteristics -  Weight (kg): 95.25   Height (cm): 183 Sex: MALE  Reaction(s)/Event(s) Reaction/event as reported by primary source- Very, very lightheaded episode where he almost passed out  Term highlighted by the reporter: YES Date of start of reaction/event: Feb2021 Outcome of reaction/event at the time of last observation: UNKNOWN  Reaction(s)/Event(s) Reaction/event as reported by primary source: Very lightheaded episode that was much more vertigo-like where things were spinning   Outcome of reaction/event at the time of last observation: RECOVERING/RESOLVING  Results of tests and procedures for investigation of the patient Date: Feb2021 Test: EKGs   Result: Normal More information available: NO  Results of tests and procedures for investigation of the patient Date: Feb2021 Test: MRIs of his head Result: Normal More information available: NO Results of tests and procedures for investigation of the patient Date: Feb2021 Test: echocardiograms of his heart Result: Normal More information available: NO Results of tests and procedures for investigation of the patient Date: 17Mar2021 Test: VNG test- Videonystagmography Result - Unknown, not resulted yet More information available: NO Results of tests and procedures for investigation of the patient Date: 10Mar2021 Test: Nuclear stress test Result: Normal More information available: NO Results of tests and procedures for investigation of the patient Date: 10Mar2021 Test: Exercise stress test   Result: Normal More information available: NO Results of tests and procedures for investigation of the patient Date: Feb2021 Test: Blood work Result: Normal More information available: NO Drug(s) Information Characterization of drug role: (SUSPECT) Proprietary medicinal product name: Pfizer-BioNTech COVID-19 Vaccine   Batch/lot number: EL9263   Dosage text: Unknown strength/volume/dose injection to left arm shoulder before 12:00   Pharmaceutical form (Dosage form): Injection   Indication for use in the case: Vaccination) Date of start of drug: (26Jan2021 Date of last administration: 15Feb2021  Drug(s) Information Characterization of drug role - CONCOMITANT   Proprietary medicinal product name: Amlodipine Dosage text: 5mg taken daily   Indication for use in the case: Blood pressure  Drug(s) Information Characterization of drug role: CONCOMITANT   Proprietary medicinal product name: Esomeprazole   Dosage text: 40mg taken daily   Drug(s) Information Characterization of drug role: CONCOMITANT Proprietary medicinal product name: Centrum Silver for people over 50 years   Dosage text: Once daily   Narrative case summary and further information Submitted by Call Centre 1 Ref: #; ININ:# Selected Report Type: Initial Is report related to a study or programme? No Is the patient also the reporter? Yes Reporter type: Consumer or other non health professional Specify Consumer or other non health professional: Patient  Dates for Very, very lightheaded episode where he almost passed out: (From: Feb2021 To: Unknown) Dates when patient was in hospital for Very, very lightheaded episode where he almost passed out: Feb2021 to Feb2021 Dates for Very lightheaded episode that was much more vertigo-like where things were spinning: (From: Feb2021 To: Ongoing)  Is Pfizer-BioNTech COVID-19 Vaccine a Pfizer product? Yes Pfizer-BioNTech COVID-19 Vaccine manufacturer: Pfizer-BioNTech Dates for Pfizer-BioNTech COVID-19 Vaccine: (Start: 26Jan2021 Stop: 15Feb2021) NDC number of Pfizer-BioNTech COVID-19 Vaccine: Unknown Expiry Date of Pfizer-BioNTech COVID-19 Vaccine: Unknown Pfizer-BioNTech COVID-19 Vaccine: Dosage previously discontinued/treatment completed  Other Products: Yes Dates for Concomitant Products Amlodipine: (Start: Unspecified Stop: Ongoing) Additional Information for Concomitant Products Amlodipine: Taken for years. Dates for Concomitant Products Esomeprazole: (Start: Unknown Stop: Ongoing) Additional Information for Concomitant Products Esomeprazole: Taken for years. Why was the patient taking Concomitant Products Esomeprazole (Verbatim): Acid reflux Dates for Concomitant Products Centrum Silver for people over 50 years: (Start: Unknown Stop: Ongoing) Additional Information for Concomitant Products Centrum Silver for people over 50 years: Taken for years. Why was the patient taking Concomitant Products Centrum Silver for people over 50 years (Verbatim): Multivitamin Patient History: No Investigation Assessment: Yes Additional Context: This consumer is the patient who has been administered both first and second doses of Pfizer-BioNTech COVID-19 Vaccines. About 8-11 days after first dose of Pfizer-BioNTech COVID-19 Vaccine he had a very, very lightheaded episode where he almost passed out. About 8-11 days after second dose of Pfizer-BioNTech COVID-19 Vaccine he had a very lightheaded episode that was much more vertigo-like where things were spinning. He clarified he thinks one event was like 8 days and the other was like 10 days after the vaccine doses were administered, but is not sure, so left it as about 8-11 days.  Consumer is not sure if the events are Pfizer-BioNTech COVID-19 Vaccine related, but they never happened to him before those doses were administered. He does not know if this is vaccine related or just coincidence that they popped up at the same time as the vaccine doses. He does not know if events could be age related, the medical community can't figure it out so he is trying to get information on if events could be related to the vaccines.   Patient: Age at onset: Over the age of 65 years. Reporter: Address: Unknown. Primary: Further address details/Email: Unknown. Very, very lightheaded episode where he almost passed out: Onset about 8-11 days after first dose was administered, maybe 09Feb2021 or 10Feb2021. He went to the emergency room on the date of event onset and was admitted to hospital from about 13:00 that day, overnight and discharged about 17:00-18:00 the following day. While in hospital he had EKGs of his head-verified this information with caller repeatedly; MRIs of his head; CTs of his head; and echocardiograms of his heart. All of those tests came back ok, nothing abnormal on results. They recommended he have a stress test done which was not performed until after the second reported event following second dose of Pfizer-BioNTech COVID-19 Vaccine. Very lightheaded episode that was much more vertigo-like where things were spinning: Onset was about 8-11 days after second dose of Pfizer-BioNTech COVID-19 Vaccine was administered. He has never had vertigo in his life before event. He went back to the emergency room on date of onset of this event, but was not admitted to the hospital at that time; was only in the emergency room about 5-6 hours. While in the emergency room he had CT scans of his head, MRIs of his head and EKGs and everything looks good, nothing abnormal on results. Outcome: He still has ongoing very lightheaded episodes for a good part of the day. Those episodes usually last about 30 minutes and occur multiple times daily but are not really severe like the 2 initial events were following the first dose and then the second dose. Pfizer-BioNTech COVID-19 Vaccine: First dose: 26Jan2021 Lot: EL9263 NDC/Expiry: Unknown, this is not on CDC vaccine record card. Dose: Unknown strength/volume/dose injection to left arm shoulder before 12:00 Second dose: 15Feb2021 Lot: EL9267 NDC/Expiry: Unknown, this is not on CDC vaccine record card. Dose: Unknown strength/volume/dose injection to left arm shoulder before 12:00 - verified with reporter that details were same for both first and second doses. This completed his prescribed therapy. Regarding concomitant products and other medical conditions caller reported he really had no issues going on prior to onset of these events. Regarding other testing/investigations done relative to these events:  He had a nuclear stress test and exercise stress test, both performed on 10Mar2021 he believes and results of those tests were they both came back good, family doctor emailed him the results which were normal. He has gone to the ENT-ear, nose and throat doctor where he had a balance test done which he referred to also as a VNG test-Videonystagmography done on 17Mar2021. He will get results of balance test on Wednesday, 24Mar2021.  He had blood work done the first time he was in the emergency room when he was admitted to the hospital in Feb2021; they took his blood 3-4 times while he was there overnight and blood work results all came back normal. He is not sure what they were testing for, but thinks they were looking for stroke type things because event almost made him pass out. They did not draw more blood the second emergency room visit.  Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that:  Reaction(s)/Event(s) MedDRA version for reaction/event term LLT  - N/A Reaction/event in MedDRA terminology (LLT) - Medical Information Potential AE  Drug(s) Information Characterization of drug Role: 1 (SUSPECT)  Proprietary medicinal product name : PFIZER-BIONTECH COVID-19 VACCINE   Active Substance Information :Active Drug substance names PFIZER-BIONTECH COVID-19 VACCINE  Narrative case summary and further information: Originating AE Request: REQ-#  Attachments: 1  Contact HCP: N/A  Patient Age: 67 Reporter Subtype: Patient PQC Present: No  AE Present: Yes  PQC Details: Request Name: REQ-#  Product:PFIZER-BIONTECH COVID-19 VACCINE  Question: AUTO-CALLBACK REQUEST 23Mar2021 10:06AM Caller received both doses of the Pfizer-BioNtech Covid-19 vaccine (1st dose 26Jan2021, 2nd dose 15Feb2021). About ten days after the first dose he had a very lightheaded episode and he almostfainted, he went to ER and had an MRI of his head, a CT scan, a CT scan with contrast and also an echocardiogram, they were relating this to a strokelike symptom however the results were normal, also his blood test results were fine. He went to his HCP and he was schedules to get a nuclear stress test and an exercise stress test, his results came back normal; before this tests he received the second dose on 15Feb2021 and 10 days later he had again a very bad episode in his house he had a lot of vertigo, he felt the walls were moving so he went back to ER and had another EKG and CT scan, his heart was ok, so they suspected it was vertigo. He has daily episodes that las a few minutes were he feels lightheaded. He went to an otolaryngologist ("ear and nose doctor") to see if this was vertigo and had a balance test done. Caller states he had never this symptoms before, his vaccination card has the lot number for both doses, he hasn't changed his medications or habits and it's odd that this happened 9-10 days after both doses of the vaccine. He would like to know if this has been reported before as a side effect related to the vaccine. Caller states that he already called Safety twice, report #. Potential duplicate E-transmitting to DSU. Response:Spoke from attached documents. Referred caller to his HCP. Request Name: REQ-# Product:PFIZER-BIONTECH COVID-19 VACCINE   Question: Caller received both doses of the Pfizer-BioNtech Covid-19 vaccine (1st dose 26Jan2021, 2nd dose 15Feb2021). About ten days after the first dose he had a very lightheaded episode and he almost fainted, he went to ER and had an MRI of his head, a CT scan, a CT scan with contrast and also an echocardiogram, they were relating this to a strokelike symptom however the results were normal, also his blood test results were fine. He went to his HCP and he was schedules to get a nuclear stress test and an exercise stress test, his results came back normal; before this tests he received the second dose on 15Feb2021 and 10 days later he had again a very bad episode in his house he had a lot of vertigo, he felt the walls were moving so he went back to ER and had another EKG and CT scan, his heart was ok, so they suspected it was vertigo. He has daily episodes that las a few minutes were he feels lightheaded. He went to an otolaryngologist ("ear and nose doctor") to see if this was vertigo and had a balance test done. Caller states he had never this symptoms before, his vaccination card has the lot number for both doses, he hasn't changed his medications or habits and it's odd that this happened 9-10 days after both doses of the vaccine. He wanted to know if his information will help somebody else who may experience the same symptoms, and is his information could be useful for Pfizer.   Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that:  Patient Details Sex - Male Height - 183 cm Or 6 feet Weight -95.25 kg Or 210 pounds Is the patient also the reporter? Yes Age - 67 Years  Reporter Details Reporter type: Consumer or other non health professional Primary / Prescribing Healthcare Professional Info  (the) Event Details I have been having some strange things; it's symptom like I never had before I had almost a very light headache where I almost fainted It might be stroke like symptom I continued to have some light headed symptoms but nothing real bad; continued to have symptoms which was not normal for me  I had another episode; this was much more vertigo like or the room is spinning and the walk and things are moving  Products Suspect products: Covid Vaccine Is this a Pfizer product? Yes NDC number: Unknown UPC number: Unknown Lot Number: EL9267 Expiry date: Unknown History Concomitant Products Other Products Yes Omeprazole Indication - Acid reflux Multivitamin Amlodipine Dosage 5 MG Indication Blood pressure   Additional Context: Consumer stated, "I have been having some symptoms but I did call into one of your number yesterday and they told me call back and try to get into you but they did gave me some case number in case help you, they did an open internet case# and I will give you that number if you like it. It's # (Hence follow-up was checked). Well I have been having some strange things that I don't know if its Covid shot related but it's symptom like I never had before. After I had received the first shot, I had almost a very light headache where I almost fainted. We went to ER, they were sort of testing, it might be stroke like symptom and they did a MRI of my brain and they did CT scan of my brain and CT scan contrast. They did micro cardiogram, some EKGs and work. All of those come back normal. So I spent the night in hospital, they sent me the next day. I continued to have some light headed symptoms but nothing real bad but continued to have symptoms which was not normal for me. After I had my shot about 10 days after the second shot, I had another episode. This was much more vertigo like or the room is spinning and the walk and things are moving. I did go back to ER again just in case there was something going on. They tested again another CT scan and EKG and everything looked normal and they said it sounded like a vertigo related. I told him I had shot about 10 days after each shot, the symptoms hit me. Because of the first episode my family doctor ordered some other testing done, and they did stress test of my heart, a nuclear stress test and an exercise stress test of my heart and both came back normal. But I am continuing to have the light headed, the episodes just about daily. Sometimes they last for 30 minutes or more, multiple times a day. Sometimes I have a good day but I have those light headed episodes and I never had it before I got the shot. I am also going ENT- ear, nose and throat doctor to check on vertigo stuff and they did some testing last week and I am supposed to get the result tomorrow on what they found about vertigo test but I never had vertigo or light headed or anything before the shot. So I don't know if anybody else is reporting this but I had 2 sorts of severe episodes both of them 10ish days after each shot and I am continuing to have light headed episodes but not severe as those 2 but I had light headed dizzy episodes daily, since the Covid vaccine. I want to report it, so you guys have a report file and other people reporting it. I guess I sort of want to know if you guys were having any other report or something like this. So that I know it might be related to the shot. I am still working with my ENT and I tried to figure out if it's vertigo. If it's not vertigo then they have really run all sorts of test and if it's not vertigo we don't know if Covid shot triggered the vertigo or not. Let me know, we don't know. So they have ran 30,000 dollar test on me and so far all my tests are coming back normal." Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer was provided with the contact# for Pfizer Medical Information as # and requested to dial the Option 3 and informed about timings as Monday to Sunday from 8 am to 8 pm EST. Consumer stated, "I already did, and that's what I just dialed. I just dialed that number and option no. 3, I just dialed. That's the no. I dialed that's #and pressed option number 3. Can you forward this call to that department?" Call could not be transferred because of some technical issue. When probed for exact date of AE, "Consumer stated, hang up one second. Let me pull my card out. I think it's all I that other file that I gave but I'll give it you again. I received my first shot on January 27 of this year and I had the first episode February 10th, then I received my second shot on February 25th of this year and I believe it was march 4th, I think when I had those episodes. Those are the 2 episodes. I had smaller episodes daily but they were two bad episodes." When probed for Physician's details, Consumer stated, "It was distributed from a count location." When probed for LOT#, Consumer stated, "Hang up one second. I haven't told you one thing, my second shot was February 15 not 25. I was looking at my visa card. My first shot was EL9263 and my second shot was EL9267." Expiration date of vaccine: Consumer stated, "I doesn't have that." Dose of vaccine: Consumer stated, "It did not write that on card." When probed for anatomical site of vaccine administration, Consumer stated, "Left arm shoulder." Lab Test: Consumer stated, "Every year I go and get my yearly test in which they had my blood work and my glucose levels are always good, cholesterol level as always good. All my other tests come back as normal." (Further not clarified hence not captured in tab) Treatment: Consumer stated, "The hospital was, the emergency room gave me something for dizziness that I am no longer taking. They gave me something for dizziness when I was there but I am no longer taking it. So I am really taking nothing. This time I am working with ENT i.e. ear, nose and throat doctor, they are doing vertigo type testing but they got nothing, the results are supposed to be back tomorrow. I don't know what test they are going to show, if they do show vertigo there will be some treatments to help me. But we don't know what brought these episodes on, other than timing wise it was during the Covid shot. And I never had anything like that and I am not blaming it on the Covid shot. That was the only thing changed in my lifestyle. There might be a possibility, because that's the only thing changed, my medication has not changed, diet doesn't changed. Nothing is changed other than I got Covid." Consumer stated, "Can you give me report#." Reportum# was provided as # #Is there a product complaint to report?No Is there a medical information request?Yes Please describe the medical information request Consumer stated, "I have been having some symptoms but I did call into one of your number yesterday and they told me call back and try to get into you but they did gave me some case number in case help you, they did an open internet case# and I will give you that number if you like it. It's 4NW3L5MR (Hence follow-up was checked). Well I have been having some strange things that I don't know if its Covid shot related but it's symptom like I never had before. After I had received the first shot, I had almost a very light headed where I almost fainted. We went to ER, they were sort of testing, it might be stroke like symptom and they did a MRI of my brain and they did CT scan of my brain and CT scan contrast. They did micro cardiogram, some EKGs and work. All of those come back normal. So I spent the night in hospital, they sent me the next day. I continued to have some light headed symptoms but nothing real bad but continued to have symptoms which was not normal for me. After I had my shot about 10 days after the second shot, I had another episode. This was much more vertigo like or the room is spinning and the walk and things are moving. I did go back to ER again just in case there was something going on. They tested again another CT scan and EKG and everything looked normal and they said it sounded like a vertigo related." Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information. Consumer was provided with the contact# for Pfizer Medical Information as #and requested to dial the Option 3 and informed about timings as Monday to Sunday from 8 am to 8 pm EST. Consumer stated, "I already did, and that's what I just dialed. I just dialed that number and option no. 3, I just dialed. That's the no. I dialed that's # and pressed option number 3. Can you forward this call to that department?" Call could not be transferred because of some technical issue.