chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neck pain, Paraesthesia, Ulnar nerve injury
Clinical narrative: weakness on his left side; felt like fell off a roof; neck problems with popping; soreness in neck; tightness in the upper part of his back; tingling from his shoulder to his fingertips in both of his arms; numbness on his fingertips; weakness in his left arm; neck issue is arthritis; his shoulder to elbow is an ulnar nerve problem; a carpal tunnel pain in the bottom of his left foot.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EN6207) as DOSE 2, SINGLE for covid-19 immunisation at age of 82 years old. There were no medical history or concomitant medications. The patient previously received the first dose of bnt162b2 on 25Feb2021 (lot number EL9266) in left arm for Covid-19 immunization at age of 82 years old. After 2 weeks, the patient was in bed one night and when he woke up, he felt like fell off a roof. He had neck problems with popping and soreness in neck, tightness in the upper part of his back, tingling from his shoulder to his fingertips in both of his arms but that went away already, numbness on his fingertips, as well as weakness in his left arm. He went to the emergency room for cat scan, MRI, and other electronic test and was told that his neck issue was arthritis and his shoulder to elbow was an ulnar nerve problem and a carpal tunnel pain in the bottom of his left foot. He had weakness on his left side. His left was the worst. The patient stated that it was worse on his left side and with the exception of the tingling, have stayed the same since March and have been 6 months already. He can stand now. After the MRIs and tests, the doctors told him not to take the booster shot. They thought since all of these symptoms came on suddenly within 7 hours that it could have been a reaction to the vaccine. They told him not to take the booster. He was torn because he didn't want his immunity to go down by not getting the booster. He had symptoms on both sides, but it was worst on the left. This happened like 2 weeks later. He thought it was 12Apr2021. The only thing that went away was the tingling. The neck problem has gotten a lot better. He has to wear wrist bands on both wrists at night. He has been doing that for 6 weeks now with no change what so ever. The events all occurred on 12Apr2021. The events required emergency room visit and physician office visit. The outcome of events neck problems with popping, soreness in neck was resolving, events tightness in the upper part of his back, numbness on his fingertips was not resolved, event tingling from his shoulder to his fingertips in both of his arms was resolved, outcome of other events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gastric haemorrhage, Immunisation, Mass, Off label use
Clinical narrative: Well, that's interesting. I just recently was diagnosed with bleeding in the lining of my stomach; I have a huge lump in my arm for about three four days; The redness is fading but it''s spreading and it''s like about it''s like big rectangle on my arm is about two and half inches wide, about four and half inches long.; I did experiences a big rash.; It was a great big circle and it itched and it itched and it itched .; Booster Pfizer; Booster Pfizer; This is a spontaneous report from a contactable consumer (Patient). A 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Oct2021 (at the age of 87-year-old) (Lot Number: FF8839) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included cyanocobalamin (VITAMIN B12); donepezil; furosemide; hydralazine; labetalol; losartan, all taken for an unspecified indication, start and stop date were not reported; levothyroxine; tolterodine, all taken for an unspecified indication, start and stop dates were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date in Feb2021 (at the age of 87-year-old) (Lot Number: not reported) as DOSE 1 (BOOSTER), SINGLE and on an unspecified date in Feb2021 (at the age of 87-year-old) (Lot Number: not reported) as DOSE 2, SINGLE for COVID-19 immunization. On 06Oct2021, the patient had a huge lump in arm for about three four days and also had accompanied with the big red rash; it was a great big circle and that it itched. Since then the patient had been applying an anti-itch lotion to it and like an anti-itch cream. The redness was fading but it was spreading and it was like big rectangle on arm was and was about two and half inches wide, and about four and half inches long. It doesn't itch much but it still was itching. The patient was diagnosed with bleeding in the lining of her stomach and received pantoprazole 20 mg once a day for bleeding in the lining of my stomach and aspirin 81 mg once a day. The outcome of the events bleeding in the lining of stomach, huge lump in arm and rash was unknown. The outcome of events redness, and itching was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Well, that's interesting. I just recently was diagnosed with bleeding in the lining of my stomach; I have a huge lump in my arm for about three four days; The redness is fading but it''s spreading and it''s like about it''s like big rectangle on my arm is about two and half inches wide, about four and half inches long.; I did experiences a big rash.; It was a great big circle and it itched and it itched and it itched .; Booster Pfizer; Booster Pfizer; This is a spontaneous report from a contactable consumer (Patient). A 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Oct2021 (at the age of 87-year-old) (Lot Number: FF8839) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included cyanocobalamin (VITAMIN B12); donepezil; furosemide; hydralazine; labetalol; losartan, all taken for an unspecified indication, start and stop date were not reported; levothyroxine; tolterodine, all taken for an unspecified indication, start and stop dates were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date in Feb2021 (at the age of 87-year-old) (Lot Number: not reported) as DOSE 1 (BOOSTER), SINGLE and on an unspecified date in Feb2021 (at the age of 87-year-old) (Lot Number: not reported) as DOSE 2, SINGLE for COVID-19 immunization. On 06Oct2021, the patient had a huge lump in arm for about three four days and also had accompanied with the big red rash; it was a great big circle and that it itched. Since then the patient had been applying an anti-itch lotion to it and like an anti-itch cream. The redness was fading but it was spreading and it was like big rectangle on arm was and was about two and half inches wide, and about four and half inches long. It doesn't itch much but it still was itching. The patient was diagnosed with bleeding in the lining of her stomach and received pantoprazole 20 mg once a day for bleeding in the lining of my stomach and aspirin 81 mg once a day. The outcome of the events bleeding in the lining of stomach, huge lump in arm and rash was unknown. The outcome of events redness, and itching was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Abscess oral, Aphthous ulcer, X-ray
Clinical narrative: canker sore in my mouth; abscess in my mouth; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Jan2021 (at age of 79 years old, Lot Number: EL8982) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that when or after had first Pfizer shot, patient got a canker sore in mouth and thought that it was an abscessed tooth. So, patient went to a dentist and they did an X-ray, no that was not it. Patient had never had an abscess in mouth before and it happened a day or may be two days after first vaccine and so, that was all that day or could contribute it to, there was nothing else different. No treatment received. The outcome of the event was recovered. The patient also reported that when had second vaccine (on 07Feb2021, lot number: EL9263) everything was fine and just had booster today on 13Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact, Immunisation, Off label use, Pain in extremity
Clinical narrative: Sore left arm/ pain in his left arm.; The patient also had reaction to the Band-Aid that was put on his left arm after the Pfizer COVID third booster; They gave him the 3rd COVID booster shot on 28Sep2021; They gave him the 3rd COVID booster shot on 28Sep2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Sep2021 (at the age of 55-year-old) (Lot number and expiration date was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient did not have medical history and concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date in Dec2020 (at the age of 54-year-old) (Lot number and expiration date was not reported) as DOSE 1, SINGLE and on an unspecified date in Jan2021 (at the age of 54-year-old) (Lot number and expiration date was not reported) as DOSE 2, SINGLE for COVID-19 immunization. On 28Sep2021, the patient had sore left arm. The patient also had reaction to the Band-Aid that was put on his left arm after the Pfizer COVID third booster. It caused a reaction on his left arm. It was like getting a tattoo. He only had a reaction from the Band-Aid on the 3rd booster. He got it in the morning around 10 to 10:30. Then, about 2 to 2:30, he took the Band-Aid off, and there was a mark on the band aid. It was like a strip mark. It was like an adhesive mark on his left arm. He peeled the adhesive off. In a couple of days, it was itchy. He went to the occupation health department for assessment. They told him to wash it with saline water and put hydrocortisone 1% on it. They told him to go to his Primary care physician at hospital. He asked if he could take Hydrocortisone 2.5% on it, and they said yes. He has continued to do that. The mark was getting lighter but it was still there. There was no other reaction or sign of reaction to the vaccine 3rd dose. The patient received treatment with paracetamol (TYLENOL). The patient had a couple days of pain in his left arm. The patient recovered from sore arm. The outcome of other events was unknown.  Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, White blood cell count, White blood cell count decreased
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program via a Regulatory Authority Support Program from a contactable other healthcare professional, physician and consumer, patient. A 57-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. Medical history included ongoing breast cancer. The concomitant medications were not reported. On an unknown date the patient experienced white blood cell count was slightly down prior to starting ibrance. patient had corona booster prior to blood work being done, Off label use and Booster. It was reported that initial: ibrance 125 mg daily times 21 days off 7 days with faslodex. patient reports white blood cell count was slightly down prior to starting ibrance. patient had corona booster prior to blood work being done. patient is dissolving her ibrance per ibrance instructions due to having a stricture of esophagus. Doctor of medicine aware. The patient underwent lab tests included white blood cell count that was slightly down on an unknown date. Case was from a Marketing program but suspect product was not part of the RA, marketing/stimulate classification and will be maintained for tracking purposes.The outcome of the event white blood cell count was slightly down prior to starting ibrance  was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer, (manufacturer control number: 21K-163-4111476-00). A contactable consumer (patient) reported that a 60-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot Number: 1153557) at unknown dose for Moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced rheumatoid arthritis flare up. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of event was not recovered. Causality for adalimumab was not provided by reporter and for bnt162b2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported event of Rheumatoid arthritis flare up. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Culture wound, Rash vesicular, Viral test
Clinical narrative: vesicular rash; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscularly administered in right deltoid on 17May2021 10:00 (lot number: EW0186; Pfizer) (52-year-old at vaccination) as single dose for COVID-19 immunisation. Patient's medical history included myelodysplatic syndrome with 5Q deletum from 04Dec2014 and ongoing (in remission), prothrombin gene mutation from 10Dec2018 and ongoing, thrombocytopenia from 20Aug2004 (controlled values normalized), hypothyroidism from 23Jun2005 to 01Jan2008 (diet controlled), hyperlipidemia from 16Feb2006 and ongoing (on medication). Family medical history relevant to AE(s) included family history of hypercholesterol, thromboembolic disease, cancer of ovary. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscularly, administered in left deltoid on 19Apr2021 at 13:00 (lot number: EW0153) for COVID-19 immunisation and experienced vesicular rash and redness. Prior vaccination included Infs press free adult 4 years (Manufacturer: Seqirus; Batch/ Lot: 290295) intramuscularly in left deltoid (No. of previous doses: 10) on 11Feb2021. Concomitant drugs included Baby aspirin for Prothrombin gene mutation orally from 2010 and ongoing, multivitamin for nutritional support Orally from 2010 and ongoing, paracetamol (TYLENOL) for Pain from vaccine orally from 19Apr2021 to 22Apr2021. Vaccination facility type was hospital/ workplace clinic. The patient was not pregnant. The patient experienced Re-occurance of vesicular rash one day post 2nd covid vaccine (on 18May2021). Seriousness criteria were important medical event. AE Required visit to emergency room (urgent care, physician office. The outcome of event was resolved with sequalae on 28May2021. Treatment received included Clobestasol ointment. The reporter considered the Pfizer product had a causal effect to the adverse event. Relevant tests included varicella zoster virus detection on 25Apr2021 with results: not detected (comments: not detected); wound culture on 25Apr2021 with comments: results not found.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted covid (was fully vaccinated); contracted covid (was fully vaccinated); This is a spontaneous report from a contactable other health professional and a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient contracted covid (was fully vaccinated) last month in Sep2021, now resolved. The outcome of the events was recovered.    The Lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the events drug ineffective and COVID-19 cannot be completely excluded.The case will be reassessed if additional information becomes available.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Amputation, Thrombosis
Clinical narrative: Blood clots; hospitalized each time and his body parts were amputated; This is a spontaneous report from a contactable consumer received via a Pfizer Sponsored Program. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date was not reported) via an unspecified route of administration on 19Mar2021 as dose 1, single and on 09Apr2021 as dose 2, single and on 02Oct2021 as dose 3 (booster dose), single for COVID-19 immunisation. The patient medical history was not reported. The patient has been taking unspecified concomitant medications. No other prior vaccinations. It was reported that, on an unspecified date in 2021, every time he got a vaccine, he ended up getting blood clots. With those blood clots, each time he was hospitalized and had to get an amputation. At the time of report, he had done three amputations and was still hospitalized. The last time, he was hospitalized on 03Oct2021, a day after he got the booster shot. The patient wanted to know if there is anything that can be done about it or if there is a study or if that's normal. The outcome of the events was not recovered.  The lot number for [BNT162B2] was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: she has an arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1283, Expiration date: Not reported), via an unspecified route of administration on 27Jan2021 (at the age of 58-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications/other products. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140, Expiration date: Not reported), via an unspecified route of administration on 05Jan2021 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization. The patient was diagnosed with arrhythmia after first two doses of vaccine in Feb2021. There was no investigation assessment reported. The outcome of the event was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID breakthrough cases where the 2 individuals had received Pfizer vaccine; the individuals were surprised they tested positive since they were vaccinated; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two different patients. This is the first of two reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 2, single, for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single, for covid-19 immunization. It was reported that there were recent COVID breakthrough in patient who received the vaccine; that was mild case of COVID, and the patient was surprised that tested positive after vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date.  It was unknown whether the patient received any treatment. The outcome of the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101376953 same reporter/drug/event and different patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis; This is a spontaneous report from a contactable consumer (the patient)  A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 (Batch/Lot Number: FE3592) as single dose for covid-19 immunisation  .  Medical history included surgery.  There were no concomitant medications.  The patient experienced cellulitis (medically significant) on 2021 with outcome of unknown.    Only reason she waited to get the second dose was because she had a skin bacteria called cellulitis.  Follow up information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: Stye; This is a spontaneous report from contactable nurse. This nurse reported similar events for 4 patients. This is one of the 4 reports (for reporter's sister son). An adult male patient received bnt162b2 (BNT162B2), Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included hordeolum from an unknown date and unknown if ongoing (patient's grandmother (his mother's mother)). The patient's concomitant medications were not reported. The patient experienced stye (medically significant) on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the event Hordeolum and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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-202101375744 Same reporter, drug and event, different patient;US-PFIZER INC-202101375851 Same reporter, drug and event, different patient;US-PFIZER INC-202101375859 Same reporter, drug and event, different patient
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Lip swelling, Migraine, Paraesthesia oral
Clinical narrative: Short of breath; because of migraine my eyes I have hard time to read; lips were swelling; my tongue was swollen and tingling; my tongue was swollen and tingling; tight chest; I am still using my accessory muscles, high in the chest to breathe; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FH8020), intramuscular, administered in Arm Left on 12Oct2021 at the age of 63-year-old as dose 1, single for covid-19 immunisation. Medical history included allergic to phosphate, sulphate, total right shoulder replacement surgery in June end, gained weight since going off with Topiramate (The reason of going off patient was 180 in January) and patient had stage three kidney disease which was apparently from Tramadol and 'Omni Prozac' generic 45% (not clarified,  Patient nephrologist told me, in January with Psychiatrist, put down dose from 200 milligram and patient finished the last dose a month ago and she went from 3 tramadol a day to 2 and next time it will be moved down to one). The patient was on a lot of medication. On 12Oct2021 patient received vaccination, she stayed there for 30 minutes and was already having the migraine as she was leaving and 30 minutes after, she was having shorter breath and the tight chest and took the quick acting inhaler and it helped to open up the tightness but remains short of breath for 6 hours. The patient's lips were swollen and tongue was swollen and tingling. She have been taking a 100 mg of Benadryl since before the shot. They were out of Moderna and Pfizer has Phosphate in it. So, her doctor told to bring Benadryl and quick acting inhaler. she had short of breath and needed the quick inhaler three times since 12Oct2021. Patient took 100 milligrams of Benadryl about every 6 to 8 hours and quick acting inhaler (Levalbuterol Tartrate HFA) that does not have Sulphate in it. Patient still using accessory muscles, high in the chest to breathe. Patient was concerned about the 2nd dose in a month, and it will be right after her physical therapy appointment. The outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal, Swollen tongue
Clinical narrative: Short of breath; because of migraine my eyes I have hard time to read; lips were swelling; my tongue was swollen and tingling; my tongue was swollen and tingling; tight chest; I am still using my accessory muscles, high in the chest to breathe; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FH8020), intramuscular, administered in Arm Left on 12Oct2021 at the age of 63-year-old as dose 1, single for covid-19 immunisation. Medical history included allergic to phosphate, sulphate, total right shoulder replacement surgery in June end, gained weight since going off with Topiramate (The reason of going off patient was 180 in January) and patient had stage three kidney disease which was apparently from Tramadol and 'Omni Prozac' generic 45% (not clarified,  Patient nephrologist told me, in January with Psychiatrist, put down dose from 200 milligram and patient finished the last dose a month ago and she went from 3 tramadol a day to 2 and next time it will be moved down to one). The patient was on a lot of medication. On 12Oct2021 patient received vaccination, she stayed there for 30 minutes and was already having the migraine as she was leaving and 30 minutes after, she was having shorter breath and the tight chest and took the quick acting inhaler and it helped to open up the tightness but remains short of breath for 6 hours. The patient's lips were swollen and tongue was swollen and tingling. She have been taking a 100 mg of Benadryl since before the shot. They were out of Moderna and Pfizer has Phosphate in it. So, her doctor told to bring Benadryl and quick acting inhaler. she had short of breath and needed the quick inhaler three times since 12Oct2021. Patient took 100 milligrams of Benadryl about every 6 to 8 hours and quick acting inhaler (Levalbuterol Tartrate HFA) that does not have Sulphate in it. Patient still using accessory muscles, high in the chest to breathe. Patient was concerned about the 2nd dose in a month, and it will be right after her physical therapy appointment. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had 2 recent Covid breakthrough cases where the 2 individuals had received Pfizer vaccine.; Had 2 recent Covid breakthrough cases where the 2 individuals had received Pfizer vaccine.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patient. This is second of the 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as DOSE 2, SINGLE, via an unspecified route of administration and via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. It was unknown if patient received other vaccine in four weeks. On an unknown specified date, the patient was tested positive for COVID and had drug ineffective. It was unknown if the patient received treatment for the events. The outcome of events was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375616 same reporter, drug and event, different patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Feeling abnormal
Clinical narrative: I thought it was early dementia. I had a little of that with the 2nd shot; The foggy headedness had me concerned and was scary; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW6201), via an unspecified route of administration, administered in Arm Right on 01Mar2021 11:00 at the age of 67-year-old as dose 2, single for covid-19 immunisation from pharmacy or drug store.  The patient medical history included biaxin allergy. Concomitant medication included vitamin d taken for an unspecified indication, start and stop date were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM9809), via an unspecified route of administration, administered in Arm Right on 08Feb2021 10:00 at the age of 67-year-old as dose 1, single for covid-19 immunisation. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. In 2021, patient experienced foggy headedness which had concerned and scared her. Patient thought it was early dementia. She had a little of that with the 2nd shot but this was much worse. The patient did not receive any treatment in response to the events. The outcome of the events was recovered.    No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: caught COVID-19 after first vaccine; caught COVID-19 after first vaccine; This is a spontaneous report from a contactable physician. A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Aug2021 16:00 (Batch/Lot number was not reported) (at the age of 21-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Attention deficit hyperactivity disorder (ADHD) from an unknown date and ongoing, vitamin d deficiency from an unknown date and ongoing. Concomitant medications included methylphenidate hydrochloride (CONCERTA) taken for ADHD from an unspecified start date and ongoing; colecalciferol (VIT D3) taken for vitamin d deficiency from an unspecified start date and ongoing. The patient caught covid-19 after first vaccine on an unspecified date and then when he had the second vaccine he had fever, chills and fatigue. The patient had covid infection between dose1 and dose2. Vaccines were not given at this clinic. Not treated for covid here. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Blood pressure measurement, Dizziness, Fatigue
Clinical narrative: lost 5 lbs; BP shot upwards/High blood pressure; dizzy; fatigue; Extreme weakness; he had been in bed for 3 days; The patient received an unknown Covid-19 vaccine as dose one and two.; The patient received an unknown Covid-19 vaccine as dose one and two.; This is a spontaneous report from a contactable consumer (the daughter).  A 96-years-old male patient received bnt162b2 (BNT162B2), dose 3 booster intramuscular on 04Oct2021 10:30 (Batch/Lot number was not reported) as single dose  for covid-19 immunization. Medical history included ongoing gout (15-20 years ago), cardiac disorder from 2013 and ongoing , back pain from 1960 and ongoing , skin cancer from 2019 to 2019 (2019 couple months before removed) , surgery on 2019, covid-19 from May2021 to an unknown date. Concomitant medications included apixaban (ELIQUIS) taken for gout from an unspecified start date and ongoing; diphenhydramine hydrochloride (BENYLIN [DIPHENHYDRAMINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing.  The patient received an unknown Covid-19 vaccine as dose one and two. The patient experienced BP shot upwards/high blood pressure  (medically significant) on 12Oct2021 with outcome of recovered , dizzy  (medically significant) on Oct2021 with outcome of unknown , lost 5 lbs  (medically significant) on an unspecified date with outcome of unknown , extreme weakness  (medically significant) on Oct2021 with outcome of recovering , fatigue  (medically significant) on Oct2021 with outcome of recovering , he had been in bed for 3 days  (medically significant) on Oct2021 with outcome of recovered.  The patient underwent lab tests and procedures which included blood pressure measurement: 180/??   on 12Oct2021   , blood pressure measurement: 120s/??   on 12Oct2021   , weight: lost 5 lb lbs on Oct2021.  Course of the event. A few days after receiving the Pfizer vaccine (he doesn't remember when it started exactly), he became extremely weak. He had to stay in bed, could not move or eat (spoke with the reporter about this, his daughter 06Oct2021 and told her he had been in bed for 3 days). He lost 5 lb. It took 4-5 days for him to start walking a little bit. Yesterday his BP shot upwards to over 180/?? (he became very dizzy). It went down at the end of the day to 120s/?? after lying down.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up..
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Interchange of vaccine products, Off label use, Weight, Weight decreased
Clinical narrative: lost 5 lbs; BP shot upwards/High blood pressure; dizzy; fatigue; Extreme weakness; he had been in bed for 3 days; The patient received an unknown Covid-19 vaccine as dose one and two.; The patient received an unknown Covid-19 vaccine as dose one and two.; This is a spontaneous report from a contactable consumer (the daughter).  A 96-years-old male patient received bnt162b2 (BNT162B2), dose 3 booster intramuscular on 04Oct2021 10:30 (Batch/Lot number was not reported) as single dose  for covid-19 immunization. Medical history included ongoing gout (15-20 years ago), cardiac disorder from 2013 and ongoing , back pain from 1960 and ongoing , skin cancer from 2019 to 2019 (2019 couple months before removed) , surgery on 2019, covid-19 from May2021 to an unknown date. Concomitant medications included apixaban (ELIQUIS) taken for gout from an unspecified start date and ongoing; diphenhydramine hydrochloride (BENYLIN [DIPHENHYDRAMINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing.  The patient received an unknown Covid-19 vaccine as dose one and two. The patient experienced BP shot upwards/high blood pressure  (medically significant) on 12Oct2021 with outcome of recovered , dizzy  (medically significant) on Oct2021 with outcome of unknown , lost 5 lbs  (medically significant) on an unspecified date with outcome of unknown , extreme weakness  (medically significant) on Oct2021 with outcome of recovering , fatigue  (medically significant) on Oct2021 with outcome of recovering , he had been in bed for 3 days  (medically significant) on Oct2021 with outcome of recovered.  The patient underwent lab tests and procedures which included blood pressure measurement: 180/??   on 12Oct2021   , blood pressure measurement: 120s/??   on 12Oct2021   , weight: lost 5 lb lbs on Oct2021.  Course of the event. A few days after receiving the Pfizer vaccine (he doesn't remember when it started exactly), he became extremely weak. He had to stay in bed, could not move or eat (spoke with the reporter about this, his daughter 06Oct2021 and told her he had been in bed for 3 days). He lost 5 lb. It took 4-5 days for him to start walking a little bit. Yesterday his BP shot upwards to over 180/?? (he became very dizzy). It went down at the end of the day to 120s/?? after lying down.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up..
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Respiratory distress, SARS-CoV-2 test, Somnolence
Clinical narrative: Respiratory distress; sleeps a lot; out of breath/ difficulty breathing; memory (short) problem; blister mouth; high blood pressure; oxygen 83-85; Temperature-100.3/100.8 Fahreinheit; Grunting; Dry cough; This is a spontaneous report from a contactable other healthcare professional. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Sep2021 23:00 (Lot Number: FC3182) (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from Jun2020 and in 30Jun2020 for 10 days in hospital with Covid. The patient's concomitant medications were not reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior event being reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Aug2021 10:44 (Lot Number: EW0176) (at the age of 79-years-old) as dose 1, single for covid-19 immunisation and experienced short term memory, brain fog, sleeping a lot, out of breath. After 2nd injection on unspecified date in 2021, patient had 100.3/100.8 Fahrenheit degrees, high blood pressure, O2 (oxygen saturation) 83-85 for 5 days and out of breath. The signs and symptoms included sleeps a lot, out of breath, memory (short) problem, blister mouth in 2021. The time course of the reaction was between approximately 5 days and now. The patient did not require medical intervention for the events. The patient was not seen in the emergency department. The patient was not admitted to an intensive care unit. The Multiorgan involvement included Respiratory (out of breath) with respiratory distress, grunting (during night the most), dry cough, difficulty breathing. There was no hoarse voice, and it was unknown if patient had recession and cyanosis. The patient provided information to the reporter regarding the reported adverse event with the use of the product and the reporter considered the Pfizer product had a causal effect to the adverse. The outcome of blood pressure high, oxygen saturation decreased, body temperature increased was recovered in 2021 and outcome of all other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported event Respiratory distress. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood pressure decreased, Blood pressure measurement, Heart rate
Clinical narrative: dropping my pulse to 41, 40, 42; weight loss; loss of taste smell; loss of taste smell; fever; blood pressure was 100/60 or 90/55; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Aug2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of Comirnaty on 23Jul2021 for Covid-19 Immunization. On an unspecified date in 2021, the patient experienced weight loss, loss of taste smell, fever, dropping my pulse to 41, 40, 42, and blood pressure was 100/60 or 90/55. The patient reported she had terrible side effects from the shots. She got her second one and it all gone worse. The patient reported that she had emergency change for her heart medicine (Unspecified Medication) because they were certainly way too strong, dropping my pulse to 41, 40, 42. Her blood pressure was 100/60 or 90/55 and she was basically dying at home (as reported). The patient added that she was losing weight and could not taste or smell anything, and fever. She mentioned that she was in the hospital (pending clarification). The patient reported, "In Mar2020 (as reported-pending clarification), I was losing weight, I could not taste or smell anything, I had a raging fever, and it was spiking back and forth, and I said I do not get a fever very frequently actually". The outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Pyrexia, SARS-CoV-2 test, Weight decreased
Clinical narrative: dropping my pulse to 41, 40, 42; weight loss; loss of taste smell; loss of taste smell; fever; blood pressure was 100/60 or 90/55; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Aug2021 (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of Comirnaty on 23Jul2021 for Covid-19 Immunization. On an unspecified date in 2021, the patient experienced weight loss, loss of taste smell, fever, dropping my pulse to 41, 40, 42, and blood pressure was 100/60 or 90/55. The patient reported she had terrible side effects from the shots. She got her second one and it all gone worse. The patient reported that she had emergency change for her heart medicine (Unspecified Medication) because they were certainly way too strong, dropping my pulse to 41, 40, 42. Her blood pressure was 100/60 or 90/55 and she was basically dying at home (as reported). The patient added that she was losing weight and could not taste or smell anything, and fever. She mentioned that she was in the hospital (pending clarification). The patient reported, "In Mar2020 (as reported-pending clarification), I was losing weight, I could not taste or smell anything, I had a raging fever, and it was spiking back and forth, and I said I do not get a fever very frequently actually". The outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.