chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Condition aggravated, Decreased appetite, Dry mouth
Clinical narrative: in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Feeling hot, Flatulence, Headache, Hyperhidrosis
Clinical narrative: in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypopnoea, Insomnia, Lacrimation increased, Malaise, Mobility decreased
Clinical narrative: in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Sneezing
Clinical narrative: in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain, Weight decreased
Clinical narrative: in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Balance disorder, Blood pressure decreased, Blood pressure measurement, Body temperature
Clinical narrative: weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of  bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Hypopnoea, Insomnia, Myalgia, Oxygen saturation
Clinical narrative: weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of  bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Vaccination site pain, Weight, Weight decreased
Clinical narrative: weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of  bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. 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: Feeling abnormal, Magnetic resonance imaging
Clinical narrative: Did not feel right; This is a spontaneous case from a contactable consumer (on behalf of a patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, at an unknown anatomical location, on an unknown date and time at a single dose for covid-19 immunisation (age at the vaccination was unknown). Medical history and concomitant medication were not reported. On an unknown date, the patient did not feel right and is currently in the hospital awaiting MRI results. The treatment received for the adverse event was unknown. This case was reported as serious. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bacterial infection, Disability, Dyspepsia, Fatigue
Clinical narrative: specifically in the stomach area; digestive problems; bacterial infection; verry ill; debilitating symptoms; disability; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program. A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter reported behalf of his sister-in-law (patient) who had the first shot of the vaccine on 28JAN2021. The day after she became very ill and at first associated her symptoms with the vaccine. She immediately experienced debilitating symptoms after consulting her doctor, they ruled that out and said that it was a coincidence. She had fatigue and digestive problems from a bacterial infection. Symptoms were that of a bacterial infection, specifically in the stomach area. She received treatment for that and had therapy for a disability. She has yet to receive her 2nd dose. Since she experienced these symptoms, she has been afraid of getting the second dose of the vaccine. Reporter would like to know what to do since she exceeded the recommended three-week window for Pfizer, as well as the six-week window for the CDC. They have consulted with doctors, pharmacist, and was aware of the CDC 42 day window and was asking for what to do with her vaccine. The outcome of the events was unknown.   No further information is expected. Batch/Lot number is not obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: specifically in the stomach area; digestive problems; bacterial infection; verry ill; debilitating symptoms; disability; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program. A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter reported behalf of his sister-in-law (patient) who had the first shot of the vaccine on 28JAN2021. The day after she became very ill and at first associated her symptoms with the vaccine. She immediately experienced debilitating symptoms after consulting her doctor, they ruled that out and said that it was a coincidence. She had fatigue and digestive problems from a bacterial infection. Symptoms were that of a bacterial infection, specifically in the stomach area. She received treatment for that and had therapy for a disability. She has yet to receive her 2nd dose. Since she experienced these symptoms, she has been afraid of getting the second dose of the vaccine. Reporter would like to know what to do since she exceeded the recommended three-week window for Pfizer, as well as the six-week window for the CDC. They have consulted with doctors, pharmacist, and was aware of the CDC 42 day window and was asking for what to do with her vaccine. The outcome of the events was unknown.   No further information is expected. Batch/Lot number is not obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pallor, Vascular occlusion
Clinical narrative: Vascular occlusion; Area blanched; Bruising; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, in Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included gastric bypass and rheumatoid arthritis. The patient's concomitant medications included botulinum toxin type A haemagglutinin complex (DYSPORT; Lot Number: T18469, Expiration Date: Aug2021), hyaluronic acid (RESTYLANE; Lot Number: 17763, Expiration Date: Sep2022), and durapatite (RADIESSE) (lower half of the face), all three from 17Feb2021; epinephrine/ lidocaine as premedication; and an unspecified multivitamin. The healthcare professional premedicated the patient with epinephrine/lidocaine. As the healthcare professional was injecting around 0.25 mL of hyaluronic acid in the right cheek, with a cannula, she noticed that the area blanched (unspecified date). The healthcare professional immediately withdrew and applied warm compresses to the area. The patient was experiencing a vascular occlusion. The healthcare professional injected 5 vials of vorhyaluronidase alfa (HYLENEX) into the area. The patient only experienced bruising which eventually resolved. All events have resolved. It is unknown if the patient has history of fillers or toxins. Almost exactly 4 weeks prior to the injection, the patient had the COVID-19 vaccine, but the healthcare professional is not sure which one the patient received (pending clarification). The healthcare professional assessed that COVID-19 is the suspect product. The patient had not had any dental procedures in the last 4 weeks leading up to injection. The healthcare professional did not know if the patient had any other vaccinations or any illness or sickness leading up to injection date. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the very close temporal association, the reported vascular occlusion with pallor and bruising seems more likely an adverse effect of hyaluronic acid injection and is deemed unrelated to BNT162b2 vaccine.  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: Back pain, Gait inability, Insomnia
Clinical narrative: no ability to stand or walk; difficulty sleeping; EXTREME back pain; This is a spontaneous report received from Pfizer. A contactable consumer reported for his wife (patient) that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) 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. It was reported that reporters wife has been suffering from what we believe to be an extreme reaction to her 1st Pfizer vaccine dose. She had reported it to the VAERS site with no response or follow up from them. Her symptoms include almost no ability to stand or walk, difficulty sleeping and EXTREME back pain. Reporter took her to the ER and she had a night in the hospital. It had been 10 days. Outcome of the events was unknown.   Information about lot/batch number has been requested
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Blindness unilateral, Fatigue, Retinal tear, Ultrasound eye, X-ray
Clinical narrative: no vision on right eye; Torn retina; Little tired; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 75-years-old, administered in Arm Left on 26Feb2021 16:55 (Lot Number: EN6200) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included prednisone taken for Ruptured disc from 11Feb2021 to 19Feb2021 and from 07Mar2021 to 17Mar2021. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 04:55 AM (Lot Number: EL9265) as a single dose for COVID-19 immunization and experienced severe back pain and sore arm. The patient reported, "I chose to not fill this auto entirely with help. I had a sore arm after dose 1, little tired after dose 2. I reported I had a torn retina days after dose 2 but did not think it was due to the vaccine. Just wondered it happened 3-10, still can't see, under doctors care. I don't think the prednisone or the eye issue was caused by the vaccine but reported it." The patient experienced torn retina on 12Mar2021 and little tired on 2021. The patient underwent lab tests and procedures which included eye ultrasound: torn retina, no vision in right eye. Still no vision 22Mar2021 (under doctors care) on 12Mar2021, X-ray: hip degeneration on 10Feb2021. The outcome of the events was unknown. The event torn retina was considered as serious (medically significant). Vaccination facility type was Hospital.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, the reported torn retina is likely an intercurrent medical condition and unrelated to BNT162B2. The patient's advanced age have been assessed as a risk factor that could have contributed to the event.
Sex: M
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male (as reported; pending clarification) patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. They wanted to know if the patient can still get the second dose of COVID-19 vaccine next Monday (05Apr2021) if the patient started antibiotics for diverticulitis on an unspecified date. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable physician. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The physician was giving Pfizer vaccines as part of his medical group to patients and employees. One patient came in today (29Mar2021) for her second dose and the day after she got her first shot, she got shingles on an unspecified date. The physician considered the event serious as other medically important condition. It was improving but has not gone away completely. The patient did not receive the second dose today, states they rescheduled her appointment for tomorrow 30Mar2021. The physician wanted to know if this is something that has been reported, could it be connected to the vaccine and if so, what is the guidance about second doses. The patient was recovering from the event.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "Shingles" cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Bone pain, Immune system disorder, Lymphadenopathy, Pain
Clinical narrative: huge hives all over her arms and leg; she was having a rare delayed response to the vaccine as her immune system kicks into high gear; fever and aches last night; fever and aches last night; bone aches; swollen lymph nodes; This is a spontaneous report from a contactable consumer.  A female patient in her mid 40s (5 decade) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient went to the doctor who said that she was having a rare delayed response to the vaccine as her immune system kicks into high gear. The reporter also took a covid test to be safe. The reporter doesn't know how long it will last but he's seen a few cases like this, swollen lymph nodes, hives, bone aches, over a week after the shot. The patient had fever and aches last night, and woke up with hives again. She will be seeing her doctor today. She developed huge hives all over her arms and leg 5 days after her second dose of the Pfizer covid vaccine. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: huge hives all over her arms and leg; she was having a rare delayed response to the vaccine as her immune system kicks into high gear; fever and aches last night; fever and aches last night; bone aches; swollen lymph nodes; This is a spontaneous report from a contactable consumer.  A female patient in her mid 40s (5 decade) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient went to the doctor who said that she was having a rare delayed response to the vaccine as her immune system kicks into high gear. The reporter also took a covid test to be safe. The reporter doesn't know how long it will last but he's seen a few cases like this, swollen lymph nodes, hives, bone aches, over a week after the shot. The patient had fever and aches last night, and woke up with hives again. She will be seeing her doctor today. She developed huge hives all over her arms and leg 5 days after her second dose of the Pfizer covid vaccine. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Arthralgia, Cyanosis, Joint swelling, Ultrasound joint
Clinical narrative: had swelling and pain in her wrist; had swelling and pain in her wrist; her fingers turned a deep blue; caller was given some medication to dilate her blood vessels; This is a spontaneous report from a contactable consumer.   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on right arm on 17Mar2021 17:00 (Batch/Lot Number: EN6206) at single dose (at the age of 68 years old) for COVID-19 immunisation.  The patient had no medical history.  Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  On 19Mar2021, the patient had swelling and pain in her left wrist, the following day her fingers turned a deep blue. The patient was sent to the hospital to rule out a blood clot, they couldn't find a clot and couldn't tell the patient if this was related to the vaccine. The patient was given some medication to dilate her blood vessels to take when the patient gets the second if she needs it. This happened in the opposite arm that the caller received the vaccine. The patient had an angiogram of the wrist on 21Mar2021, they injected dye into the patient's wrist then she went through the CT scan on 20Mar2021 and the results were negative. The patient was hospitalized on 20Mar2021 to 22Mar2021. The outcome of her fingers turned a deep blue recovered on 22Mar2021 and other events was recovered on Mar2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: had swelling and pain in her wrist; had swelling and pain in her wrist; her fingers turned a deep blue; caller was given some medication to dilate her blood vessels; This is a spontaneous report from a contactable consumer.   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on right arm on 17Mar2021 17:00 (Batch/Lot Number: EN6206) at single dose (at the age of 68 years old) for COVID-19 immunisation.  The patient had no medical history.  Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  On 19Mar2021, the patient had swelling and pain in her left wrist, the following day her fingers turned a deep blue. The patient was sent to the hospital to rule out a blood clot, they couldn't find a clot and couldn't tell the patient if this was related to the vaccine. The patient was given some medication to dilate her blood vessels to take when the patient gets the second if she needs it. This happened in the opposite arm that the caller received the vaccine. The patient had an angiogram of the wrist on 21Mar2021, they injected dye into the patient's wrist then she went through the CT scan on 20Mar2021 and the results were negative. The patient was hospitalized on 20Mar2021 to 22Mar2021. The outcome of her fingers turned a deep blue recovered on 22Mar2021 and other events was recovered on Mar2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Condition aggravated, Dysstasia, Gait disturbance, Hemiparesis
Clinical narrative: problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; dragging her feet; trouble standing up; feels like a stroke in her leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), intramuscular, administered in the left arm on 24Mar2021 at 12:30 as a single dose for COVID-19 immunization.  Medical history included stroke on Dec2015 and Feb2016 and ongoing left side, having weakness since she had a stroke. The patient's mother had a really bad stroke on an unspecified date in her 80's. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNt162B2 (lot number: EN6208) on 03Mar2021 for COVID-19 immunization and had a sore right arm. It was reported that on 26Mar2021, the patient was dragging her feet and having trouble standing up. This occurred after her second shot. She has had a problem with her left side, having weakness since she had a stroke at the age 62 years. She worked through it and it was fine. But when she took the 2nd shot, it's been bothering her through the weekend. Her left side weakness worsened. She described the feeling like the stroke. Her doctor said when she gets sick, it could mimic her stroke symptoms. She added it is worse in the morning when she tries to get up. The patient added that her leg is affected, and feels like a stroke in her leg on Mar2021. She had no treatment for her experience and doesn't know if there is a treatment for what she is experiencing. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 0.17
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: He passed out, he couldn't stay awake/ passing out; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 29Mar2021 10:45 (Batch/Lot Number: ER8132) as SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history reported as none.  Concomitant medications were not reported. The patient also had no prior vaccinations (within 4 weeks). On 29Mar2021 around 6:30 or 7 PM, the was at the house when the passing out began where he couldn't stay awake. The patient was brought to emergency room and was admitted in the hospital on that same day of 29Mar2021. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he contracted or tested positive for Covid-19 virus; This is a spontaneous report received from a Pfizer-sponsored program. A contactable Consumer reported for himself that, a male patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 17Mar2021 (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 received his 1st dose on 17Mar2021 and was not yet scheduled for 2nd dose. He mentioned that he contracted or tested positive for Covid-19 virus yesterday. He wanted to know how he would proceed with his 2nd dose. The patient experienced he contracted or tested positive for covid-19 virus on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The event assessed as medically significant. Outcome of the event was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Ear pain, Feeling abnormal, Headache
Clinical narrative: delirium; aches; chills; headache; fever; sore muscle in vaccine location; head congestion; earaches; brain fog; This is a spontaneous report from a non-contactable consumer reporting for herself   A 22-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730) on 22Mar2021 at 10:00 am at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included known allergy to sulfa. The patient received first dose of vaccine on 05Mar2021 (Lot #:EN6199) at 12:00 pm, on Left arm. Concomitant medications included ethinylestradiol, norgestimate (TRI FEMYNOR) and minocycline. On 22Mar2021 at 19:00 the patient experienced aches, chills, headache, fever, sore muscle in vaccine location, head congestion, earaches, brain fog and delirium. The patient recovered from the events on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Upper respiratory tract congestion, Vaccination site pain
Clinical narrative: delirium; aches; chills; headache; fever; sore muscle in vaccine location; head congestion; earaches; brain fog; This is a spontaneous report from a non-contactable consumer reporting for herself   A 22-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730) on 22Mar2021 at 10:00 am at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included known allergy to sulfa. The patient received first dose of vaccine on 05Mar2021 (Lot #:EN6199) at 12:00 pm, on Left arm. Concomitant medications included ethinylestradiol, norgestimate (TRI FEMYNOR) and minocycline. On 22Mar2021 at 19:00 the patient experienced aches, chills, headache, fever, sore muscle in vaccine location, head congestion, earaches, brain fog and delirium. The patient recovered from the events on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Feeling abnormal, Memory impairment, Seizure, Somnambulism
Clinical narrative: Seizures; dazelike stance for many days; forgetfulness; Feeling like sleepwalking; Memory loss; This is a spontaneous report received from a contactable consumer (patient) . A adult no pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID    The patient's concomitant medications were not reported. On 21Mar2021 the patient experienced seizures, dazelike stance for many days, forgetfulness, feeling like sleepwalking and  memory loss The adverse events resulted_in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.No treatment received for the events.The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19   Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.