chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cyanosis, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: Temperature was 102 F; Lips turned blue; Wheezing; Heart rate was elevated to 105-112 bpm; A spontaneous report was received from a dentist, a 37-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate was elevated to 105-112 bpm, wheezing, lips turned blue, and temperature was 102 F.   The patient's medical history, as provided by the reporter, included monk fruit allergy and high blood pressure. Concomitant medications reported included hydrochlorothiazide.  On an unknown date, the patient received their first of two planned doses of mRNA-1273.   On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, following vaccination, the patient experienced an elevated heart rate of 105-112 beats per minute (bpm). The patient stated that 80 bpm was normal for her. At 7:30 pm, she began wheezing and her lips turned blue, both of which resolved within 2 hours. The patient took ibuprofen, naproxen, and diphenhydramine and sat in a warm tub for an hour and felt better after she covered up in bed.  On 29 Jan 2021, the patient's temperature was 102 degrees Fahrenheit (F) at midnight and 99 degrees F at 5:00 am.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The events, wheezing and lips turned blue, were considered resolved on 28 Jan 2021. The outcome of the events, heart rate was elevated to 105-112 bpm and temperature was 102, was unknown.; Reporter's Comments: This case concerns a 37-year-old, female patient, with medical history of high blood pressure and allergies to monk fruit, who experienced serious unexpected event of cyanosis, non-serious unexpected event of wheezing, heart rate increased, and non-serious expected event of pyrexia. The event of cyanosis, wheezing, heart rate increased occurred 1 day (same day) and fever occurred 2 days after mRNA-1273 (Lot# 030L20A). Treatment included Ibuprofen, Benadryl and Naprosyn. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Temperature was 102 F; Lips turned blue; Wheezing; Heart rate was elevated to 105-112 bpm; A spontaneous report was received from a dentist, a 37-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced heart rate was elevated to 105-112 bpm, wheezing, lips turned blue, and temperature was 102 F.   The patient's medical history, as provided by the reporter, included monk fruit allergy and high blood pressure. Concomitant medications reported included hydrochlorothiazide.  On an unknown date, the patient received their first of two planned doses of mRNA-1273.   On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Jan 2021, following vaccination, the patient experienced an elevated heart rate of 105-112 beats per minute (bpm). The patient stated that 80 bpm was normal for her. At 7:30 pm, she began wheezing and her lips turned blue, both of which resolved within 2 hours. The patient took ibuprofen, naproxen, and diphenhydramine and sat in a warm tub for an hour and felt better after she covered up in bed.  On 29 Jan 2021, the patient's temperature was 102 degrees Fahrenheit (F) at midnight and 99 degrees F at 5:00 am.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The events, wheezing and lips turned blue, were considered resolved on 28 Jan 2021. The outcome of the events, heart rate was elevated to 105-112 bpm and temperature was 102, was unknown.; Reporter's Comments: This case concerns a 37-year-old, female patient, with medical history of high blood pressure and allergies to monk fruit, who experienced serious unexpected event of cyanosis, non-serious unexpected event of wheezing, heart rate increased, and non-serious expected event of pyrexia. The event of cyanosis, wheezing, heart rate increased occurred 1 day (same day) and fever occurred 2 days after mRNA-1273 (Lot# 030L20A). Treatment included Ibuprofen, Benadryl and Naprosyn. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Influenza like illness, Myalgia, Odynophagia
Clinical narrative: 3 episodes of fainting; Flu like symptoms; Chest tightness; Sore and tender upon swallowing food; Muscle aches on right arm; fever; fatigue; A spontaneous report was received from a consumer concerning a 45-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, fever, fainting, muscle aches, flu-like symptoms, chest tightness, and sore throat.  The patient's medical history, as provided by the reporter, included childhood asthma and seasonal allergies. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient had fatigue by the end of the day following vaccination.   On 29 Jan 2021, the patient presented fever and 3 episodes of fainting. She had muscles aches on her right arm, flu-like symptoms, chest tightness, and sore/tender throat area upon swallowing food. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events was not reported.; Reporter's Comments: Further information has been requested as there is limited information regarding the events, particularly the event of syncope and chest discomfort. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: 3 episodes of fainting; Flu like symptoms; Chest tightness; Sore and tender upon swallowing food; Muscle aches on right arm; fever; fatigue; A spontaneous report was received from a consumer concerning a 45-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, fever, fainting, muscle aches, flu-like symptoms, chest tightness, and sore throat.  The patient's medical history, as provided by the reporter, included childhood asthma and seasonal allergies. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient had fatigue by the end of the day following vaccination.   On 29 Jan 2021, the patient presented fever and 3 episodes of fainting. She had muscles aches on her right arm, flu-like symptoms, chest tightness, and sore/tender throat area upon swallowing food. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events was not reported.; Reporter's Comments: Further information has been requested as there is limited information regarding the events, particularly the event of syncope and chest discomfort. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia, Thrombocytopenia
Clinical narrative: Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fever; Injection site soreness; A spontaneous report was received from a consumer who was a 64-year-old, female patient who developed a platelet count of 28,000 (thrombocytopenia), generalized body pain all over (general body pain), weakness (asthenia), on and off chills (chills), low grade fever (pyrexia), and vaccination site soreness (injection site pain).  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) on 31 Dec 2020.  On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 209K20A) in the left arm for prophylaxis of COVID-19 infection.  On an undisclosed date the patient experienced injection site soreness, generalized body pain all over, chills, low grade fever and weakness.  She also went to the hospital because she had a platelet count of 28,000.   Treatment of these events was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, platelet count of 28,000, generalized body pain all over, weakness, on and off chills, low grade fever, and vaccination site soreness, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fever; Injection site soreness; A spontaneous report was received from a consumer who was a 64-year-old, female patient who developed a platelet count of 28,000 (thrombocytopenia), generalized body pain all over (general body pain), weakness (asthenia), on and off chills (chills), low grade fever (pyrexia), and vaccination site soreness (injection site pain).  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) on 31 Dec 2020.  On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 209K20A) in the left arm for prophylaxis of COVID-19 infection.  On an undisclosed date the patient experienced injection site soreness, generalized body pain all over, chills, low grade fever and weakness.  She also went to the hospital because she had a platelet count of 28,000.   Treatment of these events was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, platelet count of 28,000, generalized body pain all over, weakness, on and off chills, low grade fever, and vaccination site soreness, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Pharyngeal swelling, Swelling face, Tachycardia
Clinical narrative: Throat closing; Swelling of throat; Lip swollen; Shortness of breath; Tachycardia; Swelling of face; A spontaneous report was received from a healthcare professional concerning a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face and throat, shortness of breath, tachycardia and lip swollen.  The patient's medical history was not provided. Concomitant product use was not reported.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, one day after vaccine administration, the patient was sent to the hospital by ambulance after her throat closed. She had swelling of face and throat, shortness of breath and tachycardia.  In the ambulance, diphenhydramine, methylprednisolone, and famotidine were administered. She was discharged four hours later with prednisone, diphenhydramine, epinephrine, famotidine, and loratadine.  On 15 Jan 2021, the patient was still having daily flare ups of a swollen lip and throat closing.  Action taken with mRNA-1273 in response to the events was not reported.  The events, throat closing and lip swollen, were considered not resolved. The outcome of the events, swelling of the face and throat, shortness of breath, and tachycardia, was unknown.; Reporter's Comments: This spontaneous report concerns a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face, shortness of breath, tachycardia and lip swollen. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: 041L20A, expiration date: unknown).  Treatment provided include diphenhydramine, methylprednisolone and famotidine and outcome is unknown for swelling of the face, shortness of breath and tachycardia. Throat closing and lip swollen are not resolved. Based on the information provided which shows a temporal association, a causal association between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat closing; Swelling of throat; Lip swollen; Shortness of breath; Tachycardia; Swelling of face; A spontaneous report was received from a healthcare professional concerning a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face and throat, shortness of breath, tachycardia and lip swollen.  The patient's medical history was not provided. Concomitant product use was not reported.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, one day after vaccine administration, the patient was sent to the hospital by ambulance after her throat closed. She had swelling of face and throat, shortness of breath and tachycardia.  In the ambulance, diphenhydramine, methylprednisolone, and famotidine were administered. She was discharged four hours later with prednisone, diphenhydramine, epinephrine, famotidine, and loratadine.  On 15 Jan 2021, the patient was still having daily flare ups of a swollen lip and throat closing.  Action taken with mRNA-1273 in response to the events was not reported.  The events, throat closing and lip swollen, were considered not resolved. The outcome of the events, swelling of the face and throat, shortness of breath, and tachycardia, was unknown.; Reporter's Comments: This spontaneous report concerns a 38-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat closing, swelling of the face, shortness of breath, tachycardia and lip swollen. The events occurred 1 day after the administration of mRNA-1273 vaccine (Lot number: 041L20A, expiration date: unknown).  Treatment provided include diphenhydramine, methylprednisolone and famotidine and outcome is unknown for swelling of the face, shortness of breath and tachycardia. Throat closing and lip swollen are not resolved. Based on the information provided which shows a temporal association, a causal association between the reported events and the administration of mRNA-1273 vaccine cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Administering the 2nd dose of the moderna vaccine to patient, needling splattering occured; Needle splattering occurred; A spontaneous report was received from a heath care professional in the concerning a patient who and had administering the 2nd dose of the Moderna vaccine to patient, needling splattering occurred.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection  Physician stated that in the course of administering the 2nd dose of the Moderna vaccine to a patient, needle splattering occurred. She did not know how much of the vaccine went into the recipient's arm.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event administering the 2nd dose of the Moderna vaccine to patient, needling splattering occurred was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Underdose and Device connection issue without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood urine present, Nephrolithiasis, Vaccination site pain
Clinical narrative: kidney stones; blood in her urine; sore arm; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer, reporting for herself. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously took glipizide for diabetes and experienced bruising and bleeding. About three years ago, the patient took Glipizide ER for about 3 months (dose unknown but she was splitting the tablets and taking small amount) and noted an increased incidence of bruising which was worsening over time and longer bleeding because of it. She had blood work done and results came back within normal limits, including platelets. She discontinued the glipizide ER. The patient currently has kidney stones that can shift around and cause blood in her urine which occurred on an unspecified date in Jan2021, about 3 days after the first Pfizer COVID vaccine. After receiving this first vaccine, she had a sore arm, but no bleeding or bruising. The patient underwent lab tests and procedures which included blood work: within normal limits, including platelets on an unspecified date. The outcome of the events was unknown.    Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hypertension, Syncope
Clinical narrative: feelings of fainting; high blood pressure in the 160s, normally <120s systolic); severe headaches; dizziness; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history concomitant medications were not reported. On an unspecified date, the patient developed severe headaches, dizziness, high blood pressure (in the 160s, normally <120s systolic), and feelings of fainting 5-10 minutes after receiving the first dose of the vaccine. This adverse event was reported already, but the pharmacist was wondering if it is still recommended to get the second dose after a reaction like this. Stated "This reaction doesn't meet your definition of anaphylaxis or allergic reaction which is why I am reaching out to see if you have any recommendations on this". The patient underwent lab tests and procedures which included blood pressure: high blood pressure (in the 160s, normally <120s systolic). The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Investigation
Clinical narrative: Dysgeusia; Left hemicranial numbness/ Mild residual numbness left face; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), intramuscular in the left arm on 06Jan2021 14:30 at a single dose for covid-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. On 06Jan2021 at 15:00, the patient experienced dysgeusia 20 min after exam lasting 1 min and left hemicranial numbness times 24 hrs. The patient still has mild residual numbness on left face. The events resulted in doctor or other healthcare professional office/clinic visit. The events were not treated. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events dysgeusia and numbness with BNT162b2 can not be completely 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.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Loss of consciousness
Clinical narrative: passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendous chills and nausea; tremendous chills and nausea; low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 48-year-old) on 02Feb2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included high cholesterol and allergies to some seaweeds. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 via an unspecified route of administration in Left arm (at age of 48-year-old) for COVID-19 immunisation, lot number: EL3246. Concomitant medications in two weeks prior to the vaccination included atorvastatin and multi- vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient started about 12 hours after getting vaccinated (reported as 02Feb2021 at 10:00 PM) with a general bad feeling all over, 15 hours after (03Feb2021 at 01:00 AM) patient got out of bed because of nausea and passed out, his wife found he on the floor. Patient had tremendous chills and nausea with a low grade fever 99.5 for several more hours, maybe 6 hours, (onset date 02Feb2021) the next morning patient had a terrible headache and still some body aches. Patient was treated with extra strength paracetamol (TYLENOL) and ondansetron (ZOFRAN). Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendous chills and nausea; tremendous chills and nausea; low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 48-year-old) on 02Feb2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included high cholesterol and allergies to some seaweeds. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 via an unspecified route of administration in Left arm (at age of 48-year-old) for COVID-19 immunisation, lot number: EL3246. Concomitant medications in two weeks prior to the vaccination included atorvastatin and multi- vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient started about 12 hours after getting vaccinated (reported as 02Feb2021 at 10:00 PM) with a general bad feeling all over, 15 hours after (03Feb2021 at 01:00 AM) patient got out of bed because of nausea and passed out, his wife found he on the floor. Patient had tremendous chills and nausea with a low grade fever 99.5 for several more hours, maybe 6 hours, (onset date 02Feb2021) the next morning patient had a terrible headache and still some body aches. Patient was treated with extra strength paracetamol (TYLENOL) and ondansetron (ZOFRAN). Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Loss of consciousness, Seizure
Clinical narrative: At 4 Am the morning after my second vaccine I had a seizure.; I was found non responsive; blood pressure of 227/153; This is a spontaneous report from a contactable Other Health Professional (patient).  A 37-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 01Feb2021 10:00 at single dose on right arm for COVID-19 immunisation.  Medical history included high blood pressure. Historical vaccine included 1st dose of BNT162B2   on 11Jan2021 08:00 am via intramuscular on right arm for COVID-19 immunisation. Patient was not pregnant. Concomitant medication included labetalol and HCTZ. At 04:00 am of 02Feb2021, after second vaccine patient had a seizure. Patient was found non-responsive with a blood pressure of 227/153. Emergency room was visited. Patient have no history of seizures and it was concluded by PCP that this was an adverse response to the vaccine. Treatment was received. Outcome of the events was recovered/resolved with sequel.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events seizure, loss of consciousness and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Dysgeusia, Hallucination, Headache
Clinical narrative: hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self.  A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Somnolence
Clinical narrative: hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self.  A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: First time seizure occurred 12 hr after injection; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), via an unspecified route of administration on left arm on 30Jan2021 13:30 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. First time seizure occurred 12 hr after injection (AE resulted in: Emergency room/department or urgent care, Hospitalization for 3 days) on 31Jan2021 02:00. Therapeutic measures (LEVETIRACETAM TABLETS - (KEPPRA)) were taken as a result of event. The outcome of event was recovering.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Gastritis bacterial
Clinical narrative: bacteria on her stomach; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly into the right arm on 15Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing cholesterol and ongoing high blood pressure. Concomitant medication included losartan (LOSARTAN) for high blood pressure and atorvastatin (ATORVASTATIN) for cholesterol. It was reported that the patient had colonoscopy on 21Jan2021 and had found bacteria on her stomach. The patient was treated with 10 days antibiotic regimen of amoxicillin and clarithromycin. The patient's second dose was scheduled on 04Feb2021 and she was inquiring if she could still have the shot and if the antibiotic will affect the effectiveness of that shot. Outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Kidney infection, Urinary tract infection
Clinical narrative: kidney or urinary tract excused here; infection in urinary tract; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (30th) at single dose for covid-19 immunization. Medical history included wear hearing aids in both ears. The patient's concomitant medications were not reported. Patient found out here evidently had either a kidney or urinary tract excused here. Patient had either an infection in urinary tract. Outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: dementia; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer reported that a female patient (wife) of unspecified age was received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Calling on behalf of her wife that has dementia, she already received the 1st dose of the vaccine and was prescribed a new drug Nuplazid. Husband wanted to know the drug interaction between the two. outcome of the event was unknown.   Information on batch/lot number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diarrhoea, Fatigue, Speech disorder
Clinical narrative: stroke; couldn't speak; feeling tired; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date 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. The patient had a stroke (medically significant) after the first shot and couldn't speak, was feeling tired as well and diarrhea. She wanted to know if she could still take the second shot. Patient does not want to give any information. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke; This is a spontaneous report from a contactable consumer. A 9-decade-old (reported as: "in her 80's") female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on 28Jan2021 at single dose for COVID-19 vaccination. Recent medical history included GI complications. The patient's concomitant medications were not reported. On 01Feb2021, the patient experienced ischemic stroke requiring hospitalization. Event took place after use of product. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: mild stroke; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a mild stroke after the 1st vaccine and she's asking if she could go early to facility for the second dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: Sty on my right eye; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3246, via an unspecified route of administration on 07Jan2021 11:00 at a single dose for COVID-19 immunization.  Medical history included multiple sclerosis (MS) and environmental allergies. Concomitant medication included ascorbic acid (VIT C), colecalciferol (VIT D3), zinc, acetylcysteine (NAC) and montelukast. In Jan2021, after 1 dose the patient formed a sty on her right eye, and it was still there three weeks later. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The outcome of the event was unknown. The event was assessed as serious-medically significant.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Deafness unilateral, Magnetic resonance imaging
Clinical narrative: she lost total hearing in one ear inside of five minutes/went totally deaf in her right ear; This is a spontaneous report from a contactable consumer reported for herself. A 74-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiry date: May2021), via an unspecified route of administration on left arm on 28Jan2021 16:00 at SINGLE DOSE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia, anaemia. The patient's concomitant medications were not reported. The patient previously took morphine and experienced drug hypersensitivity. The patient received the first dose of the Pfizer COVID 19 vaccine on 28Jan2021. On the 30Jan2021 04:00 PM, she lost total hearing in one ear inside of five minutes/she went totally deaf in her right ear. She has had tests done including a CT and MRI but she is still waiting for the results, which reported as under treatment. Adds she doesn't have an appointment yet, but she is supposed to get the next dose 18Feb2021. The event reported as serious with disability, result emergency room/department or urgent care. Outcome of the event was not recovered. Patient is not pregnant at the time of vaccination. No Covid prior vaccination. No covid tested post vaccination.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haematochezia
Clinical narrative: Bloody stool; Blood in urine; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL8982 (reported as looks like EL8982 or 1982), on 29Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient got his COVID shot on Friday and he have no problem with the shot as far as the shot itself. On Sunday which is two days later, he had first blood in his stool when he went to the bathroom, no fever and then this morning went he urinated, at the end of the urination he has some blood there too, like that. The only adverse effect he have was bloody stool and blood in his urine. Yesterday (31Jan2021), he had no temperature, no fever stuff like that, only blood in his stool and urine, then this morning, next day, three days, blood in his urine. No Investigation Assessment. no treatment for the events. Outcome of the event was unknown.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Paralysis, Peripheral swelling
Clinical narrative: developed paralysis in the opposite part of the body; Her hand, fingers and knee all became swollen; Her hand, fingers and knee all became swollen; This is a spontaneous report from a contactable consumer via Pfizer Sponsored program Pfizer First Connect.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient took the first dose of the vaccine on an unknown date for COVID-19 immunization. In Feb2021, about 12 hours after getting the vaccine, the patient developed paralysis in the opposite part of the body where she didn't get the vaccine. Her hand, fingers and knee all became swollen. She had the symptoms on her right and was given the vaccine in her left. The final outcome of the events was unknown.Information on lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Ophthalmological examination, Retinitis
Clinical narrative: the reaction is inflammation to her retina; dose given 11Jan2021, and second dose LOT: EK9231 for dose given on 28Jan; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 28Jan2021 at sngle dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot: EH9899) received on 11Jan2021 for COVID-19 immunisation. Patient went to her ophthalmologist and they examined her eye. The ophthalmologist said that the reaction was inflammation to her retina. Outcome of the event was unknown.