chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Prothrombin time normal, Thrombocytopenia
Clinical narrative: LOW BLOOD PLATELET COUNT; SMALL BLISTER IN MOUTH; RED DOTS ALL OVER HER BODY PRIMARILY ON LEGS AND ARMS; HEADACHE; BRUISES; This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known allergies. the patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced bruises, and was hospitalized (date unspecified). On 16-MAR-2021, the subject experienced headache. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) no brain injury. On an unspecified date, the subject experienced low blood platelet count, small blister in mouth, and red dots all over her body primarily on legs and arms, and was hospitalized. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low blood platelet count of 4000 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises, headache, low blood platelet count, small blister in mouth and red dots all over her body primarily on legs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509067-covid-19 vaccine ad26.cov2.s - Low blood platelet count, Bruises, Small blister in mouth. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210509067-covid-19 vaccine ad26.cov2.s Headache and Red dots all over her body primarily on legs and arms. This event(s) is labeled per RSI and is therefore considered potentially related
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head normal, Contusion, Headache, Immunoglobulin therapy, Infusion
Clinical narrative: LOW BLOOD PLATELET COUNT; SMALL BLISTER IN MOUTH; RED DOTS ALL OVER HER BODY PRIMARILY ON LEGS AND ARMS; HEADACHE; BRUISES; This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known allergies. the patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced bruises, and was hospitalized (date unspecified). On 16-MAR-2021, the subject experienced headache. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) no brain injury. On an unspecified date, the subject experienced low blood platelet count, small blister in mouth, and red dots all over her body primarily on legs and arms, and was hospitalized. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low blood platelet count of 4000 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises, headache, low blood platelet count, small blister in mouth and red dots all over her body primarily on legs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509067-covid-19 vaccine ad26.cov2.s - Low blood platelet count, Bruises, Small blister in mouth. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210509067-covid-19 vaccine ad26.cov2.s Headache and Red dots all over her body primarily on legs and arms. This event(s) is labeled per RSI and is therefore considered potentially related
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Rash, Rash erythematous
Clinical narrative: LOW BLOOD PLATELET COUNT; SMALL BLISTER IN MOUTH; RED DOTS ALL OVER HER BODY PRIMARILY ON LEGS AND ARMS; HEADACHE; BRUISES; This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known allergies. the patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced bruises, and was hospitalized (date unspecified). On 16-MAR-2021, the subject experienced headache. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) no brain injury. On an unspecified date, the subject experienced low blood platelet count, small blister in mouth, and red dots all over her body primarily on legs and arms, and was hospitalized. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low blood platelet count of 4000 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises, headache, low blood platelet count, small blister in mouth and red dots all over her body primarily on legs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509067-covid-19 vaccine ad26.cov2.s - Low blood platelet count, Bruises, Small blister in mouth. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210509067-covid-19 vaccine ad26.cov2.s Headache and Red dots all over her body primarily on legs and arms. This event(s) is labeled per RSI and is therefore considered potentially related
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Contusion, Headache, Oral mucosal blistering, Platelet count
Clinical narrative: LOW BLOOD PLATELET COUNT; SMALL BLISTER IN MOUTH; RED DOTS ALL OVER HER BODY PRIMARILY ON LEGS AND ARMS; HEADACHE; BRUISES; This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known allergies. the patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced bruises, and was hospitalized (date unspecified). On 16-MAR-2021, the subject experienced headache. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) no brain injury. On an unspecified date, the subject experienced low blood platelet count, small blister in mouth, and red dots all over her body primarily on legs and arms, and was hospitalized. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low blood platelet count of 4000 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises, headache, low blood platelet count, small blister in mouth and red dots all over her body primarily on legs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509067-covid-19 vaccine ad26.cov2.s - Low blood platelet count, Bruises, Small blister in mouth. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210509067-covid-19 vaccine ad26.cov2.s Headache and Red dots all over her body primarily on legs and arms. This event(s) is labeled per RSI and is therefore considered potentially related
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Rash macular
Clinical narrative: LOW BLOOD PLATELET COUNT; SMALL BLISTER IN MOUTH; RED DOTS ALL OVER HER BODY PRIMARILY ON LEGS AND ARMS; HEADACHE; BRUISES; This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known allergies. the patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced bruises, and was hospitalized (date unspecified). On 16-MAR-2021, the subject experienced headache. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) no brain injury. On an unspecified date, the subject experienced low blood platelet count, small blister in mouth, and red dots all over her body primarily on legs and arms, and was hospitalized. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low blood platelet count of 4000 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises, headache, low blood platelet count, small blister in mouth and red dots all over her body primarily on legs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509067-covid-19 vaccine ad26.cov2.s - Low blood platelet count, Bruises, Small blister in mouth. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210509067-covid-19 vaccine ad26.cov2.s Headache and Red dots all over her body primarily on legs and arms. This event(s) is labeled per RSI and is therefore considered potentially related
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone decreased, Discomfort, Electrocardiogram normal, Eye irritation
Clinical narrative: heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Hyperhidrosis, Pruritus
Clinical narrative: heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tri-iodothyronine increased
Clinical narrative: heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Pain, Palpitations
Clinical narrative: heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Headache, Hypoaesthesia, Hypoaesthesia eye, Magnetic resonance imaging
Clinical narrative: Severe Migraines, Nausea, numbness in face and arm, chest paint discomfort, weight loss
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms, Nausea
Clinical narrative: Severe Migraines, Nausea, numbness in face and arm, chest paint discomfort, weight loss
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Echocardiogram
Clinical narrative: Severe Migraines, Nausea, numbness in face and arm, chest paint discomfort, weight loss
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging, Migraine, Nausea
Clinical narrative: Severe Migraines, Nausea, numbness in face and arm, chest paint discomfort, weight loss
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Venogram, Weight decreased
Clinical narrative: Severe Migraines, Nausea, numbness in face and arm, chest paint discomfort, weight loss
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Migraine, Nausea
Clinical narrative: Severe Migraines, Nausea, numbness in face and arm, chest paint discomfort, weight loss
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood gases, Chest X-ray, Computerised tomogram, Dyspnoea, Laboratory test
Clinical narrative: Shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  Medical history included lung cancer from an unknown date and unknown if ongoing. Concomitant medications included lorlatinib, alprazolam, rosuvastatin calcium (CRESTOR), lisinopril and steroid, all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (Batch/Lot number was not reported) for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021, the patient experienced shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization.  The patient was hospitalized for this event for 1 days. This event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included oxygen and home oxygen, albuterol nebulizer, vento. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: negative. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Ultrasound Doppler, Ultrasound scan
Clinical narrative: Shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  Medical history included lung cancer from an unknown date and unknown if ongoing. Concomitant medications included lorlatinib, alprazolam, rosuvastatin calcium (CRESTOR), lisinopril and steroid, all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (Batch/Lot number was not reported) for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021, the patient experienced shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization.  The patient was hospitalized for this event for 1 days. This event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included oxygen and home oxygen, albuterol nebulizer, vento. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: negative. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: Shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  Medical history included lung cancer from an unknown date and unknown if ongoing. Concomitant medications included lorlatinib, alprazolam, rosuvastatin calcium (CRESTOR), lisinopril and steroid, all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (Batch/Lot number was not reported) for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021, the patient experienced shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization.  The patient was hospitalized for this event for 1 days. This event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included oxygen and home oxygen, albuterol nebulizer, vento. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: negative. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Apr2021 18:00 (at the age of 46-year-old) (Lot Number: EW0170) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was diagnosed with bells palsy on 04May2021 08:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diagnosed with bells palsy, medication steroid and antiviral were used. Event outcome was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Appendicitis, Computerised tomogram
Clinical narrative: APPENDICITIS DIAGNOSED 5/6/21 WITH ONSET OF SYMPTOMS 5/2/21; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at the age of 32-years-old (Batch/Lot Number: EN6207) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included splenomegaly from an unknown date.  Patient did not have known allergies. There were no concomitant medications. The patient previously received first dose BNT162B2 administered in Arm Left on 22Mar2021 at the age of 32-years-old (Batch/Lot Number: EP7534) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced appendicitis diagnosed 06May2021 with onset of symptoms 02May2021. The event was reported as serious due to hospitalization (days for hospitalization was 1 day), life threatening. It resulted in Emergency room/department or urgent care. Treatment received for the adverse event included laparoscopic appendectomy. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06May2021. The outcome of the event was resolving.  Information about batch no/lot no cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, SARS-CoV-2 test negative
Clinical narrative: APPENDICITIS DIAGNOSED 5/6/21 WITH ONSET OF SYMPTOMS 5/2/21; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 at the age of 32-years-old (Batch/Lot Number: EN6207) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included splenomegaly from an unknown date.  Patient did not have known allergies. There were no concomitant medications. The patient previously received first dose BNT162B2 administered in Arm Left on 22Mar2021 at the age of 32-years-old (Batch/Lot Number: EP7534) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced appendicitis diagnosed 06May2021 with onset of symptoms 02May2021. The event was reported as serious due to hospitalization (days for hospitalization was 1 day), life threatening. It resulted in Emergency room/department or urgent care. Treatment received for the adverse event included laparoscopic appendectomy. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06May2021. The outcome of the event was resolving.  Information about batch no/lot no cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Embolism, Exercise lack of, Influenza like illness, Pain in extremity
Clinical narrative: Superficial blood clots in my right leg; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation.  Medical history included Alfa 1 Antitrypsin (hereditary), Sulfa allergies. Patient previously received the first dose of bnt162b2 on 27Mar2021 for covid-19 immunization (lot number=ER8734,vaccine location=Left arm). Patient was not diagnosed as COVID-19 prior vaccination. No covid tested post vaccination.The patient's concomitant medications were not reported.  The patient experienced superficial blood clots in his right leg 5 days after his second COVID 19 vaccination shot on 22Apr2021 04:00 with outcome of unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event included Rest and pain relievers. Case was reported as non-serious.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Superficial blood clots in my right leg; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation.  Medical history included Alfa 1 Antitrypsin (hereditary), Sulfa allergies. Patient previously received the first dose of bnt162b2 on 27Mar2021 for covid-19 immunization (lot number=ER8734,vaccine location=Left arm). Patient was not diagnosed as COVID-19 prior vaccination. No covid tested post vaccination.The patient's concomitant medications were not reported.  The patient experienced superficial blood clots in his right leg 5 days after his second COVID 19 vaccination shot on 22Apr2021 04:00 with outcome of unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event included Rest and pain relievers. Case was reported as non-serious.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Haemoptysis, Musculoskeletal chest pain, Pneumonia, Pulmonary embolism
Clinical narrative: diagnosed with a pulmonary embolism; dry cough; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 10:45 (Lot number: EN620A) as 2nd dose, single (at age of 75-year-old) for covid-19 immunization. Medical history included diabetes mellitus and cholesterol. Concomitant medications in two weeks prior to the vaccination included acetylsalicylic acid (ASPIRIN 81), cyanocobalamin (VITAMIN B-12) and metformin. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was administered on 18Feb2021 in Left arm (at age of 75-year-old) for COVID-19 immunization, lot number: EL9262. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on 11Mar2021 patient received his second (2nd) shot. Late in Mar2021 or early Apr2021 he developed a dry cough and on 21Apr2021 was diagnosed with a pulmonary embolism. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Onset date of the events was reported as 01Apr2021. Event pulmonary embolism required admission to hospital for one day (dates unknown) event also considered serious as life-threatening. Patient was treated for the events with blood thinner infusion with (w/) Eliquis follow up. It was reported that since the vaccination, the patient has been tested for COVID-19. As of 10May2021, it was reported that the patient had a blood clot in his lung; he has pulmonary embolism in his left lung. The patient had the last shot on 11Mar2021 and he started experiencing a clot two weeks after that and then, he was not diagnosed with the blood clot in 21Apr2021 he believed; he was experiencing coughing system two or three weeks before when he was actually diagnosed with the blood clot. The patient has been treated for blood clot for long, he doesn't know what is that, he was on Eliquis (treatment for blood clot) to break up the clot or still in his blood or whatever the process is, it takes like three months. When he was hospitalized for this, he had been on Heparin trip for about 12 hours heparin blood DNA they had been intravenous. The patient underwent laboratory tests and procedures which included sars-cov-2 test: negative on 21Apr2021. Patient was recovering from the events.  Information on the lot/batch number has been requested.  Follow-up (10May2021): New information reported from a contactable consumer includes:  medical history, concomitant medication and clinical course details.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: diagnosed with a pulmonary embolism; dry cough; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 10:45 (Lot number: EN620A) as 2nd dose, single (at age of 75-year-old) for covid-19 immunization. Medical history included diabetes mellitus and cholesterol. Concomitant medications in two weeks prior to the vaccination included acetylsalicylic acid (ASPIRIN 81), cyanocobalamin (VITAMIN B-12) and metformin. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was administered on 18Feb2021 in Left arm (at age of 75-year-old) for COVID-19 immunization, lot number: EL9262. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on 11Mar2021 patient received his second (2nd) shot. Late in Mar2021 or early Apr2021 he developed a dry cough and on 21Apr2021 was diagnosed with a pulmonary embolism. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Onset date of the events was reported as 01Apr2021. Event pulmonary embolism required admission to hospital for one day (dates unknown) event also considered serious as life-threatening. Patient was treated for the events with blood thinner infusion with (w/) Eliquis follow up. It was reported that since the vaccination, the patient has been tested for COVID-19. As of 10May2021, it was reported that the patient had a blood clot in his lung; he has pulmonary embolism in his left lung. The patient had the last shot on 11Mar2021 and he started experiencing a clot two weeks after that and then, he was not diagnosed with the blood clot in 21Apr2021 he believed; he was experiencing coughing system two or three weeks before when he was actually diagnosed with the blood clot. The patient has been treated for blood clot for long, he doesn't know what is that, he was on Eliquis (treatment for blood clot) to break up the clot or still in his blood or whatever the process is, it takes like three months. When he was hospitalized for this, he had been on Heparin trip for about 12 hours heparin blood DNA they had been intravenous. The patient underwent laboratory tests and procedures which included sars-cov-2 test: negative on 21Apr2021. Patient was recovering from the events.  Information on the lot/batch number has been requested.  Follow-up (10May2021): New information reported from a contactable consumer includes:  medical history, concomitant medication and clinical course details.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: diagnosed with a pulmonary embolism; dry cough; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 10:45 (Lot number: EN620A) as 2nd dose, single (at age of 75-year-old) for covid-19 immunization. Medical history included diabetes mellitus and cholesterol. Concomitant medications in two weeks prior to the vaccination included acetylsalicylic acid (ASPIRIN 81), cyanocobalamin (VITAMIN B-12) and metformin. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was administered on 18Feb2021 in Left arm (at age of 75-year-old) for COVID-19 immunization, lot number: EL9262. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on 11Mar2021 patient received his second (2nd) shot. Late in Mar2021 or early Apr2021 he developed a dry cough and on 21Apr2021 was diagnosed with a pulmonary embolism. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Onset date of the events was reported as 01Apr2021. Event pulmonary embolism required admission to hospital for one day (dates unknown) event also considered serious as life-threatening. Patient was treated for the events with blood thinner infusion with (w/) Eliquis follow up. It was reported that since the vaccination, the patient has been tested for COVID-19. As of 10May2021, it was reported that the patient had a blood clot in his lung; he has pulmonary embolism in his left lung. The patient had the last shot on 11Mar2021 and he started experiencing a clot two weeks after that and then, he was not diagnosed with the blood clot in 21Apr2021 he believed; he was experiencing coughing system two or three weeks before when he was actually diagnosed with the blood clot. The patient has been treated for blood clot for long, he doesn't know what is that, he was on Eliquis (treatment for blood clot) to break up the clot or still in his blood or whatever the process is, it takes like three months. When he was hospitalized for this, he had been on Heparin trip for about 12 hours heparin blood DNA they had been intravenous. The patient underwent laboratory tests and procedures which included sars-cov-2 test: negative on 21Apr2021. Patient was recovering from the events.  Information on the lot/batch number has been requested.  Follow-up (10May2021): New information reported from a contactable consumer includes:  medical history, concomitant medication and clinical course details.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Contusion, Headache
Clinical narrative: BRUISING EASILY; DAILY HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported. On 08-APR-2021, the subject experienced bruising easily. On 08-APR-2021, the subject experienced daily headaches. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from daily headaches, and bruising easily. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: Patient received dose when product was stored at room temp (72F) for 4 hours 10 minutes. Manufacturer recommends discarding vaccine at 2 hours when stored at room temp.  this was to report that handling error
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received dose when product was stored at room temp (72F) for 4 hours 10 minutes. Manufacturer recommends discarding vaccine at 2 hours when stored at room temp.  this was to report that handling error
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Mouth swelling, Oral pruritus, Papule, Rash
Clinical narrative: Patient received vaccine at Health dept 5/13/2021 at 4pm.  Presented to our office 5/14/21. seen by Dr 3:09 pm, complaint that had facial burning 1-2 hours after first dose COVID vaccine.  School nurse called and reported face swollen and throat itching took Benadryl and did not help.   no cough or wheeze, throat itchy called and spoke allergist who stated did not expect allergic run to last that long and people will idiopathic urticaria can have reactivation of urticaria- VAERS Report filed yesterday Patient returned to Saturday walk in clinic today 5/15/21 and saw me-  woke up at 2 AM c/o difficulty breathing but didn't want to bother parents on arrival 09:29 P130 sat 98%- nurses state not in distress at arrival  at my arrival in room 10:20 AM noted to have frank stridor and fair to good air movement- patient seems to have worsened while here 0.3 mg Epi given IM and felt better sent to ER by ambulance - Hospital for additional monitoring? in case more epi needed