chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: chills; excruciating dizziness; fever; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIZZINESS (excruciating dizziness), PYREXIA (fever) and CHILLS (chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No relevant medical history provided.     On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (fever) (seriousness criterion hospitalization). On 14-May-2021, the patient experienced DIZZINESS (excruciating dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion hospitalization). The patient was hospitalized on 16-May-2021 due to CHILLS, DIZZINESS and PYREXIA. The patient was treated with MECLIZINE [MECLOZINE] for Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (excruciating dizziness) had not resolved and PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient underwent two EKG, and a  CAT scan while in hospital; unknown results.  Company comment: 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.; Sender'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.
Sex: M
Vaccine: COVID19
Symptoms: Malignant neoplasm progression, Vaccination complication
Clinical narrative: Cancer patient became very malignant after receiving first vaccine; Patient got sick after receiving the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALIGNANT NEOPLASM PROGRESSION (Cancer patient became very malignant after receiving first vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced MALIGNANT NEOPLASM PROGRESSION (Cancer patient became very malignant after receiving first vaccine) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Patient got sick after receiving the vaccine). At the time of the report, MALIGNANT NEOPLASM PROGRESSION (Cancer patient became very malignant after receiving first vaccine) outcome was unknown and VACCINATION COMPLICATION (Patient got sick after receiving the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment: 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. Very limited information regarding this events has been provided at this time. No further information is expected at this time.; Sender'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. Very limited information regarding this events has been provided at this time. No further information is expected at this time.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Atrial fibrillation, Blood cholesterol, Blood magnesium, Blood phosphorus
Clinical narrative: NSTEMI; Rapid atrial fibrillation; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (NSTEMI) and ATRIAL FIBRILLATION (Rapid atrial fibrillation) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced ATRIAL FIBRILLATION (Rapid atrial fibrillation) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (NSTEMI) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 20-May-2021 due to ACUTE MYOCARDIAL INFARCTION and ATRIAL FIBRILLATION. At the time of the report, ACUTE MYOCARDIAL INFARCTION (NSTEMI) and ATRIAL FIBRILLATION (Rapid atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, SARS-CoV-2 test: positive positive (Positive) positive. On an unknown date, Blood cholesterol: 195 (Inconclusive) 195. On an unknown date, Blood magnesium: normal normal (normal) normal. On an unknown date, Blood phosphorus: normal normal (normal) normal. On an unknown date, Blood triglycerides: 169 (Inconclusive) 169. On an unknown date, Glycosylated haemoglobin: 5.3 (Inconclusive) 5.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient reported that he was healthy with no medical problems and took no medications prior to his vaccines. A pulmonary emboli was ruled out, no history or suspicion of sleep apnea.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: 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.   This case was linked to MOD-2021-163089 (Patient Link).; Sender'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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood triglycerides, Glycosylated haemoglobin, SARS-CoV-2 test
Clinical narrative: NSTEMI; Rapid atrial fibrillation; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (NSTEMI) and ATRIAL FIBRILLATION (Rapid atrial fibrillation) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced ATRIAL FIBRILLATION (Rapid atrial fibrillation) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ACUTE MYOCARDIAL INFARCTION (NSTEMI) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 20-May-2021 due to ACUTE MYOCARDIAL INFARCTION and ATRIAL FIBRILLATION. At the time of the report, ACUTE MYOCARDIAL INFARCTION (NSTEMI) and ATRIAL FIBRILLATION (Rapid atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, SARS-CoV-2 test: positive positive (Positive) positive. On an unknown date, Blood cholesterol: 195 (Inconclusive) 195. On an unknown date, Blood magnesium: normal normal (normal) normal. On an unknown date, Blood phosphorus: normal normal (normal) normal. On an unknown date, Blood triglycerides: 169 (Inconclusive) 169. On an unknown date, Glycosylated haemoglobin: 5.3 (Inconclusive) 5.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Patient reported that he was healthy with no medical problems and took no medications prior to his vaccines. A pulmonary emboli was ruled out, no history or suspicion of sleep apnea.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: 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.   This case was linked to MOD-2021-163089 (Patient Link).; Sender'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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: got sick went to the ER; product dose omission; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (got sick went to the ER) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got sick went to the ER) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (product dose omission). The patient was hospitalized for 15 days due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (got sick went to the ER) and PRODUCT DOSE OMISSION ISSUE (product dose omission) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, patient felt few days later she got sick went to the ER, and did some tests for her heart and it was fine. Then the patient went to another hospital and was admitted to the hospital, was given plasma, hospital made sure patient was stable and was discharged after 2 weeks. The patient's diagnosis was unknown for what was the problem that caused hospitalization.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Company Comment : 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.; Sender'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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart Attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: 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.; Sender's Comments: 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac Arrest  (38 days after second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac Arrest  (38 days after second vaccine)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC ARREST (Cardiac Arrest  (38 days after second vaccine)) (seriousness criteria death, medically significant and life threatening). The patient died on 08-May-2021. The reported cause of death was cardiac arrest  (38 days after second vaccine). It is unknown if an autopsy was performed.            It was reported  that Lot number 023M20A was the only lot on the vaccination card. Caller was not sure if this lot is from first or second vaccine."  Treatment information was not reported but it was reported "Paramedics were there at home and they could not resuscitate him."  Concomitant medication was not reported.  Company Comment: 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.; Sender's Comments: 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.; Reported Cause(s) of Death: Cardiac Arrest  (38 days after second vaccine)
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: clotting in body; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (clotting in body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (clotting in body) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (clotting in body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were provided. The adverse event was submitted.  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.; Sender's Comments: 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: Conjunctival haemorrhage
Clinical narrative: subconjunctival hemorrhage 2 days after 2nd dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage 2 days after 2nd dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included INSULIN, CICLOSPORIN (RESTASIS) and LATANOPROST for an unknown indication.   On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage 2 days after 2nd dose of Moderna vaccine) (seriousness criterion medically significant). The patient was treated with DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT PF) at a dose of UNK dosage form and Lumify eye drops at a dose of UNK dosage form. At the time of the report, CONJUNCTIVAL HAEMORRHAGE (subconjunctival hemorrhage 2 days after 2nd dose of Moderna vaccine) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment: 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.; Sender's Comments: 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: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Had his second shot on 5/13 and passed away on that night or morning; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Had his second shot on 5/13 and passed away on that night or morning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 13-May-2021 The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  It was reported that patient passed away on that night of vaccination or next morning. The patient's autopsy might be scheduled on 24-MAY-2021. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Swollen tongue
Clinical narrative: Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side; Tongue was also swollen; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) (seriousness criterion medically significant) and SWOLLEN TONGUE (Tongue was also swollen). At the time of the report, DEAFNESS UNILATERAL (Gone deaf in his right ear after getting the 2nd dose and cannot hear anything on right side) and SWOLLEN TONGUE (Tongue was also swollen) outcome was unknown.            Concomitant medications and treatment details were not provided.  The action taken with mRNA-1273 in response to the event was not applicable.  The patient reported that he had gone deaf in his right ear after getting the 2nd dose and could not hear anything on right side. His tongue  was also swollen after getting the 2nd dose.  Company comment:Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Haematemesis
Clinical narrative: I am having vomiting and there is blood in it; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (I am having vomiting and there is blood in it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced HAEMATEMESIS (I am having vomiting and there is blood in it) (seriousness criterion medically significant). At the time of the report, HAEMATEMESIS (I am having vomiting and there is blood in it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment : 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. No further information is available for this case.; Sender's Comments: 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. No further information is available for this case.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Pyrexia
Clinical narrative: shortness of breath/breathing wasn't easy and was not able to fill their lung; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/breathing wasn't easy and was not able to fill their lung) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 003C21A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN (TELMIKIND) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced DYSPNOEA (shortness of breath/breathing wasn't easy and was not able to fill their lung) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath/breathing wasn't easy and was not able to fill their lung) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 101 (Inconclusive) Inconclusive.         On 22-May-2021, the patient had a fever of 101 for which the patient took paracetamol. He started having shortness of breath on the evening of 22-May-2021.  He reported that his breathing wasn't easy and he was not able to fill his lung.  The patient went to an Urgent Care on 23-May-2021 and was prescribed cetirizine and benzonatate 10 mg. At the time of the report, his symptoms are not as strong but were still present.  Company Comment : 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.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: FU Received on 24-May-2021.Expiration Date(second dose): 10/23; 10/17/2021 (first dose) were updated; Sender'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.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage, Postmenopausal haemorrhage
Clinical narrative: Several menstrual (post-menopausal) bleeding ,still bleeding; still bleeding; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Several menstrual (post-menopausal) bleeding ,still bleeding) and HAEMORRHAGE (still bleeding) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Several menstrual (post-menopausal) bleeding ,still bleeding) (seriousness criterion medically significant) and HAEMORRHAGE (still bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Several menstrual (post-menopausal) bleeding ,still bleeding) and HAEMORRHAGE (still bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment for the events were not provided. this is a valid case  Company Comment : 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.no further information is available for this case.; Sender's Comments: 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.no further information is available for this case.
Sex: U
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: "symptoms of my Lyme disease pop up after 25 years, it "; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE ("symptoms of my Lyme disease pop up after 25 years, it ") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lyme disease (25 years ago).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced LYME DISEASE ("symptoms of my Lyme disease pop up after 25 years, it ") (seriousness criterion medically significant). At the time of the report, LYME DISEASE ("symptoms of my Lyme disease pop up after 25 years, it ") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: First trimester miscarriage; Received the Moderna COVID-19 Vaccine while pregnant; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (First trimester miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (First trimester miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion.  At the time of the report, ABORTION SPONTANEOUS (First trimester miscarriage) outcome was unknown and EXPOSURE DURING PREGNANCY (Received the Moderna COVID-19 Vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.  No treatment details were provided.  Company Comment : This is a case of product exposure during pregnancy with associated AEs for this female. 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.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this female. 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Headache
Clinical narrative: HA since first COVID  vaccine then 5/28/2021 2nd vaccine 36 hours later onset of left arm weakness with subacute stroke of right temporal and occipital lobs and a second area within the right frontal lobe suspicious for infarct.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Muscular weakness
Clinical narrative: HA since first COVID  vaccine then 5/28/2021 2nd vaccine 36 hours later onset of left arm weakness with subacute stroke of right temporal and occipital lobs and a second area within the right frontal lobe suspicious for infarct.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain in extremity, Rhinorrhoea, Throat irritation
Clinical narrative: Severe upper arm pain that stretched to back Headache Runny Nose Itchy Throat
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Computerised tomogram normal, Feeling cold, Headache
Clinical narrative: High prolonged fever. Severe chills. Headache, body aches. Can't get warm.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: High prolonged fever. Severe chills. Headache, body aches. Can't get warm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature abnormal, Chills, Decreased appetite
Clinical narrative: but I was dizzy/weak; but I was dizzy/weak; weak from lack of appetite and fever; weak from lack of appetite and fever; headache; had chills and shivering and couldn't get warm; had chills and shivering and couldn't get warm; My temp started to climb overnight Friday; It felt like my face was going to explode; This is a spontaneous report from a contactable other hcp. A 42-years-old female patient reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 29Jan2021 07:00 as single dose for covid-19 immunisation. The patiently previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 08Jan2021 11:00  as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that the patient got second dose Friday morning, 29Jan2021, at 07:00. By 4 pm on Friday she had chills and shivering, and couldn't get warm. By 6pm on Friday, a headache started. The headache got progressively worse overnight Friday, the worst headache she had ever experienced. It felt like her face was going to explode. Her temperature started to climb overnight Friday. Got up to 101.5 by early Saturday morning. By noon on Saturday, headache started easing up, but was dizzy/weak. By 4:00 pm Saturday she was feeling a lot better, just weak from lack of appetite and fever. The patient underwent lab tests and procedures which included body temperature: started to climb on 29Jan2021, body temperature: 101.5 on 30Jan2021. On an unspecified date, the outcome of the events was resolved.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Pyrexia
Clinical narrative: but I was dizzy/weak; but I was dizzy/weak; weak from lack of appetite and fever; weak from lack of appetite and fever; headache; had chills and shivering and couldn't get warm; had chills and shivering and couldn't get warm; My temp started to climb overnight Friday; It felt like my face was going to explode; This is a spontaneous report from a contactable other hcp. A 42-years-old female patient reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 29Jan2021 07:00 as single dose for covid-19 immunisation. The patiently previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch number and expiry date were not reported) via an unspecified route of administration, administered in Arm Left on 08Jan2021 11:00  as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. It was reported that the patient got second dose Friday morning, 29Jan2021, at 07:00. By 4 pm on Friday she had chills and shivering, and couldn't get warm. By 6pm on Friday, a headache started. The headache got progressively worse overnight Friday, the worst headache she had ever experienced. It felt like her face was going to explode. Her temperature started to climb overnight Friday. Got up to 101.5 by early Saturday morning. By noon on Saturday, headache started easing up, but was dizzy/weak. By 4:00 pm Saturday she was feeling a lot better, just weak from lack of appetite and fever. The patient underwent lab tests and procedures which included body temperature: started to climb on 29Jan2021, body temperature: 101.5 on 30Jan2021. On an unspecified date, the outcome of the events was resolved.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown), dose 1 via an unspecified route of administration, administered in arm left on 30Jan2021 at 12:15 as single dose for Covid-19 immunization. Medical history included high blood pressure. The patient had no known allergies. The patient not had Covid prior vaccination. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced soreness in the arm for a couple days. The patient had not tested Covid post vaccination. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: tiniest soreness in arm; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (Patient) reported that: A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date were not reported) dose 2 via unspecified route of administration, on 31Jan2021 (at the age of 68-year-old) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the tiniest soreness in her arm following vaccination. The patient asked if no reaction to the vaccine indicates that the vaccine is not effective. She explained reading in several different places that "when people get a reaction to the vaccine, it means that the body is working". She then asked if there any tests that indicate if she has build up an immunity after receiving the COVID-19 vaccine and also stated being "very disappointed with Pfizer" and would have expected a precise recommendation on what test to take to asses her immunity after vaccination and added she understands that a reaction would be the body's response to it working with the vaccine, she is worried about the vaccine not being effective, her arm was not her concern, it is so minute and she declines to complete a report. She was asking how will she know if it is effective in fighting off the virus if she did not have any real reaction to the vaccine. The outcome of event is unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Movement disorder
Clinical narrative: feeling light headed and dizzy; didn't think I'd be able to even get up; This is a spontaneous report from a contactable consumer (Patient).   A 65-year-old male patient started to receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date were not reported), via an unspecified route, on and unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that she received the first dose of the Pfizer vaccine on Friday and everything was fine on that day. The next morning while laying down working on some equipment, he started feeling lightheaded and dizzy. At times he was dizzy and did not think he would be able to even get up. She heard from some nurses that this could be a side effect of the vaccine, feeling lightheaded, dizzy or disoriented. omething like feeling seasick. He was feeling a little better, when he stands up it got a bit worse. The outcome of all the events were unknown.   Follow-up (30Mar2021): No new information received from the contactable consumer (Patient).  Follow-up attempts are completed. Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Hyperhidrosis, Limb discomfort
Clinical narrative: whole left arm feeling sore; feeling foggy and out of it; threw up; both legs feels sore and achy; tired; Diarrhea; hot and sweaty; nauseous; This is a spontaneous report from a Contactable consumer. A 27 years-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot number: not reported: Expiration date: not reported) via intramuscular route of administration in the left arm on 01Feb2021 at 10:20 AM as a single dose for COVID-19 immunisation (age at vaccination was 27 years). Patient's medical history includes Bipolar disorder from 2014 to unspecified stop date, ADHD (Attention deficit hyperactivity disorder) from unspecified start date and stop date. The patient's concomitant medication includes Vyvance (LISDEXAMFETAMINE MESILATE) 40mg, once a day, orally for ADHD (Attention deficit hyperactivity disorder), LAMOTRIGINE 200mg, once a day, orally for Bipolar disorder, Rexulti (BREXPIPRAZOLE) 2mg, once a day, orally for bipolar anxiety depression, Lithium 900mg, once a day, orally for Bipolar disorder. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Feb2021 patient received vaccine at 10:20AM and sat down for 10 minutes and felt good. Her whole left arm was feeling sore, the same arm where she received the injection. She got up to walk back to her car and she felt so out of it, she felt so foggy, not dizzy. She went back to the parking garage and she felt hot, sweaty, and nauseous. She threw up once about 45 minutes after the injection. Patient reported that she still feels kind of foggy and that started about 40 minutes after she got the shot. She does not know if this is normal or what she should do. Patient was advised to contact hcp. The patient reported foggy was improved with sitting down, if she is walking around it become worse. Fogginess was improved when she decided to start driving. She felt like she could not drive, and she did not drive till about an hour after. Reports both her legs felt sore and achy. She also feels tired. She had diarrhoea right before her call was answered. The outcome of the events vomiting, diarrhea, nausea, hot and sweaty was unknown, for the events whole left arm feeling sore, feeling foggy and out of it was recovering and for the event both legs feels sore and achy was not recovered.   Information on the Batch/Lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: whole left arm feeling sore; feeling foggy and out of it; threw up; both legs feels sore and achy; tired; Diarrhea; hot and sweaty; nauseous; This is a spontaneous report from a Contactable consumer. A 27 years-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot number: not reported: Expiration date: not reported) via intramuscular route of administration in the left arm on 01Feb2021 at 10:20 AM as a single dose for COVID-19 immunisation (age at vaccination was 27 years). Patient's medical history includes Bipolar disorder from 2014 to unspecified stop date, ADHD (Attention deficit hyperactivity disorder) from unspecified start date and stop date. The patient's concomitant medication includes Vyvance (LISDEXAMFETAMINE MESILATE) 40mg, once a day, orally for ADHD (Attention deficit hyperactivity disorder), LAMOTRIGINE 200mg, once a day, orally for Bipolar disorder, Rexulti (BREXPIPRAZOLE) 2mg, once a day, orally for bipolar anxiety depression, Lithium 900mg, once a day, orally for Bipolar disorder. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Feb2021 patient received vaccine at 10:20AM and sat down for 10 minutes and felt good. Her whole left arm was feeling sore, the same arm where she received the injection. She got up to walk back to her car and she felt so out of it, she felt so foggy, not dizzy. She went back to the parking garage and she felt hot, sweaty, and nauseous. She threw up once about 45 minutes after the injection. Patient reported that she still feels kind of foggy and that started about 40 minutes after she got the shot. She does not know if this is normal or what she should do. Patient was advised to contact hcp. The patient reported foggy was improved with sitting down, if she is walking around it become worse. Fogginess was improved when she decided to start driving. She felt like she could not drive, and she did not drive till about an hour after. Reports both her legs felt sore and achy. She also feels tired. She had diarrhoea right before her call was answered. The outcome of the events vomiting, diarrhea, nausea, hot and sweaty was unknown, for the events whole left arm feeling sore, feeling foggy and out of it was recovering and for the event both legs feels sore and achy was not recovered.   Information on the Batch/Lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal
Clinical narrative: kind of unsteady on her feet; dizziness; her head was feeling peculiar; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:20 (Batch/Lot Number: EL5318) (at the age of 78-years-old) as a single dose for covid-19 immunisation. The patient medical history included blood pressure issue from an unknown date and ongoing. Concomitant medication(s) included atenolol (ATENOLOL) 25mg take once daily by mouth and benazepril (BENAZEPRIL) 20mg take once daily by mouth taken for blood pressure for years (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she got the vaccine on saturday (30Jan2021 09:20) and she didn't have any side effects except dizziness. Mention she didn't see that as one on the list. Adds she was dizzy when she wakes up and feels dizzy right now if she moves her head just right. Patient was asking is are we aware of this side effect. Patient further stated that after vaccination she was sitting in the car waiting for 15 minutes she was laughing with her family and she noticed her head was feeling peculiar. Adds that may have been the start of it (dizziness). Adds the peculiar feeling was kind of right in the center of her forehead. States she thought maybe she was dehydrated and slammed water all day long yesterday and as she was going to bed she felt dizziness. Today she noticed she was still dizzy and kind of unsteady on her feet. Patient was scheduled for the second dose of the vaccine on 20Feb2021. At the time of this report head was feeling peculiar (feeling abnormal) and dizziness were not recovered and the event kind of unsteady (Unsteadiness) on her feet was unknown.  Follow-up attempts are completed. No further information is expected.