chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath and Mastectomy (She has had a left mastectomy).   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization). The patient was hospitalized from 19-Jun-2021 to 21-Jun-2021 due to DYSPNOEA. On 21-Jun-2021, DYSPNOEA (Shortness of breath) had resolved.            No concomitant medications were mentioned.  No treatment details were reported.  Based on the current available information, the temporal association between the use of the product and the start date of the event appear unlikely, however, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information, the temporal association between the use of the product and the start date of the event appear unlikely, however, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Depression, Dyspnoea, Insomnia, Myocardial ischaemia
Clinical narrative: diagnosed with Asymptomatic Cardiac Ischemia Pilot; has no energy; really depressed; trouble to sleep; shortness of breath; whistle on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) (seriousness criteria hospitalization and medically significant), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest). At the time of the report, MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reportedly, the patient needs to get an implant device on her heart.  Date of birth of patient given as   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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: diagnosed with Asymptomatic Cardiac Ischemia Pilot; has no energy; really depressed; trouble to sleep; shortness of breath; whistle on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) (seriousness criteria hospitalization and medically significant), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest). At the time of the report, MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reportedly, the patient needs to get an implant device on her heart.  Date of birth of patient given as   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: F
Vaccine: COVID19
Symptoms: Myocardial ischaemia
Clinical narrative: 4 other members of her church after receiving Moderna vaccine get ACIP diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL ISCHAEMIA (4 other members of her church after receiving Moderna vaccine get ACIP diagnosis) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL ISCHAEMIA (4 other members of her church after receiving Moderna vaccine get ACIP diagnosis) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL ISCHAEMIA (4 other members of her church after receiving Moderna vaccine get ACIP diagnosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.  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: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Bipolar disorder, Hospitalisation
Clinical narrative: admitted to the psychiatric facility for 21 days; diagnosed with bipolar disorder; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (admitted to the psychiatric facility for 21 days) and BIPOLAR DISORDER (diagnosed with bipolar disorder) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included ADHD, predominantly inattentive type and Major depressive disorder.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced HOSPITALISATION (admitted to the psychiatric facility for 21 days) (seriousness criterion hospitalization). On an unknown date, the patient experienced BIPOLAR DISORDER (diagnosed with bipolar disorder) (seriousness criterion medically significant). The patient was hospitalized from 10-Jun-2021 to 02-Jul-2021 due to HOSPITALISATION. On 02-Jul-2021, HOSPITALISATION (admitted to the psychiatric facility for 21 days) had resolved. At the time of the report, BIPOLAR DISORDER (diagnosed with bipolar disorder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. An alternative explanation is that the serious unexpected event of Bipolar disorder was more consistent with increased risk due to underlying psychiatric history. The hospitalization was probably related to Bipolar disorder.; Sender's Comments: An alternative explanation is that the serious unexpected event of Bipolar disorder was more consistent with increased risk due to underlying psychiatric history. The hospitalization was probably related to Bipolar disorder.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Patient had Bell's Palsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Patient had Bell's Palsy) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced BELL'S PALSY (Patient had Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Patient had Bell's Palsy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on oral medications to relieve the symptoms. She denied to provide the name of drug.  Company Comment : Very limited information regarding the events has been provided at this time.  Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Hypertension, Oxygen saturation decreased, Pyrexia
Clinical narrative: high blood Pressure; fever 104F; right arm hurting; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERTENSION (high blood Pressure), PYREXIA (fever 104F) and VACCINATION SITE PAIN (right arm hurting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm hurting) (seriousness criterion hospitalization). On 10-Mar-2021, the patient experienced HYPERTENSION (high blood Pressure) (seriousness criterion hospitalization) and PYREXIA (fever 104F) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (high blood Pressure) and PYREXIA (fever 104F) outcome was unknown and VACCINATION SITE PAIN (right arm hurting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) high. On 10-Mar-2021, Body temperature: 104 (High) 104 F. On 10-Mar-2021, Oxygen saturation decreased: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. No treatment medications was provided.  It was reported that patient got transferred to a big hospital within 3 days and was put on ventilator, patient was later transferred to another Rehab Centre.  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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: high blood Pressure; fever 104F; right arm hurting; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERTENSION (high blood Pressure), PYREXIA (fever 104F) and VACCINATION SITE PAIN (right arm hurting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm hurting) (seriousness criterion hospitalization). On 10-Mar-2021, the patient experienced HYPERTENSION (high blood Pressure) (seriousness criterion hospitalization) and PYREXIA (fever 104F) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (high blood Pressure) and PYREXIA (fever 104F) outcome was unknown and VACCINATION SITE PAIN (right arm hurting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) high. On 10-Mar-2021, Body temperature: 104 (High) 104 F. On 10-Mar-2021, Oxygen saturation decreased: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. No treatment medications was provided.  It was reported that patient got transferred to a big hospital within 3 days and was put on ventilator, patient was later transferred to another Rehab Centre.  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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Limb discomfort, Pain in extremity, Peripheral swelling, Skin tightness
Clinical narrative: DVT; MRSA; Left leg swelling; Pain; Hardened leg as hard as a rock; Skin is tight; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) and STAPHYLOCOCCAL INFECTION (MRSA) in a 69-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.     Concurrent medical conditions included Neuropathy and Blood pressure high. Concomitant products included CARVEDILOL (COREG) for Blood pressure high, GABAPENTIN for Neuropathy, DIGOXIN and SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for an unknown indication.    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 DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (MRSA) (seriousness criterion medically significant), PERIPHERAL SWELLING (Left leg swelling), PAIN IN EXTREMITY (Pain), LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at a dose of UNK dosage form; VANCOMYCIN ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form and CEFEPIME ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (DVT), STAPHYLOCOCCAL INFECTION (MRSA), PERIPHERAL SWELLING (Left leg swelling) and PAIN IN EXTREMITY (Pain) outcome was unknown and LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For the last 6 weeks, patient was being treated with vancomycin and cefepime for MRSA infection.  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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: DVT; MRSA; Left leg swelling; Pain; Hardened leg as hard as a rock; Skin is tight; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) and STAPHYLOCOCCAL INFECTION (MRSA) in a 69-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.     Concurrent medical conditions included Neuropathy and Blood pressure high. Concomitant products included CARVEDILOL (COREG) for Blood pressure high, GABAPENTIN for Neuropathy, DIGOXIN and SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for an unknown indication.    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 DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (MRSA) (seriousness criterion medically significant), PERIPHERAL SWELLING (Left leg swelling), PAIN IN EXTREMITY (Pain), LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at a dose of UNK dosage form; VANCOMYCIN ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form and CEFEPIME ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (DVT), STAPHYLOCOCCAL INFECTION (MRSA), PERIPHERAL SWELLING (Left leg swelling) and PAIN IN EXTREMITY (Pain) outcome was unknown and LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For the last 6 weeks, patient was being treated with vancomycin and cefepime for MRSA infection.  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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Dysstasia, Head discomfort, Headache
Clinical narrative: Head pressure; Dizziness; Headaches; such imbalance he couldnt stand for an hour; Started losing balance and kept getting worse every day; vertigo; Mini strokes; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes), BALANCE DISORDER (Started losing balance and kept getting worse every day) and DYSSTASIA (such imbalance he couldnt stand for an hour) in a 63-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.     The patient's past medical history included No adverse event.   On 12-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) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced BALANCE DISORDER (Started losing balance and kept getting worse every day) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) (seriousness criterion medically significant), DYSSTASIA (such imbalance he couldnt stand for an hour) (seriousness criterion hospitalization) and VERTIGO (vertigo). On 26-May-2021, BALANCE DISORDER (Started losing balance and kept getting worse every day) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) and DYSSTASIA (such imbalance he couldnt stand for an hour) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  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 medical history and the events has been provided at this time. Further information has been requested.; 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 medical history and the events has been provided at this time. Further information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Vertigo
Clinical narrative: Head pressure; Dizziness; Headaches; such imbalance he couldnt stand for an hour; Started losing balance and kept getting worse every day; vertigo; Mini strokes; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes), BALANCE DISORDER (Started losing balance and kept getting worse every day) and DYSSTASIA (such imbalance he couldnt stand for an hour) in a 63-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.     The patient's past medical history included No adverse event.   On 12-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) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced BALANCE DISORDER (Started losing balance and kept getting worse every day) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) (seriousness criterion medically significant), DYSSTASIA (such imbalance he couldnt stand for an hour) (seriousness criterion hospitalization) and VERTIGO (vertigo). On 26-May-2021, BALANCE DISORDER (Started losing balance and kept getting worse every day) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) and DYSSTASIA (such imbalance he couldnt stand for an hour) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  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 medical history and the events has been provided at this time. Further information has been requested.; 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 medical history and the events has been provided at this time. Further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Myocardial infarction, Rheumatoid arthritis
Clinical narrative: massive heart attack; Death; rheumatoid arthritis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (massive heart attack), DEATH (Death) and RHEUMATOID ARTHRITIS (rheumatoid arthritis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (massive heart attack) (seriousness criteria death and medically significant), DEATH (Death) (seriousness criteria death and medically significant) and RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criteria death and medically significant). The reported cause of death was massive heart attack. It is unknown if an autopsy was performed.            No laboratory was not given. No treatment information was provided by reporter. According to, "The caller stated that she does not know if her brother´s friend received a Moderna, Pfizer or J&J vaccine."  This a report of dead one day after the second dose of the product in a 55-year-old patient with concomitant Rheumatoid arthritis. Very limited information regarding the event has been provided for inferring causality. Further information has been request.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow Up information was received 08-JUL-2021 and added concomitant product and event verbatim; Sender's Comments: This a report of dead one day after the second dose of the product in a 55-year-old patient with concomitant Rheumatoid arthritis. Very limited information regarding the event has been provided for inferring causality. Further information has been request.; Reported Cause(s) of Death: massive heart attack
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Fatigue, Generalised oedema, Migraine, Pain
Clinical narrative: pneumonia; general swelling; pain; anemic; protein was 2.0/ low protein; platelets test was over 800,000; general edema; extreme fatigue; migraine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (pneumonia) and SWELLING (general swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (general swelling) (seriousness criterion hospitalization), MIGRAINE (migraine), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), PAIN (pain), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein) and PLATELET COUNT INCREASED (platelets test was over 800,000). At the time of the report, PNEUMONIA (pneumonia), SWELLING (general swelling), PAIN (pain), MIGRAINE (migraine), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein), PLATELET COUNT INCREASED (platelets test was over 800,000), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: > 800,000 > 800,000. On an unknown date, Protein total: 2.0 2.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given narcotics for pain. Low protein was treated with albumin.  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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count increased, Pneumonia, Protein total, Protein total decreased
Clinical narrative: pneumonia; general swelling; pain; anemic; protein was 2.0/ low protein; platelets test was over 800,000; general edema; extreme fatigue; migraine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (pneumonia) and SWELLING (general swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (general swelling) (seriousness criterion hospitalization), MIGRAINE (migraine), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), PAIN (pain), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein) and PLATELET COUNT INCREASED (platelets test was over 800,000). At the time of the report, PNEUMONIA (pneumonia), SWELLING (general swelling), PAIN (pain), MIGRAINE (migraine), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein), PLATELET COUNT INCREASED (platelets test was over 800,000), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: > 800,000 > 800,000. On an unknown date, Protein total: 2.0 2.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given narcotics for pain. Low protein was treated with albumin.  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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: pneumonia; general swelling; pain; anemic; protein was 2.0/ low protein; platelets test was over 800,000; general edema; extreme fatigue; migraine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (pneumonia) and SWELLING (general swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (general swelling) (seriousness criterion hospitalization), MIGRAINE (migraine), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), PAIN (pain), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein) and PLATELET COUNT INCREASED (platelets test was over 800,000). At the time of the report, PNEUMONIA (pneumonia), SWELLING (general swelling), PAIN (pain), MIGRAINE (migraine), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein), PLATELET COUNT INCREASED (platelets test was over 800,000), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: > 800,000 > 800,000. On an unknown date, Protein total: 2.0 2.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given narcotics for pain. Low protein was treated with albumin.  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: Foaming at mouth, Loss of consciousness
Clinical narrative: loss of consciousness; He started foaming at the mouth; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (loss of consciousness) in a male patient of an unknown age 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 was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (loss of consciousness) (seriousness criterion medically significant) and FOAMING AT MOUTH (He started foaming at the mouth). At the time of the report, LOSS OF CONSCIOUSNESS (loss of consciousness) and FOAMING AT MOUTH (He started foaming at the mouth) 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.   No concomitant medication reported. No treatment information was provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: stiffness in her both shoulders ,hip, neck,hand; Pain in hand; stiffness in her both shoulders ,hip, neck,hand; Pain in neck; 1-2 week after 1st dose, she started with pain in both shoulders,pain in hip; Doctor diagnosed her with polymyalgia Rheumatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included FAMOTIDINE (PEPCID AC), LOSARTAN, CALCIUM, ERGOCALCIFEROL (CALCIUM 600+VIT D), COLECALCIFEROL (VITAMIN D3), PANCREATIN (CREON), IPRATROPIUM BROMIDE, LOPERAMIDE HYDROCHLORIDE (IMODIUM) and CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip). The patient was treated with IBUPROFEN at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; MELOXICAM at a dose of UNK dosage form; CELECOXIB (CELEBREX) at a dose of UNK dosage form and METHYLPREDNISOLONE at a dose of UNK dosage form. At the time of the report, POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica), MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory was given.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: stiffness in her both shoulders ,hip, neck,hand; Pain in hand; stiffness in her both shoulders ,hip, neck,hand; Pain in neck; 1-2 week after 1st dose, she started with pain in both shoulders,pain in hip; Doctor diagnosed her with polymyalgia Rheumatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included FAMOTIDINE (PEPCID AC), LOSARTAN, CALCIUM, ERGOCALCIFEROL (CALCIUM 600+VIT D), COLECALCIFEROL (VITAMIN D3), PANCREATIN (CREON), IPRATROPIUM BROMIDE, LOPERAMIDE HYDROCHLORIDE (IMODIUM) and CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip). The patient was treated with IBUPROFEN at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; MELOXICAM at a dose of UNK dosage form; CELECOXIB (CELEBREX) at a dose of UNK dosage form and METHYLPREDNISOLONE at a dose of UNK dosage form. At the time of the report, POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica), MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory was given.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hyperthyroidism, Illness, Palpitations
Clinical narrative: After i got the vaccination my thyroid is higher; thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high; Illness; This spontaneous case was reported by a patient and describes the occurrence of HYPERTHYROIDISM (After i got the vaccination my thyroid is higher) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, SIMVASTATIN (SIMVASTIN), VITAMIN D NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTHYROIDISM (After i got the vaccination my thyroid is higher) (seriousness criterion medically significant), PALPITATIONS (thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high) and ILLNESS (Illness). At the time of the report, HYPERTHYROIDISM (After i got the vaccination my thyroid is higher), PALPITATIONS (thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high) and ILLNESS (Illness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: high (High) Thyroid level was High.         The patient stop taking the medication for a week . Treatment medication information was provided as "Decreased to 50 mcg from 75 mcg after the high thyroids".  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.  Further information is expected.; 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.  Further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Disorientation, Erythema, Pain
Clinical narrative: chills; body aches; disorientation; redness on legs, arm & abdomen; This is a spontaneous report from a contactable consumer (patient) via Team. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Feb2021 as a dose 1, single for COVID-19 immunisation. Co-suspect medication included CEFEPIME HCL (Formulation: unknown), via an unspecified route of administration on an unspecified date as 100 mg, unknown for an unspecified indication. The patient's medical history was not reported. The patient's concomitant medications included other unspecified medications. Enquired, the patient reported that, he received first pfizer covid vaccine on Friday 12Feb2021 during the morning. Stated that, on Saturday 13Feb2021, he started having chills, body aches, disorientation, redness on legs, arm and abdomen. Stated that, the patient was currently taking cefepime 100 mg which he has been on for a little over two weeks, along with other medications and had concerns about the vaccine and other medications. Stated that, the patient took Nyquil last night to help him rest. Treatment was received for the events. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of [Cefepime HCl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Cefepime HCl] has submitted the same report to the regulatory authorities.  Information about lot/batch number was requested. Follow-up attempts are completed. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness in the palms of his hands; This is a spontaneous report from a contactable consumer (patient's daughter) reported for the patient. A 89-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Feb2021 at 16:00 pm (age at vaccination was 88 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The caller was calling on behalf of her dad who received the first dose of the vaccine on last Thursday, 11Feb2021 around 16:00 pm. The patient was fine while he was waiting at the vaccination site for 15-20 minutes and on the ride home, and when she called to check on him at 20:00 pm that evening he was fine. But when she spoke with him again she said he reported later in the evening he had some itchiness in the palms of his hands at bedtime. Itching began the same day on 11Feb2021 at 22:30 pm. She asked if that was an allergic reaction and wanted to know whether that was pointing towards an allergic. She stated that by the next morning the itching was gone, he got the shot at about 16:00 pm and then he was experiencing the itching at about 22:30 pm and then in the morning the next day, he wasn't having anything. She could not think of anything else it could been unless it was hand sanitizer. She stated that she had been hearing that the second dose was the one that can make people not feel good. She stated she was also hearing that it was more prevalent in the younger people that have more robust immune systems. She asked if that was true. The case was reported as non-serious. The outcome of the event was unknown.  Follow-up (16Feb2021 and 13May2021): New information received from a contactable consumer reported for a patient included: Updated the patient's demographics, age at vaccination (88 years) and details regarding follow-up attempts (Follow-up attempts completed. No further information expected).