chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Neck mass, Pyrexia, Rash
Clinical narrative: lump in arm and neck; knee went out; lump in arm and neck; rash; arthritic pain; fever; chills; Myocardial infarction; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced LIMB MASS (lump in arm and neck), ARTHROPATHY (knee went out), NECK MASS (lump in arm and neck), RASH (rash), ARTHRALGIA (arthritic pain), PYREXIA (fever) and CHILLS (chills). In 2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Myocardial infarction), LIMB MASS (lump in arm and neck), ARTHROPATHY (knee went out), NECK MASS (lump in arm and neck), RASH (rash), ARTHRALGIA (arthritic pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: myocardial infarction (abnormal) myocardial infarction.   The physician scheduled echo on 17-Sep-2021. No concomitant medications was provided. No treatment medications 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.   This case was linked to MOD-2021-027089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received on 20-AUG-2021.event and lab data were added.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Her left arm was stiff & sore; her left arm was stiff & sore; Felt really bad chills; Headachy; Tired; sleepy headed/Fell asleep for a couple of hours; vomiting/vomited once; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore), SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), PAIN IN EXTREMITY (her left arm was stiff & sore), VOMITING (vomiting/vomited once) and CHILLS (Felt really bad chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VOMITING (vomiting/vomited once). On 09-Aug-2021, the patient experienced SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), HEADACHE (Headachy) and FATIGUE (Tired). On 16-Aug-2021, the patient experienced CHILLS (Felt really bad chills). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore) and PAIN IN EXTREMITY (her left arm was stiff & sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore), SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), PAIN IN EXTREMITY (her left arm was stiff & sore), VOMITING (vomiting/vomited once), HEADACHE (Headachy) and FATIGUE (Tired) outcome was unknown and CHILLS (Felt really bad chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vomiting
Clinical narrative: Her left arm was stiff & sore; her left arm was stiff & sore; Felt really bad chills; Headachy; Tired; sleepy headed/Fell asleep for a couple of hours; vomiting/vomited once; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore), SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), PAIN IN EXTREMITY (her left arm was stiff & sore), VOMITING (vomiting/vomited once) and CHILLS (Felt really bad chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VOMITING (vomiting/vomited once). On 09-Aug-2021, the patient experienced SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), HEADACHE (Headachy) and FATIGUE (Tired). On 16-Aug-2021, the patient experienced CHILLS (Felt really bad chills). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore) and PAIN IN EXTREMITY (her left arm was stiff & sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (Her left arm was stiff & sore), SOMNOLENCE (sleepy headed/Fell asleep for a couple of hours), PAIN IN EXTREMITY (her left arm was stiff & sore), VOMITING (vomiting/vomited once), HEADACHE (Headachy) and FATIGUE (Tired) outcome was unknown and CHILLS (Felt really bad chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash erythematous
Clinical narrative: pink rash 6 inches in diameter; tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (pink rash 6 inches in diameter) and FATIGUE (tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 028A21A) for COVID-19 vaccination.     No medical history were provided.  Concurrent medical conditions included Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Immunocompromised.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced RASH ERYTHEMATOUS (pink rash 6 inches in diameter). April 2021, the patient experienced FATIGUE (tired). At the time of the report, RASH ERYTHEMATOUS (pink rash 6 inches in diameter) and FATIGUE (tired) outcome was unknown.            No treatment information was provided by the reporter.   This case was linked to MOD-2021-289515 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Feeling cold, Pyrexia
Clinical narrative: Accidentally got a Pfizer COVID-19 vaccine for my third dose; Had fever; Chills; I felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (I felt cold), EXTRA DOSE ADMINISTERED (Accidentally got a Pfizer COVID-19 vaccine for my third dose), PYREXIA (Had fever) and CHILLS (Chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included MIRTAZAPINE (REMERON), CLONAZEPAM, LEVOTHYROXINE, TAMSULOSIN, PANTOPRAZOLE, HYDROCODONE and ROSUVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING COLD (I felt cold), PYREXIA (Had fever) and CHILLS (Chills). On 17-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Accidentally got a Pfizer COVID-19 vaccine for my third dose). On 24-Feb-2021, FEELING COLD (I felt cold), PYREXIA (Had fever) and CHILLS (Chills) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Accidentally got a Pfizer COVID-19 vaccine for my third dose) outcome was unknown.            Treatment medication were not reported. It was reported that In trying to get a third dose on 17AUG2021, the patient accidentally received a dose of the Pfizer COVID-19 vaccine.   This case was linked to MOD-2021-289789 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Circulatory collapse, Fall, Heart rate, Hip fracture
Clinical narrative: heart stopped/collapsed; slipped and fell with fractured hips; very weak; slipped and fell with fractured hips; This spontaneous case was reported by a patient and describes the occurrence of CIRCULATORY COLLAPSE (heart stopped/collapsed), HIP FRACTURE (slipped and fell with fractured hips), ASTHENIA (very weak) and FALL (slipped and fell with fractured hips) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant, Dialysis since an unknown date and Pacemaker insertion (cardiac). Concurrent medical conditions included Fistula (Patient had fistula in arm for dialysis).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced CIRCULATORY COLLAPSE (heart stopped/collapsed) (seriousness criteria hospitalization and medically significant), HIP FRACTURE (slipped and fell with fractured hips) (seriousness criteria hospitalization and medically significant), ASTHENIA (very weak) (seriousness criterion hospitalization) and FALL (slipped and fell with fractured hips) (seriousness criterion hospitalization). The patient was hospitalized on 30-Jan-2021 due to ASTHENIA, CIRCULATORY COLLAPSE, FALL and HIP FRACTURE. The patient was treated with Surgery (Pacemaker) for Circulatory collapse. At the time of the report, CIRCULATORY COLLAPSE (heart stopped/collapsed), HIP FRACTURE (slipped and fell with fractured hips), ASTHENIA (very weak) and FALL (slipped and fell with fractured hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Heart rate: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Company Comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Circulatory collapse, a causal relationship cannot be excluded. The remaining serious unexpected events of Hip fracture, Fall and Asthenia were more consistent with the possible complications secondary to circulatory collapse complicated by advanced age.; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the serious unexpected event of Circulatory collapse, a causal relationship cannot be excluded. The remaining serious unexpected events of Hip fracture, Fall and Asthenia were more consistent with the possible complications secondary to circulatory collapse complicated by advanced age.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Friend died 2 days after receiving the vaccine; 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 DEATH (Friend died 2 days after receiving the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Treatment information not provided. Concomitant medications were reported as statins and blood pressure medication.  This a report of dead, two days after Moderna COVID-19  vaccination  in a  patient of an unknown age and gender. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Sender's Comments: This a report of dead, two days after Moderna COVID-19  vaccination  in a  patient of an unknown age and gender. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: unknown cause of death.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A2HA and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Artificial cardiac pacemaker user. Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ATRIAL FIBRILLATION (He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (He found out that he had Atrial Fibrillation on a continuous bases since Mid March 2021) had not resolved.            Treatment information was not provided.  Patient went on a semi check up on 13 Aug 2021, after receiving both doses and found out that, he had Atrial Fibrillation on a continuous bases since Mid March 2021.  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. However, patient´s history of pacemaker use could suggest an underlying cardiac disorder which could be a confounding factor for the event. 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 event, a causal relationship cannot be excluded. However, patient´s history of pacemaker use could suggest an underlying cardiac disorder which could be a confounding factor for the event. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Hernia, Illness, Starvation, Weight
Clinical narrative: She is essentially starving right now; Became sick; Hernia; lost over 40 lbs/lost over 40 pounds since taking the Moderna shots in April; completely lost her appetite; This spontaneous case was reported by a consumer and describes the occurrence of STARVATION (She is essentially starving right now) in a 72-year-old female 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 Blood pressure high.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced WEIGHT DECREASED (lost over 40 lbs/lost over 40 pounds since taking the Moderna shots in April) and DECREASED APPETITE (completely lost her appetite). On an unknown date, the patient experienced STARVATION (She is essentially starving right now) (seriousness criterion medically significant), ILLNESS (Became sick) and HERNIA (Hernia). At the time of the report, STARVATION (She is essentially starving right now), ILLNESS (Became sick) and HERNIA (Hernia) outcome was unknown and WEIGHT DECREASED (lost over 40 lbs/lost over 40 pounds since taking the Moderna shots in April) and DECREASED APPETITE (completely lost her appetite) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost over 40 lbs (abnormal) lost over 40 lbs.         Products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medication once a day.  Patient reported that after receiving 2nd dose she experienced Completely lost her appetite, lost her weight over 40 pounds, and starving right now.  Treatment information was not provided.  When she went to the doctor they found a hernia so she had a surgery to remove it but she is still experiencing the same symptoms. She is now on a feeding tube after the surgery. He does not know of any treatment she is on for this AE. Her concomitant medication consists of high blood pressure medication once a day.  Company Comment  Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Live follow up received on 20-Aug-2021, included added serious event, current conditions and updated narrative.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: She is essentially starving right now; Became sick; Hernia; lost over 40 lbs/lost over 40 pounds since taking the Moderna shots in April; completely lost her appetite; This spontaneous case was reported by a consumer and describes the occurrence of STARVATION (She is essentially starving right now) in a 72-year-old female 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 Blood pressure high.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced WEIGHT DECREASED (lost over 40 lbs/lost over 40 pounds since taking the Moderna shots in April) and DECREASED APPETITE (completely lost her appetite). On an unknown date, the patient experienced STARVATION (She is essentially starving right now) (seriousness criterion medically significant), ILLNESS (Became sick) and HERNIA (Hernia). At the time of the report, STARVATION (She is essentially starving right now), ILLNESS (Became sick) and HERNIA (Hernia) outcome was unknown and WEIGHT DECREASED (lost over 40 lbs/lost over 40 pounds since taking the Moderna shots in April) and DECREASED APPETITE (completely lost her appetite) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost over 40 lbs (abnormal) lost over 40 lbs.         Products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medication once a day.  Patient reported that after receiving 2nd dose she experienced Completely lost her appetite, lost her weight over 40 pounds, and starving right now.  Treatment information was not provided.  When she went to the doctor they found a hernia so she had a surgery to remove it but she is still experiencing the same symptoms. She is now on a feeding tube after the surgery. He does not know of any treatment she is on for this AE. Her concomitant medication consists of high blood pressure medication once a day.  Company Comment  Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Live follow up received on 20-Aug-2021, included added serious event, current conditions and updated narrative.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Bell's palsy, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. It is reported that the patient was given with a steroid shot. 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: Arthralgia, Rheumatoid arthritis
Clinical narrative: having rheumatoid pain in all 6 joints; he had terrible arthritic pain for a couple of weeks after the first dose of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (having rheumatoid pain in all 6 joints) 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 information was reported.    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 RHEUMATOID ARTHRITIS (having rheumatoid pain in all 6 joints) (seriousness criterion medically significant) and ARTHRALGIA (he had terrible arthritic pain for a couple of weeks after the first dose of the vaccine.). The patient was treated with INDOMETHACIN [INDOMETACIN] for Pain, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (having rheumatoid pain in all 6 joints) and ARTHRALGIA (he had terrible arthritic pain for a couple of weeks after the first dose of the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned by reporter. The patient had terrible arthritic pain for a couple of weeks after the first dose of the vaccine. The pain kept coming back. He had to take pain medications daily, because he was having rheumatoid pain in all 6 joints. After about 5 weeks of this, the patient did not have to take pain medication anymore. The patient was taking indomethacin for the pain.  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. However, seriousness of the event "rheumatoid arthritis' has not been downgraded until further clarification.; 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. However, seriousness of the event "rheumatoid arthritis' has not been downgraded until further clarification.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: She said she had some other patients who had similar symptoms/my neuropathy in my fingers flared up; 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 NEUROPATHY PERIPHERAL (She said she had some other patients who had similar symptoms/my neuropathy in my fingers flared up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, 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 experienced NEUROPATHY PERIPHERAL (She said she had some other patients who had similar symptoms/my neuropathy in my fingers flared up) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (She said she had some other patients who had similar symptoms/my neuropathy in my fingers flared up) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood count, Cough, Decreased appetite, Electrocardiogram
Clinical narrative: EKG: Irregular heartbeat Comments: Arrythmia; severe fever/ high fever; vomiting; cough; nausea; loss of appetite; headaches; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 20Aug2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), intramuscular in left arm on 12Jul2021 at 18:15 (at the age of 20-years-old) at dose 2, single for COVID-19 immunization. Medical history included chronic migraine from Feb2013 and ongoing. She has no COVID-19 prior to vaccination. Concomitant medications were reported as none. Prior vaccines were reported as none. Family history included her brother having an autoimmune disorder and her father with NFZ and PFO (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), intramuscular in left arm on 21Jun2021 at 18:15 (at the age of 20-years-old) at dose 1, single for COVID-19 immunization. Vaccination facility type was reported as doctor's office/urgent care. On 13Jul2021 at 06:00, the patient experienced severe high fever, vomiting, cough which were reported as causing persistent/significant disability/incapacity. She also experienced nausea, loss of appetite, and headaches on Jul2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events. Vomiting was specifically treated with omeprazole-D 40 mg and cough was specifically treated with benzonatate 100 mg, 3x day. The patient underwent lab tests and procedures on 19Jul2021 which included full blood panel: normal range, EKG: irregular heartbeat/ arrhythmia, and COVID test: negative for COVID. The outcome of the event fever and vomiting was recovered on 19Jul2021; recovered on 05Aug2021 for cough; unknown for arrhythmia; and recovered with sequel on Jul2021 for all other events.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: EKG: Irregular heartbeat Comments: Arrythmia; severe fever/ high fever; vomiting; cough; nausea; loss of appetite; headaches; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 20Aug2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), intramuscular in left arm on 12Jul2021 at 18:15 (at the age of 20-years-old) at dose 2, single for COVID-19 immunization. Medical history included chronic migraine from Feb2013 and ongoing. She has no COVID-19 prior to vaccination. Concomitant medications were reported as none. Prior vaccines were reported as none. Family history included her brother having an autoimmune disorder and her father with NFZ and PFO (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186), intramuscular in left arm on 21Jun2021 at 18:15 (at the age of 20-years-old) at dose 1, single for COVID-19 immunization. Vaccination facility type was reported as doctor's office/urgent care. On 13Jul2021 at 06:00, the patient experienced severe high fever, vomiting, cough which were reported as causing persistent/significant disability/incapacity. She also experienced nausea, loss of appetite, and headaches on Jul2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events. Vomiting was specifically treated with omeprazole-D 40 mg and cough was specifically treated with benzonatate 100 mg, 3x day. The patient underwent lab tests and procedures on 19Jul2021 which included full blood panel: normal range, EKG: irregular heartbeat/ arrhythmia, and COVID test: negative for COVID. The outcome of the event fever and vomiting was recovered on 19Jul2021; recovered on 05Aug2021 for cough; unknown for arrhythmia; and recovered with sequel on Jul2021 for all other events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Dizziness, Ear discomfort, Heart rate increased, Lymphadenopathy
Clinical narrative: nausea; swollen glands; Ear plugged; Heart beating fast; dizziness; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 16Aug2021, this case now contains all required information to be considered valid.    This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), intramuscular, administered in left arm, on 05Apr2021 13:05 (at the age of 52-year old), as dose 1, single for COVID-19 immunization. Medical history included hysterectomy in 2011, ovarian cyst removal of 1 ovary due to hemorrhagic cyst in 2013, gall bladder removal in 2015, allergic to corn for 7 years (2014): corn starch, corn syrup, corn mask, dextrose and black rubber mix. Family medical history also included allergy to black rubber mix, corn syrup, corn mask, dextrose, corn starch, and lactose. There were no concomitant medications and prior vaccinations. The patient guessed that her reaction was from black butyl rubber in the stopper of vaccine. On 05Apr2021, after the first dose injection, patient experienced dizziness for 5 minutes, then it was gone. On 06Apr2021 07:00, the patient experienced swollen glands, severe dizziness, nausea, ears plugged, and heart was beating fast, all for one week, then went away after 7 days. The events were reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 23Jun2021 which included allergy patch test to all the 3 vaccine ingredients, and patch test for PEG, eye drops and polysorbate, both with negative results. The adverse events required visit to physician office. No treatment was given for the events. The outcome of the events was recovered on 13Apr2021.   Follow-up attempts are completed. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; swollen glands; Ear plugged; Heart beating fast; dizziness; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 16Aug2021, this case now contains all required information to be considered valid.    This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), intramuscular, administered in left arm, on 05Apr2021 13:05 (at the age of 52-year old), as dose 1, single for COVID-19 immunization. Medical history included hysterectomy in 2011, ovarian cyst removal of 1 ovary due to hemorrhagic cyst in 2013, gall bladder removal in 2015, allergic to corn for 7 years (2014): corn starch, corn syrup, corn mask, dextrose and black rubber mix. Family medical history also included allergy to black rubber mix, corn syrup, corn mask, dextrose, corn starch, and lactose. There were no concomitant medications and prior vaccinations. The patient guessed that her reaction was from black butyl rubber in the stopper of vaccine. On 05Apr2021, after the first dose injection, patient experienced dizziness for 5 minutes, then it was gone. On 06Apr2021 07:00, the patient experienced swollen glands, severe dizziness, nausea, ears plugged, and heart was beating fast, all for one week, then went away after 7 days. The events were reported as serious due to persistent/significant disability/incapacity. The patient underwent lab tests and procedures on 23Jun2021 which included allergy patch test to all the 3 vaccine ingredients, and patch test for PEG, eye drops and polysorbate, both with negative results. The adverse events required visit to physician office. No treatment was given for the events. The outcome of the events was recovered on 13Apr2021.   Follow-up attempts are completed. No further information was expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pruritus, Psoriasis, Rash, SARS-CoV-2 test
Clinical narrative: Resumption of period at end Jul; Skin swelling; Skin swelling, discoloration and itching on face and neck.; Skin swelling, discoloration and itching on face and neck.; Rashes on neck; Psoriasis behind ears and broken skin; Face: swelling, discoloring, peeling skin; Face: swelling, discoloring, peeling skin; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, on 16Mar2021 (at the age of 51-year-old), as dose 2, single in left arm for COVID-19 immunization at Workplace clinic. Medical history included asthma and hay fever. Patient had allergies to cats, pollen, wool and linen. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. Patient's other historical vaccine included Shingles taken 2 weeks prior to 1st shot. Concomitant medication within 2 weeks of vaccination included loratadine taken for hay fever, start and stop dates were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021, 16 days after second dose of vaccine, the patient experienced Skin swelling, discoloration and itching on face and neck. Treatment medication included tacrolimus and topical steroid creams. On an unspecified date in Jul2021, the patient experienced resumption of period at end of July. Patient had not had a period in over 2 years previously. 3 skin issues started in late March/April. On an unspecified date in Mar2021, the patient experienced rashes on neck; psoriasis behind ears and broken skin; face: swelling, discolouring, peeling skin. Patient received treatment with psoriasis cream, steroids, tacrolimus, elidel. All Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination and was tested COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test: negative, on 30Jul2021. The clinical outcome of all the events was not resolved.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin exfoliation, Skin swelling, Swelling face
Clinical narrative: Resumption of period at end Jul; Skin swelling; Skin swelling, discoloration and itching on face and neck.; Skin swelling, discoloration and itching on face and neck.; Rashes on neck; Psoriasis behind ears and broken skin; Face: swelling, discoloring, peeling skin; Face: swelling, discoloring, peeling skin; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, on 16Mar2021 (at the age of 51-year-old), as dose 2, single in left arm for COVID-19 immunization at Workplace clinic. Medical history included asthma and hay fever. Patient had allergies to cats, pollen, wool and linen. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. Patient's other historical vaccine included Shingles taken 2 weeks prior to 1st shot. Concomitant medication within 2 weeks of vaccination included loratadine taken for hay fever, start and stop dates were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021, 16 days after second dose of vaccine, the patient experienced Skin swelling, discoloration and itching on face and neck. Treatment medication included tacrolimus and topical steroid creams. On an unspecified date in Jul2021, the patient experienced resumption of period at end of July. Patient had not had a period in over 2 years previously. 3 skin issues started in late March/April. On an unspecified date in Mar2021, the patient experienced rashes on neck; psoriasis behind ears and broken skin; face: swelling, discolouring, peeling skin. Patient received treatment with psoriasis cream, steroids, tacrolimus, elidel. All Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient had no COVID prior vaccination and was tested COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test: negative, on 30Jul2021. The clinical outcome of all the events was not resolved.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Headache, Hypotension, Muscular weakness
Clinical narrative: slurred speech; dizziness; headache at the top of the head; weakness on arms; sleepiness; low blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Right on 04Aug2021 14:15 (age at vaccination 34years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes. There were no concomitant medications. The patient has Known allergies reported as unknown. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced slurred speech, dizziness, headache at the top of the head, weakness on arms, sleepiness, low blood pressure on unspecified date in Aug2021. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: slurred speech; dizziness; headache at the top of the head; weakness on arms; sleepiness; low blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Right on 04Aug2021 14:15 (age at vaccination 34years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes. There were no concomitant medications. The patient has Known allergies reported as unknown. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced slurred speech, dizziness, headache at the top of the head, weakness on arms, sleepiness, low blood pressure on unspecified date in Aug2021. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Deafness transitory, Eye swelling, Feeling abnormal, Inflammation
Clinical narrative: loss of hearing in my left ear for 4-6 hours (did not fully return until the next morning); Sensation of heart swelling in chest; Sensation of heart swelling in chest; Under eye bag swelling; general inflammation; migraines; brain fog; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0161), via an unspecified route of administration in the right arm on 16Apr2021 at 11:00 (at the age of 55-year-old), dose 2, single for COVID-19 immunisation. Medical history included likely had COVID. Concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The vaccine was administered at hospital. On 18Apr2021, the patient had sensation of heart swelling in chest, loss of hearing in his left ear for 4-6 hours which did not fully return until the next morning.  The patient also had under eye bag swelling, and general inflammation.  In addition, the patient had migraines, brain fog, some similar to when he believes he likely had COVID during 2020. The patient mentioned he was considered as essential worker and there were several outbreaks at work). The patient received unspecified treatment as he was self-treated since he did not have a doctor or insurance. The patient had not been tested for COVID-19 since vaccination. The outcome of the event loss of hearing in his left ear was recovered on 19Apr2021. The outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Swelling
Clinical narrative: loss of hearing in my left ear for 4-6 hours (did not fully return until the next morning); Sensation of heart swelling in chest; Sensation of heart swelling in chest; Under eye bag swelling; general inflammation; migraines; brain fog; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0161), via an unspecified route of administration in the right arm on 16Apr2021 at 11:00 (at the age of 55-year-old), dose 2, single for COVID-19 immunisation. Medical history included likely had COVID. Concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date, dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The vaccine was administered at hospital. On 18Apr2021, the patient had sensation of heart swelling in chest, loss of hearing in his left ear for 4-6 hours which did not fully return until the next morning.  The patient also had under eye bag swelling, and general inflammation.  In addition, the patient had migraines, brain fog, some similar to when he believes he likely had COVID during 2020. The patient mentioned he was considered as essential worker and there were several outbreaks at work). The patient received unspecified treatment as he was self-treated since he did not have a doctor or insurance. The patient had not been tested for COVID-19 since vaccination. The outcome of the event loss of hearing in his left ear was recovered on 19Apr2021. The outcome of other events was unknown.  No follow-up attempts are possible; No further information is expected.