chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWELLING OF LEGS; SWELLING OF FEET; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swelling of right leg, and swelling of right feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of legs, and swelling of feet. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: CHILLS; HEADACHE; BODY ACHES; FATIGUE; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021 17:30, the subject experienced body aches. On 03-MAY-2021 17:30, the subject experienced fatigue. On 04-MAY-2021, treatment medications included: paracetamol. On 04-MAY-2021 01:00, the subject experienced chills. On 04-MAY-2021 01:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 04-MAY-2021 06:00, and headache on 04-MAY-2021 08:00, and was recovering from fatigue, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Product leakage, Suspected product tampering
Clinical narrative: LEAKED OUT VACCINE; INCOMPLETE COURSE OF VACCINATION; SUSPECTED PRODUCT TAMPERING; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced leaked out vaccine, incomplete course of vaccination, and suspected product tampering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leaked out vaccine, incomplete course of vaccination and suspected product tampering was not reported. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; ACCIDENTAL EXPOSURE TO PRODUCT; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; .This spontaneous report received from a health care professional concerned a 17 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 12:03 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced accidental exposure to product. On 30-APR-2021, the subject experienced product administered to subject of inappropriate age. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, accidental exposure to product and product administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Contusion, Pain, Urticaria
Clinical narrative: STOMACH HURTS; BODY ACHES; HIVES ON BOTH LEGS; BRUISE ON LEFT WRIST; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 107 pounds, and height was 61 inches. The patient's past medical history included cyst on pancreas, and concurrent conditions included severe asthma, high blood pressure, non alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207421A, and batch number: 207421A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for drug used for unknown indication, omeprazole for drug used for unknown indication, ibuprofen for pain, budesonide/formoterol fumarate for severe asthma, and diltiazem. On 02-MAY-2021, the subject experienced bruise on left wrist. On 03-MAY-2021, the subject experienced hives on both legs. On 04-MAY-2021, the subject experienced stomach hurts. On 04-MAY-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on both legs, bruise on left wrist, stomach hurts, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VIAL WAS PUNCTURED AND LEFT OUTSIDE OF THE FRIDGE FOR MORE THAN 2 HOURS; ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vial was punctured and left outside of the fridge for more than 2 hours, and administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was punctured and left outside of the fridge for more than 2 hours and administration error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210506594.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE HIT A LOT HARDER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced vaccine hit a lot harder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine hit a lot harder was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: TENDERNESS AT SITE; REDNESS AT SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tenderness at site, and redness at site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness at site and redness at site was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Intentional product use issue
Clinical narrative: Recieved second dose at 52 days after first one; Broken hip; Fall; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken hip) in a 76-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.     No Medical History information was reported.   On 09-Jan-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 05-Feb-2021, the patient experienced HIP FRACTURE (Broken hip) (seriousness criterion medically significant) and FALL (Fall). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Recieved second dose at 52 days after first one). At the time of the report, HIP FRACTURE (Broken hip) and FALL (Fall) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Recieved second dose at 52 days after first one) had resolved.            No concomitant medications were reported. Treatment details was not provided. Company comment:This case concerns a 76-year-old female with a serious unexpected event of hip fracture, and non serious unexpected fall and product use issue (received second dose at 52 days after first one). Latency 28 days after first dose mRNA-1273. Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: As per the follow-up document received on 30 Apr 2021 the second dose of vaccine was administered.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of hip fracture, and nonserious unexpected fall and product use issue (received second dose at 52 days after first one). Latency 28 days after first dose mRNA-1273. Based on 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial pain, Mental impairment, Tinnitus, Trigeminal neuralgia
Clinical narrative: ringing in both ears; Trigeminal Neuralgia exacerbated; mentally more dull; Dizzy; severe pain on the right side of my face; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (mentally more dull) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Trigeminal neuralgia. Concurrent medical conditions included Allergy to chemicals (patient had a problem with chemicals). Concomitant products included TOPIRAMATE (TOPAMAX) for Trigeminal neuralgia.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MENTAL IMPAIRMENT (mentally more dull) (seriousness criterion medically significant), DIZZINESS (Dizzy), FACIAL PAIN (severe pain on the right side of my face) and TRIGEMINAL NEURALGIA (Trigeminal Neuralgia exacerbated). On 23-Apr-2021, the patient experienced TINNITUS (ringing in both ears). At the time of the report, MENTAL IMPAIRMENT (mentally more dull), DIZZINESS (Dizzy), FACIAL PAIN (severe pain on the right side of my face), TINNITUS (ringing in both ears) and TRIGEMINAL NEURALGIA (Trigeminal Neuralgia exacerbated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.  Company Comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Pyrexia, Seizure
Clinical narrative: convulsing; Hallucinating; Fever of 104 degrees; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 SEIZURE (convulsing) (seriousness criterion medically significant), HALLUCINATION (Hallucinating) and PYREXIA (Fever of 104 degrees). At the time of the report, SEIZURE (convulsing), HALLUCINATION (Hallucinating) and PYREXIA (Fever of 104 degrees) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included Paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with event safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with event safety profile.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Passed out in bathroom; Sweating; Fever; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in bathroom) in a 71-year-old female patient who received  (batch nos. 031B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021 at 10:30 PM, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 15-Apr-2021 at 2:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in bathroom) (seriousness criteria medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in bathroom), HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.            Concomitant medications included blood pressure medications. The patient took Tylenol medication for the treatment.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 13 hours after the second vaccination, a causal relationship cannot be excluded. Further information has been requested
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Passed out in bathroom; Sweating; Fever; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in bathroom) in a 71-year-old female patient who received  (batch nos. 031B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021 at 10:30 PM, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 15-Apr-2021 at 2:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in bathroom) (seriousness criteria medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in bathroom), HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.            Concomitant medications included blood pressure medications. The patient took Tylenol medication for the treatment.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 13 hours after the second vaccination, a causal relationship cannot be excluded. Further information has been requested
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Neoplasm malignant
Clinical narrative: The patient was diagnosed with cancer after the time of the vaccine; Not receive the second dose of the vaccine and is not outside of the allowed time window; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEOPLASM MALIGNANT (The patient was diagnosed with cancer after the time of the vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (The patient was diagnosed with cancer after the time of the vaccine) (seriousness criterion medically significant) and INCOMPLETE COURSE OF VACCINATION (Not receive the second dose of the vaccine and is not outside of the allowed time window). At the time of the report, NEOPLASM MALIGNANT (The patient was diagnosed with cancer after the time of the vaccine) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Not receive the second dose of the vaccine and is not outside of the allowed time window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included undergone two surgeries to combat that condition. 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug specific antibody, Dyspnoea, Fatigue
Clinical narrative: COVID -19; high fever (for over two weeks); pneumonia; difficulty breathing; headache/similar to sinus headache; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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) (unknown route) 1. On 28-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), SINUS HEADACHE (headache/similar to sinus headache), MYALGIA (achy) and FATIGUE (tired). On 12-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID -19) and PYREXIA (high fever (for over two weeks)). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficulty breathing), COVID-19 (COVID -19), SINUS HEADACHE (headache/similar to sinus headache), PYREXIA (high fever (for over two weeks)), MYALGIA (achy) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: she had pneumonia. On 12-Apr-2021, Drug specific antibody: Positive.         No concomitant medications reported by investigator.  Treatment included Levofloxacin, inhaler (albuterol) and steroid dexamethasone.  Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia,   This case was linked to US-MODERNATX, INC.-MOD-2021-095621 (Linked Report).; Sender's Comments: Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, US-MODERNATX, INC.-MOD-2021-095621:1st dose
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pneumonia, Pyrexia, Sinus headache
Clinical narrative: COVID -19; high fever (for over two weeks); pneumonia; difficulty breathing; headache/similar to sinus headache; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-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) (unknown route) 1. On 28-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), SINUS HEADACHE (headache/similar to sinus headache), MYALGIA (achy) and FATIGUE (tired). On 12-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID -19) and PYREXIA (high fever (for over two weeks)). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficulty breathing), COVID-19 (COVID -19), SINUS HEADACHE (headache/similar to sinus headache), PYREXIA (high fever (for over two weeks)), MYALGIA (achy) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: she had pneumonia. On 12-Apr-2021, Drug specific antibody: Positive.         No concomitant medications reported by investigator.  Treatment included Levofloxacin, inhaler (albuterol) and steroid dexamethasone.  Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia,   This case was linked to US-MODERNATX, INC.-MOD-2021-095621 (Linked Report).; Sender's Comments: Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, US-MODERNATX, INC.-MOD-2021-095621:1st dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Pain in extremity
Clinical narrative: Cataract; Pain in arm; This spontaneous case was reported by a physician and describes the occurrence of CATARACT (Cataract) in a 62-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    The patient's past medical history included Cataract extraction. Concurrent medical conditions included Crohns disease aggravated.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, CATARACT (Cataract) and PAIN IN EXTREMITY (Pain in arm) 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.   Concomitant medications were not provided. Treatment information was not reported. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. for Pain in Extremity but is unlikely for the event Cataracts.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. for Pain in Extremity but is unlikely for the event Cataracts.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Laboratory test, Pyrexia
Clinical narrative: intermittent rectal bleeding; dizziness; rash; Headache, head pain is so debilitating; fever/fever is mainly at nighttime; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RECTAL HAEMORRHAGE (intermittent rectal bleeding) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), RASH (rash), HEADACHE (Headache, head pain is so debilitating), PYREXIA (fever/fever is mainly at nighttime) and FATIGUE (fatigue). On an unknown date, the patient experienced RECTAL HAEMORRHAGE (intermittent rectal bleeding) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (intermittent rectal bleeding) outcome was unknown and DIZZINESS (dizziness), RASH (rash), HEADACHE (Headache, head pain is so debilitating), PYREXIA (fever/fever is mainly at nighttime) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal. On an unknown date, SARS-CoV-2 test: (Negative) Swab was taken every week after patient got her second dose..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included acetaminophen, ibuprofen, magnesium, and Excedrin(Aspirin/paracetamol/caffeine). She started taking topiramate 100 mg on 26-Mar-2021 for three months.  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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rectal haemorrhage, SARS-CoV-2 test
Clinical narrative: intermittent rectal bleeding; dizziness; rash; Headache, head pain is so debilitating; fever/fever is mainly at nighttime; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RECTAL HAEMORRHAGE (intermittent rectal bleeding) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), RASH (rash), HEADACHE (Headache, head pain is so debilitating), PYREXIA (fever/fever is mainly at nighttime) and FATIGUE (fatigue). On an unknown date, the patient experienced RECTAL HAEMORRHAGE (intermittent rectal bleeding) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (intermittent rectal bleeding) outcome was unknown and DIZZINESS (dizziness), RASH (rash), HEADACHE (Headache, head pain is so debilitating), PYREXIA (fever/fever is mainly at nighttime) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal. On an unknown date, SARS-CoV-2 test: (Negative) Swab was taken every week after patient got her second dose..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included acetaminophen, ibuprofen, magnesium, and Excedrin(Aspirin/paracetamol/caffeine). She started taking topiramate 100 mg on 26-Mar-2021 for three months.  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: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: had a friend who dropped dead after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (had a friend who dropped dead after getting 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.  This is a patient of unknown age and gender who received mRNA-1273 vaccine (batch no. unk) who died on  an unknown date after receiving the first dose of vaccine  No medical hx or concomitant products  Very limited information has been reported at this time. Further information is being followed up; Sender's Comments: This is a patient of unknown age and gender who received mRNA-1273 vaccine (batch no. unk) who died on  an unknown date after receiving the first dose of vaccine  No medical hx or concomitant products  Very limited information has been reported at this time. Further information is being followed up; Reported Cause(s) of Death: Unknown cause of death
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Loss of consciousness, Malaise
Clinical narrative: no appetite; cough; feels sick; exhausted; passed out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (passed out) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRESYNCOPE (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), COUGH (cough), MALAISE (feels sick) and FATIGUE (exhausted). At the time of the report, PRESYNCOPE (passed out), DECREASED APPETITE (no appetite), COUGH (cough), MALAISE (feels sick) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes naproxen.   Patient received the first dose of the Moderna Covid 19 vaccine (Lot:045B21A, expiration:Unknown) on 26APR2021 at a pharmacy. After the administration of the vaccine, patient passed out at a pharmacy and he had to wait there for 45 minutes. Since the administration of the vaccine patient has been exhausted, has no appetite, cough, and overall, just feels sick. Patient took Aleve to help alleviate his symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Corneal reflex decreased, Hypoaesthesia, Paraesthesia, Taste disorder
Clinical narrative: Numbness of left cheek; Tingling of left cheek; Blinking abnormality/blink was hard, blink was prolonged; Change in taste; Bell's Palsy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness of left cheek), PARAESTHESIA (Tingling of left cheek), CORNEAL REFLEX DECREASED (Blinking abnormality/blink was hard, blink was prolonged), TASTE DISORDER (Change in taste) and BELL'S PALSY (Bell's Palsy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness of left cheek) (seriousness criterion intervention required), PARAESTHESIA (Tingling of left cheek) (seriousness criterion intervention required), CORNEAL REFLEX DECREASED (Blinking abnormality/blink was hard, blink was prolonged) (seriousness criterion intervention required), TASTE DISORDER (Change in taste) (seriousness criterion intervention required) and BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness of left cheek), PARAESTHESIA (Tingling of left cheek), CORNEAL REFLEX DECREASED (Blinking abnormality/blink was hard, blink was prolonged), TASTE DISORDER (Change in taste) and 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.  There were no further change in the patient's symptoms since 29-Apr-2021. The patient was prescribed prednisone 60 mg for 7 days. The patient had no medications prior to development of symptoms.  The concomitant medications were not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Muscle spasms, Muscular weakness, Pain
Clinical narrative: wanted to die because it was soo painful; a little headache; serious pain; convulsing for almost an hour; cramps all over my body\ spasming; muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsing for almost an hour) in a 60-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 Lupus erythematosus, Rheumatoid arthritis, Fibromyalgia and Spinal fusion. Concomitant products included METHOTREXATE, ETANERCEPT (ENBREL), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (convulsing for almost an hour) (seriousness criterion medically significant), MUSCLE SPASMS (cramps all over my body\ spasming), MUSCULAR WEAKNESS (muscle weakness) and PAIN (serious pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (wanted to die because it was soo painful) and HEADACHE (a little headache). At the time of the report, SEIZURE (convulsing for almost an hour), MUSCLE SPASMS (cramps all over my body\ spasming), MUSCULAR WEAKNESS (muscle weakness), CONDITION AGGRAVATED (wanted to die because it was soo painful), HEADACHE (a little headache) and PAIN (serious pain) 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.   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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: wanted to die because it was soo painful; a little headache; serious pain; convulsing for almost an hour; cramps all over my body\ spasming; muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsing for almost an hour) in a 60-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 Lupus erythematosus, Rheumatoid arthritis, Fibromyalgia and Spinal fusion. Concomitant products included METHOTREXATE, ETANERCEPT (ENBREL), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (convulsing for almost an hour) (seriousness criterion medically significant), MUSCLE SPASMS (cramps all over my body\ spasming), MUSCULAR WEAKNESS (muscle weakness) and PAIN (serious pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (wanted to die because it was soo painful) and HEADACHE (a little headache). At the time of the report, SEIZURE (convulsing for almost an hour), MUSCLE SPASMS (cramps all over my body\ spasming), MUSCULAR WEAKNESS (muscle weakness), CONDITION AGGRAVATED (wanted to die because it was soo painful), HEADACHE (a little headache) and PAIN (serious pain) 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.   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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Hypertension
Clinical narrative: Chest pain; High Blood pressure; Dizziness; Difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), HYPERTENSION (High Blood pressure), DIZZINESS (Dizziness) and DYSPNOEA (Difficulty breathing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPERTENSION (High Blood pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to CHEST PAIN, DIZZINESS, DYSPNOEA and HYPERTENSION. At the time of the report, CHEST PAIN (Chest pain), HYPERTENSION (High Blood pressure), DIZZINESS (Dizziness) and DYSPNOEA (Difficulty breathing) outcome was unknown. Not Provided          No adverse event as Medical History was reported.  Concomitant medication information was not provided.  She was brought into Emergency Room on 01Apr2021 and was hospitalized for two days for because of the symptoms of chest pain, High Blood pressure, Dizziness and difficulty breathing. She thought she was having a heart attack.  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/ unknown.  Company comment: Very limited information regarding this events has been provided at this time.  The company physician considers the reported onset date is typo. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  The company physician considers the reported onset date is typo. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: in the hospital for an injury; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJURY (in the hospital for an injury) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJURY (in the hospital for an injury) (seriousness criterion hospitalization). At the time of the report, INJURY (in the hospital for an injury) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Moderna COVID-19 Vaccine EUA. First dose sore arm and major headache lasted one day.  Second dose, sore arm, nausea/vomiting, body aches, chills, headache, fatigue, lasted 2 days.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Moderna COVID-19 Vaccine EUA. First dose sore arm and major headache lasted one day.  Second dose, sore arm, nausea/vomiting, body aches, chills, headache, fatigue, lasted 2 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia, Sinus congestion
Clinical narrative: Cough fever headaches sinus congestion
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Dizziness, Fatigue, Hypotension, Pyrexia
Clinical narrative: Patient presented with high fevers, fatigue and lightheadedness approximately 12 hours following his second COVID-19 vaccination. He was bradycardic with borderline hypotension. He was admitted to the hospital overnight for observation and did well, returning to normal.  He was discharged the next day with the diagnosis of "expected response to vaccination".
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: occasional ringing in both ears.  Occurs about once a week and lasts 1-2 minutes.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site warmth, Rash
Clinical narrative: Very bad rash on left elbow, shoulder and between knees.  Very warm to touch on upper right arm, not just around the injection sight.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS/AIDP
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Magnetic resonance imaging abnormal, Nerve injury, Pain in extremity
Clinical narrative: GBS/AIDP
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Nausea, Pain
Clinical narrative: Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) tablet 650 mg Ondansetron ODT (ZOFRAN-ODT) disintegrating tablet 4 mg.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Fever; Cough; Fatigue; Congestion; Body aches; Nausea; Shortness of Breath; Acetaminophen (TYLENOL) tablet 650 mg Ondansetron ODT (ZOFRAN-ODT) disintegrating tablet 4 mg.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Client reported "pressure in chest" 5 minutes after vaccination.  Assessed by onsite EMS:  B/P 129/80.  Client stated it's probably my nerves. Observed for 20 minutes.  Client stated, "I'm ok now."  Declined further monitoring. Encouraged to follow up with PCP or emergency services if needed.