chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: THROMBOSIS; This spontaneous report received from a health care professional 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombosis. Treatment medications (dates unspecified) included: apixaban for thrombosis.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516823-Covid-19 vaccine ad26.cov2.s -Thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Feeling abnormal, Malaise
Clinical narrative: NOT STABLE ON LEGS; FEELING LOOPY / FEELS OFF; NOT FEELING WELL; 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: Unk) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-MAY-2021, the subject experienced not stable on legs. On 08-MAY-2021, the subject experienced feeling loopy / feels off. On 08-MAY-2021, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling loopy / feels off, not feeling well, and not stable on legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE BEING GIVEN  ERRONEOUSLY OFF LABEL TO A 16  AND 17 YEAR OLD (VACCINE ADMINISTERED TO INAPPROPRIATE AGE); This spontaneous report received from a patient concerned a 17 year old of unspecified 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced off label use, and vaccine being given erroneously off label to a 16 and 17 year old (vaccine administered to inappropriate age). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine being given erroneously off label to a 16 and 17 year old (vaccine administered to inappropriate age) was not reported. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Disorganised speech, Migraine
Clinical narrative: had all signs of a stroke (could have had a stroke); migraine headache; incoherent speech; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) in an 82-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 relevant medical history was reported.  Concomitant products included ATORVASTATIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) (seriousness criterion medically significant), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech). At the time of the report, CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech) outcome was unknown.            Additional concomitant medication included an unspecified blood pressure medication.  Treatment information was not provided.  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up/additional information included the reporters contact information (address) and the mention of had all signs of a stroke / could have had a stroke.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Immune thrombocytopenia, Rash
Clinical narrative: Immune Thrombocytopenia diagnosed by hospital; Autoimmune hemolytic anemia diagnosed by hospital; Small specks on face and chest and body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia diagnosed by hospital) and AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia diagnosed by hospital) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A22A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced RASH (Small specks on face and chest and body). On 12-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia diagnosed by hospital) (seriousness criteria hospitalization and medically significant) and AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia diagnosed by hospital) (seriousness criterion hospitalization). The patient was hospitalized for 13 days due to AUTOIMMUNE HAEMOLYTIC ANAEMIA and IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune Thrombocytopenia diagnosed by hospital), AUTOIMMUNE HAEMOLYTIC ANAEMIA (Autoimmune hemolytic anemia diagnosed by hospital) and RASH (Small specks on face and chest and body) outcome was unknown.            Concomitant product use was not provided by the reporter.  Wife on behalf of husband reported serious adverse effects after getting both the shots. After the 1st shot he developed little specks on face and chest. After his second shot on 12 Mar 2021, lot no 031A22A a day after the shot specks appeared again but this time they multiplied in thousands. He was hospitalized because of this for 13 days and doctors diagnosed him with ITP Immune thrombocytopenia. He has a complete platelet drop and his platelets numbers dropped to 1000. He had multiple platelet infusions and developed Autoimmune hemolytic anemia all because of this shot. He had no underline condition and was not taking any medication at the time of shot.  Treatment medications was not provided. Company comment:Very limited information regarding this events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-107929 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Coma
Clinical narrative: In a coma; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COMA (In a coma) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced COMA (In a coma) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on 20-Feb-2021 due to COMA. At the time of the report, COMA (In a coma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided. On unknown day in Feb 2021, patient received the first dose of the Moderna COVID-19 vaccine, five days later, the patient was hospitalized and in a coma. Per the reporter, the patient woke up the week this case was reported. No further details were provided.  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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Inappropriate schedule of product administration, Lower limb fracture
Clinical narrative: More than 36 days after the first dose without receiving second dose; Fall; Broke both her legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOWER LIMB FRACTURE (Broke both her legs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported  by reporter.  Concomitant products included INSULIN HUMAN, METHOCARBAMOL, GABAPENTIN, OXYCODONE HYDROCHLORIDE (OXYCONTIN), ONDANSETRON and DULOXETINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced LOWER LIMB FRACTURE (Broke both her legs) (seriousness criterion medically significant) and FALL (Fall). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving second dose). The patient was treated with Rehabilitation therapy (she had to get operation and had to attend rehab) for Lower limb fracture. At the time of the report, LOWER LIMB FRACTURE (Broke both her legs) and FALL (Fall) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Haemorrhage, Platelet count decreased
Clinical narrative: Gastrointestinal Bleed; low platelets; has sources of bleeding that have been active; This spontaneous case was reported by a physician and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Gastrointestinal Bleed), PLATELET COUNT DECREASED (low platelets) and HAEMORRHAGE (has sources of bleeding that have been active) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Gastrointestinal Bleed) (seriousness criterion hospitalization), PLATELET COUNT DECREASED (low platelets) (seriousness criterion hospitalization) and HAEMORRHAGE (has sources of bleeding that have been active) (seriousness criterion hospitalization). At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Gastrointestinal Bleed), PLATELET COUNT DECREASED (low platelets) and HAEMORRHAGE (has sources of bleeding that have been active) outcome was unknown. Not Provided      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.   No concomitant medications provided. No treatment information provided.  Patient has sources of bleeding that have been active. They ooze minimally.  Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Diarrhoea, Influenza virus test
Clinical narrative: Paralyzed from knees down; Diarrhea; Fever of 101.9°F; Vomiting; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed from knees down) in a 38-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.     The patient's past medical history included COVID-19 on 21-Dec-2020. Concomitant products included GABAPENTIN, DOMPERIDONE, LEVETIRACETAM and OMEPRAZOLE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralyzed from knees down) (seriousness criteria hospitalization and medically significant), DIARRHOEA (Diarrhea), PYREXIA (Fever of 101.9°F), VOMITING (Vomiting) and CHILLS (Chills). The patient was hospitalized from 15-Apr-2021 to 16-Apr-2021 due to PARALYSIS. On 16-Apr-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever of 101.9°F), VOMITING (Vomiting) and CHILLS (Chills) had resolved. On 17-Apr-2021, PARALYSIS (Paralyzed from knees down) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. On 15-Apr-2021, Blood test: normal (normal) Normal. On 15-Apr-2021, Body temperature: 101.9 (High) 101.9 Fahrenheit. On 15-Apr-2021, Influenza virus test: negative (normal) Normal. On 15-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     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.   Treatment provided was paracetamol  The lab tests were reported as MBR, infection of the spine, tumor of the spine, inflammation of the spine. The results were provided as Normal.  The event paralysis reoccurred on 16 APR 2021 at 08.00 pm and recovered on 17 APR 2-21. Again the event occurred on 17 APR 2021 at 08.00 pm  and got recovered on 18 APR 2021.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Paralyzed from knees down; Diarrhea; Fever of 101.9°F; Vomiting; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed from knees down) in a 38-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.     The patient's past medical history included COVID-19 on 21-Dec-2020. Concomitant products included GABAPENTIN, DOMPERIDONE, LEVETIRACETAM and OMEPRAZOLE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralyzed from knees down) (seriousness criteria hospitalization and medically significant), DIARRHOEA (Diarrhea), PYREXIA (Fever of 101.9°F), VOMITING (Vomiting) and CHILLS (Chills). The patient was hospitalized from 15-Apr-2021 to 16-Apr-2021 due to PARALYSIS. On 16-Apr-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever of 101.9°F), VOMITING (Vomiting) and CHILLS (Chills) had resolved. On 17-Apr-2021, PARALYSIS (Paralyzed from knees down) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. On 15-Apr-2021, Blood test: normal (normal) Normal. On 15-Apr-2021, Body temperature: 101.9 (High) 101.9 Fahrenheit. On 15-Apr-2021, Influenza virus test: negative (normal) Normal. On 15-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     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.   Treatment provided was paracetamol  The lab tests were reported as MBR, infection of the spine, tumor of the spine, inflammation of the spine. The results were provided as Normal.  The event paralysis reoccurred on 16 APR 2021 at 08.00 pm and recovered on 17 APR 2-21. Again the event occurred on 17 APR 2021 at 08.00 pm  and got recovered on 18 APR 2021.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Dry mouth, Headache
Clinical narrative: Constant dizziness; Headache; Body pain; nausea; vomiting; chills; Blood pressure went up as high as 260/114; Dry mouth; Fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) in a female 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.     Concurrent medical conditions included Systemic lupus erythematosis and Drug allergy (Allergy to sulfur). Concomitant products included HYDROCHLOROTHIAZIDE, OMEPRAZOLE, HYDROXYCHLOROQUINE and AZATHIOPRINE for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) (seriousness criterion medically significant), DRY MOUTH (Dry mouth), TACHYCARDIA (Fast heartbeat) and CHILLS (chills). On 29-Apr-2021, the patient experienced DIZZINESS (Constant dizziness), HEADACHE (Headache), MYALGIA (Body pain), NAUSEA (nausea) and VOMITING (vomiting). On 28-Apr-2021, HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) had resolved. At the time of the report, DRY MOUTH (Dry mouth), TACHYCARDIA (Fast heartbeat), DIZZINESS (Constant dizziness), CHILLS (chills), HEADACHE (Headache), MYALGIA (Body pain), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 260/114 (High) 260/114 bpm and 193/110 (High) 193/110 bpm.         Patient self-treated her pain with OTC acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-101591 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypertensive crisis, Myalgia, Nausea, Tachycardia, Vomiting
Clinical narrative: Constant dizziness; Headache; Body pain; nausea; vomiting; chills; Blood pressure went up as high as 260/114; Dry mouth; Fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) in a female 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.     Concurrent medical conditions included Systemic lupus erythematosis and Drug allergy (Allergy to sulfur). Concomitant products included HYDROCHLOROTHIAZIDE, OMEPRAZOLE, HYDROXYCHLOROQUINE and AZATHIOPRINE for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) (seriousness criterion medically significant), DRY MOUTH (Dry mouth), TACHYCARDIA (Fast heartbeat) and CHILLS (chills). On 29-Apr-2021, the patient experienced DIZZINESS (Constant dizziness), HEADACHE (Headache), MYALGIA (Body pain), NAUSEA (nausea) and VOMITING (vomiting). On 28-Apr-2021, HYPERTENSIVE CRISIS (Blood pressure went up as high as 260/114) had resolved. At the time of the report, DRY MOUTH (Dry mouth), TACHYCARDIA (Fast heartbeat), DIZZINESS (Constant dizziness), CHILLS (chills), HEADACHE (Headache), MYALGIA (Body pain), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 260/114 (High) 260/114 bpm and 193/110 (High) 193/110 bpm.         Patient self-treated her pain with OTC acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-101591 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Herpes simplex, Musculoskeletal stiffness, Ophthalmic herpes simplex
Clinical narrative: loss of appetite; tiredness; stiffness in the neck; painful HSV spread to her flank and eyes; painful HSV spread to her flank and eyes; itching; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRURITUS (itching). On 13-Apr-2021, the patient experienced OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes) (seriousness criterion medically significant) and HERPES SIMPLEX (painful HSV spread to her flank and eyes). On 22-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in the neck) and FATIGUE (tiredness). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes), PRURITUS (itching), HERPES SIMPLEX (painful HSV spread to her flank and eyes), MUSCULOSKELETAL STIFFNESS (stiffness in the neck), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: loss of appetite; tiredness; stiffness in the neck; painful HSV spread to her flank and eyes; painful HSV spread to her flank and eyes; itching; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRURITUS (itching). On 13-Apr-2021, the patient experienced OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes) (seriousness criterion medically significant) and HERPES SIMPLEX (painful HSV spread to her flank and eyes). On 22-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in the neck) and FATIGUE (tiredness). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, OPHTHALMIC HERPES SIMPLEX (painful HSV spread to her flank and eyes), PRURITUS (itching), HERPES SIMPLEX (painful HSV spread to her flank and eyes), MUSCULOSKELETAL STIFFNESS (stiffness in the neck), DECREASED APPETITE (loss of appetite) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Dizziness, Epiploic appendagitis, Nausea
Clinical narrative: epiploic appendages; nausea; dizziness; blood clot; pain on left side of abdomen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant) and ABDOMINAL PAIN (pain on left side of abdomen). On 03-May-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On an unknown date, the patient experienced EPIPLOIC APPENDAGITIS (epiploic appendages). At the time of the report, THROMBOSIS (blood clot), ABDOMINAL PAIN (pain on left side of abdomen), DIZZINESS (dizziness), EPIPLOIC APPENDAGITIS (epiploic appendages) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: epiploic appendagitis Epiploic Appendagitis.     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.   Treatment given included antibiotic amoxicillin/clavulanic acid.  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,  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However,  Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: epiploic appendages; nausea; dizziness; blood clot; pain on left side of abdomen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant) and ABDOMINAL PAIN (pain on left side of abdomen). On 03-May-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On an unknown date, the patient experienced EPIPLOIC APPENDAGITIS (epiploic appendages). At the time of the report, THROMBOSIS (blood clot), ABDOMINAL PAIN (pain on left side of abdomen), DIZZINESS (dizziness), EPIPLOIC APPENDAGITIS (epiploic appendages) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: epiploic appendagitis Epiploic Appendagitis.     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.   Treatment given included antibiotic amoxicillin/clavulanic acid.  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,  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However,  Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Encephalitis, Seizure, Transient ischaemic attack
Clinical narrative: suspected TIA or stroke vs seizure disorder; Suspected TIA or stroke vs seizure disorder; Suspected TIA or stroke vs seizure disorder; Encephalitis; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (suspected TIA or stroke vs seizure disorder), CEREBROVASCULAR ACCIDENT (Suspected TIA or stroke vs seizure disorder), SEIZURE (Suspected TIA or stroke vs seizure disorder) and ENCEPHALITIS (Encephalitis) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (suspected TIA or stroke vs seizure disorder) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (Suspected TIA or stroke vs seizure disorder) (seriousness criteria hospitalization and medically significant), SEIZURE (Suspected TIA or stroke vs seizure disorder) (seriousness criteria hospitalization and medically significant) and ENCEPHALITIS (Encephalitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 08-Apr-2021 to 19-Apr-2021 due to CEREBROVASCULAR ACCIDENT, ENCEPHALITIS, SEIZURE and TRANSIENT ISCHAEMIC ATTACK. On 19-Apr-2021, TRANSIENT ISCHAEMIC ATTACK (suspected TIA or stroke vs seizure disorder), CEREBROVASCULAR ACCIDENT (Suspected TIA or stroke vs seizure disorder), SEIZURE (Suspected TIA or stroke vs seizure disorder) and ENCEPHALITIS (Encephalitis) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient received IVIG x5 doses and prednisone, along with seizure meds for treatment. Temporary pacemaker placed 13-Apr-2021 (HR=32). The patient was improved post-treatment and was discharged on 19-Apr-2021.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: 2 episodes of postmenopausal spotting; This spontaneous case was reported by a patient and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0181321A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and RANITIDINE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment for the event.  Patient gave consent for Safety follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mental impairment, Myalgia, Pericarditis, Pyrexia
Clinical narrative: pericarditis; block-head; body aches; fever; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (pericarditis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure increased (high blood pressure) since 2000 and Arthritis rheumatoid (rheumatory arth) since 1999. Concurrent medical conditions included Seafood allergy (lobster) and Seafood allergy (Crab). Concomitant products included QUINAPRIL and AMLODIPINE for Blood pressure abnormal, IBUPROFEN and METHOTREXATE for Rheumatoid arthritis, FOLIC ACID for an unknown indication.   On 26-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced MENTAL IMPAIRMENT (block-head), MYALGIA (body aches), PYREXIA (fever) and FATIGUE (tiredness). On 10-Apr-2021, the patient experienced PERICARDITIS (pericarditis) (seriousness criterion hospitalization). On 25-Feb-2021, MENTAL IMPAIRMENT (block-head), MYALGIA (body aches), PYREXIA (fever) and FATIGUE (tiredness) had resolved. At the time of the report, PERICARDITIS (pericarditis) had resolved.            No treatment related information has been reported.  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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed persistent tinnitus/ringing in the ears. Seeking treatment with anti inflammatory.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Antinuclear antibody negative, Borrelia test negative, C-reactive protein increased, Gait disturbance
Clinical narrative: onset of fever, swelling of right knee and distal leg, malaise, inability to bear weight on right lower extremity
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: HIV test negative, Joint swelling, Liver function test normal, Malaise, Myalgia
Clinical narrative: onset of fever, swelling of right knee and distal leg, malaise, inability to bear weight on right lower extremity
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Procalcitonin increased, Pyrexia, Red blood cell sedimentation rate increased, Respiratory syncytial virus test negative
Clinical narrative: onset of fever, swelling of right knee and distal leg, malaise, inability to bear weight on right lower extremity
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test negative, Systemic inflammatory response syndrome, Ultrasound Doppler normal, Weight bearing difficulty
Clinical narrative: onset of fever, swelling of right knee and distal leg, malaise, inability to bear weight on right lower extremity
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: onset of fever, swelling of right knee and distal leg, malaise, inability to bear weight on right lower extremity
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tenderness, Vaccination complication
Clinical narrative: onset of fever, swelling of right knee and distal leg, malaise, inability to bear weight on right lower extremity
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dizziness, Headache, Nausea
Clinical narrative: 5/2/2020 2:30 pm dizziness, nausea lasted 8 hours. Went away.  Headache remained  5/2/2020 asthma symptoms flare up. Utilized nebulizer 5 times.  Headache remained  5/3/2020 utilized nebulizer 5 times . Headache remained  5/4/2020 utilized nebulizer 5 times. requested meds: received prednisone. 20 mg 2xs daily for 5 days.  Headache remained  5/5/2020  began treatment of prednisone. Utilized nebulizer 4 times. No headache  5/6/2020 utilized nebulizer 4 times  headache returns  5/7/2020 utilized nebulizer 3 times  headache remained  5/8/202 utilized nebulizer 1 time no headache  5/9/2020 discontinued use of nebulizer headache remains  5/10/2020 headache pain near brain stem occipital lobe region  5/11/2020  headache in the morning occipital lobe region.  Pain at the top of head corpus callosum  region.  Right down the middle. Awake at 3:41am w the pain.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram, Myocarditis, Troponin increased
Clinical narrative: Myopericarditis requiring hospital admission. Elevated trop and decreased EF on ECHO.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Electrocardiogram ST segment elevation
Clinical narrative: Myopericarditis requiring hospital admission. Elevated trop and decreased EF on ECHO.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Magnetic resonance imaging heart, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: Myopericarditis requiring hospital admission. Elevated trop and decreased EF on ECHO.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm, Headache
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Patient death certificate lists "natural" causes, with the Immediate Cause of Death of Cardiopulmonary Arrest.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Customer received her vaccine and whole in observation she started to have heart palpitations.  As per customer she was sitting and started feeling the palpitations and got the attention of one of the employees.  EMS and staff nurse responded.  Blood pressure taken 173/86, HR 88, O2Sat 96, Resp. even, skin warm and dry
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Extreme Tinnitus. One week out and symptoms have not let up. Had mild Tinnitus prior. Now severe. Will not get 2nd shot. Very upset.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Ocular hyperaemia, Swelling
Clinical narrative: Red eye and swelling
Sex: U
Vaccine: COVID19, UNK, UNK
Symptoms: Adverse drug reaction, Cerebrovascular accident, Confusional state, Fatigue, Hypokinesia
Clinical narrative: stroke; CONFUSED; could not remember name; tired; unable to get up from couch; Drug Reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke), CONFUSIONAL STATE (CONFUSED), MEMORY IMPAIRMENT (could not remember name), FATIGUE (tired), HYPOKINESIA (unable to get up from couch) and ADVERSE DRUG REACTION (Drug Reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products LENVATINIB MESILATE (LENVIMA) for an unknown indication and PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    The patient's past medical history included Endometrial cancer, Uterine cancer, Ovarian cancer, Blood pressure high and Bladder incontinence.   On 19-Mar-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 20 milligram. 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PEMBROLIZUMAB (KEYTRUDA) (unknown route) at an unspecified dose. On 15-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization), CONFUSIONAL STATE (CONFUSED) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (could not remember name) (seriousness criterion hospitalization), FATIGUE (tired) (seriousness criterion hospitalization), HYPOKINESIA (unable to get up from couch) (seriousness criterion hospitalization) and ADVERSE DRUG REACTION (Drug Reaction) (seriousness criterion hospitalization). The patient was hospitalized on 15-Apr-2021 due to ADVERSE DRUG REACTION, CEREBROVASCULAR ACCIDENT, CONFUSIONAL STATE, FATIGUE, HYPOKINESIA and MEMORY IMPAIRMENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), CONFUSIONAL STATE (CONFUSED), MEMORY IMPAIRMENT (could not remember name), FATIGUE (tired), HYPOKINESIA (unable to get up from couch) and ADVERSE DRUG REACTION (Drug Reaction) outcome was unknown.            Patient kept on hold of all chemo medications as they were unsure what was the cause and she had her first dose of keytruda yesterday (at the time of reporting) and patient would restart Lenvima at a lower doses soon. No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.