chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Headache
Clinical narrative: SEVERE HEADACHE; DID NOT CLARIFY SYMPTOM HAD LAST NIGHT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-JUN-2021, the subject experienced did not clarify symptom had last night. On 16-JUN-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of did not clarify symptom had last night was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Pain, Pyrexia
Clinical narrative: VIOLENT SHAKING OF THE WHOLE BODY; FEVER 101.1 DEGREE F THEN 102.1 DEGREE F; BODY ACHES; FEELING WARM; CHILLS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported.  The patient's past medical history included covid-19, and viral pneumonia, and concurrent conditions included asthma, alcohol use, non-smoker, and seasonal allergy. The patient was previously treated with for asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 14-JUN-2021, the subject experienced body aches. On 14-JUN-2021, the subject experienced feeling warm. On 14-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced violent shaking of the whole body. On 15-JUN-2021, the subject experienced fever 101.1 degree f then 102.1 degree f. Laboratory data included: Body temperature (NR: not provided) 101 degree F. On 16-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102.1 degree F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from violent shaking of the whole body on 15-JUN-2021, and feeling warm, and chills on 16-JUN-2021, and had not recovered from fever 101.1 degree f then 102.1 degree f, and body aches. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: VIOLENT SHAKING OF THE WHOLE BODY; FEVER 101.1 DEGREE F THEN 102.1 DEGREE F; BODY ACHES; FEELING WARM; CHILLS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported.  The patient's past medical history included covid-19, and viral pneumonia, and concurrent conditions included asthma, alcohol use, non-smoker, and seasonal allergy. The patient was previously treated with for asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 14-JUN-2021, the subject experienced body aches. On 14-JUN-2021, the subject experienced feeling warm. On 14-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced violent shaking of the whole body. On 15-JUN-2021, the subject experienced fever 101.1 degree f then 102.1 degree f. Laboratory data included: Body temperature (NR: not provided) 101 degree F. On 16-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102.1 degree F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from violent shaking of the whole body on 15-JUN-2021, and feeling warm, and chills on 16-JUN-2021, and had not recovered from fever 101.1 degree f then 102.1 degree f, and body aches. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Muscle tightness, Swelling face
Clinical narrative: This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced flushing in face. On 15-JUN-2021, the subject experienced tiredness. On 15-JUN-2021, the subject experienced headache. On 16-JUN-2021, the subject experienced swelling occurring at both sides of eyes temple regions. On 16-JUN-2021, the subject experienced muscle tightening at corners of mastoids. Treatment medications (dates unspecified) included: ibuprofen. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushing in face on 14-JUN-2021, and tiredness on 16-JUN-2021, was recovering from headache, and had not recovered from swelling occurring at both sides of eyes temple regions, and muscle tightening at corners of mastoids. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: HOT AND ITCHY ALLERGY LIKE BUMPS IN RANDOM AREAS OF THE BODY; RASH; ITCHY EARS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced itchy ears. On 02-JUN-2021, the subject experienced hot and itchy allergy like bumps in random areas of the body. On 02-JUN-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hot and itchy allergy like bumps in random areas of the body, and rash, and the outcome of itchy ears was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included COVID-19, and concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient otherwise healthy. The patient had no known allergies.The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 16-JUN-2021, the subject experienced strong chills. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong chills on 16-JUN-2021. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: EYE SENSITIVITY; FEVER; INJECTION SITE SORENESS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced eye sensitivity. On 15-JUN-2021, the subject experienced fever. On 15-JUN-2021, the subject experienced injection site soreness. On 15-JUN-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-JUN-2021, and had not recovered from injection site soreness, headache, eye sensitivity, and tiredness. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 04-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced poor quality vaccine administered. On 15-JUN-2021, the subject experienced incorrect product storage. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect product storage was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 04-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced poor quality vaccine administered. On 15-JUN-2021, the subject experienced incorrect product storage. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality vaccine administered and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: REAL ACHY; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced real achy. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from real achy, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hot flush
Clinical narrative: HOT WAVES; NIGHT CHILLS FOR SEVERAL HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number No concomitant medications were reported.  On an unspecified date, the subject experienced hot waves, and night chills for several hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the night chills for several hours and hot waves was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: SLIGHT MUSCLE PAIN; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 15-JUN-2021, the subject experienced slight muscle pain. On 15-JUN-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight muscle pain and slight fever was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast mass, Breast pain, Lymphadenopathy, Pain in extremity
Clinical narrative: SWOLLEN LYMPH NODES UNDER HER ARMPIT; PAIN IN LEFT BREAST; KNOT IN BREAST; EXCRUCIATING BACK PAIN THAT COMES SHARPELY AND GOSE QUICKLY; ARM PAIN WHEN THE INJECTION SIDE HAS BEEN SQUEEZED OR PRESSED; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced arm pain when the injection side has been squeezed or pressed. On 14-JUN-2021, the subject experienced excruciating back pain that comes sharpely and gose quickly. On an unspecified date, the subject experienced swollen lymph nodes under her armpit, pain in left breast, and knot in breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain when the injection side has been squeezed or pressed, swollen lymph nodes under her armpit, pain in left breast, excruciating back pain that comes sharpely and gose quickly, and knot in breast. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINATION ADMINISTERED TO A MINOR; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced vaccination administered to a minor. On 16-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination administered to a minor and off label use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000183046.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse events was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; TIREDNESS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, fever, tiredness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, tiredness, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Headache
Clinical narrative: FEVER OF 101; HEADACHE AROUND EYES; SEVERE BODY ACHES; COUGHING; HORRIBLE CHILLS; HURTING OF SHOULDER BLADES BEHIND LUNGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included shoulder blade pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced severe body aches. On JUN-2021, the subject experienced coughing. On JUN-2021, the subject experienced horrible chills. On JUN-2021, the subject experienced hurting of shoulder blades behind lungs. On JUN-2021, the subject experienced headache around eyes. On 16-JUN-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101, horrible chills, severe body aches, hurting of shoulder blades behind lungs, headache around eyes and coughing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER OF 101; HEADACHE AROUND EYES; SEVERE BODY ACHES; COUGHING; HORRIBLE CHILLS; HURTING OF SHOULDER BLADES BEHIND LUNGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included shoulder blade pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced severe body aches. On JUN-2021, the subject experienced coughing. On JUN-2021, the subject experienced horrible chills. On JUN-2021, the subject experienced hurting of shoulder blades behind lungs. On JUN-2021, the subject experienced headache around eyes. On 16-JUN-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101, horrible chills, severe body aches, hurting of shoulder blades behind lungs, headache around eyes and coughing was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT BAD FOR A COUPLE OF DAYS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 felt bad for a couple of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt bad for a couple of days. This report was non-serious. This case, from the same reporter is linked to 20210637088.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Cerebrovascular accident, Feeling abnormal, Headache, Limb discomfort
Clinical narrative: heavy legs; Stroke; runny nose; a little temp; Not feeling himself; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LIMB DISCOMFORT (heavy legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation since 2017.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy legs) (seriousness criterion hospitalization) and FEELING ABNORMAL (Not feeling himself). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and BODY TEMPERATURE ABNORMAL (a little temp). The patient was hospitalized from 29-Jan-2021 to 02-Feb-2021 due to CEREBROVASCULAR ACCIDENT and LIMB DISCOMFORT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident and Rehabilitation therapy for Limb discomfort. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LIMB DISCOMFORT (heavy legs), RHINORRHOEA (runny nose), BODY TEMPERATURE ABNORMAL (a little temp) and FEELING ABNORMAL (Not feeling himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners which patient had reportedly been taking for approximately four years to treat atrial fibrillation.  Treatment included rehabilitation and learning how to ambulate with a walker.  Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.   This case was linked to MOD-2021-008992 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Case updated to serious, events added.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: heavy legs; Stroke; runny nose; a little temp; Not feeling himself; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LIMB DISCOMFORT (heavy legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation since 2017.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy legs) (seriousness criterion hospitalization) and FEELING ABNORMAL (Not feeling himself). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and BODY TEMPERATURE ABNORMAL (a little temp). The patient was hospitalized from 29-Jan-2021 to 02-Feb-2021 due to CEREBROVASCULAR ACCIDENT and LIMB DISCOMFORT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident and Rehabilitation therapy for Limb discomfort. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LIMB DISCOMFORT (heavy legs), RHINORRHOEA (runny nose), BODY TEMPERATURE ABNORMAL (a little temp) and FEELING ABNORMAL (Not feeling himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners which patient had reportedly been taking for approximately four years to treat atrial fibrillation.  Treatment included rehabilitation and learning how to ambulate with a walker.  Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.   This case was linked to MOD-2021-008992 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Case updated to serious, events added.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Loss of consciousness
Clinical narrative: passed out in public and hit head; Cough; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out in public and hit head) in a 66-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 reported medical history.     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 LOSS OF CONSCIOUSNESS (passed out in public and hit head) (seriousness criterion medically significant) and COUGH (Cough). At the time of the report, LOSS OF CONSCIOUSNESS (passed out in public and hit head) and COUGH (Cough) 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 product use was not provided by the reporter. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Malaise, Myocardial infarction
Clinical narrative: not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved.            Concomitant medications were not reported.  Company Comment ; Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR)  upgraded case to serious, new event added, action taken updated; new reporter added.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Massive heart attack
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved.            Concomitant medications were not reported.  Company Comment ; Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR)  upgraded case to serious, new event added, action taken updated; new reporter added.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Massive heart attack
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Eyelid ptosis
Clinical narrative: Thought she had lost sight of her left eye; Left eye looking droopy; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (Thought she had lost sight of her left eye) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced EYELID PTOSIS (Left eye looking droopy). On 18-Mar-2021, the patient experienced BLINDNESS TRANSIENT (Thought she had lost sight of her left eye) (seriousness criterion medically significant). On 18-Mar-2021, BLINDNESS TRANSIENT (Thought she had lost sight of her left eye) and EYELID PTOSIS (Left eye looking droopy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: extreme pain in legs, hamstrings, shoulders and hands; extreme pain in legs, hamstrings, shoulders and hands; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in legs, hamstrings, shoulders and hands) and ARTHRALGIA (extreme pain in legs, hamstrings, shoulders and hands) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031M02A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021 at 11:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (extreme pain in legs, hamstrings, shoulders and hands) (seriousness criterion hospitalization) and ARTHRALGIA (extreme pain in legs, hamstrings, shoulders and hands) (seriousness criterion hospitalization). The patient was hospitalized from 06-May-2021 to 09-May-2021 due to ARTHRALGIA and PAIN IN EXTREMITY. The patient was treated with PREDNISONE on 06-May-2021 for Adverse event, at an unspecified dose and frequency; GABAPENTIN on 26-May-2021 for Adverse event, at an unspecified dose and frequency and MELOXICAM on 26-May-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme pain in legs, hamstrings, shoulders and hands) and ARTHRALGIA (extreme pain in legs, hamstrings, shoulders and hands) had not resolved.            No relevant concomitant medications were provided.  On 06 May 2021, patient underwent X-rays, magnetic resonance imaging (MRI) and blood work but results were not provided. He was hooked up to intravenous steroids for 3 days in hospital. On 24 May 2021, patient went to PA due to severe pain in both hands and was given a steroid shot. On 26 May 2021, he went to neurology due to severe pain in both hands.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug hypersensitivity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Drug Allergy; This spontaneous case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult 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 Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and DRUG HYPERSENSITIVITY (Drug Allergy). The patient was treated with METHOTREXATE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and DRUG HYPERSENSITIVITY (Drug Allergy) 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 was not provided by the reporter.  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Deafness unilateral, Fatigue, Headache, Tinnitus
Clinical narrative: Hearing loss in her left ear; Tinnitus in her left ear; Loss of balance; Feel exhausted; Strong headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in her left ear) and HEADACHE (Strong headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (Strong headache) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Hearing loss in her left ear) (seriousness criterion medically significant), TINNITUS (Tinnitus in her left ear), BALANCE DISORDER (Loss of balance) and FATIGUE (Feel exhausted). The patient was treated with CORTISONE at an unspecified dose and frequency. On 03-Apr-2021, HEADACHE (Strong headache) had resolved. At the time of the report, DEAFNESS UNILATERAL (Hearing loss in her left ear), TINNITUS (Tinnitus in her left ear), BALANCE DISORDER (Loss of balance) and FATIGUE (Feel exhausted) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The patient experienced a strong headache that merited her transfer to the hospital. The patient reports that despite the treatment she received, she continued with the symptoms. The patient received second dose of Moderna COVID-19 vaccine on an unknown date (batch no. 007C21A).  Patient additionally received steroid injection as treatment medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Blood clot on her lungs; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY THROMBOSIS (Blood clot on her lungs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clot on her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (Blood clot on her lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No corrective treatment was provided.  Very little information is available at this time for evaluation. Further information has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Very little information is available at this time for evaluation. Further information has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspepsia, Electrocardiogram, Endoscopy, Headache
Clinical narrative: Indigestion; Hiatal hernia; Weakness; Inflammation; Heart attack; Reflux gastritis; Headache; Fever; Sleep disturbance; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SPIRONOLACTONE, LISINOPRIL, TICAGRELOR (BRILINTA), ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and PYREXIA (Fever). On 09-May-2021, the patient experienced REFLUX GASTRITIS (Reflux gastritis). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness) and INFLAMMATION (Inflammation). The patient was treated with MAGNESIUM OXIDE HEAVY, SODIUM BICARBONATE (ANTACID C) at a dose of 1 dosage form; NITROGLYCERIN at a dose of 1 dosage form and Surgery (Stent insertion) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), SLEEP DISORDER (Sleep disturbance), DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness), INFLAMMATION (Inflammation), REFLUX GASTRITIS (Reflux gastritis), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal. In 2021, Endoscopy: abnormal (abnormal) abnormal.         Treatment information included proton pump inhibitor. 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 US-MODERNATX, INC.-MOD-2021-108529, BE-MODERNATX, INC.-MOD-2021-108559 (E2B Linked Report). This case was linked to MOD-2021-213971 (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. US-MODERNATX, INC.-MOD-2021-108529:(crosslink) BE-MODERNATX, INC.-MOD-2021-108559:(crosslink)