chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: MIGRAINE; DIARRHEA; UPSET STOMACH; TIRED; POUNDING HEADACHE; SORE THROAT; INJECTION SITE PAIN; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced pounding headache. On 04-MAY-2021, the subject experienced diarrhea. On 04-MAY-2021, the subject experienced upset stomach. On 05-MAY-2021, the subject experienced migraine. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore throat, tired, and pounding headache on 10-APR-2021, chills on 09-APR-2021, and injection site pain on 12-APR-2021, and had not recovered from migraine, diarrhea, and upset stomach. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Migraine, Oropharyngeal pain
Clinical narrative: MIGRAINE; DIARRHEA; UPSET STOMACH; TIRED; POUNDING HEADACHE; SORE THROAT; INJECTION SITE PAIN; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced pounding headache. On 04-MAY-2021, the subject experienced diarrhea. On 04-MAY-2021, the subject experienced upset stomach. On 05-MAY-2021, the subject experienced migraine. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore throat, tired, and pounding headache on 10-APR-2021, chills on 09-APR-2021, and injection site pain on 12-APR-2021, and had not recovered from migraine, diarrhea, and upset stomach. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Dizziness, Injection site pain
Clinical narrative: BLOOD PRESSURE FLUCTUATION; DIZZINESS / LIGHT HEADEDNESS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension sad, non-smoker, and social alcohol drinker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine, bupropion hydrochloride, and lisinopril. On 09-APR-2021, the subject experienced blood pressure fluctuation. On 09-APR-2021, the subject experienced dizziness / light headedness. On 09-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from injection site pain on 10-APR-2021, and had not recovered from blood pressure fluctuation, and dizziness / light headedness. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feels bad; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included rectal surgery. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 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 numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced feels bad. The action taken with covid-19 vaccine  was not applicable. The patient recovered from feels bad. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Nausea, Pain
Clinical narrative: HOT SENSATION IN LEG; SORENESS; NAUSEA; TIREDNESS; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced soreness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced tiredness. On MAY-2021, the subject experienced hot sensation in leg. The action taken with covid-19 vaccine  was not applicable. The outcome of the hot sensation in leg, nausea, tiredness and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Deep vein thrombosis, Rash macular
Clinical narrative: Blood clots in both lungs; Swelling in left breast; The arm showed Small spots; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clots in both 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.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clots in both lungs) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Blood clots in both lungs) outcome was unknown.            No concomitant medications were reported. Treatment of the events were not reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28APR2021 included a new event of "blood clots in both legs" - making this case serious.; 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: Angioedema, Arthralgia, Chills, Complement factor C3, Complement factor C4
Clinical narrative: Angioedema; Itchy rash all over for 3 months since i got the vaccination; Fever; Chills; Muscle aches; Joint pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) 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.     No medical history was not provided by reporter.  The patient's past medical history included COVID-19 in December 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), DOXEPIN, FAMOTIDINE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash all over for 3 months since i got the vaccination), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) and RASH PRURITIC (Itchy rash all over for 3 months since i got the vaccination) outcome was unknown and PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Complement factor C3: normal (normal) normal. On an unknown date, Complement factor C4: normal (normal) normal. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Famotidine, Claritin, Singulair, Doxepin, Benadryl, Kenalog injection.  Fever, Chills, Myalgia and Arthralgia Resoled after few days.  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: Full blood count, Metabolic function test, Myalgia, Pyrexia, Rash pruritic
Clinical narrative: Angioedema; Itchy rash all over for 3 months since i got the vaccination; Fever; Chills; Muscle aches; Joint pains; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) 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.     No medical history was not provided by reporter.  The patient's past medical history included COVID-19 in December 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), DOXEPIN, FAMOTIDINE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash all over for 3 months since i got the vaccination), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) and RASH PRURITIC (Itchy rash all over for 3 months since i got the vaccination) outcome was unknown and PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and ARTHRALGIA (Joint pains) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Complement factor C3: normal (normal) normal. On an unknown date, Complement factor C4: normal (normal) normal. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Famotidine, Claritin, Singulair, Doxepin, Benadryl, Kenalog injection.  Fever, Chills, Myalgia and Arthralgia Resoled after few days.  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: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pulmonary fibrosis
Clinical narrative: her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis; feeling very lethargic; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LETHARGY (feeling very lethargic). At the time of the report, PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) and LETHARGY (feeling very lethargic) outcome was unknown.            Patient was put on ventilator and in hospice care.  No concomitant medication was reported.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: blackout that happened a few times and it was described as sitting on the couch and patient was not there; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blackout that happened a few times and it was described as sitting on the couch and patient was not there) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 200GC21A) for COVID-19 vaccination.     The patient's past medical history included Stress (first blackout started and patient believed it was due to stress) in 2017 and Seizure (seizure in sleep) in January 2020. Concomitant products included LEVETIRACETAM for Seizure.   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-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (blackout that happened a few times and it was described as sitting on the couch and patient was not there) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (blackout that happened a few times and it was described as sitting on the couch and patient was not there) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-095441 (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 event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure fluctuation, Headache, Myalgia, Neck pain
Clinical narrative: blood pressure kept going up and down\she could not get her blood pressure under control; Fever at injection site (right arm); muscle aches in  neck; Sharp pains in legs; pain in stomach; had blurred vision; she had floaters; headache; she had a fever where the vaccine was given (at injection site); body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 044A01A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye operation in March 2021.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) (seriousness criterion hospitalization), VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in  neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to BLOOD PRESSURE FLUCTUATION. At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) had not resolved and VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in  neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment for the event included blood pressure medication and eye drops.  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vaccination site warmth, Vision blurred, Vitreous floaters
Clinical narrative: blood pressure kept going up and down\she could not get her blood pressure under control; Fever at injection site (right arm); muscle aches in  neck; Sharp pains in legs; pain in stomach; had blurred vision; she had floaters; headache; she had a fever where the vaccine was given (at injection site); body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 044A01A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye operation in March 2021.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) (seriousness criterion hospitalization), VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in  neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to BLOOD PRESSURE FLUCTUATION. At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) had not resolved and VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in  neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment for the event included blood pressure medication and eye drops.  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Fatigue, Headache, Urine analysis
Clinical narrative: cystitis; Headache; fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CYSTITIS (cystitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (fatigue). On 08-Apr-2021, the patient experienced CYSTITIS (cystitis) (seriousness criterion medically significant). At the time of the report, CYSTITIS (cystitis), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Urine analysis: abnormal (abnormal) urinalysis Blood 3 plus. In 2021, Urine analysis: abnormal (abnormal) urinalysis Blood 1 plus and nitrates (infection) Follow up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Cipro 2 courses. Concomitant  information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-105169 (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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Kidney infection, Malaise, SARS-CoV-2 test
Clinical narrative: kidney infection; tested positive for COVID-19; not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KIDNEY INFECTION (kidney infection) and COVID-19 (tested positive for COVID-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (diabetic and uses insulin). Concomitant products included INSULIN for Diabetes.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced KIDNEY INFECTION (kidney infection) (seriousness criterion hospitalization), COVID-19 (tested positive for COVID-19) (seriousness criterion hospitalization) and MALAISE (not feeling well). At the time of the report, KIDNEY INFECTION (kidney infection), COVID-19 (tested positive for COVID-19) and MALAISE (not feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Dehydration, Feeling abnormal, Pulmonary oedema
Clinical narrative: Fluid in lungs; Positive COVID test; Feeling poor; Dehydration; Loopy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY OEDEMA (Fluid in lungs), COVID-19 (Positive COVID test), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criterion hospitalization), COVID-19 (Positive COVID test) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), CONFUSIONAL STATE (Loopy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Feeling poor) (seriousness criterion hospitalization). The patient was hospitalized from 22-Mar-2021 to 23-Mar-2021 due to CONFUSIONAL STATE and DEHYDRATION. The patient was treated with Surgery for Pulmonary oedema. On 23-Mar-2021, PULMONARY OEDEMA (Fluid in lungs), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) had resolved. At the time of the report, COVID-19 (Positive COVID test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Blood Thinners (unspecified). The reporter did not mention any treatment medications for the events.  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.  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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Influenza like illness
Clinical narrative: Bells Palsy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 26-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) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 25-Apr-2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On 24-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.            Action taken with the mRNA-1273 in response to the events was not applicable. Treatment medication are Valacyclovir, Prednisone and Gabapentin. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: General physical condition normal, Headache
Clinical narrative: Body aches/ Over all pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL CONDITION NORMAL (Body aches/ Over all pain) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced GENERAL PHYSICAL CONDITION NORMAL (Body aches/ Over all pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, GENERAL PHYSICAL CONDITION NORMAL (Body aches/ Over all pain) and HEADACHE (Headache) outcome was unknown.            The patient was having body aches, headache, over all pain and still on going as of 30 Apr 2021. No concomitant medication No treatment medication  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.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Lip swelling, Seizure
Clinical narrative: Seizure; Spike Body temperature; Swollen Lip; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), BODY TEMPERATURE INCREASED (Spike Body temperature), LIP SWELLING (Swollen Lip) and HEADACHE (Headache). At the time of the report, SEIZURE (Seizure), BODY TEMPERATURE INCREASED (Spike Body temperature), LIP SWELLING (Swollen Lip) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: inconclusive (Inconclusive) temperature is not coming down, it is not going up, but it is also not coming down.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included paracetamol.  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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Lethargy
Clinical narrative: Bell's Palsy; lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced LETHARGY (lethargic). On 07-Mar-2021 at 12:00 PM, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On 08-Mar-2021, LETHARGY (lethargic) had resolved. At the time of the report, BELL'S PALSY (Bell's Palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient began to experience paralysis of the facial muscles on the left side of his face along with lethargy that lasted one day. He was unable to blink his left eye and the left half of his tongue had no taste. He also reported blurry vision.  He subsequently called 911 and was diagnosed with Bell's Palsy in the emergency room that evening. That week, the left side of his face was drooping. He reported that it had tightened up and was more symmetrical now, however, he was still unable to smile, frown or blink from the left side of his face. He was scheduled to receive his second dose of the vaccine on 06-Apr-2021, however, his neurologist stated that she could not guarantee that it would not make his Bell's Palsy worse, but she still recommended getting the second dose. The medical staff at the base didn't know if he should get the second dose and his civilian doctor wouldn't commit. The emergency room physician contacted an Infectious Disease doctor who felt it would be fine for him to get the second dose.  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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Headache, Heart rate, Heart rate increased
Clinical narrative: Heart beating rapidly; Headache; Lingering migraine so had to go to emergency room after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Lingering migraine so had to go to emergency room after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep deprivation.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced HEART RATE INCREASED (Heart beating rapidly). On 01-Apr-2021, HEART RATE INCREASED (Heart beating rapidly) had resolved. On 02-Apr-2021, MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: (normal) normal. On 01-Apr-2021, Electrocardiogram: (normal) normal. On 01-Apr-2021, Heart rate: (High) Heart beating rapidly. On 01-Apr-2021, Liver function test: (normal) normal. On 01-Apr-2021, Pulmonary function test: (normal) normal. On 01-Apr-2021, Renal function test: (normal) normal. On 01-Apr-2021, SARS-CoV-2 test: (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient after receiving their first dose of vaccine experienced extreme reactions and ended up going to the emergency room where they gave the patient an injection cocktail for their headache. The patient said it helped but the headache came back the next day for a total of 3 days and also reported a migraine for 3 days and their heart was beating rapidly. The patient undergone several tests which included lung test, electrocardiogram (EKG), blood test, liver, and kidney levels. All the test results appeared to be normal. The patient was also tested for COVID-19 and the result was negative.   Treatment medication for the event headache included injection cocktail.  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-2021-100742 (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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Migraine, Pulmonary function test, Renal function test, SARS-CoV-2 test
Clinical narrative: Heart beating rapidly; Headache; Lingering migraine so had to go to emergency room after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Lingering migraine so had to go to emergency room after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep deprivation.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced HEART RATE INCREASED (Heart beating rapidly). On 01-Apr-2021, HEART RATE INCREASED (Heart beating rapidly) had resolved. On 02-Apr-2021, MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: (normal) normal. On 01-Apr-2021, Electrocardiogram: (normal) normal. On 01-Apr-2021, Heart rate: (High) Heart beating rapidly. On 01-Apr-2021, Liver function test: (normal) normal. On 01-Apr-2021, Pulmonary function test: (normal) normal. On 01-Apr-2021, Renal function test: (normal) normal. On 01-Apr-2021, SARS-CoV-2 test: (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient after receiving their first dose of vaccine experienced extreme reactions and ended up going to the emergency room where they gave the patient an injection cocktail for their headache. The patient said it helped but the headache came back the next day for a total of 3 days and also reported a migraine for 3 days and their heart was beating rapidly. The patient undergone several tests which included lung test, electrocardiogram (EKG), blood test, liver, and kidney levels. All the test results appeared to be normal. The patient was also tested for COVID-19 and the result was negative.   Treatment medication for the event headache included injection cocktail.  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-2021-100742 (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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Dizziness, Hypokalaemia, Peripheral swelling, Polyuria
Clinical narrative: dizzy spells; swollen feet; frequent urination; vertigo/room was spinning around me; hypokalemia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKALAEMIA (hypokalemia) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3) and PARACETAMOL (ACETAMINOPHEN) 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 23-Apr-2021, the patient experienced HYPOKALAEMIA (hypokalemia) (seriousness criterion medically significant) and VERTIGO (vertigo/room was spinning around me). On an unknown date, the patient experienced DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet) and POLYURIA (frequent urination). At the time of the report, HYPOKALAEMIA (hypokalemia), DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet), POLYURIA (frequent urination) and VERTIGO (vertigo/room was spinning around me) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood potassium: 2.6 (Low) diagnosed with hypokalemia.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment for the event hypokalemia included 2 intravenous bag of potassium chloride.  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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizzy spells; swollen feet; frequent urination; vertigo/room was spinning around me; hypokalemia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKALAEMIA (hypokalemia) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3) and PARACETAMOL (ACETAMINOPHEN) 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 23-Apr-2021, the patient experienced HYPOKALAEMIA (hypokalemia) (seriousness criterion medically significant) and VERTIGO (vertigo/room was spinning around me). On an unknown date, the patient experienced DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet) and POLYURIA (frequent urination). At the time of the report, HYPOKALAEMIA (hypokalemia), DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet), POLYURIA (frequent urination) and VERTIGO (vertigo/room was spinning around me) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood potassium: 2.6 (Low) diagnosed with hypokalemia.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment for the event hypokalemia included 2 intravenous bag of potassium chloride.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site mass, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Cellulitis; arm was painful; COVID arm; raised bumps; hives; little bit of swelling / arm was very swollen; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (raised bumps), VACCINATION SITE URTICARIA (hives) and VACCINATION SITE SWELLING (little bit of swelling / arm was very swollen). On 02-May-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and VACCINATION SITE PAIN (arm was painful). At the time of the report, CELLULITIS (Cellulitis), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MASS (raised bumps), VACCINATION SITE URTICARIA (hives), VACCINATION SITE SWELLING (little bit of swelling / arm was very swollen) and VACCINATION SITE PAIN (arm was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included antibiotics. As per reporter, the patient has not yet started therapy, at the time of report.  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.