chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from a male patient of unspecified age, race and ethnicity. 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 administration was not reported, batch number: 202A21A , and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date, in APR-2021 for prophylactic vaccination. It was unknown if the product was stored in appropriate temperature conditions and if it was properly stored from receipt to administration. No concomitant medications were reported.  On 21-JUL-2021, the patient was tested positive for coronavirus disease (COVID-19) (suspected clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186828. The suspected product quality complaint has been confirmed to be not voided (the reported allegation could not be confirmed. A manufacturing related root cause could not be identified) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 20210747956- JANSSEN COVID-19 VACCINE-Suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Therapy non-responder
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a female 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. 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 confirmed covid-19 infection, and confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed immunological vaccine failure was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: RECEIVED VACCINE TWICE; This spontaneous report received from a health care professional 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: 1805022, and 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUL-2021, the subject experienced received vaccine twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received vaccine twice was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia
Clinical narrative: ACHES; PITIFUL FEELING; CHILLS; FEVERISH FEELING; This spontaneous report received from a patient 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 21-JUL-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 22-JUL-2021, the subject experienced aches. On 22-JUL-2021, the subject experienced pitiful feeling. On 22-JUL-2021, the subject experienced chills. On 22-JUL-2021, the subject experienced feverish feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, feverish feeling, and pitiful feeling. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USAGE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional 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, and batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 24-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced out of specification product usage. On 24-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product usage and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Nausea, Pyrexia
Clinical narrative: COUGH; CONGESTION; CHILLS; NAUSEA; HEADACHE; FEVER; 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 13:07 for prophylactic vaccination. No concomitant medications were reported.  On 17-JUL-2021, the subject experienced chills. On 17-JUL-2021, the subject experienced nausea. On 17-JUL-2021, the subject experienced headache. On 17-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced cough. On 21-JUL-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, headache, and fever, and had not recovered from cough, and congestion. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: COUGH; CONGESTION; CHILLS; NAUSEA; HEADACHE; FEVER; 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 13:07 for prophylactic vaccination. No concomitant medications were reported.  On 17-JUL-2021, the subject experienced chills. On 17-JUL-2021, the subject experienced nausea. On 17-JUL-2021, the subject experienced headache. On 17-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced cough. On 21-JUL-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, headache, and fever, and had not recovered from cough, and congestion. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE/FELT TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. On 14-MAR-2021, the subject experienced fatigue/felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue/felt tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD HEADACHE; This spontaneous report received from a patient concerned a female 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 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-JUL-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: FELT LITTLE NAUSEOUS; This spontaneous report received from a patient via a 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: Unknown) 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 felt little nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt little nauseous was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate decreased
Clinical narrative: LOW HEART RATE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, and lisinopril for high blood pressure. On 25-APR-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) below 60 bpm. On 24-JUL-2021, Laboratory data included: Heart rate (NR: not provided) 69 bpm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 115/72 mmHg, and Heart rate (NR: not provided) 68-78 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low heart rate. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia, Illness
Clinical narrative: TRIGGERED FIBROMYALGIA; HAVE BEEN SICK; This spontaneous report received from a patient 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) 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 01-APR-2021, the subject experienced have been sick. On an unspecified date, the subject experienced triggered fibromyalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the triggered fibromyalgia and have been sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Hypokinesia, Musculoskeletal stiffness, Myalgia
Clinical narrative: BODY STIFFNESS; COULD NOT MOVE/UNABLE TO MOVE; COUGH; BODY PAIN; MUSCLE ACHE; POUNDING IN HEAD/HEADACHE; 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 24-JUL-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, the subject experienced body stiffness. On 24-JUL-2021, the subject experienced could not move/unable to move. On 24-JUL-2021, the subject experienced cough. On 24-JUL-2021, the subject experienced body pain. On 24-JUL-2021, the subject experienced muscle ache. On 24-JUL-2021, the subject experienced pounding in head/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from could not move/unable to move, and body pain, and the outcome of body stiffness, muscle ache, pounding in head/headache and cough was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY STIFFNESS; COULD NOT MOVE/UNABLE TO MOVE; COUGH; BODY PAIN; MUSCLE ACHE; POUNDING IN HEAD/HEADACHE; 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 24-JUL-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, the subject experienced body stiffness. On 24-JUL-2021, the subject experienced could not move/unable to move. On 24-JUL-2021, the subject experienced cough. On 24-JUL-2021, the subject experienced body pain. On 24-JUL-2021, the subject experienced muscle ache. On 24-JUL-2021, the subject experienced pounding in head/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from could not move/unable to move, and body pain, and the outcome of body stiffness, muscle ache, pounding in head/headache and cough was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PAIN RADIATING DOWN THE ARM; PAIN IN ARM AT THE INJECTION SITE; This spontaneous report received from a patient via a 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced pain radiating down the arm, and pain in arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm at the injection site and pain radiating down the arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELING ABNORMAL FOR A WHILE; This spontaneous report received from a patient 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feeling abnormal for a while. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling abnormal for a while. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist 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: 1820096, and expiry: 06-SEP-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced administration of expired vaccine. On 24-JUL-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect storage of drug was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS; This spontaneous report received from a patient concerned a female 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diplegia, Feeling cold, Influenza like illness, Pain, Pain in extremity
Clinical narrative: paralysis in my legs; Little cold; Flu like symptoms; Very Achy; Pain in leg; Hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (paralysis in my legs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE from 24-Feb-2021 to 26-Feb-2021 for Heartburn.   On 11-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FEELING COLD (Little cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Very Achy), PAIN IN EXTREMITY (Pain in leg) and PAIN IN EXTREMITY (Hurting arm). On an unknown date, the patient experienced DIPLEGIA (paralysis in my legs) (seriousness criterion medically significant). At the time of the report, DIPLEGIA (paralysis in my legs) had resolved and FEELING COLD (Little cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Very Achy), PAIN IN EXTREMITY (Pain in leg) and PAIN IN EXTREMITY (Hurting arm) outcome was unknown.            Patient reported that she had started taking Pharmacy brand Omeprazole for heartburn maybe for a two day period but when that adverse event occurred, she immediately stopped taking it because she had thought that maybe combined with her Covid vaccine and  it caused this paralysis.  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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non Significant follow up appended to AER On 22-Jul-2021: Follow-up received on 22-Jul-2021 and included Newevent was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Areflexia, Feeling abnormal, Incoherent, Movement disorder, Speech disorder
Clinical narrative: Scatter brain; Incoherent; Brain fog; Lost his mind; Has no reflexes; Can't move but he can hear; He can't talk; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THINKING ABNORMAL (Lost his mind) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Scatter brain) (seriousness criterion hospitalization), INCOHERENT (Incoherent) (seriousness criterion hospitalization), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk). At the time of the report, THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent), FEELING ABNORMAL (Brain fog), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that the patient had been admitted to a total of 3 psychiatric hospitals and was currently there in the hospital. Reporter also stated that on 21-Apr-2021 the patient was acting normal for a total of 20 hours and then he started back acting weird.  Company Comment:  Very limited information regarding this events has been provided at this time. .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. Further information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-089085, US-MODERNATX, INC.-MOD-2021-111101 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided at this time. .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. Further information has been requested US-MODERNATX, INC.-MOD-2021-089085:MOD-2021-089085 Dose 1 case US-MODERNATX, INC.-MOD-2021-111101:cross link
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: Scatter brain; Incoherent; Brain fog; Lost his mind; Has no reflexes; Can't move but he can hear; He can't talk; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THINKING ABNORMAL (Lost his mind) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Scatter brain) (seriousness criterion hospitalization), INCOHERENT (Incoherent) (seriousness criterion hospitalization), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk). At the time of the report, THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent), FEELING ABNORMAL (Brain fog), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that the patient had been admitted to a total of 3 psychiatric hospitals and was currently there in the hospital. Reporter also stated that on 21-Apr-2021 the patient was acting normal for a total of 20 hours and then he started back acting weird.  Company Comment:  Very limited information regarding this events has been provided at this time. .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. Further information has been requested   This case was linked to US-MODERNATX, INC.-MOD-2021-089085, US-MODERNATX, INC.-MOD-2021-111101 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided at this time. .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. Further information has been requested US-MODERNATX, INC.-MOD-2021-089085:MOD-2021-089085 Dose 1 case US-MODERNATX, INC.-MOD-2021-111101:cross link
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Haemorrhage, Pain in extremity
Clinical narrative: Bleeding after the injection; Hematoma that lasted 12 days; Left arm was also sore; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding after the injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding after the injection) (seriousness criterion medically significant), HAEMATOMA (Hematoma that lasted 12 days) and PAIN IN EXTREMITY (Left arm was also sore). At the time of the report, HAEMORRHAGE (Bleeding after the injection), HAEMATOMA (Hematoma that lasted 12 days) and PAIN IN EXTREMITY (Left arm was also sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications use was not provided. Treatment information was not provided by the reporter.  The patient is scheduled to receive the second dose of the Moderna COVID-19 vaccine on 03-May-2021.  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 23-Jul-2021: Follow up received: Contain non significant information.; 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: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory data was provided.  No concomitant medications were reported. No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the event acausal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received contains  patient demographics, suspect drug start date were  updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event acausal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms, Erythema, Pruritus, Rash, Skin burning sensation
Clinical narrative: dress syndrome; Burning sensation in skin; itching; Full body rash; Rash on feet and hands; Redness; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stevens-Johnson syndrome. Concurrent medical conditions included Eczema (Treatment of prednisone caused weaker skin and more breakage) since 1994, Psoriasis (Treatment of prednisone caused weaker skin and more breakage) since 1994, Anxiety since 15-Jan-2021 and Drug allergy (Lamotrigine allergy). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Jan-2021 to an unknown date for Anxiety, DESOGESTREL, ETHINYLESTRADIOL (APRI) for Birth control.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SKIN BURNING SENSATION (Burning sensation in skin), ERYTHEMA (Redness), PRURITUS (itching), RASH (Full body rash) and RASH (Rash on feet and hands). The patient was hospitalized from 26-May-2021 to 03-Jun-2021 due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form; PANTOPRAZOLE for Adverse event, at a dose of 40 mg once a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, prn and ACETAMINOPHEN for Adverse event, at a dose of UNK, prn. On 12-Jul-2021, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) had resolved with sequelae. At the time of the report, SKIN BURNING SENSATION (Burning sensation in skin) and PRURITUS (itching) outcome was unknown, ERYTHEMA (Redness) and RASH (Full body rash) had resolved and RASH (Rash on feet and hands) had not resolved.            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-2021-219189 (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: Burning sensation, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: sore throat; diarrhea; no appetite; fatigue; back of my head was aching really bad; fever of 100°F; like the wind was knocked out of me, short of breath; feet were burning like I had neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (like the wind was knocked out of me, short of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (like the wind was knocked out of me, short of breath) (seriousness criterion medically significant), BURNING SENSATION (feet were burning like I had neuropathy), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100°F). On 23-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite) and FATIGUE (fatigue). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; LEVALBUTEROL [LEVOSALBUTAMOL] at an unspecified dose and frequency and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at a dose of 2x daily. At the time of the report, DYSPNOEA (like the wind was knocked out of me, short of breath), BURNING SENSATION (feet were burning like I had neuropathy), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100°F) had resolved.            Concomitant drugs was not provided. Treatment drugs included increased nebulizer, valeramide, Chromalin.  Patient lied down and slept for 4 hours.  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.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; diarrhea; no appetite; fatigue; back of my head was aching really bad; fever of 100°F; like the wind was knocked out of me, short of breath; feet were burning like I had neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (like the wind was knocked out of me, short of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (like the wind was knocked out of me, short of breath) (seriousness criterion medically significant), BURNING SENSATION (feet were burning like I had neuropathy), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100°F). On 23-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite) and FATIGUE (fatigue). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; LEVALBUTEROL [LEVOSALBUTAMOL] at an unspecified dose and frequency and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at a dose of 2x daily. At the time of the report, DYSPNOEA (like the wind was knocked out of me, short of breath), BURNING SENSATION (feet were burning like I had neuropathy), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100°F) had resolved.            Concomitant drugs was not provided. Treatment drugs included increased nebulizer, valeramide, Chromalin.  Patient lied down and slept for 4 hours.  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.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dementia, Fatigue
Clinical narrative: Mild dementia; Tired and exhausted for a long while; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Mild dementia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypercholesteremia, Pain and BPH. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and OXYBUTYNIN for BPH, PARACETAMOL (TYLENOL) and IBUPROFEN for Pain.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (Mild dementia) (seriousness criterion medically significant) and FATIGUE (Tired and exhausted for a long while). At the time of the report, DEMENTIA (Mild dementia) and FATIGUE (Tired and exhausted for a long while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included 11-12 unspecified medications. Treatment information was not mentioned by the reporter.  The patient reportedly might have used lozenges after vaccination  The patient went to his neurologist for mild dementia. On an unknown date, neurologist ran a battery of tests such as heart scans and blood tests to check for things such as Lyme disease and HIV. The results from his local physician showed it was positive for HIV and his second test showed HIV antibodies but no HIV in his blood.  Very limited information regarding these events have been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-262688 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Headache
Clinical narrative: Bell Palsy; Headache on  left side of his head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell Palsy) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced BELL'S PALSY (Bell Palsy) (seriousness criterion medically significant) and HEADACHE (Headache on  left side of his head). The patient was treated with PREDNISONE for Bell's palsy, at a dose of UNK dosage form. At the time of the report, BELL'S PALSY (Bell Palsy) and HEADACHE (Headache on  left side of his head) had resolved.            Concomitant medications included hypertension medication, unspecified.  The patient experienced mild Bell Palsy after the second dose and described the symptoms as left side of his face was numb and felt similar to when a dentist works on one side of the face which makes that side numb (left side of face muscles were numb for a while), droopy eye, and  he could smile only on his right side of the face. Patient also reported headache on left side of his head. The symptoms started on 07 Jul 2021 and stopped after finishing Prednisolone that was prescribed by his doctor.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine."; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") (seriousness criterion medically significant). At the time of the report, DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported. Company comment:Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Fall, Loss of consciousness, Mobility decreased, Rhabdomyolysis
Clinical narrative: Was unconscious on the floor; Couldn't get up; muscle loss (rhabdomyolysis); Ear Infection; Fell on ground; Bad reaction to 2nd dose; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was unconscious on the floor) and RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was unconscious on the floor) (seriousness criteria hospitalization and medically significant), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) (seriousness criterion medically significant), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose) and VERTIGO (vertigo). On an unknown date, the patient experienced MOBILITY DECREASED (Couldn't get up). At the time of the report, LOSS OF CONSCIOUSNESS (Was unconscious on the floor), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose), VERTIGO (vertigo) and MOBILITY DECREASED (Couldn't get up) outcome was unknown.            Ear infection at the time and was given 5 days course of steroids and the unknown medications. for other events. The blood work, CT scan, MRI, and other tests were done but none of them could pinpoint it to the vaccine. Patient was hospitalized for 3 days. No concomitant medication was reported by the reporter.  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. Very limited information has been reported at this time. Further information is expected.   This case was linked to MOD-2021-052530 (Patient Link).   Reporter did not allow further contact; 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. Very limited information has been reported at this time. Further information is expected.