chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hangover, Headache, Hyperhidrosis, Hypersomnia, Inappropriate affect
Clinical narrative: EXTREMELY THIRSTY; THROAT FEELS DRY; SOMETHING WRONG WITH STOMACH; FEELS LIKE A HANGOVER; EYES LIKE CRIED ENDLESSLY; SWEAT; FEELING EMOTIONAL; NOT FEELING GOOD AND SICK; CHILLS; HEADACHES; FELT GIGGLY LIKE DOPAMINE RUSH; UNABLE TO SLEEP; SLEEPY; FEELING WARM (HOT); SLEPT ALL DAY AND NIGHT; HEAVY ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 05-AUG-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 05-AUG-2021, the patient experienced felt giggly like dopamine rush. On 05-AUG-2021, the patient experienced unable to sleep. On 05-AUG-2021, the patient experienced sleepy. On 05-AUG-2021, the patient experienced feeling warm (hot). On 05-AUG-2021, the patient experienced slept all day and night. On 05-AUG-2021, the patient experienced heavy arm. On 06-AUG-2021, the patient experienced extremely thirsty. On 06-AUG-2021, the patient experienced throat feels dry. On 06-AUG-2021, the patient experienced something wrong with stomach. On 06-AUG-2021, the patient experienced feels like a hangover. On 06-AUG-2021, the patient experienced eyes like cried endlessly. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced feeling emotional. On 06-AUG-2021, the patient experienced not feeling good and sick. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt giggly like dopamine rush, unable to sleep, sleepy, feeling warm (hot), extremely thirsty, throat feels dry, something wrong with stomach, feels like a hangover, eyes like cried endlessly, sweat, feeling emotional, slept all day and night, heavy arm, not feeling good and sick, chills, and headaches on 07-AUG-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Malaise, Periorbital swelling, Somnolence
Clinical narrative: EXTREMELY THIRSTY; THROAT FEELS DRY; SOMETHING WRONG WITH STOMACH; FEELS LIKE A HANGOVER; EYES LIKE CRIED ENDLESSLY; SWEAT; FEELING EMOTIONAL; NOT FEELING GOOD AND SICK; CHILLS; HEADACHES; FELT GIGGLY LIKE DOPAMINE RUSH; UNABLE TO SLEEP; SLEEPY; FEELING WARM (HOT); SLEPT ALL DAY AND NIGHT; HEAVY ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 05-AUG-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 05-AUG-2021, the patient experienced felt giggly like dopamine rush. On 05-AUG-2021, the patient experienced unable to sleep. On 05-AUG-2021, the patient experienced sleepy. On 05-AUG-2021, the patient experienced feeling warm (hot). On 05-AUG-2021, the patient experienced slept all day and night. On 05-AUG-2021, the patient experienced heavy arm. On 06-AUG-2021, the patient experienced extremely thirsty. On 06-AUG-2021, the patient experienced throat feels dry. On 06-AUG-2021, the patient experienced something wrong with stomach. On 06-AUG-2021, the patient experienced feels like a hangover. On 06-AUG-2021, the patient experienced eyes like cried endlessly. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced feeling emotional. On 06-AUG-2021, the patient experienced not feeling good and sick. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt giggly like dopamine rush, unable to sleep, sleepy, feeling warm (hot), extremely thirsty, throat feels dry, something wrong with stomach, feels like a hangover, eyes like cried endlessly, sweat, feeling emotional, slept all day and night, heavy arm, not feeling good and sick, chills, and headaches on 07-AUG-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: EXTREMELY THIRSTY; THROAT FEELS DRY; SOMETHING WRONG WITH STOMACH; FEELS LIKE A HANGOVER; EYES LIKE CRIED ENDLESSLY; SWEAT; FEELING EMOTIONAL; NOT FEELING GOOD AND SICK; CHILLS; HEADACHES; FELT GIGGLY LIKE DOPAMINE RUSH; UNABLE TO SLEEP; SLEEPY; FEELING WARM (HOT); SLEPT ALL DAY AND NIGHT; HEAVY ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 05-AUG-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 05-AUG-2021, the patient experienced felt giggly like dopamine rush. On 05-AUG-2021, the patient experienced unable to sleep. On 05-AUG-2021, the patient experienced sleepy. On 05-AUG-2021, the patient experienced feeling warm (hot). On 05-AUG-2021, the patient experienced slept all day and night. On 05-AUG-2021, the patient experienced heavy arm. On 06-AUG-2021, the patient experienced extremely thirsty. On 06-AUG-2021, the patient experienced throat feels dry. On 06-AUG-2021, the patient experienced something wrong with stomach. On 06-AUG-2021, the patient experienced feels like a hangover. On 06-AUG-2021, the patient experienced eyes like cried endlessly. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced feeling emotional. On 06-AUG-2021, the patient experienced not feeling good and sick. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt giggly like dopamine rush, unable to sleep, sleepy, feeling warm (hot), extremely thirsty, throat feels dry, something wrong with stomach, feels like a hangover, eyes like cried endlessly, sweat, feeling emotional, slept all day and night, heavy arm, not feeling good and sick, chills, and headaches on 07-AUG-2021. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache
Clinical narrative: BAD HEADACHE (PULSATION IN HEAD AND FEELS LIKE ITS GOING TO EXPLODE); This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, non smoker, and potentially has gilbert syndrome, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced bad headache (pulsation in head and feels like its going to explode). Laboratory data included: Body temperature (NR: not provided) 97.5, 98. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache (pulsation in head and feels like its going to explode). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: COUGH ON AND OFF; 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 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cough on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on and off. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: DIZZINESS WHEN STANDS UP OR ROLLS OVER (WHILE LAYING FLAT IN BED OR UNDER A CAR DURING MAINTENANCE WORK) OR MAKES QUICK MOVEMENTS AND FEELS VERY DISORIENTED; MILD BODY ACHES; FEELS VERY CONFUSED; FEELS VERY NAUSEATED; MILD FATIGUE; DULL HEADACHE LOCATED MORE TOWARDS THE BACK (2 BY10 PAIN LEVEL); This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 219 pounds, and height was 72 inches. The patient's concurrent conditions included: hypertension, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced dizziness when stands up or rolls over (while laying flat in bed or under a car during maintenance work) or makes quick movements and feels very disoriented. On 07-AUG-2021, the patient experienced mild body aches. On 07-AUG-2021, the patient experienced feels very confused. On 07-AUG-2021, the patient experienced feels very nauseated. On 07-AUG-2021, the patient experienced mild fatigue. On 07-AUG-2021, the patient experienced dull headache located more towards the back (2 by10 pain level). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness when stands up or rolls over (while laying flat in bed or under a car during maintenance work) or makes quick movements and feels very disoriented, mild body aches, feels very nauseated, and feels very confused, and had not recovered from mild fatigue, and dull headache located more towards the back (2 by10 pain level). This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DIZZINESS WHEN STANDS UP OR ROLLS OVER (WHILE LAYING FLAT IN BED OR UNDER A CAR DURING MAINTENANCE WORK) OR MAKES QUICK MOVEMENTS AND FEELS VERY DISORIENTED; MILD BODY ACHES; FEELS VERY CONFUSED; FEELS VERY NAUSEATED; MILD FATIGUE; DULL HEADACHE LOCATED MORE TOWARDS THE BACK (2 BY10 PAIN LEVEL); This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 219 pounds, and height was 72 inches. The patient's concurrent conditions included: hypertension, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced dizziness when stands up or rolls over (while laying flat in bed or under a car during maintenance work) or makes quick movements and feels very disoriented. On 07-AUG-2021, the patient experienced mild body aches. On 07-AUG-2021, the patient experienced feels very confused. On 07-AUG-2021, the patient experienced feels very nauseated. On 07-AUG-2021, the patient experienced mild fatigue. On 07-AUG-2021, the patient experienced dull headache located more towards the back (2 by10 pain level). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness when stands up or rolls over (while laying flat in bed or under a car during maintenance work) or makes quick movements and feels very disoriented, mild body aches, feels very nauseated, and feels very confused, and had not recovered from mild fatigue, and dull headache located more towards the back (2 by10 pain level). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Limb discomfort, Nasopharyngitis, Nausea
Clinical narrative: WHOLE BODY WAS SORE; TERRIBLE HEADACHE; VERY NAUSEOUS; COLD; ARM WAS SORE; ARM FELT VERY HEAVY; SHIVERING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-AUG-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 08-AUG-2021, the patient experienced cold. On 08-AUG-2021, the patient experienced arm was sore. On 08-AUG-2021, the patient experienced arm felt very heavy. On 08-AUG-2021, the patient experienced shivering. On 09-AUG-2021, the patient experienced whole body was sore. On 09-AUG-2021, the patient experienced terrible headache. On 09-AUG-2021, the patient experienced very nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm was sore, and terrible headache, and the outcome of arm felt very heavy, cold, shivering, whole body was sore and very nauseous was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: WHOLE BODY WAS SORE; TERRIBLE HEADACHE; VERY NAUSEOUS; COLD; ARM WAS SORE; ARM FELT VERY HEAVY; SHIVERING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-AUG-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 08-AUG-2021, the patient experienced cold. On 08-AUG-2021, the patient experienced arm was sore. On 08-AUG-2021, the patient experienced arm felt very heavy. On 08-AUG-2021, the patient experienced shivering. On 09-AUG-2021, the patient experienced whole body was sore. On 09-AUG-2021, the patient experienced terrible headache. On 09-AUG-2021, the patient experienced very nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm was sore, and terrible headache, and the outcome of arm felt very heavy, cold, shivering, whole body was sore and very nauseous was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: RECEIVED A DOSE OF THE VACCINE FROM A VIAL THAT HAD BEEN OPEN A WEEK PRIOR (FOUR PATIENTS); VIAL THAT HAD BEEN OPEN A WEEK PRIOR ADMINISTRATION OF VACCINE KEPT IN THE  FRIDGE THE WHOLE TIME; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 02-OCT-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-AUG-2021, the patient experienced received a dose of the vaccine from a vial that had been open a week prior (four patients). On 06-AUG-2021, the patient experienced vial that had been open a week prior administration of vaccine kept in the fridge the whole time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a dose of the vaccine from a vial that had been open a week prior (four patients) and vial that had been open a week prior administration of vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain in extremity
Clinical narrative: RIGORS; SEVER ARM PAIN FOR A WEEK; FELT UNWELL; HEADACHE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rigors, sever arm pain for a week, felt unwell, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rigors, headache, sever arm pain for a week and felt unwell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817490 and 20210817554.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: MILD HEADACHE; FEVERISH; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced mild headache, feverish, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild headache, feverish and fatigue was not reported. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: MUSCLE CRAMPS EVERY SINGLE DAY MOSTLY AT NIGHT SPECIALLY IN THE CALF AND THE THIGH AREA IN THE LEFT LEG; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included: gall bladder remover, and tonsil removed, and concurrent conditions included: alcohol user, non-smoker, hypertension, high cholesterol, gerd, back pain, depression, and anxiety. 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced muscle cramps every single day mostly at night specially in the calf and the thigh area in the left leg. Treatment medications (dates unspecified) included: morphine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle cramps every single day mostly at night specially in the calf and the thigh area in the left leg. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID 19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin 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,1 total, administered on MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. On AUG-2021, the patient had covid 19 test positive and suspected clinical vaccination failure.  Laboratory data 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 covid 19 test positive and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210702013.; Sender's Comments: V0. 20210817456-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination 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: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pain assessment, Pyrexia
Clinical narrative: ACHES; FEVER; TIREDNESS; SORENESS AT POINT OF SHOT (10/10); 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 patient experienced aches, fever, tiredness, and soreness at point of shot (10/10). Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 10/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, tiredness and soreness at point of shot (10/10) was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: NAUSEA; TINNITUS; FEELING UNWELL; SEVERE ARM PAIN; SEVERE RIGORS; HEADACHE; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced tinnitus. On MAY-2021, the patient experienced feeling unwell. On MAY-2021, the patient experienced severe arm pain. On MAY-2021, the patient experienced severe rigors. On MAY-2021, the patient experienced headache. On 07-MAY-2021, the patient experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe arm pain, severe rigors, and headache on MAY-2021, had not recovered from tinnitus, and the outcome of feeling unwell and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817407 and 20210817554.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: NAUSEA; TINNITUS; FEELING UNWELL; SEVERE ARM PAIN; SEVERE RIGORS; HEADACHE; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced tinnitus. On MAY-2021, the patient experienced feeling unwell. On MAY-2021, the patient experienced severe arm pain. On MAY-2021, the patient experienced severe rigors. On MAY-2021, the patient experienced headache. On 07-MAY-2021, the patient experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe arm pain, severe rigors, and headache on MAY-2021, had not recovered from tinnitus, and the outcome of feeling unwell and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817407 and 20210817554.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: SWEATS PROFUSELY; ABDOMEN PAIN; CHILLS; HEADACHE; FEVER; NAUSEA; VERY TIRED; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced sweats profusely. On AUG-2021, the patient experienced abdomen pain. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fever, sweats profusely, nausea, abdomen pain and very tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: SWEATS PROFUSELY; ABDOMEN PAIN; CHILLS; HEADACHE; FEVER; NAUSEA; VERY TIRED; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced sweats profusely. On AUG-2021, the patient experienced abdomen pain. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fever, sweats profusely, nausea, abdomen pain and very tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced product administered to patient of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain in extremity
Clinical narrative: SEVERE RIGORS; SEVERE ARM PAIN; FELT UNWELL; HEADACHE; This spontaneous report received from a consumer concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced severe rigors. On MAY-2021, the patient experienced severe arm pain. On MAY-2021, the patient experienced felt unwell. On MAY-2021, the patient experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe rigors, severe arm pain, and headache on MAY-2021, and the outcome of felt unwell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817407 and 20210817490.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Dyspnoea, Feeling of body temperature change
Clinical narrative: ABDOMINAL PAIN GETTING WORSE AFTER EATING; FEELS LIKE FOOD POISONING; ACHES AND PAIN IN THE BODY; SHORTNESS OF BREATH; FELT HOT AND COLD; PAINFUL TOES; NUMBNESS IN THE LEFT FOOT; ACHINESS IN THE JOINTS; FEVER WAS BURNING UP; BREAKING OUT WITH HIVES IN BOTH ARMS; WANTED TO THROW UP AFTER EATING BUT COULD NOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included: addiction, and other pre-existing medical conditions included: The patient had no health issues and no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced abdominal pain getting worse after eating. On 08-AUG-2021, the patient experienced feels like food poisoning. On 08-AUG-2021, the patient experienced aches and pain in the body. On 08-AUG-2021, the patient experienced shortness of breath. On 08-AUG-2021, the patient experienced felt hot and cold. On 08-AUG-2021, the patient experienced painful toes. On 08-AUG-2021, the patient experienced numbness in the left foot. On 08-AUG-2021, the patient experienced achiness in the joints. On 08-AUG-2021, the patient experienced fever was burning up. On 08-AUG-2021, the patient experienced breaking out with hives in both arms. On 08-AUG-2021, the patient experienced wanted to throw up after eating but could not. Laboratory data included: Body temperature (NR: not provided) normal, Oxygen saturation (NR: not provided) normal, and Pain scale (NR: not provided) pain was at 8/10 (joint ache). Treatment medications included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aches and pain in the body, achiness in the joints, shortness of breath, fever was burning up, felt hot and cold, breaking out with hives in both arms, numbness in the left foot, and painful toes, had not recovered from abdominal pain getting worse after eating, and feels like food poisoning, and the outcome of wanted to throw up after eating but could not was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Food poisoning, Hypoaesthesia, Nausea, Oxygen saturation, Pain
Clinical narrative: ABDOMINAL PAIN GETTING WORSE AFTER EATING; FEELS LIKE FOOD POISONING; ACHES AND PAIN IN THE BODY; SHORTNESS OF BREATH; FELT HOT AND COLD; PAINFUL TOES; NUMBNESS IN THE LEFT FOOT; ACHINESS IN THE JOINTS; FEVER WAS BURNING UP; BREAKING OUT WITH HIVES IN BOTH ARMS; WANTED TO THROW UP AFTER EATING BUT COULD NOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included: addiction, and other pre-existing medical conditions included: The patient had no health issues and no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced abdominal pain getting worse after eating. On 08-AUG-2021, the patient experienced feels like food poisoning. On 08-AUG-2021, the patient experienced aches and pain in the body. On 08-AUG-2021, the patient experienced shortness of breath. On 08-AUG-2021, the patient experienced felt hot and cold. On 08-AUG-2021, the patient experienced painful toes. On 08-AUG-2021, the patient experienced numbness in the left foot. On 08-AUG-2021, the patient experienced achiness in the joints. On 08-AUG-2021, the patient experienced fever was burning up. On 08-AUG-2021, the patient experienced breaking out with hives in both arms. On 08-AUG-2021, the patient experienced wanted to throw up after eating but could not. Laboratory data included: Body temperature (NR: not provided) normal, Oxygen saturation (NR: not provided) normal, and Pain scale (NR: not provided) pain was at 8/10 (joint ache). Treatment medications included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aches and pain in the body, achiness in the joints, shortness of breath, fever was burning up, felt hot and cold, breaking out with hives in both arms, numbness in the left foot, and painful toes, had not recovered from abdominal pain getting worse after eating, and feels like food poisoning, and the outcome of wanted to throw up after eating but could not was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: ABDOMINAL PAIN GETTING WORSE AFTER EATING; FEELS LIKE FOOD POISONING; ACHES AND PAIN IN THE BODY; SHORTNESS OF BREATH; FELT HOT AND COLD; PAINFUL TOES; NUMBNESS IN THE LEFT FOOT; ACHINESS IN THE JOINTS; FEVER WAS BURNING UP; BREAKING OUT WITH HIVES IN BOTH ARMS; WANTED TO THROW UP AFTER EATING BUT COULD NOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included: addiction, and other pre-existing medical conditions included: The patient had no health issues and no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced abdominal pain getting worse after eating. On 08-AUG-2021, the patient experienced feels like food poisoning. On 08-AUG-2021, the patient experienced aches and pain in the body. On 08-AUG-2021, the patient experienced shortness of breath. On 08-AUG-2021, the patient experienced felt hot and cold. On 08-AUG-2021, the patient experienced painful toes. On 08-AUG-2021, the patient experienced numbness in the left foot. On 08-AUG-2021, the patient experienced achiness in the joints. On 08-AUG-2021, the patient experienced fever was burning up. On 08-AUG-2021, the patient experienced breaking out with hives in both arms. On 08-AUG-2021, the patient experienced wanted to throw up after eating but could not. Laboratory data included: Body temperature (NR: not provided) normal, Oxygen saturation (NR: not provided) normal, and Pain scale (NR: not provided) pain was at 8/10 (joint ache). Treatment medications included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aches and pain in the body, achiness in the joints, shortness of breath, fever was burning up, felt hot and cold, breaking out with hives in both arms, numbness in the left foot, and painful toes, had not recovered from abdominal pain getting worse after eating, and feels like food poisoning, and the outcome of wanted to throw up after eating but could not was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: BAD REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: SLEPT MORE THAN USUAL; MORE TIRED AND DRAINED THAN USUAL; This spontaneous report received from a consumer 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 was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced slept more than usual, and more tired and drained than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more tired and drained than usual and slept more than usual was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: WORSE CHEST PAIN; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced worse chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from worse chest pain. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: SLEPT ALL DAY; MORE TIRED THAN USUAL; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the patient experienced slept all day. On 08-APR-2021, the patient experienced more tired than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more tired than usual and slept all day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818227.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Muscle spasms, Pyrexia, Vaccination site pain
Clinical narrative: Cramp in right leg; soreness around the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramp in right leg), VACCINATION SITE PAIN (soreness around the injection site) and PYREXIA (Fever ) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     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 11-Jan-2021, the patient experienced MUSCLE SPASMS (Cramp in right leg), VACCINATION SITE PAIN (soreness around the injection site) and PYREXIA (Fever ). At the time of the report, MUSCLE SPASMS (Cramp in right leg), VACCINATION SITE PAIN (soreness around the injection site) and PYREXIA (Fever ) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication included Tylenol and tramadol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Some difficulty breathing; A spontaneous report was received from a consumer who was also a 45-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some difficulty breathing.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 11J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, in the evening, the patient had some difficulty breathing and used her inhaler once. She also reported using her inhaler twice on the same day. Treatment included an inhaler (not specified).  Action taken with mRNA-1273 in response to the event was not reported.  The event, some difficulty breathing, was not resolved.; Reporter's Comments: This case concerns a 45-year old female patient. The medical history is not provided. The patient experienced an unexpected non-serious event of Difficulty breathing approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot number: 11J20A). Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in injection arm). At the time of the report, VACCINATION SITE PAIN (soreness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment information was provided.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Abdominal Cramps; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Cramps) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Cramps) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal Cramps) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.