chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:10 for prophylactic vaccination. Concomitant medications included naproxen. On 12-APR-2021 13:15, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: PERIODIC RINGING IN HIS EARS, EPISODES LASTING ABOUT 30 SECONDS AT A TIME; 4-5 TIMES/WEEK; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 166 pounds, and height was 65 inches. The patient's concurrent conditions included penicillin allergy, alcohol use, non smoker, and rash. The patient had no relevant medical history. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced periodic ringing in his ears, episodes lasting about 30 seconds at a time; 4-5 times/week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from periodic ringing in his ears, episodes lasting about 30 seconds at a time; 4-5 times/week. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHING; CHILLS; PAINFUL INJECTION; FEVER; This spontaneous report received from a patient concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 12:20 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aching. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced painful injection. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aching, chills, and fever on 09-APR-2021, and painful injection on 08-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bedridden, Muscular weakness, Pain
Clinical narrative: BEDRIDDEN; SORE ALL OVER; WEAK MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bedridden. On APR-2021, the subject experienced sore all over. On APR-2021, the subject experienced weak muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bedridden on APR-2021, and the outcome of sore all over and weak muscles was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspepsia, Nausea
Clinical narrative: BEDRIDDEN; SORE ALL OVER; WEAK MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bedridden. On APR-2021, the subject experienced sore all over. On APR-2021, the subject experienced weak muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bedridden on APR-2021, and the outcome of sore all over and weak muscles was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breath odour, Change in sustained attention, Confusional state, Dyspnoea, Fatigue
Clinical narrative: BEDRIDDEN; SORE ALL OVER; WEAK MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bedridden. On APR-2021, the subject experienced sore all over. On APR-2021, the subject experienced weak muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bedridden on APR-2021, and the outcome of sore all over and weak muscles was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypopnoea, Injection site pain, Lung disorder, Myalgia, Nausea
Clinical narrative: BEDRIDDEN; SORE ALL OVER; WEAK MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bedridden. On APR-2021, the subject experienced sore all over. On APR-2021, the subject experienced weak muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bedridden on APR-2021, and the outcome of sore all over and weak muscles was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Saliva altered, Sluggishness
Clinical narrative: BEDRIDDEN; SORE ALL OVER; WEAK MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bedridden. On APR-2021, the subject experienced sore all over. On APR-2021, the subject experienced weak muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bedridden on APR-2021, and the outcome of sore all over and weak muscles was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bedridden, Muscular weakness, Pain
Clinical narrative: SHORTNESS OF BREATH / BREATH TAKEN AWAY; SHALLOW BREATHING; FOUL BREATH; CHANGE IN SALIVA; HARSH FEELING IN LUNGS; LESS ATTENTION; SLUGGISH; CONFUSION; MUSCLE SORENESS; EXHAUSTED; NAUSEA; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: /JUN/2020) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced shortness of breath / breath taken away. On 09-APR-2021, the subject experienced shallow breathing. On 09-APR-2021, the subject experienced foul breath. On 09-APR-2021, the subject experienced change in saliva. On 09-APR-2021, the subject experienced harsh feeling in lungs. On 09-APR-2021, the subject experienced less attention. On 09-APR-2021, the subject experienced sluggish. On 09-APR-2021, the subject experienced confusion. On 09-APR-2021, the subject experienced muscle soreness. On 09-APR-2021, the subject experienced exhausted. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, muscle soreness, and nausea, had not recovered from confusion, exhausted, change in saliva, shortness of breath / breath taken away, shallow breathing, foul breath, and harsh feeling in lungs, and the outcome of sluggish and less attention was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspepsia, Nausea
Clinical narrative: SHORTNESS OF BREATH / BREATH TAKEN AWAY; SHALLOW BREATHING; FOUL BREATH; CHANGE IN SALIVA; HARSH FEELING IN LUNGS; LESS ATTENTION; SLUGGISH; CONFUSION; MUSCLE SORENESS; EXHAUSTED; NAUSEA; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: /JUN/2020) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced shortness of breath / breath taken away. On 09-APR-2021, the subject experienced shallow breathing. On 09-APR-2021, the subject experienced foul breath. On 09-APR-2021, the subject experienced change in saliva. On 09-APR-2021, the subject experienced harsh feeling in lungs. On 09-APR-2021, the subject experienced less attention. On 09-APR-2021, the subject experienced sluggish. On 09-APR-2021, the subject experienced confusion. On 09-APR-2021, the subject experienced muscle soreness. On 09-APR-2021, the subject experienced exhausted. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, muscle soreness, and nausea, had not recovered from confusion, exhausted, change in saliva, shortness of breath / breath taken away, shallow breathing, foul breath, and harsh feeling in lungs, and the outcome of sluggish and less attention was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breath odour, Change in sustained attention, Confusional state, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH / BREATH TAKEN AWAY; SHALLOW BREATHING; FOUL BREATH; CHANGE IN SALIVA; HARSH FEELING IN LUNGS; LESS ATTENTION; SLUGGISH; CONFUSION; MUSCLE SORENESS; EXHAUSTED; NAUSEA; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: /JUN/2020) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced shortness of breath / breath taken away. On 09-APR-2021, the subject experienced shallow breathing. On 09-APR-2021, the subject experienced foul breath. On 09-APR-2021, the subject experienced change in saliva. On 09-APR-2021, the subject experienced harsh feeling in lungs. On 09-APR-2021, the subject experienced less attention. On 09-APR-2021, the subject experienced sluggish. On 09-APR-2021, the subject experienced confusion. On 09-APR-2021, the subject experienced muscle soreness. On 09-APR-2021, the subject experienced exhausted. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, muscle soreness, and nausea, had not recovered from confusion, exhausted, change in saliva, shortness of breath / breath taken away, shallow breathing, foul breath, and harsh feeling in lungs, and the outcome of sluggish and less attention was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypopnoea, Injection site pain, Lung disorder, Myalgia, Nausea
Clinical narrative: SHORTNESS OF BREATH / BREATH TAKEN AWAY; SHALLOW BREATHING; FOUL BREATH; CHANGE IN SALIVA; HARSH FEELING IN LUNGS; LESS ATTENTION; SLUGGISH; CONFUSION; MUSCLE SORENESS; EXHAUSTED; NAUSEA; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: /JUN/2020) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced shortness of breath / breath taken away. On 09-APR-2021, the subject experienced shallow breathing. On 09-APR-2021, the subject experienced foul breath. On 09-APR-2021, the subject experienced change in saliva. On 09-APR-2021, the subject experienced harsh feeling in lungs. On 09-APR-2021, the subject experienced less attention. On 09-APR-2021, the subject experienced sluggish. On 09-APR-2021, the subject experienced confusion. On 09-APR-2021, the subject experienced muscle soreness. On 09-APR-2021, the subject experienced exhausted. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, muscle soreness, and nausea, had not recovered from confusion, exhausted, change in saliva, shortness of breath / breath taken away, shallow breathing, foul breath, and harsh feeling in lungs, and the outcome of sluggish and less attention was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Saliva altered, Sluggishness
Clinical narrative: SHORTNESS OF BREATH / BREATH TAKEN AWAY; SHALLOW BREATHING; FOUL BREATH; CHANGE IN SALIVA; HARSH FEELING IN LUNGS; LESS ATTENTION; SLUGGISH; CONFUSION; MUSCLE SORENESS; EXHAUSTED; NAUSEA; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: /JUN/2020) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site soreness. On 09-APR-2021, the subject experienced shortness of breath / breath taken away. On 09-APR-2021, the subject experienced shallow breathing. On 09-APR-2021, the subject experienced foul breath. On 09-APR-2021, the subject experienced change in saliva. On 09-APR-2021, the subject experienced harsh feeling in lungs. On 09-APR-2021, the subject experienced less attention. On 09-APR-2021, the subject experienced sluggish. On 09-APR-2021, the subject experienced confusion. On 09-APR-2021, the subject experienced muscle soreness. On 09-APR-2021, the subject experienced exhausted. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, muscle soreness, and nausea, had not recovered from confusion, exhausted, change in saliva, shortness of breath / breath taken away, shallow breathing, foul breath, and harsh feeling in lungs, and the outcome of sluggish and less attention was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: ACHINESS; LIGHT FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced achiness, and light fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light fatigue and achiness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia
Clinical narrative: HEADACHE; FATIGUE; NUMBNESS ON ARMS AND LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included stroke.  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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On APR-2021, the subject experienced numbness on arms and legs. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from headache, and numbness on arms and legs. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: INJECTION SITE ITCHING; INJECTION SITE SWELLING; INJECTION SITE REDNESS; SHOOTING PAIN IN ARM; LOW GRADE FEVER; INJECTION SITE HARD LUMP; INJECTION SITE TENDERNESS; TThis spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with methylprednisolone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site hard lump. On MAR-2021, the subject experienced injection site tenderness. On 19-MAR-2021, the subject experienced shooting pain in arm. On 19-MAR-2021, the subject experienced low grade fever. On 21-MAR-2021, the subject experienced injection site itching. On 21-MAR-2021, the subject experienced injection site swelling. On 21-MAR-2021, the subject experienced injection site redness.  Treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site itching on 2021, and shooting pain in arm, and low grade fever on 21-MAR-2021, was recovering from injection site swelling, had not recovered from injection site tenderness, and injection site hard lump, and the outcome of injection site redness was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: INJECTION SITE ITCHING; INJECTION SITE SWELLING; INJECTION SITE REDNESS; SHOOTING PAIN IN ARM; LOW GRADE FEVER; INJECTION SITE HARD LUMP; INJECTION SITE TENDERNESS; TThis spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with methylprednisolone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site hard lump. On MAR-2021, the subject experienced injection site tenderness. On 19-MAR-2021, the subject experienced shooting pain in arm. On 19-MAR-2021, the subject experienced low grade fever. On 21-MAR-2021, the subject experienced injection site itching. On 21-MAR-2021, the subject experienced injection site swelling. On 21-MAR-2021, the subject experienced injection site redness.  Treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site itching on 2021, and shooting pain in arm, and low grade fever on 21-MAR-2021, was recovering from injection site swelling, had not recovered from injection site tenderness, and injection site hard lump, and the outcome of injection site redness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hot flush, Migraine, Muscular weakness, Pain in extremity
Clinical narrative: WHOLE BODY FELT REALLY HOT; FACE FELT HOT; MIGRAINE; SKIN FELT REALLY HOT; SWOLLEN ARM; ARM HOT TO THE TOUCH; CANT RAISE ARM; SORE ARM; HALF DOLLAR (1 INCH) RED RAISED SPOT ON ARM; This spontaneous report received from a parent concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced whole body felt really hot. On 09-APR-2021, the subject experienced face felt hot. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced skin felt really hot. On 09-APR-2021, the subject experienced swollen arm. On 09-APR-2021, the subject experienced arm hot to the touch. On 09-APR-2021, the subject experienced cant raise arm. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced half dollar (1 inch) red raised spot on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body felt really hot, face felt hot, and migraine on 11-APR-2021, and skin felt really hot on 10-APR-2021, and had not recovered from sore arm, cant raise arm, swollen arm, half dollar (1 inch) red raised spot on arm, and arm hot to the touch. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Skin warm
Clinical narrative: WHOLE BODY FELT REALLY HOT; FACE FELT HOT; MIGRAINE; SKIN FELT REALLY HOT; SWOLLEN ARM; ARM HOT TO THE TOUCH; CANT RAISE ARM; SORE ARM; HALF DOLLAR (1 INCH) RED RAISED SPOT ON ARM; This spontaneous report received from a parent concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced whole body felt really hot. On 09-APR-2021, the subject experienced face felt hot. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced skin felt really hot. On 09-APR-2021, the subject experienced swollen arm. On 09-APR-2021, the subject experienced arm hot to the touch. On 09-APR-2021, the subject experienced cant raise arm. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced half dollar (1 inch) red raised spot on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body felt really hot, face felt hot, and migraine on 11-APR-2021, and skin felt really hot on 10-APR-2021, and had not recovered from sore arm, cant raise arm, swollen arm, half dollar (1 inch) red raised spot on arm, and arm hot to the touch. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: ACHES; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, tossed and turned all night, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches and tossed and turned all night was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: WEAKNESS IN LEGS; HEADACHES; SEVERE CHILLS; FEVER; HANDS AND FEET WERE NUMB; DEHYDRATION; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent condition included multiple sclerosis. 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, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced dehydration. On 10-APR-2021 16:00, the subject experienced hands and feet were numb. On 10-APR-2021 16:00, the subject experienced fever. On 10-APR-2021 16:00, the subject experienced severe chills. On 11-APR-2021, the subject experienced headaches. On 12-APR-2021, the subject experienced weakness in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hands and feet were numb on 11-APR-2021 15:00, and fever on 11-APR-2021, was recovering from dehydration, and had not recovered from weakness in legs, and headaches. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: WEAKNESS IN LEGS; HEADACHES; SEVERE CHILLS; FEVER; HANDS AND FEET WERE NUMB; DEHYDRATION; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent condition included multiple sclerosis. 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, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced dehydration. On 10-APR-2021 16:00, the subject experienced hands and feet were numb. On 10-APR-2021 16:00, the subject experienced fever. On 10-APR-2021 16:00, the subject experienced severe chills. On 11-APR-2021, the subject experienced headaches. On 12-APR-2021, the subject experienced weakness in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hands and feet were numb on 11-APR-2021 15:00, and fever on 11-APR-2021, was recovering from dehydration, and had not recovered from weakness in legs, and headaches. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing; Hot flashes; Diarrhea; Dizziness; Unable to sleep; Intense Chills; Joint pain; muscle pain; Headache; Nausea; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: 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 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced diarrhea. On 2021, the subject experienced dizziness. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced intense chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced muscle pain. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, hot flashes, diarrhea, dizziness, unable to sleep, intense chills, joint pain, muscle pain, headache, and nausea on 2021. This report was non-serious. This case, from the same reporter is linked to 20210420860.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Insomnia, Myalgia, Nausea
Clinical narrative: Difficulty breathing; Hot flashes; Diarrhea; Dizziness; Unable to sleep; Intense Chills; Joint pain; muscle pain; Headache; Nausea; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: 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 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced diarrhea. On 2021, the subject experienced dizziness. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced intense chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced muscle pain. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, hot flashes, diarrhea, dizziness, unable to sleep, intense chills, joint pain, muscle pain, headache, and nausea on 2021. This report was non-serious. This case, from the same reporter is linked to 20210420860.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Diarrhoea, Malaise
Clinical narrative: BACK PAIN; STOMACH ACHE; MALAISE; CHILLS; MUSCLE PAIN; INTENSE DIARRHEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced intense diarrhea. On 27-MAR-2021, the subject experienced malaise. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced muscle pain. On 28-MAR-2021, treatment medications included: ibuprofen. On 31-MAR-2021, the subject experienced stomach ache. On 31-MAR-2021 08:15, treatment medications included: bismuth subsalicylate. On an unspecified date, the subject experienced back pain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5/10. Additional treatment medications (dates unspecified) included: cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense diarrhea, and the outcome of malaise, chills, muscle pain, back pain and stomach ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain assessment
Clinical narrative: BACK PAIN; STOMACH ACHE; MALAISE; CHILLS; MUSCLE PAIN; INTENSE DIARRHEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced intense diarrhea. On 27-MAR-2021, the subject experienced malaise. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced muscle pain. On 28-MAR-2021, treatment medications included: ibuprofen. On 31-MAR-2021, the subject experienced stomach ache. On 31-MAR-2021 08:15, treatment medications included: bismuth subsalicylate. On an unspecified date, the subject experienced back pain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5/10. Additional treatment medications (dates unspecified) included: cannabis sativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense diarrhea, and the outcome of malaise, chills, muscle pain, back pain and stomach ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, body aches, and fatigue. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; RIGHT ARM PAIN; This spontaneous report received from a parent concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient have no known allergies, the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced neck pain. On 11-APR-2021, the subject experienced right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, and right arm pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; DIARRHEA; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, tiredness and diarrhea was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Hypokinesia, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SORENESS; REDNESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, high cholesterol, outside weeds allergy, eczema, and hives.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19-JUL-2021) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for thrombolytic event. On 28-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) Positive. On 08-APR-2021, the subject experienced raised around the injection. On 08-APR-2021, the subject experienced warm to touch around the injection. On 08-APR-2021, the subject experienced hurts to lift left arm. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced redness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, raised around the injection, warm to touch around the injection, left arm soreness, and hurts to lift left arm. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SORENESS; REDNESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, high cholesterol, outside weeds allergy, eczema, and hives.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19-JUL-2021) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for thrombolytic event. On 28-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) Positive. On 08-APR-2021, the subject experienced raised around the injection. On 08-APR-2021, the subject experienced warm to touch around the injection. On 08-APR-2021, the subject experienced hurts to lift left arm. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced redness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, raised around the injection, warm to touch around the injection, left arm soreness, and hurts to lift left arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: FULL BODY ACHES; CHILLS; ARM PAIN; LOW-GRADE FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21a,expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced full body aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced low-grade fever. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body aches, chills, low-grade fever, and fatigue on APR-2021, and had not recovered from arm pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: BODY ACHES; GENERAL LETHARGY; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-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 APR-2021, the subject experienced body aches. On APR-2021, the subject experienced general lethargy. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, general lethargy, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash pruritic, Tremor
Clinical narrative: SHAKY; RASH BEHIND NECK; ITCHINESS BEHIND NECK; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced shaky. On 06-APR-2021, the subject experienced rash behind neck. On 06-APR-2021, the subject experienced itchiness behind neck. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaky, and fever on 07-APR-2021, and had not recovered from itchiness behind neck, and rash behind neck. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seafood allergy, and shellfish allergy.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 12-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/ PQC reported at this time; MMR II (stored in freezer) and VARlVAX, temperature excursion; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's pertinent medical history, concomitant medication, drug reactions/ allergies were not reported.     On 17-MAR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 ml,  strength and route were not reported, lot # T025945 has been verified as valid, expiration date 30-JUL-2022) for prophylaxis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (0.5 (unit not provided), strength and route were not reported, lot # S039319 has been verified as valid, expiration date 04-DEC-2021) (stored in freezer) for prophylaxis.  The varicella virus vaccine live (Oka/Merck) (VARIVAX) administered experienced a temperature excursion of -10 degree Celsius to 8 degree Celsius (-1.6 C), for a time frame of 1 hour 36 minutes 0 seconds.  The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered experienced a temperature excursion of -50 degree Celsius to 8 degree Celsius (-1.6 C), for a time frame of 1 hour 36 minutes 0 seconds. There was no previous temperature excursion. Digital data logger was involved. No additional adverse event reported at the reporting time. The outcome of the event was unknown.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Incomplete course of vaccination, Lip blister, Oral discomfort
Clinical narrative: I got single in my face by the right side of my lips; I got single / right side of my lips it burns no only the blisters; it burns no only the blisters but internally/ everything came burning me.; first single shot before the pandemia / dr never call me again for / second dosis; This case was reported by a consumer via an Agency and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, lip blister, burning sensation and incomplete course of vaccination. On an unknown date, the outcome of the shingles, lip blister, burning sensation and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, lip blister and burning sensation to be related to Shingles vaccine.  Additional details was reported as follows: The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient received 1st dose of Shingrix before the pandemic and got shingle on face by the right side of the lips, it burnt, had not only the blisters but internally the patient felt like burning, even when use the toilet everything came burning . Till the reporting patient did not received 2nd dose and the doctor also never called the patient again, which led to incomplete course of vaccination.