chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nasopharyngitis, Somnolence
Clinical narrative: MILD THIRST; DROWSINESS; DIZZINESS; COLD; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced mild thirst, drowsiness, dizziness, cold, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild thirst, drowsiness, dizziness, headache, cold and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: MILD THIRST; DROWSINESS; DIZZINESS; COLD; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced mild thirst, drowsiness, dizziness, cold, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild thirst, drowsiness, dizziness, headache, cold and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; EXTREMELY BAD HEADACHE; 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fever, and extremely bad headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.9 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extremely bad headache and body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose, Wrong technique in product usage process
Clinical narrative: PARTIAL DOSE GIVEN FLUID LEAKED FROM ARM; INJECTION NEEDLE WAS INSERTED  THROUGH A SPECIAL BAND AID, PRESSED DOWN ON THE SYRINGE, THE NEEDLE POPPED BACK IN.; This spontaneous report received from a health care professional 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced partial dose given fluid leaked from arm. On 08-APR-2021, the subject experienced injection needle was inserted through a special band aid, pressed down on the syringe, the needle popped back in. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose given fluid leaked from arm and injection needle was inserted through a special band aid, pressed down on the syringe, the needle popped back in. was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: POTENTIAL ERROR IN ROUTE OF ADMINISTRATION; This spontaneous report received from a pharmacist 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, subcutaneous, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced potential error in route of administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential error in route of administration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: SWEATING; MUSCLE ACHE; FATIGUE; BODY ACHE; FEVER; SHIVERING; ARM SORENESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018,  expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced shivering. On 08-APR-2021, the subject experienced arm soreness. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 37.3 C, 36.9 C. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, shivering, fever, and fatigue on 09-APR-2021, and arm soreness on 08-APR-2021, and had not recovered from body ache, and muscle ache. This report was non-serious. This case, from the same reporter is linked to 20210421744.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: SWEATING; MUSCLE ACHE; FATIGUE; BODY ACHE; FEVER; SHIVERING; ARM SORENESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018,  expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced shivering. On 08-APR-2021, the subject experienced arm soreness. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 37.3 C, 36.9 C. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, shivering, fever, and fatigue on 09-APR-2021, and arm soreness on 08-APR-2021, and had not recovered from body ache, and muscle ache. This report was non-serious. This case, from the same reporter is linked to 20210421744.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a parent concerned a 23 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 not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cyst, Fatigue, Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; SLIGHT INCREASE IN TEMP 99.6 -99.8; TIREDNESS; CYST IN ARMPIT FROM AN INFECTED HAIR FOLLICLE; This spontaneous report received from a patient concerned a 36 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: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol.  On 09-APR-2021, the subject experienced cyst in armpit from an infected hair follicle. On 09-APR-2021, the subject experienced slight increase in temp 99.6 -99.8. On 09-APR-2021, the subject experienced tiredness.  Laboratory data included: Body temperature (NR: not provided) 99.6 -99.8 F. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight increase in temp 99.6 -99.8, had not recovered from sore arm, headache, and tiredness, and the outcome of cyst in armpit from an infected hair follicle was not reported. This report was non-serious.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE ARM; HEADACHE; SLIGHT INCREASE IN TEMP 99.6 -99.8; TIREDNESS; CYST IN ARMPIT FROM AN INFECTED HAIR FOLLICLE; This spontaneous report received from a patient concerned a 36 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: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride, ibuprofen, and paracetamol.  On 09-APR-2021, the subject experienced cyst in armpit from an infected hair follicle. On 09-APR-2021, the subject experienced slight increase in temp 99.6 -99.8. On 09-APR-2021, the subject experienced tiredness.  Laboratory data included: Body temperature (NR: not provided) 99.6 -99.8 F. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight increase in temp 99.6 -99.8, had not recovered from sore arm, headache, and tiredness, and the outcome of cyst in armpit from an infected hair follicle was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: BODY ACHES; HOT FEELING; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. The Batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On 08-APR-2021 18:00, the subject experienced body aches. On 08-APR-2021 18:00, the subject experienced hot feeling. On 08-APR-2021 18:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, hot feeling, and headache on 10-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210422653.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Heart rate, Heart rate increased, Hot flush
Clinical narrative: FEVER; FAST HEART RATE; DIFFICULTY SLEEPING; HOT FLASHES; FEELS CRUDDY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubal ligation, high fever, and hospitalization, and concurrent conditions included high blood pressure, hypothyroidism, strawberry allergy, random medication allergy, non-smoker, and non alcoholic, and other pre-existing medical conditions included dtap vaccination while pregnant and had reaction or virus at same time in 2018. 3 children, with 1 daughter born with 1/2 of her heart. no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:45 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) 100-105 {beats}/min. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced difficulty sleeping. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced feels cruddy. On 07-APR-2021 19:00, the subject experienced fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) 3-4 times negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate, hot flashes, and fever on 08-APR-2021, and difficulty sleeping on 09-APR-2021, and was recovering from feels cruddy. This report was non-serious. This case, from the same reporter is linked to 20210420086.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, SARS-CoV-2 test
Clinical narrative: FEVER; FAST HEART RATE; DIFFICULTY SLEEPING; HOT FLASHES; FEELS CRUDDY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubal ligation, high fever, and hospitalization, and concurrent conditions included high blood pressure, hypothyroidism, strawberry allergy, random medication allergy, non-smoker, and non alcoholic, and other pre-existing medical conditions included dtap vaccination while pregnant and had reaction or virus at same time in 2018. 3 children, with 1 daughter born with 1/2 of her heart. no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:45 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) 100-105 {beats}/min. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced difficulty sleeping. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced feels cruddy. On 07-APR-2021 19:00, the subject experienced fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) 3-4 times negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart rate, hot flashes, and fever on 08-APR-2021, and difficulty sleeping on 09-APR-2021, and was recovering from feels cruddy. This report was non-serious. This case, from the same reporter is linked to 20210420086.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Chills, Cough
Clinical narrative: NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Gait disturbance, Headache
Clinical narrative: NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Pain, Pyrexia, Restlessness
Clinical narrative: NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Off label use, Product administration error, Underdose
Clinical narrative: ADMINISTRATION ERROR; OFF LABEL USE; GOT MORE THAN HALF DOSE; PATIENT FELT LIQUID ON THEIR ARM; This spontaneous report received from a pharmacist 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: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced administration error. On 09-APR-2021, the subject experienced off label use. On 09-APR-2021, the subject experienced got more than half dose. On 09-APR-2021, the subject experienced subject felt liquid on their arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error, off label use, got more than half dose and patient felt liquid on their arm was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased, Hypertension
Clinical narrative: PULSE RACING; BLOOD PRESSURE WAS UP; FELT ANXIOUS; This spontaneous report received from a patient concerned a 64 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 not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt anxious. On 27-MAR-2021, the subject experienced pulse racing. On 27-MAR-2021, the subject experienced blood pressure was up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulse racing on 2021, and had not recovered from blood pressure was up, and felt anxious. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Fatigue, Feeling hot, Headache
Clinical narrative: COULD NOT SLEEP; EYE IRRITATION; PRESSURE BEHIND EYES; MUSCLE ACHES; HEADACHES; FEVER; LEFT ARM SORENESS; TIRED; FEELING VERY WARM; 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced feeling very warm. On APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced headaches. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced eye irritation. On 09-APR-2021, the subject experienced pressure behind eyes. Treatment medications included: paracetamol. On 09-APR-2021 02:00, the subject experienced could not sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 09-APR-2021, had not recovered from eye irritation, tired, muscle aches, headaches, and pressure behind eyes, and the outcome of left arm soreness, feeling very warm and could not sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420006.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: COULD NOT SLEEP; EYE IRRITATION; PRESSURE BEHIND EYES; MUSCLE ACHES; HEADACHES; FEVER; LEFT ARM SORENESS; TIRED; FEELING VERY WARM; 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced feeling very warm. On APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced headaches. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced eye irritation. On 09-APR-2021, the subject experienced pressure behind eyes. Treatment medications included: paracetamol. On 09-APR-2021 02:00, the subject experienced could not sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 09-APR-2021, had not recovered from eye irritation, tired, muscle aches, headaches, and pressure behind eyes, and the outcome of left arm soreness, feeling very warm and could not sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420006.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned multiple patients. 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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unspecified adverse event on 2021. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Lethargy, Pain, Productive cough
Clinical narrative: A TON OF PHLEGM; FELT SO LETHARGIC THAT COULD  BARELY MOVE; RUNNY NOSE; BODY ACHES.; DIARRHEA; HYSTERICAL COUGH TO THE POINT IT HURTS AND HURTS TO TALK; FEVER; This spontaneous report received from a patient concerned a 51 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 not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced a ton of phlegm. On 30-MAR-2021, the subject experienced felt so lethargic that could barely move. On 30-MAR-2021, the subject experienced runny nose. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced diarrhea. On 30-MAR-2021, the subject experienced hysterical cough to the point it hurts and hurts to talk. On 30-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a ton of phlegm, felt so lethargic that could barely move, runny nose, fever, body aches., diarrhea, and hysterical cough to the point it hurts and hurts to talk. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A TON OF PHLEGM; FELT SO LETHARGIC THAT COULD  BARELY MOVE; RUNNY NOSE; BODY ACHES.; DIARRHEA; HYSTERICAL COUGH TO THE POINT IT HURTS AND HURTS TO TALK; FEVER; This spontaneous report received from a patient concerned a 51 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 not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced a ton of phlegm. On 30-MAR-2021, the subject experienced felt so lethargic that could barely move. On 30-MAR-2021, the subject experienced runny nose. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced diarrhea. On 30-MAR-2021, the subject experienced hysterical cough to the point it hurts and hurts to talk. On 30-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a ton of phlegm, felt so lethargic that could barely move, runny nose, fever, body aches., diarrhea, and hysterical cough to the point it hurts and hurts to talk. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Headache, Nasopharyngitis
Clinical narrative: SEVER COLD; FEVER; SHORTNESS OF BREATH; THROW UP; COUGH; SEVERE BODY PAINS; WEAKNESS; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 21 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 not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced throw up. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced severe body pains. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced constant headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021 20:30, the subject experienced sever cold. On 10-APR-2021 20:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever cold, and fever on 11-APR-2021, and had not recovered from constant headache, cough, shortness of breath, nausea, severe body pains, weakness, and throw up. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: SEVER COLD; FEVER; SHORTNESS OF BREATH; THROW UP; COUGH; SEVERE BODY PAINS; WEAKNESS; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 21 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 not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced throw up. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced severe body pains. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced constant headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021 20:30, the subject experienced sever cold. On 10-APR-2021 20:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever cold, and fever on 11-APR-2021, and had not recovered from constant headache, cough, shortness of breath, nausea, severe body pains, weakness, and throw up. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye pain, Fatigue, Headache, Myalgia
Clinical narrative: PAIN IN NECK; EYE PAIN; STOMACH PAIN; MUSCLE ACHE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included headache. The patient was previously treated with influenza vaccine for prophylactic vaccination.  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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pain in neck. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and was recovering from headache, pain in neck, eye pain, muscle ache, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: PAIN IN NECK; EYE PAIN; STOMACH PAIN; MUSCLE ACHE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included headache. The patient was previously treated with influenza vaccine for prophylactic vaccination.  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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pain in neck. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and was recovering from headache, pain in neck, eye pain, muscle ache, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: Inappropriate dose of drug administered; OFF LABEL USE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autistic disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced inappropriate dose of drug administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate dose of drug administered and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked to 20210416449.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: AFTER ADMINISTRATION OF VACCINE 0.1ML LEFT IN THE SYRINGE; This spontaneous report received from a patient concerned multiple female patients. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced after administration of vaccine 0.1ml left in the syringe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of after administration of vaccine 0.1ml left in the syringe was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Nausea, SARS-CoV-2 test positive
Clinical narrative: WEAKNESS; FATIGUE; LOSS OF APPETITE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included Covid-19 infection, and concurrent conditions included floxacin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had history of any 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced loss of appetite. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced fatigue. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and nausea on 09-APR-2021, and had not recovered from fatigue, and weakness. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash erythematous
Clinical narrative: RED FLAT LINE ON LEFT SIDE; ACHY; This spontaneous report received from a parent concerned a 27 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 not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced red flat line on left side. On 10-APR-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red flat line on left side, and achy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.