chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Taste disorder
Clinical narrative: FLU LIKE SYMPTOMS/MUSCLE ACHE/BODY ACHE/HEADACHE/FEVER/CHILLS/COUGH WITH PHELGM/FATIGUE; WEIRD TASTE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On 03-APR-2021, the subject experienced flu like symptoms/muscle ache/body ache/headache/fever/chills/cough with phelgm/fatigue. On 03-APR-2021, the subject experienced weird taste. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms/muscle ache/body ache/headache/fever/chills/cough with phelgm/fatigue, and weird taste. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Injection site pain, Insomnia
Clinical narrative: VOMITING; RASH ON FACE; NAUSEA; COLD; CHILLS; FEVER; HURTS INJECTION SITE; TIREDNESS; SLEEP LOSS; This spontaneous report received from a patient concerned a 55 year old female. 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 had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:50 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sleep loss. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced hurts injection site. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 22:00, the subject experienced cold. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced rash on face. On 08-APR-2021, the subject experienced nausea.  Laboratory data included: Body temperature (NR: not provided) 102 F, 101.8 F, 99 F.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fever, and nausea, had not recovered from rash on face, hurts injection site, tiredness, and sleep loss, and the outcome of cold was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: VOMITING; RASH ON FACE; NAUSEA; COLD; CHILLS; FEVER; HURTS INJECTION SITE; TIREDNESS; SLEEP LOSS; This spontaneous report received from a patient concerned a 55 year old female. 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 had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 13:50 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sleep loss. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced hurts injection site. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 22:00, the subject experienced cold. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced rash on face. On 08-APR-2021, the subject experienced nausea.  Laboratory data included: Body temperature (NR: not provided) 102 F, 101.8 F, 99 F.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fever, and nausea, had not recovered from rash on face, hurts injection site, tiredness, and sleep loss, and the outcome of cold was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Eye disorder, Headache, Nausea, Ocular hyperaemia
Clinical narrative: BURNING SENSATION ALL OVER BODY; RED EYES; HOT EYES; BODY ACHE; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 34 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, route of admin not reported, batch number: 202A218, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced burning sensation all over body. On 08-APR-2021, the subject experienced red eyes. On 08-APR-2021, the subject experienced hot eyes. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation all over body, headache, red eyes, body ache, nausea, and hot eyes. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BURNING SENSATION ALL OVER BODY; RED EYES; HOT EYES; BODY ACHE; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 34 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, route of admin not reported, batch number: 202A218, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced burning sensation all over body. On 08-APR-2021, the subject experienced red eyes. On 08-APR-2021, the subject experienced hot eyes. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation all over body, headache, red eyes, body ache, nausea, and hot eyes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. it was unknown if the patient was drug abuse or had illicit drug usage, alcohol consumption and smoke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number is not reported. The company is unable to follow-up request for batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: FROZEN PRODUCT HAD BEEN ADMINISTERED TO A BUNCH OF PATIENTS (PRODUCT ADMINISTRATION ERROR); ADMINISTRATION ERROR INVOLVING VACCINE ACCIDENTALLY FROZEN UPON RECEIPT FROM  MANUFACTURER AND VACCINE WAS PLACED IN THE FREEZER FOR APPROXIMATELY 4.5 HOURS (INCORRECT PRODUCT STORAGE); This spontaneous report received from a pharmacist 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: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced frozen product had been administered to a bunch of subjects (product administration error). On APR-2021, the subject experienced administration error involving vaccine accidentally frozen upon receipt from manufacturer and vaccine was placed in the freezer for approximately 4.5 hours (incorrect product storage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error involving vaccine accidentally frozen upon receipt from manufacturer and vaccine was placed in the freezer for approximately 4.5 hours (incorrect product storage) and frozen product had been administered to a bunch of patients (product administration error) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: FEELS WARM; HEADACHE; 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: 046AZIA, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feels warm. On 09-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, and feels warm. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: PEEING BLOOD; This spontaneous report received from a consumer concerned a 56 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced peeing blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from peeing blood. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain
Clinical narrative: MIGRAINE; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 44 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced migraine. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, chills, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; BURNING UP; FEVER; HEADACHE; 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: 043A21A, 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 body aches. On 09-APR-2021, the subject experienced burning up. On 09-APR-2021, the subject experienced fever. On 09-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 fever, headache, body aches, and burning up. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Chills, Erythema, Fatigue
Clinical narrative: BACK PAIN; BURNING SENSATION ON  HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; REDNESS ON   HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; ITCHING ON  HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; BODY ACHES; CHILLS; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced tiredness. On 06-APR-2021, the subject experienced redness on head, face, cheeks, neck, elbow, stomach, thighs and hands. On 06-APR-2021, the subject experienced itching on head, face, cheeks, neck, elbow, stomach, thighs and hands. On 09-APR-2021, the subject experienced burning sensation on head, face, cheeks, neck, elbow, stomach, thighs and hands. On an unspecified date, the subject experienced back pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and tiredness on 05-APR-2021, and back pain, and had not recovered from redness on head, face, cheeks, neck, elbow, stomach, thighs and hands, itching on head, face, cheeks, neck, elbow, stomach, thighs and hands, and burning sensation on head, face, cheeks, neck, elbow, stomach, thighs and hands. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: BACK PAIN; BURNING SENSATION ON  HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; REDNESS ON   HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; ITCHING ON  HEAD, FACE, CHEEKS, NECK, ELBOW, STOMACH, THIGHS AND  HANDS; BODY ACHES; CHILLS; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced tiredness. On 06-APR-2021, the subject experienced redness on head, face, cheeks, neck, elbow, stomach, thighs and hands. On 06-APR-2021, the subject experienced itching on head, face, cheeks, neck, elbow, stomach, thighs and hands. On 09-APR-2021, the subject experienced burning sensation on head, face, cheeks, neck, elbow, stomach, thighs and hands. On an unspecified date, the subject experienced back pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and tiredness on 05-APR-2021, and back pain, and had not recovered from redness on head, face, cheeks, neck, elbow, stomach, thighs and hands, itching on head, face, cheeks, neck, elbow, stomach, thighs and hands, and burning sensation on head, face, cheeks, neck, elbow, stomach, thighs and hands. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING SENSATION IN THE FACE; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced tingling sensation in the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation in the face. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Intermenstrual bleeding, Pain
Clinical narrative: BODY ACHES; CHILLS; MENSTRUAL SPOTTING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any drug abuse, illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A,expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 22:00, the subject experienced menstrual spotting. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual spotting, chills, and body aches. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Nausea
Clinical narrative: COLD; CHILLS; NAUSEA; This spontaneous report received from a consumer concerned a 35 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced fever and muscle pain when treated with tetanus vaccine for prophylactic vaccination.  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 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cold, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: SWOLLEN LEGS AND FEET; PAIN IN NECK; PAIN IN HIPS; PAIN IN ARMS; EXHAUSTED; This spontaneous report received from a patient concerned a 60 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swollen legs and feet, pain in neck, pain in hips, pain in arms, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from exhausted, pain in hips, pain in arms, pain in neck, and swollen legs and feet. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Euphoric mood
Clinical narrative: DIZZINESS; FEELING HIGH; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 167 pounds, and height was not reported. The patient's past medical history included blood clots, and concurrent conditions included flu shot and weed smoker. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feeling high. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weakness, and the outcome of feeling high was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: TINGLING IN RIGHT LEG; HEADACHE; This spontaneous report received from a patient concerned an adult 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: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced tingling in right leg and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling in right leg and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Mobility decreased, Pain, Pneumonia
Clinical narrative: FELT LIKE PNEUMONIA; FELT LIKE DYING; COULD BARELY MOVE; EVERYTHING HURT; POUNDING, EXCRUCIATING HEADACHES; This spontaneous report received from a patient via a company representative from social media 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 and expiry were unknown) dose was not reported, 1 total administered on 10-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 11-APR-2021, the patient felt like dying, felt like pneumonia, could barely move, everything hurt and pounding, excruciating headaches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like dying, felt like pneumonia, could barely move, everything hurt and pounding, excruciating headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422051-covid-19 vaccine ad26.cov2.s - felt like pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Eye irritation, Eye swelling, Headache
Clinical narrative: CRANKY; REDNESS OF EYE; HEADACHE; DIZZINESS; BOTH EYES ARE SWOLLEN AND RED; RIGHT EYE BURNS; VISIBILITY NOT GREAT DUE TO SWELLING OF EYE; CHEEK BONE SWELLING; DIARRHEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison oak, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included no illicit drug use. 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 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced visibility not great due to swelling of eye. On APR-2021, the subject experienced cheek bone swelling. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced both eyes are swollen and red. On 08-APR-2021, the subject experienced right eye burns. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced redness of eye. On an unspecified date, the subject experienced cranky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from both eyes are swollen and red, right eye burns, and dizziness, and the outcome of cranky, diarrhea, cheek bone swelling, visibility not great due to swelling of eye and redness of eye was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Ocular hyperaemia, Swelling face, Visual impairment
Clinical narrative: CRANKY; REDNESS OF EYE; HEADACHE; DIZZINESS; BOTH EYES ARE SWOLLEN AND RED; RIGHT EYE BURNS; VISIBILITY NOT GREAT DUE TO SWELLING OF EYE; CHEEK BONE SWELLING; DIARRHEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison oak, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included no illicit drug use. 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 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced visibility not great due to swelling of eye. On APR-2021, the subject experienced cheek bone swelling. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced both eyes are swollen and red. On 08-APR-2021, the subject experienced right eye burns. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced redness of eye. On an unspecified date, the subject experienced cranky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from both eyes are swollen and red, right eye burns, and dizziness, and the outcome of cranky, diarrhea, cheek bone swelling, visibility not great due to swelling of eye and redness of eye was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Eye haemorrhage, Hyperhidrosis, Loss of consciousness
Clinical narrative: PASSING OUT; RUPTURED BLOOD VESSEL IN THE EYE; MIGRAINE/SEVERE VOMITING/INABILITY TO RETAIN FLUIDS/NAUSEA; TREMBLING; SWEATING; FELT SICK; FEVER OF 101F; This spontaneous report received from a consumer (father) concerned a 22 year old not Hispanic or Latino, white female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient reported no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, frequency 1 total, administered to left deltoid on 08-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 20:00, the patient felt sick and was incapacitated by severe vomiting (coded as migraine/severe vomiting/inability to retain fluids/nausea), sweating, trembling, fever of 101 F that resulted in her passing out. Vomiting was so severe that patient was unable to retain fluids and ruptured a blood vessel in her eye (coded as Broken Blood vessel in eye). Patient was hospitalized on 09-APR-2021 at 12:24 am. During hospitalization she received IV fluids and medicines for migraine and nausea and multiple blood samples were collected. Patient was discharged on 09-APR-2021 around 6 AM. Patient was hospitalized for around 6 hours. Patient reported that symptoms had recovered except was still having nausea and ruptured eye vessel from severe vomiting. (it was Confirmed with patient that she had no  past medical history of migraine and was referring to her headache as migraine.) Laboratory data included: Body temperature (NR: not provided) 101 F, Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from trembling, sweating, passing out, and felt sick on APR-2021, and fever of 101F, and had not recovered from migraine/severe vomiting/inability to retain fluids/nausea, and ruptured blood vessel in the eye. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s -Passing out, Ruptured blood vessel in the eye, Migraine/severe vomiting/inability to retain fluid/nausea, trembling, sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210422127-covid-19 vaccine ad26.cov2.s -Fever, Felt sick. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Pyrexia, Tremor
Clinical narrative: PASSING OUT; RUPTURED BLOOD VESSEL IN THE EYE; MIGRAINE/SEVERE VOMITING/INABILITY TO RETAIN FLUIDS/NAUSEA; TREMBLING; SWEATING; FELT SICK; FEVER OF 101F; This spontaneous report received from a consumer (father) concerned a 22 year old not Hispanic or Latino, white female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient reported no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, frequency 1 total, administered to left deltoid on 08-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 20:00, the patient felt sick and was incapacitated by severe vomiting (coded as migraine/severe vomiting/inability to retain fluids/nausea), sweating, trembling, fever of 101 F that resulted in her passing out. Vomiting was so severe that patient was unable to retain fluids and ruptured a blood vessel in her eye (coded as Broken Blood vessel in eye). Patient was hospitalized on 09-APR-2021 at 12:24 am. During hospitalization she received IV fluids and medicines for migraine and nausea and multiple blood samples were collected. Patient was discharged on 09-APR-2021 around 6 AM. Patient was hospitalized for around 6 hours. Patient reported that symptoms had recovered except was still having nausea and ruptured eye vessel from severe vomiting. (it was Confirmed with patient that she had no  past medical history of migraine and was referring to her headache as migraine.) Laboratory data included: Body temperature (NR: not provided) 101 F, Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from trembling, sweating, passing out, and felt sick on APR-2021, and fever of 101F, and had not recovered from migraine/severe vomiting/inability to retain fluids/nausea, and ruptured blood vessel in the eye. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s -Passing out, Ruptured blood vessel in the eye, Migraine/severe vomiting/inability to retain fluid/nausea, trembling, sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210422127-covid-19 vaccine ad26.cov2.s -Fever, Felt sick. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: PARTIAL DOSE ADMINISTRATION; NEEDLE GOT UNSCREWED FROM THE SYRINGE; 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced partial dose administration. On 12-APR-2021, the subject experienced needle got unscrewed from the syringe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose administration and needle got unscrewed from the syringe was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Epistaxis, Influenza like illness, Injection site reaction
Clinical narrative: BLOODY NOSE WITH CLOTS; COULD NOT SLEEP WELL; FLU LIKE SYMPTOMS; INJECTION SITE DID NOT LOOK NORMAL; EXCRUCIATING SHARP PAIN AT BOTTOM OF FEET; BREATHING CHALLENGES; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 110 pounds, and height was 155.448 centimeters. The patient's past medical history included influenza virus, and suspected covid-19. 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced breathing challenges. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced injection site did not look normal. On 10-APR-2021, the subject experienced excruciating sharp pain at bottom of feet. Laboratory data included: Body temperature (NR: not provided) 101 unit unspecified, 102.3 unit unspecified. On 11-APR-2021, the subject experienced bloody nose with clots. On 11-APR-2021, the subject experienced could not sleep well. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from breathing challenges, flu like symptoms, and injection site did not look normal, had not recovered from could not sleep well, and the outcome of bloody nose with clots and excruciating sharp pain at bottom of feet was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: BLOODY NOSE WITH CLOTS; COULD NOT SLEEP WELL; FLU LIKE SYMPTOMS; INJECTION SITE DID NOT LOOK NORMAL; EXCRUCIATING SHARP PAIN AT BOTTOM OF FEET; BREATHING CHALLENGES; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 110 pounds, and height was 155.448 centimeters. The patient's past medical history included influenza virus, and suspected covid-19. 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced breathing challenges. On 10-APR-2021, the subject experienced flu like symptoms. On 10-APR-2021, the subject experienced injection site did not look normal. On 10-APR-2021, the subject experienced excruciating sharp pain at bottom of feet. Laboratory data included: Body temperature (NR: not provided) 101 unit unspecified, 102.3 unit unspecified. On 11-APR-2021, the subject experienced bloody nose with clots. On 11-APR-2021, the subject experienced could not sleep well. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from breathing challenges, flu like symptoms, and injection site did not look normal, had not recovered from could not sleep well, and the outcome of bloody nose with clots and excruciating sharp pain at bottom of feet was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; MILD HEADACHE; 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: Unk) 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 sore arm. On APR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and mild headache was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON FACE, CHEST, FOREHEAD, FOREARMS, HANDS IN  BETWEEN FINGERS; This spontaneous report received from a patient concerned a 77 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced rash on face, chest, forehead, forearms, hands in between fingers. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash on face, chest, forehead, forearms, hands in between fingers. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required according to standard operating procedure.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ADMINISTRATION SITE  SWELLING  OF SIZE OF A GOLF BALL; REDNESS ALMOST LIKE A SUNBURN; PAIN, HURTS WHEN TOUCHED; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included consumer had covid-19 on may 10, 2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced redness almost like a sunburn. On 09-APR-2021, the subject experienced pain, hurts when touched. On 11-APR-2021, the subject experienced administration site swelling of size of a golf ball. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administration site swelling of size of a golf ball, redness almost like a sunburn, and pain, hurts when touched. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: DEBILITATING HEADACHE; 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced debilitating headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from debilitating headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: RASH EVERYWHERE; HEADACHE; FEVER; 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 rashes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 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 fever. On 10-APR-2021, the subject experienced rash everywhere. 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 fever, and headache on 11-APR-2021, and had not recovered from rash everywhere. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PASSED OUT; This spontaneous report received from a consumer 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, administered 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced passed out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210422259- Covid-19 vaccine ad26.cov2.s- passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event..
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Loss of consciousness
Clinical narrative: MULTI PASSING OUT; FEELING SOME SIDE EFFECTS MORE STRONGLY THAN AVERAGE; This spontaneous report received via social media from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is mutant.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 06-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, Patient reported that as he is a mutant, he was feeling some side effects more strongly than average (coded as adverse drug reaction) and experienced multi passing out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling some side effects more strongly than average and multi passing out was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210422293- Covid-19 vaccine ad26.cov2.s- multi passing out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19. This report was non-serious.; Sender's Comments: V0  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.