chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; JOINT PAIN; SORE ARM; FATIGUE; HEADACHE; This solicited pregnancy report received from a consumer concerned a 38 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 68.93 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-MAR-2021 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 MAR-2021, the patient experienced maternal exposure during pregnancy. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced joint pain. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, headache, joint pain, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, joint pain, sore arm, fatigue, and headache was related.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS FROZEN AND THAWED OUT PRIOR ADMINISTRATION; FROZEN AND THAWED OUT VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUL-2021, the subject experienced frozen and thawed out vaccine administered. On an unspecified date, the subject experienced vaccine was frozen and thawed out prior administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the frozen and thawed out vaccine administered and vaccine was frozen and thawed out prior administration was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Cyst, Gait disturbance, Insomnia
Clinical narrative: LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; 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 pre-existing medical conditions included the patient had no related medical history. patient feels normal, super good and fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location was not reported. 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; 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 pre-existing medical conditions included the patient had no related medical history. patient feels normal, super good and fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location was not reported. 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Feeling hot, Lower respiratory tract infection, Nasopharyngitis
Clinical narrative: LOSS OF SMELL; WARM; LOSS OF TASTE; CHEST COLD; HEAD COLD; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and the patient had no known allergies. The patient did not have 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: 1805025, expiry: UNKNOWN)  dose was not reported, 1 total, administered on 08-APR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the patient had head cold and chest cold. On 10-JUL-2021, the patient had loss of smell, taste and was warm. On 13-JUL-2021, the patient was scheduled for COVID test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head cold, loss smell, warm, chest cold, and loss of taste. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210725918-COVID-19 VACCINE AD26.COV2.S-chest cold. 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).
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN GLANDS FOR JUST A MINUTE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced swollen glands for just a minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands for just a minute. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Generalised tonic-clonic seizure, Insomnia, Loss of personal independence in daily activities, Suicidal ideation
Clinical narrative: SUDDEN ONSET GRAND MAL SEIZURES; SUICIDAL THOUGHTS AND IDEATIONS; COULD NOT SLEEP; COULD NOT EAT; NOT ABLE TO LIVE LIFE ANYMORE; This spontaneous report received from a consumer concerned a 35 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total 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 patient could not sleep, could not eat; also experienced suicidal thoughts and ideations, and not able to live life anymore. On 29-APR-2021, the patient experienced sudden onset grand mal seizures. She had been having countless doctor visits. On an unspecified date, she was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sudden onset grand mal seizures, could not sleep, could not eat, suicidal thoughts and ideations, and not able to live life anymore. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210726025- covid-19 vaccine ad26.cov2.s- sudden onset grand mal seizures, could not sleep, could not eat, suicidal thoughts and ideations, and not able to live life anymore.. This event(s) is considered un-assessable. 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).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypersomnia, Nausea, Retching
Clinical narrative: DONT FEEL GOOD AT ALL; I SLEPT ALL THE DAY; DRY HEAVES; VIOLENT HEADACHE; EXTREMELY NAUSEOUS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUL-2021, the subject experienced dry heaves. On 09-JUL-2021, the subject experienced violent headache. On 09-JUL-2021, the subject experienced extremely nauseous. On 10-JUL-2021, the subject experienced i slept all the day. On 12-JUL-2021, the subject experienced dont feel good at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry heaves on 09-JUL-2021, and i slept all the day on 11-JUL-2021, had not recovered from violent headache, and extremely nauseous, and the outcome of dont feel good at all was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Immobile, Migraine, Pain in extremity
Clinical narrative: IMOBILE; MIGRAINE; SLEPT FOR A WEEK STRAIGHT; COULD NOT TALK; SORE ARM; TIREDNESS; NO ENERGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered to left arm on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient suffered from a severe headache and slept for a week straight since patient was unable to move or open eyes, it felt like a migraine. The patient was imboile. Patient could barely move to the bathroom, could not talk, that could not watch television, and had to stay in a dark room. Patient also had sore arm and it was still there event after two months of vaccination. Patient also had tiredness. The patient's headache had finally gone away, but still didn't have any energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from sore arm, and no energy, and the outcome of tiredness, migraine, slept for a week straight, imobile and could not talk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210726165- COVID-19 VACCINE AD26.COV2.S-Imobile. 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).
Sex: U
Vaccine: COVID19
Symptoms: Somnolence, Speech disorder
Clinical narrative: IMOBILE; MIGRAINE; SLEPT FOR A WEEK STRAIGHT; COULD NOT TALK; SORE ARM; TIREDNESS; NO ENERGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered to left arm on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient suffered from a severe headache and slept for a week straight since patient was unable to move or open eyes, it felt like a migraine. The patient was imboile. Patient could barely move to the bathroom, could not talk, that could not watch television, and had to stay in a dark room. Patient also had sore arm and it was still there event after two months of vaccination. Patient also had tiredness. The patient's headache had finally gone away, but still didn't have any energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from sore arm, and no energy, and the outcome of tiredness, migraine, slept for a week straight, imobile and could not talk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210726165- COVID-19 VACCINE AD26.COV2.S-Imobile. 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).
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: TOOK TWO DIFFERENT COVID 19 VACCINES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination. 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 20-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced took two different covid 19 vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of took two different covid 19 vaccines was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: VERTIGO; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722977.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; FEELING UNWELL; SORE ARM; HEADACHE; This solicited pregnancy report received from a patient concerned a 37 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines number: C00366). The patient's weight was 79.36 kilograms, and height was not reported. The patient's past medical history included multigravida, miscarriage, intracytoplasmic sperm injection, and in vitro fertilization. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid, ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide, docosahexaenoic acid, and progesterone.  On 05-MAY-2021, the patient experienced maternal exposure during pregnancy. On 05-MAY-2021, the patient experienced feeling unwell. On 05-MAY-2021, the patient experienced sore arm. On 05-MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling unwell, headache, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and feeling unwell, sore arm, and headache was related.  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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS OF VACCINE SUCK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effects of vaccine suck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects of vaccine suck was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Head discomfort, Headache, Pain, Scan
Clinical narrative: PRESSURE IN EAR AND JAW; MASSIVE EAR AND JAW PAIN; PRESSURE IN HEAD; MASSIVE PAIN IN HEAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported 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 2021, the subject experienced pressure in ear and jaw. On 2021, the subject experienced massive ear and jaw pain. On 2021, the subject experienced pressure in head. On 2021, the subject experienced massive pain in head. Laboratory data (dates unspecified) included: Scan (NR: not provided) was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive pain in head, massive ear and jaw pain, pressure in head and pressure in ear and jaw was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Headache
Clinical narrative: OUT OF BREATH, SHORTNESS OF BREATH; HEADACHES; FELT DIZZY,FELT LIKE SHE WAS GOING TO PASS OUT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, temporomandibular joint disorder, deviated septum, and jaw pain, and concurrent conditions included low blood pressure (110/50), tooth problems, penicillin allergy, celery and avocado allergy, and allergy to animal products. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the subject experienced felt dizzy, felt like she was going to pass out. On 06-APR-2021, the subject experienced out of breath, shortness of breath. On 06-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 110/50 (low). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches on 30-JUN-2021, was recovering from felt dizzy, felt like she was going to pass out, and had not recovered from out of breath, shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN GLANDS; This spontaneous report received from a consumer via Pfizer on 09-JUL-2021 and concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 swollen glands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: FLU SYMPTOMS/FEVER/CHILLS/BODY ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu symptoms/fever/chills/body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms/fever/chills/body ache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Localised infection, Loss of consciousness, Magnetic resonance imaging, Neurodevelopment test
Clinical narrative: FAINTING; SEIZURES; INFECTION ON LEG; BLOOD CLOT IN LOWER LEFT LEG; BLACKOUT; CELLULITIS; This spontaneous report received from a consumer concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included old blood clot history, and concurrent conditions included hypertension, and hyperthyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) frequency 1 total dose was not reported, administered at left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. 22-MAY-2021, Patient went to emergency room for fainting/blacking out and on 05-JUN-2021, blood clot was discovered in lower left leg. Also had infection, they said cellulitis in the right leg. Seizures at the end of MAY-2021. Patient was admitted on 05-JUN-2021 to hospital until 09-JUN-2021. Patient was hospitalized for 5 days. Vertigo medication from primary care provider. Patient went back to hospital for infection on leg from 16-JUN-2021 to 21-JUN-2021. Patient was hospitalized for 6 days. Neuro testing last week (results was unknown). Physician 12- JUL-2021 called them seizures and prescribed the Magnetic resonance imaging (MRI) results was unknown. Treatment medications (dates unspecified) included: (Xarelto) rivaroxaban.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in lower left leg, and blackout, and the outcome of cellulitis, seizures, fainting and infection on leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 - 20210726614- covid-19 vaccine ad26.cov2.s-Blood clot in lower left leg. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210726614-covid-19 vaccine ad26.cov2.s-Blackout, Cellulitis, Seizures, Fainting, Infection on leg. 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).
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Thrombosis
Clinical narrative: FAINTING; SEIZURES; INFECTION ON LEG; BLOOD CLOT IN LOWER LEFT LEG; BLACKOUT; CELLULITIS; This spontaneous report received from a consumer concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included old blood clot history, and concurrent conditions included hypertension, and hyperthyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) frequency 1 total dose was not reported, administered at left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. 22-MAY-2021, Patient went to emergency room for fainting/blacking out and on 05-JUN-2021, blood clot was discovered in lower left leg. Also had infection, they said cellulitis in the right leg. Seizures at the end of MAY-2021. Patient was admitted on 05-JUN-2021 to hospital until 09-JUN-2021. Patient was hospitalized for 5 days. Vertigo medication from primary care provider. Patient went back to hospital for infection on leg from 16-JUN-2021 to 21-JUN-2021. Patient was hospitalized for 6 days. Neuro testing last week (results was unknown). Physician 12- JUL-2021 called them seizures and prescribed the Magnetic resonance imaging (MRI) results was unknown. Treatment medications (dates unspecified) included: (Xarelto) rivaroxaban.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in lower left leg, and blackout, and the outcome of cellulitis, seizures, fainting and infection on leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 - 20210726614- covid-19 vaccine ad26.cov2.s-Blood clot in lower left leg. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210726614-covid-19 vaccine ad26.cov2.s-Blackout, Cellulitis, Seizures, Fainting, Infection on leg. 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).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a patient concerned a 44 year old female. The patient was enrolled in a non-company sponsored study: COVID 19 Registryt number: C00031). The patient's weight was 47.62 kilograms, and height was not reported. The patient's past medical history included multigravida, and concurrent conditions included anxiety, and low blood pressure. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos, cetirizine hydrochloride, and famotidine. On 06-MAR-2021, the patient experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE ARM SORENESS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included little arm soreness, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 17-MAR-2021, the subject experienced little arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little arm soreness on 18-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210726161.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: NAUSEA; HEADACHE; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and herniated disc, and concurrent conditions included copd. 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 oxygen for copd. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced general body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, headache, and general body aches on 04-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Cerebrovascular accident, Liver function test, Liver function test increased
Clinical narrative: LIVER ISSUE/NUMBERS HIGH; STROKE; This spontaneous report received from a patient concerned a 63 year old male ,unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown ,expiry :unknown ) dose was not reported,one total, administered on 02-JUN-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number:Unknown ,expiry: Unknown ) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis; and methotrexate ( batch number: unknown expiry:Unknown, form of admin, route of admin, and were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  No concomitant medications were reported. On 06-JUN-2021, the patient experienced stroke. On an unspecified date, the patient experienced liver issue/numbers high.  Laboratory data (dates unspecified) included: Liver function test (NR: not provided) Numbers high (increased). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with adalimumab was not reported; and treatment with methotrexate was withdrawn. The patient recovered from stroke on 2021, and was recovering from liver issue/numbers high. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210726698-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Stroke. 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: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Hypersomnia, Nausea
Clinical narrative: SLEPT LIKE SHIT; LACK OF APPETITE; CHILLS; BAD JOINT PAIN; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced slept like shit. On JUL-2021, the subject experienced lack of appetite. On JUL-2021, the subject experienced chills. On JUL-2021, the subject experienced bad joint pain. On JUL-2021, the subject experienced fever. On JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, lack of appetite, and bad joint pain, and the outcome of slept like shit, fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SLEPT LIKE SHIT; LACK OF APPETITE; CHILLS; BAD JOINT PAIN; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced slept like shit. On JUL-2021, the subject experienced lack of appetite. On JUL-2021, the subject experienced chills. On JUL-2021, the subject experienced bad joint pain. On JUL-2021, the subject experienced fever. On JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, lack of appetite, and bad joint pain, and the outcome of slept like shit, fever and chills was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Computerised tomogram, Cough, Dysphonia, Dyspnoea, Nasopharyngitis
Clinical narrative: COLD; HOARSE AND RASPY VOICE; RECURRENT COUGH; WHEN INHALES PATIENT COULD TAKE DEEP BREATHS,WHEN ABOUT TO EXHALE, FELT LIKE A HAND IN NECK THAT NEEDED TO COUGH TO BE ABLE TO EXPEL THE AIR INSIDE; WEIGHT GAIN; This spontaneous report received from a physician concerned a 45 year old female. The patient's weight was 250 pounds, and height was 63 inches. The patient's past medical history included face swell, and concurrent conditions included cough variant asthma, alcohol use, sulfa drugs allergy manifested by hives, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 180206, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number and expiry were not reported) 15 mg, every 1 total, from JAN-2020, frequency was not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2020, the subject experienced when inhales subject could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside. On 2020, the subject experienced weight gain. On APR-2021, the subject experienced recurrent cough. On 21-MAY-2021, Laboratory data included: CT scan (NR: not provided) No pneumonia, No significant findings. On JUN-2021, the subject experienced hoarse and raspy voice. On 23-JUN-2021, the subject experienced cold. Treatment medications (dates unspecified) included: mometasone furoate, budesonide/formoterol fumarate, benzonatate, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient had not recovered from hoarse and raspy voice, weight gain, recurrent cough, and cold, and the outcome of when inhales patient could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Weight increased
Clinical narrative: COLD; HOARSE AND RASPY VOICE; RECURRENT COUGH; WHEN INHALES PATIENT COULD TAKE DEEP BREATHS,WHEN ABOUT TO EXHALE, FELT LIKE A HAND IN NECK THAT NEEDED TO COUGH TO BE ABLE TO EXPEL THE AIR INSIDE; WEIGHT GAIN; This spontaneous report received from a physician concerned a 45 year old female. The patient's weight was 250 pounds, and height was 63 inches. The patient's past medical history included face swell, and concurrent conditions included cough variant asthma, alcohol use, sulfa drugs allergy manifested by hives, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 180206, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number and expiry were not reported) 15 mg, every 1 total, from JAN-2020, frequency was not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2020, the subject experienced when inhales subject could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside. On 2020, the subject experienced weight gain. On APR-2021, the subject experienced recurrent cough. On 21-MAY-2021, Laboratory data included: CT scan (NR: not provided) No pneumonia, No significant findings. On JUN-2021, the subject experienced hoarse and raspy voice. On 23-JUN-2021, the subject experienced cold. Treatment medications (dates unspecified) included: mometasone furoate, budesonide/formoterol fumarate, benzonatate, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient had not recovered from hoarse and raspy voice, weight gain, recurrent cough, and cold, and the outcome of when inhales patient could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received esketamine (nasal spray, solution, route of admin not reported ) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, administered on 08-APR-2021 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 sick. The action taken with covid-19 vaccine ad26.cov2.s, and esketamine was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gout
Clinical narrative: BAD ARTHRITIS FLARE UPS; POSSIBLE GOUT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad arthritis flare ups, and possible gout. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad arthritis flare ups, and the outcome of possible gout was not reported. 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: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Fatigue
Clinical narrative: NOT HIMSELF; FEELING TIRED; .This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 not himself, and feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling tired and not himself was not reported. This report was non-serious.