chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Balance test, Dizziness, Nausea, Scan, Vomiting
Clinical narrative: SEVER DIZZINESS; NAUSEA; VOMITING; 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: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced sever dizziness. On 12-APR-2021, the patient experienced nausea. On 12-APR-2021, the patient experienced vomiting. Laboratory data (dates unspecified) included: Balance test (NR: not provided) no findings, and Scan (NR: not provided) no findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, nausea, and vomiting. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Needle issue, Pain in extremity, Pruritus, Wound
Clinical narrative: NEEDLE ISSUE (NEEDLE OF THE VACCINE ITSELF WAS CAUSTIC, THERE WAS SOMETHING IN THE INOCULATION THAT WAS CAUSTIC); TERRIBLY ITCHY; ARM ACHE; WOUND WITH SCAB (THAT COMES OFF, DOES NOT HEAL  AND LARGE IN DIAMETER); LOT OF DISCOMFORT; 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: kidney problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced wound with scab (that comes off, does not heal and large in diameter). On APR-2021, the patient experienced lot of discomfort. On APR-2021, the patient experienced terribly itchy. On APR-2021, the patient experienced arm ache. On 08-APR-2021, the patient experienced needle issue (needle of the vaccine itself was caustic, there was something in the inoculation that was caustic). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from wound with scab (that comes off, does not heal and large in diameter), arm ache, lot of discomfort, and terribly itchy, and the outcome of needle issue (needle of the vaccine itself was caustic, there was something in the inoculation that was caustic) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217470.
Sex: M
Vaccine: COVID19
Symptoms: Bone fragmentation, Shoulder injury related to vaccine administration
Clinical narrative: INJURY TO HIS SHOULDER CAUSED BY COVID VACCINE INJECTION; INJURY WAS CAUSED BY THE NEEDLE CHIPPING OFF A PIECE OF BONE; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced injury to his shoulder caused by covid vaccine injection, and injury was caused by the needle chipping off a piece of bone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injury to his shoulder caused by covid vaccine injection and injury was caused by the needle chipping off a piece of bone was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Complex regional pain syndrome, Discomfort, Erythema, Gait inability, Headache
Clinical narrative: COULDN'T WALK; FLARE OF AUTOIMMUNE REFLEX SYMPATHETIC DYSTROPHY (RSD) SYMPTOMS; SPLITTING MIGRAINE; INJECTION SITE UNCOMFORTABLE; WAS VERY UNCOMFORTABLE; REDNESS GREW DOWN ARM TO ALMOST ELBOW; INJECTION SITE SORE; HEADACHE; HOTNESS AT INJECTION SITE; REDNESS AT INJECTION SITE; DIFFICULTY MOVING ARMS AND LEGS; This spontaneous report received from a pharmacist concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sympathetic nerve cut, and surgery, and concurrent conditions included: multiple autoimmune disorders, reflex sympathetic dystrophy, penicillin allergy, lymphoma, allergy to dye/filler in generic medications, pet allergy, oak and pine trees allergy, and outdoor allergens, and other pre-existing medical conditions included: The patient experiences allergy with things around the house, anything that blooms. The patient experienced stomach problems when treated with gabapentin for reflex sympathetic dystrophy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On 02-DEC-2021, the patient experienced difficulty moving arms and legs. On 02-DEC-2021, the patient experienced hotness at injection site. On 02-DEC-2021, the patient experienced redness at injection site. On 03-DEC-2021, the patient experienced splitting migraine. On 03-DEC-2021, the patient experienced was very uncomfortable. On 03-DEC-2021, the patient experienced redness grew down arm to almost elbow. On 03-DEC-2021, the patient experienced injection site uncomfortable. On 03-DEC-2021, the patient experienced injection site sore. On 03-DEC-2021, the patient experienced headache. On 04-DEC-2021, the patient experienced flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms. On 04-DEC-2021, the patient experienced couldn't walk. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from splitting migraine, and headache on 04-DEC-2021, had not recovered from redness at injection site, difficulty moving arms and legs, couldn't walk, flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms, injection site sore, and hotness at injection site, and the outcome of was very uncomfortable, injection site uncomfortable and redness grew down arm to almost elbow was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth, Migraine
Clinical narrative: COULDN'T WALK; FLARE OF AUTOIMMUNE REFLEX SYMPATHETIC DYSTROPHY (RSD) SYMPTOMS; SPLITTING MIGRAINE; INJECTION SITE UNCOMFORTABLE; WAS VERY UNCOMFORTABLE; REDNESS GREW DOWN ARM TO ALMOST ELBOW; INJECTION SITE SORE; HEADACHE; HOTNESS AT INJECTION SITE; REDNESS AT INJECTION SITE; DIFFICULTY MOVING ARMS AND LEGS; This spontaneous report received from a pharmacist concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sympathetic nerve cut, and surgery, and concurrent conditions included: multiple autoimmune disorders, reflex sympathetic dystrophy, penicillin allergy, lymphoma, allergy to dye/filler in generic medications, pet allergy, oak and pine trees allergy, and outdoor allergens, and other pre-existing medical conditions included: The patient experiences allergy with things around the house, anything that blooms. The patient experienced stomach problems when treated with gabapentin for reflex sympathetic dystrophy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On 02-DEC-2021, the patient experienced difficulty moving arms and legs. On 02-DEC-2021, the patient experienced hotness at injection site. On 02-DEC-2021, the patient experienced redness at injection site. On 03-DEC-2021, the patient experienced splitting migraine. On 03-DEC-2021, the patient experienced was very uncomfortable. On 03-DEC-2021, the patient experienced redness grew down arm to almost elbow. On 03-DEC-2021, the patient experienced injection site uncomfortable. On 03-DEC-2021, the patient experienced injection site sore. On 03-DEC-2021, the patient experienced headache. On 04-DEC-2021, the patient experienced flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms. On 04-DEC-2021, the patient experienced couldn't walk. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from splitting migraine, and headache on 04-DEC-2021, had not recovered from redness at injection site, difficulty moving arms and legs, couldn't walk, flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms, injection site sore, and hotness at injection site, and the outcome of was very uncomfortable, injection site uncomfortable and redness grew down arm to almost elbow was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: COULDN'T WALK; FLARE OF AUTOIMMUNE REFLEX SYMPATHETIC DYSTROPHY (RSD) SYMPTOMS; SPLITTING MIGRAINE; INJECTION SITE UNCOMFORTABLE; WAS VERY UNCOMFORTABLE; REDNESS GREW DOWN ARM TO ALMOST ELBOW; INJECTION SITE SORE; HEADACHE; HOTNESS AT INJECTION SITE; REDNESS AT INJECTION SITE; DIFFICULTY MOVING ARMS AND LEGS; This spontaneous report received from a pharmacist concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sympathetic nerve cut, and surgery, and concurrent conditions included: multiple autoimmune disorders, reflex sympathetic dystrophy, penicillin allergy, lymphoma, allergy to dye/filler in generic medications, pet allergy, oak and pine trees allergy, and outdoor allergens, and other pre-existing medical conditions included: The patient experiences allergy with things around the house, anything that blooms. The patient experienced stomach problems when treated with gabapentin for reflex sympathetic dystrophy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On 02-DEC-2021, the patient experienced difficulty moving arms and legs. On 02-DEC-2021, the patient experienced hotness at injection site. On 02-DEC-2021, the patient experienced redness at injection site. On 03-DEC-2021, the patient experienced splitting migraine. On 03-DEC-2021, the patient experienced was very uncomfortable. On 03-DEC-2021, the patient experienced redness grew down arm to almost elbow. On 03-DEC-2021, the patient experienced injection site uncomfortable. On 03-DEC-2021, the patient experienced injection site sore. On 03-DEC-2021, the patient experienced headache. On 04-DEC-2021, the patient experienced flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms. On 04-DEC-2021, the patient experienced couldn't walk. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from splitting migraine, and headache on 04-DEC-2021, had not recovered from redness at injection site, difficulty moving arms and legs, couldn't walk, flare of autoimmune reflex sympathetic dystrophy (rsd) symptoms, injection site sore, and hotness at injection site, and the outcome of was very uncomfortable, injection site uncomfortable and redness grew down arm to almost elbow was not reported. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217956, 20211218297, 20211218548 and 20211218731.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: MENOPAUSAL BREAK THROUGH BLEEDING; This spontaneous report received from a consumer concerned a older female of unspecified age, race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of administration, and batch number were not reported and expiry: unknown) dose, start therapy date were not reported, frequency 01 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported at the time of reporting.  Reporter stated that, a pharmacist had several females report menstrual abnormalities after receiving a COVID-19 vaccine. On an unspecified date, the older female in menopause experienced break through bleeding and further stated additional females had experienced an abnormal cycle following vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menopausal break through bleeding was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211217848-COVID-19 VACCINE AD26.COV2.S-menopausal break through bleeding. 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: Appendicitis
Clinical narrative: APPENDICITIS; This spontaneous report received from a patient via social media of unspecified age, race, ethnicity 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, 1 total administered on 15-NOV-2021 for prophylactic vaccination (dose series 1). 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 patient experienced appendicitis and stated "just had to have it removed" on 06-DEC-2021, three weeks post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of appendicitis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210408818.; Sender's Comments: V0: 20211218018-covid-19 vaccine ad26.cov2.-Appendicitis. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: POSITIVE COVID-19 TEST; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced positive covid-19 test. Laboratory data (dates unspecified) included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid-19 test was not reported. This report was non-serious. This case, from the same reporter is linked to 20211203852.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Nonspecific reaction
Clinical narrative: BAD REACTION; 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: unk) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 13 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 18-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-SEP-2021, the patient experienced off label use. On 18-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218297, 20211218731 and 20211218731.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination (Dose series number : 1). No concomitant medications were reported. On 13-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219807, 20211219686 and 20211219731.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: HEADACHE; TIREDNESS; FEVER OF 102; MUSCLE ACHES; NAUSEA; FEELING SICK; LEGS HURT/SORE; THROWING UP; This spontaneous report received from a patient 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: 213 (B or D)218, and  expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, the patient experienced feeling sick. On DEC-2021, the patient experienced legs hurt/sore. On DEC-2021, the patient experienced throwing up. On DEC-2021, the patient experienced tiredness. On DEC-2021, the patient experienced fever of 102. On DEC-2021, the patient experienced muscle aches. On DEC-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102. On 07-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of throwing up, tiredness, fever of 102, muscle aches, legs hurt/sore, feeling sick and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: HEADACHE; TIREDNESS; FEVER OF 102; MUSCLE ACHES; NAUSEA; FEELING SICK; LEGS HURT/SORE; THROWING UP; This spontaneous report received from a patient 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: 213 (B or D)218, and  expiry: UNKNOWN) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On DEC-2021, the patient experienced feeling sick. On DEC-2021, the patient experienced legs hurt/sore. On DEC-2021, the patient experienced throwing up. On DEC-2021, the patient experienced tiredness. On DEC-2021, the patient experienced fever of 102. On DEC-2021, the patient experienced muscle aches. On DEC-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102. On 07-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of throwing up, tiredness, fever of 102, muscle aches, legs hurt/sore, feeling sick and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: MAJOR NEUROLOGICAL DAMAGE IN ONE ARM; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1).  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 patient experienced major neurological damage in one arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major neurological damage in one arm was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219731 and 20211219807.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 31-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-OCT-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 31-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219686 and 20211219807.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219386, 20211219731, 20211219686, 20211220206 and 20211220552.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219926, 20211220206, 20211220129, 20211220552, 20211220916, 20211220152, 20211219681, 20211220262, 20211220250, 20211220155, 20211220129, 20211219926, 20211165041, 20211220145, 20211202199, 20211202161, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211220619, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211200675, 20211200717, 20211220697 and 20211220928.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased, Urticaria
Clinical narrative: ANXIOUS; RAPID HEART BEAT; HIVES; This spontaneous report received from a health care professional concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced anxious. On MAR-2021, the patient experienced rapid heart beat. On MAR-2021, the patient experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives, anxious and rapid heart beat was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: OVERDOSE (RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced overdose (received 2.5ml of the janssen covid-19 vaccine). On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the overdose (received 2.5ml of the janssen covid-19 vaccine) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220916,  20211220233, 20211220262, 20211220216, 20211220460, 20211220206, 20211219686, 20211220527, 20211220537, 20211220552, 20211220619, 20211220697, 20211220754, 20211220764, 20211219714, 20211219731, 20211219926, 20211219701 and 20211220948.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5 ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced received 2.5 ml of the vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of the vaccine and off label use was not reported. This report was non-serious. This case, involving the same patient is linked to 20211202250. This case, from the same reporter is linked to 20211219926, 20211219871, 20211220146, 20211220262, 20211220250, 20211220152, 20211220145, 20211220155, 20211220916, 20211219681, 20211220152, 20211220145, 20211220155, 20211165041, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202371 and 20211165041.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 21-SEP-2021) 2.5 ml, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient experienced administered 2.5ml of the vaccine. On 07-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220146, 20211220916, 20211220152, 20211219926, 20211165041, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202250, 20211202371, 20211165041, 20211200675, 20211200717, 20211200723, 20211201082, 20211200994, 20211201168, 20211201179, 20211201286, 20211201304, 20211201351, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211219871, 20211220155 and 20211219681.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220129, 20211220916, 20211200769, 20211200675, 20211200717, 20211201082, 20211200994, 20211201168, 20211201179, 20211201286, 20211201304, 20211201351, 20211201392, 20211201443, 20211201450, 20211202161, 20211202199, 20211220262, 20211220250, 20211219871, 20211219926, 20211219681, 20211219871, 20211202207, 20211220619, 20211219926, 20211220145, 20211220155, 20211202246, 20211202250 and 20211202371.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVING 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) 2.5 ml, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-NOV-2021, the patient experienced receiving 2.5ml of the janssen covid-19 vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the receiving 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ADMINISTRATION OF 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced administration of 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219686, 20211219701, 20211219807 and 20211219871.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: WORSENED OF PAIN AFTER GETTING THE VACCINE; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's past medical history included: chronic pain. The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced worsened of pain after getting the vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of worsened of pain after getting the vaccine was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVING ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-NOV-2021, the patient experienced receiving 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the receiving 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Application site pain
Clinical narrative: LITTLE SORENESS; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced little soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little soreness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211220462.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: FEELING VERY UNWELL; SEVERE HEADACHES; MUSCLE PAIN; NAUSEOUS; EXTREMELY FEVERISH; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included: spinal fusion in neck, and concurrent conditions included: cerebral palsy, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-DEC-2021, the patient experienced extremely feverish. On 08-DEC-2021, the patient experienced feeling very unwell. On 08-DEC-2021, the patient experienced severe headaches. On 08-DEC-2021, the patient experienced muscle pain. On 08-DEC-2021, the patient experienced nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely feverish on 08-DEC-2021, and had not recovered from severe headaches, muscle pain, nauseous, and feeling very unwell. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219681, 20211219953, 20211220301, 20211220460, 20211220206, 20211220178, 20211220537, 20211220177, 20211220552, 20211220155, 20211220619, 20211220697, 20211220146, 20211220754, 20211220129, 20211220764, 20211220916, 20211220948, 20211219714, 20211219701, 20211219686, 20211219731 and 20211219807. .
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVING 2.5ML OF THE  JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-NOV-2021, the patient experienced receiving 2.5ml of the janssen covid-19 vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the receiving 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5 ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received only 2.5 ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219686, 20211219701, 20211219807 and 20211219871.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.