chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Underdose
Clinical narrative: UNDERDOSE; MEDICATION ERROR; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) .4 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose administered, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose administered by nursing error and medication error was not reported. This report was non-serious.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: VACCINE ADMINISTERED FROM PUNCTURED VIAL OPEN 17 HOURS; 6 DOSES DRAWN UP PER VIAL; This spontaneous report received from a health care professional concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25/MAR/2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced 6 doses drawn up per vial. On 27-MAR-2021, the subject experienced vaccine administered from punctured vial open 17 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered from punctured vial open 17 hours and 6 doses drawn up per vial was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Dizziness, Headache, Limb discomfort
Clinical narrative: ACHING IN BILATERAL HANDS; CHILLS; FEVER; HEADACHE; NAUSEA; NO TASTE; DIZZINESS; ARM FEELS HEAVY; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 145 pounds, and height was 62 inches. The patient's past medical history included glaucoma, and concurrent conditions included no known drug allergies, nonsmoker, non alcohol user, and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced no taste. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced arm feels heavy. On 25-MAR-2021, the subject experienced aching in bilateral hands. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 26-MAR-2021, and had not recovered from fever, no taste, chills, headache, arm feels heavy, dizziness, and aching in bilateral hands. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: ACHING IN BILATERAL HANDS; CHILLS; FEVER; HEADACHE; NAUSEA; NO TASTE; DIZZINESS; ARM FEELS HEAVY; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 145 pounds, and height was 62 inches. The patient's past medical history included glaucoma, and concurrent conditions included no known drug allergies, nonsmoker, non alcohol user, and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced no taste. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced arm feels heavy. On 25-MAR-2021, the subject experienced aching in bilateral hands. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 26-MAR-2021, and had not recovered from fever, no taste, chills, headache, arm feels heavy, dizziness, and aching in bilateral hands. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: HEADACHE; FEVER; BODY ACHE; CHILLS; This spontaneous report received from a patient concerned a 61 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: 1808978, Expiry) dose was not reported, administered on 25-MAR-2021 at 18:30 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced body ache. On 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from headache, fever, body ache, and chills. This report was non-serious.  Additional information received from patient on 31-Mar-2021. The following information was updated and incorporated into the case narrative: Due diligence was scheduled. Upon review, the following information was amended: Vaccination site was updated in therapy details and narrative.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included congested in nose. The patient experienced drug allergy when treated with acetylsalicylic acid, and ibuprofen. 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 27-MAR-2021 09:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amlodipine, diphenhydramine hydrochloride, loratadine, and pantoprazole sodium sesquihydrate.  On 27-MAR-2021, at 17:00 the subject experienced chills till 20:00. On 27-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 C. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 27-MAR-2021 20:00, and the outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain
Clinical narrative: FELT HORRIBLE; BODY ACHES; CHILLS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 24-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt horrible, chills and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Hypersensitivity, Pain
Clinical narrative: FEVER; HEADACHE ON AND OFF; GENERAL WEAKNESS; DIZZINESS; PALPITATION; BODY ACHES; ITCHY; LITTLE LUMPS BACK AND FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hashimoto, and concurrent conditions included acetominophen allergy, and ibuprofen allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced little lumps back and face. On 24-MAR-2021, the subject experienced itchy. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache on and off. On 25-MAR-2021, the subject experienced general weakness. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced palpitation. On 25-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little lumps back and face, and itchy on 25-MAR-2021, was recovering from headache on and off, dizziness, palpitation, general weakness, and body aches, and had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Pyrexia
Clinical narrative: FEVER; HEADACHE ON AND OFF; GENERAL WEAKNESS; DIZZINESS; PALPITATION; BODY ACHES; ITCHY; LITTLE LUMPS BACK AND FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hashimoto, and concurrent conditions included acetominophen allergy, and ibuprofen allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced little lumps back and face. On 24-MAR-2021, the subject experienced itchy. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache on and off. On 25-MAR-2021, the subject experienced general weakness. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced palpitation. On 25-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little lumps back and face, and itchy on 25-MAR-2021, was recovering from headache on and off, dizziness, palpitation, general weakness, and body aches, and had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal rigidity, Body temperature, Body temperature decreased, Feeling hot
Clinical narrative: FEELING HOT; FEVER; THROWING UP EVERY 20-30  STARTING AROUND 21.00-22.00 UNTIL AROUND 08.00 NEXT DAY, CONTINUED THROWING UP LESS FREQUENTLY ON NEXT DAY, BUT THE VOMITING GOT WORSE AGAIN AND UNABLE TO EAT AS BEGAN THROWING UP AGAIN MORE FREQUENTLY; LOW TEMPERATURE; SWEATS; SEVERE ABDOMINAL PAIN; STOMACH  SPASMING; FEELING VERY SICK AROUND 19.00-20.00; ARM HURT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805081, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 at around 14.00 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced low temperature. On 24-MAR-2021, the subject experienced sweats. On 24-MAR-2021, the subject experienced severe abdominal pain. On 24-MAR-2021, the subject experienced stomach spasming. On 24-MAR-2021, the subject experienced feeling very sick around 19.00-20.00. On 24-MAR-2021, the subject experienced arm hurt. Laboratory data included: Body temperature (NR: not provided) 95.7 F. On 24-MAR-2021 21:00, the subject experienced throwing up every 20-30 starting around 21.00-22.00 until around 08.00 next day, continued throwing up less frequently on next day, but the vomiting got worse again and unable to eat as began throwing up again more frequently. On 25-MAR-2021, the subject experienced feeling hot. On 25-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) over 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt on 24-MAR-2021, had not recovered from throwing up every 20-30 starting around 21.00-22.00 until around 08.00 next day, continued throwing up less frequently on next day, but the vomiting got worse again and unable to eat as began throwing up again more frequently, severe abdominal pain, and stomach spasming, and the outcome of low temperature, fever, sweats, feeling hot and feeling very sick around 19.00-20.00 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: FEELING HOT; FEVER; THROWING UP EVERY 20-30  STARTING AROUND 21.00-22.00 UNTIL AROUND 08.00 NEXT DAY, CONTINUED THROWING UP LESS FREQUENTLY ON NEXT DAY, BUT THE VOMITING GOT WORSE AGAIN AND UNABLE TO EAT AS BEGAN THROWING UP AGAIN MORE FREQUENTLY; LOW TEMPERATURE; SWEATS; SEVERE ABDOMINAL PAIN; STOMACH  SPASMING; FEELING VERY SICK AROUND 19.00-20.00; ARM HURT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805081, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 at around 14.00 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced low temperature. On 24-MAR-2021, the subject experienced sweats. On 24-MAR-2021, the subject experienced severe abdominal pain. On 24-MAR-2021, the subject experienced stomach spasming. On 24-MAR-2021, the subject experienced feeling very sick around 19.00-20.00. On 24-MAR-2021, the subject experienced arm hurt. Laboratory data included: Body temperature (NR: not provided) 95.7 F. On 24-MAR-2021 21:00, the subject experienced throwing up every 20-30 starting around 21.00-22.00 until around 08.00 next day, continued throwing up less frequently on next day, but the vomiting got worse again and unable to eat as began throwing up again more frequently. On 25-MAR-2021, the subject experienced feeling hot. On 25-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) over 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt on 24-MAR-2021, had not recovered from throwing up every 20-30 starting around 21.00-22.00 until around 08.00 next day, continued throwing up less frequently on next day, but the vomiting got worse again and unable to eat as began throwing up again more frequently, severe abdominal pain, and stomach spasming, and the outcome of low temperature, fever, sweats, feeling hot and feeling very sick around 19.00-20.00 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood glucose decreased, Body temperature, Eye pain
Clinical narrative: ALMOST PASSED OUT; LOW BLOOD SUGAR; A LOT OF GAS; VOMITED; PEED ON HERSELF; NAUSEATED; HALLUCINATION; FEVER; FELT COLD AND SAID SHE WAS FREEZING; PAIN IN LEFT KNEE; VERY WEAK, COULD HARDLY GET TO BED; EYES HURT WHEN TOUCHED; FELT MEDICATION GOING IN; SHALLOW BREATHING; HEADACHE; SHAKINESS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes and depression, 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 Degree. On 25-MAR-2021, the subject experienced shallow breathing. On 25-MAR-2021, the subject experienced eyes hurt when touched. On 25-MAR-2021, the subject experienced felt medication going in. On 25-MAR-2021, the subject experienced shakiness. On 25-MAR-2021, the subject experienced very weak, could hardly get to bed. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021 18:30, the subject experienced pain in left knee. On 25-MAR-2021 19:30, the subject experienced felt cold and said she was freezing. On 26-MAR-2021, the subject experienced hallucination. On 26-MAR-2021, the subject experienced low blood sugar. On 26-MAR-2021, the subject experienced vomited. On 26-MAR-2021, the subject experienced peed on herself. On 26-MAR-2021, the subject experienced a lot of gas. On 26-MAR-2021, the subject experienced nauseated. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021 01:00, the subject experienced almost passed out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt medication going in, peed on herself, shakiness, a lot of gas, pain in left knee, and nauseated on 26-MAR-2021, was recovering from felt cold and said she was freezing, very weak, could hardly get to bed, almost passed out, and fever, had not recovered from headache, and eyes hurt when touched, and the outcome of vomited, shallow breathing, hallucination and low blood sugar was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354256-JANSSEN COVID-19 VACCINE Ad26.COV2. S- Hallucination. This event is considered not related. The event 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 than the drug. Specifically: Medical History of Depression.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Flatulence, Hallucination, Headache, Hypopnoea
Clinical narrative: ALMOST PASSED OUT; LOW BLOOD SUGAR; A LOT OF GAS; VOMITED; PEED ON HERSELF; NAUSEATED; HALLUCINATION; FEVER; FELT COLD AND SAID SHE WAS FREEZING; PAIN IN LEFT KNEE; VERY WEAK, COULD HARDLY GET TO BED; EYES HURT WHEN TOUCHED; FELT MEDICATION GOING IN; SHALLOW BREATHING; HEADACHE; SHAKINESS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes and depression, 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 Degree. On 25-MAR-2021, the subject experienced shallow breathing. On 25-MAR-2021, the subject experienced eyes hurt when touched. On 25-MAR-2021, the subject experienced felt medication going in. On 25-MAR-2021, the subject experienced shakiness. On 25-MAR-2021, the subject experienced very weak, could hardly get to bed. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021 18:30, the subject experienced pain in left knee. On 25-MAR-2021 19:30, the subject experienced felt cold and said she was freezing. On 26-MAR-2021, the subject experienced hallucination. On 26-MAR-2021, the subject experienced low blood sugar. On 26-MAR-2021, the subject experienced vomited. On 26-MAR-2021, the subject experienced peed on herself. On 26-MAR-2021, the subject experienced a lot of gas. On 26-MAR-2021, the subject experienced nauseated. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021 01:00, the subject experienced almost passed out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt medication going in, peed on herself, shakiness, a lot of gas, pain in left knee, and nauseated on 26-MAR-2021, was recovering from felt cold and said she was freezing, very weak, could hardly get to bed, almost passed out, and fever, had not recovered from headache, and eyes hurt when touched, and the outcome of vomited, shallow breathing, hallucination and low blood sugar was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354256-JANSSEN COVID-19 VACCINE Ad26.COV2. S- Hallucination. This event is considered not related. The event 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 than the drug. Specifically: Medical History of Depression.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Nausea, Presyncope, Pyrexia, Tremor
Clinical narrative: ALMOST PASSED OUT; LOW BLOOD SUGAR; A LOT OF GAS; VOMITED; PEED ON HERSELF; NAUSEATED; HALLUCINATION; FEVER; FELT COLD AND SAID SHE WAS FREEZING; PAIN IN LEFT KNEE; VERY WEAK, COULD HARDLY GET TO BED; EYES HURT WHEN TOUCHED; FELT MEDICATION GOING IN; SHALLOW BREATHING; HEADACHE; SHAKINESS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes and depression, 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 Degree. On 25-MAR-2021, the subject experienced shallow breathing. On 25-MAR-2021, the subject experienced eyes hurt when touched. On 25-MAR-2021, the subject experienced felt medication going in. On 25-MAR-2021, the subject experienced shakiness. On 25-MAR-2021, the subject experienced very weak, could hardly get to bed. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021 18:30, the subject experienced pain in left knee. On 25-MAR-2021 19:30, the subject experienced felt cold and said she was freezing. On 26-MAR-2021, the subject experienced hallucination. On 26-MAR-2021, the subject experienced low blood sugar. On 26-MAR-2021, the subject experienced vomited. On 26-MAR-2021, the subject experienced peed on herself. On 26-MAR-2021, the subject experienced a lot of gas. On 26-MAR-2021, the subject experienced nauseated. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021 01:00, the subject experienced almost passed out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt medication going in, peed on herself, shakiness, a lot of gas, pain in left knee, and nauseated on 26-MAR-2021, was recovering from felt cold and said she was freezing, very weak, could hardly get to bed, almost passed out, and fever, had not recovered from headache, and eyes hurt when touched, and the outcome of vomited, shallow breathing, hallucination and low blood sugar was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354256-JANSSEN COVID-19 VACCINE Ad26.COV2. S- Hallucination. This event is considered not related. The event 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 than the drug. Specifically: Medical History of Depression.
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: ALMOST PASSED OUT; LOW BLOOD SUGAR; A LOT OF GAS; VOMITED; PEED ON HERSELF; NAUSEATED; HALLUCINATION; FEVER; FELT COLD AND SAID SHE WAS FREEZING; PAIN IN LEFT KNEE; VERY WEAK, COULD HARDLY GET TO BED; EYES HURT WHEN TOUCHED; FELT MEDICATION GOING IN; SHALLOW BREATHING; HEADACHE; SHAKINESS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes and depression, 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 Degree. On 25-MAR-2021, the subject experienced shallow breathing. On 25-MAR-2021, the subject experienced eyes hurt when touched. On 25-MAR-2021, the subject experienced felt medication going in. On 25-MAR-2021, the subject experienced shakiness. On 25-MAR-2021, the subject experienced very weak, could hardly get to bed. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021 18:30, the subject experienced pain in left knee. On 25-MAR-2021 19:30, the subject experienced felt cold and said she was freezing. On 26-MAR-2021, the subject experienced hallucination. On 26-MAR-2021, the subject experienced low blood sugar. On 26-MAR-2021, the subject experienced vomited. On 26-MAR-2021, the subject experienced peed on herself. On 26-MAR-2021, the subject experienced a lot of gas. On 26-MAR-2021, the subject experienced nauseated. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021 01:00, the subject experienced almost passed out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt medication going in, peed on herself, shakiness, a lot of gas, pain in left knee, and nauseated on 26-MAR-2021, was recovering from felt cold and said she was freezing, very weak, could hardly get to bed, almost passed out, and fever, had not recovered from headache, and eyes hurt when touched, and the outcome of vomited, shallow breathing, hallucination and low blood sugar was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354256-JANSSEN COVID-19 VACCINE Ad26.COV2. S- Hallucination. This event is considered not related. The event 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 than the drug. Specifically: Medical History of Depression.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness
Clinical narrative: LIGHTHEADED; WEAKNESS; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced lightheaded. On 14-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 14-MAR-2021, and had not recovered from weakness, and lightheaded. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Biopsy intestine, Biopsy oesophagus, Feeding disorder, Gait inability
Clinical narrative: LIGHTHEADED; WEAKNESS; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced lightheaded. On 14-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 14-MAR-2021, and had not recovered from weakness, and lightheaded. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal oedema, Hypersomnia, Lethargy, Nausea, Ultrasound abdomen
Clinical narrative: LIGHTHEADED; WEAKNESS; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced lightheaded. On 14-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 14-MAR-2021, and had not recovered from weakness, and lightheaded. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Somnolence
Clinical narrative: GROGGY; HEADACHE PRETTY MUCH THROUGHOUT THE DAY; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced groggy. On 26-MAR-2021, the subject experienced headache pretty much throughout the day. On 26-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from groggy, headache pretty much throughout the day, and soreness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 103F; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included special needs, crohn's disease, cerebral palsy, seizures, gi issues, and bladder issues. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced fever of 103f. Laboratory data included: Body temperature (NR: not provided) 103 F. On 27-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever of 103f on 27-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Swelling face
Clinical narrative: SWELLING OF EYEBROWS; CHILLS; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included blood disorder called mus.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 swelling of eyebrows, chills, fever, fatigue, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of eyebrows, fever, chills, fatigue and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, vaccination site not reported) dose was not reported, administered on 25-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 subject experienced headache. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia
Clinical narrative: TINGLING OF LEFT SIDE OF FACE; REDNESS OF THE LEFT SIDE OF THE FACE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa drugs, non alcohol, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination on left arm in the morning. No concomitant medications were reported. On 27-MAR-2021, the subject experienced tingling of left side of face. On 27-MAR-2021, the subject experienced redness of the left side of the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling of left side of face, and redness of the left side of the face. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: BODY ACHE; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 in left arm for prophylactic vaccination. Concomitant medications included thiamazole for hyperthyroidism. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) NEGATIVE, NEGATIVE, and COVID-19 antigen test (NR: not provided) FALSE POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fatigue. This report was non-serious. This parent/child case is linked to 20210357033.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure via breast milk
Clinical narrative: BODY ACHE; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 in left arm for prophylactic vaccination. Concomitant medications included thiamazole for hyperthyroidism. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) NEGATIVE, NEGATIVE, and COVID-19 antigen test (NR: not provided) FALSE POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fatigue. This report was non-serious. This parent/child case is linked to 20210357033.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, once a total administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210354299.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Exposure via breast milk
Clinical narrative: DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, once a total administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210354299.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fall, Pain in extremity, Tremor
Clinical narrative: DIZZINESS; STARTED WITH SHAKES/TREMOR; RUNS/DIARRHEA; ARM SORENESS; GOT OUT OF BED TOOK 3 STEPS, FELL FORWARD; SAT IN ROCKING CHAIR, CALLED OUT OF WORK, STOOD UP AND WHOLE ROOM STARTED SPINNING; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, one total, administered on 17-MAR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced started with shakes. On 18-MAR-2021, the subject experienced runs. On 18-MAR-2021, the subject experienced arm soreness. On 18-MAR-2021, the subject experienced got out of bed took 3 steps, fell forward. On 18-MAR-2021, the subject experienced sat in rocking chair, called out of work, stood up and whole room started spinning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runs on 18-MAR-2021, was recovering from arm soreness, had not recovered from dizziness, and started with shakes, and the outcome of got out of bed took 3 steps, fell forward and sat in rocking chair, called out of work, stood up and whole room started spinning was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: DIZZINESS; STARTED WITH SHAKES/TREMOR; RUNS/DIARRHEA; ARM SORENESS; GOT OUT OF BED TOOK 3 STEPS, FELL FORWARD; SAT IN ROCKING CHAIR, CALLED OUT OF WORK, STOOD UP AND WHOLE ROOM STARTED SPINNING; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, one total, administered on 17-MAR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced started with shakes. On 18-MAR-2021, the subject experienced runs. On 18-MAR-2021, the subject experienced arm soreness. On 18-MAR-2021, the subject experienced got out of bed took 3 steps, fell forward. On 18-MAR-2021, the subject experienced sat in rocking chair, called out of work, stood up and whole room started spinning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runs on 18-MAR-2021, was recovering from arm soreness, had not recovered from dizziness, and started with shakes, and the outcome of got out of bed took 3 steps, fell forward and sat in rocking chair, called out of work, stood up and whole room started spinning was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: CHILLS; MUSCLE ACHE IN THE BACK AND BILATERAL ARM; FEVER; This spontaneous report received from a patient concerned a 73 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced muscle ache in the back and bilateral arm. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and muscle ache in the back and bilateral arm, and the outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS (WHICH WAS DESCRIBED AS SICKER THAN A DOG); This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sickness (which was described as sicker than a dog). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness (which was described as sicker than a dog) was not reported. This report was non-serious.