chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test, Somnolence, Ultrasound scan
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Electrocardiogram, Heart rate, Hypoaesthesia
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Pulmonary thrombosis, SARS-CoV-2 test, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a 62 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Ultrasound scan
Clinical narrative: BODY ACHES 2 WEEKS AFTER  ADMINISTRATION; LEG PAIN; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-APR-2021, the subject experienced leg pain. On an unspecified date, the subject experienced body aches 2 weeks after administration. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine  was not applicable. The outcome of the leg pain and body aches 2 weeks after administration was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Headache, Hypoaesthesia
Clinical narrative: HEART HURT; FINGERS NUMB ON LEFT SIDE; HEADACHE; This spontaneous report received from a physician via a company representative concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced heart hurt, fingers numb on left side, and headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the heart hurt, fingers numb on left side and headache was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age.  Initial information was processed along with additional information received on 10-MAY-2021. 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 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAY-2021, the patient experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. It was reported that, the patient trying to find out if there was anything else that might need to be done after she recover from Covid and was there any impact on her vaccines effectiveness. She was not fully vaccinated at the time of covid-19 infection due to the timeframes (6 days elapsed between vaccine and test).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178967 The suspected product quality complaint has been confirmed to be voided due to no PQC identified within the complaint record.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: SEQUENTIAL ADMINISTRATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced sequential administration. The action taken with covid-19 vaccine  was not applicable. The outcome of sequential administration was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN LUNG; This spontaneous report received from a patient concerned a male of unspecified age. The reporter obtained the information from news/media. 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had blood clot in lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210519715- covid-19 vaccine ad26.cov2.s - blood clot in lung . This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: Malaise
Clinical narrative: FELT ILL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt ill. The action taken with covid-19 vaccine  was not applicable. The outcome of felt ill was not reported. This report was non-serious. This case, from the same reporter is linked to 20210522019.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKING A LOT; 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  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-MAY-2021 16:00 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 10-MAY-2021, the subject experienced shaking a lot. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The outcome of shaking a lot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous report received from a patient 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 (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 fever, and headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHE OR PAIN; FEVER; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced ache or pain. On 2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever and ache or pain was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: LIGHT HEADED; FATIGUE; WEAK; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816022, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced light headed. On MAY-2021, the subject experienced fatigue. On MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine was not applicable. The outcome of the fatigue, light headed and weak was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Somnolence
Clinical narrative: SLEEPY; This spontaneous report received from a pharmacist concerned a 62 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Positive (units unspecified). On an unspecified date, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy. This report was non-serious. This case, from the same reporter is linked to 20210519895.
Sex: M
Vaccine: COVID19
Symptoms: Injection site hypersensitivity
Clinical narrative: MILD ALLERGIC REACTION AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an elderly male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced mild allergic reaction at the site of injection. The action taken with covid-19 vaccine  was not applicable. The outcome of mild allergic reaction at the site of injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Arthritis
Clinical narrative: LOSS OF TASTE; SUSPECTED ARTHRITIS IN HER KNEES; HIPS ACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis.  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 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On 11-MAY-2021, the subject experienced loss of taste.  On 11-MAY-2021, the subject experienced joint pain. On 11-MAY-2021, the subject experienced knees hurt all the time. On 11-MAY-2021, the subject experienced hips ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, and joint pain, and the outcome of knees hurt all the time and hips ache was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache, Pain in extremity, Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT CALF; PAIN IN ANKLE; PAIN SLOWLY MOVING UP TO THE CALF; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and  expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included blood-pressure pills, water pills and Omega-3. On 02-APR-2021, the patient experienced a slight headache for about 2 days. On 29-APR-2021, the patient  felt some pain in  ankle, which was slowly moving up to the calf (left leg). The patient was brought  to the emergency room, where an ultrasound and blood work was performed. Ultrasound detected a blood clot in her left calf and prescribed with Xarelto daily for 3 months.  Patient stated that pain reached its most intense status on 01-MAY-2021 and is slowly getting better.  Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-APR-2021, was recovering from pain in ankle, and pain moving up to the calf, and had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520686 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Thrombosis. The event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: BLOOD CLOT IN LEFT CALF; PAIN IN ANKLE; PAIN SLOWLY MOVING UP TO THE CALF; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and  expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included blood-pressure pills, water pills and Omega-3. On 02-APR-2021, the patient experienced a slight headache for about 2 days. On 29-APR-2021, the patient  felt some pain in  ankle, which was slowly moving up to the calf (left leg). The patient was brought  to the emergency room, where an ultrasound and blood work was performed. Ultrasound detected a blood clot in her left calf and prescribed with Xarelto daily for 3 months.  Patient stated that pain reached its most intense status on 01-MAY-2021 and is slowly getting better.  Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-APR-2021, was recovering from pain in ankle, and pain moving up to the calf, and had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520686 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Thrombosis. The 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: Pain, Pyrexia, Vomiting
Clinical narrative: ACHY BODY; VOMITED; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced achy body. On MAY-2021, the subject experienced vomited. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, achy body and vomited was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521685.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: ADMINISTRATION ERROR; VIAL LEFT OUTSIDE AT THE ROOM TEMPERATURE FOR 4 HOURS TO VACCINATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced administration error, and vial left outside at the room temperature for 4 hours to vaccinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and vial left outside at the room temperature for 4 hours to vaccinate was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: MAGNET STICKS TO HER ARM; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced magnet sticks to her arm. The action taken with covid-19 vaccine  was not applicable. The outcome of magnet sticks to her arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21B expiry: 21-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a 78 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested.. No concomitant medications were reported. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache. This report was non-serious. This case, involving the same patient is linked to 20210520783
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED VACCINE WAS LEFT AT ROOM TEMPERATURE FOR 4 HOURS; This spontaneous report received from a pharmacist concerned a 21 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced administered vaccine was left at room temperature for 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine was left at room temperature for 4 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210520992.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED VACCINE WAS LEFT AT ROOM TEMPERATURE FOR 4 HOURS; This spontaneous report received from a pharmacist concerned a 21 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: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced administered vaccine was left at room temperature for 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine was left at room temperature for 4 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210520992.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: STRAIT TRIPPING LIKE A SUMMER NIGHT; 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  (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 2021, the subject experienced strait tripping like a summer night. The action taken with covid-19 vaccine was not applicable. The outcome of strait tripping like a summer night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; 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, administered on 09-MAY-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 11-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious. This case, from the same reporter is linked to 20210519757.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS CHANGED IN NATURE; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included tinnitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced tinnitus changed in nature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tinnitus changed in nature. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: UNSTEADY ON HER FEET; DIZZY AND LIGHTHEADED; HEADACHE; VERY FATIGUED; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included consumer was instructed to take hydrate.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Antibody test (NR: not provided) Unknown. On 08-MAY-2021, the subject experienced body aches. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced very fatigued. On 11-MAY-2021, the subject experienced unsteady on her feet. On 11-MAY-2021, the subject experienced dizzy and lightheaded. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, and very fatigued on 09-MAY-2021, and headache on MAY-2021, and had not recovered from dizzy and lightheaded, and unsteady on her feet. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: UNSTEADY ON HER FEET; DIZZY AND LIGHTHEADED; HEADACHE; VERY FATIGUED; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included consumer was instructed to take hydrate.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Antibody test (NR: not provided) Unknown. On 08-MAY-2021, the subject experienced body aches. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced very fatigued. On 11-MAY-2021, the subject experienced unsteady on her feet. On 11-MAY-2021, the subject experienced dizzy and lightheaded. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, and very fatigued on 09-MAY-2021, and headache on MAY-2021, and had not recovered from dizzy and lightheaded, and unsteady on her feet. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: UNSTEADY ON HER FEET; DIZZY AND LIGHTHEADED; HEADACHE; VERY FATIGUED; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included consumer was instructed to take hydrate.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Antibody test (NR: not provided) Unknown. On 08-MAY-2021, the subject experienced body aches. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced very fatigued. On 11-MAY-2021, the subject experienced unsteady on her feet. On 11-MAY-2021, the subject experienced dizzy and lightheaded. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, and very fatigued on 09-MAY-2021, and headache on MAY-2021, and had not recovered from dizzy and lightheaded, and unsteady on her feet. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Labyrinthitis, Nausea, Pain, Physical examination, Vertigo
Clinical narrative: UNSTEADY ON HER FEET; DIZZY AND LIGHTHEADED; HEADACHE; VERY FATIGUED; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included consumer was instructed to take hydrate.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Antibody test (NR: not provided) Unknown. On 08-MAY-2021, the subject experienced body aches. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced very fatigued. On 11-MAY-2021, the subject experienced unsteady on her feet. On 11-MAY-2021, the subject experienced dizzy and lightheaded. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, and very fatigued on 09-MAY-2021, and headache on MAY-2021, and had not recovered from dizzy and lightheaded, and unsteady on her feet. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; 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 expiry: Unknown) dose was not reported, frequency 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAY-2021, the patient experienced confirmed immunological vaccine failure. Patient did the antibody test. Laboratory data included: Immunoglobulin G (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522244-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test negative, Pain, Pyrexia, Vaccination failure
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; 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 expiry: Unknown) dose was not reported, frequency 1 total, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAY-2021, the patient experienced confirmed immunological vaccine failure. Patient did the antibody test. Laboratory data included: Immunoglobulin G (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522244-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea haemorrhagic, Dyspnoea, Fatigue, Flushing
Clinical narrative: FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic gout.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pain in extremity
Clinical narrative: FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic gout.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19/AUG/2021) dose was not reported, administered on 10-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.