chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: CHEST PAIN; MIGRAINES; STOMACH PAIN; DIARRHEA; SWELLING IN BOTH LEGS; BLURRED VISION; CHILLS; PAIN IN BOTH LEGS; TIRED FEELING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection (twice), and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AZ1A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced chest pain. On 10-MAY-2021, the subject experienced migraines. On 10-MAY-2021, the subject experienced stomach pain. On 10-MAY-2021, the subject experienced diarrhea. On 10-MAY-2021, the subject experienced swelling in both legs. On 10-MAY-2021, the subject experienced blurred vision. On 10-MAY-2021, the subject experienced chills. On 10-MAY-2021, the subject experienced pain in both legs. On 10-MAY-2021, the subject experienced tired feeling. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, migraines, stomach pain, diarrhea, blurred vision, chills, pain in both legs, tired feeling, and nausea on 10-MAY-2021, was recovering from swelling in both legs, and the outcome of 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 assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: CHEST PAIN; MIGRAINES; STOMACH PAIN; DIARRHEA; SWELLING IN BOTH LEGS; BLURRED VISION; CHILLS; PAIN IN BOTH LEGS; TIRED FEELING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection (twice), and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AZ1A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced chest pain. On 10-MAY-2021, the subject experienced migraines. On 10-MAY-2021, the subject experienced stomach pain. On 10-MAY-2021, the subject experienced diarrhea. On 10-MAY-2021, the subject experienced swelling in both legs. On 10-MAY-2021, the subject experienced blurred vision. On 10-MAY-2021, the subject experienced chills. On 10-MAY-2021, the subject experienced pain in both legs. On 10-MAY-2021, the subject experienced tired feeling. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, migraines, stomach pain, diarrhea, blurred vision, chills, pain in both legs, tired feeling, and nausea on 10-MAY-2021, was recovering from swelling in both legs, and the outcome of 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 assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac stress test, Computerised tomogram, Electrocardiogram, Full blood count
Clinical narrative: SORE ARM; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimotos disease, and high cholesterol, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A) 1 total, administered on 11-APR-2021 to right deltoid for prophylactic vaccination.  Concomitant medications included levothyroxine sodium for hashimotos disease.  On 17-APR-2021 one week after vaccination patient's blood pressure was elevated. On 18-APR-2021, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 155/90. On 20-APR-2021, the patient was taken to emergency room for high blood pressure of 208/153. Patient was continuously monitoring her blood pressure. Laboratory data included: Blood pressure (NR: not provided) 135/88, 208/153, CBC (complete blood count) (NR: not provided) Normal, CT (computed tomography) scan (NR: not provided) Normal, and EKG (electrocardiography ) (NR: not provided) Normal. On an unspecified date, the patient experienced sore arm. Laboratory data (dates unspecified) included: Stress test (NR: not provided) Normal.  On 21-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 180/110.  Treatment medications (dates unspecified) included: clonidine, losartan, and amlodipine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood pressure, and sore arm. This report was serious (Other Medically Important Condition).  Additional information was received via on 11-MAY-2021. The following information was updated and incorporated into the case narrative: Laboratory data was updated.; Sender's Comments: V0. 20210518309-COVID-19 VACCINE AD26.COV2.S-ELEVATED BLOOD PRESSURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY -  hashimoto's disease, high cholesterol
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain in extremity
Clinical narrative: SORE ARM; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimotos disease, and high cholesterol, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A) 1 total, administered on 11-APR-2021 to right deltoid for prophylactic vaccination.  Concomitant medications included levothyroxine sodium for hashimotos disease.  On 17-APR-2021 one week after vaccination patient's blood pressure was elevated. On 18-APR-2021, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 155/90. On 20-APR-2021, the patient was taken to emergency room for high blood pressure of 208/153. Patient was continuously monitoring her blood pressure. Laboratory data included: Blood pressure (NR: not provided) 135/88, 208/153, CBC (complete blood count) (NR: not provided) Normal, CT (computed tomography) scan (NR: not provided) Normal, and EKG (electrocardiography ) (NR: not provided) Normal. On an unspecified date, the patient experienced sore arm. Laboratory data (dates unspecified) included: Stress test (NR: not provided) Normal.  On 21-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 180/110.  Treatment medications (dates unspecified) included: clonidine, losartan, and amlodipine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood pressure, and sore arm. This report was serious (Other Medically Important Condition).  Additional information was received via on 11-MAY-2021. The following information was updated and incorporated into the case narrative: Laboratory data was updated.; Sender's Comments: V0. 20210518309-COVID-19 VACCINE AD26.COV2.S-ELEVATED BLOOD PRESSURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY -  hashimoto's disease, high cholesterol
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose, start therapy date were not reported for prophylactic vaccination. Batch number is not reported but a follow-up will be requested. Concomitant medications included Prednisone for drug used for unknown indication.  On an unspecified date, the subject experienced confirmed immunological vaccine failure. The patient called the physician to inform that she did not have any issues in tolerating the vaccine but was concerned that the immunization did not happen. She also mentioned that she did couple of antibody tests after 6 weeks from the day of vaccination and found out that the results were negative. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Results were negative. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of confirmed immunological vaccine failure was unknown. This report is serious (confirmed immunological vaccine failure). This report was associated with product quality complaint: 90000179026; Sender's Comments: V0;20210518327-covid-19 vaccine ad26.cov2.-confirmed immunological vaccine failure. This events 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: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, SARS-CoV-2 test, Suspected COVID-19, Syncope
Clinical narrative: FAINTED; EARACHE IN BOTH EARS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a female patient of unspecified age. The patient's weight, height, and medical history were not reported. 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,1 total, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, COVID-19 virus test confirmed Suspected COVID-19 infection. On an unspecified date, the patient experienced earache in both ears, fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the earache in both ears, fainted and Suspected COVID-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518581- covid-19 vaccine ad26.cov2.s -Fainted. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 antibody test, Somnolence, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SLEEPY; PAIN AT INJECTION SITE; This spontaneous report received from a pharmacist concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: unknown) dose, start therapy date were not reported, 1 total administrated to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient received the covid-19 vaccine around 2 months ago. At the same day of vaccination, she felt sleepy and slept for about 1 to 2 hours. One week after the vaccination she also had pain at injection site. On 06-MAY-2021, she did an COVID-19 antibody test and the result came negative (coded as confirmed immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, and the outcome of pain at injection site and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179322. The suspected product quality complaint has been confirmed to be non-voided (The reported allegation could not be confirmed. A manufacturing related root cause could not be identified). based on the PQC evaluation/investigation performed. This case, from the same reporter was linked to 20210519950.; Sender's Comments: V0:20210519895-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine failure . 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: SPECIAL SITUATIONS
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a pharmacist concerned a 26 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient had no known drug allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: unknown) dose was not reported, 1 total dose, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date (after vaccination), the patient experienced blood clot. The pharmacist thought, that she has been treated, and at the time of this report she was at home, but he was not 100% sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522731-Covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS IN LEFT LEG; BLOOD CLOTS IN BOTH LUNGS; This spontaneous report received from a patient via social media 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 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient reports that 3 weeks later(after vaccination) on an unspecified date APR-2021, the patient was in urgent care with blood clots in left leg and blood clots in both lungs. The patient also reports that she was literally headed to her 1 week follow up when it was flashed on the news about blood clots. And reports that since month she was on very expensive unspecified medication, injection and pills and also undergone unspecified labs and diagnostics. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in left leg and blood clots in both lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210523088-covid-19 vaccine ad26.cov2.s-Blood clots in left leg, blood clots in both 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).
Sex: U
Vaccine: COVID19
Symptoms: Blood test, International normalised ratio, International normalised ratio decreased, Platelet disorder
Clinical narrative: BLOOD PLATELETS ENLARGED; INR DROPPED FROM 2.3 TO 1.6.; 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 genetic blood clotting factor 5d.T he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin for genetic blood clotting factor 5d.  On an unspecified date, the subject experienced blood platelets enlarged, and inr dropped from 2.3 to 1.6. Laboratory data (dates unspecified) included: Blood test (NR: not provided) blood platelets are enlarge, and INR (NR: not provided) INR DROPPED FROM 2.3 TO 1.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood platelets enlarged and inr dropped from 2.3 to 1.6. was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: HOT FLASHES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included hot flashes, and concurrent conditions included menopause.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, administered on 30-APR-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 hot flashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: LOSS OF APPETITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and cigarette smoker (half pack of cigarettes a day), and other pre-existing medical conditions included no medical history. The patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-MAY-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, SARS-CoV-2 test
Clinical narrative: STOMACH PAINS; This spontaneous report received from a patient concerned a 29-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 11-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 13-MAY-2021, the subject experienced stomach pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pains. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site pain, Pyrexia
Clinical narrative: CHILLS; FEVER; INJECTION SITE PAIN LEFT ARM; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. 's medical history patient gave tylenol 500mg (a total of 2 tablets were given in the past day, 1 at 9am and 1 at 2am).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 12-MAY-2021 13:00 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced injection site pain left arm. Laboratory data included: Body temperature (NR: not provided) 99.4 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and injection site pain left arm. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a consumer concerned a 59 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: Unknown) dose was not reported, administered on 09-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 APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 27 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included covid-19 vaccine for prophylactic vaccination.  On an unspecified date, the subject experienced inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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: unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: MEDICATION ERROR; GIVEN  EXPIRED DOSE; This spontaneous report received from a pharmacist concerned a 49 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 and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced medication error, and given expired dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and given expired dose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: MEDICATION ERROR; GIVEN  EXPIRED DOSE; This spontaneous report received from a pharmacist concerned a 49 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 and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced medication error, and given expired dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error and given expired dose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product temperature excursion issue
Clinical narrative: JANSSEN VACCINE ADMINISTERED PAST ITS TEMPERATURE EXCURSION; POOR QUALITY DRUG ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned an adult 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 janssen vaccine administered past its temperature excursion, poor quality drug administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen vaccine administered past its temperature excursion, off label use and poor quality drug administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Oropharyngeal pain
Clinical narrative: SORE THROAT; LEFT EYE PAIN; LEFT EYE SWELLING UPTO EYEBROWS / FELT LIKE IT WAS SEALED SHUT; This spontaneous report received from a patient concerned a 50 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: 202A21A, and batch number: 205AZIA expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced left eye pain. On MAY-2021, the subject experienced left eye swelling up to eyebrows / felt like it was sealed shut. On 11-MAY-2021, the subject experienced sore throat. Treatment medications (dates unspecified) included: sodium chloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye pain, sore throat, and left eye swelling up to eyebrows / felt like it was sealed shut. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case.No concomitant medications were reported. On 02-MAY-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick on 08-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210527035.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: FEELING BAD; FEVER; This spontaneous report received from a consumer via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feeling bad, and fever. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of feeling bad was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: PRODUCT OPENED ON PREVIOUS DAY OF REPORTING WAS LEFT IN THE FRIDGE AND USED ON NEXT DAY; This spontaneous report received from a pharmacist concerned a 66 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: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced product opened on previous day of reporting was left in the fridge and used on next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product opened on previous day of reporting was left in the fridge and used on next day was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PRODUCT OPENED ON PREVIOUS DAY OF REPORTING WAS LEFT IN THE FRIDGE AND USED ON NEXT DAY; This spontaneous report received from a pharmacist concerned a 66 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: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced product opened on previous day of reporting was left in the fridge and used on next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product opened on previous day of reporting was left in the fridge and used on next day was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache
Clinical narrative: LIGHT HEADACHE; POSSIBLE ANXIETY; This spontaneous report received from a patient concerned a 29 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: 201A201A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced possible anxiety. On 13-MAY-2021, the subject experienced light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headache and possible anxiety was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; SORENESS AT AROUND INJECTION SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 140 pounds, and height was 65 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced sore arm. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced soreness at around injection site.  Treatment medications (dates unspecified) included: Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, was recovering from sore arm, and the outcome of soreness at around injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Thrombosis
Clinical narrative: LEG CLOT; SICK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported ,1 in total administered 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 experienced leg clot and sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg clot and sick was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210526445 and 20210525676.; Sender's Comments: V0:20210526416  -Covid-19 vaccine ad26.cov2.s- Thrombosis - This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: NOSEBLEED THIS AM FROM 0700 - 0715H.  ONE EPISODE; HEADACHE - FRONT OF HEAD CONSTANT TODAY; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney stones, and on birth control, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not had no known drug allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced headache - front of head constant today. On an unspecified date, the subject experienced nosebleed this am from 0700 - 0715h. one episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache - front of head constant today, and the outcome of nosebleed this am from 0700 - 0715h. one episode was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer concerned a 57 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, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 09-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry mouth, Dysgeusia, Fatigue, Headache
Clinical narrative: TROUBLE TO MOVE HEAD AND ARM; JOINT PAIN; MUSCLE PAIN; TIREDNESS; HEADACHE; DRY MOUTH; BITTER TASTE; This spontaneous report received from a patient concerned a 53 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: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced dry mouth. On 06-MAY-2021, the subject experienced bitter taste. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced trouble to move head and arm. On 07-MAY-2021, the subject experienced joint pain. On 07-MAY-2021, the subject experienced muscle pain. On 07-MAY-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: naproxen sodium, and cyclobenzaprine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, headache, dry mouth, bitter taste, tiredness, and joint pain, and the outcome of trouble to move head and arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia
Clinical narrative: TROUBLE TO MOVE HEAD AND ARM; JOINT PAIN; MUSCLE PAIN; TIREDNESS; HEADACHE; DRY MOUTH; BITTER TASTE; This spontaneous report received from a patient concerned a 53 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: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced dry mouth. On 06-MAY-2021, the subject experienced bitter taste. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced trouble to move head and arm. On 07-MAY-2021, the subject experienced joint pain. On 07-MAY-2021, the subject experienced muscle pain. On 07-MAY-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: naproxen sodium, and cyclobenzaprine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, headache, dry mouth, bitter taste, tiredness, and joint pain, and the outcome of trouble to move head and arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Injection site pain, Malaise
Clinical narrative: MINOR SHORTNESS OF BREATH SIX HOURS AFTER THE SHOT; 16 HOURS AFTER SHOT WITH 5 HOURS SLEEP GENERAL FEELING NOT QUITE WELL/ TIRED; EXTREME FATIGUE/TIREDNESS 1 HOUR AFTER THE SHOT FOR 2 HOURS THAT FELT LIKE BEING DRUGGED TO PUT TO SLEEP; MINIMAL SORENESS AT THE VACCINATION SITE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced minor shortness of breath six hours after the shot, 16 hours after shot with 5 hours sleep general feeling not quite well/ tired, extreme fatigue/tiredness 1 hour after the shot for 2 hours that felt like being drugged to put to sleep, and minimal soreness at the vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor shortness of breath six hours after the shot, 16 hours after shot with 5 hours sleep general feeling not quite well/ tired, extreme fatigue/tiredness 1 hour after the shot for 2 hours that felt like being drugged to put to sleep, and minimal soreness at the vaccination site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness exertional, Fatigue, Headache
Clinical narrative: EXTREME DIZZINESS UPON EXERTION; LOSS OF APPETITE; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Q07AQ1A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 13:00  for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced fatigue. On 05-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.1 F. On 07-MAY-2021, the subject experienced extreme dizziness upon exertion. On 07-MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from fatigue, headache, loss of appetite, and extreme dizziness upon exertion. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: EXTREME DIZZINESS UPON EXERTION; LOSS OF APPETITE; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Q07AQ1A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 13:00  for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced fatigue. On 05-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.1 F. On 07-MAY-2021, the subject experienced extreme dizziness upon exertion. On 07-MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from fatigue, headache, loss of appetite, and extreme dizziness upon exertion. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: LIGHTHEADED; HEADACHE THAT GOES FROM NECK AROUND THE SKULL, AROUND FACE AND HAIR AREA; NAUSEA; FATIGUE; DOESN'T FEEL LIKE HERSELF; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced doesn't feel like herself. On 13-MAY-2021, the subject experienced lightheaded. On 13-MAY-2021, the subject experienced headache that goes from neck around the skull, around face and hair area. On 13-MAY-2021, the subject experienced nausea. On 13-MAY-2021, the subject experienced fatigue. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and lightheaded, had not recovered from headache that goes from neck around the skull, around face and hair area, and fatigue, and the outcome of doesn't feel like herself was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold
Clinical narrative: STUFFINESS FEELING LIKE A COLD; SORE SHOULDER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: MSL-319813 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore shoulder. On 06-MAR-2021, the subject experienced stuffiness feeling like a cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from stuffiness feeling like a cold on 08-MAR-2021, and sore shoulder on 09-MAR-2021. This report was non-serious.