chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient had done antibody test 3 times on 16-JUN-2021, 13-JUL-2021, 11-AUG-2021 respectively and the results was negative for all the tests (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirm immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000189404; Sender's Comments: V0: 20210824390-covid-19 vaccine ad26.cov2.s-confirm 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: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed with the additional information received on 13-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter called to report about male who she knew was vaccinated with Janssen COVID-19 vaccine and was sick with COVID after being vaccinated (suspected clinical vaccination failure, and suspected COVID-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189628. This case, from the same reporter is linked to 20210824895 and 20210821314.; Sender's Comments: V0: 20210824869-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination 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: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Sluggishness
Clinical narrative: SLUGGISHNESS; GENERAL PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 experienced sluggishness, general pain, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, general pain, headache, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age.   The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, with frequency as 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  In Aug-2021, the patient reported that he recently had an antibody test and the result showed no antibody in his body. Laboratory data included: COVID-19 antibody test (NR: not provided) No antibody. (coded as confirmed immunological vaccine failure). 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: V0.20210825088-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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Oropharyngeal pain, Pain assessment, Pain in extremity
Clinical narrative: SORE THROAT WITHOUT REDNESS OR WHITE PATCHES; SORE LEFT ARM WITHOUT REDNESS AND SWELLING; ARM FELT HEAVY; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 145 pounds, and height was 66 inches. The patient's concurrent conditions included: hypothyroidism, hypertension, sleep apnea, latex allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination, 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: 1820096, expiry: 21-OCT-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced sore left arm without redness and swelling. On 11-AUG-2021, the patient experienced arm felt heavy. Laboratory data included: Pain scale (NR: not provided) 9/10. On 12-AUG-2021, the patient experienced sore throat without redness or white patches. Laboratory data included: Pain scale (NR: not provided) 2-3/10, 4/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore left arm without redness and swelling, had not recovered from sore throat without redness or white patches, and the outcome of arm felt heavy was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Eczema, Headache, Insomnia, Lethargy
Clinical narrative: ECZEMA FLARES ON BACK, ARMS (USUALLY ONLY SMALL SPOTS); 5 ENLARGED/INFLAMED LYMPH NODES IN CHEST; BAD HEADACHE FELT LIKE HORSE KICKED IN HEAD; COULD NOT SLEEP; FELT LETHARGIC; MINIMAL SORENESS IN ARM; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's past medical history included: testicular cancer, and radical orchiectomy, and concurrent conditions included: hyper immune system, eczema, alcoholic, and non-smoker, and other pre-existing medical conditions included: The patient did not have any history of 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: 1805020, expiry: 31-MAR-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for eczema. On 01-APR-2021, the patient experienced could not sleep. On 01-APR-2021, the patient experienced felt lethargic. On 01-APR-2021, the patient experienced minimal soreness in arm. On 01-APR-2021, the patient experienced bad headache felt like horse kicked in head. On 19-MAY-2021, the patient experienced 5 enlarged/inflamed lymph nodes in chest. Laboratory data included: CT scan (NR: not provided) 5 enlarged lymph gland nodes in chest. On 22-JUL-2021, Laboratory data included: PET scan (NR: not provided) lymph nodes hot, extremely active. On an unspecified date, the patient experienced eczema flares on back, arms (usually only small spots). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, felt lethargic, minimal soreness in arm, and bad headache felt like horse kicked in head on 03-APR-2021, and had not recovered from 5 enlarged/inflamed lymph nodes in chest, and eczema flares on back, arms (usually only small spots). This report was non-serious. This case, from the same reporter is linked to 20210826152.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Positron emission tomogram
Clinical narrative: ECZEMA FLARES ON BACK, ARMS (USUALLY ONLY SMALL SPOTS); 5 ENLARGED/INFLAMED LYMPH NODES IN CHEST; BAD HEADACHE FELT LIKE HORSE KICKED IN HEAD; COULD NOT SLEEP; FELT LETHARGIC; MINIMAL SORENESS IN ARM; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's past medical history included: testicular cancer, and radical orchiectomy, and concurrent conditions included: hyper immune system, eczema, alcoholic, and non-smoker, and other pre-existing medical conditions included: The patient did not have any history of 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: 1805020, expiry: 31-MAR-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for eczema. On 01-APR-2021, the patient experienced could not sleep. On 01-APR-2021, the patient experienced felt lethargic. On 01-APR-2021, the patient experienced minimal soreness in arm. On 01-APR-2021, the patient experienced bad headache felt like horse kicked in head. On 19-MAY-2021, the patient experienced 5 enlarged/inflamed lymph nodes in chest. Laboratory data included: CT scan (NR: not provided) 5 enlarged lymph gland nodes in chest. On 22-JUL-2021, Laboratory data included: PET scan (NR: not provided) lymph nodes hot, extremely active. On an unspecified date, the patient experienced eczema flares on back, arms (usually only small spots). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, felt lethargic, minimal soreness in arm, and bad headache felt like horse kicked in head on 03-APR-2021, and had not recovered from 5 enlarged/inflamed lymph nodes in chest, and eczema flares on back, arms (usually only small spots). This report was non-serious. This case, from the same reporter is linked to 20210826152.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: JOINT PAIN; FEVER; HEADACHE/LIGHT HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 patient experienced joint pain, fever, and headache/light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and joint pain, and had not recovered from headache/light headache. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Influenza like illness, Laboratory test interference, Ventricular extrasystoles
Clinical narrative: PREMATURE VENTRICULAR CONTRACTIONS (PVCS); FLU LIKE SYMPTOMS; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight was 135 pounds, and height was 154.94 centimeter. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient reported no history of injuries and surgeries. No known drug allergies reported. No drug abuse or illicit usage 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced flu like symptoms. On 31-JUL-2021, the patient experienced premature ventricular contractions (pvcs). On AUG-2021, Laboratory data included: Laboratory test interference NOS (NR: not provided) Negative. On 02-AUG-2021, Laboratory data included: Electrocardiogram (NR: not provided) PVC (Premature ventricular contraction). On 03-AUG-2021, Laboratory data included: Blood test (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) PVC (Premature ventricular contraction). On 11-AUG-2021, Laboratory data included: Electrocardiogram (NR: not provided) PVC (Premature ventricular contraction). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and had not recovered from premature ventricular contractions (pvcs). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: ARM STIFFNESS AROUND INJECTION SITE; SORE ARM AROUND INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-AUG-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 10-AUG-2021, the patient experienced arm stiffness around injection site. On 10-AUG-2021, the patient experienced sore arm around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm around injection site and arm stiffness around injection site was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Antibody test, Dysstasia
Clinical narrative: TOES ARE STIFF; COULD NOT WALK FOR MORE THAN 2 BLOCKS; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DISCOMFORT IN STOMACH; PAIN IN LEGS; DISCOMFORT IN LEGS; STOMACH WAS SWELLED UP AND WAS VERY BIG AND FELT LIKE WAS 6 MONTHS PREGNANT; PAIN IN STOMACH; COULD NOT STAND UP FOR MORE THAN 2 MINUTES; This spontaneous report received from a consumer concerned a 66 year old female. 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, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, 3 days after the vaccination, the patient felt discomfort and pain in legs and in stomach. The patient's stomach was swelled up and was very big and felt like the patient was 6 months pregnant. The patient had a lot of pain in legs and could not stand up for a long time, not more than 2 minutes. The patient went to a PCP (primary care physician) for a check-up. Patient's legs were in a very bad condition and after 2 months and a half, patient could not walk for more than 2 blocks. When patient squad on the floor, it became very difficult to stand up as legs hurt. Patient's leg discomfort was better but still legs from knees down sometimes felt bad and toes were stiff and it hurt. The patient's stomach was less swollen and was recovering. Physician of the patient ordered an antibodies test on unspecified date in Apr-2021, after a month and a half of vaccination and it was negative (confirmed immunological vaccine failure). On 06-AUG-2021, the patient again underwent the antibody test and the result was negative. The patient did not know what type of antibody test the doctor preformed but it was a blood test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach was swelled up and was very big and felt like was 6 months pregnant, and discomfort in legs, and the outcome of toes are stiff, pain in legs, confirmed immunological vaccine failure, pain in stomach, could not stand up for more than 2 minutes, could not walk for more than 2 blocks and discomfort in stomach was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210826244-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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Limb discomfort, Musculoskeletal stiffness, Pain in extremity, Therapy non-responder
Clinical narrative: TOES ARE STIFF; COULD NOT WALK FOR MORE THAN 2 BLOCKS; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DISCOMFORT IN STOMACH; PAIN IN LEGS; DISCOMFORT IN LEGS; STOMACH WAS SWELLED UP AND WAS VERY BIG AND FELT LIKE WAS 6 MONTHS PREGNANT; PAIN IN STOMACH; COULD NOT STAND UP FOR MORE THAN 2 MINUTES; This spontaneous report received from a consumer concerned a 66 year old female. 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, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, 3 days after the vaccination, the patient felt discomfort and pain in legs and in stomach. The patient's stomach was swelled up and was very big and felt like the patient was 6 months pregnant. The patient had a lot of pain in legs and could not stand up for a long time, not more than 2 minutes. The patient went to a PCP (primary care physician) for a check-up. Patient's legs were in a very bad condition and after 2 months and a half, patient could not walk for more than 2 blocks. When patient squad on the floor, it became very difficult to stand up as legs hurt. Patient's leg discomfort was better but still legs from knees down sometimes felt bad and toes were stiff and it hurt. The patient's stomach was less swollen and was recovering. Physician of the patient ordered an antibodies test on unspecified date in Apr-2021, after a month and a half of vaccination and it was negative (confirmed immunological vaccine failure). On 06-AUG-2021, the patient again underwent the antibody test and the result was negative. The patient did not know what type of antibody test the doctor preformed but it was a blood test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach was swelled up and was very big and felt like was 6 months pregnant, and discomfort in legs, and the outcome of toes are stiff, pain in legs, confirmed immunological vaccine failure, pain in stomach, could not stand up for more than 2 minutes, could not walk for more than 2 blocks and discomfort in stomach was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210826244-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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nucleic acid test, SARS-CoV-2 RNA, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: Nucleic acid amplification test (NR: not provided) positive, SARS-CoV-2 RNA (NR: not provided) positive, and SARS-CoV-2 RT-PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Decreased appetite, Fatigue
Clinical narrative: TIRED; DID NOT FEEL HUNGRY/APPETITE SUPPRESSION; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes type 2, osteoarthritis, and clogged arteries, and other pre-existing medical conditions included: Patient had no fever, no diarrhea and no stomach pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced did not feel hungry/appetite suppression. On 08-APR-2021, the patient experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, and Body temperature (NR: not provided) under 98 and normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel hungry/appetite suppression, and tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Dysgeusia, Pyrexia, Taste disorder
Clinical narrative: BEDRIDDEN FOR TWO DAYS; METALLIC COPPERY TASTE; EGGS PORK AND CHICKCEN TASTE AWFUL; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 an unspecified date, the patient experienced bedridden for two days, metallic coppery taste, eggs pork and chickcen taste awful, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, bedridden for two days, metallic coppery taste and eggs pork and chickcen taste awful was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; 104 FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and 104 fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 104. The action taken with covid-19 vaccine was not applicable. The patient was recovering from 104 fever, and the outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast swelling, Chills, Dysmenorrhoea, Hypoaesthesia
Clinical narrative: SEVERE BODY ACHES; BOOBS GOT BIGGER; PAINFUL PERIOD; NUMBNESS IN ARM; MILD PAIN IN ARM; CHILLS; JOINT PAIN; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced severe body aches, boobs got bigger, painful period, numbness in arm, mild pain in arm, chills, joint pain, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild pain in arm, severe body aches, and joint pain, and the outcome of chills, mild fever, boobs got bigger, painful period and numbness in arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: SEVERE BODY ACHES; BOOBS GOT BIGGER; PAINFUL PERIOD; NUMBNESS IN ARM; MILD PAIN IN ARM; CHILLS; JOINT PAIN; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced severe body aches, boobs got bigger, painful period, numbness in arm, mild pain in arm, chills, joint pain, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild pain in arm, severe body aches, and joint pain, and the outcome of chills, mild fever, boobs got bigger, painful period and numbness in arm was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: ARM HURT / PAIN AT THE ARM; DIARRHEA; MINOR FEVER; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: breast cancer, and mastectomy. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient experienced arm hurt / pain at the arm. On 10-APR-2021, the patient experienced diarrhea. On 10-APR-2021, the patient experienced minor fever. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt / pain at the arm, diarrhea, and minor fever on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chromaturia, Ear irrigation, Faeces discoloured
Clinical narrative: HEAVY POST NASAL DRIP; HEAVY NIGHT SWEATING; TINNITUS IN HEARING; LITTLE TO NO PAIN IN THE INJECTION SITE MUSCLE; TEMPERATURE 97.6 BEFORE AND AFTER DAYS OF SHOT; LOST 4LBS (POUNDS); INJECTION SITE MUSCLE FIRM AND HARD; HEAR VERY FAINT THINGS NOW; EARS FEEL LIKE THEY WERE  ALWAYS DRAINING; URINE DARK; STOOL DARK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced lost 4lbs (pounds). On AUG-2021, the patient experienced injection site muscle firm and hard. On AUG-2021, the patient experienced hear very faint things now. On AUG-2021, the patient experienced ears feel like they were always draining. On AUG-2021, the patient experienced urine dark. On AUG-2021, the patient experienced stool dark. On AUG-2021, the patient experienced little to no pain in the injection site muscle. On AUG-2021, the patient experienced temperature 97.6 before and after days of shot. Laboratory data included: Body temperature (NR: not provided) 97.6. On 09-AUG-2021, the patient experienced heavy night sweating. On 09-AUG-2021, the patient experienced heavy post nasal drip. On 09-AUG-2021, the patient experienced tinnitus in hearing. The action taken with covid-19 vaccine was not applicable. The outcome of the heavy night sweating, lost 4lbs (pounds), injection site muscle firm and hard, heavy post nasal drip, tinnitus in hearing, hear very faint things now, ears feel like they were always draining, urine dark, stool dark, little to no pain in the injection site muscle and temperature 97.6 before and after days of shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis, Injection site pain, Injection site reaction, Night sweats, Tinnitus
Clinical narrative: HEAVY POST NASAL DRIP; HEAVY NIGHT SWEATING; TINNITUS IN HEARING; LITTLE TO NO PAIN IN THE INJECTION SITE MUSCLE; TEMPERATURE 97.6 BEFORE AND AFTER DAYS OF SHOT; LOST 4LBS (POUNDS); INJECTION SITE MUSCLE FIRM AND HARD; HEAR VERY FAINT THINGS NOW; EARS FEEL LIKE THEY WERE  ALWAYS DRAINING; URINE DARK; STOOL DARK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced lost 4lbs (pounds). On AUG-2021, the patient experienced injection site muscle firm and hard. On AUG-2021, the patient experienced hear very faint things now. On AUG-2021, the patient experienced ears feel like they were always draining. On AUG-2021, the patient experienced urine dark. On AUG-2021, the patient experienced stool dark. On AUG-2021, the patient experienced little to no pain in the injection site muscle. On AUG-2021, the patient experienced temperature 97.6 before and after days of shot. Laboratory data included: Body temperature (NR: not provided) 97.6. On 09-AUG-2021, the patient experienced heavy night sweating. On 09-AUG-2021, the patient experienced heavy post nasal drip. On 09-AUG-2021, the patient experienced tinnitus in hearing. The action taken with covid-19 vaccine was not applicable. The outcome of the heavy night sweating, lost 4lbs (pounds), injection site muscle firm and hard, heavy post nasal drip, tinnitus in hearing, hear very faint things now, ears feel like they were always draining, urine dark, stool dark, little to no pain in the injection site muscle and temperature 97.6 before and after days of shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome, Weight decreased
Clinical narrative: HEAVY POST NASAL DRIP; HEAVY NIGHT SWEATING; TINNITUS IN HEARING; LITTLE TO NO PAIN IN THE INJECTION SITE MUSCLE; TEMPERATURE 97.6 BEFORE AND AFTER DAYS OF SHOT; LOST 4LBS (POUNDS); INJECTION SITE MUSCLE FIRM AND HARD; HEAR VERY FAINT THINGS NOW; EARS FEEL LIKE THEY WERE  ALWAYS DRAINING; URINE DARK; STOOL DARK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced lost 4lbs (pounds). On AUG-2021, the patient experienced injection site muscle firm and hard. On AUG-2021, the patient experienced hear very faint things now. On AUG-2021, the patient experienced ears feel like they were always draining. On AUG-2021, the patient experienced urine dark. On AUG-2021, the patient experienced stool dark. On AUG-2021, the patient experienced little to no pain in the injection site muscle. On AUG-2021, the patient experienced temperature 97.6 before and after days of shot. Laboratory data included: Body temperature (NR: not provided) 97.6. On 09-AUG-2021, the patient experienced heavy night sweating. On 09-AUG-2021, the patient experienced heavy post nasal drip. On 09-AUG-2021, the patient experienced tinnitus in hearing. The action taken with covid-19 vaccine was not applicable. The outcome of the heavy night sweating, lost 4lbs (pounds), injection site muscle firm and hard, heavy post nasal drip, tinnitus in hearing, hear very faint things now, ears feel like they were always draining, urine dark, stool dark, little to no pain in the injection site muscle and temperature 97.6 before and after days of shot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 103 F ALL DAY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-AUG-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 12-AUG-2021, the patient experienced fever of 103 f all day. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever of 103 f all day. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Nausea
Clinical narrative: DISCOMFORT; TIREDNESS; FEELING MILD NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-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 APR-2021, the patient experienced discomfort. On APR-2021, the patient experienced tiredness. On APR-2021, the patient experienced feeling mild nausea. On APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort, tiredness, feeling mild nausea, and headache on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Myositis, Tendonitis
Clinical narrative: INFLAMMATION IN VARIOUS MUSCLES; INFLAMMATION IN  TENDONS; INFLAMMATION IN JOINTS/INFLAMMATION MOVING AREA TO AREA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced inflammation in various muscles, inflammation in tendons, and inflammation in joints/inflammation moving area to area. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from inflammation in various muscles, inflammation in tendons, and inflammation in joints/inflammation moving area to area. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SYMPTOMS/UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced symptoms/unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms/unspecified adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20210826468.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; FATIGUE; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 patient experienced sore arm, fatigue, and slight fever. The action taken with covid-19 vaccine was not applicable. The outcome of the sore arm, fatigue and slight fever was not reported. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BRUISES ON MIDDLE OF FOREHEAD, EYEBROWS AND LEFT EYE WHICH HURTS; This spontaneous report received from a consumer concerned a 26 year old male. The patient's weight was 180 pounds, and height was 75 inches. The patient's concurrent conditions included: smoker, non-alcohol user, and bipolar, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced bruises on middle of forehead, eyebrows and left eye which hurts. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bruises on middle of forehead, eyebrows and left eye which hurts. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINATION FROM VIAL THAT WAS PUNCTURED LONGER THAN 6 HOURS (25 HOURS); VIAL WAS KEPT IN REFRIGERATOR FOR MORE THAN 6 HOURS AFTER PUNCTURE; This spontaneous report received from a health care professional concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: 21-SEP-2021) dose was not reported, administered on 12-AUG-2021 13:00 for prophylactic vaccination.  No concomitant medications were reported.  On 12-AUG-2021, the patient experienced vaccination from vial that was punctured longer than 6 hours (25 hours). On 12-AUG-2021, the patient experienced vial was kept in refrigerator for more than 6 hours after puncture. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccination from vial that was punctured longer than 6 hours (25 hours) and vial was kept in refrigerator for more than 6 hours after puncture was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: FELT A BIT WARM; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 an unspecified date, the patient experienced felt a bit warm, and headache. The action taken with covid-19 vaccine was not applicable. The outcome of the headache and felt a bit warm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: RHABDOMYOLYSIS; This spontaneous report received from a patient of unspecified age and sex with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  About 2 weeks later after vaccination patient had really bad cramps and spasms all over body 4 to 5 times a day. On 12-JUL-2021 patient went to hospital for having cramps like an heart attack. But did not had heart attack. Patient was said it was rhabdomyolysis. Patient had given intravenous fluids. But was still having them in legs, arms butt chest growing area calfs side and back. Pain lasted about 30 mins each time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rhabdomyolysis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210826860-covid-19 vaccine ad26.cov2.s-Rhabdomyolysis. 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: Abdominal pain upper, Asthenia, Body temperature, Decreased appetite, Diarrhoea
Clinical narrative: LOW BLOOD PRESSURE; STOMACH HURTING; DIZZINESS; LETHARGY; NOT EATING WELL; NO APPETITE; DIARRHEA; WEAK; HIGH TEMPERATURE OF 102.1; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lung surgery, hernia surgery, tied tubes, and back surgery, and concurrent conditions included: peripheral artery disease, lung cancer, and seasonal allergy, and other pre-existing medical conditions included: Patient had Imder allergy. The patient experienced drug allergy when treated with clotrimazole, oxycodone hydrochloride/paracetamol, and simvastatin.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 31-JUL-2021, the patient experienced low blood pressure. On 31-JUL-2021, the patient experienced stomach hurting. On 31-JUL-2021, the patient experienced dizziness. On 31-JUL-2021, the patient experienced lethargy. On 31-JUL-2021, the patient experienced not eating well. On 31-JUL-2021, the patient experienced no appetite. On 31-JUL-2021, the patient experienced diarrhea. On 31-JUL-2021, the patient experienced weak. On 31-JUL-2021, the patient experienced high temperature of 102.1. Laboratory data included: Body temperature (NR: not provided) 102.1. The action taken with covid-19 vaccine was not applicable. The outcome of the diarrhea, stomach hurting, low blood pressure, high temperature of 102.1, dizziness, lethargy, not eating well, weak and no appetite was not reported. This report was non-serious. This case, involving the same patient is linked to 20210826468.