chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site mass, Tenderness
Clinical narrative: LUMP AT INJECTION SITE; TENDERNESS AT A POINT IN THE LUMP; This spontaneous report received from a pharmacist concerned a 42 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tenderness at a point in the lump. On 19-MAR-2021, the subject experienced lump at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lump at injection site and tenderness at a point in the lump was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AFTER VACCINATION; 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 was not reported, administered on 20-MAR-2021 to left elbow for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced pain after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain after vaccination was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: HEADACHE; CHILLS; 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 (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, batch number was not reported and has been requested, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The outcome of the headache and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: DIZZY; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced dizzy. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, tiredness and dizzy was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Dizziness, Dyspnoea, Pain in extremity
Clinical narrative: FEEL SLUGGISH; BREATHING KIND OF HEAVY, OUT OF BREATH A LITTLE BIT; DEHYDRATED; TEMPERATURE 98.8; ARM SORENESS; LIGHTHEADED, DIZZINESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate asthma, penicillin allergy, and egg and chicken allergy, and other pre-existing medical conditions included that patient got flu shot in 2011 and had fever afterwards, but usually never gets fevers. patient had allergies (took shots as kid) and stated some complaints "could be pollen". The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 at10:15  in right arm for prophylactic vaccination. Concomitant medications included loratadine. On 29-MAR-2021, the subject experienced lightheaded, dizziness. On 29-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F, 97.1 F. Treatment medications included: paracetamol. On 30-MAR-2021 20:00, the subject experienced temperature 98.8. On an unspecified date, the subject felt sluggish and experienced breathing kind of heavy, out of breath a little bit, and dehydrated. The action taken with covid-19 vaccine was not applicable. The patient recovered from temperature 98.8 on 31-MAR-2021, had not recovered from arm soreness, and the outcome of feel sluggish, lightheaded, dizziness, breathing kind of heavy, out of breath a little bit and dehydrated was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: FEEL SLUGGISH; BREATHING KIND OF HEAVY, OUT OF BREATH A LITTLE BIT; DEHYDRATED; TEMPERATURE 98.8; ARM SORENESS; LIGHTHEADED, DIZZINESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate asthma, penicillin allergy, and egg and chicken allergy, and other pre-existing medical conditions included that patient got flu shot in 2011 and had fever afterwards, but usually never gets fevers. patient had allergies (took shots as kid) and stated some complaints "could be pollen". The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 at10:15  in right arm for prophylactic vaccination. Concomitant medications included loratadine. On 29-MAR-2021, the subject experienced lightheaded, dizziness. On 29-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F, 97.1 F. Treatment medications included: paracetamol. On 30-MAR-2021 20:00, the subject experienced temperature 98.8. On an unspecified date, the subject felt sluggish and experienced breathing kind of heavy, out of breath a little bit, and dehydrated. The action taken with covid-19 vaccine was not applicable. The patient recovered from temperature 98.8 on 31-MAR-2021, had not recovered from arm soreness, and the outcome of feel sluggish, lightheaded, dizziness, breathing kind of heavy, out of breath a little bit and dehydrated was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Injection site pain
Clinical narrative: SEVERE TINNITUS BOTH EARS; STOMACH PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; ARM PAIN ON INJECTION SITE; DIARRHEA; This spontaneous report received from a patient concerned a 54 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 18-MAR-2021, the subject experienced arm pain on injection site. On 24-MAR-2021, the subject experienced severe tinnitus both ears. On 24-MAR-2021, the subject experienced stomach pain. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from stomach pain, diarrhea, chills, fever, arm pain on injection site, and nausea on 2021, and had not recovered from headache, and severe tinnitus both ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Tinnitus
Clinical narrative: SEVERE TINNITUS BOTH EARS; STOMACH PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; ARM PAIN ON INJECTION SITE; DIARRHEA; This spontaneous report received from a patient concerned a 54 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 18-MAR-2021, the subject experienced arm pain on injection site. On 24-MAR-2021, the subject experienced severe tinnitus both ears. On 24-MAR-2021, the subject experienced stomach pain. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from stomach pain, diarrhea, chills, fever, arm pain on injection site, and nausea on 2021, and had not recovered from headache, and severe tinnitus both ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Chills, Computerised tomogram, Computerised tomogram head, Decreased appetite
Clinical narrative: SEVERE TINNITUS BOTH EARS; STOMACH PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; ARM PAIN ON INJECTION SITE; DIARRHEA; This spontaneous report received from a patient concerned a 54 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 18-MAR-2021, the subject experienced arm pain on injection site. On 24-MAR-2021, the subject experienced severe tinnitus both ears. On 24-MAR-2021, the subject experienced stomach pain. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from stomach pain, diarrhea, chills, fever, arm pain on injection site, and nausea on 2021, and had not recovered from headache, and severe tinnitus both ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Gastrointestinal pain
Clinical narrative: SEVERE TINNITUS BOTH EARS; STOMACH PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; ARM PAIN ON INJECTION SITE; DIARRHEA; This spontaneous report received from a patient concerned a 54 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 18-MAR-2021, the subject experienced arm pain on injection site. On 24-MAR-2021, the subject experienced severe tinnitus both ears. On 24-MAR-2021, the subject experienced stomach pain. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from stomach pain, diarrhea, chills, fever, arm pain on injection site, and nausea on 2021, and had not recovered from headache, and severe tinnitus both ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glomerular filtration rate, Headache, Hypotension, Insomnia, Laboratory test
Clinical narrative: SEVERE TINNITUS BOTH EARS; STOMACH PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; ARM PAIN ON INJECTION SITE; DIARRHEA; This spontaneous report received from a patient concerned a 54 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 18-MAR-2021, the subject experienced arm pain on injection site. On 24-MAR-2021, the subject experienced severe tinnitus both ears. On 24-MAR-2021, the subject experienced stomach pain. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from stomach pain, diarrhea, chills, fever, arm pain on injection site, and nausea on 2021, and had not recovered from headache, and severe tinnitus both ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Parosmia, Pyrexia, Tinnitus
Clinical narrative: SEVERE TINNITUS BOTH EARS; STOMACH PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; ARM PAIN ON INJECTION SITE; DIARRHEA; This spontaneous report received from a patient concerned a 54 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 18-MAR-2021, the subject experienced arm pain on injection site. On 24-MAR-2021, the subject experienced severe tinnitus both ears. On 24-MAR-2021, the subject experienced stomach pain. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from stomach pain, diarrhea, chills, fever, arm pain on injection site, and nausea on 2021, and had not recovered from headache, and severe tinnitus both ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Skin induration
Clinical narrative: ARM SWELLING; ARM HARD; ARM PAIN; FATIGUE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced arm swelling. On 31-MAR-2021, the subject experienced arm hard. On 31-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from arm swelling, and arm hard, and the outcome of arm pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; 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: 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 rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nausea, Neck pain
Clinical narrative: NECK PAIN; SICK (AFTER ABOUT 8 HOURS); CHILLS; HIGH FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 40 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) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 11-MAR-2021, the subject experienced neck pain. On 11-MAR-2021, the subject experienced sick (after about 8 hours). On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced high fever. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, chills, high fever, nausea, and headache on 13-MAR-2021, and the outcome of sick (after about 8 hours) was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NECK PAIN; SICK (AFTER ABOUT 8 HOURS); CHILLS; HIGH FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 40 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) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 11-MAR-2021, the subject experienced neck pain. On 11-MAR-2021, the subject experienced sick (after about 8 hours). On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced high fever. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, chills, high fever, nausea, and headache on 13-MAR-2021, and the outcome of sick (after about 8 hours) was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: TIREDNESS; CHILLS; ARM SORENESS; FEVER; ACHINESS; LOW ENERGY LEVEL; This spontaneous report received from a patient concerned a 55 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) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on Left Deltoid. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On MAR-2021, the subject experienced low energy level. On 24-MAR-2021, after 10 hours, the subject experienced achiness about. On 24-MAR-2021,after 12 hours the subject experienced fever. On 25-MAR-2021, after 12 hours the subject experienced chills. On 25-MAR-2021, the subject experienced arm soreness. On 26-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness on 26-MAR-2021, and chills, and fever on 25-MAR-2021, was recovering from tiredness, and arm soreness, and the outcome of low energy level was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: TIREDNESS; CHILLS; ARM SORENESS; FEVER; ACHINESS; LOW ENERGY LEVEL; This spontaneous report received from a patient concerned a 55 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) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on Left Deltoid. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On MAR-2021, the subject experienced low energy level. On 24-MAR-2021, after 10 hours, the subject experienced achiness about. On 24-MAR-2021,after 12 hours the subject experienced fever. On 25-MAR-2021, after 12 hours the subject experienced chills. On 25-MAR-2021, the subject experienced arm soreness. On 26-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness on 26-MAR-2021, and chills, and fever on 25-MAR-2021, was recovering from tiredness, and arm soreness, and the outcome of low energy level was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; TIRED FOR 2 DAYS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, and tired for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and tired for 2 days was not reported. This report was non-serious. This case, from the same reporter is linked to 20210356458.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose abnormal
Clinical narrative: BLOOD SUGAR ISSUES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced blood sugar issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar issues was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 subject experienced fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache
Clinical narrative: POUNDING HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. 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: 1805022, and expiry: not reported) dose was not reported, administered on 30-MAR-2021 to right arm at 11:45 AM for prophylactic vaccination. On 31-MAR-2021, the subject experienced pounding headache. Laboratory data included: Body temperature (NR: not provided) high temp of 101.4 (units unspecified), low asw 100.1 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pounding headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: FLOATERS IN EYE; This spontaneous report received from a health care professional 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced floaters in eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of floaters in eye was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: REFROZEN VACCINE ADMINSITERED TO MULTIPLE PATIENTS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The batch number was not reported and has been requested. On an unspecified date, the subject experienced refrozen vaccine administered to multiple subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of refrozen vaccine administered to multiple patients was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dysphonia, Headache, Oropharyngeal pain
Clinical narrative: SORE THROAT; HOARSE VOICE; CHILLS; FEVER; HEADACHE; ACHES; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced aches. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. On 20-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 F. On 30-MAR-2021, the subject experienced sore throat. On 30-MAR-2021, the subject experienced hoarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, fever, and headache on 21-MAR-2021, and had not recovered from sore throat, and hoarse voice. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SORE THROAT; HOARSE VOICE; CHILLS; FEVER; HEADACHE; ACHES; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced aches. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. On 20-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 F. On 30-MAR-2021, the subject experienced sore throat. On 30-MAR-2021, the subject experienced hoarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, fever, and headache on 21-MAR-2021, and had not recovered from sore throat, and hoarse voice. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain lower, Back pain, Polymerase chain reaction
Clinical narrative: LOW ABDOMINAL PAIN; LOW BACK PAIN NEAR SPINE; LOW ABDOMINAL PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, copd, hypertension (htn), alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy and there was 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 31-MAR-2021 09:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative. On 31-MAR-2021 21:30, the subject experienced low abdominal pain. On 31-MAR-2021 21:30, the subject experienced low back pain near spine. On 31-MAR-2021 21:30, the subject experienced low abdominal pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low abdominal pain, low back pain near spine, and low abdominal pressure. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Injection site rash, Pain, Paraesthesia
Clinical narrative: ARM TINGLING; ACHY; BRUISE; SITE GOT RED & BLOTCHY; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported.  Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced arm tingling. On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced bruise. On MAR-2021, the subject experienced site got red & blotchy. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise, and the outcome of site got red & blotchy, arm tingling, tired and achy was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Culture stool, Diarrhoea, Nausea
Clinical narrative: DIARRHEA; NAUSEA; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 390 pounds, and height was 68 inches. The patient's past medical history included benign cranial pherengioma, legally blind, history of multiple shunt revision., sigmoid colostomy, rectal fissure, and neoplasm of unspecified nature of brain, and concurrent conditions included latex allergy, allergy to strawberry, non alcohol user, non smoker, and non drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose, start therapy date were not reported for prophylactic vaccination at right deltoid on approximately 26/Mar/2021. The batch number was not reported and has been requested. Concomitant medications included phenoxymethylpenicillin potassium. On 28-MAR-2021, the subject experienced diarrhea. On 28-MAR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Negative for C-Diff, and Stool culture (NR: not provided) Negative for C-Diff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and nausea on 29-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure, since case assessed as non serious
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Initial insomnia, Injection site pain
Clinical narrative: FELT A LITTLE WEIRD; LITTLE TROUBLE FALLING ASLEEP; FELT SLIGHT WEAK; SORE AT THE SIGHT OF THE NEEDLE STICK; This spontaneous report received from a patient concerned a 71 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: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced felt a little weird. On 15-MAR-2021, the subject experienced little trouble falling asleep. On 15-MAR-2021, the subject experienced felt slight weak. On 15-MAR-2021, the subject experienced sore at the sight of the needle stick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little weird, little trouble falling asleep, felt slight weak, and sore at the sight of the needle stick on 16-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Fatigue, Hypotension, Myalgia
Clinical narrative: LOWER BLOOD PRESSURE; CHEST DISCOMFORT; TIREDNESS; MUSCLE ACHE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced lower blood pressure. On 16-MAR-2021, the subject experienced fatigue. On 16-MAR-2021, the subject experienced chest discomfort. On 16-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower blood pressure, and chest discomfort on MAR-2021, and was recovering from fatigue, and muscle ache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bone marrow oedema, Headache, Occipital neuralgia, Pain, Pyrexia
Clinical narrative: BODY ACHE; NERVE PAIN AT THE OCCIPITAL LOBE; EDEMA AT THE SKULL; HEADACHE; FEVER; 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 back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, frequency 1 total administered on 26-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced nerve pain at the occipital lobe. On 26-MAR-2021, the subject experienced edema at the skull. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, headache, and fever, and had not recovered from nerve pain at the occipital lobe, and edema at the skull. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Palpitations
Clinical narrative: HEART PALPITATIONS OFF AND ON; FEEL LIKE STUFF MOVING AROUND BODY ESPECIALLY IN LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 subject experienced heart palpitations off and on, and feel like stuff moving around body especially in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like stuff moving around body especially in legs, and the outcome of heart palpitations off and on was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: BURNING TOES OF THE LEFT FEET; STINGING TOES OF THE LEFT FEET; This spontaneous report received from a patient concerned a 57 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: 1808978, and expiry: 03-JUN-2021) dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced burning toes of the left feet. On 31-MAR-2021, the subject experienced stinging toes of the left feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning toes of the left feet, and stinging toes of the left feet. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure, since case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Wrong technique in product usage process
Clinical narrative: OFF-LABEL USE; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: 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 subject experienced off-label use, and inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease, Oral discomfort
Clinical narrative: TIREDNESS; BURNING SENSATION IN ROOF OF MOUTH AND ON TONGUE; ACID REFLUX; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included very rare instances of heart burn, but not acid reflux, osteoporosis, high blood pressure, lung cancer, sulfa drug allergy, no alcohol use, and non smoker. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on left arm on 30-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced acid reflux. On 30-MAR-2021 15:00, the subject experienced burning sensation in roof of mouth and on tongue. On 31-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acid reflux on 30-MAR-2021, and had not recovered from burning sensation in roof of mouth and on tongue, and tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHEST PAIN; SHORT OF BREATH; 103 FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced body aches. On 2021, the subject experienced chest pain. On 2021, the subject experienced short of breath. On 2021, the subject experienced 103 fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chest pain, and short of breath on 2021, and 103 fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; LOW FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, low fever, extreme fatigue, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, low fever, extreme fatigue and nausea was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chest discomfort, Dizziness, Ear pruritus
Clinical narrative: DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcoholic, penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient had anaphylaxis with tetanus booster shot 4 years ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 12:18 p.m. vaccinated on left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, and fluticasone propionate for allergy. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced face swelled. On 31-MAR-2021, the subject experienced throat closing. On 31-MAR-2021, the subject experienced chest tightness. On 31-MAR-2021, the subject experienced itch in ear. On 31-MAR-2021, the subject experienced heart beat racing. On 31-MAR-2021, the subject experienced wheezing. On 31-MAR-2021, the subject experienced weakness. Laboratory data included: Blood pressure (NR: not provided) Unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, face swelled, throat closing, chest tightness, heart beat racing, wheezing, and weakness on 31-MAR-2021, and had not recovered from itch in ear. 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