chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Hypoaesthesia
Clinical narrative: SLIGHT DIFFICULTY IN BREATHING; DRY COUGH; CHEST TIGHTNESS; ALMOST UNRESPONSIVE AT DINNER TABLE; HIGH LEVEL OF FATIGUE AND SLEPT ALL DAY; NAUSEA; HEADACHE; SLIGHT NUMBNESS TO FACE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery to left foot at late adolescent, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 11:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced slight numbness to face. On 30-MAR-2021, the subject experienced slight difficulty in breathing. On 30-MAR-2021, the subject experienced dry cough. On 30-MAR-2021, the subject experienced chest tightness. On 30-MAR-2021, the subject experienced almost unresponsive at dinner table. On 30-MAR-2021, the subject experienced high level of fatigue and slept all day. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from high level of fatigue and slept all day, dry cough, nausea, headache, chest tightness, slight difficulty in breathing, and almost unresponsive at dinner table, and the outcome of slight numbness to face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: SLIGHT DIFFICULTY IN BREATHING; DRY COUGH; CHEST TIGHTNESS; ALMOST UNRESPONSIVE AT DINNER TABLE; HIGH LEVEL OF FATIGUE AND SLEPT ALL DAY; NAUSEA; HEADACHE; SLIGHT NUMBNESS TO FACE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery to left foot at late adolescent, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 11:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced slight numbness to face. On 30-MAR-2021, the subject experienced slight difficulty in breathing. On 30-MAR-2021, the subject experienced dry cough. On 30-MAR-2021, the subject experienced chest tightness. On 30-MAR-2021, the subject experienced almost unresponsive at dinner table. On 30-MAR-2021, the subject experienced high level of fatigue and slept all day. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from high level of fatigue and slept all day, dry cough, nausea, headache, chest tightness, slight difficulty in breathing, and almost unresponsive at dinner table, and the outcome of slight numbness to face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Nausea, Pain
Clinical narrative: FEVER; NAUSEA; BODY ACHES; CHILLS; MALAISE; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-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 body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced malaise. On MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 approximately. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches, malaise and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; NAUSEA; BODY ACHES; CHILLS; MALAISE; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-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 body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced malaise. On MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 approximately. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches, malaise and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced tiredness.  Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, headache, and tiredness on 30-MAR-2021. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: THE INJECTION WAS BELOW THE STANDARD IM DELTOID AREA, APPROXIMATELY MIDWAY IN ARM (APPROXIMATELY 2 INCHES BELOW THE LOWER DEFINITION OF DELTOID); This spontaneous report received from a health care professional concerned a 66 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 31-MAR-2021 at deltoid area approximately midway in arm (approximately 2 inches below the lower definition of deltoid) for prophylactic vaccination. The batch number was not reported and has been requested.   Concomitant medications included guselkumab for psoriasis. On 31-MAR-2021, the subject experienced the injection was below the standard im deltoid area, approximately midway in arm (approximately 2 inches below the lower definition of deltoid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection was below the standard im deltoid area, approximately midway in arm (approximately 2 inches below the lower definition of deltoid) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 15:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 23:00, the subject experienced chills. On 30-MAR-2021 23:00, the subject experienced fatigue. On 30-MAR-2021 23:00, the subject experienced fever. On an unspecified date, the subject experienced aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, chills, fever and aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: TEMPERATURE OF 99.4; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included RA. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced temperature of 99.4. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.4 F. Treatment medications (dates unspecified) included: celecoxib, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temperature of 99.4 was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Lethargy
Clinical narrative: LETHARGY; DIARRHEA; SORE ARM; MINOR HEADACHE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic anxiety, and depression. 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 25-MAR-2021 for prophylactic vaccination on left deltoid. 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 26-MAR-2021, the subject experienced lethargy. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced sore arm. On 26-MAR-2021, the subject experienced minor headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor headache on MAR-2021, and had not recovered from sore arm, lethargy, and diarrhea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD HEADACHE.; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad headache was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia
Clinical narrative: DID NOT SLEEP; FEELING HOT; This spontaneous report received from a vaccine facility concerned a 42 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included unspecified medical history from military service. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-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 31-MAR-2021, the subject experienced did not sleep. On 31-MAR-2021, the subject experienced feeling hot. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep on 01-APR-2021 and the outcome of feeling hot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Pruritus
Clinical narrative: CRANKY; ITCHING ON OPPOSITE ARM; TIRED; This spontaneous report received from a patient concerned an adult of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-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 22-MAR-2021, the subject experienced cranky. On 22-MAR-2021, the subject experienced itching on opposite arm. On 22-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, cranky and itching on opposite arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: 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 01-APR-2021 for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Aches; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included penicillin allergy, and anaphylactic shock when expose to penicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. the batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210347232. .  .
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Eye pain, Fatigue, Flushing, Headache
Clinical narrative: LOW GRADE FEVER; MINOR OR BRIEF HEADACHES; FATIGUED; FLUSHED; HOT FLASHES; PAIN BEHIND HIS EYES; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. 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 28-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced pain behind his eyes. On MAR-2021, the subject experienced flushed. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced low grade fever. On 29-MAR-2021, the subject experienced minor or brief headaches. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, flushed, hot flashes, fatigued, and minor or brief headaches, and the outcome of pain behind his eyes was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Pyrexia
Clinical narrative: LOW GRADE FEVER; MINOR OR BRIEF HEADACHES; FATIGUED; FLUSHED; HOT FLASHES; PAIN BEHIND HIS EYES; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. 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 28-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced pain behind his eyes. On MAR-2021, the subject experienced flushed. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced low grade fever. On 29-MAR-2021, the subject experienced minor or brief headaches. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, flushed, hot flashes, fatigued, and minor or brief headaches, and the outcome of pain behind his eyes was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain
Clinical narrative: LETHARGY; BODY ACHE; HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported to right deltoid administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced lethargy. On 01-APR-2021, the subject experienced body ache. On 01-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lethargy, body ache, and headache. This report was non-serious.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Nervousness
Clinical narrative: ANXIETY; NERVOUSNESS; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 63 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right deltoid  for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced anxiety. On 31-MAR-2021, the subject experienced nervousness. On 31-MAR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, lightheadedness, and nervousness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vocal cord paralysis
Clinical narrative: VOCAL CORD PARALYSIS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 55 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: 1802072 and  expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 vaccinated on left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced vocal cord paralysis. On 25-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and headache on 28-MAR-2021, and had not recovered from vocal cord paralysis. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; 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) 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 shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: HEADACHE; ARM HURTING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 31-MAR-2021, vaccinated on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and arm hurting. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and arm hurting on 01-APR-2021. This report was non-serious.  Version (1) created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Age group, age at the time of vaccination was updated.
Sex: U
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash
Clinical narrative: PITYRIASIS ROSEA; RASH; .This spontaneous report received from a parent concerned a 27 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy, and fragile x gene mutation, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18005022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced rash. On an unspecified date, the subject experienced pityriasis rosea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, and the outcome of pityriasis rosea was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain
Clinical narrative: MIGRAINE; ACHY FEELING; CHILLS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:20 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced achy feeling. On 01-APR-2021, the subject experienced chills. On 01-APR-2021 12:30, the subject experienced migraine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, chills, and achy feeling. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: INCORRECT DOSE ADMINISTERED; 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, intramuscular, batch number: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced incorrect dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of incorrect dose administered was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000175101. The suspected product quality complaint has been confirmed to be voided (did not meet product quality complaint criteria) based on the PQC evaluation/investigation performed.
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia, Tremor
Clinical narrative: HEADACHE/MIGRAINE; ACHY; TREMBLING; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to left deltoid 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 26-MAR-2021, the subject experienced headache/migraine. On 26-MAR-2021, the subject experienced achy. On 26-MAR-2021, the subject experienced trembling. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache/migraine, fever, achy and trembling was not reported. This report was non-serious. This case, from the same reporter is linked to 20210358539.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS (FEVER AND CHILLS); This spontaneous report received from a vaccine facility 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, 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 flu-like symptoms (fever and chills). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (fever and chills). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: BUMP AT INJECTION SITE ON RIGHT ARM; SORENESS INJECTION ARM; 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 was not reported, administered on 26-MAR-2021 vaccinated at right arm 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 26-MAR-2021, the subject experienced soreness injection arm. On 31-MAR-2021, the subject experienced bump injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness injection arm on 27-MAR-2021, and was recovering from bump injection site. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Headache, Nervousness
Clinical narrative: FRUSTRATED; NERVOUS; HEADACHE; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 31-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 01-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced frustrated, and nervous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of frustrated and nervous was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Paraesthesia
Clinical narrative: STING IN THE AREA OF THE LEFT KIDNEY, ACHINESS AND PAIN IN THE LEFT SIDE OF THE BODY (ALMOST LIKE A BACK PAIN AND PAIN CONTINUED ON AND OFF FOR 1 DAY); TINGLING SENSATION ON THE LEFT SIDE OF BODY; LETHARGY; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included a benign tumor in left kidney (known as angiomyolipoma), high blood pressure, and pre-diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced sting in the area of the left kidney, achiness and pain in the left side of the body (almost like a back pain and pain continued on and off for 1 day). On 08-MAR-2021, the subject experienced tingling sensation on the left side of body. On 08-MAR-2021, the subject experienced lethargy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting in the area of the left kidney, achiness and pain in the left side of the body (almost like a back pain and pain continued on and off for 1 day) on 15-MAR-2021, and lethargy on 10-MAR-2021, and the outcome of tingling sensation on the left side of body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: TIREDNESS; SLIGHT HEADACHE; WAVES OF NAUSEA; LOW GRADE FEVER; 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, 1 total, start therapy date were not reported 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 30-MAR-2021, the subject experienced tiredness. On 30-MAR-2021, the subject experienced slight headache. On 30-MAR-2021, the subject experienced waves of nausea. On 30-MAR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, slight headache, waves of nausea, and low grade fever on 31-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Influenza, Pyrexia
Clinical narrative: chills; FEVER; Tired; Flu; 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) once a total dose was not reported, administered on 26-MAR-2021 10:14 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced tired. On 26-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 99.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, chills, fever, and tired on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980) dose was not reported, administered on 31-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lip swelling, Tinnitus
Clinical narrative: TOP LIP WAS SWOLLEN AS MY LOWER LIP; CHILLS; HEADACHE; RINGING IN EAR; This spontaneous report received from a patient concerned a 49 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: 1805020, expiry: not reported) dose was not reported, administered on 12-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 22:30, the subject experienced ringing in ear. On 12-MAR-2021 22:30, the subject experienced chills. On 12-MAR-2021 22:30, the subject experienced headache. On 13-MAR-2021 14:30, the subject experienced top lip was swollen as my lower lip. On 13-MAR-2021 15:30, treatment medications included: ibuprofen. On 13-MAR-2021 17:30, treatment medications included: diphenhydramine hydrochloride. On 30-MAR-2021 17:30, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, chills, and headache on 13-MAR-2021, and was recovering from top lip was swollen as my lower lip. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute, Chills, Headache, Pain
Clinical narrative: ADDISONIAN CRISIS AND EXTREME FATIGUE; ACHE; CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 43 year old white male. The patient's height, and weight were not reported. The patient's concurrent conditions included addison disease, hyperpituitarism, hypogonadism, and hypothyroidism. The patient experienced drug allergy when treated with baclofen, and pseudoephedrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, in the evening the patient began to experience addisonian crisis and extreme fatigue, ache, chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 2021, and was recovering from headache, addisonian crisis and extreme fatigue, and ache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407359-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Addisonian crisis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Poor quality sleep, Pyrexia, Restlessness
Clinical narrative: FAINTED; QUALITY OF SLEEP WAS LOW/DID NOT SLEEP WELL; FELT VERY RESTLESS; CHILLS; FEVER (UNKNOWN TEMPERATURE); EXTREME NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history included the patient had several comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, frequency 1 total, administered on 03-APR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, On 04-APR-2021 at approximately 04:00 a.m. in the morning, the patient experienced chills, extreme nausea, fever (unknown temperature, felt like she had a fever, hot) and she fainted. She also stated that when she went to sleep her quality of sleep was low and poor as she felt very restless. She stated that before fainting she called out to her husband who then carried her back to her bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quality of sleep was low/ did not sleep well, chills, fever (unknown temperature), fainted, extreme nausea and felt very restless was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210408190-Covid-19 Vaccine ad26. cov2.s-Fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED; QUALITY OF SLEEP WAS LOW/DID NOT SLEEP WELL; FELT VERY RESTLESS; CHILLS; FEVER (UNKNOWN TEMPERATURE); EXTREME NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history included the patient had several comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, frequency 1 total, administered on 03-APR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, On 04-APR-2021 at approximately 04:00 a.m. in the morning, the patient experienced chills, extreme nausea, fever (unknown temperature, felt like she had a fever, hot) and she fainted. She also stated that when she went to sleep her quality of sleep was low and poor as she felt very restless. She stated that before fainting she called out to her husband who then carried her back to her bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quality of sleep was low/ did not sleep well, chills, fever (unknown temperature), fainted, extreme nausea and felt very restless was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210408190-Covid-19 Vaccine ad26. cov2.s-Fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Hypoaesthesia eye, Sensory loss
Clinical narrative: similar to bell's palsy; 30 mins later, the shoulder, lower jaw and upper right eye became numb; shoulder was numb for 40 minutes; right eye and jaw were numb all day Thursday and Friday; right eye and jaw were numb all day Thursday and Friday; right eye and jaw were numb all day Thursday and Friday; A spontaneous report was received from a reporter like consumer concerning a 46yr old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 30 mins later, the shoulder, lower jaw and upper right eye became numb, shoulder was numb for 40 minutes, right eye and jaw were numb all day Thursday and Friday.  The patient's medication history was not provided. Concomitant medications reported include5mg Levocetirizine daily.  On 11th Feb 2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch016M20A) in the anatomical location on the right arm for prophylaxis of of COVID-19 infection.  On 11th Feb 2021, 30 minutes after vaccine administration the patient experienced events like the shoulder, lower jaw and upper right eye became numb, shoulder was numb for 40 minutes, right eye and jaw were numb all day, thursday and friday. Event similar to bell's palsy was considered medically significant.  Laboratory details were not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  On an unknown date, the outcome of the events,30 mins later, the shoulder, lower jaw and upper right eye became numb was resolved. On 11 Feb 2021, the outcome of the event, shoulder was numb for 40 minutes was resolved. On 13 Feb 2021, the outcome of the event, right eye and jaw were numb all day Thursday and Friday was resolved. On an unknown date, the outcome of the event,similar to bell's palsy was unknown.; Reporter's Comments: This case concerns a 46 Y/O F with a serious unexpected event of facial paralysis, and nonserious unexpected hypoaesthesia, hypoaesthesia eye, sensory loss. Event onset 30 minutes after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Vaccination complication
Clinical narrative: Sick; Cough; Chest pressure; A spontaneous report was received from a consumer concerning a 76- year old male patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pressure/ chest discomfort, sick/ vaccination complication and cough.  The patient's medical history was not provided. Concomitant medications included acetylsalicylic acid, vitamin d nos, famotidine, isosorbide mononitrate, levothyroxine, metoprolol, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc, fish oil, pantoprazole and simvastatin for unknown indication.  On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, same day of receiving vaccine, the patient fell sick, has chest pressure and was taken to emergency room by ambulance on 19 Feb 2021. He is coughing and took cough medications that will not relief his cough. He was discharged 2 days later, on 21 Feb 2021.   Treatment medication included Promethazine and Codeine 5mg: takes 5ml q6H, Benzonatate 100mg TID.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; A spontaneous report was received from a physician concerning an unknown years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event bell's palsy/ facial paralysis.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On unknown date on Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On 22 Mar 2021, patient experienced bell's palsy and was sent to emergency department. It was medically significant event.  No laboratory data was not provided. The patient is being treated with prednisone for bell's palsy.  Action taken with mRNA-1273 in response to the events was not reported.   The event bell's palsy was not recovered.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.