chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECT CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female of unknown race end ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 21-SEP-2021) dose, 1 total, was not reported, administered at left arm on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, patient started to had a congestion. On 22-SEP-2021, patient lost her taste and smell senses and started to had a a cough (suspected covid-19 infection). On 23-SEP-2021 patient tried home test for Covid-19 and resulted positive for Covid-19 virus infection (suspect clinical vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspect clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210949899- COVID-19 VACCINE AD26.COV2.S-Suspected Clinical Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Chills, Headache, Hyperhidrosis, Imaging procedure
Clinical narrative: SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 71 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not in the age group for blood clots. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Imaging procedure (NR: not provided) no Sinus blood clots were found. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949951.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 71 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not in the age group for blood clots. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Imaging procedure (NR: not provided) no Sinus blood clots were found. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949951.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 65 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949990.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210950001 and 20210949993.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced off label use, and inappropriate route of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate route of vaccination was not reported. This report was non-serious.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 34 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint stiffness, Malaise, Migraine, Pain
Clinical narrative: SEVERE MIGRAINE; GENERAL NOT FEELING WELL/ BEGAN TO FEEL POORLY AGAIN; SUBJECTIVE FEVER; HEADACHE; ACHY BODY; STIFF JOINTS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced stiff joints. On 17-SEP-2021, the patient experienced achy body. On 17-SEP-2021, the patient experienced subjective fever. On 17-SEP-2021, the patient experienced headache. On 23-SEP-2021, the patient experienced severe migraine. On 23-SEP-2021, the patient experienced general not feeling well/ began to feel poorly again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff joints, achy body, subjective fever, and headache on 20-SEP-2021, and had not recovered from severe migraine, and general not feeling well/ began to feel poorly again. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SEVERE MIGRAINE; GENERAL NOT FEELING WELL/ BEGAN TO FEEL POORLY AGAIN; SUBJECTIVE FEVER; HEADACHE; ACHY BODY; STIFF JOINTS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-SEP-2021, the patient experienced stiff joints. On 17-SEP-2021, the patient experienced achy body. On 17-SEP-2021, the patient experienced subjective fever. On 17-SEP-2021, the patient experienced headache. On 23-SEP-2021, the patient experienced severe migraine. On 23-SEP-2021, the patient experienced general not feeling well/ began to feel poorly again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff joints, achy body, subjective fever, and headache on 20-SEP-2021, and had not recovered from severe migraine, and general not feeling well/ began to feel poorly again. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Chills, Headache, Hyperhidrosis, Laboratory test
Clinical narrative: SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not allergic to the J&J Vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Lab test (NR: not provided) No sinus blood clots were found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949900.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SWEATING; OTHER SYMPTOMS; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not allergic to the J&J Vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sweating, other symptoms, chills, fever, and severe headache. Laboratory data (dates unspecified) included: Lab test (NR: not provided) No sinus blood clots were found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, other symptoms, chills, fever, and severe headache. This report was non-serious. This case, from the same reporter is linked to 20210950596 and 20210949900.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Speech disorder
Clinical narrative: UNABLE TO TALK; NOT FEELING WELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-SEP-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 24-SEP-2021, the patient experienced unable to talk. On 24-SEP-2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to talk and not feeling well was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 24-SEP-2021. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949219, 20210949881, 20210949901 and 20210949251.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210950001.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949322, 20210949808, 20210949974, 20210950004, 20210950006 and 20210950120.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949993 and 20210949906.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Myalgia
Clinical narrative: LITTLE SORE ARM; CHILLS; 102 TEMPERATURE; MUSCLE ACHES; FELT KIND OF TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be request for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced little sore arm, chills, 102 temperature, muscle aches, and felt kind of tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (unit not reported). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, 102 temperature, muscle aches, and felt kind of tired, and had not recovered from little sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE SORE ARM; CHILLS; 102 TEMPERATURE; MUSCLE ACHES; FELT KIND OF TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be request for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced little sore arm, chills, 102 temperature, muscle aches, and felt kind of tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (unit not reported). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, 102 temperature, muscle aches, and felt kind of tired, and had not recovered from little sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949996, 20210949974, 20210949322, 20210950120, 20210949808 and 20210950006.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949302, 20210949996, 20210949974 and 20210950004.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHT HEADED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light headed was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Fatigue
Clinical narrative: FEW SIDE EFFECTS; FELT A LITTLE TIRED; This spontaneous report received from a consumer concerned an adult of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient experienced few side effects, and felt a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the few side effects and felt a little tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous report received from a health care professional concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982 and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine administered outside of recommended storage conditions, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS (FEVER); This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced flu-like symptoms (fever). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (fever). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Musculoskeletal stiffness
Clinical narrative: BODY ACHES; STIFFNESS; FELT BAD ENOUGH TO STAY IN BED; CHILL; FEVER OF 101.4; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) fever of 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; STIFFNESS; FELT BAD ENOUGH TO STAY IN BED; CHILL; FEVER OF 101.4; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) fever of 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, stiffness, felt bad enough to stay in bed, chill, fever of 101.4, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Cough, Dyspnoea
Clinical narrative: COUGH; LOSS OF TASTE; SOME BREATHING ISSUES; LOSS OF SMELL; JOINT PAIN; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cough, loss of taste, some breathing issues, loss of smell, joint pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever, loss of taste, joint pain, some breathing issues and loss of smell was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COUGH; LOSS OF TASTE; SOME BREATHING ISSUES; LOSS OF SMELL; JOINT PAIN; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cough, loss of taste, some breathing issues, loss of smell, joint pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever, loss of taste, joint pain, some breathing issues and loss of smell was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia
Clinical narrative: PRETTY SICK FOR A WEEK; BAD HEADACHES; MUSCLE PAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced pretty sick for a week, bad headaches, and muscle pain. The action taken with covid-19 vaccine was not applicable. The outcome of the pretty sick for a week, bad headaches and muscle pain was not reported. This report was non-serious.     .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: FEELING DIZZY; PAIN IN THE BACK OF BOTH LEGS (BOTH CALVES) AND FEELING PAIN ON THE OTHER ARM (RIGHT ARM); HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced feeling dizzy. On 23-SEP-2021, the patient experienced pain in the back of both legs (both calves) and feeling pain on the other arm (right arm). On 23-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from feeling dizzy, and headache on SEP-2021, and had not recovered from pain in the back of both legs (both calves) and feeling pain on the other arm (right arm). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pain, Pyrexia
Clinical narrative: BODY ACHES; HORRIBLY SICK; CHILLS; FEVER; BAD HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, horribly sick, chills, fever, and bad headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from horribly sick, and the outcome of fever, chills, body aches and bad headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: NIGHT OF FLU LIKE SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced night of flu like symptoms. The action taken with covid-19 vaccine was not applicable. The patient recovered from night of flu like symptoms. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Tremor
Clinical narrative: SHAKING; BODY SORE FROM SHAKING; CHILLS; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced shaking. On 25-SEP-2021, the patient experienced body sore from shaking. On 25-SEP-2021, the patient experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from shaking, and chills on 25-SEP-2021, and the outcome of body sore from shaking was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; VERY SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, chills, and very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and very slight fever. This report was non-serious. This case, from the same reporter is linked to 20210950993.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous (non-serious) report received from a patient, concerned a patient, of unspecified age and sex. The patient's height, weight, past medical history, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, batch/lot# unknown), route of admin, dose and start therapy date not reported, for immunization. Per procedure, no follow-up will be requested for this case. On an unspecified date, patient experienced chills and fever. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from chills and fever.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; VERY SLIGHT FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, chills, and very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and very slight fever. This report was non-serious. This case, from the same reporter is linked to 20210950782.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrooesophageal reflux disease, Hyperhidrosis, Vomiting
Clinical narrative: SWEATING; THROAT FEELS ACIDY FROM THROWING UP; DIARRHEA; VOMITING/THROWING UP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 24-SEP-2021, the patient experienced sweating. On 24-SEP-2021, the patient experienced throat feels acidy from throwing up. On 24-SEP-2021, the patient experienced diarrhea. On 24-SEP-2021, the patient experienced vomiting/throwing up. The action taken with covid-19 vaccine was not applicable. The outcome of the diarrhea, vomiting/throwing up, sweating and throat feels acidy from throwing up was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20210940935.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: joint pain wrist and shoulder pain; fatigue; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Allergic to sulfa drugs), Hypothyroidism, Asthma, COPD and Allergic reaction to antibiotics (allergic to cefin). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, METHOTREXATE and ETANERCEPT (ENBREL) for Rheumatoid arthritis, SALBUTAMOL (ALBUTEROL HFA), DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) and LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021 at 11:13 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 3 Tab. At the time of the report, ARTHRALGIA (joint pain wrist and shoulder pain), FATIGUE (fatigue), MYALGIA (muscle aches) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114888, MOD-2021-114888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up was received on 07-MAY-2021. Patient's race and ethnicity, medical history- COPD, Asthma, Hypothyroidism  and allergies- sulfa, cefin were added. Second dose details were added. Concomitant medications- Enberel, diltiazem, albuterol, levothyroxine were added.