chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Headache, Plantar fasciitis
Clinical narrative: UPSET STOMACH; PLANTAR FASCIITIS IN LEFT HEEL; HEADACHE; This spontaneous report received from a patient concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced upset stomach, plantar fasciitis in left heel, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach, and headache, and was recovering from plantar fasciitis in left heel. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Tinnitus
Clinical narrative: STIFFNESS IN THE NECK; RINGING IN THE EAR; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stiffness in the neck, and ringing in the ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiffness in the neck, and ringing in the ear. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: FEELING FAINT; NAUSEA; PARESTHESIA IN THE EXTREMITIES AND TINGLING IN THE RIGHT HAND AND IN FEET; FEELING NUMBNESS IN THE LEFT ARM IMMEDIATELY AFTER RECEIVING THE INJECTION, WHICH RADIATED TO THE LEFT HAND AND FINGERS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: dust allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced feeling faint. On 22-SEP-2021, the patient experienced nausea. On 22-SEP-2021, the patient experienced paresthesia in the extremities and tingling in the right hand and in feet. On 22-SEP-2021, the patient experienced feeling numbness in the left arm immediately after receiving the injection, which radiated to the left hand and fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling faint, and nausea on 22-SEP-2021, had not recovered from paresthesia in the extremities and tingling in the right hand and in feet, and the outcome of feeling numbness in the left arm immediately after receiving the injection, which radiated to the left hand and fingers was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's weight was 188 pounds, and height was 65 inches. The patient's concurrent conditions included: penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. 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 10:30 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a 39 year old female. The patient's weight was 247 pounds, and height was 60 inches. The patient's concurrent conditions included: gestational diabetes, and other pre-existing medical conditions included: The patient was pregnant at the time of reporting. The patient experienced drug allergy when treated with dimeticone, and titanium dioxide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included insulin aspart for gestational diabetes, and insulin human for gestational diabetes. On 22-SEP-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period was 01-APR-2021 and expected delivery date was 09-JAN-2022. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 37 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: 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 administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from expired vaccine administered. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHINESS; LOW GRADE FEVER; This spontaneous report received from a consumer and concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bundle branch block, post-traumatic stress disorder, and panic attacks. 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. Concomitant medications included acetylsalicylic acid for as a precaution for blood clots.  On an unspecified date, the patient experienced achiness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and achiness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943927.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED DOSE ADMINISTERED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional 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: 211A21A, expiry: 14-DEC-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced expired dose administered, and incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect product storage and expired dose administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature decreased, Chills, Hypersomnia, Nausea
Clinical narrative: LOW TEMPERATURE; SLEPT OFF AN ON FOR ABOUT 24 HRS; CHILLS; LITTLE SICK ON STOMACH TUM HANDLE; CHEAPNESS ABOUT 4 HOURS; 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. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced low temperature, slept off an on for about 24 hrs, chills, little sick on stomach tum handle, and cheapness about 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low temperature, slept off an on for about 24 hrs, chills, little sick on stomach tum handle, and cheapness about 4 hours. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: EXPIRED DOSE ADMINISTERED; OFF LABEL USE; 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  (suspension for injection, route of admin not reported, batch number: 205A21A 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 dose administered. On 22-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the off label use and expired dose administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: ADMINISTERED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned 2 female patients. 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: 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 administered expired vaccine. On 22-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the administered expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944551.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysmenorrhoea, Heart rate, Heart rate increased, Heavy menstrual bleeding
Clinical narrative: LONGER MENSTRUAL PERIOD; CHEST PAIN; INCREASED HEART RATE; PAINFUL MENSTRUATION THAN USUAL; 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 Expiry: 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 longer menstrual period, chest pain, increased heart rate, and painful menstruation than usual. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the longer menstrual period, chest pain, increased heart rate and painful menstruation than usual was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse drug reaction, Pyrexia
Clinical narrative: ADVERSE EVENT NOS; FEVER; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE023B0301 expiry: 30-APR-2025) 10 mg, 1 time every 1 day, therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin sodium. On 11-SEP-2021, the patient experienced adverse event nos. On 11-SEP-2021, the patient experienced fever. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the adverse event nos and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHINESS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 70 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: 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 achiness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and achiness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943871.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED EXPIRED VACCINE; 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: 1808982, 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 received expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED  DOSE OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional 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, intramuscular, batch number: 203A21A, 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 received an expired dose of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired dose of the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944792 and 20210943969.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a patient 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 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 administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. 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 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, intramuscular, batch number: 203A21A, 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. This case, from the same reporter is linked to 20210944792 and 20210943966.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Off label use, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: OFF LABEL USE; VACCINE RECEIVED AT HOME BY 17 YEARS OLD PATIENT; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 17 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the patient experienced off label use. On 22-JUN-2021, the patient experienced vaccine received at home by 17 years old patient. On 22-JUN-2021, the patient experienced headache. On 22-JUN-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and fever on 23-JUN-2021, and the outcome of off label use and vaccine received at home by 17 years old patient was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 20 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: 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 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.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: HEART ISSUE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced heart issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943837.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: SEVERE RIGHT SIDED LOWER BACK PAIN; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. 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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced severe right sided lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe right sided lower back pain. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstruation delayed, Pain, Pyrexia
Clinical narrative: DELAYED MENSTRUAL CYCLE; TIRED; BODY SORENESS; FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no change in lifestyle or medications. 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 08-SEP-2021 for prophylactic vaccination. Concomitant medications included ethinylestradiol/norgestimate.  On 08-SEP-2021, the patient experienced body soreness. On 08-SEP-2021, the patient experienced fever. On 09-SEP-2021, the patient experienced tired. On 21-SEP-2021, the patient experienced delayed menstrual cycle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness, and fever on 09-SEP-2021, and had not recovered from tired, and delayed menstrual cycle. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 34 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: 206A21A, 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 administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a consumer concerned a 63 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: 206A21A, 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 administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Cough, Dyspnoea, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE; DIFFICULTY BREATHING; DRY COUGH; PRESSURE ON CHEST (FELT LIKE SOMEONE WAS STANDING ON CHEST); This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and ex-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced pressure on chest (felt like someone was standing on chest). On 22-SEP-2021, the patient experienced difficulty breathing. On 22-SEP-2021, the patient experienced dry cough. On an unspecified date, the patient experienced high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine was not applicable. The outcome of the dry cough, difficulty breathing, pressure on chest (felt like someone was standing on chest) and high blood pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE (ADMINISTERED VACCINE ON 22-SEP-2021 WHICH EXPIRED ON 21-SEP-2021); This spontaneous report received from a health care professional concerned multiple patients.  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, 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 administration of expired vaccine (administered vaccine on 22-sep-2021 which expired on 21-sep-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine (administered vaccine on 22-sep-2021 which expired on 21-sep-2021) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED DOSE GIVEN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, 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 dose given. The action taken with covid-19 vaccine was not applicable. The outcome of expired dose given was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Headache, Laboratory test
Clinical narrative: SYMPTOMS OF HEADACHE; 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 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, Laboratory data included: Blood test (not provided) Not Reported, CAT scan (not provided) Not Reported, and Lab test (not provided) Not Reported. On 01-SEP-2021, the patient experienced symptoms of headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms of headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; 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 (suspension for injection, route of admin not reported, batch number: 202A21A, 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 administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH AT GROIN AREA (INITIALLY IN MINOR AMOUNT, OINTMENT MADE IT WORSE); This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, non smoker, penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, the patient experienced rash at groin area (initially in minor amount, ointment made it worse). On 21-SEP-2021, treatment medications included: hydrocortisone. The action taken with covid-19 vaccine was not applicable. The patient was recovering from rash at groin area (initially in minor amount, ointment made it worse). This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 19 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 allergies and the patient was doing well and did not have any adverse event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, 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 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. This case, from the same reporter is linked to 20210944784.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; LIGHT HEADACHE; This spontaneous report received from a consumer concerned a 40 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: 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 fatigue, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and light headache. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: CONTINUAL INTENSE TINNITUS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced continual intense tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from continual intense tinnitus. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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, intramuscular, batch number: 203A21A, 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 administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943966 and 20210943969.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; 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 (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 administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: SIGNIFICANT IRREGULARITY IN MENSURAL CYCLES AND IRREGULAR VISCOUS BLEEDING; ALTERED MENSTRUAL CYCLE; 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: birth control. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced significant irregularity in mensural cycles and irregular viscous bleeding. On APR-2021, the patient experienced altered menstrual cycle. The action taken with covid-19 vaccine was not applicable. The outcome of the significant irregularity in mensural cycles and irregular viscous bleeding and altered menstrual cycle was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; 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: 206A21A, 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 administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944245.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS STORED PAST RECOMMENDED STORAGE CONDITIONS AFTER PUNCTURE; 1 DOSE OF VACCINE THAT WAS STORED PAST RECOMMENDED STORAGE CONDITIONS ADMINISTERED; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60 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: 207A21A and expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced vaccine was stored past recommended storage conditions after puncture. On 21-SEP-2021, the patient experienced 1 dose of vaccine that was stored past recommended storage conditions administered. On 21-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine was stored past recommended storage conditions after puncture, 1 dose of vaccine that was stored past recommended storage conditions administered and off label use was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature, Chills
Clinical narrative: Vaccination adverse reaction; chills; fever of 100.3 degrees Fahrenheit; pain on the left shoulder joint; panic attack; blood pressure is 180/103; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attack), BLOOD PRESSURE INCREASED (blood pressure is 180/103), VACCINATION COMPLICATION (Vaccination adverse reaction), CHILLS (chills) and PYREXIA (fever of 100.3 degrees Fahrenheit) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PANIC ATTACK (panic attack), BLOOD PRESSURE INCREASED (blood pressure is 180/103), CHILLS (chills), PYREXIA (fever of 100.3 degrees Fahrenheit) and ARTHRALGIA (pain on the left shoulder joint). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, PANIC ATTACK (panic attack), BLOOD PRESSURE INCREASED (blood pressure is 180/103), VACCINATION COMPLICATION (Vaccination adverse reaction), CHILLS (chills), PYREXIA (fever of 100.3 degrees Fahrenheit) and ARTHRALGIA (pain on the left shoulder joint) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 80/103 mmhg (High) 180/103 mmHg. In 2021, Body temperature: 100.3 (High) 100.3 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    treatment to the events not reported. The patient reported "I called my insurance nurse line and was allowed to take my anxiety meds".   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up contains updated event outcomes.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Pyrexia, Vaccination complication
Clinical narrative: Vaccination adverse reaction; chills; fever of 100.3 degrees Fahrenheit; pain on the left shoulder joint; panic attack; blood pressure is 180/103; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attack), BLOOD PRESSURE INCREASED (blood pressure is 180/103), VACCINATION COMPLICATION (Vaccination adverse reaction), CHILLS (chills) and PYREXIA (fever of 100.3 degrees Fahrenheit) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PANIC ATTACK (panic attack), BLOOD PRESSURE INCREASED (blood pressure is 180/103), CHILLS (chills), PYREXIA (fever of 100.3 degrees Fahrenheit) and ARTHRALGIA (pain on the left shoulder joint). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, PANIC ATTACK (panic attack), BLOOD PRESSURE INCREASED (blood pressure is 180/103), VACCINATION COMPLICATION (Vaccination adverse reaction), CHILLS (chills), PYREXIA (fever of 100.3 degrees Fahrenheit) and ARTHRALGIA (pain on the left shoulder joint) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 80/103 mmhg (High) 180/103 mmHg. In 2021, Body temperature: 100.3 (High) 100.3 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    treatment to the events not reported. The patient reported "I called my insurance nurse line and was allowed to take my anxiety meds".   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up contains updated event outcomes.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Patient thinks she caught either the Delta Variance or COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient thinks she caught either the Delta Variance or COVID-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Patient thinks she caught either the Delta Variance or COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Patient thinks she caught either the Delta Variance or COVID-19) outcome was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Hyperhidrosis, Incorrect dose administered, Pain in extremity
Clinical narrative: Sore arm; Sweaty; Headache, less severe; Fever, less severe; Had a full third dose of the Moderna vaccine and they are not immunocompromised; Had a full third dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweaty), HEADACHE (Headache, less severe), PYREXIA (Fever, less severe) and EXTRA DOSE ADMINISTERED (Had a full third dose of the Moderna vaccine and they are not immunocompromised) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Had a full third dose of the Moderna vaccine and they are not immunocompromised). 24-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Had a full third dose of the Moderna vaccine). On 25-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweaty), HEADACHE (Headache, less severe) and PYREXIA (Fever, less severe). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 25-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 26-Aug-2021, PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweaty), HEADACHE (Headache, less severe) and PYREXIA (Fever, less severe) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Had a full third dose of the Moderna vaccine and they are not immunocompromised) and INCORRECT DOSE ADMINISTERED (Had a full third dose of the Moderna vaccine) outcome was unknown.            The consumer stated that he had a full third dose of the Moderna vaccine and he was not immunocompromised. The consumer stated that the onset of symptoms was the day after getting the shot and lasted for a day after the third dose.  The consumer stated that he took Advil as a treatment medication after the first 24 hours.  No concomitant product use was provided by the reporter.   This case was linked to MOD-2021-309106 (Patient Link).