chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: GOT SICK; MESSED UP; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got sick, and messed up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from got sick, and messed up. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hypertension, Injection site pruritus
Clinical narrative: ITCHING AT SITE OF INJECTION; OOZING SITE OF INJECTION; DIZZINESS; HIGH BLOOD PRESSURE; NAUSEA; HEADACHES; This spontaneous report received from a patient concerned a 34 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: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced itching at site of injection. On OCT-2021, the patient experienced oozing site of injection. On OCT-2021, the patient experienced dizziness. On OCT-2021, the patient experienced high blood pressure. On OCT-2021, the patient experienced nausea. On OCT-2021, the patient experienced headaches. Laboratory data included: Blood pressure (NR: not provided) high. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching at site of injection, oozing site of injection, nausea, dizziness, headaches, and high blood pressure. This report was non-serious. This case, from the same reporter is linked to 20211014731.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Nausea
Clinical narrative: ITCHING AT SITE OF INJECTION; OOZING SITE OF INJECTION; DIZZINESS; HIGH BLOOD PRESSURE; NAUSEA; HEADACHES; This spontaneous report received from a patient concerned a 34 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: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On OCT-2021, the patient experienced itching at site of injection. On OCT-2021, the patient experienced oozing site of injection. On OCT-2021, the patient experienced dizziness. On OCT-2021, the patient experienced high blood pressure. On OCT-2021, the patient experienced nausea. On OCT-2021, the patient experienced headaches. Laboratory data included: Blood pressure (NR: not provided) high. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching at site of injection, oozing site of injection, nausea, dizziness, headaches, and high blood pressure. This report was non-serious. This case, from the same reporter is linked to 20211014731.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 24 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: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-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 20211014509, 20211015239, 20211014463 and 20211015303.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Expired product administered, Peripheral coldness, Vaccination site pain
Clinical narrative: COLD SWEAT; ADMINISTRATION OF EXPIRED VACCINE; COLD ARM; LOT OF PAIN IN THE ARM WHERE SHE GOT THE VACCINE/ PAIN FROM SHOULDER TO ELBOW; This spontaneous report received from a patient concerned a 43 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient experienced cold sweat. On 07-OCT-2021, the patient experienced administration of expired vaccine. On 07-OCT-2021, the patient experienced cold arm. On 07-OCT-2021, the patient experienced lot of pain in the arm where she got the vaccine/ pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweat, cold arm, and lot of pain in the arm where she got the vaccine/ pain from shoulder to elbow, and the outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: RECEIVED JANSSEN COVID-19 VACCINE THREE TIMES; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient 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 received janssen covid-19 vaccine three times, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received janssen covid-19 vaccine three times and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: BRAIN FOG; This spontaneous report received from a patient concerned an elderly 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain fog was not reported. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 23 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-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 20211014509, 20211015239, 20211015303 and 20211014279.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; 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: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-OCT-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 20211014463 and 20211014279.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEEL CRAPPY FOR A SHORT PERIOD OF TIME; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced feel crappy for a short period of time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel crappy for a short period of time. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POTENTIALLY EXPIRED VACCINE ADMINISTERED (VIAL WAS OPENED ON 06-OCT-2021 AT 9 AM AND VACCINE ADMINISTERED ON 07-OCT-2021 AT AROUND 12:30 TO 1 PM); This spontaneous report received from a pharmacist concerned a 19 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: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-OCT-2021, the patient experienced potentially expired vaccine administered (vial was opened on 06-oct-2021 at 9 am and vaccine administered on 07-oct-2021 at around 12:30 to 1 pm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potentially expired vaccine administered (vial was opened on 06-oct-2021 at 9 am and vaccine administered on 07-oct-2021 at around 12:30 to 1 pm) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE VIAL WAS WARMED AT ROOM TEMPERATURE BUT DOES NOT KNOW HOW MUCH TIME HAD PASSED AND WAS ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. 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 vial was warmed at room temperature but does not know how much time had passed and was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine vial was warmed at room temperature but does not know how much time had passed and was administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211015012.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hypersomnia, Hypertension
Clinical narrative: ITCHING AT SITE OF INJECTION; OOZING AT SITE OF INJECTION; EXCESSIVE SLEEP; HIGH BLOOD PRESSURE; DIZZINESS; HEADACHE; NUMBNESS OF FACE AND ARM; NAUSEA; This spontaneous report received from a consumer concerned a 35 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, and batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced itching at site of injection. On OCT-2021, the patient experienced oozing at site of injection.  On OCT-2021, the patient experienced excessive sleep. On OCT-2021, the patient experienced high blood pressure. On OCT-2021, the patient experienced dizziness. On OCT-2021, the patient experienced headache. On OCT-2021, the patient experienced numbness of face and arm. On OCT-2021, the patient experienced nausea. Laboratory data included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, itching at site of injection, oozing at site of injection, high blood pressure, dizziness, and nausea, and the outcome of numbness of face and arm and excessive sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20211014251.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pruritus, Injection site reaction, Nausea
Clinical narrative: ITCHING AT SITE OF INJECTION; OOZING AT SITE OF INJECTION; EXCESSIVE SLEEP; HIGH BLOOD PRESSURE; DIZZINESS; HEADACHE; NUMBNESS OF FACE AND ARM; NAUSEA; This spontaneous report received from a consumer concerned a 35 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, and batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced itching at site of injection. On OCT-2021, the patient experienced oozing at site of injection.  On OCT-2021, the patient experienced excessive sleep. On OCT-2021, the patient experienced high blood pressure. On OCT-2021, the patient experienced dizziness. On OCT-2021, the patient experienced headache. On OCT-2021, the patient experienced numbness of face and arm. On OCT-2021, the patient experienced nausea. Laboratory data included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, itching at site of injection, oozing at site of injection, high blood pressure, dizziness, and nausea, and the outcome of numbness of face and arm and excessive sleep was not reported. This report was non-serious. This case, from the same reporter is linked to 20211014251.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Hypokinesia
Clinical narrative: LACK OF APPETITE (FORCING HERSELF TO EAT AND DRINK); BODY ACHES; UNABLE TO MOVE (CAN'T GO TO THE  BATHROOM); FEVER; NAUSEA; EXTREME FATIGUE; BAD HEADACHE; This spontaneous report received from a physician 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 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-OCT-2021, the patient experienced lack of appetite (forcing herself to eat and drink). On 05-OCT-2021, the patient experienced body aches. On 05-OCT-2021, the patient experienced unable to move (can't go to the bathroom). On 05-OCT-2021, the patient experienced fever. On 05-OCT-2021, the patient experienced nausea. On 05-OCT-2021, the patient experienced extreme fatigue. On 05-OCT-2021, the patient experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 104 F, 103 or 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, nausea, extreme fatigue, bad headache, lack of appetite(forcing herself to eat and drink), and unable to move (can't go to the bathroom). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: LACK OF APPETITE (FORCING HERSELF TO EAT AND DRINK); BODY ACHES; UNABLE TO MOVE (CAN'T GO TO THE  BATHROOM); FEVER; NAUSEA; EXTREME FATIGUE; BAD HEADACHE; This spontaneous report received from a physician 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 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-OCT-2021, the patient experienced lack of appetite (forcing herself to eat and drink). On 05-OCT-2021, the patient experienced body aches. On 05-OCT-2021, the patient experienced unable to move (can't go to the bathroom). On 05-OCT-2021, the patient experienced fever. On 05-OCT-2021, the patient experienced nausea. On 05-OCT-2021, the patient experienced extreme fatigue. On 05-OCT-2021, the patient experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 104 F, 103 or 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, nausea, extreme fatigue, bad headache, lack of appetite(forcing herself to eat and drink), and unable to move (can't go to the bathroom). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; 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 numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickness. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity, Somnolence, Tenderness
Clinical narrative: LIKE A GLAND WAS SWOLLEN ON THE FRONT OF NECK, LIKE A BUMP AND IT WAS TENDER TO TOUCH; TENDERNESS IN THROAT; TENDERNESS UNDER CHIN; SLEEP ALL DAY; SORE ARM; SO FATIGUED; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) dose was not reported, administered on 01-OCT-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-OCT-2021, the patient experienced sleep all day. On 03-OCT-2021, the patient experienced sore arm. On 03-OCT-2021, the patient experienced so fatigued. On 04-OCT-2021, the patient experienced tenderness under chin. On 05-OCT-2021, the patient experienced tenderness in throat. Treatment medications included: paracetamol. On 07-OCT-2021, the patient experienced like a gland was swollen on the front of neck, like a bump and it was tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep all day, sore arm, and so fatigued on 06-OCT-2021, and had not recovered from tenderness under chin, tenderness in throat, and like a gland was swollen on the front of neck, like a bump and it was tender to touch. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: LIKE A GLAND WAS SWOLLEN ON THE FRONT OF NECK, LIKE A BUMP AND IT WAS TENDER TO TOUCH; TENDERNESS IN THROAT; TENDERNESS UNDER CHIN; SLEEP ALL DAY; SORE ARM; SO FATIGUED; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) dose was not reported, administered on 01-OCT-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-OCT-2021, the patient experienced sleep all day. On 03-OCT-2021, the patient experienced sore arm. On 03-OCT-2021, the patient experienced so fatigued. On 04-OCT-2021, the patient experienced tenderness under chin. On 05-OCT-2021, the patient experienced tenderness in throat. Treatment medications included: paracetamol. On 07-OCT-2021, the patient experienced like a gland was swollen on the front of neck, like a bump and it was tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep all day, sore arm, and so fatigued on 06-OCT-2021, and had not recovered from tenderness under chin, tenderness in throat, and like a gland was swollen on the front of neck, like a bump and it was tender to touch. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: DRUG ADMINISTRATION ERROR; This spontaneous report received from a health care professional concerned 3 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: 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 drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug administration error was not reported. This report was non-serious. This case, from the same reporter is linked to 20211014697.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VACCINE STORED IN REFRIGERATOR FOR LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS PASSED; ADMINISTERED VACCINE STORED LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS HAD PASSED; This spontaneous report received from a pharmacist concerned a 31 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: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-OCT-2021, the patient experienced administered vaccine stored longer than 6 hours approximately 24 hours had passed. On an unspecified date, the patient experienced punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored longer than 6 hours approximately 24 hours had passed and punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: JOINT PAIN IN WRIST AND SHOULDER; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced joint pain in wrist and shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain in wrist and shoulder. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VACCINE STORED IN REFRIGERATOR FOR LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS PASSED; ADMINISTERED VACCINE STORED LONGER THAN 6 HOURS APPROXIMATELY 24 HOURS HAD PASSED; This spontaneous report received from a health care professional concerned a 24 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: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-OCT-2021, the patient experienced administered vaccine stored longer than 6 hours approximately 24 hours had passed. On an unspecified date, the patient experienced punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored longer than 6 hours approximately 24 hours had passed and punctured vaccine stored in refrigerator for longer than 6 hours approximately 24 hours passed was not reported. This report was non-serious. This case, from the same reporter is linked to 20211015057.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional 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: 202A21A, and  expiry: 21-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-OCT-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 20211014279, 20211014509, 20211015303 and 20211014463.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Neck pain
Clinical narrative: NECK PAIN; SHOULDER PAIN; FATIGUE; RED INJECTION SITE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: difficulties in intimacy, felt self conscious, itchy, skin affected social, leisure activities, skin had prevented from working, sore, painful, right shoulder pain, hidradenitis suppurativa, and skin pain, stinging skin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 21-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 SEP-2021, the patient experienced neck pain. On SEP-2021, the patient experienced shoulder pain. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced red injection site. On SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, shoulder pain, fatigue, red injection site, and headache on SEP-2021. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 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: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-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 20211015239, 20211014463, 20211014279 and 20211014509.
Age: 78.0
Sex: F
Vaccine: COVID19, UNK, COVID19, UNK, UNK, UNK
Symptoms: Alopecia, Malaise, Rash, SARS-CoV-2 test, Skin exfoliation
Clinical narrative: FACE STARTED FLAKING; RASH ON ONE SIDE OF NECK; HAIR LOSS (FALL OUT IN CLUMPS); FELT SICK; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, hospitalization, and pneumonia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 13:30 for prophylactic vaccination. Non-company suspect drugs included: salicylic acid (cream, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative for 3 times. On 30-MAR-2021, the patient experienced felt sick. On 06-APR-2021, the patient experienced hair loss (fall out in clumps). On an unspecified date, the patient experienced face started flaking, and rash on one side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with salicylic acid was not reported. The patient recovered from felt sick on 31-MAR-2021, was recovering from hair loss (fall out in clumps), and the outcome of rash on one side of neck and face started flaking was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19, UNK, COVID19, UNK, UNK, UNK
Symptoms: Application site hypersensitivity, Scab, Skin exfoliation
Clinical narrative: FACE STARTED FLAKING; RASH ON ONE SIDE OF NECK; HAIR LOSS (FALL OUT IN CLUMPS); FELT SICK; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, hospitalization, and pneumonia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 13:30 for prophylactic vaccination. Non-company suspect drugs included: salicylic acid (cream, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative for 3 times. On 30-MAR-2021, the patient experienced felt sick. On 06-APR-2021, the patient experienced hair loss (fall out in clumps). On an unspecified date, the patient experienced face started flaking, and rash on one side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with salicylic acid was not reported. The patient recovered from felt sick on 31-MAR-2021, was recovering from hair loss (fall out in clumps), and the outcome of rash on one side of neck and face started flaking was not reported. 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 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: 207A21A, and expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and FATIGUE (Tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achy) and FATIGUE (Tired). At the time of the report, PAIN (Achy) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-339288, MOD-2021-339317 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission in error
Clinical narrative: It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose..He did not know that there was a limited amount of time to receive the second dose) had resolved.            Patient date of birth given as 1971.  Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received, contains no new information. Corrected: event start date removed, event outcome updated to resolved and action taken updated to not applicable from initial.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Second dose outside the 30 day window, 4 days after 24-Jun-2021; Patients received doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 11:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Significant followup received included time of second dose vaccination details were updated and additional event of inappropriate schedule of vaccine administered
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered BUD (on day 32); This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medications were provided.  Patient has experienced no side effects with no unusual symptoms was reported.  The 8 patients received a dose from a vial that was stored refrigerated for more than 30 days which was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit, was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Significant follow-up received on 04-OCT-2021 and included first dose information.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Pain
Clinical narrative: aches; fatigue; Administered 7 doses past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of PAIN (aches), FATIGUE (fatigue) and EXPIRED PRODUCT ADMINISTERED (Administered 7 doses past 30 days in the fridge) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 7 doses past 30 days in the fridge). On an unknown date, the patient experienced PAIN (aches) and FATIGUE (fatigue). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered 7 doses past 30 days in the fridge) had resolved. At the time of the report, PAIN (aches) and FATIGUE (fatigue) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medication were provided.   The vials were stored in the refrigerator on 03 May2021 and administered to the patient  on 27 Aug 2021.  Vials were placed in the refrigerator on 03 May2021 and were administered as recent as September 2021, some were vaccinated in August 2021 and 1 patient in September2021.    Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up was received and the patient demographics was  updated,  second dose information was updated. On 01-Oct-2021: Follow up was received and the first dose information was updated. On 05-Oct-2021: Follow-up was received and new events aches and fatigue were updated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in the same arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the same arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and ATORVASTATIN for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced PARAESTHESIA (tingling in the same arm). At the time of the report, PARAESTHESIA (tingling in the same arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-335482 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast pain, Illness, Lethargy, Menstrual disorder
Clinical narrative: third dose had an impact on her hormones; sick with all three doses; had the period start and it is still coming; breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra; fever not above a 100°F after dose 3; extremely lethargic after dose 3; Too much sleep after dose 3; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (had the period start and it is still coming), VACCINATION COMPLICATION (third dose had an impact on her hormones), ILLNESS (sick with all three doses), LETHARGY (extremely lethargic after dose 3) and SOMNOLENCE (Too much sleep after dose 3) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100°F after dose 3). On 22-Sep-2021, the patient experienced BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra). On 28-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENSTRUAL DISORDER (had the period start and it is still coming). On an unknown date, the patient experienced VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses). The patient was treated with IBUPROFEN on 29-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 29-Aug-2021, LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100°F after dose 3) had resolved. At the time of the report, MENSTRUAL DISORDER (had the period start and it is still coming) had not resolved, VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses) outcome was unknown and BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 100 (High) fever not above 100°F.         No relevant concomitant medications were reported. PAPs smear was completely normal.   This case was linked to MOD-2021-335764, MOD-2021-335745 (Patient Link).