chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative through social media concerned a 6-decade old male patient of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, one total for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, as per the reporter, "Johnson & Johnson tons of vaccinated people have gotten Covid. I have several family members and I lost a cousin in his 50's just a few days ago" (suspected clinical vaccine failure, and suspected covid-19 infection). On an unspecified date, the patient died from suspected covid-19 infection. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211214582. This report was associated with a product quality complaint: 90000205685.; Sender's Comments: V0:20211214240- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected COVID-19 infection. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).   20211214240- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: AN EXCRUCIATING RIGHT LEG PAIN; 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 was not reported, administered on JUN-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 JUN-2021, the patient experienced an excruciating right leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from an excruciating right leg pain. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: 2 BLOOD CLOTS IN BRAIN; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. Dose number series was 1. 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 2 blood clots in brain, and was hospitalized (date unspecified). The reporter stated that "reporter's ex-girlfriend who had 2 blood clots in brain after the shot and was in the hospital for 3 months. This company has hurt more then just her".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2 blood clots in the brain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211215117-COVID-19 VACCINE AD26.COV2.S- 2 blood clots in brain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus
Clinical narrative: DARK SKIN CANCER RASH/LICHEN PLANUS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 23-NOV-2021, Laboratory data included: Biopsy (NR: not provided) lichen planus. On an unspecified date, the patient experienced dark skin cancer rash/lichen planus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dark skin cancer rash/lichen planus. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series-1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, 1 total, administered at left arm on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-DEC-2021, the patient experienced runny nose, slight headache, sinus pressure and started fever on 03-DEC-2021. On 04-DEC-2021, patient tested positive for Covid-19 and results in confirmed clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000205631.; Sender's Comments: V0-20211215420-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Colitis, Headache, Hunger, Insomnia
Clinical narrative: HUNGRY ALL THE TIME; STEROIDS MADE UNABLE TO SLEEP; HEAD COLD; HEADACHE; FULL BLOWN COLITIS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-AUG-2021 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 ulcerative colitis. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) colitis was 7300. On JUN-2021, Laboratory data included: Blood test (NR: not provided) colitis was 41. On AUG-2021, Laboratory data included: Blood test (NR: not provided) colitis was 4500. On 16-AUG-2021, the patient experienced full blown colitis. On an unspecified date, the patient experienced hungry all the time, steroids made unable to sleep, head cold, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the full blown colitis, hungry all the time, steroids made unable to sleep, headache and head cold was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis
Clinical narrative: HUNGRY ALL THE TIME; STEROIDS MADE UNABLE TO SLEEP; HEAD COLD; HEADACHE; FULL BLOWN COLITIS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 10-AUG-2021 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 ulcerative colitis. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) colitis was 7300. On JUN-2021, Laboratory data included: Blood test (NR: not provided) colitis was 41. On AUG-2021, Laboratory data included: Blood test (NR: not provided) colitis was 4500. On 16-AUG-2021, the patient experienced full blown colitis. On an unspecified date, the patient experienced hungry all the time, steroids made unable to sleep, head cold, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the full blown colitis, hungry all the time, steroids made unable to sleep, headache and head cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscle spasms, Neck pain, Pain in extremity, Urticaria
Clinical narrative: NECK PAIN; SICK ALL THE TIME; LEG CRAMPS; ARM PAIN; HIVES; This spontaneous report received from a parent 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, 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 neck pain, sick all the time, leg cramps, arm pain, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, sick all the time, hives, leg cramps and arm pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Nervous system disorder
Clinical narrative: NEUROLOGICAL ISSUES; INFLAMMATORY RESPONSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced neurological issues, and inflammatory response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological issues, and inflammatory response. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site bruising, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: WALNUT SIZED, WARM LUMP AT INJECTION SITE; TENDERNESS ON HER ARM; SEVERE CHILLS; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; FEVERISH; SICK FEELING FOR 2-3 DAYS; WARMTH AT INJECTION SITE; BRUISING TO INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included: esophageal narrowing, and concurrent conditions included: hay fever, cats allergy, allergy to environmental, and pre-osteoporosis. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced warmth at injection site. On 04-JUN-2021, the patient experienced bruising to injection site. On 04-JUN-2021, the patient experienced sick feeling for 2-3 days. On 04-JUN-2021, the patient experienced severe chills. On 04-JUN-2021, the patient experienced pain at injection site. On 04-JUN-2021, the patient experienced swelling at injection site. On 04-JUN-2021, the patient experienced feverish. On an unspecified date, the patient experienced walnut sized, warm lump at injection site, and tenderness on her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth at injection site, bruising to injection site, and pain at injection site, and sick feeling for 2-3 days, severe chills, and feverish on JUN-2021, had not recovered from walnut sized, warm lump at injection site, and tenderness on her arm, and the outcome of swelling at injection site was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Malaise, Pain in extremity, Pyrexia
Clinical narrative: WALNUT SIZED, WARM LUMP AT INJECTION SITE; TENDERNESS ON HER ARM; SEVERE CHILLS; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; FEVERISH; SICK FEELING FOR 2-3 DAYS; WARMTH AT INJECTION SITE; BRUISING TO INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included: esophageal narrowing, and concurrent conditions included: hay fever, cats allergy, allergy to environmental, and pre-osteoporosis. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced warmth at injection site. On 04-JUN-2021, the patient experienced bruising to injection site. On 04-JUN-2021, the patient experienced sick feeling for 2-3 days. On 04-JUN-2021, the patient experienced severe chills. On 04-JUN-2021, the patient experienced pain at injection site. On 04-JUN-2021, the patient experienced swelling at injection site. On 04-JUN-2021, the patient experienced feverish. On an unspecified date, the patient experienced walnut sized, warm lump at injection site, and tenderness on her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth at injection site, bruising to injection site, and pain at injection site, and sick feeling for 2-3 days, severe chills, and feverish on JUN-2021, had not recovered from walnut sized, warm lump at injection site, and tenderness on her arm, and the outcome of swelling at injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex (local case). The patient's height, and weight were not reported. The patient's concurrent conditions included: pulmonary embolism. 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 adverse effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had adverse effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO FIVE PATIENTS; 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: 206A21A, 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 expired vaccine administered to five subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to five patients was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Pain in extremity
Clinical narrative: NORMAL INJECTION SYMPTOMS; LONG-LASTING ARM ACHE; This spontaneous report received from a patient concerned a 7 decade old male. The patient's height, and weight were not reported. The patient's past medical history included: fracture of the right humerus bone, and concurrent conditions included: arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced normal injection symptoms, and long-lasting arm ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long-lasting arm ache, and the outcome of normal injection symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217753.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); This spontaneous report received from a patient concerned a 7 decade 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chronic obstructive pulmonary disease (copd). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chronic obstructive pulmonary disease (copd) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217530.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE FOR 3 TO 4 DAYS; This spontaneous report received from a parent 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, 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 severe headache for 3 to 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache for 3 to 4 days. This report was non-serious. This case, from the same reporter is linked to 20211217508.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced hives and trouble breathing when treated with Augmentin (amoxicillin/clavulanic acid).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 06-AUG-2021 for prophylactic vaccination. The dose number in series was 1. No concomitant medications were reported.  On 06-DEC-2021, the patient started experiencing sneezing. On 07-DEC-2021, the patient got tested with rapid home Covid-19 test which resulted positive (suspected covid-19 infection, suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211217553-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; 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: 10808609, and expiry: 07-SEP-2021) dose was not reported, administered on 04-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-DEC-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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: FEVER OF OVER 100 F; BODY ACHE; PAIN ON BOTH ARMS; NAUSEA; This spontaneous report received from a parent concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: quadriplegia, alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for coronavirus 19 prevention. No concomitant medications were reported.  On 08-APR-2021, the patient experienced body ache. On 08-APR-2021, the patient experienced pain on both arms. On 08-APR-2021, the patient experienced nausea. On 09-APR-2021, the patient experienced fever of over 100 f. Laboratory data included: Body temperature (NR: not provided) OVER 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 11-APR-2021, pain on both arms, and fever of over 100 f on 10-APR-2021, and nausea on 09-APR-2021. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Skin discolouration, Urticaria
Clinical narrative: SKIN DISCOLORATIONS ON RIGHT SIDE GLUTEUS; DIZZINESS; VERY TIRED; WELT UNDER RIGHT BREAST AND ON STOMACH AREA; VERY NAUSEOUS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, non-smoker, and non-alcoholic user, and other pre-existing medical conditions included: the patient had No known drug allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A, expiry: UNKNOWN) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced very nauseous. On 03-DEC-2021, the patient experienced welt under right breast and on stomach area. On 04-DEC-2021, the patient experienced skin discolorations on right side gluteus. On 04-DEC-2021, the patient experienced dizziness. On 04-DEC-2021, the patient experienced very tired. Treatment medications (dates unspecified) included: methylprednisolone, and cetirizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, very nauseous, and very tired on 06-DEC-2021, and had not recovered from skin discolorations on right side gluteus, and welt under right breast and on stomach area. This report was non-serious. This case, from the same reporter is linked to 20211217775.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR FALLING OUT IN CLUMPS/ HAIR THINNING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 NOV-2021, the patient experienced hair falling out in clumps/ hair thinning. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from hair falling out in clumps and hair thinning. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Pain, Pyrexia
Clinical narrative: ACHES; ACHED -BACK OF THE INSIDE OF MY EYEBALLS AND IT HURTS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number was 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 aches, ached -back of the inside of my eyeballs and it hurts, and fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from ached -back of the inside of my eyeballs and it hurts, and the outcome of aches and fever was not reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms for couple of days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Tracheostomy (tracheotomy on their neck). Concurrent medical conditions included Lung disorder NOS, Blood pressure high and Blood glucose abnormal. Concomitant products included VITAMIN D [VITAMIN D NOS] and VITAMIN B NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms for couple of days). At the time of the report, PAIN IN EXTREMITY (sore arms for couple of days) had resolved.            Concomitant product include medication for sugar,medication for high blood pressure and 4 different inhalers for lung problems. No treatment information was provided.   This case was linked to MOD-2021-405059, MOD-2021-405079 (Patient Link).
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: half dose given instead of full dose,patient never received 2nd full dose; 2nd dose (0.25 ml) given > 35 days from 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (half dose given instead of full dose,patient never received 2nd full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose (0.25 ml) given > 35 days from 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B and J07BX03) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 30-Nov-2021, the patient experienced UNDERDOSE (half dose given instead of full dose,patient never received 2nd full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose (0.25 ml) given > 35 days from 1st dose). On 30-Nov-2021, UNDERDOSE (half dose given instead of full dose,patient never received 2nd full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose (0.25 ml) given > 35 days from 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-405897 (Patient Link).
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021 at 11:32 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Sep-2021 at 1:27 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported   This case was linked to MOD-2021-405869 (Patient Link).
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 11:51 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant medication information provided. No treatment information provided.   This case was linked to MOD-2021-405858 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients administered unpunctured vials stored in refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered unpunctured vials stored in refrigerator beyond 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered unpunctured vials stored in refrigerator beyond 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered unpunctured vials stored in refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow-up received contains: no new information.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 9:26 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 4:14 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 11-Nov-2021 at 4:14 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Nov-2021 at 4:14 PM, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment details provided. The reporter stated that the vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021 at 11:08 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 30-Sep-2021 at 11:08 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Sep-2021 at 11:08 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.  Reporter stated that the vaccine facility members placed the vaccines into the freezer the same day they were delivered. They only removed a vial from the freezer and put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.  Vaccine facility members did not have a vial stay in the refrigerator for more than a week, since all unused vials were utilized for the patients. Then only removed enough vials to provide vaccines for those scheduled for that day and provided scheduled vaccines, no walk-ins.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Feeling abnormal, Vaccination complication, Vaccination site pain
Clinical narrative: A little bit more of a reaction,much more severe; Truck ran over,felt 90% (at the end of the day),lay down for a couple of hours; For the booster dose, patient had a sore arm arm (left) immediately; It says 0.5 mL (instead of half dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A little bit more of a reaction,much more severe), FEELING ABNORMAL (Truck ran over,felt 90% (at the end of the day),lay down for a couple of hours), VACCINATION SITE PAIN (For the booster dose, patient had a sore arm arm (left) immediately) and ACCIDENTAL OVERDOSE (It says 0.5 mL (instead of half dose)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 002B21A and 040B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, IRBESARTAN and ATORVASTATIN for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced VACCINATION SITE PAIN (For the booster dose, patient had a sore arm arm (left) immediately) and ACCIDENTAL OVERDOSE (It says 0.5 mL (instead of half dose)). On 05-Dec-2021, the patient experienced VACCINATION COMPLICATION (A little bit more of a reaction,much more severe) and FEELING ABNORMAL (Truck ran over,felt 90% (at the end of the day),lay down for a couple of hours). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of Couple of Motrin. On 04-Dec-2021, ACCIDENTAL OVERDOSE (It says 0.5 mL (instead of half dose)) had resolved. At the time of the report, VACCINATION COMPLICATION (A little bit more of a reaction,much more severe), FEELING ABNORMAL (Truck ran over,felt 90% (at the end of the day),lay down for a couple of hours) and VACCINATION SITE PAIN (For the booster dose, patient had a sore arm arm (left) immediately) outcome was unknown.            No medical history was provided by the reporter.  The patient stated that they went to get the Moderna booster shot and when they saw their vaccination card, it said that they got a full dose of 0.5 mL. The patient stated that they had a little bit more of a reaction to the booster and also mentioned that for the booster, the agent couldn't confirm if it was full dose or half dose, the patient had a sore arm on the left immediately. On 05-Dec-2021 the patient felt like a truck ran over them and had to lay down for a couple of hours. And it had to pass most of the day for them to feel around 90% of how they usually felt, and it was much more severe than the first two shots.  It was also reported that the patient had couple of Motrin and it helped.   This case was linked to MOD-2021-405279, MOD-2021-405832 (Patient Link).
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 9:17 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-399960 (Patient Link).
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 16-Sep-2021 at 9:16 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 16-Sep-2021 at 9:16 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021 at 9:16 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-405653, MOD-2021-399960 (Patient Link).
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No Treatment were reported