chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Abdominal pain, Atrial fibrillation, Constipation, Diarrhoea, Flatulence
Clinical narrative: A FIB; GAS; ABDOMINAL PAIN; STOMACH PROBLEMS; CONSTIPATION; DIARRHEA; This spontaneous report received from patient via other manufacturer concerned a 70 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: idiopathic pulmonary fibrosis. 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, 1 total, for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nintedanib esilate (capsule, oral, batch number was not reported) 150 mg, 1 time every 12 hours, from 24-MAY-2021 for idiopathic pulmonary fibrosis.  Concomitant medications included loperamide for drug used for unknown indication.  On an unspecified date (around Christmas, also reported as was diagnosed in JAN), the patient experienced A fib (atrial fibrillation).  The patient received company suspect Xarelto (rivaroxaban) (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for atrial fibrillation.  On an unspecified date, the patient experienced gas, abdominal pain, stomach problems, constipation, and diarrhea. The patient had emergency room (ER) visit for pain 2 days ago and she was diagnosed of gas pocket. The patient stated that he had been experiencing stomach problems. He mentioned that he went to the emergency room Saturday Night and they told him that it was gas, but he don't think that was the problem. He stated that he thought he needed to try different foods with the medication. In MAR-2022, the patient had surgery for watchman device.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with rivaroxaban was not reported; and dose of nintedanib esilate was not changed. The patient had not recovered from diarrhea, constipation, and a fib, and the outcome of stomach problems, abdominal pain, and gas was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220910239.; Sender's Comments: V0: 20220864773-covid-19 vaccine ad26.cov2.s- Atrial fibrillation. 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). Therefore, this event(s) is considered unassessable.  20220864773-Xarelto -Atrial fibrillation. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Gastric disorder
Clinical narrative: A FIB; GAS; ABDOMINAL PAIN; STOMACH PROBLEMS; CONSTIPATION; DIARRHEA; This spontaneous report received from patient via other manufacturer concerned a 70 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: idiopathic pulmonary fibrosis. 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, 1 total, for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nintedanib esilate (capsule, oral, batch number was not reported) 150 mg, 1 time every 12 hours, from 24-MAY-2021 for idiopathic pulmonary fibrosis.  Concomitant medications included loperamide for drug used for unknown indication.  On an unspecified date (around Christmas, also reported as was diagnosed in JAN), the patient experienced A fib (atrial fibrillation).  The patient received company suspect Xarelto (rivaroxaban) (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for atrial fibrillation.  On an unspecified date, the patient experienced gas, abdominal pain, stomach problems, constipation, and diarrhea. The patient had emergency room (ER) visit for pain 2 days ago and she was diagnosed of gas pocket. The patient stated that he had been experiencing stomach problems. He mentioned that he went to the emergency room Saturday Night and they told him that it was gas, but he don't think that was the problem. He stated that he thought he needed to try different foods with the medication. In MAR-2022, the patient had surgery for watchman device.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with rivaroxaban was not reported; and dose of nintedanib esilate was not changed. The patient had not recovered from diarrhea, constipation, and a fib, and the outcome of stomach problems, abdominal pain, and gas was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220910239.; Sender's Comments: V0: 20220864773-covid-19 vaccine ad26.cov2.s- Atrial fibrillation. 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). Therefore, this event(s) is considered unassessable.  20220864773-Xarelto -Atrial fibrillation. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Weight decreased
Clinical narrative: WEIGHT LOSS; SIDE EFFECTS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced weight loss, and side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weight loss and side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Condition aggravated, Psoriasis
Clinical narrative: PSORIASIS; CONDITION AGGRAVATED; COVID-19 RECURRENT; This spontaneous report received from a patient concerned an adult female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total (first dose, 1 in 1 once) administered on 21-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from JUL-2022 for an unspecified indication.   On an unspecified date, the patient had bad reaction to the covid vaccine, severe fatigue, fever, headache, muscle pain and felt like she had COVID-19 again  (covid-19 recurrent), limbs stiffness (psoriasis) and condition aggravated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn on JUL-2022. The patient had not recovered from condition aggravated, and the outcome of psoriasis and covid-19 recurrent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220901910- Covid-19 vaccine ad26.cov2.s- Psoriasis. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Endometriosis, Uterine leiomyoma
Clinical narrative: ENDOMETRIOSIS; FIBROIDS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced endometriosis, and fibroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the endometriosis and fibroids was not reported. This report was non-serious. This case, involving the same patient is linked to 20220908814.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: A MILD 8 HOUR DELAYED BLAH FEELING REACTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on MAR-2021 for covid-19 prophylaxis.  The patient had no adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient additionally received a booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced a mild 8 hour delayed blah feeling reaction to the booster (Dose number in series 2).  The reporter stated that both them (patient) and his elderly mother had been initially vaccinated with J and J vaccine and boosted with J and J vaccine. No adverse event experienced for first dose and patient experienced 8 hour delayed blah feeling reaction to the booster. So far neither of them had a positive or symptomatic covid infection (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a mild 8 hour delayed blah feeling reaction on DEC-2021. This report was non-serious. This case, from the same reporter is linked to 20220909064.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via other company (Pfizer) concerned a 44 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: drug allergy (unspecified), and other pre-existing medical conditions included: patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series was 1) (form, route of administration, batch number, dose were not reported, expiry: unknown) for prophylactic vaccination.  No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received non-company suspect Paxlovid (Nirmatrelvir; ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) therapy started on 12-AUG-2022. Therapy ended on 17-AUG-2022 administered for covid-19 treatment. On 16-AUG-2022, the patient experienced covid-19 again (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: 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. The patient's concurrent conditions included: systemic lupus erythematosus, and allergy. 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 12-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 42 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Thrombosis
Clinical narrative: BLOOD CLOT; LOST SIGHT IN LEFT EYE; This spontaneous report received from a patient via a company representative via social media concerned a female of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had a blood clot and lost sight in the left eye. The patient reported that " Had a blood clot lost sight in my left eye over the J&J shot ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and lost sight in left eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220906147-covid-19 vaccine ad26.cov2.s-Blood Clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220906147- Covid-19 vaccine ad26.cov2.s- Lost sight in left eye . 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hysterectomy
Clinical narrative: HYSTERECTOMY; This spontaneous report received from a patient via other company (Agency) concerned an adult female  The patient's height, and weight were not reported.  The patient's pre-existing medical conditions included: There was no reported medical history. The patient previously received covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  On an unspecified date, patient experienced endometriosis and fibroids following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Non-company suspect drug included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication.  On an unspecified date, the patient experienced hysterectomy (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of hysterectomy was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220902080 (Dose number in series 1 case).; Sender's Comments: V0: 20220908814-covid-19 vaccine ad26.cov2.s-Hysterectomy. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: A MILD 8 HOUR DELAYED BLAH FEELING REACTION; This spontaneous report received from a consumer concerned an elderly female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for covid-19 prophylaxis.  The patient had no adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on DEC-2021 for covid-19 prophylaxis. Drug start period was 8 hours. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced a mild 8 hour delayed blah feeling reaction to the booster (Dose number in series 2).  Reporter stated that both him and the patient (elderly mother) had been initially vaccinated with J and J vaccine and also boosted with J and J vaccine. No adverse event experienced for first dose and patient experienced 8 hour delayed blah feeling reaction to the booster. So far neither of them had a positive or symptomatic covid infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a mild 8 hour delayed blah feeling reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220904494.
Sex: U
Vaccine: COVID19
Symptoms: Dialysis
Clinical narrative: DIALYSIS 2 DAYS AFTER COVID VACCINE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced dialysis 2 days after covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dialysis 2 days after covid vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: BLIND IN RIGHT EYE; This spontaneous report received from a parent via a company representative via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient go blind in his right eye. The reporter stated that "The J-and J shots made my son go blind in his right eye". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blind in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220909463-covid-19 vaccine ad26.cov2.s -blind in right eye. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19, UNK, UNK
Symptoms: Feeling abnormal
Clinical narrative: FELT BAD THE DAY; This spontaneous report received from patient via other manufacturer (Company) concerned a 70 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included: idiopathic pulmonary fibrosis. The patient received covid-19 vaccine ad26.cov2.s  (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for covid-19 prophylaxis.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date of APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested.  Non-company suspect drugs included: nintedanib esilate (capsule, oral, batch number was not reported) 150 mg, 1 time every 12 hours, from 24-MAY-2021 for idiopathic pulmonary fibrosis.  Concomitant medications included loperamide for drug used for unknown indication.  On an unspecified date (around Christmas, also reported as was diagnosed in JAN), the patient experienced A fib (atrial fibrillation)(Dose number in series 1).  The patient received company suspect Xarelto (rivaroxaban) (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for atrial fibrillation.  On an unspecified date, the patient experienced gas, abdominal pain, stomach problems, constipation, and diarrhea (Dose number in series 1). The patient had emergency room (ER) visit for pain 2 days ago and she was diagnosed of gas pocket. The patient stated that he had been experiencing stomach problems . He mentioned that he went to the emergency room Saturday Night and they told him that it was gas, but he don't think that was the problem. He stated that he thought he needed to try different foods with the medication. On APR-2022, the patient experienced felt bad the day (dose number in series 2). In MAR-2022, the patient experienced surgery for watchman device (Dose number in series 1).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with rivaroxaban was not reported; and dose of nintedanib esilate was not changed. The outcome of felt bad the day was not reported. This report was non-serious. This case, involving the same patient is linked to 20220864773.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Death
Clinical narrative: DEATH; ADVERSE REACTION; 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 weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse reaction and death. On an unspecified date, the patient died from adverse reaction to vaccine. The reporter reported "My friend's ex wife just dropped dead shortly after an adverse reaction to vaccine. She was forced yo get it or lose her job. Now her 20 yr old daughter has no parents. Covid VAX is a death sentence for those age 30-50. Do not get it." It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of adverse reaction was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220910829-covid-19 vaccine ad26.cov2.s -Death, Adverse reaction. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: ADVERSE REACTION TO VACCINE
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Tinnitus
Clinical narrative: POSITIVE FOR COVID; TINNITUS (HAS GOTTEN PROGRESSIVELY WORSE IN BOTH EARS); This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 16-FEB-2022) dose was not reported, administered on 06-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 60 years old. No concomitant medications were reported. On OCT-2021, the patient experienced tinnitus (has gotten progressively worse in both ears). On JUL-2022, the patient experienced positive for covid. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus (has gotten progressively worse in both ears), and the outcome of positive for covid was not reported. This report was non-serious. This report was associated with product quality complaint 90000249347
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. The batch number was not reported and has been requested. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, from the same reporter is linked to 20220913642 and 20220913752.
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 1 administered for covid-19 prophylaxis. On an unspecified the patient experienced penis got bigger (Dose number in series 1). The outcome of penis got bigger was not reported. The patient had received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 2 administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total, dose 3 administered for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that "Janssen please bring a covid booster back to market, im a healthcarehero and i had 3 jandj shots and the only side effect i had was my penis got bigger. I refuse to take a mrna vaccine. If yall dont want a [redacted] to lose his job please make a new omicron/flu booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220909146 (Dose number in series 1).
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Headache, Respiratory disorder, Tongue disorder
Clinical narrative: LOSS OF BALANCE; BREATHING PROBLEMS; PROBLEMS WITH TONGUE; HEADACHES; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (LOSS OF BALANCE), RESPIRATORY DISORDER (BREATHING PROBLEMS), TONGUE DISORDER (PROBLEMS WITH TONGUE) and HEADACHE (HEADACHES) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On an unknown date, the patient experienced BALANCE DISORDER (LOSS OF BALANCE), RESPIRATORY DISORDER (BREATHING PROBLEMS), TONGUE DISORDER (PROBLEMS WITH TONGUE) and HEADACHE (HEADACHES). At the time of the report, BALANCE DISORDER (LOSS OF BALANCE), RESPIRATORY DISORDER (BREATHING PROBLEMS), TONGUE DISORDER (PROBLEMS WITH TONGUE) and HEADACHE (HEADACHES) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2022: Upon internal review on 08-Sep-2022, non-significant correction was performed to uncheck Drug not administered check box for suspect.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia
Clinical narrative: Patient had a low grade fever and stayed in bed for 1 day; Patient had a low grade fever and stayed in bed for 1 day; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Patient had a low grade fever and stayed in bed for 1 day) and PYREXIA (Patient had a low grade fever and stayed in bed for 1 day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 023M20A and 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ASTHENIA (Patient had a low grade fever and stayed in bed for 1 day) and PYREXIA (Patient had a low grade fever and stayed in bed for 1 day). On 28-Jan-2021, ASTHENIA (Patient had a low grade fever and stayed in bed for 1 day) and PYREXIA (Patient had a low grade fever and stayed in bed for 1 day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: Her normal temperature is usually at 97.9F and she could feel it was higher but does not remember the reading..         No concomitant medication were reported.  It was reported that patient took booster dose on 11-NOV-2021 of Lot-067F21A.  It was reported that patient had a low grade fever and stayed in bed for one day even after Dose 2 of Moderna vaccine. After the booster, She did not had any side effects.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 27Jul2022, vaccine administered on 31Aug2022).    No concomitant medications were reported. It was reported that 3 kids who got the Moderna 6 month to 5-year-old lot number AS1412B yesterday 31Aug2022 and it looks like it expired on the 27th.  The patient was under 5 years of age. The vial was initially stored in the refrigerator on 27-Jul-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine expired on 20May2022, vial was initially stored in the refrigerator on 7JUN2022, vaccine administrated on 8JUN2022; No adverse event; 27 Patient received booster doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (27 Patient received booster doses of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (vaccine expired on 20May2022, vial was initially stored in the refrigerator on 7JUN2022, vaccine administrated on 8JUN2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (27 Patient received booster doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine expired on 20May2022, vial was initially stored in the refrigerator on 7JUN2022, vaccine administrated on 8JUN2022). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (27 Patient received booster doses of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (vaccine expired on 20May2022, vial was initially stored in the refrigerator on 7JUN2022, vaccine administrated on 8JUN2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (27 Patient received booster doses of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (vaccine expired on 20May2022, vial was initially stored in the refrigerator on 7JUN2022, vaccine administrated on 8JUN2022).    Concomitant medication information was not provided by the reporter.  The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-642647.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Follow-up received contains suspect product details added. On 02-Sep-2022: Follow-up received contains no new information
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022; No adverse event; Patient administerd booster dose of expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administerd booster dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 20-May-2022 and stored in refrigerator on 07-Jun-2022 and administered on 08-Jun-2022).    No concomitant medications were reported.  The patient received booster dose.  It was reported that the medical assistant saw that the expiration date was 20-Jun-2022 when looked that up before however medical assistant had nothing in writing or printed to confirm the expiration date of 20-Jun-2022. Patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date.  It was reported that the vial was initially stored in the refrigerator on 07-Jun-2022. The vial did not undergo any temperature excursions.  The patient did not experienced any adverse events.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow up received contains product dose details added. Expiry date updated. On 02-Sep-2022: Live follow up received contains non significant information.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: Liver enzymes up; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (Liver enzymes up) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Liver enzymes up). At the time of the report, HEPATIC ENZYME INCREASED (Liver enzymes up) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Up and went down.         Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. On unknown date, the patient experienced HURMIRA STOPPED WORKING with HUMIRA (ADALIMUMAB).
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022; No adverse event; Booster dose given after 19 days of expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.), PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.), PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Booster dose given after 19 days of expiration date.) and PRODUCT STORAGE ERROR (Vial expired on 20-May-2022 was initialy stored in refrigerator on 7-Jun-2022 and was administered on 8-Jun-2022).    No concomitant medications were reported. It was reported that vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo temperature excursions. No adverse event was reported. The expiration date of vial was reported as 20-May-2022. No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow-up contains: Patient demographics and suspect product details updated. On 02-Sep-2022: Live follow-up contains no new information.