chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Heavy menstrual bleeding, Juvenile idiopathic arthritis, Menstruation irregular, Off label use, Pyrexia
Clinical narrative: JUVENILE IDIOPATHIC ARTHRITIS AGGRAVATED/ POSSIBLE OUT GROWN JUVENILE IDIOPATHIC ARTHRITIS; IRREGULAR PERIODS; HEAVY PERIODS; GOT SICK WITH A FEVER; DENTAL FILLINGS; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 14 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: moderate to severe polyarticular juvenile idiopathic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for covid-19 prophylaxis which was an Off label use (off label use in unapproved age group). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 14 years old. No concomitant medications were reported. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1159243 and 1162439 expiry: UNKNOWN) dose was not reported, citrate free, frequency not reported, and therapy dates were not reported administered for moderate to severe polyarticular juvenile idiopathic arthritis.   On 28-JUN-2022, the patient experienced dental fillings.  On an unspecified date, the patient experienced juvenile idiopathic arthritis aggravated/ possible out grown juvenile idiopathic arthritis, irregular periods, heavy periods, and got sick with a fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the irregular periods, heavy periods, dental fillings, juvenile idiopathic arthritis aggravated/ possible out grown juvenile idiopathic arthritis, got sick with a fever, and off label use in unapproved age group was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220848362-covid-19 vaccine ad26.cov2.s-Juvenile idiopathic arthritis aggravated/ possible out grown juvenile idiopathic arthritis. 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: UNDERLYING DISEASE. Therefore, this event(s) is considered not related.
Age: 14.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tooth restoration
Clinical narrative: JUVENILE IDIOPATHIC ARTHRITIS AGGRAVATED/ POSSIBLE OUT GROWN JUVENILE IDIOPATHIC ARTHRITIS; IRREGULAR PERIODS; HEAVY PERIODS; GOT SICK WITH A FEVER; DENTAL FILLINGS; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 14 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: moderate to severe polyarticular juvenile idiopathic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for covid-19 prophylaxis which was an Off label use (off label use in unapproved age group). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 14 years old. No concomitant medications were reported. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1159243 and 1162439 expiry: UNKNOWN) dose was not reported, citrate free, frequency not reported, and therapy dates were not reported administered for moderate to severe polyarticular juvenile idiopathic arthritis.   On 28-JUN-2022, the patient experienced dental fillings.  On an unspecified date, the patient experienced juvenile idiopathic arthritis aggravated/ possible out grown juvenile idiopathic arthritis, irregular periods, heavy periods, and got sick with a fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the irregular periods, heavy periods, dental fillings, juvenile idiopathic arthritis aggravated/ possible out grown juvenile idiopathic arthritis, got sick with a fever, and off label use in unapproved age group was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220848362-covid-19 vaccine ad26.cov2.s-Juvenile idiopathic arthritis aggravated/ possible out grown juvenile idiopathic arthritis. 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: UNDERLYING DISEASE. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received elasomeran (Moderna Covid-19 vaccine) (dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, for covid-19 prophylaxis. No adverse events were reported following vaccination with elasomeran (Moderna Covid-19 vaccine) (dose number in series 1). The patient additionally received 2 or 3 booster covid-19 vaccine (unspecified manufacturer, some of them were also with Moderna). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient was very vague when he was asked if he took JNJ vaccine. Non-company suspect vaccine included: elasomeran (Moderna) (dose number in series 3) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis.- On an unspecified date in AUG-2022, the patient contracted COVID (suspected covid-19 infection, dose number in series 3) and took a medication called Paxlovid (nirmatrelvir, ritonavir) on 22-AUG-2022. The patient received non-company suspect Paxlovid (nirmatrelvir, ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 22-AUG-2022 for covid-19 treatment. On an unspecified date in AUG-2022, the patient experienced diarrhea (dose number in series 3). He wanted to know if he could take Imodium (loperamide) for his symptoms. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the diarrhea and suspected covid-19 infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a patient concerned an adult male 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 and expiry: unknown) dose was not reported, 01 total administered, 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.  On an unspecified date (3 days after vaccination), the patient experienced bells palsy (left side of the face and eye were drooping). Patient visited ED (emergency department) and was receiving physical therapy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bells palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220849826- covid-19 vaccine ad26.cov2.s -Bell's palsy. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Multiple allergies
Clinical narrative: ALLERGIES; This spontaneous report received from a pharmacist 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergies was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: TWO COVIDS; This spontaneous report received from a patient 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 two covids. Treatment medications (dates unspecified) included: hydroxychloroquine and ivermectin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two covids was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000247860.
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Menstrual disorder
Clinical narrative: MENSTRUATION CHANGES; HORMONAL CHANGES; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced menstruation changes, and hormonal changes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the menstruation changes and hormonal changes was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a consumer concerned a 66 year old male. 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 was not reported, administered on APR-2021 for covid-19 prophylaxis. Age at time of vaccination 66 years old. The batch number was not reported and has been vaccinated. No concomitant medications were reported. On 2021, the patient experienced got Covid. Laboratory data (dates unspecified) included: Antibody test had monoclonal antibody, and COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got Covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220832455.
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Peripheral swelling, Pruritus, Rash, Scab
Clinical narrative: his arms and hands became very itchy; started to swell up; eczema; lead to open sores, scabs, and puss; create rashes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (his arms and hands became very itchy), PERIPHERAL SWELLING (started to swell up), ECZEMA (eczema), SCAB (lead to open sores, scabs, and puss) and RASH (create rashes) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (his arms and hands became very itchy), PERIPHERAL SWELLING (started to swell up), ECZEMA (eczema), SCAB (lead to open sores, scabs, and puss) and RASH (create rashes). At the time of the report, PRURITUS (his arms and hands became very itchy), PERIPHERAL SWELLING (started to swell up), ECZEMA (eczema), SCAB (lead to open sores, scabs, and puss) and RASH (create rashes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided. The patient was in his 30s. Patient had received the Moderna dose last year. No changes were noticed immediately after the administration of vaccine. However, after 3 weeks to a month, he started to experience the adverse events. It was almost a year by the time of reporting, and patient was still dealing with the complicated effects of having this vaccine.  Patient was given cream for his eczema which was healing for some time but whenever it healed, the itchiness would come back and cause his scabs to reopen or create puss again. It was further reported that the patient's hands and arms seriously looked painful and almost rotten in certain areas. Patient was completely healthy, and he doesn't get as sick either.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: Dry cough/Persistent dry cough; received 2 dose more than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough/Persistent dry cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 dose more than 35 days after 1st dose) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 052BZZA and 016J212A) for COVID-19 prophylaxis.     Patient had no known allergies. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in 2021 and Skin disorder. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for Headache.   On 28-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 10-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 10-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 dose more than 35 days after 1st dose). On 11-Aug-2022, the patient experienced COUGH (Dry cough/Persistent dry cough). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Dry cough/Persistent dry cough) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 dose more than 35 days after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: (Positive) Positive.         It was reported that they tried to get patient vaccinated sooner but were not able to. Patient had COVID test before vaccines in Summer of 2021. Not hospitalized, was sick for 2 weeks. Symptoms lasted 2 weeks, however, cough lingered for 1 month.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 95-year-old female patient who received mRNA-1273 for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) hours post puncture).    Concomitant drugs were not reported.  It was reported that patient received second booster dose.  It was reported that the vial was initially stored in refrigerator on 04-Aug-2022. The vial was stored at room temperature post puncture for 25 hours and did not undergo any temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-633797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-633797:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder, Eczema
Clinical narrative: Covid-19; Eczema; heartbeat problems; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), ECZEMA (Eczema) and CARDIAC DISORDER (heartbeat problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19), ECZEMA (Eczema) and CARDIAC DISORDER (heartbeat problems). At the time of the report, COVID-19 (Covid-19), ECZEMA (Eczema) and CARDIAC DISORDER (heartbeat problems) outcome was unknown.            No concomitant medications were reported. It was reported that patient had skin problems and itching and patient went to dermatologist to get the medication to treat the itching and was diagnosed with eczema. Symptoms of COVID-19 was reported as breathing problems. Symptoms of Eczema were reported as hives, itching, skin problems and rash problem. No treatment medications were reported.  Company Comment This spontaneous case concerns an unknown-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of eczema, cardiac disorder and other expected event  unknown days after 2nd. dose of  mRNA-1273 vaccine.  Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of eczema, cardiac disorder and other expected event  unknown days after 2nd. dose of  mRNA-1273 vaccine.  Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions), EXPIRED PRODUCT ADMINISTERED (Vial was at frozen storage condition at the time of the excursion) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A and 022C2AA) for COVID-19 prophylaxis. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions), EXPIRED PRODUCT ADMINISTERED (Vial was at frozen storage condition at the time of the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions), EXPIRED PRODUCT ADMINISTERED (Vial was at frozen storage condition at the time of the excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Vial was at frozen storage condition at the time of the excursion). Patient had no Allergies reported. Patient did not have any medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient was never diagnosed COVID-19 Positive. Patient had not experienced similar event in the past. No other vaccine was administered 1 month prior to Moderna vaccine. No concomitant medications were reported. It was reported that the temperature excursions started from the day vaccines were received on 24-Jun-2022 until 24-Aug-2022 because the freezer was not acceptable, there were no details at what temperature the vials were kept due to unavailability. Total 4 doses were administered out of 100 doses. Administered dose out of a 100 doses past the 30 day use by date. The vial was never stored in the refrigerator. Vial did undergo Temperature Excursions, including the storage condition at the time of the excursion was Frozen storage. The vial was never moved from freezer to refrigerator. Vials were then stored in the Freezer. There was no visual inspection noted on vaccine state change. Total 96 doses were impacted. Total one vial was punctured and discarded. No treatment details were reported.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna) and NO ADVERSE EVENT (No adverse event) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Aug-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Incorrect product/dosage was administered, resulting in a lower-than-authorized dose of Moderna).    No concomitant medication was reported.  It was reported that they inadvertently gave lot AR4504B 0.5ml IM instead of Regular Moderna. On 23-Aug-2022, a patient received the first dose of the Moderna COVID-19 vaccine from a vial authorized for use in a different age group. The patient had not reported any adverse reactions.  No treatment information was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first 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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            No concomitant drug were reported. No treatment medications were reported.  The reporter's causality for the event of COVID with Humira (ADALIMUMAB) was no reasonable possibility.  Co-suspect product ADALIMUMAB (HUMIRA) action taken was withdrawn.  Company Comment:    This is an spontaneous case concerning an unknown-years-old female patient with medical history of Co-suspect product included non-company product ADALIMUMAB who experienced the unexpected AESI of COVID-19  unknown days after the 3rd. dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment:    This is an spontaneous case concerning an unknown-years-old female patient with medical history of Co-suspect product included non-company product ADALIMUMAB who experienced the unexpected AESI of COVID-19  unknown days after the 3rd. dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Adverse side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Adverse side effects) in an 8-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Adverse side effects). At the time of the report, IMMUNISATION REACTION (Adverse side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Impaired work ability, Peroneal nerve palsy
Clinical narrative: not being able to work/I can't work; not being able to walk; diagnosed with foot drop of the left foot, neurological symptom/ Patient can't lift her foot to walk, which makes her fall; This spontaneous case was reported by a nurse and describes the occurrence of IMPAIRED WORK ABILITY (not being able to work/I can't work), GAIT INABILITY (not being able to walk) and PERONEAL NERVE PALSY (diagnosed with foot drop of the left foot, neurological symptom/ Patient can't lift her foot to walk, which makes her fall) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 032l20a) for COVID-19 vaccination.     The patient had never been diagnosed with/ tested positive for COVID-19.  The patient had no acute and chronic illness at the time of vaccination.  Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  The patient to seek medical care like office visit due to adverse events and patient did not had insurance when patient received the vaccine.  The patient had not experienced similar adverse event in the past.  Concurrent medical conditions included Latex allergy, Sulfonamide allergy (Sulfa drugs), Asthma and Blood pressure. Concomitant products included LISINOPRIL and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PERONEAL NERVE PALSY (diagnosed with foot drop of the left foot, neurological symptom/ Patient can't lift her foot to walk, which makes her fall). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (not being able to work/I can't work) and GAIT INABILITY (not being able to walk). The patient was treated with Physical therapy for Gait inability and Physical therapy for Peroneal nerve palsy. At the time of the report, IMPAIRED WORK ABILITY (not being able to work/I can't work) and GAIT INABILITY (not being able to walk) outcome was unknown and PERONEAL NERVE PALSY (diagnosed with foot drop of the left foot, neurological symptom/ Patient can't lift her foot to walk, which makes her fall) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included Asthma medication, Inhaler as needed, Blood Pressure medication. Patient was not happy. There is no treatment, there is physical therapy.   This case was linked to MOD-2021-034005 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022; No adverse event; Moderna dose administered to patient 2 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna dose administered to patient 2 days after beyond use date) and PRODUCT STORAGE ERROR (The vial used to administer this dose was placed in the refrigerator on 21-JUL-2022 and vaccine was administered on 22-Aug-2022).    No concomitant drug was reported. The patient had not reported and adverse reactions at that time. No treatment drug was reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1st shot of the primary series, a 1st booster and a 2nd booster dose of the Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The concomitant medication included steroids (unspecified).  On an unknown date, the patient received the 1st booster dose and 2nd booster dose. The patient did not get 2nd dose and 3rd dose of the primary series as for immunocompromised people. The reporter was confused because did not understand if her husband should get another shot to be fully protected.  It was unknown if patient experienced any symptoms or if any treatment was given.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; bone marrow transplant patient given 0.25ml as 1st dose for the restart dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bone marrow transplant in April 2022.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 assessment was provided for INCORRECT DOSE ADMINISTERED (bone marrow transplant patient given 0.25ml as 1st dose for the restart dose).    No concomitant medications were reported.  Reporter stated that a patient had a bone marrow transplant and received the Moderna Covid-19 vaccine at 0.25ml in Jul2022. HCP stated that they need to restart the series in bone marrow transplant patients.  No treatment details were reported.   Reporter did not allow further contact
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red bumps at the injections site) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red bumps at the injections site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) had not resolved and VACCINATION SITE ERYTHEMA (red bumps at the injections site) had resolved with sequelae. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. A week later, patient got some red bumps at the injections site that had smoothed out. She now had some itching at the injection site. The recent changes in status such as improvement or worsened condition for the event, vaccination site erythema was reported as improved with outcome residual effects and for the event vaccination site pruritus reported as Worsened with ongoing outcome.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient was immunocompromised and received a 1 shot of the primary series, 1st booster and a 2nd booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant drug was reported.  Patient was confused because patient did not understand if due to her condition, patient should get another shot to be fully protected. Patient wanted to know whether patient could receive another shot of the vaccine after patient received 1 primary shot and 2 boosters.  It was unknown if patient experienced any symptoms or if any treatment was given.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: No adverse event; Patient received a full third dose and 1st booster dose , Patient was not immunocompromised; Patient received a full third dose , Patient was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received a full third dose , Patient was not immunocompromised), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a full third dose and 1st booster dose , Patient was not immunocompromised) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033R212A, 062E21A, 012A21A and 041L21A) for COVID-19 vaccination.     Family history included Immunocompromised (Patient stated his immunocompromise wife) since an unknown date. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 01-Sep-2021 to an unknown date for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 22-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received a full third dose , Patient was not immunocompromised). On 27-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a full third dose and 1st booster dose , Patient was not immunocompromised). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Patient received a full third dose , Patient was not immunocompromised), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a full third dose and 1st booster dose , Patient was not immunocompromised) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Patient had no Allergies with medications, food and other products.   Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-026251.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026251:Dose 2
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2022 at 2:23 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 22-Feb-2022 at 2:23 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022).    Concomitant medications were not reported.  Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no chronic long standing health conditions. On 10-Dec-2021, at 12:38 PM patient received first dose of Moderna Covid-19 vaccine at a posology of 0.5 ml intramuscularly on left deltoid. The batch number was reported as 037f21a.  There was no ill reaction associated with this event.  Treatment medications were not reported.   This case was linked to MOD-2022-632620 (Patient Link).