chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, PNC13
Symptoms: Animal bite
Clinical narrative: Dog bite; This spontaneous case was reported by an other health care professional and describes the occurrence of ANIMAL BITE (Dog bite) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication.    Previously administered products included for Dog bite: RABIES VACCINE. Past adverse reactions to the above products included No adverse event with RABIES VACCINE.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (unknown route) Dose 1. In April 2021, the patient experienced ANIMAL BITE (Dog bite). At the time of the report, ANIMAL BITE (Dog bite) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Ligament sprain, Musculoskeletal stiffness, Nasopharyngitis, Pain
Clinical narrative: Cold; Fall; Stiffness; Sprained ankle; Scratch; Pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), FALL (Fall), MUSCULOSKELETAL STIFFNESS (Stiffness), LIGAMENT SPRAIN (Sprained ankle) and SCRATCH (Scratch) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), FALL (Fall), MUSCULOSKELETAL STIFFNESS (Stiffness), LIGAMENT SPRAIN (Sprained ankle), SCRATCH (Scratch) and PAIN (Pain). At the time of the report, NASOPHARYNGITIS (Cold), FALL (Fall), LIGAMENT SPRAIN (Sprained ankle) and SCRATCH (Scratch) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (Pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment medication information provided  No concomitant medication information provided
Sex: F
Vaccine: COVID19, UNK
Symptoms: Scratch
Clinical narrative: Cold; Fall; Stiffness; Sprained ankle; Scratch; Pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), FALL (Fall), MUSCULOSKELETAL STIFFNESS (Stiffness), LIGAMENT SPRAIN (Sprained ankle) and SCRATCH (Scratch) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), FALL (Fall), MUSCULOSKELETAL STIFFNESS (Stiffness), LIGAMENT SPRAIN (Sprained ankle), SCRATCH (Scratch) and PAIN (Pain). At the time of the report, NASOPHARYNGITIS (Cold), FALL (Fall), LIGAMENT SPRAIN (Sprained ankle) and SCRATCH (Scratch) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiffness) and PAIN (Pain) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment medication information provided  No concomitant medication information provided
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Mood swings, Nausea
Clinical narrative: Mood swings; Nausea; Headache; On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MOOD SWINGS (Mood swings), HEADACHE (Headache), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient had no known allergies.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Oct-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) at an unspecified dose once a week. On 10-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose). On 27-Oct-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced MOOD SWINGS (Mood swings) and NAUSEA (Nausea). At the time of the report, MOOD SWINGS (Mood swings), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Apr 2021 received 1st dose, on 10 Oct 2021 received 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The reporter's causality for the event of headache with Humira was reported as reasonable possibility. The reporter's causality for the events of nausea and mood swings with Humira was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after received covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after received covid vaccine) in a 68-year-old 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 an unknown indication.    No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after received covid vaccine). In 2021, VACCINATION SITE PAIN (Sore arm after received covid vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624313 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Muscular weakness
Clinical narrative: Flu-like symptoms; The next day had very weak arms and legs; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MUSCULAR WEAKNESS (The next day had very weak arms and legs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   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 INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MUSCULAR WEAKNESS (The next day had very weak arms and legs). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MUSCULAR WEAKNESS (The next day had very weak arms and legs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Vaccination site pain/arm sore after second one; Knee pain/left knee pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/arm sore after second one) and ARTHRALGIA (Knee pain/left knee pain) in an adult 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.    There was no reported medical history.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received 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 VACCINATION SITE PAIN (Vaccination site pain/arm sore after second one) and ARTHRALGIA (Knee pain/left knee pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/arm sore after second one) and ARTHRALGIA (Knee pain/left knee pain) had resolved.      No concomitant medication details were provided. No treatment medication details were provided.  The reporter's causality for the event vaccination site pain with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of arthralgia was not provided. ~  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624271 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
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 a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19). In 2021, COVID-19 (COVID-19) had resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The Humira was reported as HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB),  The treatment medication was not provided.  CC: This spontaneous case concerns a 69-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 28 days apart. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with unknown event's onset date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 69-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 28 days apart. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with unknown event's onset date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (But does not want to take Modernaa since a friendof mine ended up with blood clot in her lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported. No concomitant medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of pulmonary embolism. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient 'ended up with blood clot in her lungs'. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of pulmonary embolism. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient 'ended up with blood clot in her lungs'. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Psoriasis
Clinical narrative: Allergy to vaccine; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine) and PSORIASIS (Psoriasis) 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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine) and PSORIASIS (Psoriasis). At the time of the report, ALLERGY TO VACCINE (Allergy to vaccine) and PSORIASIS (Psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient reported non-serious events Allergic reaction to moderna shot and Psoriasis with HUMIRA 40MG/0.4ML (ADALIMUMAB).   On unknown dates, the patient experienced Allergic reaction to moderna shot and Psoriasis.  COVID-19 VACCINE MODERNA (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Hidradenitis, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Hidradenitis suppurativa flare up/one spot at belt line; Hidradenitis suppurativa flare up/one spot at belt line; 12 Mar 2021 received first dose, 20 Mar 2021 received second dose; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up/one spot at belt line), CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/one spot at belt line), FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (12 Mar 2021 received first dose, 20 Mar 2021 received second dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (12 Mar 2021 received first dose, 20 Mar 2021 received second dose). In 2021, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up/one spot at belt line) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/one spot at belt line). In 2021, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up/one spot at belt line) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/one spot at belt line) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (12 Mar 2021 received first dose, 20 Mar 2021 received second dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The reporter's causality for the events of fatigue and sore arm with humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of hidradenitis suppurativa flare up/one spot at belt line with humira (adalimumab) was a reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Fatigue, Lymphadenopathy, Skin exfoliation
Clinical narrative: Skin peeling; Eczema; Fatigue; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin peeling), ECZEMA (Eczema), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 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) 1 dosage form. In September 2021, the patient experienced ECZEMA (Eczema), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes). On an unknown date, the patient experienced SKIN EXFOLIATION (Skin peeling). At the time of the report, SKIN EXFOLIATION (Skin peeling), ECZEMA (Eczema), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The reporter causality for the events with respect to Humira was reported as not reported.   The treatment medication was not provided.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed.            Concomitant products were not provided. Treatment medication were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. company comment-This spontaneous case concerns an adolescent female patient aged 15 years with no medical history reported, who experienced the fatal serious (medically significant) unexpected event of Cardiac arrest which occurred after second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. The reported cause of death was Cardiac arrest. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to doses was available in the report. Patient died on an unknown date. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up  Non-Significant information accepted.; Sender's Comments: This spontaneous case concerns an adolescent female patient aged 15 years with no medical history reported, who experienced the fatal serious (medically significant) unexpected event of Cardiac arrest which occurred after second dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. The reported cause of death was Cardiac arrest. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the event and details pertaining to doses was available in the report. Patient died on an unknown date. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Reported Cause(s) of Death: Cardiac arrest
Age: 1.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Seizure
Clinical narrative: Seizure; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 1-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). The patient died on an unknown date. The reported cause of death was Seizure. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.            The concomitant medication was not reported by reporter. It was reported that patient died two days after Moderna with previous severe seizure. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 1-year-old patient of unknown gender, with no reported medical history, who experienced the unexpected serious fatal AESI of Seizure after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. It was reported that patient had severe seizure and died 2 days post vaccination with the reported cause of death was seizure and unknown if autopsy was done. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 1-year-old patient of unknown gender, with no reported medical history, who experienced the unexpected serious fatal AESI of Seizure after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. It was reported that patient had severe seizure and died 2 days post vaccination with the reported cause of death was seizure and unknown if autopsy was done. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Reported Cause(s) of Death: Seizure
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: ARM HURTS FROM COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER). At the time of the report, VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.   This case was linked to MOD-2021-623130 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Psoriasis
Clinical narrative: Psoriasis breakout on hands; Became sick right after; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis breakout on hands) and IMMUNISATION REACTION (Became sick right after) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PSORIASIS (Psoriasis breakout on hands) and IMMUNISATION REACTION (Became sick right after). At the time of the report, PSORIASIS (Psoriasis breakout on hands) had not resolved and IMMUNISATION REACTION (Became sick right after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient reported non-serious events psoriasis breakout on hands and had took both moderna covid vaccines and became sick right after with HUMIRA (ADALIMUMAB).  On unknown dates, the patient experienced psoriasis breakout on hands and had took both moderna covid vaccines and became sick right after.  On an unknown date, had took both moderna covid vaccines and became sick right after resolved.  MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, COVID-19, Renal disorder, SARS-CoV-2 test, Sluggishness
Clinical narrative: Sluggishness; bladder issues/did not know what the issue was; kidney issue/did not know what the issue was; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness), BLADDER DISORDER (bladder issues/did not know what the issue was), RENAL DISORDER (kidney issue/did not know what the issue was) and COVID-19 (COVID-19) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 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) CF. On 01-Sep-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness), BLADDER DISORDER (bladder issues/did not know what the issue was) and RENAL DISORDER (kidney issue/did not know what the issue was). In 2021, COVID-19 (COVID-19) had resolved. At the time of the report, SLUGGISHNESS (Sluggishness), BLADDER DISORDER (bladder issues/did not know what the issue was) and RENAL DISORDER (kidney issue/did not know what the issue was) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: (Positive) Positive.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant  medication information provided  No treatment medication information provided  On Oct 2021, patient received first dose COVID-19 vaccine manufactured by Moderna  Humira Causality as per reporter (Drug/Vaccine) : No reasonable possibility
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION . At the time of the report, IMMUNISATION REACTION  outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear infection, Therapeutic response shortened, Urticaria
Clinical narrative: Wearing off effect; Hives; DOUBLE EAR INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (DOUBLE EAR INFECTION), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and URTICARIA (Hives) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Plaque psoriasis.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. In 2021, the patient experienced EAR INFECTION (DOUBLE EAR INFECTION) and URTICARIA (Hives). On an unknown date, the patient experienced THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). In 2021, EAR INFECTION (DOUBLE EAR INFECTION) and URTICARIA (Hives) had resolved. At the time of the report, THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  On an unknown date, the patient experienced an outbreak about two weeks before. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624906 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her head, which she developed after her 1st Moderna vaccination, and 2nd Moderna vaccine it got out of control; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her head, which she developed after her 1st Moderna vaccination, and 2nd Moderna vaccine it got out of control) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) injection for Rash and DUPILUMAB (DUPIXENT) injection for Rash.    The patient's past medical history included Basal cell carcinoma. Concurrent medical conditions included Drug hypersensitivity (Violently allergic to Aleve and Motrin) and Urticaria. Concomitant products included FLUOCINONIDE for Rash.   In 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On 09-Sep-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced RASH (Rash on her head, which she developed after her 1st Moderna vaccination, and 2nd Moderna vaccine it got out of control). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Illness and Tendon discomfort, at an unspecified dose and frequency. At the time of the report, RASH (Rash on her head, which she developed after her 1st Moderna vaccination, and 2nd Moderna vaccine it got out of control) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624324 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Inappropriate schedule of vaccine administered; Pain in right side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in right side) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 78-year-old 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 Crohn's disease.    No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In 2021, the patient experienced PAIN (Pain in right side). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at an unspecified dose and frequency. At the time of the report, PAIN (Pain in right side) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Body chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Body chills) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (Body chills). At the time of the report, HEADACHE (Headache) and CHILLS (Body chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Fall, Fatigue, Headache
Clinical narrative: Osteoarthritis aggravated; Nodule on extremity; Tiredness; Low grade fever; Headache; Fall; Leg injury; Bruising; Knee injury; Skin abrasion; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury) and CONTUSION (Bruising) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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) at an unspecified dose. In 2021, the patient experienced JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), LIMB INJURY (Leg injury), CONTUSION (Bruising) and FALL (Fall). In September 2021, the patient experienced FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis aggravated) and NODULE (Nodule on extremity). At the time of the report, JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury), CONTUSION (Bruising), NODULE (Nodule on extremity), FALL (Fall), FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: low grade fever.         On unknown dates, the patient experienced osteoarthritis worsened and knots in hands. In 2021, the patient experienced felt down/hurt both legs and knees/ended up getting bruising and hands scrapped. In September 2021, the patient experienced tired, low grade fever and headache. Case level outcome was reported as worsened. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Limb injury, Nodule, Osteoarthritis, Pyrexia
Clinical narrative: Osteoarthritis aggravated; Nodule on extremity; Tiredness; Low grade fever; Headache; Fall; Leg injury; Bruising; Knee injury; Skin abrasion; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury) and CONTUSION (Bruising) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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) at an unspecified dose. In 2021, the patient experienced JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), LIMB INJURY (Leg injury), CONTUSION (Bruising) and FALL (Fall). In September 2021, the patient experienced FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis aggravated) and NODULE (Nodule on extremity). At the time of the report, JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury), CONTUSION (Bruising), NODULE (Nodule on extremity), FALL (Fall), FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: low grade fever.         On unknown dates, the patient experienced osteoarthritis worsened and knots in hands. In 2021, the patient experienced felt down/hurt both legs and knees/ended up getting bruising and hands scrapped. In September 2021, the patient experienced tired, low grade fever and headache. Case level outcome was reported as worsened. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.