chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise
Clinical narrative: Not feeling so well; All joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling so well) and ARTHRALGIA (All joints hurt) in a 61-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.    The patient's past medical history included Rheumatoid arthritis.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2021, received third 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. On 29-Dec-2021, the patient experienced MALAISE (Not feeling so well) and ARTHRALGIA (All joints hurt). At the time of the report, MALAISE (Not feeling so well) and ARTHRALGIA (All joints hurt) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolism; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821AA) for COVID-19 prophylaxis.    Co-suspect product included non-company product APIXABAN (ELIQUIS) for Pulmonary embolism.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient started APIXABAN (ELIQUIS) (unknown route) 5 milligram twice a day. On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown. Not Provided          Treatment medication was not provided by the reporter.  It was reported that eliquis 5mg that was tampered with and is missing 2 pills. she got three 60 count bottles from Walgreen's pharmacy, and on this bottle the safety seal was pulled off and there were 2 tablets missing.  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 56-year-old patient female, with body mass index of 37.029, with relevant medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI Pulmonary embolism on an unknown date after receiving the mRNA-1273 vaccine as 2nd dose. Clinical course and treatment details were not reported. The outcome of event was unknown. Patient's high body mass index and concurrent rheumatoid arthritis could be considered as risk factors and co-suspect Apixaban as a confounder. 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 56-year-old patient female, with body mass index of 37.029, with relevant medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI Pulmonary embolism on an unknown date after receiving the mRNA-1273 vaccine as 2nd dose. Clinical course and treatment details were not reported. The outcome of event was unknown. Patient's high body mass index and concurrent rheumatoid arthritis could be considered as risk factors and co-suspect Apixaban as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
Age: 27.0
Sex: M
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 a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (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) was resolving.            No concomitant medication provided. No treatment information mentioned.  On an unknown date patient experienced COVID.   Reporters causality of events with Skyrizi was no 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.  Company comment: This spontaneous case concerns a 27-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first and second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 27-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first and second dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthritis, Fatigue, Nasopharyngitis, Vaccination site pain
Clinical narrative: Arthritis in feet; Cold like symptoms; Vaccinations had sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis in feet), NASOPHARYNGITIS (Cold like symptoms), VACCINATION SITE PAIN (Vaccinations had sore arm) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ARTHRITIS (Arthritis in feet), NASOPHARYNGITIS (Cold like symptoms), VACCINATION SITE PAIN (Vaccinations had sore arm) and FATIGUE (Fatigue). At the time of the report, ARTHRITIS (Arthritis in feet) had not resolved and NASOPHARYNGITIS (Cold like symptoms), VACCINATION SITE PAIN (Vaccinations had sore arm) and FATIGUE (Fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of arthritis in feet, vaccinations had sore arm, fatigue and cold like symptoms with SKYRIZI was no reasonable possibility.  No treatment information 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint effusion, Joint swelling
Clinical narrative: Swelling of L knee; Pain in knee; Effusion of knee; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling of L knee), JOINT EFFUSION (Effusion of knee) and ARTHRALGIA (Pain in knee) in a 43-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.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 15-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2022, 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. In January 2021, the patient experienced JOINT EFFUSION (Effusion of knee). On an unknown date, the patient experienced JOINT SWELLING (Swelling of L knee) and ARTHRALGIA (Pain in knee). In 2021, JOINT EFFUSION (Effusion of knee) had resolved. At the time of the report, JOINT SWELLING (Swelling of L knee) and ARTHRALGIA (Pain in knee) had resolved.            No treatment medications was reported.  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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Moderna made me sick/it's only mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Moderna made me sick/it's only mild symptoms) in a 63-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Moderna made me sick/it's only mild symptoms). At the time of the report, ILLNESS (Moderna made me sick/it's only mild symptoms) had resolved.            No concomitant medications were reported. No treatment drugs 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hidradenitis, Vaccination site pain
Clinical narrative: hidradenitis suppurativa flare up in groin area; after receiving the Moderna vaccines had arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (hidradenitis suppurativa flare up in groin area) and VACCINATION SITE PAIN (after receiving the Moderna vaccines had arm hurt) in a 35-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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Feb-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 20-Oct-2021, received third 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 pen. In 2021, the patient experienced VACCINATION SITE PAIN (after receiving the Moderna vaccines had arm hurt). On an unknown date, the patient experienced HIDRADENITIS (hidradenitis suppurativa flare up in groin area). At the time of the report, HIDRADENITIS (hidradenitis suppurativa flare up in groin area) had not resolved and VACCINATION SITE PAIN (after receiving the Moderna vaccines had arm hurt) outcome was unknown.            No concomitant medications were reported.   The reporter's causality for the event(s) of after receiving the Moderna vaccines had arm hurt with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of hidradenitis suppurativa flare up in groin area with Humira(adalimumab) was a reasonable possibility. The reporter assessed event after receiving the Moderna vaccines had arm hurt as not related with Moderna Covid-19 vaccine.  No treatment details 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.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Plaque psoriasis two large spots on both thighs and hands/plaque psoriasis spots got bad after received first covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis two large spots on both thighs and hands/plaque psoriasis spots got bad after received first covid vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.  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 09-Apr-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis two large spots on both thighs and hands/plaque psoriasis spots got bad after received first covid vaccine). At the time of the report, PSORIASIS (Plaque psoriasis two large spots on both thighs and hands/plaque psoriasis spots got bad after received first covid vaccine) had not resolved.     No concomitant medication information was reported. No treatment medication information was reported. 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, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: COVID-19; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Scleroderma (Limited Scleroderma), Psychiatric symptom and Reynold's syndrome. Concurrent medical conditions included GERD and Asthma (Adult Asthma).   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            Concomitant medications details were not reported.  The patient was the mother of the reporter and reporter was informed at around 11:30 (local time) on 09 Feb 2022.   The patient had underlying health conditions all of which were prior to vaccination. The patient had a mild Covid 19, and was currently quarantined and had not needed hospitalization at that time.  No treatment information 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, SARS-CoV-2 antibody test
Clinical narrative: Itching; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and FATIGUE (Tiredness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for CLL.    Concurrent medical conditions included CLL.   On 10-Sep-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram three times a day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching) and FATIGUE (Tiredness). At the time of the report, PRURITUS (Itching) and FATIGUE (Tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: (Negative) Negative.         No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event(s) of itching and tired with Imbruvica (ibrutinib) was a reasonable possibility. The reporter's causality for the event(s) of not developed antibodies upon covid vaccinations was not provided.  No treatment details 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots) 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 Plaque psoriasis.  No Medical History information was reported.  On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-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 April 2021, the patient experienced PSORIASIS (Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots). At the time of the report, PSORIASIS (Plaque psoriasis breakout on inside of legs/backs/arms/couple tiny spots) had resolved with sequelae.     No concomitant medication information was reported. No treatment medication information was reported. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: covid arm; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (covid arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus erythematosus systemic.    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 (covid arm). At the time of the report, IMMUNISATION REACTION (covid arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.  No concomitant medication was reported.  No treatment medication was reported.    This case was linked to MOD-2022-622819 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2022: Live significant follow up - Medical history added.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Vaccination site pain
Clinical narrative: high blood pressure; Arm was sore the day after each covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and VACCINATION SITE PAIN (Arm was sore the day after each covid-19 vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and Crohn's disease.    Concurrent medical conditions included Ankylosing spondylitis and Crohn's disease.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third 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 an unknown date, the patient experienced HYPERTENSION (high blood pressure) and VACCINATION SITE PAIN (Arm was sore the day after each covid-19 vaccine). At the time of the report, HYPERTENSION (high blood pressure) had not resolved and VACCINATION SITE PAIN (Arm was sore the day after each covid-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high.         No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown dates, the patient experienced high blood pressure, never been high in life and arm was sore the day after each covid-19 vaccine.  The reporter's causality for the event(s) of high blood pressure, never been high in life and arm was sore the day after each covid-19 vaccine with Humira (adalimumab) was no reasonable possibility. The reporter assessed events high blood pressure and arm was sore the day after each covid-19 as reasonable possibly related to Moderna Covid-19 vaccine.  No treatment details 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: 3 month neurological reaction after her first Covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of NEUROLOGICAL SYMPTOM (3 month neurological reaction after her first Covid vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic kidney disease and Vascular disorder.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (3 month neurological reaction after her first Covid vaccine). At the time of the report, NEUROLOGICAL SYMPTOM (3 month neurological reaction after her first Covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient was not taking the second Covid vaccine due to adverse event. 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
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 43-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.  No Medical History information was reported.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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) at an unspecified dose. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In December 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.     No concomitant medication information was reported. No treatment medication information was reported. 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: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Took the Moderna COVID19 vaccine had adverse reaction to it; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Took the Moderna COVID19 vaccine had adverse reaction to it) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Took the Moderna COVID19 vaccine had adverse reaction to it). At the time of the report, IMMUNISATION REACTION (Took the Moderna COVID19 vaccine had adverse reaction to it) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Patient was asking whether it was safe for him to get the Pfizer Biontech COVID-19 vaccine as his second dose. 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
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Swollen lymph node; She experiencing rash/leg rash/Rash on legs & arms/around her ankle; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node) and RASH (She experiencing rash/leg rash/Rash on legs & arms/around her ankle) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus erythematosus (Lupus).   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, 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 LYMPHADENOPATHY (Swollen lymph node) and RASH (She experiencing rash/leg rash/Rash on legs & arms/around her ankle). At the time of the report, LYMPHADENOPATHY (Swollen lymph node) and RASH (She experiencing rash/leg rash/Rash on legs & arms/around her ankle) 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 patient was received Moderna vaccine second shot in a different arm.  No concomitant medication was reported.  Couple of weeks later the patient was experienced rash all over body and rash anywhere elastic was. It was reported that treatment medication was prescribed to the patient for rash.  The patient wants to know if she can get the Pfizer COVID booster shot. She was 73 years old, about to turn 74.   This case was linked to MOD-2022-622773 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2022: Significant live follow up - medical history was added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ILLNESS (Sickness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In September 2021, the patient experienced ILLNESS (Sickness). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ILLNESS (Sickness) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.  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-2022-622841 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Urticaria
Clinical narrative: One COVID vaccine causes heart problems; Hives; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (One COVID vaccine causes heart problems) and URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) 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) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CARDIAC DISORDER (One COVID vaccine causes heart problems) and URTICARIA (Hives). At the time of the report, CARDIAC DISORDER (One COVID vaccine causes heart problems) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported getting hives and heart problems with Moderna COVID vaccine.  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: Chills, Pain, Sinusitis
Clinical narrative: Respiratory infection in sinus/chest and ear; Body ached; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Respiratory infection in sinus/chest and ear), PAIN (Body ached) and CHILLS (Chills) 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 Rheumatoid arthritis.    No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-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. On 02-Jun-2021, the patient experienced PAIN (Body ached) and CHILLS (Chills). On an unknown date, the patient experienced SINUSITIS (Respiratory infection in sinus/chest and ear). In June 2021, PAIN (Body ached) and CHILLS (Chills) had resolved. At the time of the report, SINUSITIS (Respiratory infection in sinus/chest and ear) had not resolved.   No concomitant medication information was reported. No treatment medication information was reported. 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: sick for one day with his first dose of covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (sick for one day with his first dose of covid-19 vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 05-Jan-2022, 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. On 05-Jan-2022, the patient experienced IMMUNISATION REACTION (sick for one day with his first dose of covid-19 vaccine). In January 2022, IMMUNISATION REACTION (sick for one day with his first dose of covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient felt that SKYRIZI did not work on him as well as it should. Plaque psoriasis just cleared up a little bit but still had some and it came back stronger by the three month. He was sick for one day with his first dose of covid-19 vaccine.  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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Significant live follow up (event coding updated).
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Diagnosed with rare form of cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Diagnosed with rare form of cancer) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Diagnosed with rare form of cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Diagnosed with rare form of cancer) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       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."  No treatment information was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, serious (medically significant) event of Neoplasm malignant(reported as rare form of cancer), approximately 1 month after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, serious (medically significant) event of Neoplasm malignant(reported as rare form of cancer), approximately 1 month after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation reaction, Malaise
Clinical narrative: COVID-19; Feeling unwell/Not feeling well; Vaccination adverse reaction/Reaction to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), MALAISE (Feeling unwell/Not feeling well) and IMMUNISATION REACTION (Vaccination adverse reaction/Reaction to COVID vaccine) in a 22-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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third 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. In December 2021, the patient experienced COVID-19 (COVID-19), MALAISE (Feeling unwell/Not feeling well) and IMMUNISATION REACTION (Vaccination adverse reaction/Reaction to COVID vaccine). At the time of the report, COVID-19 (COVID-19) had not resolved and MALAISE (Feeling unwell/Not feeling well) and IMMUNISATION REACTION (Vaccination adverse reaction/Reaction to COVID vaccine) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of COVID-19, Malaise and Vaccination complication was not provided with HUMIRA (ADALIMUMAB).  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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown.            Relevant concomitant medications were not reported.  Patient received first and second dose of Moderna COVID-19 vaccine and experienced heart palpitations really bad for 6 weeks. After that patient took Pfizer COVID-19 vaccine as booster dose and experienced same event and it kept the patient up for hours at night.  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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Rash, Vaccination site pain
Clinical narrative: HIGH FEVER WITH COVID VACCINATION; CHILLS WITH COVID VACCINATION; ACHINESS WITH COVID VACCINATION; OUTBREAKS LOCATED ON SHINS AND FOREARM; This spontaneous case was reported by a consumer and describes the occurrence of RASH (OUTBREAKS LOCATED ON SHINS AND FOREARM), PYREXIA (HIGH FEVER WITH COVID VACCINATION), CHILLS (CHILLS WITH COVID VACCINATION) and VACCINATION SITE PAIN (ACHINESS WITH COVID VACCINATION) in an adult male 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.    Concurrent medical conditions included Plaque psoriasis.   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. In November 2021, the patient experienced RASH (OUTBREAKS LOCATED ON SHINS AND FOREARM). On an unknown date, the patient experienced PYREXIA (HIGH FEVER WITH COVID VACCINATION), CHILLS (CHILLS WITH COVID VACCINATION) and VACCINATION SITE PAIN (ACHINESS WITH COVID VACCINATION). At the time of the report, RASH (OUTBREAKS LOCATED ON SHINS AND FOREARM) was resolving and PYREXIA (HIGH FEVER WITH COVID VACCINATION), CHILLS (CHILLS WITH COVID VACCINATION) and VACCINATION SITE PAIN (ACHINESS WITH COVID VACCINATION) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of OUTBREAKS LOCATED ON SHINS AND FOREARM with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of HIGH FEVER WITH COVID VACCINATION, CHILLS WITH COVID VACCINATION and ACHINESS WITH COVID VACCINATION with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment details 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.
Sex: F
Vaccine: COVID19
Symptoms: Stress fracture
Clinical narrative: right foot stress fracture, then hit the sand and it broke; This spontaneous case was reported by a consumer and describes the occurrence of STRESS FRACTURE (right foot stress fracture, then hit the sand and it broke) 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.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Aug-2021, received third 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) UNK,. On an unknown date, the patient experienced STRESS FRACTURE (right foot stress fracture, then hit the sand and it broke). At the time of the report, STRESS FRACTURE (right foot stress fracture, then hit the sand and it broke) had not resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event menstruation frequent was no reasonable possibility. 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.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Biopsy site unspecified abnormal, Influenza like illness, Sigmoidoscopy
Clinical narrative: Flu like symptoms; Biopsy NOS abnormal; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and BIOPSY SITE UNSPECIFIED ABNORMAL (Biopsy NOS abnormal) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    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) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and BIOPSY SITE UNSPECIFIED ABNORMAL (Biopsy NOS abnormal). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and BIOPSY SITE UNSPECIFIED ABNORMAL (Biopsy NOS abnormal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Sigmoidoscopy: Results not Provided. On an unknown date, Biopsy: Results not Provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment Drug 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.