chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Immunisation reaction, Interchange of vaccine products
Clinical narrative: the first dose of the Moderna Vaccine, and had a bad reaction to it; Patient took the first and second dose with different products; Patient took the first and second dose with different products; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (the first dose of the Moderna Vaccine, and had a bad reaction to it), COVID-19 IMMUNISATION (Patient took the first and second dose with different products) and INTERCHANGE OF VACCINE PRODUCTS (Patient took the first and second dose with different products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    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 second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (the first dose of the Moderna Vaccine, and had a bad reaction to it), COVID-19 IMMUNISATION (Patient took the first and second dose with different products) and INTERCHANGE OF VACCINE PRODUCTS (Patient took the first and second dose with different products). At the time of the report, IMMUNISATION REACTION (the first dose of the Moderna Vaccine, and had a bad reaction to it), COVID-19 IMMUNISATION (Patient took the first and second dose with different products) and INTERCHANGE OF VACCINE PRODUCTS (Patient took the first and second dose with different products) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Patient got the first dose of the Moderna COVID-19 Vaccine, and had a bad reaction to that, and he spoke to an HCP and recommended he to get Pfizer COVID-19 vaccine for his second dose and he took Pfizer vaccine for his second dose. Patient completed the first and second dose with different products.  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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: FELT CRUMMY; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (FELT CRUMMY) and PAIN IN EXTREMITY (SORE ARM) in a 41-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 Plaque psoriasis.    No Medical History information was reported.   On 20-Aug-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) 40 milligram. In August 2021, the patient experienced MALAISE (FELT CRUMMY) and PAIN IN EXTREMITY (SORE ARM). At the time of the report, MALAISE (FELT CRUMMY) and PAIN IN EXTREMITY (SORE ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment details were not 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
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Quick tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Quick tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Quick tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Quick tired) outcome was unknown.            No concomitant medications were reported.  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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Headache
Clinical narrative: Colonoscopy; MODERNA BOOSTER AND HAD SLIGHT HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (MODERNA BOOSTER AND HAD SLIGHT HEADACHE) and COLONOSCOPY (Colonoscopy) in a 25-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 Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-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) at an unspecified dose. On 29-Nov-2021, the patient experienced HEADACHE (MODERNA BOOSTER AND HAD SLIGHT HEADACHE). On an unknown date, the patient experienced COLONOSCOPY (Colonoscopy). In 2021, HEADACHE (MODERNA BOOSTER AND HAD SLIGHT HEADACHE) had resolved. At the time of the report, COLONOSCOPY (Colonoscopy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: Everything look good.         No concomitant drugs were taken.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity, Somnolence
Clinical narrative: Nose bleed; Sleepy; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleed), SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (SORE ARM) in a 54-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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-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) UNK, Citrate Free. In 2021, the patient experienced SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (SORE ARM). On an unknown date, the patient experienced EPISTAXIS (Nose bleed). In 2021, SOMNOLENCE (Sleepy) and PAIN IN EXTREMITY (SORE ARM) had resolved. At the time of the report, EPISTAXIS (Nose bleed) had resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Mobility decreased, Vaccination site pain, Visual impairment
Clinical narrative: Losing vision; Less mobility; Joints were inflamed; COVID vaccines reaction/sore arm after covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Losing vision), MOBILITY DECREASED (Less mobility), ARTHRITIS (Joints were inflamed) and VACCINATION SITE PAIN (COVID vaccines reaction/sore arm after covid vaccines) in a 76-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 Rheumatoid arthritis.    No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 2021, the patient experienced VACCINATION SITE PAIN (COVID vaccines reaction/sore arm after covid vaccines). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Losing vision), MOBILITY DECREASED (Less mobility) and ARTHRITIS (Joints were inflamed). In 2021, VACCINATION SITE PAIN (COVID vaccines reaction/sore arm after covid vaccines) had resolved. At the time of the report, VISUAL IMPAIRMENT (Losing vision) had not resolved and MOBILITY DECREASED (Less mobility) and ARTHRITIS (Joints were inflamed) 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 was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of COVID vaccines reaction/sore arm after COVID vaccines and losing vision with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of less mobiltiy was not provided. The reporter's causality for the events of joints were inflamed with Humira(adalimumab) was a reasonable possibility.
Sex: M
Vaccine: COVID19
Symptoms: Bite, Dizziness
Clinical narrative: Bite on arm; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of BITE (Bite on arm) and DIZZINESS (Dizzy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   On an unknown date, the patient received first 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 BITE (Bite on arm) and DIZZINESS (Dizzy). At the time of the report, BITE (Bite on arm) and DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  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.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died after taking short of Moderna experimental vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died after taking short of Moderna experimental vaccine) in a  patient of an unknown age and gender 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided 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 patient of unknown age and gender with no medical history reported, who died (unexpected, fatal event) an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, pre-existing conditions, diagnostic tests, and treatment provided has not been disclosed. Cause of death was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who died (unexpected, fatal event) an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, pre-existing conditions, diagnostic tests, and treatment provided has not been disclosed. Cause of death was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Couple fingers were in pain; Had trouble opening back up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Couple fingers were in pain) and JOINT RANGE OF MOTION DECREASED (Had trouble opening back up) in a 72-year-old 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Couple fingers were in pain) and JOINT RANGE OF MOTION DECREASED (Had trouble opening back up). At the time of the report, PAIN IN EXTREMITY (Couple fingers were in pain) and JOINT RANGE OF MOTION DECREASED (Had trouble opening back up) outcome was unknown.            Concomitant medication was not reported.  The patient thought she had a reaction to the COVID vacation where a couple fingers were in pain and had trouble opening back up. Patient agrees to have physician contacted.  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: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna) in a  patient of an unknown age and gender 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 COVID-19 (Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter 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.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, 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.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, 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.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Basically the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Basically the flu) 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA (Basically the flu). At the time of the report, INFLUENZA (Basically the flu) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of basically the flu 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.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Fatigue, Influenza like illness
Clinical narrative: Harmful side effects; Flu like symptoms after second dose covid vaccine; Fatigue after second dose covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Harmful side effects), INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose covid vaccine) and FATIGUE (Fatigue after second dose covid vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Harmful side effects), INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose covid vaccine) and FATIGUE (Fatigue after second dose covid vaccine). At the time of the report, ADVERSE DRUG REACTION (Harmful side effects), INFLUENZA LIKE ILLNESS (Flu like symptoms after second dose covid vaccine) and FATIGUE (Fatigue after second dose covid vaccine) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the 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.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 96-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.    No Medical History information was reported.   On 28-Aug-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. In 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria death and medically significant). The patient died on 05-Sep-2021. The reported cause of death was Guillain Barre syndrome. It is unknown if an autopsy was performed.            No concomitant medication information was provided. The patient died after having side effect from COVID vaccine. She had gamber ray side effect from the COVID vaccine also known as guillain barre syndrome. 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. No treatment medication was provided.  Company comment: This spontaneous case concerns a 96-year-old female patient, with no reported medical history, treated with co-suspect drug Adalimumab for rheumatoid arthritis (start date not reported) who experienced the unexpected serious fatal AESI Guillain-Barre syndrome on an unknown date after receiving the 1st dose of mRNA-1273 vaccine. Patient reported gamber ray side effect from the COVID vaccine. Clinical course and treatment details were not reported. Patient died 8 days post vaccination, with the reported cause of death as Guillain-Barre syndrome and unknown if autopsy was done. Co-suspect  Adalimumab could be considered 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 96-year-old female patient, with no reported medical history, treated with co-suspect drug Adalimumab for rheumatoid arthritis (start date not reported) who experienced the unexpected serious fatal AESI Guillain- Barre syndrome on an unknown date after receiving the 1st dose of mRNA-1273 vaccine. Patient reported gamber ray side effect from the COVID vaccine. Clinical course and treatment details were not reported. Patient died 8 days post vaccination, with the reported cause of death as Guillain Barre syndrome and unknown if autopsy was done. Co-suspect  Adalimumab could be considered as a confounder. 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: GUILLAIN BARRE SYNDROME
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Pain
Clinical narrative: Felt hungover / Hangover; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (Felt hungover / Hangover) and PAIN (Achiness) 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) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis).   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 HANGOVER (Felt hungover / Hangover) and PAIN (Achiness). At the time of the report, HANGOVER (Felt hungover / Hangover) and PAIN (Achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination complication
Clinical narrative: Moderna had more side effects than the Pfizer one; Got really bad chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna had more side effects than the Pfizer one) and CHILLS (Got really bad 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 VACCINATION COMPLICATION (Moderna had more side effects than the Pfizer one) and CHILLS (Got really bad chills). At the time of the report, VACCINATION COMPLICATION (Moderna had more side effects than the Pfizer one) and CHILLS (Got really bad chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  On an unknow date, patient got really bad chills after receiving Moderna vaccine. It seems like Moderna had more side effects than the Pfizer one. Treatment details 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Immunisation reaction
Clinical narrative: MODERNA VACCINATION REACTION; Dizziness; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (MODERNA VACCINATION REACTION), DIZZINESS (Dizziness) and COVID-19 (COVID-19) 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 Crohn's disease.    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 ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced IMMUNISATION REACTION (MODERNA VACCINATION REACTION), DIZZINESS (Dizziness) and COVID-19 (COVID-19). At the time of the report, IMMUNISATION REACTION (MODERNA VACCINATION REACTION) and DIZZINESS (Dizziness) outcome was unknown and COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.   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: 34.0
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 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product HUMIRA for Plaque psoriasis.   Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic 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) at an unspecified dose. In July 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) 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.   CC: This spontaneous case concerns a 34-year-old, female patient with a concurrent condition of chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact onset latency of said event relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Vaccination history included one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic 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.; Sender's Comments: This spontaneous case concerns a 34-year-old, female patient with a concurrent condition of chronic plaque psoriasis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Exact onset latency of said event relative to vaccination cannot be determined with unknown event's onset date and vaccination date. Vaccination history included one dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying psoriatic 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.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza, Psoriasis
Clinical narrative: Flu; Sickness; Psoriasis facial; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), ILLNESS (Sickness) and PSORIASIS (Psoriasis facial) in a male patient of an unknown age 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 Plaque psoriasis.    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) UNK, Citrate free. On an unknown date, the patient experienced INFLUENZA (Flu), ILLNESS (Sickness) and PSORIASIS (Psoriasis facial). At the time of the report, INFLUENZA (Flu), ILLNESS (Sickness) and PSORIASIS (Psoriasis facial) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. 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
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) outcome was unknown.            Concomitant medication were not provided.  The caller had reported the patient got second dose yesterday, thought it was Moderna COVID vaccine and that morning the patient passed out, was on the way to the hospital.  Treatment medication were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Loss of consciousness, which occurred 1 day after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Loss of consciousness, which occurred 1 day after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Corneal disorder
Clinical narrative: Patient experienced eye cornea flares ups; This spontaneous case was reported by a consumer and describes the occurrence of CORNEAL DISORDER (Patient experienced eye cornea flares ups) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection 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) (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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In 2021, the patient experienced CORNEAL DISORDER (Patient experienced eye cornea flares ups). The patient was treated with PREDNISONE for Corneal disorder, at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) for Corneal disorder, at an unspecified dose and frequency. At the time of the report, CORNEAL DISORDER (Patient experienced eye cornea flares ups) outcome was unknown.            No concomitant medications were reported. The patient reported that after Moderna second covid vaccine dose she got eye cornea flare ups. 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, UNK
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) 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 PALBOCICLIB (IBRANCE) tablet for an unknown indication.    No Medical History information was reported.   On 01-Sep-2021, the patient started PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion
Clinical narrative: SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED) in an 83-year-old 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 Psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   On 03-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) 1 dosage form. In 2021, the patient experienced PERICARDIAL EFFUSION (SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED) (seriousness criterion medically significant). In 2021, PERICARDIAL EFFUSION (SIDE EFFECTS, LIQUID AROUND THE HEART WAS WATCHED) had resolved.            After second vaccine of Covid, the patient had a bit of side effects. They were watching liquid around the heart but it mellowed out. No concomitant drugs taken.  The reporter's causality for the event(s) of side effects, liquid around the heart was watched with respect to Skyrizi(risankizumab) was no reasonable possibility.  No treatment medication was reported.  No known allergy.  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.  Company comment: This is a spontaneous case concerning a 83-year-old female patient with Moderate to severe plaque psoriasis, who experienced the serious (medically significant) unexpected event Pericardial effusion, on an unknown date (on the same year) after receiving the second dose of mRNA-1273. It was reported that "They were watching liquid around the heart but it mellowed out". Clinical course, diagnostic tests and treatment details were not provided. At the time of the report, the event had resolved. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 83-year-old female patient with Moderate to severe plaque psoriasis, who experienced the serious (medically significant) unexpected event Pericardial effusion, on an unknown date (on the same year) after receiving the second dose of mRNA-1273. It was reported that "They were watching liquid around the heart but it mellowed out". Clinical course, diagnostic tests and treatment details were not provided. At the time of the report, the event had resolved. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Device issue, Off label use, Product storage error, Pyrexia
Clinical narrative: Incorrect storage of drug; Device issue; Fever; Off label use; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PRODUCT STORAGE ERROR (Incorrect storage of drug), DEVICE ISSUE (Device issue) and OFF LABEL USE (Off label use) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013F21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Patient had no known allergies.  The patient's past medical history included Non-smoker, Abstains from alcohol and Joint replacement. Concomitant products included MELOXICAM for Arthritis, MONTELUKAST for Asthma and Bronchitis, LOSARTAN for Blood pressure.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2019, the patient experienced OFF LABEL USE (Off label use). On 27-Nov-2021, the patient experienced PYREXIA (Fever). On 01-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (Incorrect storage of drug) and DEVICE ISSUE (Device issue). On 02-Dec-2021, PYREXIA (Fever) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Incorrect storage of drug) and DEVICE ISSUE (Device issue) outcome was unknown and OFF LABEL USE (Off label use) had not resolved.        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.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  In 2019, the patient experienced Off-label use. On 27-Nov-2021, the patient experienced recurring fever. On 01-Dec-2021, the patient experienced pen was out for a little more than 20 minutes/the gray cap was removed, and the end of the pen was broken. On 02-Dec-2021, the recurring fever resolved.  No treatment medication reported.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PAIN IN EXTREMITY (Pain in arm) 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.    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 FATIGUE (Fatigue) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication information was not provided by the 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.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my cousin just "died" taking the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my cousin just "died" taking the Moderna shot) in a  patient of an unknown age and gender 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. 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 patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious event of death. 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 "just 'died' (further not clarified) taking the Moderna shot". No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, serious event of death. 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 "just 'died' (further not clarified) taking the Moderna shot". No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: my cousin just "died" taking the Moderna shot