chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Psoriasis
Clinical narrative: Psoriasis/ Minor patches of psoriasis; Lethargy; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis/ Minor patches of psoriasis), LETHARGY (Lethargy), FATIGUE (Fatigue) and HEADACHE (Headache) 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 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis/ Minor patches of psoriasis), LETHARGY (Lethargy), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PSORIASIS (Psoriasis/ Minor patches of psoriasis), LETHARGY (Lethargy), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hidradenitis, Pain
Clinical narrative: Hidradenitis suppurativa; Ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa), PAIN (Ache) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PAIN (Ache) and FATIGUE (Fatigue). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) had not resolved and PAIN (Ache) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported.  Patient received Humira (1159931).  No treatment medications were reported.  The reporter assessed the event of hidradenitis as not related to Moderna vaccine. The reporter assessed the events of ache and fatigue to be probably related to Moderna vaccine.  The reporter assessed the event of hidradenitis as reasonably possible with Humira. The reporter assessed the events of ache and fatigue as not reasonably possible to Humira.  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: Hospitalisation
Clinical narrative: Friend got hospitalized after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Friend got hospitalized after Moderna) in a  patient of an unknown age and gender 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 HOSPITALISATION (Friend got hospitalized after Moderna) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Friend got hospitalized after Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       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.  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 hospitalisation. 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 got hospitalized after receiving the mRNA-1273 vaccine. No further clinical information (including symptoms, details about hospitalization, laboratory test/s and treatment) was available for medical review. 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 hospitalisation. 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 got hospitalized after receiving the mRNA-1273 vaccine. No further clinical information (including symptoms, details about hospitalization, laboratory test/s and treatment) was available for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for Covid) 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 COVID-19 (Positive for Covid). At the time of the report, COVID-19 (Positive for Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Patient received Moderna. Patient was positive of COVID. 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 female patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as Positive for Covid) in the context of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date was not disclosed. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the unexpected non serious AESI event of COVID-19 (reported as Positive for Covid) in the context of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date was not disclosed. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement
Sex: F
Vaccine: COVID19
Symptoms: Device issue, Renal mass
Clinical narrative: Renal mass; Catheter access port issue; This spontaneous case was reported by a consumer and describes the occurrence of RENAL MASS (Renal mass) and DEVICE ISSUE (Catheter access port issue) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RENAL MASS (Renal mass) and DEVICE ISSUE (Catheter access port issue). At the time of the report, RENAL MASS (Renal mass) and DEVICE ISSUE (Catheter access port issue) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient received Humira (1156745).  No treatment medications were reported.  The reporter assessed the events as possibly related to Moderna vaccine and did not provide any causality assessment for the events with Humira.  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: Tinnitus
Clinical narrative: My dad reacted to moderna jab he now has tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (My dad reacted to moderna jab he now has tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (My dad reacted to moderna jab he now has tinnitus). At the time of the report, TINNITUS (My dad reacted to moderna jab he now has tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., dose of COVID-19 VACCINE (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.            No concomitant medications were reported.  Patient received booster dose.  No treatment medications were reported.  The reporter assessed the event as not related to Moderna vaccine, Covid-19 vaccine and Humira.  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: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.     Concomitant product use was not provided by the reporter.  On an unknown date, the patient received booster dose of mRNA-1273 (Moderna COVID-19 Vaccine).  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of pain was not provided.  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: 28.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia, Somnolence
Clinical narrative: Sleepy/ SLEEPIER THAN NORMAL; Stiffness/ STIFF; Sores mouth/ DEVELOPED SORES IN MOUTH; Headache; Fever; Pain/ Aches and Pains/ Sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/ Aches and Pains/ Sore), SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF), STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH) and HEADACHE (Headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Ulcerative colitis and Plaque psoriasis.    Concurrent medical conditions included Rheumatoid arthritis, Ulcerative colitis and Plaque psoriasis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received 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. In 2021, the patient experienced PAIN (Pain/ Aches and Pains/ Sore), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF) and STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH). At the time of the report, PAIN (Pain/ Aches and Pains/ Sore), SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF), STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  The patient had covid vaccine issues such as headache, fever, aches and pains with booster. It was unknown if she 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2022: Significant Live Follow Up received included events were added.
Age: 28.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Stomatitis
Clinical narrative: Sleepy/ SLEEPIER THAN NORMAL; Stiffness/ STIFF; Sores mouth/ DEVELOPED SORES IN MOUTH; Headache; Fever; Pain/ Aches and Pains/ Sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/ Aches and Pains/ Sore), SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF), STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH) and HEADACHE (Headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Ulcerative colitis and Plaque psoriasis.    Concurrent medical conditions included Rheumatoid arthritis, Ulcerative colitis and Plaque psoriasis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received 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. In 2021, the patient experienced PAIN (Pain/ Aches and Pains/ Sore), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF) and STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH). At the time of the report, PAIN (Pain/ Aches and Pains/ Sore), SOMNOLENCE (Sleepy/ SLEEPIER THAN NORMAL), MUSCULOSKELETAL STIFFNESS (Stiffness/ STIFF), STOMATITIS (Sores mouth/ DEVELOPED SORES IN MOUTH), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  The patient had covid vaccine issues such as headache, fever, aches and pains with booster. It was unknown if she 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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2022: Significant Live Follow Up received included events were added.
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness
Clinical narrative: Knees were tight; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Knees were tight) in an adult 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 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received 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 an unknown date, the patient experienced JOINT STIFFNESS (Knees were tight). At the time of the report, JOINT STIFFNESS (Knees were tight) outcome was unknown.     Concomitant product use was not provided by the reporter.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Rinvoq (Upadacitinib) for the event of knees were tight was not provided.  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, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; revaccination with different covid19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid19 vaccine) in an elderly female patient 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.    Concurrent medical conditions included Immunocompromised.   On 19-Jan-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jun-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.   This case was linked to MOD-2022-624689 (Patient Link).
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021) and NO ADVERSE EVENT (No adverse event) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ankylosing spondylitis. Concomitant products included ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 1st dose on 5th march and 2nd dose on 3rd may 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            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   This case was linked to MOD-2022-619122 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Viral infection
Clinical narrative: Viral infection; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral infection) and SUSPECTED COVID-19 (Suspected 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 an unknown indication.    No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-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) Citrate Free. On an unknown date, the patient experienced VIRAL INFECTION (Viral infection) and SUSPECTED COVID-19 (Suspected COVID-19). The patient was treated with OXYGEN for Adverse event, at a dose of Unknown. At the time of the report, VIRAL INFECTION (Viral infection) and SUSPECTED COVID-19 (Suspected COVID-19) outcome was unknown.            No concomitant medications were 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     There was no reported medical history.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 30-Apr-2021/second dose on 04-Jun-2021/received second dose at day 36) and NO ADVERSE EVENT (No adverse event) 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.   This case was linked to MOD-2022-619230 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; which was not 5 months out to be able to count as a booster dose; third and forth dose of Moderna were 0.5 mL doses; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose), ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COMIRNATY (Dose 1) on 19-Jan-2021 and COMIRNATY (Dose 2) on 09-Feb-2021. Past adverse reactions to the above products included No adverse event with COMIRNATY and COMIRNATY.   On 19-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose) and ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose), ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (which was not 5 months out to be able to count as a booster dose) and ACCIDENTAL OVERDOSE (third and forth dose of Moderna were 0.5 mL doses).    No concomitant medication was reported.   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.   This case was linked to MOD-2022-624659 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 38-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2022, 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. On 15-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) 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.   This case was linked to MOD-2022-620042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document contains updated co-suspect dose description.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash). At the time of the report, RASH (Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications 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: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Weight
Clinical narrative: alot of itching on her chin/itches all over, every now and then/ itchy on her skin; consistent flaky skin on her forehead; rash on her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (alot of itching on her chin/itches all over, every now and then/ itchy on her skin), SKIN EXFOLIATION (consistent flaky skin on her forehead) and RASH (rash on her forehead) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma chronic.    No Medical History information was reported.   On 05-Feb-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 28-Feb-2020, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram every two weeks. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, the patient experienced PRURITUS (alot of itching on her chin/itches all over, every now and then/ itchy on her skin), SKIN EXFOLIATION (consistent flaky skin on her forehead) and RASH (rash on her forehead). At the time of the report, PRURITUS (alot of itching on her chin/itches all over, every now and then/ itchy on her skin) had not resolved, SKIN EXFOLIATION (consistent flaky skin on her forehead) had resolved and RASH (rash on her forehead) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  On 05-Feb-2020 was taking initial loading dose of 600mg, subcutaneously followed by maintenance dose of 300mg, subcutaneously, every other week, for asthma. On 28-Feb-2020 DUPILUMAB dosage was changed to 300 mg QOW. On an unknown date in 2020, patient reported that itches all over, every now and then (pruritus; latency: unknown). Upon follow-up, patient reported that she had rash on her forehead and was experiencing a lot of itching on her chin. Patient spoke with MD (medical doctor) who advised her that this was a common side effect of dupilumab connected to pharmacist to further educate the patient. Since starting dupilumab, patient reported she had consistent flaky skin on her forehead and itching on her chin since starting the medication.  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.   This case was linked to MOD-2022-624730 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: alot of itching on her chin/itches all over, every now and then/ itchy on her skin; consistent flaky skin on her forehead; rash on her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (alot of itching on her chin/itches all over, every now and then/ itchy on her skin), SKIN EXFOLIATION (consistent flaky skin on her forehead) and RASH (rash on her forehead) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma chronic.    No Medical History information was reported.   On 05-Feb-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 28-Feb-2020, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram every two weeks. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, the patient experienced PRURITUS (alot of itching on her chin/itches all over, every now and then/ itchy on her skin), SKIN EXFOLIATION (consistent flaky skin on her forehead) and RASH (rash on her forehead). At the time of the report, PRURITUS (alot of itching on her chin/itches all over, every now and then/ itchy on her skin) had not resolved, SKIN EXFOLIATION (consistent flaky skin on her forehead) had resolved and RASH (rash on her forehead) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  On 05-Feb-2020 was taking initial loading dose of 600mg, subcutaneously followed by maintenance dose of 300mg, subcutaneously, every other week, for asthma. On 28-Feb-2020 DUPILUMAB dosage was changed to 300 mg QOW. On an unknown date in 2020, patient reported that itches all over, every now and then (pruritus; latency: unknown). Upon follow-up, patient reported that she had rash on her forehead and was experiencing a lot of itching on her chin. Patient spoke with MD (medical doctor) who advised her that this was a common side effect of dupilumab connected to pharmacist to further educate the patient. Since starting dupilumab, patient reported she had consistent flaky skin on her forehead and itching on her chin since starting the medication.  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.   This case was linked to MOD-2022-624730 (Patient Link).   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 35-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.    Concurrent medical conditions included Plaque psoriasis.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient took second dose of vaccine earlier than expected time gap for dose of vaccine. On unknown dates had reactions to vaccine. Felt bad, run down and tired, belt buckle area had a plaque psoriasis attack and sore arm. Later on unknown dates, sore arm, felt run down and felt bad resolved.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-619219 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Rash, Urticaria, Vertigo
Clinical narrative: Vertigo; Fatigue; Rash over arms/rash on arm; Hives; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FATIGUE (Fatigue), RASH (Rash over arms/rash on arm), URTICARIA (Hives) and DIZZINESS (Dizziness) 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 Ankylosing spondylitis and Psoriatic arthritis.    Concurrent medical conditions included Ankylosing spondylitis and Psoriatic arthritis.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-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 an unknown date, the patient experienced VERTIGO (Vertigo), FATIGUE (Fatigue), RASH (Rash over arms/rash on arm), URTICARIA (Hives) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo), FATIGUE (Fatigue), RASH (Rash over arms/rash on arm) and URTICARIA (Hives) had resolved and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The causality for humira (adalimumab) for the event(s) of fatigue and dizziness was not provided. the reporter's causality for the event(s) of rash on arm, hives and vertigo with humira(adalimumab) was a reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Action taken with humira (adalimumab) with response to the event fatigue was Dose not changed.  No treatment details 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Vaccination site pain; Fatigue/tired; All over body pain after covid vaccine/ right leg hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All over body pain after covid vaccine/ right leg hurt so bad), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue/tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    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 17-Feb-2022, 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. In February 2022, the patient experienced PAIN (All over body pain after covid vaccine/ right leg hurt so bad) and FATIGUE (Fatigue/tired). On 17-Feb-2022, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In April 2022, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, PAIN (All over body pain after covid vaccine/ right leg hurt so bad) had not resolved and FATIGUE (Fatigue/tired) 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 provided.  No treatment medication was provided. Humira daily dose was reported as CF.   This case was linked to MOD-2022-623765 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a 79-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 Panuveitis.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 20-Apr-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) 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.   This case was linked to MOD-2022-624801 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: NOT FEELING WELL; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FEELING WELL) and HEADACHE (Headache) in a 79-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 Panuveitis.    No Medical History information was reported.   On 05-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On 28-Feb-2022, the patient experienced MALAISE (NOT FEELING WELL) and HEADACHE (Headache). In 2022, HEADACHE (Headache) had resolved. At the time of the report, MALAISE (NOT FEELING WELL) 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.   This case was linked to MOD-2022-624796 (Patient Link).