chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Erythema, Hepatic enzyme, Myalgia, Pain
Clinical narrative: Heartburn; Localised erythema; Body Ache; Generalized aching/pain all over; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), ERYTHEMA (Localised erythema), PAIN (Generalized aching/pain all over), PYREXIA (Fever) and MYALGIA (Body Ache) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 28-Feb-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 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Generalized aching/pain all over) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPEPSIA (Heartburn), ERYTHEMA (Localised erythema) and MYALGIA (Body Ache). At the time of the report, DYSPEPSIA (Heartburn) and ERYTHEMA (Localised erythema) had not resolved and PAIN (Generalized aching/pain all over), PYREXIA (Fever) and MYALGIA (Body Ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Elevated..         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. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-624447 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Significant follow up information received on 22-OCT-2021. Moderna vaccine administration date was updated. On 28-Feb-2022: Significant follow up information received on 28-FEB-2021. Event details, suspect product information, reporter opinion of causality, and narrative description were updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Heartburn; Localised erythema; Body Ache; Generalized aching/pain all over; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn), ERYTHEMA (Localised erythema), PAIN (Generalized aching/pain all over), PYREXIA (Fever) and MYALGIA (Body Ache) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 28-Feb-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 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PAIN (Generalized aching/pain all over) and PYREXIA (Fever). On an unknown date, the patient experienced DYSPEPSIA (Heartburn), ERYTHEMA (Localised erythema) and MYALGIA (Body Ache). At the time of the report, DYSPEPSIA (Heartburn) and ERYTHEMA (Localised erythema) had not resolved and PAIN (Generalized aching/pain all over), PYREXIA (Fever) and MYALGIA (Body Ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Elevated..         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. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-624447 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Significant follow up information received on 22-OCT-2021. Moderna vaccine administration date was updated. On 28-Feb-2022: Significant follow up information received on 28-FEB-2021. Event details, suspect product information, reporter opinion of causality, and narrative description were updated.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Malaise
Clinical narrative: Feeling sick; Headache; Fatigue; Inappropriate Schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), HEADACHE (Headache), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced MALAISE (Feeling sick), HEADACHE (Headache), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered). At the time of the report, MALAISE (Feeling sick), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was reported. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that Humira daily dose was citrate free.   This case was linked to MOD-2021-623538 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Exposure to SARS-CoV-2, Interchange of vaccine products, Product administration error
Clinical narrative: Had a Covid 19 exposer; Revaccination with different COVID-19 vaccine; Completed Moderna Covid 19 vaccine series. Had a Covid 19 exposer and went to a local pharmacy to get a Covid test and was inadvertantly given a Pfizer Covid 19 Vaccine dose; Inadvertantly given a Pfizer Covid 19 Vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Had a Covid 19 exposer), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Completed Moderna Covid 19 vaccine series. Had a Covid 19 exposer and went to a local pharmacy to get a Covid test and was inadvertantly given a Pfizer Covid 19 Vaccine dose) and PRODUCT ADMINISTRATION ERROR (Inadvertantly given a Pfizer Covid 19 Vaccine dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Had a Covid 19 exposer), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Completed Moderna Covid 19 vaccine series. Had a Covid 19 exposer and went to a local pharmacy to get a Covid test and was inadvertantly given a Pfizer Covid 19 Vaccine dose) and PRODUCT ADMINISTRATION ERROR (Inadvertantly given a Pfizer Covid 19 Vaccine dose). At the time of the report, EXPOSURE TO SARS-COV-2 (Had a Covid 19 exposer), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Completed Moderna Covid 19 vaccine series. Had a Covid 19 exposer and went to a local pharmacy to get a Covid test and was inadvertantly given a Pfizer Covid 19 Vaccine dose) and PRODUCT ADMINISTRATION ERROR (Inadvertantly given a Pfizer Covid 19 Vaccine dose) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided. It was reported that patient had completed Moderna Covid 19 vaccine series. Had a Covid 19 exposer and went to a local to get a Covid test and was inadvertently given a Pfizer Covid 19 Vaccine dose. There were no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) with other authorized COVID-19 vaccines to complete the primary vaccination series or booster dose.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Erythema, Hepatic enzyme, Hepatic enzyme increased, Pain
Clinical narrative: ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED; HEARTBURN; HEART ERYTHEMA; PAIN ALL OVER; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN), ERYTHEMA (HEART ERYTHEMA), PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In 2021, the patient experienced PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN) and ERYTHEMA (HEART ERYTHEMA). At the time of the report, HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN) and ERYTHEMA (HEART ERYTHEMA) had not resolved and PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: ELEVATED.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The reporter's causality for the events of elevated liver enzymes/liver enzymes raised and heartburn with rinvoq(upadacitinib) was a reasonable possibility. The reporter's causality for the events of heart erythema, first covid 19 injection had sore arm with rinvoq(upadacitinib) was no reasonable possibility. The reporter's causality for the event of pain all over was not provided.  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.   This case was linked to MOD-2021-624363 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Significant follow up received included event information, reporter opinion of causality, suspect drug information and narrative description updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED; HEARTBURN; HEART ERYTHEMA; PAIN ALL OVER; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN), ERYTHEMA (HEART ERYTHEMA), PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In 2021, the patient experienced PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN) and ERYTHEMA (HEART ERYTHEMA). At the time of the report, HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN) and ERYTHEMA (HEART ERYTHEMA) had not resolved and PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: ELEVATED.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The reporter's causality for the events of elevated liver enzymes/liver enzymes raised and heartburn with rinvoq(upadacitinib) was a reasonable possibility. The reporter's causality for the events of heart erythema, first covid 19 injection had sore arm with rinvoq(upadacitinib) was no reasonable possibility. The reporter's causality for the event of pain all over was not provided.  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.   This case was linked to MOD-2021-624363 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Significant follow up received included event information, reporter opinion of causality, suspect drug information and narrative description updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced HEADACHE (TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE). In 2021, HEADACHE (TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE) had resolved.            No concomitant medication was reported.  In 2021, the patient experienced TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE. In 2021, the TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was not available.    Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of TOOK COVID BOOSTER SHOT AND DEVELOPED A HEADACHE with HUMIRA 40MG/0.4ML(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.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle spasms
Clinical narrative: FLARE UP WITH CRAMPING; Disorder aggravation; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (FLARE UP WITH CRAMPING) and CONDITION AGGRAVATED (Disorder aggravation) 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 and Ulcerative colitis.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced MUSCLE SPASMS (FLARE UP WITH CRAMPING) and CONDITION AGGRAVATED (Disorder aggravation). At the time of the report, MUSCLE SPASMS (FLARE UP WITH CRAMPING) and CONDITION AGGRAVATED (Disorder aggravation) outcome was unknown.            No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the events of FLARE UP WITH CRAMPING unknown onset and FLARE UP WITH CRAMPING unknown onset was not provided. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Thinking abnormal
Clinical narrative: Memory loss; LOSING TRAIN OF THOUGHT; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss) and THINKING ABNORMAL (LOSING TRAIN OF THOUGHT) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 AMNESIA (Memory loss) and THINKING ABNORMAL (LOSING TRAIN OF THOUGHT). At the time of the report, AMNESIA (Memory loss) had not resolved and THINKING ABNORMAL (LOSING TRAIN OF THOUGHT) outcome was unknown.            No concomitant medication was reported. On unknown dates, the patient experienced MEMORY LOSS and LOSING TRAIN OF THOUGHT. COVID-19 VACCINE MODERNA (ELASOMERAN) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of MEMORY LOSS with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of LOSING TRAIN OF THOUGHT 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: Eye swelling, Lacrimation increased, Ocular discomfort
Clinical narrative: Pressure under eyes; Watery eyes; Swelling of her left eye; This spontaneous case was reported by an other health care professional and describes the occurrence of OCULAR DISCOMFORT (Pressure under eyes), LACRIMATION INCREASED (Watery eyes) and EYE SWELLING (Swelling of her left eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Restylane-L (was injected approximately 3.5 months prior to receiving vaccine.). Past adverse reactions to the above products included No adverse reaction with Restylane-L.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Pressure under eyes), LACRIMATION INCREASED (Watery eyes) and EYE SWELLING (Swelling of her left eye). At the time of the report, OCULAR DISCOMFORT (Pressure under eyes), LACRIMATION INCREASED (Watery eyes) and EYE SWELLING (Swelling of her left eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  It was reported after lips started swelling patient went to ER (previous injection of Volbella approximately 1.5 years ago) where she was treated with IV steroids and was sent home with an oral steroid script took for the following 5 days.  Currently 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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: SIDE EFFECT FROM BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SIDE EFFECT FROM BOOSTER SHOT) 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.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (SIDE EFFECT FROM BOOSTER SHOT). At the time of the report, IMMUNISATION REACTION (SIDE EFFECT FROM BOOSTER SHOT) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of SIDE EFFECT FROM BOOSTER SHOT with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; Moderna COVID-19 vaccine: first dose was 5 months ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID-19 vaccine: first dose was 5 months ago) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. In 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID-19 vaccine: first dose was 5 months ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID-19 vaccine: first dose was 5 months ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Moderna COVID-19 vaccine: first dose was 5 months ago).    No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder, Muscle disorder
Clinical narrative: Bones and Muscles have been affected; Bones and Muscles have been affected; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISORDER (Bones and Muscles have been affected) and BONE DISORDER (Bones and Muscles have been affected) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE DISORDER (Bones and Muscles have been affected) and BONE DISORDER (Bones and Muscles have been affected). At the time of the report, MUSCLE DISORDER (Bones and Muscles have been affected) and BONE DISORDER (Bones and Muscles have been affected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was 50 something years old.  Patient was healthy.  No concomitant medications were reported.  Patient said that she had Moderna vaccine and after that her bones and muscles had been affected. It was scary.  Patient was walking with a cane and was half her weight. Patient was skinny already.   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: COVID-19
Clinical narrative: Patient developed covid after all 3 vaccines Moderna; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient developed covid after all 3 vaccines 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient developed covid after all 3 vaccines Moderna). At the time of the report, COVID-19 (Patient developed covid after all 3 vaccines Moderna) outcome was unknown.            No relevant concomitant medications were 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 unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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) (Unknown) was unknown.       Concomitant Drugs Not Reported. The patient received first Moderna vaccine on 04-Feb-2021 and was scheduled for second on 02-Mar-2021. Patient was diagnosed with Covid on 26-Feb-2021 and was in isolation until 06-Mar-2021. 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 an unknown age and gender with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred  22 days after receiving the first dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred  22 days after receiving the first dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site movement impairment
Clinical narrative: Unable to lift arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift arm) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for an unknown indication.    No Medical History information was reported.   On 05-Jun-2021, the patient started PALBOCICLIB (IBRANCE) (unknown route) 125 milligram. 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 SITE MOVEMENT IMPAIRMENT (Unable to lift arm) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift arm) and PYREXIA (Low grade fever) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: ARM SWELLED UP; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (ARM SWELLED UP) and PYREXIA (Fever) in an 80-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.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE SWELLING (ARM SWELLED UP) and PYREXIA (Fever). In 2021, VACCINATION SITE SWELLING (ARM SWELLED UP) and PYREXIA (Fever) had resolved.            No concomitant medications were reported. No treatment 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation reaction, Inappropriate schedule of product administration, Injection site reaction, Pyrexia
Clinical narrative: Injection site reaction; 14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose; Sick after second covid vaccine; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), IMMUNISATION REACTION (Sick after second covid vaccine), CHILLS (Chills), PYREXIA (Low grade fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose) in a 20-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.    No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 03-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose). In October 2021, the patient experienced IMMUNISATION REACTION (Sick after second covid vaccine), CHILLS (Chills) and PYREXIA (Low grade fever). On an unknown date, the patient experienced INJECTION SITE REACTION (Injection site reaction). In October 2021, IMMUNISATION REACTION (Sick after second covid vaccine), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, INJECTION SITE REACTION (Injection site reaction) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 Aug 2021 received 1st dose, 03 Oct 2021 received 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The reporter's causality for the events of SICK AFTER SECOND COVID VACCINE LOW GRADE FEVER AND CHILLS onset in Oct 2021, SICK AFTER SECOND COVID VACCINE LOW GRADE FEVER AND CHILLS onset in Oct 2021 and SICK AFTER SECOND COVID VACCINE LOW GRADE FEVER AND CHILLS onset in October 2021 was not provided. The reporter's causality for the event of INJECTION SITE REACTION 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Energy decreased/Run down; Tiredness; Chills; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased/Run down), FATIGUE (Tiredness), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2022, received first 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 an unknown date, the patient experienced ASTHENIA (Energy decreased/Run down), FATIGUE (Tiredness), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ASTHENIA (Energy decreased/Run down), FATIGUE (Tiredness) and CHILLS (Chills) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of tired, run down and chills 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.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Illness, Intervertebral disc disorder, Pain in extremity
Clinical narrative: Back pain/pain in back; Intervertebral disc disorder/disc messed up in back; Sickness; Pain legs; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain/pain in back), INTERVERTEBRAL DISC DISORDER (Intervertebral disc disorder/disc messed up in back), ILLNESS (Sickness) and PAIN IN EXTREMITY (Pain legs) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain/pain in back), INTERVERTEBRAL DISC DISORDER (Intervertebral disc disorder/disc messed up in back), ILLNESS (Sickness) and PAIN IN EXTREMITY (Pain legs). At the time of the report, BACK PAIN (Back pain/pain in back), INTERVERTEBRAL DISC DISORDER (Intervertebral disc disorder/disc messed up in back) and PAIN IN EXTREMITY (Pain legs) had not resolved and ILLNESS (Sickness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported.   The reporter's causality for the event(s) of pain in back, pain in legs, sick and disc messed up in back was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain
Clinical narrative: WEATHER WAS BAD, PAIN/PAIN ALL OVER; Headaches; Chills; RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (WEATHER WAS BAD, PAIN/PAIN ALL OVER), HEADACHE (Headaches), CHILLS (Chills) and ARTHRALGIA (RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER) in a 50-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 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 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. On an unknown date, the patient experienced PAIN (WEATHER WAS BAD, PAIN/PAIN ALL OVER), HEADACHE (Headaches), CHILLS (Chills) and ARTHRALGIA (RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER). At the time of the report, PAIN (WEATHER WAS BAD, PAIN/PAIN ALL OVER), HEADACHE (Headaches), CHILLS (Chills) and ARTHRALGIA (RHEUMATOID ARTHRITIS HAD BEEN PAINFUL DUE TO WEATHER) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter did not provide any causality assessment for the events of headache and chills with Humira. The reporter did not provide any causality assessment for the events of general body pain, headaches and chills with Moderna vaccine.  The reporter assessed the event of general body pain and arthritic pains to be reasonably possible to Humira. The reporter assessed the event of arthritic pains as not related to Moderna vaccine.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Vaccination site bruising
Clinical narrative: BRUISES ON RIGHT LEG AFTER MODERNA VACCINE; HAND SWELLING; HAND PAIN WORSENED/COMES AND GOES; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (BRUISES ON RIGHT LEG AFTER MODERNA VACCINE), PERIPHERAL SWELLING (HAND SWELLING) and PAIN (HAND PAIN WORSENED/COMES AND GOES) in a 63-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 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 VACCINATION SITE BRUISING (BRUISES ON RIGHT LEG AFTER MODERNA VACCINE), PERIPHERAL SWELLING (HAND SWELLING) and PAIN (HAND PAIN WORSENED/COMES AND GOES). The patient was treated with TRAMADOL at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (BRUISES ON RIGHT LEG AFTER MODERNA VACCINE) had resolved and PERIPHERAL SWELLING (HAND SWELLING) and PAIN (HAND PAIN WORSENED/COMES AND GOES) was resolving.        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.  The reporter's causality for the event of bruises on right leg after moderna vaccine with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event of hand swelling and hand pain worsened/comes and goes with humira(adalimumab) was a reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Osteoarthritis
Clinical narrative: right knee was bone on bone; Right Knee pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (right knee was bone on bone), FATIGUE (fatigue) and ARTHRALGIA (Right Knee pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Knee replacement (Left Knee replacement).   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 21-Sep-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced OSTEOARTHRITIS (right knee was bone on bone) and ARTHRALGIA (Right Knee pain). At the time of the report, OSTEOARTHRITIS (right knee was bone on bone), FATIGUE (fatigue) and ARTHRALGIA (Right Knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-633751 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Influenza like illness
Clinical narrative: she may have a heart murmur; Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC MURMUR (she may have a heart murmur) and INFLUENZA LIKE ILLNESS (Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Down's syndrome (was diagnosed with  Down's syndrome at birth).    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC MURMUR (she may have a heart murmur) and INFLUENZA LIKE ILLNESS (Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.). At the time of the report, CARDIAC MURMUR (she may have a heart murmur) and INFLUENZA LIKE ILLNESS (Stated that after the first one that they all felt really bad like they had the flu after they had the vaccine. Stated that they all had the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was on Medicaid. 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.   This case was linked to MOD-2021-626223 (Patient Link).   Reporter did not allow further contact