chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo administered without reconstitution; Menveo administered without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 14th September 2022, the patient received Menveo. On 14th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The nurse reported that a new staff member administered a dose of Menveo to the patient without reconstituting with the powder portion. Therefore, the patient only received the liquid CYW component of the vaccine. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case is for 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received only liquid CYW component of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022135067:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Nov2019, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 and 23-Sept-2022 Reporter's comment: The caller wanted to know how to proceed with vaccination. Since the caller was not an health care professional information could not be provided and the caller finished the call before collecting patient´s data and consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24/9/2022) dose was not reported, administered on 07-MAR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 41 years old. No concomitant medications were reported. On 07-MAR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945831, 20220945933, 20220945957, 20220948245 and 20220948255.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 07-MAR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 39 years old. No concomitant medications were reported.  On 07-MAR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945957, 20220945831, 20220948245 and 20220948255.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION  COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 19-APR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 30 years old. No concomitant medications were reported.  On 19-APR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945831, 20220945933, 20220948245 and 20220948255.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 09-MAR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 26 years old. No concomitant medications were reported. On 09-MAR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945957, 20220945831, 20220948255 and 20220945933.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 06-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 65 years old. No concomitant medications were reported. On 06-JUL-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220948245, 20220945831 and 20220945933.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Having very heavy periods after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Having very heavy periods after the 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Having very heavy periods after the 2nd dose) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Having very heavy periods after the 2nd dose) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  It was reported that patient was perfectly healthy. Patient have been post menopausal for 15  years.  Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Upon internal review on 23-Sep-2022, non-significant correction was performed to update case received from field to blank.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Kidney infection, Pain
Clinical narrative: Kidney infection; "some much of pain"; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant) and PAIN ("some much of pain"). At the time of the report, KIDNEY INFECTION (Kidney infection) and PAIN ("some much of pain") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not reported. Treatment was not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Upon internal review on 23-Sep-2022, non-significant correction was performed to update case received from field to blank.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: feel like theres something heavy on my lungs when i ay down; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (feel like theres something heavy on my lungs when i ay down) in a  patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUNG DISORDER (feel like theres something heavy on my lungs when i ay down). At the time of the report, LUNG DISORDER (feel like theres something heavy on my lungs when i ay down) had not resolved.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       No concomitant medication were provided.  It was reported that patient got first dose few days ago and still felt like there was something heavy on lungs when patient lay down.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Upon internal review on 26-Sep-2022, significant correction was performed to update Patient country, obtain drug country and drug authorization country of suspect vaccine, reporter and Agency causality and Narrative.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Nearly killing me; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Nearly killing me) in a  patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Nearly killing me). At the time of the report, FEELING ABNORMAL (Nearly killing me) outcome was unknown.            No concomitant medication information was provided.   It was reported that literally the second dose was nearly killing the patient.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Upon internal review on 26-Sep-2022, significant correction was performed to update Patient country,  obtain drug country and drug authorization country of suspect vaccine, reporter and MAH causality and Narrative.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested covid positive last week; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested covid positive last week) in a 58-year-old male patient 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 COVID-19 (tested covid positive last week). At the time of the report, COVID-19 (tested covid positive last week) had 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.       No concomitant medications were provided  It was reported that patient tested covid positive last week and he was doing well. He believed this was because moderna vaccine had trained his body so that it could put-up a good fight.   No treatment medications were provided.  Company comment: This is a spontaneous case concerning a 58-year-old male patient, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. A positive SARS-CoV-2 test was performed on an unknown date. No information disclosed about clinical course, other lab tests or treatments received. At the moment of report the outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Upon internal review on 26-Sep-2022, significant correction was performed to update Patient country, height, obtain drug country and drug authorization country of suspect vaccine, reporter and causality and Narrative. Sender's Comments: This is a spontaneous case concerning a 58-year-old male patient, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. A positive SARS-CoV-2 test was performed on an unknown date. No information disclosed about clinical course, other lab tests or treatments received. At the moment of report the outcome of the event was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Nausea
Clinical narrative: Nauseous; Knee arthritis; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and ARTHRITIS (Knee arthritis) 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 (severe).   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous) and ARTHRITIS (Knee arthritis). At the time of the report, NAUSEA (Nauseous) had resolved and ARTHRITIS (Knee arthritis) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       Concomitant Drugs Not Reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of arthritic condition on left side of knee was not provided. the reporter's causality for the event(s) of felt nauseous with the second Moderna covid-19 vaccine with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs Not Reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment: This spontaneous case concerns an elderly female patient with concurrent severe rheumatoid arthritis, who experienced the unexpected non serious AESI of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent severe rheumatoid arthritis could be confounding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an elderly female patient with concurrent severe rheumatoid arthritis, who experienced the unexpected non serious AESI of Arthritis , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact date of the event, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Concurrent severe rheumatoid arthritis could be confounding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: arm has been red, and warm ever since the injection at that Moderna site; arm has been red, and warm ever since the injection at that Moderna site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm has been red, and warm ever since the injection at that Moderna site) and VACCINATION SITE ERYTHEMA (arm has been red, and warm ever since the injection at that Moderna site) in a 58-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 Atopic dermatitis.    No Medical History information was reported.   In March 2020, the patient received dose of DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On 05-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 05-Nov-2021, the patient experienced VACCINATION SITE WARMTH (arm has been red, and warm ever since the injection at that Moderna site) and VACCINATION SITE ERYTHEMA (arm has been red, and warm ever since the injection at that Moderna site). At the time of the report, VACCINATION SITE WARMTH (arm has been red, and warm ever since the injection at that Moderna site) and VACCINATION SITE ERYTHEMA (arm has been red, and warm ever since the injection at that Moderna site) had not resolved.            No concomitant medications were reported No treatment medications were reported. Patient had taken dupilumab previously. The consumer also said that Dupixent has been a life saver for her, her skin has never been clear, and she is able to wear short sleeved clothes again, so she has had positive effects in using the Dupixent. At the time of the report, Dupixent was continued." It was not reported if the patient received a corrective treatment for the events.   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: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product  (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 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) In 2021, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) had resolved.            No concomitant and treatment medication was provided. There was no reasonable possibility of event sick with Humira. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0271121b) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: oep6955, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM) on 22-Mar-2021, Pfizer (Dose Number: 2 Batch/Lot No: ew0153, Location of injection: Arm Left and Vaccine Administration Time: 02:00 PM) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 06-Dec-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2022, COVID-19: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant drug information contains Flu and Shingles. An unknown drug was reported with allergy as relevant past drug. Lab data contains Nasal Swab test with unknown result.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Nausea
Clinical narrative: Nauseated; Arthritis aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis aggravated) and NAUSEA (Nauseated) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced ARTHRITIS (Arthritis aggravated). On an unknown date, the patient experienced NAUSEA (Nauseated). At the time of the report, ARTHRITIS (Arthritis aggravated) and NAUSEA (Nauseated) was resolving. Not Provided          No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the event(s) of ARTHRITIS WORSENED was not provided. The reporters causality for the event(s) of NAUSEATED 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: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: COVID-19; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PYREXIA (FEVER) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and PYREXIA (FEVER). At the time of the report, COVID-19 (COVID-19) had resolved and PYREXIA (FEVER) 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.  Company Comment: This spontaneous case concerns a male patient of unknown age who received the non-company product, co-suspect drug Adalimumab for Psoriasis and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the first dose of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age who received the non-company product, co-suspect drug Adalimumab for Psoriasis and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the first dose of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Palpitations
Clinical narrative: Chest Pain; palpitations; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), PALPITATIONS (palpitations) and DIZZINESS (dizziness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0729J21B and 052C21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer BioNTech (Dose Number: 1 Batch/Lot No: EW0216) on 25-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer BioNTech.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced CHEST PAIN (Chest Pain), PALPITATIONS (palpitations) and DIZZINESS (dizziness). At the time of the report, CHEST PAIN (Chest Pain), PALPITATIONS (palpitations) and DIZZINESS (dizziness) outcome was unknown. Not Provided          No concomitant and treatment medication were provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Hypophagia
Clinical narrative: DID NOT EAT MUCH; SLEPT A LOT; TIRED AND FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of HYPOPHAGIA (DID NOT EAT MUCH), HYPERSOMNIA (SLEPT A LOT) and FATIGUE (TIRED AND FATIGUE) in a 74-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 an unknown indication.    No Medical History information was reported.   On 15-Oct-2018, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced FATIGUE (TIRED AND FATIGUE). On an unknown date, the patient experienced HYPOPHAGIA (DID NOT EAT MUCH) and HYPERSOMNIA (SLEPT A LOT). On 30-Dec-2021, FATIGUE (TIRED AND FATIGUE) had resolved. At the time of the report, HYPOPHAGIA (DID NOT EAT MUCH) and HYPERSOMNIA (SLEPT A LOT) outcome was unknown.            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.  Company comment: This spontaneous case concerns a 74-years-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and non-serious events of Fatigue and Hypophagia.The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The co-suspect UPADACITINIB (RINVOQ)  remains a confounder.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 74-years-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI of Hypersomnia and non-serious events of Fatigue and Hypophagia. The events occurred on an unknown date in context to second dose of mRNA-1273 vaccine. Latency cannot be assessed since event onset date was not disclosed. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. The co-suspect UPADACITINIB (RINVOQ)  remains a confounder. 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Moderna, first 2 and patient had a stomach reaction to those; very severe with Moderna; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Moderna, first 2 and patient had a stomach reaction to those; very severe with Moderna) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Moderna, first 2 and patient had a stomach reaction to those; very severe with Moderna). At the time of the report, ABDOMINAL DISCOMFORT (Moderna, first 2 and patient had a stomach reaction to those; very severe with Moderna) had resolved.            No concomitant and treatment medication were provided Patient had a stomach reaction too but it was about 3 or 4 hours the next day but that was, Patient could face that kind of, but it was severe with Moderna so she didn't report it because it was gone in a day. 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: Eczema, Fatigue, Hypersensitivity, Rash
Clinical narrative: Eczema; Skin rash on scalp/ ankles/ footA/ wrist/ elbows and buttocks; Allergy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema), RASH (Skin rash on scalp/ ankles/ footA/ wrist/ elbows and buttocks), HYPERSENSITIVITY (Allergy) and FATIGUE (Fatigue) in a 64-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 Panuveitis. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ECZEMA (Eczema), RASH (Skin rash on scalp/ ankles/ footA/ wrist/ elbows and buttocks) and HYPERSENSITIVITY (Allergy). At the time of the report, ECZEMA (Eczema), RASH (Skin rash on scalp/ ankles/ foot/ wrist/ elbows and buttocks) and HYPERSENSITIVITY (Allergy) had not resolved and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication was not reported.  Treatment medication was not reported.  The patient had non-serious fatigue, eczema, skin rashes on scalp, ankles, foot/ wrist/ elbows and buttocks and allergies 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.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Fatigue
Clinical narrative: Constipation; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) and FATIGUE (Fatigue) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Plaque psoriasis.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 1 wk). In 2021, the patient experienced CONSTIPATION (Constipation) and FATIGUE (Fatigue). At the time of the report, CONSTIPATION (Constipation) had not resolved and FATIGUE (Fatigue) outcome was unknown.            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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain; Fatigue; Fever 38.6C; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain), FATIGUE (Fatigue) and PYREXIA (Fever 38.6C) 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe arm pain), FATIGUE (Fatigue) and PYREXIA (Fever 38.6C). At the time of the report, PAIN IN EXTREMITY (Severe arm pain), FATIGUE (Fatigue) and PYREXIA (Fever 38.6C) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38.6 degree Celsius. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. This case was linked to US-MODERNATX, INC.-MOD-2022-623795 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-623795:Case 1 of family's 3rd - Moderna(same reporter).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: COVID-19; Interchange of vaccine products; revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) outcome was unknown.            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.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event (had COVID 2 times), clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received other COVID-19 vaccine (Pfizer as booster dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event (had COVID 2 times), clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received other COVID-19 vaccine (Pfizer as booster dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Liver function test, Pain in extremity, Vaccination site pain
Clinical narrative: Vaccination site pain; SORE ARM AND HIP; SORE ARM AND HIP; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (SORE ARM AND HIP) and ARTHRALGIA (SORE ARM AND HIP) 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.  The patient's past medical history included Polycystic ovarian syndrome.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In February 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (SORE ARM AND HIP) and ARTHRALGIA (SORE ARM AND HIP). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (SORE ARM AND HIP) and ARTHRALGIA (SORE ARM AND HIP) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: Elevated.         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.   This case was linked to MOD-2022-624427 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient received Moderna as their 1st booster dose and still contracted COVID-19.; Lack of effect; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Patient received Moderna as their 1st booster dose and still contracted COVID-19.) and DRUG INEFFECTIVE (Lack of effect) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received Moderna as their 1st booster dose and still contracted COVID-19.) and DRUG INEFFECTIVE (Lack of effect). At the time of the report, COVID-19 (Patient received Moderna as their 1st booster dose and still contracted COVID-19.) and DRUG INEFFECTIVE (Lack of effect) outcome was unknown.            No concomitant and treatment medication were provided.  It was reported that patient did not heard anything new and got very little COVID news anymore. Further it was reported that patient had COVID despite doing everything patient could to prevent it.  Company comment: This spontaneous case concerns a female patient of about 6 decades old, with no reported medical history, who experienced the non-serious unexpected AESI of COVID 19 which occurred unknown days after administration of third dose of mRNA-1273.222 bivalent vaccine. Drug ineffective was also reported as an event. Further details are not mentioned in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine, is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of about 6 decades old, with no reported medical history, who experienced the non-serious unexpected AESI of COVID 19 which occurred unknown days after administration of third dose of mRNA-1273.222 bivalent vaccine. Drug ineffective was also reported as an event. Further details are not mentioned in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine, is not affected by this report.