chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted COVID/I tested positive for COVID/Sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (contracted COVID/I tested positive for COVID/Sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID/I tested positive for COVID/Sick). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID/I tested positive for COVID/Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant products were not reported.  It was reported that patient had two vaccines with unspecified vaccine and booster with moderna.  Company comment: This spontaneous case concerns female patient (of an unknown age and gender), with no medical history reported, who received a booster dose of mRNA-1273 vaccine (reported as third dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir). No further clinical information was available for medical reviewing. 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 female patient (of an unknown age and gender), with no medical history reported, who received a booster dose of mRNA-1273 vaccine (reported as third dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir). No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I had a reaction when they gave me the injection of both companies; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I had a reaction when they gave me the injection of both companies) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Comirnaty (Dose 2) and Comirnaty (Dose 1). Past adverse reactions to the above products included Vaccination adverse reaction with Comirnaty and Comirnaty.    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, the patient experienced IMMUNISATION REACTION (I had a reaction when they gave me the injection of both companies). At the time of the report, IMMUNISATION REACTION (I had a reaction when they gave me the injection of both companies) outcome was unknown.            No concomitant medication was reported. The patient had the first 2 shots of Pfizer vaccine and switched to Moderna for the booster. Patient had a reaction when patient got injection of both companies. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I also have covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I also have covid) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I also have covid). At the time of the report, COVID-19 (I also have covid) had not resolved.            No concomitant medications were reported. Patient stated that he was a anti vaccine person. Patient had two shots and both were Moderna. Patient stated that this stuff was bad and was prescribed to different medications, going on for 7 days.  Company comment: This Spontaneous case reported by patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient had previously received the Moderna vaccine on an unknown date. No other information regarding comorbidities, risk factors, symptoms, labs, diagnostic procedures, concomitant medications and treatment was available in the report. Ongoing Covid 19 pandemia is a confounder. The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case reported by patient concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient had previously received the Moderna vaccine on an unknown date. No other information regarding comorbidities, risk factors, symptoms, labs, diagnostic procedures, concomitant medications and treatment was available in the report. Ongoing Covid 19 pandemia is a confounder. The event had not resolved.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture).    This case contains information for the 1st of 3 patients described by the reporter.  No concomitant medication was reported.  It was unknown when the vial was initially stored in the refrigerator.  On 08-Aug-2022, the vial was first punctured.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-627651, US-MODERNATX, INC.-MOD-2022-627652 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627651:case for patient 2 US-MODERNATX, INC.-MOD-2022-627652:case for patient 3
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine).    No concomitant medications were reported.No treatment details were reported. Reporter was asking if patient had to get second dose of Moderna vaccine series.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Feverish) in a 66-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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Feverish). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Feverish) outcome was unknown.            No concomitant medication were provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality with Humira was not reported.   This case was linked to MOD-2022-576606 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got vaccinated still tested positive for covid19 afterwards; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got vaccinated still tested positive for covid19 afterwards) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EK730) 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 05-Jul-2022, the patient experienced COVID-19 (Got vaccinated still tested positive for covid19 afterwards). At the time of the report, COVID-19 (Got vaccinated still tested positive for covid19 afterwards) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The ethnicity was reported. No concomitant medications were reported. It was reported that patient had no prior vaccinations(within 4 weeks). No treatment medications were reported.  Company comment: This spontaneous case concerns 44 years old male patient, with no medical history, who experienced the unexpected non serious AESI event of Covid -19 (reported as Got vaccinated still tested positive for covid19 afterwards), which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. At the time of report outcome of the event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 44 years old male patient, with no medical history, who experienced the unexpected non serious AESI event of Covid -19 (reported as Got vaccinated still tested positive for covid19 afterwards), which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. At the time of report outcome of the event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture).    The 3 adult patients who received the vaccine on 08-Aug-2022.  No concomitant medications information was reported.  It was reported that date when the vial was initially stored in the refrigerator was unknown and the vial was first punctured on  08 Aug 2022.  It was unknown how the vial was stored post puncture. It was unknown whether vial undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C which was equal to 46 degree to 77 degree F was unknown.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-627652 (Linked Report). This case was linked to MOD-2022-627652, MOD-2022-627637 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627652:case for patient 2
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction; Received expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse reaction) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours after first puncture).    This case contains information for the 3rd of 3 patients described by the reporter. No concomitant medication was reported. It was unknown when the vial was initially stored in the refrigerator. On 08-Aug-2022, the vial was first punctured. It was unknown if the vial stored post puncture was stored in RT/fridge. It was unknown if the vial had undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was unknown. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-627637, US-MODERNATX, INC.-MOD-2022-627651 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627637:case for patient 1 US-MODERNATX, INC.-MOD-2022-627651:case for patient 2
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Psoriasis
Clinical narrative: Psoriasis flare-up/ Inverse psoriasis outbreak; Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/ Inverse psoriasis outbreak) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (moderate to severe chronic).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 02-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/ Inverse psoriasis outbreak). At the time of the report, PSORIASIS (Psoriasis flare-up/ Inverse psoriasis outbreak) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days) outcome was unknown.            Concomitant medications details were not reported by the reporter.  On an unknown date, the patient experienced inverse psoriasis outbreak. on an unknown date, inverse psoriasis outbreak resolved.  The patient reported that when she took second Covid vaccine Inverse psoriasis outbreak. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment details were not reported by the reporter.  Causality for Skyrizi(risankizumab): The reporter's causality for the event of inverse psoriasis outbreak was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Herpes zoster, Transient ischaemic attack
Clinical narrative: Shingles; Ministroke; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and TRANSIENT ISCHAEMIC ATTACK (Ministroke) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for B-cell chronic lymphocytic leukaemia.    No known allergies.  Concurrent medical conditions included Gout and Diabetic. Concomitant products included ALLOPURINOL, PARACETAMOL (TYLENOL), METFORMIN HCL, LOSARTAN POTASSIUM and NAPROXEN for an unknown indication.   On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 21-Apr-2022, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion hospitalization) and TRANSIENT ISCHAEMIC ATTACK (Ministroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 21-Apr-2022 due to HERPES ZOSTER and TRANSIENT ISCHAEMIC ATTACK. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown and TRANSIENT ISCHAEMIC ATTACK (Ministroke) was resolving.            Company comment: This is a spontaneous case concerning a 64-year-old male patient with medical history of B-cell chronic lymphocytic leukaemia and diabetes, who experienced the serious unexpected events transient ischaemic attack and herpes zoster, that lead to hospitalization. Events occurred approximately 5 months after the third dose of mRNA-1273.  Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for B-cell chronic lymphocytic leukaemia. Patient´s reported  medical history remains a confounder for events. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The patient had other concomitant therapy of multi for him.   The reporter's causality with IMBRUVICA(IBRUTINIB) for the events of Herpes zoster and transient ischaemic attack was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.; Sender's Comments: Company comment: This is a spontaneous case concerning a 64-year-old male patient with medical history of B-cell chronic lymphocytic leukaemia and diabetes, who experienced the serious unexpected events transient ischaemic attack and herpes zoster, that lead to hospitalization. Events occurred approximately 5 months after the third dose of mRNA-1273.  Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for B-cell chronic lymphocytic leukaemia. Patient´s reported  medical history remains a confounder for events. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Skin exfoliation
Clinical narrative: Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger; Plaque Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger) and PSORIASIS (Plaque Psoriasis flare-up) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Psoriasis flare-up.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN EXFOLIATION (Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger) and PSORIASIS (Plaque Psoriasis flare-up). The patient was treated with BETAMETHASONE for Peeling, at an unspecified dose and frequency. At the time of the report, SKIN EXFOLIATION (Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger) had resolved and PSORIASIS (Plaque Psoriasis flare-up) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient indicated that he thought the COVID vaccinations may had caused this flare up to appear. It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of Peeling on two fingers sometimes/ Middle finger and the one next to the pinky finger and plaque psoriasis flare up was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest discomfort, Cough, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: Shortness of breath; Tightness in chest; Tickle cough; Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest), COUGH (Tickle cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021) in a 56-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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021). In 2022, the patient experienced DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and COUGH (Tickle cough). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (DELSYM) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Tightness in chest) and COUGH (Tickle cough) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 25 Mar 2021 and second dose on 01 Aug 2021) outcome was unknown.            No concomitant medication was provided.  It was reported that Albuterol and Delsum but continued to cough and it worsened. Physician suggested to stop Rinvoq and last dose was on 06 Jul 2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of shortness of breath and Tickle cough with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event of tightness in chest was not provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, COVID-19, Immunisation reaction
Clinical narrative: COVID-19; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and IMMUNISATION REACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, COVID-19 (COVID-19) and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Has gotten her blood work back and it was almost in the range that it should be.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Daily dose of Humira was reported as citrate free and Moderna as 1 in 1 once.   Company Comment: This spontaneous case concerns an adult female patient (age not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. On an unknown date, Blood test reported as: was almost in the range that it should be. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient (age not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. On an unknown date, Blood test reported as: was almost in the range that it should be. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion; The caller states that 5 patients received vaccine that experienced excursion in the refrigerator; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse reaction) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator).    No concomitant medication was reported by reporter.  Vial was in refrigerator during temperature excursion. Lot number 060A22A had 2 unpunctured and 1 punctured vial with expiry date 28-Aug-2022, lot number 013B22A had 1 punctured vial with expiry date 22-Nov-2022 which were affected. Vial was moved from freezer to refrigerator on 25-Jul-2022. Unpunctured vials were returned to refrigerator and punctured vials were discarded. during visual inspection before vaccination it was normal. Before this there was no prior temperature excursion.  No treatment medication was reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-627779 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2022: Live Follow Up -Significant Information include narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627779:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Poor quality product administered; Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and NO ADVERSE EVENT (No adverse reaction) in a 60-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion in the refrigerator with maximum 49.3 F and minimum 45.8 F temperature/ the refrigerator door was left open for 10 minutes).    No concomitant medication was reported by reporter.  Vial was in refrigerator during temperature excursion. Lot number 060A22A had 2 unpunctured and 1 punctured vial with expiry date 28-Aug-2022, lot number 013B22A had 1 punctured vial with expiry date 22-Nov-2022 which were affected. Vial was moved from freezer to refrigerator on 25-Jul-2022. Unpunctured vials were returned to refrigerator and punctured vials were discarded. during visual inspection before vaccination it was normal. Before this there was no prior temperature excursion.  No treatment medication was reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-627647, US-MODERNATX, INC.-MOD-2022-627771, US-MODERNATX, INC.-MOD-2022-627784, US-MODERNATX, INC.-MOD-2022-627786 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2022: Live follow-up was received and lot number and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627647: US-MODERNATX, INC.-MOD-2022-627771: US-MODERNATX, INC.-MOD-2022-627784: US-MODERNATX, INC.-MOD-2022-627786:
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Foot fracture, Headache, Influenza
Clinical narrative: Flu symptoms; Broke foot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FOOT FRACTURE (Broke foot), INFLUENZA (Flu symptoms) and HEADACHE (Headache) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-May-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced HEADACHE (Headache). In March 2022, the patient experienced FOOT FRACTURE (Broke foot). On an unknown date, the patient experienced INFLUENZA (Flu symptoms). In 2021, HEADACHE (Headache) had resolved. At the time of the report, FOOT FRACTURE (Broke foot) and INFLUENZA (Flu symptoms) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant product use was reported.  The patient received 1st, 2nd and booster vaccine dose one in once. Humira was citrate free.   No treatment information was provided.  The reporter's causality with humira for the events of broke foot, flu symptoms and headache were not reported.  The reporter's causality with Janssen covid-19 vaccine for the events of broke foot and flu symptoms were not reported. The reporter's causality with Janssen covid-19 vaccine for event headache was reported as probable.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Immunisation reaction
Clinical narrative: Vaccination adverse reaction; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) and COVID-19 (COVID-19) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction) and COVID-19 (COVID-19). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information provided.  Company Comment: This spontaneous case concerns a 55-year-old patient (gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old patient (gender not specified) with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVE LIKE BREAK OUT ALL OVER; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (HIVE LIKE BREAK OUT ALL OVER) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (HIVE LIKE BREAK OUT ALL OVER). At the time of the report, URTICARIA (HIVE LIKE BREAK OUT ALL OVER) had not resolved. Not Provided          Concomitant products were not reported. Causality as per reporter for Humira was reported as not related. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Illness, Therapeutic product effect incomplete
Clinical narrative: Drug effect incomplete; the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and ILLNESS (the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and ILLNESS (the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK). At the time of the report, THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and ILLNESS (the patient experienced HUMIRA HAS WORKED 90 PERCENT and SICK) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Daily dose was reported as CF for Humira and 1 in 1 once for Moderna. On unknown dates, the patient experienced HUMIRA has worked 90 percent and Sick. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  The reporter's causality for the event(s) of HUMIRA HAS WORKED 90 PERCENT and SICK was not provided. No treatment medications were reported.  Company comment: This spontaneous case concerns a male patient of unknown age with relevant medical history of Chronic plaque psoriasis, who experienced unexpected, non-serious event of Ilness. Therapeutic product effect incomplete was reported as an additional event. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with relevant medical history of Chronic plaque psoriasis, who experienced unexpected, non-serious event of Ilness. Therapeutic product effect incomplete was reported as an additional event. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza
Clinical narrative: Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a 77-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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In June 2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) was resolving. Not Provided          It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st Dose on 15-oct-2021 and 2nd dose on 02-Nov-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-oct-2021 and 2nd dose on 02-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-oct-2021 and 2nd dose on 02-Nov-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 15-oct-2021 and 2nd dose on 02-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided          No concomitant product reported by reporter. No treatment medication reported by reporter.    This case was linked to MOD-2022-627913 (Patient Link).