chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)). No concomitant medication was provided. It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose. It was unknown if patient experienced any symptoms after getting the vaccine. No treatment details were provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow up received includes significant information: Case report type was updated, patient details were added, suspect vaccine start date, event coding and event start date were updated and narrative updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS ON BACK, LEGS, ARM AND FOREHEAD AND HAD DARK SPOTS ON STOMACH AND THIGHS/ IT WAS STILL VISIBLE AFTER ONE YEAR OF SKYRIZI TREATMENT) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third 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 PSORIASIS (PLAQUE PSORIASIS ON BACK, LEGS, ARM AND FOREHEAD AND HAD DARK SPOTS ON STOMACH AND THIGHS/ IT WAS STILL VISIBLE AFTER ONE YEAR OF SKYRIZI TREATMENT). At the time of the report, PSORIASIS (PLAQUE PSORIASIS ON BACK, LEGS, ARM AND FOREHEAD AND HAD DARK SPOTS ON STOMACH AND THIGHS/ IT WAS STILL VISIBLE AFTER ONE YEAR OF SKYRIZI TREATMENT) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.- No concomitant medications information was reported. The patient had developed plaque psoriasis after receiving the Covid vaccine. She was still experiencing psoriasis on her back, legs, arm, and forehead and has dark spots on her stomach and thighs. Plaque psoriasis was 90 percent over the body and in 2022, it was 80 percent. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation reaction, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis pain in arms and legs/Arthritic pains; Vaccination related malaise; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain in arms and legs/Arthritic pains) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No relevant history was reported.  Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.   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) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain in arms and legs/Arthritic pains) (seriousness criterion medically significant), IMMUNISATION REACTION (Vaccination related malaise) and CHILLS (Chills). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain in arms and legs/Arthritic pains), IMMUNISATION REACTION (Vaccination related malaise) and CHILLS (Chills) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The formulation for co-suspect product Humira was reported as Solution for injection in pre-filled pen.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of MODERNA CAUSED CHILLS AND MADE FELT SICK unknown, MODERNA CAUSED CHILLS AND MADE FELT SICK unknown and RHEUMATOID ARTHRITIS PAINS IN ARMS AND LEGS was not provided.  No treatment medications were reported.  Company comment- This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, serious (medically significant) AESI Rheumatoid arthritis which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient reported that after vaccination with mRNA-1273, she experienced chills and felt sick. She also noted arthritic pain in the arms and legs. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, serious (medically significant) AESI Rheumatoid arthritis which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient reported that after vaccination with mRNA-1273, she experienced chills and felt sick. She also noted arthritic pain in the arms and legs. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured), PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis. No Medical History information was reported. What On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured), PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured) and PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM). Patient had no allergy and never tested positive for COVID. No concomitant medication was reported. Number of doses/vials was 2/1. Vials were initially refrigerated on 14-Jul-2022. Vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range 8 to 25 degree Celsius= 46 to 77 Fahrenheit was 30 minutes. Time of administration to 2 patients were on 2-Aug-2022 9:15 and 9:30 AM. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2022-620931. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow-up was received and case validity updated, patient identifier added, suspect dose details added and narrative updated. Sender's Comments: US-MODERNATX, INC.-MOD-2022-620931: same reporter 2nd patient.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (SORE JOINTS MOSTLY ELBOWS AND KNEES/JOINT PAIN FROM WRIST TO OPPOSITE ELBOW) in a 60-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 Chronic lymphoid leukemia. There was no reported medical history. Concurrent medical conditions included Chronic lymphoid leukemia. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (SORE JOINTS MOSTLY ELBOWS  AND KNEES/JOINT PAIN FROM WRIST TO OPPOSITE ELBOW). At the time of the report, COVID-19 (COVID-19) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and ARTHRALGIA (SORE JOINTS MOSTLY ELBOWS  AND KNEES/JOINT PAIN FROM WRIST TO OPPOSITE ELBOW) had not resolved. Concomitant medication information was not provided by the reporter. The reporter's causality for the events was not reported with respect to IMBRUVICA (IBRUTINIB). Treatment information was not provided by the reporter. Company Comment: This spontaneous case concerns a 60-year-old, male patient with current condition of Chronic lymphocytic leukemia and treated with Ibrutinib who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred an unknown interval after receiving an unknown dose number of mRNA-1273. The clinical course, diagnostic evaluation including SARS-CoV-2 test and treatment information were not provided in the report. At the time of report, COVID-19 has resolved. Underlying chronic lymphocytic leukemia and treatment with Ibrutinib are associated with abnormalities in immune function and increased risk for infections. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 60-year-old, male patient with current condition of Chronic lymphocytic leukaemia and treated with Ibrutinib who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred an unknown interval after receiving an unknown dose number of mRNA-1273. The clinical course, diagnostic evaluation including SARS-CoV-2 test and treatment information were not provided in the report. At the time of report, COVID-19 has resolved. Underlying chronic lymphocytic leukemia and treatment with Ibrutinib are associated with abnormalities in immune function and increased risk for infections. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (SICK WITH COVID) in an adult 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 Psoriatic arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (SICK WITH COVID). At the time of the report, COVID-19 (SICK WITH COVID) outcome was unknown. Not Provided. No concomitant product reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for SKYRIZI for the event(s) of SICK WITH COVID was not provided. Patient had been prescribed with medication by physician as treatment medication. Company Comment: This spontaneous case concerns an adult female patient on concomitant immunosuppressant Risankizumab for psoriatic arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 (reported as Sick with Covid) on an unknown date after receiving a dose of mRNA-1273 vaccine. Latency could not be established as the date of vaccination and the onset date of the event were not provided. A COVID-19 test was not reported. Patient was prescribed unspecified medicine by a physician. Clinical course and outcome are unknown. Information on the primary series of COVID-19 vaccination was undisclosed. Another unspecified dose of mRNA-1273 vaccine was received by the patient on an unknown date. The concomitant immunosuppressant Risankizumab for psoriatic arthritis may decrease the efficacy and immune response to the vaccine leading. 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 on concomitant immunosuppressant Risankizumab for psoriatic arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 (reported as Sick with Covid) on an unknown date after receiving a dose of mRNA-1273 vaccine. Latency could not be established as the date of vaccination and the onset date of the event were not provided. A COVID-19 test was not reported. Patient was prescribed unspecified medicine by a physician.  Clinical course and outcome are unknown. Information on the primary series of COVID-19 vaccination was undisclosed. Another unspecified dose of mRNA-1273 vaccine was received by the patient on an unknown date. The concomitant immunosuppressant Risankizumab for psoriatic arthritis may decrease the efficacy and immune response to the vaccine leading. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Atopic dermatitis and Psoriasis vulgaris.    No medical history information was reported.  Concomitant products included PREDNISONE, AZITHROMYCIN (Z-PAK) and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.   On 18-Mar-2022, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 26-Jul-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     No known drug allergy were reported.  No treatment medication reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Co-suspect Rinvoq action taken were unknown.  Company Comment: This is a spontaneous case concerning a 54-year-old male patient with intake of the co-suspect, non-company product UPADACITINIB (RINVOQ), who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and approximately 4 months after receiving the co-suspect, non-company product UPADACITINIB (RINVOQ). SARS-CoV-2 test was positive, no further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with intake of the co-suspect, non-company product UPADACITINIB (RINVOQ), who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and approximately 4 months after receiving the co-suspect, non-company product UPADACITINIB (RINVOQ). SARS-CoV-2 test was positive, no further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in an adult 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.   On 21-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with MOLNUPIRAVIR (LAGEVRIO) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.            No concomitant medication was reported.  Patient reported that she had Covid a couple days after her Skyrizi injection. She took COVID antiviral medication lagevrio. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter contact for lot number information was unsuccessful.  Company comment: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred in the context of booster dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had covid a couple of days after her co suspect Skyrizi injection (for her medical condition chronic palque psoriasis). She took covid antiviral medication lagevrio.  No further information on risk factors, detailed clinical course, investigations and details pertaining to the previous doses was available in the report. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred in the context of booster dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had covid a couple of days after her co suspect Skyrizi injection (for her medical condition chronic palque psoriasis). She took covid antiviral medication lagevrio.  No further information on risk factors, detailed clinical course, investigations and details pertaining to the previous doses was available in the report. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult 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.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by him was related to covid vaccine. The reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for SKYRIZI for the event(s) of SICK WITH COVID was not provided.  Company Comment: This is a spontaneous case concerns an adult male patient (age not specified), with no medical history, who experienced the unexpected non serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date. The Clinical course, Concomitant medication, treatment details were not provided, and the outcome of event reported as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerns an adult male patient (age not specified), with no medical history, who experienced the unexpected non serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date. The Clinical course, Concomitant medication, treatment details were not provided, and the outcome of event reported as not resolved. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, pre-filled pen. On 27-Jul-2022, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were provided. Co-suspect Humira action taken were unknown. Company comment: This is a spontaneous case concerning 60 years old male, with no medical history, who experienced the unexpected non serious AESI event of Covid-19 (reported as Tested positive for COVID) which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This is a spontaneous case concerning 60 years old male, with no medical history, who experienced the unexpected non serious AESI event of Covid-19 (reported as Tested positive for COVID) which occurred unspecified days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is Positive. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Warm feeling in her toes after 2nd booster/Toes are warm more in the evenings, after 2nd booster; Toes are tingling more in the evenings, after 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Warm feeling in her toes after 2nd booster/Toes are warm more in the evenings, after 2nd booster) and PARAESTHESIA (Toes are tingling more in the evenings, after 2nd booster) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B22A and 067H21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Lot and Exp. Date was unknown) on 17-Mar-2021 and Pfizer vaccine (Lot and Exp. Date was unknown) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, the patient experienced FEELING HOT (Warm feeling in her toes after 2nd booster/Toes are warm more in the evenings, after 2nd booster) and PARAESTHESIA (Toes are tingling more in the evenings, after 2nd booster). At the time of the report, FEELING HOT (Warm feeling in her toes after 2nd booster/Toes are warm more in the evenings, after 2nd booster) and PARAESTHESIA (Toes are tingling more in the evenings, after 2nd booster) outcome was unknown.            Patient stated that she did not have a history of Diabetes or anything else. No concomitant medication was reported.  Patient did not remember how long after the 2nd booster she started having warm feeling in her toes. Patient was wondered if those events were related to the 2nd booster. No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: was sick/clarified as flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (was sick/clarified as flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Relapsing-remitting multiple sclerosis, Sulfonamide allergy and Drug allergy (Dilaudid). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (was sick/clarified as flu like symptoms). In April 2021, INFLUENZA LIKE ILLNESS (was sick/clarified as flu like symptoms) had resolved. The patient received first vaccine on 16-Mar-2021 and had no symptoms then 28 days later had second vaccine on 13-Apr-2021 and was sick (clarified as flu like symptoms) for 48 hours from 10 am to 2 the next morning. No treatment information was provided.   This case was linked to MOD-2022-621237 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow up received included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date), PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date), PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine experienced multiple warm excursions and was administered past it's expiry date) and PRODUCT STORAGE ERROR (Vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (is true max, 75.2F was most likely battery change)). Concomitant product use was not provided by the reporter. Moderna product was stored in the freezer (prior to moving to the fridge). Vaccine experienced multiple warm excursions and was administered past its expiry date. The vaccine was damaged out at the time of report. Lot 048L21A was delivered on 17-Mar-2022. Vaccine was moved to the fridge on 31-Jul-2022 and administered on 01-Aug-2022 and vial removed from fridge and punctured at 1:00pm. The vaccine was above 5F for a total of 20 reported hours and reached a max temperature of 19.4F (was true max, 75.2F was most likely battery change). The reporting interval changes on 07-Apr-2022 at 9:13am from a 5-minute reporting interval to a 15-minute reporting interval. There was missing freezer temperature data from 09-Jun-2022 to 18-Jul-2022. The sharp spike was most likely when the team changed the battery and placed the TempAlert device back in the freezer. When the data came back there were two warm excursions. Treatment information was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Psoriasis
Clinical narrative: COVID-19; PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM) and COVID-19 (COVID-19) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In March 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In April 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2022, the patient experienced PSORIASIS (PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM). In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, PSORIASIS (PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM) and COVID-19 (COVID-19) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of PSORIASIS SPOTS APPEARING ON LEFT FOOT, LEFT CALM, RIGHT FOREARM and COVID was not provided. No concomitant drug reported. No treatment information was provided by the reporter.  Company comment: This is a spontaneous case concerning 38 years old male, with no relevant medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose (reported as booster dose) of mRNA-1273 vaccine. The patient was noted to have received two doses with TOZINAMERAN (Interchange of vaccine products). Outcome of the event is unknown. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning 38 years old male, with no medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after third dose (reported as booster dose) of mRNA-1273 vaccine. The patient was noted to have received two doses with TOZINAMERAN (Interchange of vaccine products). Outcome of the event is unknown. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022).    Concomitant medications were not reported.  Patient received half dose. They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    No concomitant product use was reported. Patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022).    No concomitant medications were provided by the reporter.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022). No concomitant product use was reported. Reportedly, Patient received half dose. Vial did not undergone any temperature excursions. No treatment information was provided.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 28Jul2022).    Concomitant medications were not reported.  They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.