chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 dose was administered after being at room temperature for more than 24 hours. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1 with batch no.: 027A21A.) on 04-Mar-2021, MODERNA COVID-19 VACCINE (Dose 2 with batch no.: 026B21A.) on 01-Apr-2021, MODERNA COVID-19 VACCINE (1st Booster with batch no.: 041J21A.) on 16-Dec-2021 and MODERNA COVID-19 VACCINE (2nd Booster with batch no.: 059A22A.) on 23-Jun-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 29-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 29-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose was administered after being at room temperature for more than 24 hours.).    No concomitant medication was reported.  Reportedly, 1 dose was administered after being at room temperature for more than 24 hours. The patient did not report any side effects.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine).    No concomitant medication information was reported. It was reported that a patient was given a booster bivalent vaccination as their who had not received any prior shots for the covid vaccine. IE (They never received the any of the two primary doses). The HCP confirmed that a patient received a bivalent booster dose as their first COVID19 vaccine. The HCP wanted to know what to do next. The HCP declined to provide any patient information. No treatment medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; 8 patients received doses after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date).    No Concomitant medication was reported. No treatment information was provided. This case contains information for the 2nd of 8 patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-696087 (E2B Linked Report).Sender's Comments:  MODERNATX, INC.-MOD-2023-696087:Patient 2 out of 8 Patients
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (contracted Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A. and 939902) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient received her first dose of Moderna Covid-19 vaccine on 2OCT2021 lot number 939902 expiration date was not known. No expiration date was provided. The caller reports that her daughter contracted Covid-19 at some point after the first dose. The patient received her second dose of the Moderna Covid-19 vaccine on 30OCT2021 lot number 004F21A. No expiration date was provided. Caller was not sure if her daughter had any adverse reactions. The caller said that she did not know if her daughter received any Moderna booster doses. No treatment was reported.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 10-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (We gave a 10 yr old 0.5mL of Moderna Covid-19 vaccine, Bivalent).    Concomitant product information was not provided by the reporter.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pseudolymphoma, Rash erythematous, Rash maculo-papular, SARS-CoV-2 test
Clinical narrative: Had a positive covid test; Sounds like pseudo-lymphoma; had hives in some exposed areas. Much of it on her lower extremities; Red maccular papular rash; Red maccular papular rash; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Had a positive covid test), PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities), RASH MACULO-PAPULAR (Red maccular papular rash) and RASH ERYTHEMATOUS (Red maccular papular rash) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included Overweight.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had a positive covid test), PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities), RASH MACULO-PAPULAR (Red maccular papular rash) and RASH ERYTHEMATOUS (Red maccular papular rash). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Had a positive covid test) and RASH ERYTHEMATOUS (Red maccular papular rash) outcome was unknown and PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities) and RASH MACULO-PAPULAR (Red maccular papular rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient was very overweight, and at higher risk.  Patient received bivalent booster in early fall 2022. She had also had boosters before that. Had a positive covid test, no medical treatment. Patient developed hives in some exposed areas. Much of it on her lower extremities. Red maccular papular rash. Sounds like pseudo-lymphoma. Patient was told to take a Medrol dose pack.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Had a positive covid test; Sounds like pseudo-lymphoma; had hives in some exposed areas. Much of it on her lower extremities; Red maccular papular rash; Red maccular papular rash; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Had a positive covid test), PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities), RASH MACULO-PAPULAR (Red maccular papular rash) and RASH ERYTHEMATOUS (Red maccular papular rash) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included Overweight.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had a positive covid test), PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities), RASH MACULO-PAPULAR (Red maccular papular rash) and RASH ERYTHEMATOUS (Red maccular papular rash). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Had a positive covid test) and RASH ERYTHEMATOUS (Red maccular papular rash) outcome was unknown and PSEUDOLYMPHOMA (Sounds like pseudo-lymphoma), URTICARIA (had hives in some exposed areas. Much of it on her lower extremities) and RASH MACULO-PAPULAR (Red maccular papular rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient was very overweight, and at higher risk.  Patient received bivalent booster in early fall 2022. She had also had boosters before that. Had a positive covid test, no medical treatment. Patient developed hives in some exposed areas. Much of it on her lower extremities. Red maccular papular rash. Sounds like pseudo-lymphoma. Patient was told to take a Medrol dose pack.
Age: 59.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently given a 0.5mL dose from a punctured vial of Moderna Bivalent 6+ that was at room temp for exactly 18 hours 15 minutes prior to the dose being given).    No Concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: blood clots on her lung; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (blood clots on her lung) in a female 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, the patient experienced PULMONARY EMBOLISM (blood clots on her lung) (seriousness criteria death and medically significant). The reported cause of death was blood clots on her lung. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.   It was reported that patient passed away in the summer after developing blood clots on her lungs.  Treatment information was not provided.   Reporter did not allow further contact; Reporter's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) fatal event of pulmonary embolism (AESI) an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests, treatment provided, and autopsy report has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: blood clots on her lung
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Moderna killed my father in law; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Moderna killed my father in law) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 27-Aug-2021 The patient died on 27-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-695787.; Reporter's Comments: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the fatal, unexpected serious (death and medically significant) event of Death that occurred on unspecified day in context to a dose of mRNA-1273 vaccine. The event was reported as Moderna  killed my father-in-law. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695787:Mother's case; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Moderna killed my mother 4 September 2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Moderna killed my mother 4 September 2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 04-Sep-2021 The patient died on 04-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant and treatment medications were not reported.  Company comment: This is a spontaneous case female patient of unknown gender, with no medical history, who experienced unexpected fatal serious (medically significant) event of death (reported as Moderna killed my mother 4 September 2021), which occurred unspecified days after a dose of mRNA-1273 vaccine. Death occurred on 04-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-695779.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695779:Father in law's case; Reported Cause(s) of Death: unknown cause of death
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Our fridge being out of range on 02-Dec-2022 for one hour; No adverse event; 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour).    No concomitant medications were provided by the reporter.  HCP reported that 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09-Dec-2022 and 9 patients were vaccinated on 16-Dec-2022. Excursion happened on 02-Dec-2022 during 1 hour and minimum temperature reached was 1.2 A degree C.   No adverse events were reported.  No treatment medications were provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-695843, MODERNATX, INC.-MOD-2023-695862 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Follow-up received contains non-significant information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-695862:Same reporter MODERNATX, INC.-MOD-2023-695843:Same reporter
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.; patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.), POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 02-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.). In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.), POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (our fridge being out of range on 12/02/22 for one hour and and minimum temperature reached was 1.2°C.) and POOR QUALITY PRODUCT ADMINISTERED (patient vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened).    10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. Excursion happened on 02 Dec 2022 for 1 hour reand minimum temperature reached was 1.2°C. No AEs were reported  Concomitant medication not reported. Treatment medication not reported.   This case was linked to MODERNATX, INC.-MOD-2023-695843, MODERNATX, INC.-MOD-2023-695862, MODERNATX, INC.-MOD-2023-695870 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Live-follow-up: Non-Significant follow-up received.; Sender's Comments:  MODERNATX, INC.-MOD-2023-695843:Same reporter MODERNATX, INC.-MOD-2023-695862:Same reporter MODERNATX, INC.-MOD-2023-695870:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Severe flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Severe flu-like symptoms) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Severe flu-like symptoms) outcome was unknown.     Concomitant medications were not reported.   Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Limb deformity
Clinical narrative: When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic; once his arm stopped working after; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic) and LIMB DEFORMITY (once his arm stopped working after) 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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic) and LIMB DEFORMITY (once his arm stopped working after). At the time of the report, IMMUNISATION REACTION (When I checked these batch numbers a year ago, it seemed like my dads first two were ranked pretty toxic) and LIMB DEFORMITY (once his arm stopped working after) outcome was unknown.      No concomitant drug information was provided.  It was reported that the patient would no longer get the vaccine and made this correlation when patient's arm stopped working.  No treatment medication information was provided.   This case was linked to MOD-2023-695950 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Moderna, several health issues since the booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Moderna, several health issues since the booster) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Moderna, several health issues since the booster). At the time of the report, IMMUNISATION REACTION (Moderna, several health issues since the booster) outcome was unknown.            No concomitant medication was reported.  The dose patient received was booster.  No treatment medication was reported.   This case was linked to MOD-2023-695939 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards; Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards; Skin rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards), PRURITUS (Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards) and RASH (Skin rash) in a 40-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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN LESION (Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards) and PRURITUS (Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards). an unknown date, the patient experienced RASH (Skin rash). At the time of the report, SKIN LESION (Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards), PRURITUS (Severe itching skin lesions developed over the lower abdomen initially, but spread to the neck, trunk and four limbs afterwards) and RASH (Skin rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MODERNATX, INC.-MOD-2023-695829 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-695829:Post number 26
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 8 patients received doses after the 30-day Use By Date; No Adverse Event; 8 patients received doses after the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date), PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (8 patients received doses after the 30-day Use By Date) and PRODUCT STORAGE ERROR (8 patients received doses after the 30-day Use By Date).    Concomitant products were not provided. Treatment medication were not reported. It was unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials were 2.5 ml size taken from  open carton 4. It was initially stored in the refrigerator on 5 Dec 2022. Vials did not undergo any temperature excursion. This case contains information for the 4th of 8 patients described by the report.; Sender's Comments:  MODERNATX, INC.-MOD-2023-695798:Patient 1 out of 8 Patients MODERNATX, INC.-MOD-2023-696048:Patient 2 out of 8 Patients MODERNATX, INC.-MOD-2023-696086:Patient 3 out of 8 Patients MODERNATX, INC.-MOD-2023-696088:Patient 5 out of 8 Patients MODERNATX, INC.-MOD-2023-696089:Patient 6 out of 8 Patients MODERNATX, INC.-MOD-2023-696090:Patient 7 out of 8 Patients MODERNATX, INC.-MOD-2023-696091:Patient 8out of 8 Patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Dyspnoea, Interchange of vaccine products, Pharyngeal swelling
Clinical narrative: the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing; throat swelled up; the 1st dose of Moderna and received Jansen as a second dose; the 1st dose of Moderna and received Jansen as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing), PHARYNGEAL SWELLING (throat swelled up), INTERCHANGE OF VACCINE PRODUCTS (the 1st dose of Moderna and received Jansen as a second dose) and COVID-19 IMMUNISATION (the 1st dose of Moderna and received Jansen as a second dose) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) 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 DYSPNOEA (the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing), PHARYNGEAL SWELLING (throat swelled up), INTERCHANGE OF VACCINE PRODUCTS (the 1st dose of Moderna and received Jansen as a second dose) and COVID-19 IMMUNISATION (the 1st dose of Moderna and received Jansen as a second dose). At the time of the report, DYSPNOEA (the patient stopped breathing after receiving the 1st dose of Moderna /Patient experienced trouble breathing), PHARYNGEAL SWELLING (throat swelled up), INTERCHANGE OF VACCINE PRODUCTS (the 1st dose of Moderna and received Jansen as a second dose) and COVID-19 IMMUNISATION (the 1st dose of Moderna and received Jansen as a second dose) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that, patient received JANSSEN Covid-19 vaccine as second dose. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: red thumb-print sized bump on his left arm; This spontaneous case was reported by a physician and describes the occurrence of SKIN MASS (red thumb-print sized bump on his left arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Influenza and DTAP. Past adverse reactions to the above products included No adverse event with DTAP and Influenza. Concurrent medical conditions included Type 2 diabetes mellitus and Pneumonia.   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN MASS (red thumb-print sized bump on his left arm). At the time of the report, SKIN MASS (red thumb-print sized bump on his left arm) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had a red thumb-print sized bump on his left arm that started after receiving his first booster dose. This became more indurated, inflamed, and painful after an additional 2 booster doses of the vaccine.  Patient had tried anti-inflammatories, topical steroids, oral steroids, and anti-fungal with minimal improvement. patient requested a biopsy, and this lump was diagnosed as a patch stage T-Cell Lymphoma. patient had received 5 doses of the Moderna COVID-19 vaccines in total all to the left arm.   This case was linked.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Pain" (unspecified if ongoing), notes: Other medical history: Chronic pain. The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "Nausea with sulfa drugs", notes: Known allergies: Nausea with sulfa drugs. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 with paxlovid treatment from 27Dec2022 and 01Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 02Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: 5 days later symptoms come back and I am testing positive again; (25Dec2022) Positive, notes: I tested positive for COVID with a home test on Christmas morning; (30Dec2022) Negative, notes: Tested negative, 30Dec and 31; (31Dec2022) Negative, notes: Tested negative, 30Dec and 31; (07Jan2023) Positive, notes: Still positive on 07Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient tested positive for COVID with a home test on Christmas morning. Patient did a tele-visit with the Clinic and the doctor gave me Paxlovid. Symptoms were scratchy throat and mild cough. Patient finished the 5 days, no worsening of symptoms. Tested negative 30Dec and 31. 5 days later symptoms come back, and patient was testing positive again. Same sore throat and mild cough. Saw doctor again, said no more Paxlovid. Using OTC to treat symptoms. Still positive on 07Jan. No AE treatment and no known allergies. No, other medication in 2 weeks. Yes, reported about covid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 17:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL, start date: 31Dec2022, stop date: 04Jan2023; NYQUIL, start date: 31Dec2022, stop date: 04Jan2023. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Symptoms came back and started testing positive again. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.1 (BNT162B2, BNT162B2 OMI BA.1), on 15Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 24Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown). The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive, notes: positive for COVID for more than 1 week. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.1, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300014666 202300011385 ;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection; Covid infection; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GJ6742) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 15Mar2021 as dose 2, single (Lot number: EL3247), in left arm, on 01Sep2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: EL3247), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension, asthma; "asthma" (unspecified if ongoing). Concomitant medication(s) included: LIPTOR [ATORVASTATIN]; CHLORTHALIDONE; KCL; VIT C; VITAMIN B12 [VITAMIN B12 NOS]; and multivitamins. Past drug history included: Mucinex, reaction(s): "Known allergy: Mucinex", notes: Known allergy: Mucinex.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Jan2023, outcome "recovering", described as "COVID infection"; COVID-19 (medically significant) with onset 08Jan2023, outcome "recovering", described as "Covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure and covid-19 which included Paxlovid.; Sender's Comments: The reported COVID-19 positive after company products immunization is considered ineffective of products, and the Company cannot completely exclude the possible causality between the reported events and the product administration