chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine.  These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years. Concomitant product use was not provided by the reporter. It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A & Exp. Date: unknown), (Lot number 216K22A & Exp. Date: unknown). Treatment information was not provided.  This case contains information about patient 7th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 7 out of 11
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine.  These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years. Concomitant product use was not provided by the reporter. It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A & Exp. Date: unknown), (Lot number 216K22A & Exp. Date: unknown). Treatment information was not provided.  This case contains information about patient 2nd out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 02 out of 11
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Expiry Date was unknown), (Lot number 216K22A and Expiry Date was unknown).  Treatment information was not provided.  This case contains information about patient 8 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Expiry Date was unknown), (Lot number 216K22A and Expiry Date was unknown).  Treatment information was not provided.  This case contains information about patient 3 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 09th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 10th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    Patient was never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 4 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 04 out of 11
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) 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.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2023, 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. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    Patient was never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 11 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 1 out of 11
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (no adverse event) 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.    In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and  Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 6th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case (Patient 1)
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: picked up COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (picked up COVID) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In August 2023, the patient experienced COVID-19 (picked up COVID). At the time of the report, COVID-19 (picked up COVID) had not resolved.            No concomitant medication was reported.  Reporter stated that, he/she was fully vaccinated & boosted with Moderna & then two Pfizer vaccinations. Patient picked up COVID in August and still had it.  No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Pain
Clinical narrative: generalized body pain from head to toe; This spontaneous case was reported by a patient and describes the occurrence of PAIN (generalized body pain from head to toe) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Idiopathic intracranial hypertension.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (generalized body pain from head to toe). The patient was treated with TRAMADOL for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (generalized body pain from head to toe) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: 1/1280 and 141.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The 2nd dose lot number was 032L20A and it was administered on 19-Feb-2021. The 3rd dose lot number was 058F21A and it was administered on 05-Nov-2021. No concomitant medication was reported. Patient's rheumatologist was working on her autoimmune problem. Her results were high for example her ANA was 1/1280 and her anti-centromere b was 141. She started having side effect 4 days after the first dose. She went to the doctor. They gave her medication and told her it may go away. After the second dose the pain never went away. The pain was there 24/7.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (no adverse event) 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.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2023, 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. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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 (Patient received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    Patient was never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 1 out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740035, US-MODERNATX, INC.-MOD-2023-740036, US-MODERNATX, INC.-MOD-2023-740039, US-MODERNATX, INC.-MOD-2023-740042, US-MODERNATX, INC.-MOD-2023-740040, US-MODERNATX, INC.-MOD-2023-740049, US-MODERNATX, INC.-MOD-2023-740048, US-MODERNATX, INC.-MOD-2023-740057, US-MODERNATX, INC.-MOD-2023-740077 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740039:Patient 8 out of 11 US-MODERNATX, INC.-MOD-2023-740036:Patient 02 out of 11 US-MODERNATX, INC.-MOD-2023-740035:Patient 7 out of 11 US-MODERNATX, INC.-MOD-2023-740057:Patient 05 out of 11 US-MODERNATX, INC.-MOD-2023-740042:Patient 9 out of 11 US-MODERNATX, INC.-MOD-2023-740040:Patient 03 out of 11 US-MODERNATX, INC.-MOD-2023-740049:Patient 11 out of 11 US-MODERNATX, INC.-MOD-2023-740048:Patient 04 out of 11 US-MODERNATX, INC.-MOD-2023-740077:Patient 06 out of 11
Age: 54.0
Sex: U
Vaccine: UNK
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: Unexpected Therapeutic Effect; my illness went away completely with the first and second vaccinations for about 8 months; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected Therapeutic Effect) and PRE-EXISTING CONDITION IMPROVED (my illness went away completely with the first and second vaccinations for about 8 months) in a 54-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     The patient had incurable disease since patient was 13 years old.     On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected Therapeutic Effect) and PRE-EXISTING CONDITION IMPROVED (my illness went away completely with the first and second vaccinations for about 8 months). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected Therapeutic Effect) and PRE-EXISTING CONDITION IMPROVED (my illness went away completely with the first and second vaccinations for about 8 months) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication not reported.   The patient had incurable disease for 13 years of age, for more than 40 years, no doctor was able to help, 2 years University of redacted even without success, It was an invisible and non-life-threatening disease, but it was very painful for people. Patient was vaccinated with Corona vaccinations, interestingly with first and second vaccinations disease had completely gone away for about 8 months, after about 8 months the disease returned, wanted to continue testing whether vaccination 3 and 4 unfortunately helps without success, patient do not know whether the vaccinations were different or not. patient willing to communicate because of illness maybe help to bring medication to market that can cure millions of people. Patient received vaccine before 1 Sep 2023.  Treatment medication not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeding disorder, Pain in extremity, Pyrexia
Clinical narrative: unable to eat; pain in her arm; diarrhea; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (unable to eat), PAIN IN EXTREMITY (pain in her arm), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient didnot received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Fruit allergy (Citrus), Shellfish allergy, Grass allergy and Allergy to plants (Trees).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (unable to eat), PAIN IN EXTREMITY (pain in her arm), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). At the time of the report, FEEDING DISORDER (unable to eat), PAIN IN EXTREMITY (pain in her arm), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Following 3rd shot, got COVID infection 3 weeks later; Following 3rd shot, got COVID infection 3 weeks later; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 8 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Following 3rd shot, got COVID infection 3 weeks later". Clinical course: Note, patient is 8 weeks pregnant and the doctor was recommending 4th COVID dose.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had three COVID vaccinations from your company;this past Friday came down with COVID; had three COVID vaccinations from your company;this past Friday came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "had three COVID vaccinations from your company;this past Friday came down with COVID". Clinical course: Patient had three COVID vaccinations and this past Friday came down with COVID. Four years now patient had been very careful even while vaccinated and somehow ended up with COVID. Patient did not plan on being vaccinated anymore.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Age: 66.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 30Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Sep2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Jun2022 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 01Sep2023 to 05Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: feeling better and a negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 31Aug2023 to 04Sep2023 as treatment of COVID-19.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298227 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Sep2023 to 07Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298348 Same reporter/patient, different drug/AE.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cephalosporin, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Streptococcus test: Negative. Reporter is the patient.  Patient was tested positive for Covid-19. Patient notified doctor and was prescribed paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 at 13:00 as dose 4 (booster), single (Lot number: GJS342) at the age of 68 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 11Feb2021 at 09:00 as dose 1, single (Lot number: EL9267), in right arm, on 04Mar2021 at 09:30 as dose 2, single (Lot number: EN6198), in left arm and on 28Sep2021 at 12:15 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated HbgA1c" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 69.0
Sex: F
Vaccine: COVID19, 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 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Tetnus, for immunization, reaction(s): "known allergies: Tetnus". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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: Treatment of COVID-19; (08Sep2023) Negative, notes: Tested negative on Friday; (10Sep2023) Positive, notes: Subsequently tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was given Paxlovid from 31Aug2023 to 04Sep2023 for treatment of COVID-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as COVID 19 treatment from 28Aug2023 to 02Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right 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, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "migraine with aura" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (07Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2023) Negative, notes: Negative test 3 days after Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Aug2023 to 04Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2021, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.