chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo powder reconstituted with sterile water; administered the powder component of Menveo  reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA765A) for prophylaxis.   On 29-JUN-2023, the patient received Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo powder reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: administered the powder component of Menveo  reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 03-JUL-2023 The nurse stated that on 29 June 2023 another staff member administered the powder component of Menveo after it was reconstituted with sterile water. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter declined to provide patient information. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) 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)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-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 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration 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 (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date).    Pharmacist called to report that Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.  He stated that he wanted to wait on the assessment as it was just 1 day after expiration date.  Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry  The vial size was 2.5 mL  The date the vial was initially stored in the refrigerator was 19Jun2023 , 22Jun2023, and 23Jun2023  The vial did not undergo any temperature excursions. This case was for patient 5th out of 5. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730746 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730746:Master case (Patient 1)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022).    No concomitant medication was reported.   It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023. Expiry date was reported as 27-Mar-2022.  No treatment information was reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 patients received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022).    No concomitant medication was reported.  The dosage text was reported as unknown. It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-Jun-2022 and 3 doses of Moderna Covid-19 vaccine were administered on 22-Jun-2022. The expiry date was reported as 27-Mar-2022. No treatment information was reported.  This case contains information for patient 3rd out of 7 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2023 which was expired in 27-MAR-2022).    No concomitant medication was reported.   It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023.  No treatment information was reported.  This case contains information for patient 6th out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case patient (1)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired by 27-MAR-2022).    No concomitant medication was reported.  It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023. No treatment information was reported.  This case contains information for patient 5th out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case patient 1
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 22-JUN-2022 which was expired in 27-MAR-2022).    No concomitant medication was reported.  Dosage text was reported as unknown. No treatment information was reported.  This case contains information for patient 6 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.     This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: after each immunization she experienced fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (after each immunization she experienced fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 012M20A, 062E21A and 038A22A) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-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 PYREXIA (after each immunization she experienced fever). At the time of the report, PYREXIA (after each immunization she experienced fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On the third dose, she told the health care professional that she would like to receive half dose of the vaccine since after each immunization she experienced fever and she said that she knows better. Health care professional administered the full dose anyway.  She received the flu vaccine on November/December 2019 and 4 weeks after the 5th dose of the Moderna Covid-19 vaccine. Fifth dose 04 Nov 2022 Lot number 016H22A last dose of the Moderna bivalent vaccine.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731727:Monovalent case for same patient
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Bivalent vaccine was administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date) 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)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-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 19-Jun-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered after expiration 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 (Moderna Bivalent vaccine was administered after expiration date).    Pharmacist called to report that Moderna Bivalent vaccine was administered after expiration date from 3 Individual vials with same lot number.  He stated that he wanted to wait on the assessment as it was just 1 day after expiration date.  Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry  The vial size was 2.5 mL  The date the vial was initially stored in the refrigerator was 19Jun2023 , 22Jun2023, and 23Jun2023  The vial did not undergo any temperature excursions. This case was for patient 1 out of 5. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730721, US-MODERNATX, INC.-MOD-2023-730757, US-MODERNATX, INC.-MOD-2023-731657, US-MODERNATX, INC.-MOD-2023-731671 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730721:patient 2 US-MODERNATX, INC.-MOD-2023-730757:Patient 3 US-MODERNATX, INC.-MOD-2023-731657:patient 4 US-MODERNATX, INC.-MOD-2023-731671:Patient 5
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: Pain in her arms; Then all her Lymphedema disappeared for ever/the improvement on her hands and arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in her arms) and THERAPEUTIC RESPONSE UNEXPECTED (Then all her Lymphedema disappeared for ever/the improvement on her hands and arms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 002A21A, 071F21A and 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Lymphedema (primary Lymphedema on both hands and middle of forearms for 40 years).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arms). In February 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Then all her Lymphedema disappeared for ever/the improvement on her hands and arms). At the time of the report, PAIN IN EXTREMITY (Pain in her arms) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (Then all her Lymphedema disappeared for ever/the improvement on her hands and arms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient was not enrolled in clinical trial.  Patient stated that she had a medical history of primary Lymphedema on both hands and middle of forearms for 40 years. However, 3 days after the first vaccine, on 06FEB2021, in the middle of the night, patient noticed some pain in her arms, then all her Lymphedema disappeared for ever. She stated that when she visited her doctor's office for her annual mammogram someone at the office also noticed the improvement on her hands and arms. She did share the vaccination site but mentioned that it may have been closed for good. Patient further reported that she had pictures of her hands and arms before vaccination and she can email them.   Patient received dose 5 of Bivalent Booster on 12OCT2022 (Lot: 060F22A) at a grocery store pharmacy.  Treatment medication information was not provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023; No adverse event; The vaccine was administered on day 37; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on day 37), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a child male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 26-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 26-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on day 37). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on day 37), PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vaccine was administered on day 37) and PRODUCT STORAGE ERROR (The vial was stored in refrigerator on 17-May-2023 and was adminsitered to patient on 23-Jun-2023).    Concomitant product use was not provided by the reporter.  Unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Suspect product dosage text was reported as unknown.  The intact carton 0.4 ml did not undergo any temperature excursions. Vials were kept between 2-8 C for the entire time.  It was reported that vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use, provided the expiration date was not exceeded.  Moderna COVID-19 Vaccine, Bivalent should be used 30 days from the date the vaccine was exposed to temperatures above 36°F (2°C). Vials can be used by the end of day on day 30.  Expired vaccine or vaccine past the 30-day beyond use date (BUD) will need to be discarded.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730937 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730937:Same reporter
Age: 75.0
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: AE is being filed for potential lack of efficacy claim; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim) and NO ADVERSE EVENT (No adverse event) in a 75-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)) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (AE is being filed for potential lack of efficacy claim).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. It was reported that the vaccines stock available expired on 15-MAY-2023. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Abdominal pain, COVID-19, Constipation, Fatigue
Clinical narrative: she started with COVID symptoms/she had nauseas/ fever; still so sick/felt physically very sick; abdominal pain; constipation; fatigue; GI distress is overwhelming; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 04-Nov-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) 1 dosage form. On 12-Apr-2023, the patient experienced COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (GI distress is overwhelming). At the time of the report, COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (GI distress is overwhelming) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had First dose on 14 Jan 2021 Lot number 026L20A, second dose on 11 Feb 2021 Lot number 012M20A, third dose on 04Nov2021 Lot number 062E21A, fourth dose on 14Jul2022 Lot number 038A22A. she received the flu vaccine in November or December 2019 and 4 weeks after the 5th dose of the Moderna Covid-19 vaccine.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732071 (E2B Linked Report).
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: she started with COVID symptoms/she had nauseas/ fever; still so sick/felt physically very sick; abdominal pain; constipation; fatigue; GI distress is overwhelming; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 04-Nov-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) 1 dosage form. On 12-Apr-2023, the patient experienced COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (GI distress is overwhelming). At the time of the report, COVID-19 (she started with COVID symptoms/she had nauseas/ fever), ILLNESS (still so sick/felt physically very sick), ABDOMINAL PAIN (abdominal pain), CONSTIPATION (constipation), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (GI distress is overwhelming) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had First dose on 14 Jan 2021 Lot number 026L20A, second dose on 11 Feb 2021 Lot number 012M20A, third dose on 04Nov2021 Lot number 062E21A, fourth dose on 14Jul2022 Lot number 038A22A. she received the flu vaccine in November or December 2019 and 4 weeks after the 5th dose of the Moderna Covid-19 vaccine.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732071 (E2B Linked Report).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine on 18-JUN-2022 which was expired in 27-MAR-2022).    No concomitant medication was reported.  It was reported that 4 doses of the Moderna Covid-19 vaccine were administered on 18-JUN-2022. 3 doses of Moderna Covid-19 vaccine were administered on 22-June-2023. No treatment information was reported.  This case contains information for patient 1 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-731896, US-MODERNATX, INC.-MOD-2023-731899, US-MODERNATX, INC.-MOD-2023-731901, US-MODERNATX, INC.-MOD-2023-731900, US-MODERNATX, INC.-MOD-2023-731898, US-MODERNATX, INC.-MOD-2023-731897 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731896:Patient 2 (18-JUN-2022) US-MODERNATX, INC.-MOD-2023-731899:Patient 5 (22-JUN-2023) US-MODERNATX, INC.-MOD-2023-731901:Patient 7(22-JUN-2023) US-MODERNATX, INC.-MOD-2023-731900:Patient 6 (22-JUN-2023) US-MODERNATX, INC.-MOD-2023-731898:Patient 4 (18-JUN-2022) US-MODERNATX, INC.-MOD-2023-731897:Patient 3 (18-JUN-2022)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023) 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)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-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 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023) 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 (Dose administered after Manufacturer Date of ExpiryVaccine expired on 13Jun2023, 1 dose administered on 20Jun2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731903 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731903:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days; Vaccine administered to patient after 30 days of storage in fridge; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine administered to patient after 30 days of storage in fridge) 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)) (batch no. 201L228) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine administered to patient after 30 days of storage in fridge) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine administered to patient after 30 days of storage in fridge) 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 (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days) and PRODUCT STORAGE ERROR (Vaccine administered to patient after 30 days of storage in fridge).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days; Vaccine was in fridge over 30 days; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days) 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)) (batch no. 201L228) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days) 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 (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days) and PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731925 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731925:same
Sex: M
Vaccine: COVID19
Symptoms: Lipoma, Magnetic resonance imaging head, Neoplasm malignant, Protein total, SARS-CoV-2 test
Clinical narrative: Cancer; fat brain/ Lipoma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in Jul2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Patient is allergic to not having crystal methamphetamines" (unspecified if ongoing). Concomitant medication(s) included: METHAMPHETAMINE [METAMFETAMINE], start date: 01Sep1996. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "not recovered", described as "Cancer"; LIPOMA (medically significant), outcome "not recovered", described as "fat brain/ Lipoma". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging head: fat brain; Protein total: Inconclusive; SARS-CoV-2 test: Inconclusive. Therapeutic measures were not taken as a result of neoplasm malignant, lipoma. Clinical course: Patient was reporting for himself. Facility type vaccine unknown. He received Other vaccine in four weeks and Other medications in two weeks. Administration time: 12:00 AM. Adverse event: Unable to receive more methamphetamines he did need that to go along with his secured medicines. Unable to receive his original documents of MRI (Magnetic resonance imaging) fat brain and he wanted see his back brain back intact and he need his methamphetamines to go along with his cancer treatment, he thought that's what's going on was he wrong get back to him come back. No COVID prior vaccination. COVID was tested post vaccination. Other medical history: Patient was very concerned he cannot get his original MRI documents around the 2000 and 3 area in (Withheld).  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose 2, single (Lot number: EW0151) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch number: ER8727, Administration time: 01:00 PM, Anatomical location: Left arm), administration date: Mar2021, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 29Aug2022 at 05:00, outcome "recovered with sequelae", described as "Bells Palsy". The event "bells palsy" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy via acupuncture. Clinical course: The patient did not suffer from COVID-19 prior vaccination and it was unknown if COVID-19 tested post vaccination.
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). 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 28Apr2023 as dose 6 (booster), single (Lot number: GJ3270), 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (30Jun2023) Negative, notes: Rebound-initially tested negative over 2 days following Paxlovid course end on 28Jun2023; (30Jun2023) Negative, notes: Rebound-initially tested negative over 2 days following Paxlovid course end on 28Jun2023; (03Jul2023) Positive, notes: Symptoms recurred on 02Jul2023 and tested (strongly) positive with rapid antigen test on 03Jul2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.