chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine was initially stored in the refrigerator - 05Jan2023 and administered on 06Feb2023; No adverse event; administered doses of the bivalent booster which were beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator - 05Jan2023 and administered on 06Feb2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023 at 1:34 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator - 05Jan2023 and administered on 06Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered doses of the bivalent booster which were beyond the 30 day BUD), PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator - 05Jan2023 and administered on 06Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 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 (administered doses of the bivalent booster which were beyond the 30 day BUD) and PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator - 05Jan2023 and administered on 06Feb2023).    No concomitant medication were reported.  It was reported that there 2 doses were administered on 06Feb2023 and 2 doses on 07Feb2023. The vaccine was initially stored in the refrigerator on 05Jan2023.  No treatment medication were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-709192, US-MODERNATX, INC.-MOD-2023-710235, US-MODERNATX, INC.-MOD-2023-710238 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710235:Patient   US-MODERNATX, INC.-MOD-2023-709192:Patient - Female US-MODERNATX, INC.-MOD-2023-710238:Patient - Male
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date).    No Concomitant medication was reported.  It was reported that 2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date. Vials expired on 11Feb2023. No AEs were reported. Caller did not have any patient demographics but stated patients were children.  No treatment information was provided.  This case contains information for the 2nd of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710266:Master case
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient has not reported any side effects.; child received an adult Covid vaccine for their primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received an adult Covid vaccine for their primary series) and NO ADVERSE EVENT (Patient has not reported any side effects.) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     Previously administered products included for Vaccination: Hepatitis A. Past adverse reactions to the above products included No adverse event with Hepatitis A.    On 03-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received an adult Covid vaccine for their primary series). On 03-Feb-2023, the patient experienced NO ADVERSE EVENT (Patient has not reported any side effects.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received an adult Covid vaccine for their primary series) and NO ADVERSE EVENT (Patient has not reported any side effects.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (Patient has not reported any side effects.) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (child received an adult Covid vaccine for their primary series).    No Concomitant medication was reported. It was reported by HCP that on 03Jan2023 a child received an adult Covid vaccine for their primary series. Patient has not reported any side effects. This was the patients second dose. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event) in a kid patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.).    No Concomitant medication was reported.  It was reported that 2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710203 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710203:Master case
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Parosmia
Clinical narrative: parosmia; anosmia; This spontaneous case was reported by a physician and describes the occurrence of PAROSMIA (parosmia) and ANOSMIA (anosmia) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAROSMIA (parosmia) and ANOSMIA (anosmia). At the time of the report, PAROSMIA (parosmia) and ANOSMIA (anosmia) had not resolved.        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.   No concomitant medications were reported. It was reported that a patient who within a minute after getting the 1st dose of vaccine has experienced events. No treatment medications were reported.  Company comment: This spontaneous case reported by a physician concerns a 52-year-old male patient with no reported medical history, who experienced the non- serious unexpected events of Anosmia (AESI) and Parosmia which occurred on the same day (within 1 minute) after administration of first dose of mRNA-1273 vaccine. Events were ongoing at the time of the report. Rest of the details are not available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Reporter did not allow further contact
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received an expired primary series dose as a second dose; Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 057A22A and 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Feb-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023).    No concomitant medication was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial size was reported as 5.5 milliliter. On 13-Feb-2023, the vial was initially stored in the refrigerator and thawed on the same day of administration.  Vial did not undergo any temperature excursions.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) in a kids patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:unknown.     On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date).    No Concomitant medication was reported.  It was reported that 2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date. Vials expired on 11Feb2023. No AEs were reported. Caller did not have any patient demographics but stated patients were kids.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-710351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710351:Patient 2 case
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: 5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) 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.   Case contains information of 1 of 5 patients reported.  Concomitant products were not reported.  It was reported that it was whether patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the whales. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But they At the time when they had them they took an antihistamine and relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems, which was good.   This case was linked to US-MODERNATX, INC.-MOD-2023-710371, US-MODERNATX, INC.-MOD-2023-710376, US-MODERNATX, INC.-MOD-2023-710383, US-MODERNATX, INC.-MOD-2023-710387 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710376:3 of 5 patient US-MODERNATX, INC.-MOD-2023-710371:2 of 5 patient US-MODERNATX, INC.-MOD-2023-710387:5 of 5 patient US-MODERNATX, INC.-MOD-2023-710383:4 of 5 patient
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; No adverse event; Expired dose was administered on 11FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication information provided. Individual vial size was 2.5 ml.  Date the vial was initially stored in the refrigerator was 24-Jan-2023  The vial did not undergo any temperature excursions. No treatment information provided.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: After the Bivalent booster she started feeling bad; bumps; Dizzy; Injection site hurting; Fever/ Hot; Tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting) and PYREXIA (Fever/ Hot) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting), PYREXIA (Fever/ Hot) and FATIGUE (Tired). At the time of the report, FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting), PYREXIA (Fever/ Hot) and FATIGUE (Tired) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received first and second primary monovalent dose from Pfizer Lot and expiry date unknown. Third shot from J and J on 12-Jan-2022. Fourth monovalent booster shot from moderna on 31-Aug-2022.   Treatment medications were not reported.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: After the Bivalent booster she started feeling bad; bumps; Dizzy; Injection site hurting; Fever/ Hot; Tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting) and PYREXIA (Fever/ Hot) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting), PYREXIA (Fever/ Hot) and FATIGUE (Tired). At the time of the report, FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting), PYREXIA (Fever/ Hot) and FATIGUE (Tired) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received first and second primary monovalent dose from Pfizer Lot and expiry date unknown. Third shot from J and J on 12-Jan-2022. Fourth monovalent booster shot from moderna on 31-Aug-2022.   Treatment medications were not reported.
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient was given the Moderna bivalent vaccine as the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was given the Moderna bivalent vaccine as the first dose) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 12-Feb-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 12-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient was given the Moderna bivalent vaccine as the first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was given the Moderna bivalent vaccine as the first dose) 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 was given the Moderna bivalent vaccine as the first dose).    No concomitant medications were reported.  It was reported unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported no reported adverse event from the patient as per HCP.  No treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator: 12JAN2023, (BUD: 11-FEB-2023); No adverse event; 1 dose was administered after the 30 day BUD yesterday, 13FEB2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered after the 30 day BUD yesterday, 13FEB2023.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator: 12JAN2023, (BUD: 11-FEB-2023)) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-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 13-Feb-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 (1 dose was administered after the 30 day BUD yesterday, 13FEB2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator: 12JAN2023, (BUD: 11-FEB-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was administered after the 30 day BUD yesterday, 13FEB2023.), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator: 12JAN2023, (BUD: 11-FEB-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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 dose was administered after the 30 day BUD yesterday, 13FEB2023.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator: 12JAN2023, (BUD: 11-FEB-2023)).    No concomitant medications were reported. It was reported that patient had received Moderna COVID-19 bivalent boosters that are 3 days beyond the 30 day use by date 11-Feb-2023. Patient was not reported any adverse reactions at this time. Individual vials or intact cartons: Unknown.  Vial size? 0.4 mL, 2.5 mL or 5.5 mL: 5 ml. Vial was not undergone to any temperature excursions. No treatment medications were reported.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received dose of the Moderna covid-19 vaccine after the published expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose of the Moderna covid-19 vaccine after the published expiration date.).    Concomitant products were not reported.  It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment medications were not reported.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Jan2023 as dose 5 (booster), single (Lot number: GL0446) at the age of 62 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), 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 included: "GERD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hiatal hernia" (unspecified if ongoing); "Known allergies: CT contrast dyes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril"; Losartan, reaction(s): "Known allergies: losartan". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received COVID 19 Treatment from 29Jan2023 to 03Feb2023.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: high fever; cough; ST; sneezing; HA; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3, Booster dose; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary immunization complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Primary immunization complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 06Feb2023, outcome "not recovered", described as "HA"; OROPHARYNGEAL PAIN (non-serious) with onset 06Feb2023, outcome "not recovered", described as "ST"; COUGH (non-serious) with onset 06Feb2023, outcome "not recovered"; FATIGUE (non-serious) with onset 06Feb2023, outcome "not recovered"; PYREXIA (non-serious) with onset 06Feb2023, outcome "not recovered", described as "high fever"; SNEEZING (non-serious) with onset 06Feb2023, outcome "not recovered". The events "high fever", "cough", "st", "sneezing", "ha" and "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, cough, oropharyngeal pain, sneezing, headache, fatigue.  Additional information : Unknown exposure symptoms high fever 101.3 cough ST sneezing HA fatigue then Tested positive: 08Feb2023.If Covid prior vaccination Unknown. If Covid tested post vaccination Yes  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-202300062267 same patient different dose/drug/event;
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test, Sneezing
Clinical narrative: high fever; cough; ST; sneezing; HA; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3, Booster dose; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary immunization complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, Primary immunization complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 06Feb2023, outcome "not recovered", described as "HA"; OROPHARYNGEAL PAIN (non-serious) with onset 06Feb2023, outcome "not recovered", described as "ST"; COUGH (non-serious) with onset 06Feb2023, outcome "not recovered"; FATIGUE (non-serious) with onset 06Feb2023, outcome "not recovered"; PYREXIA (non-serious) with onset 06Feb2023, outcome "not recovered", described as "high fever"; SNEEZING (non-serious) with onset 06Feb2023, outcome "not recovered". The events "high fever", "cough", "st", "sneezing", "ha" and "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, cough, oropharyngeal pain, sneezing, headache, fatigue.  Additional information : Unknown exposure symptoms high fever 101.3 cough ST sneezing HA fatigue then Tested positive: 08Feb2023.If Covid prior vaccination Unknown. If Covid tested post vaccination Yes  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-202300062267 same patient different dose/drug/event;
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: ag test 10Feb2023; ag test 10Feb2023; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Feb2023, outcome "recovering" and all described as "ag test 10Feb2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Approximately 3 1/2 hours after receiving vaccine patient vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 3-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Feb2023 at 12:30 as dose 3 (booster), single (Lot number: K1657) at the age of 3 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, lot number=Ft9142,), administration date: 19Nov2022, when the patient was 3-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (Dose 1,lot number=Ft9142,), administration date: 22Oct2022, when the patient was 3-year-old, for COVID-19 IMMUNIZATION. The following information was reported: VOMITING (non-serious) with onset 11Feb2023 at 16:00, outcome "recovered", described as "Approximately 3 1/2 hours after receiving vaccine patient vomited". Therapeutic measures were not taken as a result of vomiting.  Additional Information: Patient had no known allergies. The patient did not receive other vaccine in two and four weeks. Post vaccination, the patient had not been tested for COVID.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694), 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) 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), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (10Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 31Jan2023 to 03Feb2023.  Clinical information: Other medication in 2 weeks was Yes Lisinopril. There is no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccination Failure; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 09Feb2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 09Feb2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2023) Positive, notes: Nasal Swab. Clinical course: Patient started experiencing sore throat yesterday which quickly developed into muscle aches. Today, dry hacking cough started. No prior to vaccination, was the patient diagnosed with COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.,Linked Report(s) : US-PFIZER INC-202300062567 same patient, different event, different dose.;US-PFIZER INC-202300063952 same patient, different event, different dose.;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; Vaccine brand other: Moderna/vaccine administration date: 26May2022; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26May2022, outcome "unknown", described as "Vaccine brand other: Moderna/vaccine administration date: 26May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Feb2023 at 14:00, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (09Feb2023) Positive, notes: Return of mild cold symptoms and positive test for Covid (14:00). Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient has no known allergies.  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: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other 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), 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: "Asthma" (unspecified if ongoing). The patient's 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (31Jan2023) Positive, notes: tested positive 31Jan2023; (09Feb2023) Negative, notes: Tested negative 09Feb2023 and 10Feb2023 and had no symptoms; (10Feb2023) Negative, notes: Tested negative 09Feb2023 and 10Feb2023 and had no symptoms; (11Feb2023) Positive, notes: Symptoms restarted on 11Feb2023 and I got a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. product was COVID 19 Treatment, brand was paxlovid,, treatment start date at 01Feb2023, treatment stop date at 05Feb2023.  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: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19".
Age: 37.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GH9696) at the age of 37 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), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 1 day after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound COVID 3 days after finishing paxlovid and 1 day after testing negative. Starting feeling sick with sore throat and sneezing.