chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The suspect product dosage text was reported as unknown. No concomitant medication was reported. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors were part of it along with Moderna. No treatment medication was reported.   Company comment This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. The reported cause of death was Cancer. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master; Reported Cause(s) of Death: Cancer
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: General physical condition abnormal, Malaise
Clinical narrative: Patient felt slightly depressed Physically; Patient felt a little punk the next day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient felt a little punk the next day) and GENERAL PHYSICAL CONDITION ABNORMAL (Patient felt slightly depressed Physically) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20S, 011A21A, 017F2A and 067F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Prostate cancer (The patient had Prostrate cancer since 2013. The patient was using Eligard for the cancer.) since 2013. Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for Prostate cancer.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MALAISE (Patient felt a little punk the next day). On an unknown date, the patient experienced GENERAL PHYSICAL CONDITION ABNORMAL (Patient felt slightly depressed Physically). At the time of the report, MALAISE (Patient felt a little punk the next day) and GENERAL PHYSICAL CONDITION ABNORMAL (Patient felt slightly depressed Physically) outcome was unknown.            It was unknown if patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Expiry date was not reported for any of the four doses.  Patient had felt a little punk next day after the first primary series dose and patient felt slightly depressed Physically after the first primary series dose. Patient did not experience any adverse event after the 2nd, 3rd and 4th dose.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-736300 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736300:Master case (Same patient with differnet dose- Bivalent)
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 093D21A and 3002331) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021).    No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717838 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717838:Bivalent case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: had swollen lymph nodes in her throat; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (had swollen lymph nodes in her throat) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (had swollen lymph nodes in her throat). At the time of the report, LYMPHADENOPATHY (had swollen lymph nodes in her throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LYMPHADENOPATHY (had swollen lymph nodes in her throat) to be related.    Concomitant medication was not reported.  Patient had a reaction 2.5 years ago when she received her first shot and had swollen lymph nodes in her throat and did not need to go to the doctor and was okay the next day.   It was mentioned that patient has received other doses and now has an EpiPen.  Treatment medication was not reported.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours; No adverse event; dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7647B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Aug-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 of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured) and PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours).    No concomitant medication was reported. The expiry date was reported as 15-OCT-2023. The Vial size was 5.0 mL. The vial was initially stored in the refrigerator either 4-JUL-2023 or 5-JUL-2023 and the beyond use date was 5-AUG-2023. The vial was first punctured: on 3-AUG-2023 9:00 AM. The patient had not reported any adverse reactions at this time. No treatment medication was reported.
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLUX, PNC20
Symptoms: COVID-19, Influenza, SARS-CoV-2 test
Clinical narrative: influenza; tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) and INFLUENZA (influenza) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71418) for COVID-19 prophylaxis.    Co-suspect products included non-company products PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for an unknown indication and INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    The patient's past medical history included Prostate cancer in 2013 and Hernia repair on 09-Sep-2022. Concomitant products included LEUPRORELIN ACETATE (ELIGARD) for Cancer.   On 23-Sep-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 07-Oct-2022, the patient received dose of PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On 07-May-2023, the patient experienced COVID-19 (tested positive for Covid-19). On an unknown date, the patient experienced INFLUENZA (influenza). At the time of the report, COVID-19 (tested positive for Covid-19) and INFLUENZA (influenza) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2023, SARS-CoV-2 test: Positive.         No treatment information was reported.   This case was linked to MOD-2023-736316 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient 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.     It was unknown if patient had any relevant medical history, allergy, concomitant diseases and risk factor and information regarding previous vaccination was unknown. It was also unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 18-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) .5 milliliter. On 18-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 (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 (Expired vaccine used).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was unknown when the vial was initially stored in the refrigerator for this patient. The individual vial did not underwent any temperature excursions. No treatment medication was reported. This case contains information about patient 1st out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736479, US-MODERNATX, INC.-MOD-2023-736474 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736474:Same reporter, Patient 2 US-MODERNATX, INC.-MOD-2023-736479:Same reporter, Patient 3
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-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 PAIN (Pain) and PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN (Pain) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  The patient had pain, sore arm for two days after Moderna booster in November 2021. She got the shingle shot and flu shot in Dec 2021.  Treatment medication not reported.
Sex: F
Vaccine: COVID19
Symptoms: Bipolar I disorder, Inappropriate schedule of product administration, Suicidal ideation, Wrong product administered
Clinical narrative: Threw me into manic depression suicidal; Threw me into manic depression suicidal; patient received dose 2 on 30Jun2023 but dose 1 was received on 12Aug2021; patient received as bivalent BNT162B2 as dose 2; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Jun2023 as dose 2, single (Lot number: Gj6743), in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1; lot number: FC3183; vaccine location: Left arm), administration date: 12Aug2021, for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Jun2023, outcome "unknown", described as "patient received as bivalent BNT162B2 as dose 2"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Jun2023, outcome "unknown", described as "patient received dose 2 on 30Jun2023 but dose 1 was received on 12Aug2021"; SUICIDAL IDEATION (medically significant), BIPOLAR I DISORDER (medically significant) all with onset 08Jul2023, outcome "recovering" and all described as "Threw me into manic depression suicidal". The event "threw me into manic depression suicidal" required physician office visit. Therapeutic measures were taken as a result of suicidal ideation, bipolar i disorder which included medicine. Additional information: the patient has no known allergies. The patient had no prior vaccination and was not covid tested post vaccination. The patient did not receive any other vaccines 4 weeks prior.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted COVID 5 days ago; contracted COVID 5 days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78-year-old male patient received BNT162b2 (BNT162B2), 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 in Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "contracted COVID 5 days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: states her husband contracted COVID 5 days ago and he is still testing positive on the 5th day. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received 2 shot series and then 2 boosters with the last Pfizer COVID-19 booster sometime last Aug2022. He was also on blood thinners which is why he couldn't take Paxlovid. He is currently taking Lagevrio for COVID-19 illness and it has significantly reduced effects of COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: soy" (unspecified if ongoing); "known allergies: salmon" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 28Jun2023 to 02Jul2023.  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-202300270875 same patient, different drug, different event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; 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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 041L20A), in left arm, on 27Feb2021 as dose 2, single (Lot number: 013A21A), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm and on 31Mar2023 as dose 5 (booster), single (Lot number: 083J21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271066 same patient, different drug/event;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Pyrexia
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Pfizer / BioNTech, Patient Drug Start date: 29Apr2023; Name of Drug as Reported: Moderna Bivalent, Patient Drug Start date: 10Sep2022; 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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Apr2023 at 14:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 66 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 10Sep2022 as dose 5 (booster), single (Lot number: A57143C) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2021 as dose 1, single (Lot number: 016B21A), on 30Apr2021 as dose 2, single (Lot number: 04bA21A), on 30Aug2021 as dose 3 (booster), single (Lot number: 025C21A) and on 06Apr2022 as dose 4 (booster), single (Lot number: 066K21A) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: 01Jan2009, stop date: 22Jul2023; ENBREL, start date: Jan2017, stop date: 23Jul2023. Past drug history included: Humira, start date: Jan2010, stop date: Dec2016. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2023 at 14:00, outcome "unknown", described as "Name of Drug as Reported: Pfizer / BioNTech, Patient Drug Start date: 29Apr2023; Name of Drug as Reported: Moderna Bivalent, Patient Drug Start date: 10Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Pyrexia: (07Aug2023) 99-100 Fahrenheit, notes: 99-100  degree Fahrenheit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated for COVID with Paxlovid from 29Jul2023 to 02Aug2023 and experienced rebound of symptoms; mild fever (99-100 degree Fahrenheit), sinus congestion, occasional clearing cough on 07Aug2023.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna; 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 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: 6H9703) at the age of 48 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 2, single (Lot number: 008B21A), in Mar2021 as dose 1, single (Lot number: 013A21A) and in Nov2021 as dose 3 (booster), single (Lot number: 039F21A) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Sep2022, outcome "not recovered", described as "Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive tests; Negative, notes: negative test. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing); "depression" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: walnuts" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 29Jul2023 to 02Aug2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I got covid ~3 weeks after the vaccine (25Sep2022); I got covid ~3 weeks after the vaccine (25Sep2022); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262, Expiration Date: 31May2021), on 14Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: 30Jun2021), on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA) and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2016 (unspecified if ongoing), notes: Breast cancer had breast cancer like 7 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "I got covid ~3 weeks after the vaccine (25Sep2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Negative, notes: symptoms on the 13th and that was negative; (15Oct2022) Positive, notes: tested again and was positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient received the Pfizer bivalent Covid 19 vaccine on 25Sep2022 and got covid 3 weeks after that because she went to a wedding. About 4-5 days after the wedding, she started getting some mild symptoms. Her home test showed negative at first, then had sore throat and then tested again and was positive for Covid on 15Oct2022. Patient was a light case with very mild symptoms. The date she felt better and stated she started with symptoms on the 13th and that was negative but retested on the 15Oct2022 and was going to see her family and then by the 17Oct2022 or 18Oct2022 she was fine. In total it was about 5-6 days from the beginning of her symptoms and not necessarily from when she tested positive for how long this lasted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271821 Same patient/same product, different dose/event;US-PFIZER INC-202300271839 Same patient/same product, different dose/event;US-PFIZER INC-202300271841 Same patient/same product, different dose/event;US-PFIZER INC-202300271840 Same patient/same product, different dose/event;US-PFIZER INC-202300271999 Same patient/same product, different dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: I got covid ~3 weeks after the vaccine (25Sep2022); I got covid ~3 weeks after the vaccine (25Sep2022); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262, Expiration Date: 31May2021), on 14Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: 30Jun2021), on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA) and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2016 (unspecified if ongoing), notes: Breast cancer had breast cancer like 7 years ago. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Oct2022, outcome "unknown" and all described as "I got covid ~3 weeks after the vaccine (25Sep2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Negative, notes: symptoms on the 13th and that was negative; (15Oct2022) Positive, notes: tested again and was positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient received the Pfizer bivalent Covid 19 vaccine on 25Sep2022 and got covid 3 weeks after that because she went to a wedding. About 4-5 days after the wedding, she started getting some mild symptoms. Her home test showed negative at first, then had sore throat and then tested again and was positive for Covid on 15Oct2022. Patient was a light case with very mild symptoms. The date she felt better and stated she started with symptoms on the 13th and that was negative but retested on the 15Oct2022 and was going to see her family and then by the 17Oct2022 or 18Oct2022 she was fine. In total it was about 5-6 days from the beginning of her symptoms and not necessarily from when she tested positive for how long this lasted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271821 Same patient/same product, different dose/event;US-PFIZER INC-202300271839 Same patient/same product, different dose/event;US-PFIZER INC-202300271841 Same patient/same product, different dose/event;US-PFIZER INC-202300271840 Same patient/same product, different dose/event;US-PFIZER INC-202300271999 Same patient/same product, different dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: some local arm tenderness/tenderness of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: breast cancer like 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EL9262, Expiration date: 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm", "chills"; BNT162b2 (Dose: 02, Lot: EM9810, Expiration date: 30Jun2021), administration date: 14Feb2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm"; BNT162b2 (Dose: 03, Lot: 30155BA), administration date: 29Sep2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm"; BNT162b2 (Dose: 04, Lot: FK9895), administration date: 13Apr2022, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "some local arm tenderness/tenderness of the arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: She did not have any significant reaction to any of them regarding her Pfizer covid vaccines and states she had no reactions just some local arm tenderness and thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 same patient, different vaccine doses and different AE.;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: some local arm tenderness/tenderness of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: breast cancer like 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EL9262, Expiration date: 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm", "chills"; BNT162b2 (Dose: 02, Lot: EM9810, Expiration date: 30Jun2021), administration date: 14Feb2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm"; BNT162b2 (Dose: 03, Lot: 30155BA), administration date: 29Sep2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm"; BNT162b2 (Dose: 04, Lot: FK9895), administration date: 13Apr2022, when the patient was 68-year-old, for COVID-19 Immunization, reaction(s): "tenderness of the arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "some local arm tenderness/tenderness of the arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: She did not have any significant reaction to any of them regarding her Pfizer covid vaccines and states she had no reactions just some local arm tenderness and thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 same patient, different vaccine doses and different AE.;
Age: 46.0
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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). There were no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Aug2023 at 12:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient was sneezing and had a runny nose yesterday and today she was stuffy and it's yellow. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: arm tenderness; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262, Expiration Date: 31May2021) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: had breast cancer like 7 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm tenderness"; CHILLS (non-serious) with onset 2021, outcome "unknown". Additional information: She did not have any significant reaction to any of them regarding her Pfizer covid vaccines and states she had no reactions just some local arm tenderness and one time that she can't tell when it was she had some chills but no fever at night and thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines and the chills might be from the first dose but she cannot remember.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 Same reporter/patient, same drug/different dose, different AE (dose 1);
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin disorder, Skin exfoliation, Skin hypertrophy, Skin plaque
Clinical narrative: Skin issues; plaque buildup; extra skin growth; scales; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 at 12:00 as dose 2, single (Lot number: EW0179) at the age of 42 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8729, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), for COVID-19 immunisation. The following information was reported: SKIN DISORDER (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "Skin issues"; SKIN HYPERTROPHY (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "extra skin growth"; SKIN PLAQUE (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "plaque buildup"; SKIN EXFOLIATION (non-serious) with onset 17Sep2021 at 13:00, outcome "not recovered", described as "scales". The events "skin issues", "plaque buildup", "extra skin growth" and "scales" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin disorder, skin plaque, skin hypertrophy, skin exfoliation.   Additional information: Being treated by dermatologists as they provide immediate care. methotrexate, steroids, etc. Patient did receive other vaccine in four weeks and medications in two weeks. Patient had perfect health.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271860 same reporter/patient, different product/AE;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: local arm tenderness/tenderness of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2016 (unspecified if ongoing), notes: Breast cancer had breast cancer like 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, Pfizer covid vaccine with lot EL9262 with expiry date 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "local arm tenderness/tenderness of the arm", "Chills"; BNT162b2 (dose 2 with lot EM9810 and expiry date 30Jun2021), administration date: 14Feb2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "local arm tenderness/tenderness of the arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "local arm tenderness/tenderness of the arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Patient did not have any significant reaction to any of them regarding her Pfizer covid vaccines and stated she had no reactions just some local arm tenderness and thought the tenderness of the arm she had that from all of the Pfizer Covid vaccines.; Sender's Comments: Linked Report(s): US-PFIZER INC-202300271774 Same reporter/patient, same drug/different dose, different AE.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some local arm tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: like 7 years before reporting. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, lot EL9262, expiry date 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "some local arm tenderness", "chills"; BNT162b2 (Dose 2, lot EM9810, expiry date 30Jun2021), administration date: 14Feb2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "some local arm tenderness"; BNT162b2 (Dose 3, lot 30155BA), administration date: 29Sep2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "some local arm tenderness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "some local arm tenderness". Therapeutic measures were not taken as a result of pain in extremity.   Additional information: She did not have any significant reaction to any of them regarding her Pfizer covid vaccines and states she had no reactions just some local arm tenderness and thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 Same reporter/patient, same drug, different dose, different AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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; coviD-19 vaccine (COVID-19 VACCINE), on 07Sep2022 as dose 5 (booster), single (Lot number: AJ71406), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Phenobarbitol, reaction(s): "drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2023, outcome "recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset Jul2023, outcome "recovered", described as "COVID-19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received as treatment paxlovid from 22Jul2023 to 26Jul2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.