chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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 (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown. The vial did not undergo any temperature excursions. Suspect vaccine expiry date was 11-May-2023.  It was reported that no adverse reactions have been reported by any patients.  No treatment medication was reported.  This case is reported for patient 40th out of 50 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-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 (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 41 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received expired doses of the Moderna COVID19 vaccine bivalent from the same vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) and NO ADVERSE EVENT (No adverse event) 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. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jul-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 31-Jul-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 (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial) 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 (received expired doses of the Moderna COVID19 vaccine bivalent from the same vial).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about 2nd patient out of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-735211 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735211:Master case Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223; No adverse event; Vaccine past the expiration date administered to adult patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine past the expiration date administered to adult patient), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-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 26-Jul-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 (Vaccine past the expiration date administered to adult patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine past the expiration date administered to adult patient), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223) 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 (Vaccine past the expiration date administered to adult patient) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 21-JUN-2023 and administred to patient on 26-JUL-0223).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 Vaccine. No concomitant medication was reported.  The vial was initially stored in refrigerator on 21-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 1 out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2023-735313, US-MODERNATX, INC.-MOD-2023-735317 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735313:Patient 2 US-MODERNATX, INC.-MOD-2023-735317:Patient 3
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th 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 EXPIRED PRODUCT ADMINISTERED (Patient should be revaccinated after receiving a dose of the Moderna COVID19 vaccine bivalent after 30-day Use By Date as a 6th dose).    Concomitant medication not reported.   Treatment medication not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lethargy
Clinical narrative: lethargic; covid 19; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and COVID-19 (covid 19) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003K21-29) for COVID-19 prophylaxis.     Patient was tested Positive for COVID-19 in OCT or NOV 2022.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose with lot number 025J20-2A) on 06-Jan-2021, Moderna COVID-19 Vaccine (2nd dose with lot number 030L20A) on 03-Feb-2021 and Moderna COVID-19 Vaccine (3rd dose with lot number 939902) on 22-Sep-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 07-Mar-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargic) and COVID-19 (covid 19). At the time of the report, LETHARGY (lethargic) and COVID-19 (covid 19) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735462 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735462:Husband case
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: administered PREVNAR 20; the tip of the syringe broke when the safety needle was activated, leaving a sharp and broken glass tip; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY DEVICE USED (non-serious), described as "administered PREVNAR 20"; DEVICE BREAKAGE (non-serious), described as "the tip of the syringe broke when the safety needle was activated, leaving a sharp and broken glass tip". Additional information: One of the staff administered PREVNAR 20, and the tip of the syringe broke when the safety needle was activated, leaving a sharp and broken glass tip. They still have the syringe and would like to know how to proceed. The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (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) all with onset 21Jul2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Jul2023 to 27Jul2023. Clinical Course: She took Paxlovid her first day of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300267733 Same patient/reporter, different drug/event;
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: Injury; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: INJURY (non-serious), outcome "unknown".  Additional information: Patient had an injury. Patient wanted to know if compensation for an injury was given from the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Loss of personal independence in daily activities, Tinnitus
Clinical narrative: Tinnitus is now 24/7; hyperacusis; all making it difficult to complete my tasks; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hearing loss " (unspecified if ongoing), notes: hearing loss from about 12 yrs ago. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 02Jan2023, outcome "unknown", described as "Tinnitus is now 24/7"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 02Jan2023, outcome "unknown", described as "all making it difficult to complete my tasks"; HYPERACUSIS (non-serious) with onset 02Jan2023, outcome "unknown". The events "tinnitus is now 24/7", "hyperacusis" and "all making it difficult to complete my tasks" required physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus, hyperacusis, loss of personal independence in daily activities.  Additional information: It was reported that "The Covid booster I got in January has dramatically changed a hearing loss from about 12 yrs ago. Tinnitus was now 24/7 and hyperacusis was often in overdrive. The 2 printers, Eyecon counter, phones, customers, employees, AC unit, and soda machine were all making it difficult to complete my tasks. If I can't give you 100%, I won't give you anything. The CDC contacted me in April to discuss the entries in the VSafe app and encouraged me to send them a encouraged me to send them a VAERS report". It was unknown if patient had covid prior vaccination and if covid tested post vaccination. It was unknown if patient had other vaccine in four weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 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: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid". 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.  Clinical course: The patient has received other vaccine and medication in 2 weeks. 4 days after stopping Paxlovid, the patient started experiencing symptoms of Covid again. Paxlovid was given as treatment for COVID-19 from 24Jul2023 to 29Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Modern vaccine number=4/Pfizer BioNTech, vaccine number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Sep2022 as dose 4 (booster), single (Lot number: AS7147B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: other medical history: ADHD; "scoliosis" (unspecified if ongoing), notes: other medical history: scoliosis; "known allergies: Shrimp" (unspecified if ongoing), notes: known allergies: Shrimp. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "Modern vaccine number=4/Pfizer BioNTech, vaccine number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Barely tested positive for COVID-19, started PAXLOVID; (unspecified date) Positive, notes: two days after that, VERY strong positive, and slight return of symptoms; (30Jul2023) Positive, notes: at end of treatment still only had very faint positive,; (01Aug2023) Negative, notes: two days later, negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient has received other medication in 2 weeks and was barely tested positive for COVID-19, started PAXLOVID, at end of treatment still only had very faint positive, two days later negative, two days after that, VERY strong positive, and slight return of symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: sore shoulder; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 68 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN4202), administration date: 02Mar2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "sore shoulder", "Lethargy"; BNT162b2 (DOSE 2, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 23Mar2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "sore shoulder", "Lethargy". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore shoulder"; LETHARGY (non-serious), outcome "unknown". Additional information: I rarely have even mild reactions (sore shoulder; a day of lethargy) after each dose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: sore shoulder; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EP6955) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Site and route of injection: Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EN4202), administration date: 02Mar2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "sore shoulder", "lethargy". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore shoulder"; LETHARGY (non-serious), outcome "unknown".  Additional information: It was reported that the patient had contracted COVID 3 mos. After his 5th dose (Bivalent). He rarely had even mild reactions (sore shoulder; a day of lethargy) after each dose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: sore shoulder; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6202) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore shoulder"; LETHARGY (non-serious), outcome "unknown".  Additional information: It was reported that patient had contracted COVID 3 mos after his 5th dose (Bivalent). He rarely had even mild reactions (sore shoulder; a day of lethargy) after each dose.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: persistent, intense itching - diffuse, no rash, lasted over a year; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FF8841) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: 30145BA, dose number: 1), for Covid-19 Immunization. The following information was reported: PRURITUS (medically significant), outcome "recovering", described as "persistent, intense itching - diffuse, no rash, lasted over a year". The event "persistent, intense itching - diffuse, no rash, lasted over a year" required physician office visit. Therapeutic measures were taken as a result of pruritus which includes UV therapy and hydroxychloroquine.; Sender's Comments: On the basis of the limited information available in this report, a medically meaningful assessment of the case cannot be made. Details regarding the drug-event temporal relationship and clinical course are not provided. However on conservative basis, the possible causality cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. This case will be reassessed once additional information is available.
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 14-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization.  The following information was reported: VITILIGO (non-serious) with onset 2023, outcome "unknown".  Additional information: Caller states that his son has received all the recommended Pfizer COVID 19 vaccines, on schedule, when they became available. His last vaccination was months ago and he has now been diagnosed with vitiligo (auto-immune disease) this summer.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Moderna Dose Number 3 Pfizer / BioNTech Dose Number 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 16:30 as dose 4 (booster), single (Lot number: GJ6665) at the age of 47 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 at 11:15 as dose 1, single (Lot number: 07821A), in left arm, on 14Apr2021 as dose 2, single (Lot number: 046B21A), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: 051F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Nov2022 at 16:30, outcome "unknown", described as "Moderna Dose Number 3 Pfizer / BioNTech Dose Number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: CYSTITIS (non-serious), outcome "unknown", described as "bladder infection".  Additional information: The patient took COVID and thinks that the patient has a bladder infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: sore shoulder; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN4202), administration date: 02Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "sore shoulder", "lethargy"; BNT162b2 (DOSE 2, SINGLE, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 23Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "sore shoulder", "lethargy"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of Injection: left arm, Route of administration: Intramuscular, Batch/Lot number: FH8020), administration date: 21Oct2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "sore shoulder", "lethargy". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore shoulder"; LETHARGY (non-serious), outcome "unknown". Additional information: Patient rarely had even mild reactions (sore shoulder; a day of lethargy) after each dose.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Renal atrophy, Renal failure, Ultrasound scan
Clinical narrative: And within 8 months I came to know that my right kidney has no use; I came to know my right kidney is significantly atrophic; suddenly due to my right side abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 10Dec2021 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. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 09Apr2021, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 19Mar2021, for Covid-19 Immunization. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "And within 8 months I came to know that my right kidney has no use"; RENAL ATROPHY (medically significant), outcome "unknown", described as "I came to know my right kidney is significantly atrophic"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "suddenly due to my right side abdominal pain". The events "and within 8 months i came to know that my right kidney has no use", "i came to know my right kidney is significantly atrophic" and "suddenly due to my right side abdominal pain" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (02Nov2022) right kidney was significantly atrophic. Compensation for organ loss due to Pfizer Covid19 Vaccine Like everyone, the patient had given covid-19 vaccine of pfizer (1st dose 19Mar2021, 2nd dose 09Apr2021, booster 10Dec2021, 4th dose 22Dec2022). And suddenly due to the patient's right side abdominal pain, doctor did an ultrasound on 02Nov2022 where for the 1st time the patient came to know his/her right kidney was significantly atrophic. And within 8 months, the patient came to know that his/her right kidney had no use. The patient didn't have any previous history of kidney disease or injury.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: And within 8 months I came to know that my right kidney has no use; I came to know my right kidney is significantly atrophic; suddenly due to my right side abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 10Dec2021 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. Vaccination history included: BNT162b2 (DOSE 2, SINGLE), administration date: 09Apr2021, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE), administration date: 19Mar2021, for Covid-19 Immunization. The following information was reported: RENAL FAILURE (medically significant), outcome "unknown", described as "And within 8 months I came to know that my right kidney has no use"; RENAL ATROPHY (medically significant), outcome "unknown", described as "I came to know my right kidney is significantly atrophic"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "suddenly due to my right side abdominal pain". The events "and within 8 months i came to know that my right kidney has no use", "i came to know my right kidney is significantly atrophic" and "suddenly due to my right side abdominal pain" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (02Nov2022) right kidney was significantly atrophic. Compensation for organ loss due to Pfizer Covid19 Vaccine Like everyone, the patient had given covid-19 vaccine of pfizer (1st dose 19Mar2021, 2nd dose 09Apr2021, booster 10Dec2021, 4th dose 22Dec2022). And suddenly due to the patient's right side abdominal pain, doctor did an ultrasound on 02Nov2022 where for the 1st time the patient came to know his/her right kidney was significantly atrophic. And within 8 months, the patient came to know that his/her right kidney had no use. The patient didn't have any previous history of kidney disease or injury.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: TDAP
Symptoms: Occupational exposure to product, Skin laceration, Syringe issue
Clinical narrative: while administering Tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the RN's finger; while administering Tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the RN's finger.; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age and gender and while administering diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel], the base of the syringe body broke off and cause a laceration to the rn's finger.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jul-2023, the patient received a unknown dose of suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength, expiry date: not reported and lot U7869AA) via intramuscular route in unknown administration site for Prophylactic vaccination (immunization) and the base of the syringe body broke off and cause a laceration to the rn's finger. (occupational exposure to product) (latency: same day).  On an unknown date while administering tdap (adacel) vaccine, the base of the syringe body broke off and cause a laceration to the rn's finger (skin laceration) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6-year-old received a dose of PENTACEL last week with no reported adverse event; Initial information was received from on 31-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male patient who received a dose of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] last week with no reported adverse event.  The patient's past vaccination(s) included measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine, hepatitis a vaccine, hepatitis b vaccine, Prevnar 13 and Pentacel. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for prophylactic vaccination (immunisation); measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine (measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine) for prophylactic vaccination (immunisation); hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination (immunisation); and hepatitis a vaccine (hepatitis a vaccine) for prophylactic vaccination (immunisation).  Last week on 28-Jul-2023, a 6-year-old patient received dose 2 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection at dose of 0.5 ml  once (lot number: UJ877AA, expiration date: 22-Mar-2024) via intramuscular route in the right deltoid for prophylactic vaccintation (immunisation) with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 6-year-old received a dose of pentacel last week with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured ipol temperature reached: 46.6 F duration of temperature excursion was 2 minutes with no reported adverse event; patient was given IPOL after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015(CLUSTER), 2023SA235023(CLUSTER), 2023SA235246(CLUSTER), 2023SA236046(CLUSTER), 2023SA235058(CLUSTER) and 2023SA234814(CLUSTER).  This case involves a 6-year-old male patient and punctured IPV (VERO) [IPOL] temperature reached: 46.6 f duration of temperature excursion was 2 minutes with no reported adverse event and patient was given IPV (VERO) [IPOL] after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 12-Jun-2023, the patient received a dose 3 of 0.5 ml dose of suspect IPV (VERO) Suspension for injection (strength: unknown) (lot: W1A191M) (expiry date: 16-Feb-2025) via intramuscular route in the left thigh for immunization.  On an unknown date, punctured ipol temperature reached: 46.6 f duration of temperature excursion was 2 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  On 12-Jun-2023 the patient was given ipol after the temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  It was unknown if any lab data/test results available.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was given a third dose of Menquadfi (with no reported adverse event); patient was given a third dose of MENQUADFI instead of Bexsero (with no reported adverse event); Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16-year-old male patient was given a third dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] (with no reported adverse event) and patient was given a third dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [Menquadfi] instead of Bexsero.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 24-Jul-2023, the patient received a dose 3 of 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength: unknown) (lot: U75968B, expiry date: 14-Mar-2025) via intramuscular route in the left deltoid for Immunization and unknown dose of suspect BEXSERO not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for immunization.  On 24-JUL-2023 the patient was given a third dose of menquadfi (with no reported adverse event) (extra dose administered) and patient was given a third dose of menquadfi instead of bexsero (with no reported adverse event) (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of BEXSERO.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) was not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.