chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-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 29-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 (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vial was first punctured on 28-JUN-2023. Treatment details was not reported by the reporter.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022) and NO ADVERSE EVENT (No adverse event) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on august 28 2021 and administered on 7Jan2022).    Concomitant medication details not reported by the reporter. Vial size was unknown. NDC number reported as 80777027399. HCP was not sure that the vial was initially stored in the refrigerator. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-731749 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731749:Same Reporter
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023) and NO ADVERSE EVENT (no adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-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 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine on 06/28/2023 that expired 17-JUN-2023).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-731651 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731651:Same reporter
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 14-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) and PFIZER BIONTECH COVID-19 VACCINE (2nd dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 30-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-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 (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 bivalent vaccine on 30-JUN-2023, but when HCP went to chart it, she realized that the vaccine had expired on 12-JUN-2023).    No concomitant information was reported. The individual 2.5 ml vial was initially stored in the refrigerator on 29-JUN-2023 and did not underwent temperature excursions. The patient had not reported any adverse reactions to this dose. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE during this time; Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022) and NO ADVERSE EVENT (No AE during this time) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No AE during this time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022) and NO ADVERSE EVENT (No AE during this time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No AE during this time) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Regarding administrating vaccine expired on 28-AUG-2021 and administered on 7-Jan-2022).    Concomitant medication details not reported by the reporter. Vial size was unknown. NDC number reported as 80777027399. HCP was not sure that the vial was initially stored in the refrigerator. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-731703 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731703:Same Reporter(Husband case)
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: The reaction is so severe; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (The reaction is so severe) 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 IMMUNISATION REACTION (The reaction is so severe). At the time of the report, IMMUNISATION REACTION (The reaction is so severe) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.    Reporter did not allow further contact
Age: 38.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC.; Pharmacy technician called to report a T/E and it was reported that VARIVAX that was improperly stored was administered to a patient on 6-JUN-2023. Denies side effects or symptomatic events. No additional AE/No PQC.         ?    Names of vaccines i; Information has been received from a pharmacy technician, referring to a 38 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # reported as "X00100, with expiration date on 09-JAN-2025" subcutaneous injection (strength, route of administration, and anatomical location were not reported) for prophylaxis. No adverse effects were reported.   The vaccine had a temperature excursions of 24 hours with a lowest recorded temperature of 39 Fahrenheit (F).It was confirmed that no previous excursions occurred.  Lot number X00100 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details; Improper storage of product in use; This spontaneous report has been received from a pharmacist concerning a 13-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug/allergy history, and concomitant therapies were not reported.  On 02-MAR-2023, a temperature excursion was registered for varicella virus vaccine live (oka/merck) (VARIVAX) (temperature of 70 Fahrenheit [F] for 9 minutes).   On 08-JUN-2023, the patient was vaccinated with the improper stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter/once, Lot# W025273, expiration date was reported as 02-JUN-2023, but upon internal validation, it was established as 10-AUG-2024 (anatomical location and route of administration were not reported) administered for prophylaxis (product storage error).  No adverse events were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient received an improperly stored PROQUAD vaccine; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown gender or age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 16-JUN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, product quantity: 1, lot #W039841, expiration date: 12-JUN-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). There were no adverse events reported (no adverse event).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA009685:009507513
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; HCP called to report patient received expired dose of MMR II.; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUN-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #U014655, expiration date: 07-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 27-JUN-2023, HCP called to report patient received expired dose of MMR II. Case Number 02416785. No Additional AE/No PQC.
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Vaccine positive rechallenge
Clinical narrative: patient experienced a seizure approximately one week later after the first dose of GARDASIL 9, then with second dose she experienced a seizure; patient experienced a seizure approximately one week later after the first dose of GARDASIL 9, then with second dose she experienced a seizure; This spontaneous report was received from  a Physician via employee and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2016, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, two dose series, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2016, approximately one week later after the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced seizure. Outcome of the event was unknown.  On an unknown date, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), then with second dose she experienced a seizure on an unspecified date (reported as the following day), as well. The outcome of the second episode od seizures was not recovered as it was reported that the patient continued to experience seizures. Both events of seizures were treated (treatment was unspecified) and the patient sought medical attention for both events.   The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding first episode of seizure was Not Applicable wit positive rechallenge and due to second episode of seizure it was not applicable.   The causal relationship between both episodes of seizure and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review both episodes of seizure  were determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The PROQUAD also suffered from a non supported temperature excursion.; No additional AE; HCP called to report that the patient was given PROQUAD instead of MMR II.; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-JUN-2023, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) therapy type: rHA, valid lot #W029552, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided), instead of measles, mumps, and rubella (WISTAR RA 27-3) virus vacc, live (MMR II). The measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) vaccine suffered from a non-supported temperature excursion, with temperature of 8 C, during a time frame of 1872 hours. No additional information or adverse event was reported.
Sex: F
Vaccine: RAB
Symptoms: Medication error, No adverse event, Product dose omission issue
Clinical narrative: Patient got initial dose and missed second dose, now is at day 21; Case reference number US-BN-2022-001169 is a spontaneous case report initially received on 01-Jun-2022 from other health professional (reference number: USBAV22-0255) and concerns a 19-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 16-May-2022, the patient received the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP), batch number were not provided), at an unknown dose and site of administration, at intramuscular route for pre exposure prophylaxis.   As reported, the patient missed their second dose and are now at a day 21. (Explicitly coded as 'missed dose').  At the time of this report, it was unknown whether the patient experienced any adverse events due to Rabavert vaccine.   Additional information received from Bavarian Nordic on 03-Jun-2022 included local case ID.; Reporter's Comments: A 19-year-old female patient missed the second dose after the patient received the first dose of RabAvert for pre exposure prophylaxis, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 19-year-old female patient missed the second dose after the patient received the first dose of RabAvert for pre exposure prophylaxis, which is considered as product dose omission issue. No associated adverse events have been reported with the reported medication error. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Animal bite, Inappropriate schedule of product administration
Clinical narrative: Bitten by a stray cat, once again; The patient was bitten by a stray cat again and asked if previous vaccination with RabAvert was still good; Case reference number US-BN-2022-001170 is a spontaneous case report initially received on 01-Jun-2022 from a consumer (reference number: USBAV22-0259) and concerns an adult female patient.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date in Oct-2021, the patient was vaccinated with RabAvert vaccine (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not reported) at an unknown dose, route of administration or anatomical location, for post-exposure immunization against rabies due to a stray cat bite. The patient was not sure how many doses were administered.  On an unspecified date, an unknown amount of time after the last dose of RabAvert, the patient was bitten by a stray cat again and the patient was wondering if previous vaccination with RabAvert was still good for protection (explicitly coded as 'Inappropriate schedule of vaccine administered').  The outcome for the event of 'cat bite' was not provided.  The reporter did not provide seriousness and causality assessment.  Additional information received on 03-Jun-2022 included local case ID.; Reporter's Comments: An adult female patient was bitten by a stray cat and was wondering if previous vaccination with RabAvert was still good for protection which is considered as inappropriate schedule of vaccine administered. Animal bite is unlisted according to insert for Rabies, Inactivated, Whole Virus Vaccine while inappropriate schedule of vaccine administered is considered listed as per convention. Animal bite is assessed as not related to suspect vaccine. Inappropriate schedule of vaccine administered is also assessed as not related to suspect vaccine but to human factor. The case is considered as non-serious.; Sender's Comments: An adult female patient was bitten by a stray cat  and was wondering if previous vaccinations with RabAvert was still good for protection which is considered as inappropriate schedule of vaccine administered. Animal bite is unlisted according to insert for Rabies, Inactivated, Whole Virus Vaccine while inappropriate schedule of vaccine administered is considered listed as per convention. Animal bite is assessed as not related to suspect vaccine. Inappropriate schedule of vaccine administered is also assessed as not related to suspect vaccine but to human factor. The case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Animal bite, Inappropriate schedule of product administration
Clinical narrative: The patient received a dose of RabAvert about a month after a dog bite; Case reference number DE-BN-2022-001171  is a spontaneous case report initially received on 01-Jun-2022 from other health care professional (reference number: USBAV22-0257) and concerns an adult male patient.  The patient's medical history and concomitant medication details were not reported.   On 10-Apr-2022, the patient was bitten by a dog who had a bat next to a food bowl.  On 07-May-2022, 27 days after a dog bite, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid, for a post exposure after a dog bite (explicitly coded as 'inappropriate schedule of vaccine administered').  On 10-May-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid.  On 14-May-2022, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid.  On 21-May-2022, 14 days after the first dose, the patient was vaccinated with the fourth dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number was not provided), at a dose reported as one shot, intramuscularly in the deltoid.  It was reported that the patient didn't have any symptoms.  Additional information received on 03-Jun-2022 included local ID.; Reporter's Comments: An adult male patient was vaccinated with the first dose of RabAvert 27 days after a dog bite, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the first dose of RabAvert 27 days after a dog bite, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not reported. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; Case reference number US-BN-2022-001322 is a spontaneous case report initially received on 21-Jun-2022 from a nurse (reference number: USBAV22-0371) and concerns a female patient.  The patient's medical history and concomitant medication details were not provided.  On 16-Jun-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP), batch number: unknown), at an unknown dose, via unknown route of administration, for pre exposure immunization.   On an unknown date, an unknown amount of time after the first dose, the patient tested positive for Covid.   The seriousness and causality assessment of the event 'COVID-19' was not provided.  Additional information received from Bavarian Nordic on 21-Jun-2022 included local case ID.; Reporter's Comments: A female patient experienced a non-serious event of COVID-19 on an unknown date, an unknown amount of time after the vaccination with the first dose of RabAvert for pre-exposure immunization. COVID-19 is not listed for RabAvert according to the insert and Datasheet. Time-to-onset was not provided, therefore chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. The event of COVID-19 has been considered as not related to the suspect vaccine, but to a viral infection. This case is considered as non-serious.; Sender's Comments: A female patient experienced a non-serious event of COVID-19 on an unknown date, an unknown amount of time after the vaccination with the first dose of RabAvert for pre-exposure immunization. COVID-19 is not listed for RabAvert according to the insert and Datasheet. Time-to-onset was not provided, therefore chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. The event of COVID-19 has been considered as not related to the suspect vaccine, but to a viral infection. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: A lot of it leaked out over the daughter's leg and her hand; Case reference number US-BN-2022-001528 is a spontaneous case report initially received on 05-Jul-2022 from consumer (reference number: USBAV22-0473) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 05-Jul-2022, while her 19-months-old daughter was receiving first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown) (see case US-BN-2022-001474) a lot of it leaked out over the daughter's leg and her hand (explicitly coded as 'accidental exposure to product').  At the time of this report, it was unknown if the patient experienced any adverse event due to Rabavert.  This case is linked with to the case US-BN-2022-001474, daughter case.  Additional information received on 12-Jul-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A female patient of unknown age was exposed to product while her 19-months-old daughter was receiving first dose of Rabavert and a lot of it leaked out over the daughter's leg and her hand, which is considered as accidental exposure to product. No associated adverse events were reported. Accidental exposure to product is listed per company convention. The patient's medical history and concomitant medication details were not provided. Accidental exposure to product is assessed as not related to Rabavart, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was exposed to product while her 19-months-old daughter was receiving first dose of Rabavert and a lot of it leaked out over the daughter's leg and her hand, which is considered as accidental exposure to product. No associated adverse events were reported. Accidental exposure to product is listed per company convention. The patient's medical history and concomitant medication details were not provided. Accidental exposure to product is assessed as not related to Rabavart, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: RabAvert administered in a leg; Case reference number US-BN-2022-001533 is a spontaneous case report initially received on 12-Jul-2022 from a pharmacist (reference number: USBAV22-0533) and concerns a female patient of unknown age.  The patient was immunocompromised.  Concomitant medication details were not reported.  On an unspecified date, the patient received RabAvert (Rabies Virus (Inactivated, Strain Flury LEP), batch number: Unknown), at an unknown dosage, administered in a leg, via unknown route of administration, for post-exposure immunisation against rabies due to a flying bat. As reported, the patient did not have a site for RabAvert vaccination and chose leg for administration (explicitly coded as 'Product administered at inappropriate site')  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received on 12-Jul-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: On an unspecified date, a female patient of unknown age received RabAvert at an unknown dosage, administered in a leg, via unknown route of administration, for post-exposure immunisation against rabies due to a flying bat, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient was immunocompromised and concomitant medication details were not reported. Product administered at inappropriate site is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, a female patient of unknown age received RabAvert at an unknown dosage, administered in a leg, via unknown route of administration, for post-exposure immunisation against rabies due to a flying bat, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient was immunocompromised and concomitant medication details were not reported. Product administered at inappropriate site is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Third dose of RabAvert was given on day 13 instead on day seven; Case reference number US-BN-2022-002160 is a spontaneous case report initially received on 30-Aug-2022 from pharmacist (reference number: USBAV22-1220) and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 17-Aug-2022, the patient was vaccinated with first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not provided) at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies.   On 20-Aug-2022, three days after the first dose, the patient was vaccinated with second dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not provided) at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies.  On 30-Aug-2022, 13 days after the first dose, the patient was vaccinated with third dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not provided) at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced adverse event.  Additional information received from Bavarian Nordic on 30-Aug-2022 included local case ID.; Reporter's Comments: A patient of unknown age and gender was vaccinated with third dose of RabAvert,13 days after the first dose (three days after the first dose, the patient was vaccinated with second dose of RabAvert), at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with third dose of RabAvert,13 days after the first dose (three days after the first dose, the patient was vaccinated with second dose of RabAvert), at dose reported as 2.5 units, administered intramuscularly at an unknown anatomical site for post exposure immunization to rabies, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced adverse event. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Didn't get RabAvert follow up booster on the 15th; Case reference number US-BN-2022-002258 is a spontaneous case report initially received on 01-Sep-2022 from other healthcare professional (reference number: USBAV22-1247) and concerns a 27-year-old female patient.  The patient's medical history and concomitant medication details were not provided. As reported, the patient was not pregnant at the time of this report.  On 08-Aug-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at a dose reported as one vaccine, at unknown site and route of administration for pre-exposure for school.  As reported, the patient did not get the follow up booster on the 15th (explicitly coded as 'missed dose').  At the time of this report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received on 01-Sep-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A 27-year-old female patient was vaccinated with the first dose of RabAvert as a pre-exposure immunization for school and as reported the patient did not get the follow up booster on the 15th, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 27-year-old female patient was vaccinated with the first dose of RabAvert as a pre-exposure immunization for school and as reported the patient did not get the follow up booster on the 15th, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: The patient skipped day seven for the second dose of RabAvert; Case reference number US-BN-2022-002285 is a spontaneous case report initially received on 08-Sep-2022 from a health care professional (reference number: USBAV22-1310) and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 18-Aug-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown) at an unknown dose, via unknown route of administration, at an unknown anatomical site, for pre-exposure for rabies.   It was reported that the patient was not vaccinated with the second dose of RabAvert seven days after the first dose (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse events.  Non-significant case correction performed for information received from Bavarian Nordic on 08-Sep-2022 to include the local case ID.  The case is linked with cases no. US-BN-2022-002286 and US-BN-2022-002287 due to the same reporter.; Reporter's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: The patient skipped day seven for the second dose of RabAvert; Case reference number US-BN-2022-002286 is a spontaneous case report initially received on 08-Sep-2022 from a health care professional (reference number: USBAV22-1310) and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 18-Aug-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown) at an unknown dose, via unknown route of administration, at an unknown anatomical site, for pre-exposure for rabies.   It was reported that the patient was not vaccinated with the second dose of RabAvert seven days after the first dose (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse events.   Non-significant case correction performed for information received from Bavarian Nordic on 08-Sep-2022 to include the local case ID.  The case is linked with US-BN-2022-002285 and US-BN-2022-002287 due to the same reporter.; Reporter's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: The patient skipped day seven for the second dose of RabAvert; Case reference number US-BN-2022-002287 is a spontaneous case report initially received on 08-Sep-2022 from a health care professional (reference number: USBAV22-1310) and concerns a patient of unknown age.  The patient's relevant medical history and concomitant medications were not reported.  On 18-Aug-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: unknown) at an unknown dose, via unknown route of administration, at an unknown anatomical site, for pre-exposure for rabies.   It was reported that the patient was not vaccinated with the second dose of RabAvert seven days after the first dose (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse events.   Non-significant case correction performed for information received from Bavarian Nordic on 08-Sep-2022 to include the local case ID.  The case is linked with cases no. US-BN-2022-002285 and US-BN-2022-002286 due to the same reporter.; Reporter's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age was not vaccinated with the second dose of RabAvert seven days after the first dose which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: Second dose of RabAvert was not administered by the schedule; Case reference number US-BN-2022-002301 is a spontaneous case report initially received on 08-Sep-2022 from a health care professional via Communication (reference number: USBAV22-1313) and concerns a 22-year-old female patient born in 1999.  The patient's relevant medical history and concomitant medications were not reported.  On 22-Aug-2022, the patient was vaccinated with first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: unknown) administered intramuscularly at a dose reported as 1ml, at unknown anatomical site for pre-exposure to rabies.   It was reported that second dose of RabAvert was not administered by the schedule (explicitly coded as 'Missed dose').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 08-Sep-2022 included local case ID.; Reporter's Comments: A 22-year-old female patient born in 1999, was not administered by the schedule with the second dose of RabAvert which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 22-year-old female patient born in 1999, was not administered by the schedule with the second dose of RabAvert which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event. The patient's relevant medical history and concomitant medications were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.