chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: We have someone who missed the 2nd dose; We have someone who missed the 2nd dose; They are calling to reschedule; Case reference number US-BN-2021-002144 is a spontaneous case report initially received from a health care professional via regulatory authority (reference number: USBAV21-0392) on 03-Aug-2021 and concerns an adult female patient of unspecified age.   The patient's medical history and concomitant medication details were not provided.  On 26-Jul-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus; batch number was not provided), at unknown dose, reported as standard dose, administered intramuscularly, for pre-exposure prophylaxis.   The reporter stated that the patient missed the second dose and called to reschedule (explicitly coded as Missed dose' and Inappropriate schedule of vaccine administered').  The reporter assessed the events as not related.   The reporter did not give consent for follow up.  No further information was provided.; Reporter's Comments: Product dose omission issue and inappropriate schedule of product administration are listed for RabAvert per convention. Reportedly, the patient missed the second dose and that there was a reschedule request, which is consider as product dose omission issue and inappropriate schedule of product administration. No information regarding concomitant and co-suspect medication and medical history were provided. No adverse event was reported. Reported events are not related to suspect vaccine, but to human action. The case is considered as non-serious.; Sender's Comments: Product dose omission issue and inappropriate schedule of product administration are listed for RabAvert per convention. Reportedly, the patient missed the second dose and that there was a reschedule request, which is consider as product dose omission issue and inappropriate schedule of product administration. No information regarding concomitant and co-suspect medication and medical history were provided. No adverse event was reported. Reported events are not related to suspect vaccine, but to human action. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Hot flush
Clinical narrative: Hot flashes; Case reference number US-BN-2021-002161 is a spontaneous case report initially received from a consumer via Agency (reference number: USBAV21-0409) on 12-Aug-2021 and concerns a 58-year-old female patient.  The patient's historical condition included hysterectomy. The patient's current condition included postmenopausal symptoms.  The patient's concomitant medication details were not provided.  On 12-Jun-2021, the patient was vaccinated with first dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number: not provided), at a dose reported as 'standard', administered intramuscularly for post-exposure.   On the same date, the patient experienced hot flashes.   On 15-Jun-2021, the patient was vaccinated with second dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number: not provided), at a dose reported as 'standard', administered intramuscularly for post-exposure.   On 19-Jun-2021, the patient was vaccinated with third dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number: not provided), at a dose reported as 'standard', administered intramuscularly for post-exposure.   On 26-Jun-2021, the patient was vaccinated with fourth dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number: not provided), at a dose reported as 'standard', administered intramuscularly for post-exposure.   The reporter stated that all four vaccinations were done by the emergency room and that hot flashes were under control before this series of vaccines.  At the time of this report, the outcome of the event 'hot flashes' was unknown. However, it was also reported that the stop date of the event was 26-Jun-2021 (pending query).  The reporter assessed the event as non-serious. The reporter did not provide causality assessment.    No further information was provided.; Reporter's Comments: Hot flush is unlisted for RabAvert according to to the  Information. Reportedly, the patient was vaccinated with first dose of RabAvert and on the same day experienced hot flashes. The temporal relationship is considered plausible. The patient's current condition of postmenopausal symptoms could have contributed in development of the event. However, as temporal relationship is suggestive, the causality is assessed as possibly related to RabAvert.; Sender's Comments: Hot flush is unlisted for RabAvert according to to the Information. Reportedly, the patient was vaccinated with first dose of RabAvert and on the same day experienced hot flashes. The temporal relationship is considered plausible. The patient's current condition of postmenopausal symptoms could have contributed in development of the event. However, as temporal relationship is suggestive, the causality is assessed as possibly related to RabAvert.
Sex: F
Vaccine: RAB
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Some how one of the sterile waters for injection did not get mixed with the powder; There was a 25% chance that the patient received just water; Case reference number US-BN-2021-002170 is a spontaneous case report initially received from a pharmacist via regulatory authority on 10-Aug-2021 and concerns a 9-year-old female patient.  The patient's medical history was not reported.   The patient's concomitant medication details were not provided. The patient's historical vaccine included RabAvert for primary immunization.  On 09-Aug-2021, the patient received a booster dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) in the deltoid, at 1.0 mL dose, administered intramuscularly, for pre-exposure.  It was reported that the pharmacist might not have mixed the sterile water with the vaccine and that there was a 25% chance that the patient received just water (explicitly coded as Product not dissolved before administration' and 'Product administration error').  This case is linked to case US-BN-2021-002171 (same reporter).  Additional information received on 10-Aug-2021 from regulatory authority included local case ID.  Additional information received on 10-Aug-2021 from regulatory authority (reference number: USBAV21-0403) included the adverse event report with additional reporter details, patient details, vaccination details, description of the event and reference number.  Additional information received on 10-Aug-2021 from regulatory authority (reference number: USBAV21-0402) included additional reference number and event details.; Reporter's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.; Sender's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.
Sex: F
Vaccine: RAB
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: One of the ones I believed I had mixed had not been mixed (top was still on vial and powder was still inside); I had already given 2 of the injections. I am not sure if one got just the sterile water and not the vaccine.; Case reference number US-BN-2021-002171 is a spontaneous case report initially received from a pharmacist via Agency (reference number: USBAV21-0402) on 10-Aug-2021 and concerns an adult female patient, reported in her 40s.   The patient's medical history and concomitant medication details were not provided.  On 09-Aug-2021, reporter prepared vaccines for a family of six, she personally drew four doses and the intern finished them. On the same date, the reporter administered two doses. The patient was vaccinated with the booster dose of RabAvert (inactivated rabies virus; batch number was not provided), at dose of 1 milliliter, administered intramuscularly, for pre-exposure immunisation.   On the same date, after vaccination, the intern noticed that one of the doses, that reporter believes she had mixed, had not been mixed as the top was still on vial and powder was still inside. The reporter stated that she had already given 2 of the injections, and was not sure if one got just the sterile water and not the vaccine (explicitly coded as Product not dissolved before administration' and 'Product administration error').  The reporter wanted to make sure that there is not a major issue for the patient if they only got sterile water and, since she doesn't know whether the patient got the vaccine, when can the patient have another booster dose.  The reporter gave consent for follow up.  This case is linked to case US-BN-2021-002170 (same reporter)  No further information was provided.; Reporter's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.; Sender's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: She received her second dose on day 6 instead of on the recommended day 7; Case reference number US-BN-2021-002186, initially downloaded on 16-Aug-2021, is a spontaneous case report received from a health professional via health authority (ID: 1371244-1) and concerns a 31-year-old female patient.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus; batch numbe: ARBA801B), at an unknown dose, administered intramuscularly, for pre-exposure prophylaxis.   On 18-May-2021, reported also as a day six, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus; batch numbe: ARBA801B), at an unknown dose, administered intramuscularly, for pre-exposure prophylaxis (explicitly coded as Inappropriate schedule of product administration').  On an unspecified date, reported also as day 21, the patient was vaccinated with the third dose of RabAvert (inactivated rabies virus; batch numbe: ARBA801B), at an unknown dose, administered intramuscularly, for pre-exposure prophylaxis.  It was reported that the patient did not experience any adverse event as of the date of this report.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the 2nd dose of RabAvert 6 days after receiving the 1st dose, which is considered inappropriate schedule of product administration. The patient did not experience any associated adverse events. Inappropriate schedule of product administration is not related to RabAvert but to human action.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the 2nd dose of RabAvert 6 days after receiving the 1st dose, which is considered inappropriate schedule of product administration. The patient did not experience any associated adverse events. Inappropriate schedule of product administration is not related to RabAvert but to human action.
Sex: F
Vaccine: RAB
Symptoms: Arrhythmia, Hot flush
Clinical narrative: Cardiac arrhythmia; hot flashes; Case reference number US-BN-2021-002196 is a spontaneous case report initially received from a consumer via GSK on 18-Aug-2021, and concerns 64-years-old female patient.  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, the patient received RabaVert vaccine (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an unknown dose or route of administration, for an unknown indication.  On an unspecified date, an unknown amount of time after receiving the vaccine, the patient developed cardiac arrhythmia and hot flashes.  Outcome for the events was not provided.  The reporter did not provide seriousness or causality assessment for the events of cardiac arrhythmia and hot flashes.  Additional information received from GSK on 18-Aug-2021 included confirmation for the country of occurrence.  No further information was provided.; Reporter's Comments: Arrhythmia and hot flush are not listed for RabAvert per PI and PI. Reportedly, the patient experienced mentioned events after vaccination with suspect product, but chronology needs more clarification. Advanced age of patient (64-years-old) may have contributed to the development of the events. No information regarding patient's medical history and co-suspect and concomitant medication were provided. Based on available information causality between suspect product and event hot flush is assessed as possible and for event arrythmia as not related. The case is considered as non-serious.; Sender's Comments: Arrhythmia and hot flush are not listed for RabAvert per PI and PI. Reportedly, the patient experienced mentioned events after vaccination with suspect product, but chronology needs more clarification. Advanced age of patient (64-years-old) may have contributed to the development of the events. No information regarding patient's medical history and co-suspect and concomitant medication were provided. Based on available information causality between suspect product and event hot flush is assessed as possible and for event arrythmia as not related. The case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Product dose omission issue
Clinical narrative: Schedule for dose 2 of Rabavert today, but he missed Day 7. Today is Day 18; Case reference number US-BN-2021-002197  is a spontaneous case report initially received from a nurse via Agency (reference number: USBAV21-0419) on 18-Aug-2021, and concerns an adult male patient (in his 30s).  The patient's medical history and concomitant medication details were not provided.  On 30-Jul-2021, the patient received the first dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at dose of 1 milliliter (mL), administered intramuscularly, for pre-exposure prophylaxis for international travel.  It was reported that the patient was on the schedule for the second dose, on day 7, but missed the second dose (explicitly coded as 'Product dose omission'), and had not received it yet as of day 18, which is the time of this report.  At the time of this report, it was unknown whether the patient developed any adverse event nor if the patient received the second dose yet.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed for RabAvert per convention. Reportedly, the patient missed the scheduled second dose on day 7 after first vaccination for pre-exposure prophylaxis, which is consider as product dose omission issue. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.; Sender's Comments: Product dose omission issue is listed for RabAvert per convention. Reportedly, the patient missed the scheduled second dose on day 7 after first vaccination for pre-exposure prophylaxis, which is consider as product dose omission issue. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Schedule for dose 2 of Rabavert today, but she missed Day 7. Today is Day 18; Case reference number US-BN-2021-002198 is a spontaneous case report initially received from a nurse via Communications (reference number USBAV21-0420) on 18-Aug-2021, and concerns a female patient in her 30's.  The patient's medical history and concomitant medication details were not provided.  On 30-Jul-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at a dose of 1.0 mL, administered intramuscularly, for pre-exposure prophylaxis due to international travel.    It was reported that the patient was on the schedule for the second dose, on day 7, but missed the second dose (explicitly coded as 'Product dose omission'), and had not received it yet as of day 18, which is the time of this report.  At the time of this report, it was unknown whether the patient received the second dose nor if the patient experienced any adverse event.  The reporter assessed the event as non-serious.   No further information was provided.; Reporter's Comments: Product dose omission issue is listed for RabAvert per convention. Reportedly, the patient missed the scheduled second dose on day 7 after first vaccination for pre-exposure prophylaxis, which is consider as product dose omission issue. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.; Sender's Comments: Product dose omission issue is listed for RabAvert per convention. Reportedly, the patient missed the scheduled second dose on day 7 after first vaccination for pre-exposure prophylaxis, which is consider as product dose omission issue. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Hives; Case reference number US-BN-2021-002216 is a spontaneous case report initially received from a physician via Agency (reference number USBAV21-0435) on 25-Aug-2021, and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date in May-2020, the patient was vaccinated with RabAvert (inactivated rabies virus vaccine; batch number was not provided), at unknown dose or route of administration, for unknown indication.    On unspecified date, an unknown amount of time since receiving the vaccine, (reported as "after the vaccine"), the patient experienced hives.   The outcome of the event hives was unknown.  The reporter did not provide seriousness and causality assessment for the event.  The reporter did not give consent for follow-up.  No further information was provided.; Reporter's Comments: Urticaria is listed for RabAvert per Agency. Reportedly, the patient experienced the mentioned events after (time interval not specified) vaccination with suspect vaccine, for unknown indication. At the time of the report, the outcome of the event is unknown. No information regarding patient's medical history and co-suspect and concomitant medication were provided. Based on available information causality between suspect vaccine and event is assessed as possibly related. The case is considered as non-serious.; Sender's Comments: Urticaria is listed for RabAvert per Agency. Reportedly, the patient experienced the mentioned events after (time interval not specified) vaccination with suspect vaccine, for unknown indication. At the time of the report, the outcome of the event is unknown. No information regarding patient's medical history and co-suspect and concomitant medication were provided. Based on available information causality between suspect vaccine and event is assessed as possibly related. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First dose administered in February, the patient said no one told her to get another one in 7 days; second dose received in August; Case reference number US-BN-2021-002224 is a spontaneous case report initially received from a nurse via Agency (reference number: USBAV21-0440) on 27-Aug-2021 and concerns an adult female patient (probably in her 30s).  The patient's medical history and concomitant medication details were not provided.  On 18-Feb-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) at an unknown dose, intramuscularly, for pre-exposure immunisation.  On 27-Aug-2021, six months and nine days after receiving the first dose, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine, batch number: ARBA851B) at a dose reported as one shot/vaccine, administered intramuscularly, for pre-exposure immunisation.  The reporter stated that the patient claimed that she didn't know that the second dose of RabAvert had to be given seven days after the first dose (explicitly coded as Inappropriate schedule of product administration').  The reporter asked if the patient should start over the series.  It was not reported if the patient experienced any adverse events.  The reporter assessed the event as non-serious and not-related to the vaccine.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient received second dose of the suspect product six months and nine days after the first dose because patient did not know that second dose should be administered seven days after first dose, which is considered as inappropriate schedule of product administration. No associated adverse events were reported. No information regrading medical history and concomitant medication were provided. Inappropriate schedule of product administration is not related to suspect product but to human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient received second dose of the suspect product six months and nine days after the first dose because patient did not know that second dose should be administered seven days after first dose, which is considered as inappropriate schedule of product administration. No associated adverse events were reported. No information regrading medical history and concomitant medication were provided. Inappropriate schedule of product administration is not related to suspect product but to human action. The case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: They got the day 0 dose on 24AUG2021 and their 2nd dose they got on 01SEP2021; Case reference number BN-2021-002242 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV21-0454) on 02-Sep-2021 and concerns a 21-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 24-Aug-2021, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine, administered intramuscularly, for post-exposure immunisation.   On 01-Sep-2021, nine days after receiving the first dose ('Inappropriate schedule of vaccine administered'), the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number: ARBA801A), at a dose reported as one vaccine, administered intramuscularly, for post-exposure immunization.  It was not reported if the patient experienced any adverse event due to RabAvert.  The reporter assessed the event as not related to vaccine.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the second dose of RabAvert, for post-exposure immunisation, nine days after the first dose of RabAvert was administrated, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. The case is considered non serious.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the second dose of RabAvert, for post-exposure immunisation, nine days after the first dose of RabAvert was administrated, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. The case is considered non serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A patient had an exposure and received day 7 dose on day 5; Case reference number US-BN-2021-002264 is a spontaneous case report initially received from a pharmacist via regulatory authority (reference number: USBAV21-0465) on 09-Sep-2021 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 04-Sep-2021, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided; Expiry date: Jan-2024), at a dose reported as one vaccine per dose, administered intramuscularly, and for post-exposure immunisation.   On 07-Sep-2021, the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided; Expiry date: Jan-2024), at a dose reported as one vaccine per dose, administered intramuscularly, and for post-exposure immunisation.   On 09-Sep-2021, the patient was vaccinated with the third dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided; Expiry date: Jan-2024), at a dose reported as one vaccine per dose, administered intramuscularly, and for post-exposure immunisation.   The reporter stated that the patient had an exposure and requested to get the day seven dose on day five. The reporter confirmed that the patient was vaccinated on day five (explicitly coded as Inappropriate schedule of vaccine administered').  It was not reported if the patient experienced any adverse event due to RabAvert.  The reporter assessed the event as non-serious and not related.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert for post-exposure immunisation, on day five, instead of day seven, which is considered inappropriate schedule of product administration. It was not reported if the patient experienced any associated adverse event. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert for post-exposure immunisation, on day five, instead of day seven, which is considered inappropriate schedule of product administration. It was not reported if the patient experienced any associated adverse event. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Third dose was given on day 0, 7 and 14; Case reference number US-BN-2021-002269 is a spontaneous case report initially received from a health professional via Agency (reference number: USBAV21-0467) on 10-Sep-2021 and concerns a male patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine per dose, via unknown route or site of administration and for pre-exposure immunisation.   On an unspecified date, also reported as on a day seven, the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine per dose, via unknown route or site of administration, for pre-exposure immunisation.   On an unspecified date, also reported as on a day 14, the patient was vaccinated with the third dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine per dose, via unknown route or site of administration, for pre-exposure immunisation. The reporter stated that it was an accelerated dosing (explicitly codes as Inappropriate schedule of vaccine administered').  The reporter asked if the patient was going to get an adequate response duo to changed vaccination schedule.  It was not reported if the patient experienced any adverse event due to RabAvert.  The reporter assessed the event as non-serious and not related to RabAvert vaccine.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert, for pre-exposure immunisation, on Day 14, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the third dose of RabAvert, for pre-exposure immunisation, on Day 14, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. This case is considered non-serious.
Sex: F
Vaccine: RAB
Symptoms: Nervousness
Clinical narrative: Nervous; Case reference number US-BN-2021-002271 is a spontaneous case report initially received from a consumer via regulatory authority (reference number: USBAV21-0462) on 08-Sep-2021 and concerns a female patient of an unspecified age.   The patients' medical history and concomitant medication details were not provided.  On an unspecified date, something flew into a patient at night, and in case of it being a bat, the patient started the RabAvert vaccine series.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided) at an unknown dose, route or site of administration, for a possible bat exposure.  On an unspecified date, the patient experienced nervousness.  The reporter stated that, except for nervousness, no other side effects occurred.  The reporter asked about incidence of neuroparalytic side effects.  At the time of this report, outcome of the event nervousness was unknown.  The reporter did not provide seriousness or causality assessment.  No further information was provided.; Reporter's Comments: Nervousness is unlisted for Rabipur according to the Prescriber Information. Reportedly, on an unspecified date, the patient was vaccinated with the first dose of RabAvert for a possible bat exposure. On an unspecified date, the patient experienced nervousness. Vaccination date and the date when the event occurred were unknown; therefore, chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. Due to lack of information and missing evidence for temporal causal relationship between the suspect product and the reported event, and since contributory role of the suspect product cannot be excluded with certainty, the causality for this event is assessed as possibly related. This case is considered non-serious.; Sender's Comments: Nervousness is unlisted for Rabipur according to the Prescriber Information. Reportedly, on an unspecified date, the patient was vaccinated with the first dose of RabAvert for a possible bat exposure. On an unspecified date, the patient experienced nervousness. Vaccination date and the date when the event occurred were unknown; therefore, chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. Due to lack of information and missing evidence for temporal causal relationship between the suspect product and the reported event, and since contributory role of the suspect product cannot be excluded with certainty, the causality for this event is assessed as possibly related. This case is considered non-serious.
Sex: F
Vaccine: RAB
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed itchy rash along arm, bra line, between the legs, torso; Developed itchy rash along arm, bra line, between the legs, torso; Case reference number US-BN-2021-002300, initially downloaded on 27-Sep-2021, is a spontaneous case received from a consumer via health authority (Worldwide Unique Identifier 1467228-1) and concerns a 20-year-old female patient.  The patient had no current illnesses, no medical history and no known allergies.  The patient did not use any medication at the time of vaccination.   On unspecified dates, the patient was vaccinated with the first and with the second dose of RabaVert (inactivated rabies virus vaccine; batch number was not provided) at unknown dose or route of administration, for unknown indication.   On 07-Jul-2021, the patient received the third dose of RabaVert (inactivated rabies virus vaccine; batch number was not provided) at unknown dose, administered intramuscularly, for unknown indication.   On the same day, the patient developed itchy rash along arm, bra line, between the legs and torso. The patient was seen by a physician, who prescribed steroid shot and cortisone cream as treatment.  On an unspecified date, reported also as by Saturday, the steroid shot and cortisone cream cleared everything up.  At the time of this report, the patient had recovered from the events.   The reporter assessed the events as non-serious. The causality assessment was not provided.  No further information was provided.; Reporter's Comments: Rash and rash pruritic are listed for RabAvert according to the Prescriber Information. The patient developed rash and rash pruritic on the same day the patient received the third dose of RabaVert. Due to plausible temporal relationship and known vaccine safety profile, the causality for the events is assessed as possibly related to the suspect product. This case is considered non-serious.; Sender's Comments: Rash and rash pruritic are listed for RabAvert according to the Prescriber Information. The patient developed rash and rash pruritic on the same day the patient received the third dose of RabaVert. Due to plausible temporal relationship and known vaccine safety profile, the causality for the events is assessed as possibly related to the suspect product. This case is considered non-serious.
Sex: F
Vaccine: RAB, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The vaccine was given in gluteal muscle; Case reference number US-BN-2021-002338 is a spontaneous case report initially received from a health care professional via regulatory authority (reference ID: USBAV21-0524) on 12-Oct-2021, and concerns a 35 years old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported also as on initial visit, the patient was vaccinated with immune globulin (batch number: unknown), at an unknown dose or route of administration, for an unknown indication.  On 06-Oct-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: ARBA911B), at a dose of 1 ml, via unknown route of administration, for post-exposure prophylaxis.  On 09-Oct-2021, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine; batch number: ARBA911B), at dose of 1 ml, via intragluteal route of administration, for post-exposure prophylaxis (explicitly coded as  'Vaccine administered at inappropriate site').  At the time of this report, it was not known whether the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: The 35-year-old female patient was vaccinated with the first dose of RabAvert for post-exposure prophylaxis. As reported, the patient was vaccinated with the second dose of RabAvert via intragluteal route of administration, which is considered product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. Product administered at inappropriate site is considered listed per convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human action. This case is considered non-serious.; Sender's Comments: The 35-year-old female patient was vaccinated with the first dose of RabAvert for post-exposure prophylaxis. As reported, the patient was vaccinated with the second dose of RabAvert via intragluteal route of administration, which is considered product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. Product administered at inappropriate site is considered listed per convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human action. This case is considered non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: The patient came on her Day 16 to get second vaccine; The patient missed her Day 7 dosage; Case reference number US-BN-2021-002379 is a spontaneous case report initially received from other health professional via regulatory authority (reference ID: USBAV21-0547) on 28-Oct-2021 and concerns a 23-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 12-Oct-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: ARBA851C), at a dose reported as 'standard', administered intramuscularly, for pre-exposure.   On an unspecified date in Oct-2021, the patient missed her day seven dose (explicitly coded as 'Missed dose'), and the patient came on day 16 to get second vaccine (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown whether the patient experienced any adverse event.  The reporter assessed the case as non-serious and not related to RabAvert.  No further information was provided.; Reporter's Comments: The 23-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, on an unspecified date the patient missed her day seven dose, which is considered product dose omission issue, and the patient came on day 16 to get second vaccine, which is considered inappropriate schedule of product administration. No associated adverse events were reported with the reported medication errors. The events of product dose omission issue and inappropriate schedule of product administration are considered listed per convention. The patient's medical history and concomitant medication details were not provided. The causality for the events of product dose omission issue and inappropriate schedule of product administration is assessed as not related to the suspect vaccine, but to a human action. This case is considered non-serious.; Sender's Comments: The 23-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, on an unspecified date the patient missed her day seven dose, which is considered product dose omission issue, and the patient came on day 16 to get second vaccine, which is considered inappropriate schedule of product administration. No associated adverse events were reported with the reported medication errors. The events of product dose omission issue and inappropriate schedule of product administration are considered listed per convention. The patient's medical history and concomitant medication details were not provided. The causality for the events of product dose omission issue and inappropriate schedule of product administration is assessed as not related to the suspect vaccine, but to a human action. This case is considered non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3 days late for their 2nd dose for post exposure; Case reference number US-BN-2021-002397 is a spontaneous case report initially received from other health care professional via Agency (reference number USBAV21-0556) on 02-Nov-2021 and concerns a male patient of unspecified date.  The patient's medical history and concomitant medication details were not provided.  On 27-Oct-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided), at a dose described as one vaccine per dose, adminsitered intramuscularly, for post exposure.  On an unspecified date in 2021, the patient was coming for the second dose of RabAvert (inactivated rabies virus vaccine; batch number was not provided) and was about three days late for the dose (explicitly coded as 'Inappropriate schedule of vaccine administered').    At the time of this report, it was unknown whether the patient received the second dose or if the patient experienced any adverse event.  Significant correction (amendment) identified on 12-Nov-2021, for the information received on 02-Nov-2021 included removal of the event 'Product dose omission issue'.  No further information was provided.; Reporter's Comments: The male patient was vaccinated with the first dose of RabAvert for post exposure. On an unspecified date, reported as about three days late for the second dose, the patient was coming for the second dose of RabAvert, which is considered as inappropriate schedule of product administration. It was unknown whether the patient received the second dose. No associated adverse events have been reported with the reported medication error. The event of inappropriate schedule of product administration is considered listed per convention. The patient's medical history and concomitant medication details were not provided. The event of inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered non-serious.; Sender's Comments: The male patient was vaccinated with the first dose of RabAvert for post exposure. On an unspecified date, reported as about three days late for the second dose, the patient was coming for the second dose of RabAvert, which is considered as inappropriate schedule of product administration. It was unknown whether the patient received the second dose. No associated adverse events have been reported with the reported medication error. The event of inappropriate schedule of product administration is considered listed per convention. The patient's medical history and concomitant medication details were not provided. The event of inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human action. This case is considered non-serious.