chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB, RAB
Symptoms: Formication, Pain in extremity
Clinical narrative: Lower leg pain with crawling sensations and sore feet; Lower leg pain with crawling sensations and sore feet; Case reference number US-BN-2022-000915, initially downloaded from VAERS on 11-Apr-2022, is a spontaneous case received from a health professional via Health authority (VAERS ID: 2206652-1) and concerns a 62-years-old female patient.  The patient's concurrent condition included hypothyroidism and latex allergy.  The patient's concomitant medication included Losartin (losartan potassium), Prozac (fluoxetine hydrochloride), Synthroid (levothyroxine sodium) and multivitamin (vitamins nos).  On 25-Feb-2022, the patient was vaccinated with a dose of RabAvert (inactivated rabies virus vaccine; batch number: not reported) at an unknown dose, intramuscularly, in the left arm, for unknown indication.  On 04-Mar-2022, seven days after the RabAvert, the patient experienced lower leg pain with crawling sensations and sore feet.  At the time of initial report, the patient had not 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: A 62-year-old female patient experienced non-serious events of lower leg pain with crawling sensations and sore feet on the day 7 after the vaccination with a dose of RabAvert for unknown indication. The events of formication and pain in extremity are not listed for RabAvert according to the PI and Datasheet. The patient's concurrent condition included hypothyroidism and latex allergy and concomitant medication included Losartin, Prozac, Synthroid and multivitamin and the patient had no concomitant vaccination. Reportedly, the patient had not recovered from the events. Since the evaluation did not find enough evidence to completely exclude contributory role of the suspect vaccine to the development of the events, formication and pain in extremity have been conservatively considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A 62-year-old female patient experienced non-serious events of lower leg pain with crawling sensations and sore feet on the day 7 after the vaccination with a dose of RabAvert for unknown indication. The events of formication and pain in extremity are not listed for RabAvert according to the PI and Datasheet. The patient's concurrent condition included hypothyroidism and latex allergy and concomitant medication included Losartin, Prozac, Synthroid and multivitamin and the patient had no concomitant vaccination. Reportedly, the patient had not recovered from the events. Since the evaluation did not find enough evidence to completely exclude contributory role of the suspect vaccine to the development of the events, formication and pain in extremity have been conservatively considered as related to RabAvert. This case is considered as non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 2320197) on 02-JUL-2022, concerned a 39 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total administered in left arm on 12-SEP-2021 for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 38 years old. No concomitant medications were reported. On 19-OCT-2021, the patient experienced deep vein thrombosis, and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unsure the patient discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged).  Version created to amend previously reported information on 02-JUL-2022. Upon review following information was amended: Core labeling of event Deep vein thrombosis updated from unlabeled to labeled, vaccination site (left arm) added in narrative.; Sender's Comments: V1: Upon review following information was amended, Core labeling of event Deep vein thrombosis updated from unlabeled to labeled, vaccination site (left arm) added in narrative.  20220704725-covid-19 vaccine ad26.cov2-Deep Vein Thrombosis. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dark circles under eyes, Discomfort, Henoch-Schonlein purpura, Inflammation
Clinical narrative: Diagnosis by Doctor - HSP vasculitis pityriasis.  Two days after covid vaccination (second dose) child develops fever of 101 for one night. Child is lethargic and uncomfortable. After fever child develops small spot red rash on feet and hands and inflammation. Rash is extremely itchy and painful - child screams in pain for three nights. After 2-3 days rash has spread other body areas. Rash is largest on lymph nodes in armpits, groin and behind knees. Swelling and darkness in eyelids and under eyes.  Child continues to lose energy and the rash persists for 5-7 weeks at it's most affected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pityriasis, Pyrexia, Rash, Rash erythematous
Clinical narrative: Diagnosis by Doctor - HSP vasculitis pityriasis.  Two days after covid vaccination (second dose) child develops fever of 101 for one night. Child is lethargic and uncomfortable. After fever child develops small spot red rash on feet and hands and inflammation. Rash is extremely itchy and painful - child screams in pain for three nights. After 2-3 days rash has spread other body areas. Rash is largest on lymph nodes in armpits, groin and behind knees. Swelling and darkness in eyelids and under eyes.  Child continues to lose energy and the rash persists for 5-7 weeks at it's most affected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Screaming, Skin discolouration, Swelling of eyelid, Urine analysis
Clinical narrative: Diagnosis by Doctor - HSP vasculitis pityriasis.  Two days after covid vaccination (second dose) child develops fever of 101 for one night. Child is lethargic and uncomfortable. After fever child develops small spot red rash on feet and hands and inflammation. Rash is extremely itchy and painful - child screams in pain for three nights. After 2-3 days rash has spread other body areas. Rash is largest on lymph nodes in armpits, groin and behind knees. Swelling and darkness in eyelids and under eyes.  Child continues to lose energy and the rash persists for 5-7 weeks at it's most affected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: Diagnosis by Doctor - HSP vasculitis pityriasis.  Two days after covid vaccination (second dose) child develops fever of 101 for one night. Child is lethargic and uncomfortable. After fever child develops small spot red rash on feet and hands and inflammation. Rash is extremely itchy and painful - child screams in pain for three nights. After 2-3 days rash has spread other body areas. Rash is largest on lymph nodes in armpits, groin and behind knees. Swelling and darkness in eyelids and under eyes.  Child continues to lose energy and the rash persists for 5-7 weeks at it's most affected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Axillary Lymphadenopathy
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Soreness at injection site following administration of PPSV23 onset same day, improved next day. PPSV23 dose was given per age 65yo, was later discovered pt had already received PPSV23 on 1/6/22.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Tic
Clinical narrative: sporadic muscle ticks/spasms that move around my body, a new location every day, the muscle spasms last for a minute or two.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 017C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy, Chronic kidney disease and COPD. Concomitant products included TRAZODONE for Insomnia, BUPRENORPHINE, SALBUTAMOL SULFATE (ALBUTEROL SULFATE), LISINOPRIL, GABAPENTIN and METHOCARBAMOL for an unknown indication.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Sep-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on (14-Jul-2021), second dose received on (01-Sep-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2022-600713 (Patient Link).
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse prescriber is reporting administration of an expired PNEUMOVAX 23; This non-valid spontaneous report was received from a nurse prescriber and refers to an unknown patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2022, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #T028093 and expiration date: 24-APR-2022, (strength, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). Caller confirmed vaccine was stored within the recommended storage range until administration. No additional adverse event reported (no adverse event).  This is non-valid report due to lack of the patient's identifiers.  Follow-up information has been received from a nurse on 05-JUL-2022, refers to 54-year-old female patient. Details regarding vaccination was updated. Usage of vaccine was reported as single use of vaccine/vaccine device. Operator of vaccine/vaccine device was reported as  healthcare professional.  The initial report was missing the patient's identifier. Upon follow-up information received on 05-JUL-2022, the case contained all elements to make the case valid
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC.; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 13-APR-2022, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# U022819, expiration date 14-JAN-2023; formulation, strength, dose, frequency and route were not provided) for prophylaxis after a non-supported temperature excursion (product storage error). The storage temperature of the vaccine was 70 degrees Fahrenheit for a time frame of 96 hours. There was no previous temperature excursions. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event was reported; Medical Assistant calling in to report a temperature excursion of GARDASIL 9. Medical Assistant reported that the GARDASIL 9 was administered to a patient on 06/09/2022..; This spontaneous report was received from a medical assistant, concerning a 18-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 09-JUN-2022, the patient was vaccianted with an improperly stored rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strenght, dose, frequency, route of administration, lot number and expiration date were not provided). No adverse event was reported.   The temperature excursion was not provided nor if there was a previous temperature excursion.
Age: 11.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE information provided.; she may have used the MENACTRA as the diluent when administering the PROQUAD; This spontaneous report was received from a registered nurse, referring to an 11-year-old male patient.  The patient's medical history and concurrent conditions were not provided. The concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA).  On 08-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) 0.5 mL subcutaneous (SC) (valid lot #U031561, expiration date: 06-APR-2023) as prophylaxis (also reported as Measles, Mumps and Rubella (MMR) and varicella vaccine); however medical assistant was unsure if she accidentally used the a/c/y/w conj (dip tox) (MENACTRA) vaccine as diluent, instead of the sterile diluent (strength, dose, lot #, expiry date, anatomical location were route of administration were not provided) (Product preparation error). Paracetamol (TYLENOL) was given prophylactically round the clock for 24 hours. On 09-JUN-2022, the patient had an appointment with the healthcare professional, and it was stated that the subject was fine, with no reactions, fever, or nothing (also reported as no issues). No additional adverse events were reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Accidental overdose, Extra dose administered, No adverse event
Clinical narrative: No symptomatic AEs reported.; PROQUAD was inadvertently co-administered with MMR-II.; This spontaneous report was received from a medical assistant referring to a patient whom gender, age, race and age group were unknown. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 14-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) plus an sterile diluent (MRK), subcutaneous injection, (lot #U024509, expiration date: 02-FEB-2023) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection ,(lot #T025930, expiration date: 30-JUL-2022), (dose, frequency, strength, anatomical location and route of administration were not provided for any of the vaccines administered) both given as prophylaxis.  On the same day, the patient was inadvertently co-administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (accidental overdose). no symptomatic AEs reported. (no adverse event).
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; the patient received the doses outside of the recommended administration schedule in the prescribing information; the patient was vaccinated with the third dose on 21-JUN-2022; the patient received the doses outside of the recommended administration schedule in the prescribing information; On 17-AUG-2021, the patient was vaccinated with the second dose; This spontaneous report has been received from a registered nurse (reported as a health care professional (HCP)) and referred to a 14-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 12-NOV-2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot#, and expiration date were not reported) for prophylaxis. On 17-AUG-2021, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot#, and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). On 21-JUN-2022, because the HCP was originally unaware that the patient had received doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) previously, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml once (1 dose) at the right upper arm, syringe formulation (valid lot# U008897 with expiration date 16-MAY-2023; strength, and route were not reported) for prophylaxis (inappropriate schedule of product administration). The patient received the doses outside of the recommended administration schedule in the prescribing information (for the patient who started the vaccine before age 15, only 2 doses were needed, however, the patient received 3 doses, and for age 9-14 years old, the 3 doses should be indicated as 2, 4 months intervals). No additional adverse effects were reported (no adverse event). There was no prescription drug treatment for the experience required.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; administered dose of improperly stored PROQUAD; This spontaneous report was received from an office manager and refers to a 5-year-old male patient. His concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 14-JUN-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, lot #U017140, expiration date: 28-NOV-2022 (exact dose, vaccination schedule, and route of administration were not provided), administered in right thigh for prophylaxis (Product storage error). It was reported the temperature in the freezer was higher than the recommended temperature for a total of 32 minutes. The reporter stated the freezer corrected itself to the proper range, the Company was contacted. No additional adverse event was reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: A HCP called and reported an AE. The HCP stated that a husband and wife received their first doses of VAQTA on 24 FEB 2020, but then never received their booster dose 6 to 18 months later.; No additional adverse event reported; This spontaneous report was received from the pharmacist and refers to currently 72-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-FEB-2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), but then, never received booster dose (6 to 18 months later) (booster dose missed). No other adverse event was reported   This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008877:
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The HCP stated that a husband and wife received their first doses of VAQTA on 24 FEB 2020, but then never received their booster dose 6 to 18 months later.; No other additional AEs.; This spontaneous report was received from the pharmacist and refers to currently 72-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-FEB-2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), but then, never received booster dose (6 to 18 months later) (booster dose missed). No other adverse event was reported   This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008817:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse side effects reported; HCP reporting GARDASIL 9 vaccine was accidentally administered to a 12 month old; This spontaneous report was received from the nurse and refers to a 12-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-JUN-2022, the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose number, strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). There was no adverse side effects reported so far.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reported MMR II administered after temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2022, the patient was vaccinated with an improper storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II) 0.5 milliliter, administered subcutaneously (SQ), lot # T033814, expiration date 05-OCT-2022, as prophylaxis (anatomical location was not provided) (Product storage error). Lot # T033814 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human Albumin (rHA) (M-M-R II), expiration date: 05-OCT-2022. No adverse events were reported.  The improper storage lot # underwent a temperature excursion of 46.5 degrees Fahrenheit (F) for about 24 hours and 38 minutes without previous excursions. No adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: The patient did not have any symptoms or adverse effects of receiving only partial dose; A patient moved while receiving their dose of VAQTA and received only about half the dose; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 01-JUL-2022, the patient was vaccinated with the second dose of Hepatitis A vaccine, inactivated (VAQTA) as prophylaxis (exact dose, route of administration, and anatomical site of vaccination were not provided; lot number W007375 has been verified to be valid, expiration date reported and established as 16-JAN-2023). It was reported that the patient moved while receiving the vaccine and received only about half the dose (incorrect dose administered).  The patient did not have any symptoms or adverse effects due to receiving only a partial dose (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired vaccine was administered to a patient; This spontaneous report has been received from a nurse referring to a patient of unspecified age and gender. Information regarding medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was not provided.   On 05-JUL-2022 the patient was administered an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, and anatomical site of vaccination were not reported; lot number T008151 has been verified to be valid, expiration date reported and established as 21-JUN-2022) (expired product administered).  It was reported that the vaccine was stored according to prescribing information through the date of administration. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The patient did not experience any other AE; The caller said the patient received a dose after a temperature excursion occurred.; This spontaneous report was received from medical assistant, referring to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2022, the patient was vaccinated with one dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1858935 has been verified to be a valid lot, expiration date: 25-MAR-2023), administered orally for prophylaxis (strength was not provided).   Additionally, it was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent to a temperature excursion of 9.8 degree Celsius (°C) for 47 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: M
Vaccine: RAB, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Rabavert received on 06Apr2021 and 13Apr2021, Imovax received on 11-May-2021; Case reference number US-BN-2021-001691, spontaneous case report initially received on 12-May-2021 from a physician via regulatory authority (reference number: USBAV21-0211) and concerns a 10-month-old male patient.  The patient's medical history and concomitant medication were not reported.  On 06-Apr-2021, the patient was vaccinated with the first dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not provided) *at a dose reported as a full dose*, administered intramuscularly, for a bat exposure as indication.  On 13-Apr-2021, the patient received the second dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not provided) *at a dose reported as a full dose*, administered intramuscularly, for a bat exposure as indication.   On 11-May-2021, on day 35, the patient was vaccinated with Imovax (rabies vaccine; batch number: not reported) at a dose reported as a full dose, via unknown route of administration, for an unknown indication (explicitly coded as 'Inappropriate schedule of vaccine administered').   At the time of initial reporting, it was not known whether the patient experienced any adverse event.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).   Follow up information was received from a physician on 28-Jun-2021: New information included one additional reporter and a confirmation that the patient was vaccinated with a full dose, rather than half a dose as previously reported (''underdose'' removed as an event).; Reporter's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, 10-months old patient received first and second dose of RabAvert at full dose. On day 35 the patient was vaccinated with Imovax and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered are not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, 10-months old patient received first and second dose of RabAvert at full dose. On day 35 the patient was vaccinated with Imovax and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered are not related to the suspect product but to a human action. The case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Injection site pain, Vaccination error
Clinical narrative: It felt more like a normal injection feels with soreness; There seems to have been some fumbling when they were giving it; Case reference number US-BN-2021-001731 is a spontaneous case report initially received from a consumer via regulatory authority (USBAV21-0256) on 03-Jun-2021, and concerns a 51 years-old male patient.  The patient's medical history was not provided.  The patient's concomitant medication details included HRIG (as reported).  On 26-May-2021, the patient received RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, administered intramuscularly after being bitten by a bat.  On 29-May-2021, the patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, administered intramuscularly.  On 02-Jun-2021, the patient received third dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, administered intramuscularly. The patient reported that a third shot really felt like a normal injection and he felt soreness.   The reporter assessed the events as non-serious. The reporter did not provide causality and seriousness assessment for the event of soreness.  No further information was provided.; Reporter's Comments: Pain is listed for Rabipur according to the Datasheet. Vaccination error is listed by convention. Reportedly, the patient received RabaVert after a bat bite. Three days later, the patient received a 2nd dose of RabaVert and four days after the 2nd dose, the patient has received a 3rd dose. After the 3th dose, the patient experienced normal injection feels with soreness and reported there seems to have been some fumbling when they were giving it, which is considered vaccination error. Due to suggestive temporal relationship, event of soreness is possibly related to RabaVert. Vaccination error is not  related to RabaVert.; Sender's Comments: Pain is listed for Rabipur according to the Datasheet. Vaccination error is listed by convention. Reportedly, the patient received RabaVert after a bat bite. Three days later, the patient received a 2nd dose of RabaVert and four days after the 2nd dose, the patient has received a 3rd dose. After the 3th dose, the patient experienced normal injection feels with soreness and reported there seems to have been some fumbling when they were giving it, which is considered vaccination error. Due to suggestive temporal relationship, event of soreness is possibly related to RabaVert. Vaccination error is not related to RabaVert.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: She is due for shot day 7 today. We forgot to order it; Case reference number US-BN-2021-002005 is a spontaneous case initially received from a pharmacist via regulatory authority (reference number: USBAV21-0272) on 11-Jun-2021 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication were not provided.  On 01-Jun-2011, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine, batch number not provided) at unknown dose or route of administration, for post exposure.  On 04-Jun-2011, after three days, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine, batch number not provided) at unknown dose or route of administration, for post exposure.  On 11-Jun-2021, the third dose of RabAvert was scheduled, but the provider forgot to placed the order for the third dose to be delivered on time (explicitly coded as 'Missed dose').  At the time of initial reporting, it was unknown if the patient experienced any adverse event.  Additional information received from regulatory authority on 11-Jun-2021 included new information: Updated reporter's phone number.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert and the third dose was scheduled, but the order was forgotten to be placed on time. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert and the third dose was scheduled, but the order was forgotten to be placed on time. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.
Sex: F
Vaccine: RAB
Symptoms: Drug ineffective, No adverse event, Product administered at inappropriate site
Clinical narrative: If the vaccine doesn't work right; Gave the Rabavert in my butt; Case reference number US-BN-2021-002029 is a spontaneous case report initially received from a consumer via regulatory authority (reference number USBAV21-0298) on 23-Jun-2021, and concerns a 27 year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medications included HRIG (immunoglobulin human anti-rabies, given in both arms).  On 21-Jun-2021, the patient went into the emergency room (ER) and received RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at a dose of 1 mL, administered intramuscularly, in the gluteal region (Product administered at inappropriate site), for post-exposure prophylaxis, stating that she had a small break in the skin and that it was not a bite. The patient worried if the vaccine will not work right (Drug ineffective) and considered the event as serious.   At the time of this report, it was not known whether the patient experienced any adverse events due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: Drug ineffective and product administered at inappropriate site are listed by convention. Reportedly, the patient received RabaVert, administered intramuscularly, in the gluteal region, for post-exposure prophylaxis which is considered as product administered at inappropriate site. The patient worried if the vaccine will not work right which is considered as drug ineffective. No adverse events were reported. Product administration error is not related to RabaVert, but to human action. In this case, drug ineffective is not related to RabaVert, either.; Sender's Comments: Drug ineffective and product administered at inappropriate site are listed by convention. Reportedly, the patient received RabaVert, administered intramuscularly, in the gluteal region, for post-exposure prophylaxis which is considered as product administered at inappropriate site. The patient worried if the vaccine will not work right which is considered as drug ineffective. No adverse events were reported. Product administration error is not related to RabaVert, but to human action. In this case, drug ineffective is not related to RabaVert, either.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Day 14 and the patient hasn't gotten their second shot; Case reference number US-BN-2021-002039 is a spontaneous case report initially received on 28-Jun-2021 from pharmacist via regulatory authority (reference number: EUBAV21-0309) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 14-Jun-2021, the patient was vaccinated with the first dose of RabAvert (Rabies Virus Inactivated, batch number: not provided) at dose reported as one vaccine, received intramuscularly and for pre-exposure.  On an unspecified date in 2021, through miscommunication, they were on day 14 and the patient had not received the second shot (explicitly coded as 'Inappropriate schedule of product administration').   At the time of initial reporting, it was unknown whether the patient experienced any adverse event.  The reporter assessed the case as non-serious and not related to the RabAvert.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, the patient had not received the second shot on day 14 through miscommunication and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration for RabAvert is listed by convention. Reportedly, the patient had not received the second shot on day 14 through miscommunication and that is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Received her HRIG and Rabavert in the same arm; Case reference number US-BN-2021-002081 is a spontaneous case report initially received on 08-Jul-2021 from pharmacist via Agency (reference number: USBAV21-0343) and concerns a female patient of unknown age.  The patient's medical history was not provided.   Concomitant medication included HRIG.  On 06-Jul-2021, the patient was vaccinated with the first dose of RabAvert (Rabies Virus Inactivated, batch number: not provided) intramuscularly at dose reported as standard dose, for post exposure bat bite. It was reported that the patient Received her HRIG and Rabavert in the same arm (explicitly coded to product administration error).  At the time of this report it was unknown if the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: Product administration error is listed for RabAvert by convention. Reportedly, the patient received on the same day and in the same arm first dose of RabAvert vaccine and HRIG vaccine, which is considered as product administration error. No information regarding medical history was provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Product administration error is listed for RabAvert by convention. Reportedly, the patient received on the same day and in the same arm first dose of RabAvert vaccine and HRIG vaccine, which is considered as product administration error. No information regarding medical history was provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient who got her vaccinations on Day 0 and Day 9; Case reference number US-BN-2021-002082 is a spontaneous case report initially received on 08-Jul-2021 from pharmacist via Agency (reference number: USBAV21-0339) and concerns 31-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 18-Jun-2021, the patient was vaccinated with first dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch number: not provided) at unknown dosage regimen, administered intramuscularly, for pre-exposure prophylaxis.   On 26-Jun-2021, nine days after receiving the first dose, the patient received a second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch number: not provided) at unknown dosage regimen, administered intramuscularly, for pre-exposure prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').   At the time of this report, it was unknown whether the patient developed any adverse event.  The reporter assessed the case as non-serious and not related to RabaVert.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed for RabAvert by convention. Reportedly, the patient received second dose of vaccine on day nine after first dose, which is considered as inappropriate schedule of product administration. No information regarding medical history and concomitant medication were provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed for RabAvert by convention. Reportedly, the patient received second dose of vaccine on day nine after first dose, which is considered as inappropriate schedule of product administration. No information regarding medical history and concomitant medication were provided. No adverse event was reported. Reported event is not related to the suspect product but to a human action. The case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Person got dose 1, Dose 2 is 4 days overdue; Case reference number US-BN-2021-002098 is a spontaneous case report initially received on 15-Jul-2021 from other health care professional via Agency (reference number: USBAV21-0361) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 08-Jul-2021, the patient was vaccinated with first dose of RabaVert (Inactivated Rabies Virus Vaccine, batch number: not provided) at unknown dose, administered intramuscularly, for post-exposure prophylaxis.   On an unspecified date in Jul-2021, the patient was supposed to receive a second dose, but it was four days overdue (explicitly coded as 'Inappropriate schedule of vaccine administered').  At the time of this report, it was unknown whether the patient developed any adverse event.  The reporter assessed the case as non-serious and not related to RabaVaert.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the 2nd dose of Rabavert that was four days overdue, which was considered inappropriate schedule of product administration. No adverse events were reported. Inappropriate schedule of product administration is not related to Rabvert, but due to human action.; Sender's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the 2nd dose of Rabavert with  four days overdue, which was considered inappropriate schedule of product administration. No adverse events were reported. Inappropriate schedule of product administration is not related to Rabvert, but due to human action.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: On July 2nd she got her 2nd vaccine (should have been given on June 30th);; Case reference number US-BN-2021-002109 is a spontaneous case report initially received on 20-Jul-2021 from a health care professional via Agency (reference number: USBAV21-0367) and concerns a 33-year-old female patient.  The patient's current medical conditions included bipolar disorder and schizophrenia. The patient was a smoker.   The patient's concomitant medications included HRIG (immunoglobulin human anti-rabies).  On 27-Jun-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 injection, administered intramuscularly, for post-exposure prophylaxis.  On 30-Jun-2021, the patient was supposed to receive the second dose, but the patient did not show up. On 02-Jul-2021, 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 injection, administered intramuscularly, for post-exposure prophylaxis (explicitly coded as 'Inappropriate schedule of vaccine administered').    The day 7 shot should have been on 4-Jul-2021, but since the patient was vaccinated with the second dose two days earlier, no vaccine was administered on that day.  At the time of this report, it was unknown whether the patient developed any adverse event.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient did not show up when second dose of vaccine was scheduled and received it two days after, what bis considered as inappropriate schedule of product administration. No adverse event was reported. Inappropriate schedule of product administration is not related to pharmacological properties of suspect product, but to human action. Case is considered as non-serious.; Sender's Comments: Inappropriate schedule of product administration is listed for RabAvert per convention. Reportedly, the patient did not show up when second dose of vaccine was scheduled and received it two days after, what bis considered as inappropriate schedule of product administration. No adverse event was reported. Inappropriate schedule of product administration is not related to pharmacological properties of suspect product, but to human action. Case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: Hot flush
Clinical narrative: Hot flashes; Case reference number US-BN-2021-002122 is a spontaneous case report initially received from a physician via Agency (reference number: USBAV21-0372) on 23-Jul-2021 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date in 2019, the patient was vaccinated with RabAvert (inactivated rabies virus; batch number: not provided), at unknown dose or route of administration and for unknown indication.   On an unspecified date, an unknown amount of time after the vaccination, the patient experienced hot flashes.  At the time of this report, the patient had not recovered from the event.  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 not listed for RabAvert per Agency Information. Reportedly, the patient experienced reported event after receiving suspect vaccine. The exact timeline was not reported. At the time of the report the patient did not recover yet. No information regarding concomitant and co-suspect medication and medical history were provided. Due to lack of information causality between suspect product and reported event cannot be excluded and is assessed as possibly related. The case is considered as non-serious.; Sender's Comments: Hot flush is not listed for RabAvert per Agency Information. Reportedly, the patient experienced reported event after receiving suspect vaccine. The exact timeline was not reported. At the time of the report the patient did not recover yet. No information regarding concomitant and co-suspect medication and medical history were provided. Due to lack of information causality between suspect product and reported event cannot be excluded and is assessed as possibly related. The case is considered as non-serious.