chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle strain, Painful respiration
Clinical narrative: Patient reported R arm was sore to provider on same day of administration (05/14/2024) later in the day when seen outside of clinic, near clinic site. Provider encouraged member to make appointment for follow-up evaluation.  Patient did not schedule appointment until 07/08/2024. Patient evaluated for "shoulder pain" on 07/08/2024 that he reported to provider is ongoing since vaccine administration to R deltoid on 05/14/2024.  Provider assessment revealed patient-endorsed pain at R bicep, R tricep, and R shoulder joint.  Patient denied pain at R deltoid where immunization was administered.  Provider prescribed muscle relaxant today to alleviate symptoms of suspected muscle strain.  Patient reported to provider, with this reporter as witness, that the pain was "new onset" since receiving the Shingrix vaccine on 05/14/2024.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Blindness, Blood test, Electromyogram, Magnetic resonance imaging, Nerve injury
Clinical narrative: Vision loss followed by severe nerve damage and gbs like symptoms
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Neuralgia, Neurological symptom
Clinical narrative: Vision loss followed by severe nerve damage and gbs like symptoms
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody positive, Autoimmune disorder, Brain fog, Cytogenetic analysis, Detoxification
Clinical narrative: PFIZER #1 3/24/2021 PFIZER #2 4/24/2021  MODERNA #3 12/26/2021 DEVELOPED VACCINE INDUCED SMALL FIBER NEUROPATHY, POST EXERTIONAL MALAISE, BRAIN FOG, HOSPITALIZED FOR TIA, REYNAUDS, DUPYTRENS, PEYRONIES, AND ANA POSITIVE. DIAGNOSED WITH COVID VACCINE AUTOIMMUNE SYNDROME AND VACCINE NEUROPATHY.  POOR RESPONSE TO GABAPENTIN ALONE.  STARTED ON HCQ 200 BID, COLCHICINE 0.6 MG QD, NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dupuytren's contracture, Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test
Clinical narrative: PFIZER #1 3/24/2021 PFIZER #2 4/24/2021  MODERNA #3 12/26/2021 DEVELOPED VACCINE INDUCED SMALL FIBER NEUROPATHY, POST EXERTIONAL MALAISE, BRAIN FOG, HOSPITALIZED FOR TIA, REYNAUDS, DUPYTRENS, PEYRONIES, AND ANA POSITIVE. DIAGNOSED WITH COVID VACCINE AUTOIMMUNE SYNDROME AND VACCINE NEUROPATHY.  POOR RESPONSE TO GABAPENTIN ALONE.  STARTED ON HCQ 200 BID, COLCHICINE 0.6 MG QD, NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Peyronie's disease, Raynaud's phenomenon, Small fibre neuropathy, Therapeutic response changed
Clinical narrative: PFIZER #1 3/24/2021 PFIZER #2 4/24/2021  MODERNA #3 12/26/2021 DEVELOPED VACCINE INDUCED SMALL FIBER NEUROPATHY, POST EXERTIONAL MALAISE, BRAIN FOG, HOSPITALIZED FOR TIA, REYNAUDS, DUPYTRENS, PEYRONIES, AND ANA POSITIVE. DIAGNOSED WITH COVID VACCINE AUTOIMMUNE SYNDROME AND VACCINE NEUROPATHY.  POOR RESPONSE TO GABAPENTIN ALONE.  STARTED ON HCQ 200 BID, COLCHICINE 0.6 MG QD, NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Transient ischaemic attack, Ultrasound scan
Clinical narrative: PFIZER #1 3/24/2021 PFIZER #2 4/24/2021  MODERNA #3 12/26/2021 DEVELOPED VACCINE INDUCED SMALL FIBER NEUROPATHY, POST EXERTIONAL MALAISE, BRAIN FOG, HOSPITALIZED FOR TIA, REYNAUDS, DUPYTRENS, PEYRONIES, AND ANA POSITIVE. DIAGNOSED WITH COVID VACCINE AUTOIMMUNE SYNDROME AND VACCINE NEUROPATHY.  POOR RESPONSE TO GABAPENTIN ALONE.  STARTED ON HCQ 200 BID, COLCHICINE 0.6 MG QD, NICOTINE PATCH AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Vomiting
Clinical narrative: Patient felt light-headedness, and nausea immediately after vaccine administration. Patient vomited shortly after. Gave patient an ice pack, drink, and a candy bar and had patient sit down until he felt better.
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9, MNQ, TDAP
Symptoms: Fatigue, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: potentially received 12 yo Moderna vaccine instead of the 11 yo vaccine.  per provider Explain the higher dose will also generate covid ab and protection. per doctor Recommend to bring child in for evaluation if pt continues to show fatigue.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Product administered at inappropriate site, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient's mother reported redness, swelling, and warm to the touch at vaccine site.  The vaccine was given more laterally and on the perimeter of the vastus lateralis muscle instead of anterolaterally. Upon communication with Dr. the head of the vaccine department of our floor he said he is confident the vaccines were given within the muscle and count as a valid dose.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received vaccine that was marked as expired on manufacture box
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Feeling cold, Full blood count, Gingival bleeding, Gingival swelling
Clinical narrative: high fevers 102.8, chills, headache, dizzines, sore thoat, mouth sores, un able to eat cuz of the sore in mouth,bleeding gums,
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Headache, Influenza virus test negative, Pyrexia, SARS-CoV-2 test positive, Stomatitis
Clinical narrative: high fevers 102.8, chills, headache, dizzines, sore thoat, mouth sores, un able to eat cuz of the sore in mouth,bleeding gums,
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Streptococcus test negative, Urine analysis
Clinical narrative: high fevers 102.8, chills, headache, dizzines, sore thoat, mouth sores, un able to eat cuz of the sore in mouth,bleeding gums,
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: was not symptomatic in any way; She did breast feed; This spontaneous report was received from physician and refers to a 29-year-old female patient.  The patient's medical history included chickenpox (not verified) and pregnancy. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-MAY-2024 at 05:07, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 milliliter, lot #X026790 was valid, expiration date 14-NOV-2025, administered subcutaneously in left arm) for prophylaxis. On 05-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (exact dose, lot #, expiration date route of administration and anatomical location were not provided) for prophylaxis. She did not develop vesicles and was not symptomatic in any way (No adverse event). She did breast feed (Maternal exposure during breast feeding).  Lot# has been requested and will be submitted if received.  This is one of two reports from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: female patient received the Gardasil vaccine between 2007 and 2009 and was diagnosed with HPV in 2019; This spontaneous report was received from an unspecified reporter via Company representative, concerning to a female patient of unspecified age.  Her medical history, concurrent conditions and concomitant therapies were not informed.  On unknown date between 2007 and 2009, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis.  On an unknown date in 2019, she was diagnosed with human papillomavirus (HPV) (papilloma viral infection), however, the exact strain was unknown. On an unspecified date, further testing (unspecified test) was performed showing that it was not strains 16 or 18.   As of unspecified date in 2024, the patient was still positive for HPV (not recovered) and had to undergo a loop electrosurgical excision procedure (LEEP) to remove abnormal cells.  The causal relationship between papilloma viral infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  Additional information was not expected.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX was administered to a patient after experiencing a T/E; This spontaneous report was received from an Other Health Professional and referred to a 15-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknwon date, varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #X021930, expiration date: 29-AUG-2025) was underwent a temperature excursion (T/E). On 01-MAR-2024 (after T/E), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021930, expiration date: 29-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional AE.
Sex: F
Vaccine: PNC15
Symptoms: Accident at work, Device connection issue
Clinical narrative: injured by a piece of glass from the broken VAXNEUVANCE; luer lock detached from the syringe; This spontaneous report was received from an office manager and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-JUL-2024, the patient, as a health care professional (HCP), was attaching a needle to one pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 ml syringe (lot #X027947 has been verified to be a valid lot number, expiration date reported as and also upon internal validation established as 12-JAN-2026; dose and route of administration was not provided) for prophylaxis, and the luer lock detached from  the  syringe. When the HCP went to clean up, she was injured by a piece of glass from the broken pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe (syringe issue and injury associated with device).  The outcome of the event of injury and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe was not provided.
Sex: U
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: The patient received first dose of RabAvert intramuscularly in the gluteal region; Case reference number US-BN-2023-001013 is a spontaneous case report initially received from a health care professional via Company (reference number: USBAV23-0761) on 15-Jun-2023 and concerns a patient of unknown demographics.    The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (batch number not provided) administered intramuscularly in the gluteal region (explicitly coded as 'vaccine administered at inappropriate site'), at an unknown dose, for an unknown indication.    At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received from Bavarian Nordic on 16-Jun-2023 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of RabAvert, administered intramuscularly in the gluteal region, which is considered as vaccine administered at inappropriate site, at an unknown dose, for an unknown indication. It was unknown if the patient developed any adverse event due to RabAvert vaccine. Product administered at inappropriate site is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of RabAvert, administered intramuscularly in the gluteal region, which is considered as vaccine administered at inappropriate site, at an unknown dose, for an unknown indication. It was unknown if the patient developed any adverse event due to RabAvert vaccine. Product administered at inappropriate site is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was vaccinated with RabAvert vaccine that expired in May 2023; Case reference number US-BN-2023-001048 is a spontaneous case report initially received from other health professional via Communications (reference number: USBAV23-0783) on 20-Jun-2023 and concerns a 75-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was exposed to racoon scratch. The patient had immediate medical attention 30 minutes after the exposure.  On an unspecified date, an unknown amount of time after the exposure, the patient was vaccinated with the first dose of RabAvert (batch number not provided) at unknown dose, anatomical site and route of administration, for post-exposure to rabies.  On an unspecified date, an unknown amount of time after the exposure, the patient was vaccinated with the second dose of expired RabAvert vaccine (batch number: ARBA571A; expiration date May-2023), at unknown dose, anatomical site and route of administration (explicitly coded as 'expired vaccine used').    At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received from Bavarian Nordic on 21-Jun-2023 included the local BN case ID.; Reporter's Comments: A 75-year-old female patient was vaccinated with the second dose of expired RabAvert vaccine for post-exposure to rabies, which is considered as expired vaccine used. No associated adverse events were reported. Expired vaccine used is listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired vaccine is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 75-year-old female patient was vaccinated with the second dose of expired RabAvert vaccine for post-exposure to rabies, which is considered as expired vaccine used. No associated adverse events were reported. Expired vaccine used is listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired vaccine is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Antibody test abnormal
Clinical narrative: The patient's antibodies were low; Case reference number US-BN-2023-001050 is a spontaneous case report initially received on 21-Jun-2023 from a pharmacist via Communication (reference number: USBAV23-0784) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided. As reported, patient was a veterinary technician.  On an unspecified date, reported as two and a half - almost three years ago, the patient was exposed to rabies.  On unspecified dates, reported as two and a half - almost three years ago, an unknown amount of time after the exposure, the patient was vaccinated with the unknown number of doses of RabAvert, reported as complete rabies series (batch numbers: unknown) at an unknown dosage, route or site of administration for rabies exposure.  On an unspecified date, the patient checked the titers, and the patient's antibodies were low.   As reported, the reporter was wondering how to proceed with the immunization and should the patient receive a booster or two doses of the vaccine.  At the time of initial report, the outcome for the event of 'antibody result abnormal' was unknown.  The reporter assessed the event of 'antibody result abnormal' as non-serious and related to RabAvert.  Additional information received from Bavarian Nordic on 22-Jun-2023 included local BN case ID.; Reporter's Comments: A female patient of unknown age was exposed to rabies and was vaccinated with an unknown number of doses of RabAvert as post-exposure prophylaxis. On an unknown date, reported as 2.5-3 years later, the patient's antibodies were too low. No other adverse events were reported. Antibody test abnormal is unlisted per the CCDS V1 and USPI for RabAvert. The patient was a veterinary technician. No medical history was reported. According to the CCDS for RabAvert, antibody testing and periodic booster doses (every 2-5 years) are recommended for people whose occupation puts them at continual or frequent risk of exposure. As humoral immunity tends to wane over time, the event of antibody test abnormal is considered related to RabAvert. The case is non-serious.; Sender's Comments: A female patient of unknown age was exposed to rabies and was vaccinated with an unknown number of doses of RabAvert as post-exposure prophylaxis. On an unknown date, reported as 2.5-3 years later, the patient's antibodies were too low. No other adverse events were reported. Antibody test abnormal is unlisted per the CCDS V1 and USPI for RabAvert. The patient was a veterinary technician. No medical history was reported. According to the CCDS for RabAvert, antibody testing and periodic booster doses (every 2-5 years) are recommended for people whose occupation puts them at continual or frequent risk of exposure. As humoral immunity tends to wane over time, the event of antibody test abnormal is considered related to RabAvert. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product dose omission issue
Clinical narrative: Missed RabAvert dose on day seven, second RabAvert dose administered on 08-Jul-2023, on day 21; Case reference number US-BN-2023-001196 is a spontaneous case report initially received on 10-Jul-2023 from a consumer via agency (reference number: USBAV23-0892) and concerns a female patient of unknown age.   The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date, reported as day one, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at an unknown dose, route, or anatomical location for pre-exposure, before exposure, as reported.   On 08-Jul-2023, reported as 21 days after the first dose, on a Saturday, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, route, or anatomical location (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient missed the RabAvert dose on day seven (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse events due to RabAvert.  Additional information received from Bavarian Nordic on 11-Jul-2023 included local BN case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the second dose of RabAvert, 21 days after the first dose for pre-exposure immunization, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the second dose of RabAvert, 21 days after the first dose for pre-exposure immunization, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered at inappropriate site
Clinical narrative: 48 to 60 hours after the presumed exposure the patient was vaccinated with the first dose of RabAvert in glutes/gluteal region; 48 to 60 hours after the presumed exposure the patient was vaccinated with the first dose of RabAvert in glutes/gluteal region; Case reference number US-BN-2023-001236 is a spontaneous case report initially received on 16-Jul-2023 from a non-healthcare professional via agency (reference number: USBAV23-0949) and concerns a 16-years-old male patient.   The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date, the patient had, as reported, a presumed exposure (verbatim as reported).  On 15-Jul-2023, reported as last Saturday and as 48 to 60 hours after the presumed exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, intramuscularly, as reported, in glutes/gluteal region, for post exposure vaccination (explicitly coded as 'vaccine administered at inappropriate site' and 'inappropriate schedule of vaccine administered'). As reported, the patient was a runner and did not have a lot of fat and the doctors said it was okay as they were able to administer the dose intramuscularly in the gluteal area.  At the time of initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccination.  Additional information received from Bavarian Nordic on 18-Jul-2023 included BN reference number.; Reporter's Comments: A 16-years-old male patient was vaccinated with the first dose of RabAvert in glutes/gluteal region, 48 to 60 hours after the presumed exposure, for post exposure vaccination, which is considered as product administered at inappropriate site and inappropriate schedule of vaccine administered. No associated adverse events were reported. Product administered at inappropriate site and inappropriate schedule of vaccine administered are listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Product administered at inappropriate site and inappropriate schedule of vaccine administered are not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 16-years-old male patient was vaccinated with the first dose of RabAvert in glutes/gluteal region, 48 to 60 hours after the presumed exposure, for post exposure vaccination, which is considered as product administered at inappropriate site and inappropriate schedule of vaccine administered. No associated adverse events were reported. Product administered at inappropriate site and inappropriate schedule of vaccine administered are listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Product administered at inappropriate site and inappropriate schedule of vaccine administered are not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient started post-exposure to rabies series with first dose on day 0, second dose on day 3, and patient came back seven days after Day 3; Case reference number US-BN-2023-001359 is a spontaneous case report initially received from a pharmacist via agency (reference number: USBAV23-1141) on 07-Aug-2023 and concerns a 48-year-old female patient.  The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, reported as day 0, the patient was vaccinated with the first dose of RabAvert vaccine (batch number: ARBA9718A) at an unknown dose, route or site of administration, for post-exposure to rabies.  On an unspecified date, an unknown amount of time after the first dose (reported as day 3), the patient was vaccinated with the second dose of RabAvert vaccine (batch number: ARBA9718A) at an unknown dose, route or site of administration. Patient came back seven days after day 3 administration (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received from Bavarian Nordic on 08-Aug-2023 included local BN case ID.; Reporter's Comments: A 48-year-old female patient was vaccinated with the second dose of RabAvert vaccine seven days after day 3 administration, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 48-year-old female patient was vaccinated with the second dose of RabAvert vaccine seven days after day 3 administration, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second RabAvert dose was delayed, given at 12 days instead of seven days; Case reference number US-BN-2023-001373 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV23-1153) on 08-Aug-2023, and concerns a patient of unknown demographics.  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 (batch number: unknown), intramuscularly (IM) at unknown dose or site of administration for indication reported as before exposure.  On 02-Aug-2023, reported as at 12 days after first RabAvert dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), IM at unknown dose or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, second dose was delayed and given at 12 days instead of seven days (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event after RabAvert vaccination.  Additional information received from Bavarian Nordic on 09-Aug-2023 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of RabAvert 12 days after the first dose, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of RabAvert 12 days after the first dose, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second RabAvert dose was administered with a few says of delay, specifically at 11 days; Case reference number US-BN-2023-001374 is a spontaneous case initially received from a consumer via agency (reference number USBAV23-1155) on 08-Aug-2023, and concerns a female patient of 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 (batch number: unknown), intramuscularly (IM) at unknown dose or site of administration for indication reported as before exposure.  On an unspecified date, reported as at 11 days after first RabAvert dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), IM at unknown dose or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, second dose was administered with a few says of delay. As reported, the patient was advised by a program director that doses should have been spaces seven days apart and to restart the vaccination.  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received from Bavarian Nordic on 09-Aug-2023 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of RabAvert 11 days after the first dose, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of RabAvert 11 days after the first dose, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Administered RabAvert in the intragluteal region instead of the deltoid area; Case reference number US-BN-2023-001379 is a spontaneous case initially received from other healthcare professional via agency(reference number USBAV23-1167) on 09-Aug-2023, and concerns a patient of unknown demographics.  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 (batch number: unknown), at unknown dose or route of administration in the intragluteal region instead of the deltoid area for an unknown indication (explicitly coded as 'vaccine administered at inappropriate site').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination and second and third RabAvert doses were not administered yet, as reported.  Additional information received from Bavarian Nordic on 10-Aug-2023 included local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of RabAvert, administered in the intragluteal region instead of the deltoid area for an unknown indication, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is  not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of RabAvert, administered in the intragluteal region instead of the deltoid area for an unknown indication, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is  not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: RabAvert shot zero administered in buttock instead of the deltoid; Case reference number US-BN-2023-001381 is a spontaneous case initially received from a consumer via Med Communications (reference number USBAV23-1162) on 09-Aug-2023, and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as yesterday, the patient started the rabies series and was vaccinated with the first dose of RabAvert (batch number: unknown), at unknown dose or route of administration in in the buttock instead of the deltoid for an unknown indication (explicitly coded as 'vaccine administered at inappropriate site') and with co-suspect unspecified immunoglobulins (brand name unknown), at unknown dose or route of administration in the buttock area but in the other side. As reported, RabAvert dose was shot zero of the series.  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination and second and third RabAvert doses were not administered yet, as reported.  Additional information received from Bavarian Nordic on 09-Aug-2023 included local BN case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert, administered in the buttock instead of the deltoid area, for an unknown indication, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is  not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert, administered in the buttock instead of the deltoid area, for an unknown indication, which is considered as product administered at inappropriate site. No associated adverse events were reported. Product administered at inappropriate site is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is  not related to RabAvert, but to a human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: An event of a needle stick for a nurse after RabAvert vaccine was administered; Case reference number US-BN-2023-001388 is a spontaneous case initially received from other healthcare professional (reference number USBAV23-1191) on 11-Aug-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, RabAvert (batch number unknown) was administered and after administration an event of a needle stick for the patient (a nurse) occurred (explicitly coded as 'occupational exposure to product'). As reported, provided needle in the RabAvert kit was not a safety needle.  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert needle stick.  Additional information received from Bavarian Nordic on 11-Aug-2023 included confirmation that the case did not contain a PQC.  Additional information received from Bavarian Nordic on 11-Aug-2023 included local BN case ID.; Reporter's Comments: On an unspecified date, RabAvert was administered and after administration an event of a needle stick for the patient (a nurse) occurred, which is considered as occupational exposure to product. No associated adverse events were reported. No associated adverse events were reported. Occupational exposure to product is listed per company convention. The patient's medical history and concomitant medication details were not provided. Occupational exposure to product is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: On an unspecified date, RabAvert was administered and after administration an event of a needle stick for the patient (a nurse) occurred, which is considered as occupational exposure to product. No associated adverse events were reported. No associated adverse events were reported. Occupational exposure to product is listed per company convention. The patient's medical history and concomitant medication details were not provided. Occupational exposure to product is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received first dose of RabAvert on 06-Aug-2023 and second, on 11-Aug-2023 for post exposure immunisation; Case reference number US-BN-2023-001439 is a spontaneous case report initially received from nurse via Regulatory Authority (reference number: USBAV23-1298) on 22-Aug-2023 and concerns a 16-year-old female patient.   The patient's medical history and concomitant medication details were not provided.  On 06-Aug-2023, the patient was vaccinated with a first dose of RabAvert vaccine; (batch number: Unknown), at an unknown dose, intramuscularly, at unknown site of administration, for indication reported as post-exposure.  On 11-Aug-2023, four days after the first dose, the patient was vaccinated with a second dose of RabAvert vaccine; (batch number: Unknown), at an unknown dose, intramuscularly, at unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received from Health Authority on 25-Aug-2023 included local case ID.; Reporter's Comments: A 16-year-old female patient was vaccinated with a second dose of RabAvert vaccine four days after the first dose for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 16-year-old female patient was vaccinated with a second dose of RabAvert vaccine four days after the first dose for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose of RabAvert on 18-Jul-2023 and second on 22-Aug-2023; Case reference number US-BN-2023-001453 is a spontaneous case report initially received from other health professional via MedCommunication (reference number: USBAV23-1346) on 29-Aug-2023 and concerns an adult female patient.   The patient's medical history and concomitant medication details were not provided.  On 18-Jul-2023, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at a dose reported as standard, via unknown route or site of administration for pre-exposure.  On 22-Aug-2023, 35 days after administration of first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at a dose reported as standard, via unknown route or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.   Additional information received from other health professional via MedCommunication (reference number: USBAV23-1348) on 30-Aug-2023 included additional reporter, date of birth and second dose date of administration.  Additional information received from Bavarian Nordic on 30-Aug-2023 included local BN case ID.  Additional information received from from MedCommunication on 30-Aug-2023 included confirmation that reports USBAV23-1348 and USBAV23-1346 were crosslinked.; Reporter's Comments: An adult female patient was vaccinated with the second dose of RabAvert (35 days after administration of first dose), at a dose reported as standard, via unknown route or site of administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, t was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient was vaccinated with the second dose of RabAvert (35 days after administration of first dose), at a dose reported as standard, via unknown route or site of administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, t was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received first dose of RabAvert two days after the exposure; Case reference number US-BN-2023-001493 is a spontaneous case report initially received from a nurse via Agency (reference number: USBAV23-1410) on 06-Sep-2023 and concerns a child male patient.   The patient's medical history and concomitant medication details were not provided.  On 31-Aug-2023, the patient had an exposure. As reported, the patient was bit.  On 02-Sep-2023, two days after the exposure, and also reported as on day three, the patient was vaccinated with the first dose of RabAvert (batch number not provided), at a dose reported as standard, via unknown route or site of administration, for post-exposure (explicitly coded as 'inappropriate schedule of vaccine administered').  As reported, further doses of RabAvert were not given at the time.   At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received from Agency on 08-Sep-2023 included local Agency case ID.; Reporter's Comments: A male child patient was vaccinated with the first dose of RabAvert, two days after an animal exposure (also reported as on day three) at a dose reported as standard, via unknown route or site of administration, for post-exposure which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male child patient was vaccinated with the first dose of RabAvert, two days after an animal exposure (also reported as on day three) at a dose reported as standard, via unknown route or site of administration, for post-exposure which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of RabAvert administered one day early (day six) by mistake; Case reference number US-BN-2023-001511 is a spontaneous case report initially received from a pharmacist (reference number: USBAV23-1452) on 11-Sep-2023 and concerns a patient of unspecified demographics.   The patient's medical history and concomitant medication details were not provided.  On unspecified date, reported as day zero, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administrations, for pre-exposure immunization.  On unspecified day, reported as on day six after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration. As reported, the second dose was administered one day early by mistake (explicitly coded as 'inappropriate schedule of vaccine administered').  The reporter asked when the patient should receive the next indicated immunization of RabAvert to complete the pre-exposure series.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received on 12-Sep-2023 included local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of RabAvert (on day six after the first dose) which was administered one day early by mistake and that is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of RabAvert (on day six after the first dose) which was administered one day early by mistake and that is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.