chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: COVID19-2, DTAPIPV, MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given Moderna Bivalent Pink cap, as first dose.  No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Sensory loss, Tenderness
Clinical narrative: Patient complained about Right arm weakness after HPV injection. Patient completed electronic medical self-triage questionnaire; advice outcome of questionnaire was to call the ambulance. Patient had a video visit with MD on 05/24/2023, then had an in person visit with an MD to follow on 05/24/23, outcome of in person visit was a referral to Neurology.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Grip strength decreased, Hypoaesthesia, Mobility decreased
Clinical narrative: Patient complained about Right arm weakness after HPV injection. Patient completed electronic medical self-triage questionnaire; advice outcome of questionnaire was to call the ambulance. Patient had a video visit with MD on 05/24/2023, then had an in person visit with an MD to follow on 05/24/23, outcome of in person visit was a referral to Neurology.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac stress test normal, Chest pain, Dyspepsia, Electrocardiogram normal, Hypertension
Clinical narrative: chest pain and heartburn for 5 days, high blood pressure
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Injection site pain
Clinical narrative: The adverse events I experienced were tachycardia, chest pain, shortness of breath, and dizziness that began after I got the vaccine.  I also experienced pain where I got the vaccine, fatigue, and nausea.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tachycardia
Clinical narrative: The adverse events I experienced were tachycardia, chest pain, shortness of breath, and dizziness that began after I got the vaccine.  I also experienced pain where I got the vaccine, fatigue, and nausea.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Antinuclear antibody, Arthralgia, Blood thyroid stimulating hormone, Haematology test, Pyrexia
Clinical narrative: High fever, extreme joint pain, elevated rheumatoid factors. Triggered onset of rheumatoid arthritis.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Rheumatoid arthritis, Rheumatoid factor increased
Clinical narrative: High fever, extreme joint pain, elevated rheumatoid factors. Triggered onset of rheumatoid arthritis.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19, FLU3
Symptoms: Rheumatoid arthritis
Clinical narrative: High fever, extreme joint pain, elevated rheumatoid factors. Triggered onset of rheumatoid arthritis.
Age: 10.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Eye movement disorder, Moaning, Musculoskeletal stiffness
Clinical narrative: Approximately two minutes after receiving the HPV vaccine, my son's eyes rolled backward, his arms began to posture and stiffen and he started moaning.  That continued for roughly three minutes.  He suddenly came to his regular state but has felt slightly dizzy for the remainder of the day.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: High pitched ringing in the ears at all times.  Unsure of date of onset.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient has not complained of any adverse events; however, it was realized, after the fact, that the dose administered was expired.
Age: 1.67
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash
Clinical narrative: 5/20/2023: 5:30am started with 102 fever went to petting zoo on 5/20/2023, then went to beach on Saturday 5/21/2023.  5/21/2023: Started with tiny rash on stomach
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure
Clinical narrative: started having seizure after vaccines and has been hospitalized
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Loss of consciousness, Nodule, Pain in extremity
Clinical narrative: Vaccine Saturday. Sunday knot and sore arm. Passed  out Monday, May 8th @ 3am & 5am went to hospital. Treated for passing out but hospital never really acknowledged shot. Bruising down arm of shot and a bruise on thigh left side.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 2/2/21 lot# EN6200;  Pfizer 3/15/21 lot# EN6207;
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Vaccination failure, Weight
Clinical narrative: In addition to my previous report, I began having difficult hearing in April 2023. Everything was muffled. I saw my doctor and was referred to an ENT. I have not seen the ENT yet. Also, in mid-May 2023, I saw a doctor due an issue with my wisdom tooth. My dentist said that my jawbone was growing out of the back of my mouth. An oral surgeon stated this was most likely caused by the drug I was taking for my osteoporosis. My dentist gave me some special mouthwash to help with care.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Hypoacusis, Jaw disorder, Tooth disorder
Clinical narrative: In addition to my previous report, I began having difficult hearing in April 2023. Everything was muffled. I saw my doctor and was referred to an ENT. I have not seen the ENT yet. Also, in mid-May 2023, I saw a doctor due an issue with my wisdom tooth. My dentist said that my jawbone was growing out of the back of my mouth. An oral surgeon stated this was most likely caused by the drug I was taking for my osteoporosis. My dentist gave me some special mouthwash to help with care.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: malaise; dizziness; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of malaise in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-MAR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced malaise (Verbatim: malaise), dizziness (Verbatim: dizziness) and nausea (Verbatim: nausea). The outcome of the malaise, dizziness and nausea were not resolved.   It was unknown if the reporter considered the malaise, dizziness and nausea to be related to Shingrix.     It was unknown if the company considered the malaise, dizziness and nausea to be related to Shingrix.   Additional Information: GSK receipt date:26-MAY-2023 The reporter reported that after receiving his second dose of Shingrix he began to experienced nausea, dizziness, malaise. Adverse event filed. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: malaise; dizziness; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of malaise in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-MAR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced malaise (Verbatim: malaise), dizziness (Verbatim: dizziness) and nausea (Verbatim: nausea). The outcome of the malaise, dizziness and nausea were not resolved.   It was unknown if the reporter considered the malaise, dizziness and nausea to be related to Shingrix.     It was unknown if the company considered the malaise, dizziness and nausea to be related to Shingrix.   Additional Information: GSK receipt date:26-MAY-2023 The reporter reported that after receiving his second dose of Shingrix he began to experienced nausea, dizziness, malaise. Adverse event filed. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cerebrovascular accident, Chest pain, Hypoaesthesia, Illness
Clinical narrative: sickness that led to a visit at the emergency room for COVID 19; sickness that led to a visit at the emergency room for COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EB8731), in left arm and on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "sickness that led to a visit at the emergency room for COVID 19". The event "sickness that led to a visit at the emergency room for covid 19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical information: Patient had no known allergies. Patient did not receive other vaccine in four weeks and no other medications in two weeks, patient did not have covid prior vaccination and was tested post vaccination. Reported that, In December patient experienced about 2 weeks of sickness that led to a visit at the emergency room for COVID 19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201080 same reporter/patient/product, different doses/AEs;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: sickness that led to a visit at the emergency room for COVID 19; sickness that led to a visit at the emergency room for COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EB8731), in left arm and on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "sickness that led to a visit at the emergency room for COVID 19". The event "sickness that led to a visit at the emergency room for covid 19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical information: Patient had no known allergies. Patient did not receive other vaccine in four weeks and no other medications in two weeks, patient did not have covid prior vaccination and was tested post vaccination. Reported that, In December patient experienced about 2 weeks of sickness that led to a visit at the emergency room for COVID 19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201080 same reporter/patient/product, different doses/AEs;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: sickness that led to a visit at the emergency room for COVID 19; sickness that led to a visit at the emergency room for COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EB8731), in left arm and on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "sickness that led to a visit at the emergency room for COVID 19". The event "sickness that led to a visit at the emergency room for covid 19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical information: Patient had no known allergies. Patient did not receive other vaccine in four weeks and no other medications in two weeks, patient did not have covid prior vaccination and was tested post vaccination. Reported that, In December patient experienced about 2 weeks of sickness that led to a visit at the emergency room for COVID 19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201080 same reporter/patient/product, different doses/AEs;
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: sickness that led to a visit at the emergency room for COVID 19; sickness that led to a visit at the emergency room for COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EB8731), in left arm and on 08May2021 as dose 2, single (Lot number: EW0176) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "not recovered" and all described as "sickness that led to a visit at the emergency room for COVID 19". The event "sickness that led to a visit at the emergency room for covid 19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical information: Patient had no known allergies. Patient did not receive other vaccine in four weeks and no other medications in two weeks, patient did not have covid prior vaccination and was tested post vaccination. Reported that, In December patient experienced about 2 weeks of sickness that led to a visit at the emergency room for COVID 19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201080 same reporter/patient/product, different doses/AEs;
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Influenza like illness, Sluggishness
Clinical narrative: Hardly talk; I couldn't breathe; I couldn't walk; Feeling Exhausted; First dose of Shingrix vaccine a month ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of speech disorder in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22-MAY-2023, the patient received the 2nd dose of Shingrix (left arm). On 22-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: First dose of Shingrix vaccine a month ago). On 23-MAY-2023, the patient experienced speech disorder (Verbatim: Hardly talk), difficulty breathing (Verbatim: I couldn't breathe), walking difficulty (Verbatim: I couldn't walk) and exhaustion (Verbatim: Feeling Exhausted). The outcome of the speech disorder, difficulty breathing, walking difficulty and exhaustion were not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the speech disorder, difficulty breathing, walking difficulty and exhaustion to be related to Shingrix.     It was unknown if the company considered the speech disorder, difficulty breathing, walking difficulty and exhaustion to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2023. The patient was self-reported this case. The patient received first dose of Shingrix vaccine a month ago, then second dose in her left arm.  Then a day after vaccination patient felt exhausted, she could not walk or breathe and also hardly talk. The symptoms persist till the time of reporting. The reporter did consent to follow up. The reporter reported that the time interval between the first and second dose of Shingrix vaccine was less than 2 months, which lead to drug dose administration interval too short.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Inappropriate schedule of product administration, Speech disorder
Clinical narrative: Hardly talk; I couldn't breathe; I couldn't walk; Feeling Exhausted; First dose of Shingrix vaccine a month ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of speech disorder in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22-MAY-2023, the patient received the 2nd dose of Shingrix (left arm). On 22-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: First dose of Shingrix vaccine a month ago). On 23-MAY-2023, the patient experienced speech disorder (Verbatim: Hardly talk), difficulty breathing (Verbatim: I couldn't breathe), walking difficulty (Verbatim: I couldn't walk) and exhaustion (Verbatim: Feeling Exhausted). The outcome of the speech disorder, difficulty breathing, walking difficulty and exhaustion were not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the speech disorder, difficulty breathing, walking difficulty and exhaustion to be related to Shingrix.     It was unknown if the company considered the speech disorder, difficulty breathing, walking difficulty and exhaustion to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2023. The patient was self-reported this case. The patient received first dose of Shingrix vaccine a month ago, then second dose in her left arm.  Then a day after vaccination patient felt exhausted, she could not walk or breathe and also hardly talk. The symptoms persist till the time of reporting. The reporter did consent to follow up. The reporter reported that the time interval between the first and second dose of Shingrix vaccine was less than 2 months, which lead to drug dose administration interval too short.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Starting 3 hours after dose, patient developed slight fever (maximum of 100.1-100.6 F). She said her baseline is 97.5F. The fever has been on and off for the last 7 days. She only took Tylenol to help lower the fever one day (3 doses) but it was making her dizzy so she stopped using it. On day 6 post vaccine she developed AFib and was treated at a local emergency room. She tested negative for COVID, Flu and heart attack during her visit there. She was discharged with a prescription for Diltiazem.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Cardiac function test normal, Fibrin D dimer normal, Influenza virus test negative, Pyrexia
Clinical narrative: Starting 3 hours after dose, patient developed slight fever (maximum of 100.1-100.6 F). She said her baseline is 97.5F. The fever has been on and off for the last 7 days. She only took Tylenol to help lower the fever one day (3 doses) but it was making her dizzy so she stopped using it. On day 6 post vaccine she developed AFib and was treated at a local emergency room. She tested negative for COVID, Flu and heart attack during her visit there. She was discharged with a prescription for Diltiazem.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: SARS-CoV-2 test negative, Troponin normal
Clinical narrative: Starting 3 hours after dose, patient developed slight fever (maximum of 100.1-100.6 F). She said her baseline is 97.5F. The fever has been on and off for the last 7 days. She only took Tylenol to help lower the fever one day (3 doses) but it was making her dizzy so she stopped using it. On day 6 post vaccine she developed AFib and was treated at a local emergency room. She tested negative for COVID, Flu and heart attack during her visit there. She was discharged with a prescription for Diltiazem.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the patient was given a dose of VAXNUEVANCE after the dose was stored improperly; This spontaneous report was received from Other Health Professional and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-MAY-2023, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5ml/ series, lot #W027275, expiration date: 09-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 05-MAY-2023, HCP called to report the patient was given a dose of VAXNUEVANCE after the dose was stored improperly. TE case with the supported outcome is 02385439. Pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was impropertly stored in 34 F degrees for 7 hours. No additional AE/PQC.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; patient received the first dose of GARDASIL 9 in Oct 2022. Patient just received the second dose of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 40-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On an unknown date in October 2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 10-MAY-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W011455, expiration date: 11-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate schedule of product administration). No additional adverse events reported. No PQC reported.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered on 05-DEC-2003; This spontaneous report was received from a physician via an immunization record from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (2303USA000366), and concerns an approximately 5-month-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 23-OCT-2003, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #, expiry date, route of administration and anatomical location were not provided). On 05-DEC-2003, she was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #, expiry date, route of administration and anatomical location were not provided), which was considered an inappropriate schedule of vaccine administered.   This is one of four reports regarding the same patient.; Sender's Comments:  US-009507513-2303USA000366: US-009507513-2305USA005506: US-009507513-2305USA005505:
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: third dose administered on 25-MAR-2004; second dose administered on 25-jul-2003; This spontaneous report was received from a physician via an immunization record from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (2303USA000366) and concerns an approximately 4-week-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 23-JUN-2003, 25-JUL-2003 and on 25-MAR-2004, the patient was vaccinated with the first, second and third dose respectively of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis. This was considered an inappropriate schedule of vaccine administered.   This is one of four reports regarding the same patient.; Sender's Comments:  US-009507513-2305USA005506: US-009507513-2303USA000366: US-009507513-2305USA005504:
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered on 14-NOV-2013; This spontaneous report was received from a physician via an immunization record from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (MARRS # 2303USA000366) and concerns an approximately 10-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 07-DEC-2011 and 14-NOV-2013, the patient was vaccinated with the first and second dose respectively of hepatitis a vaccine, inactivated (VAQTA) (lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis. This was considered an inappropriate schedule of vaccine administered.   This is one of four reports regarding the same patient.; Sender's Comments:  US-009507513-2303USA000366: US-009507513-2305USA005505: US-009507513-2305USA005504:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Visual impairment
Clinical narrative: Shingles; Vision problems; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 13-MAY-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) in a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by providers for shingles and vision problems. Pt claimed damages as a result of injury to herself. The outcome of shingles and vision problems was unknown and the causal relationship between the events and zoster vaccine live (ZOSTAVAX) was considered related.
Sex: U
Vaccine: HEP, HEP, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Additional AEs; Caller reported a 30 year old patient received a pediatric dose of Hepatitis B.; Caller reported a 30 year old patient received a pediatric dose of Hepatitis B. HCP was told this was the patient's first dose of Hepatitis B but she states the state immunization records show patient received Hepatitis B Vaccine; immunization records show patient received Hepatitis B Vaccine in May 2000 (0.5 ml) and April 2002 (0.5 ml).; This spontaneous report was received from a medical assistant and refers to a 30-year-old patient. No information on patient's medical history, current condition and concomitant medications was provided.      On 12-MAY-2023 the patient was vaccinated with 0.5 milliliter hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # W016731 and expiration date 03-DEC-2024, intramuscularly for prophylaxis.  Other suspect therapies included and hepatitis b vaccine rhbsag (yeast) (HEPLISAV B). The reporter didn't know if it was hepatitis b vaccine rhbsag (yeast) (HEPLISAV B) or hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (product administered to patient of inappropriate age, inappropriate schedule of product administration and no adverse event). Health care professional reported that the state immunization records show that in MAY-2000 and APR-2002, patient received 0.5 milliliter of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (inappropriate schedule of product administration).
Sex: F
Vaccine: HPV4
Symptoms: Scoliosis
Clinical narrative: She reports that her daughter developed scoliosis post vaccination of the GARDASIL; This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No information patient's medical history, current conditions and concomitant medications was provided.     On 22-NOV-2013 the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for human papilloma virus immunization (exact dose, route of administration, lot# and expiration date were not provided). On 22-JAN-2014 the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for human papilloma virus immunization (exact dose, route of administration, lot# and expiration date were not provided). On 02-JUN-2014 the patient was vaccinated with third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for human papilloma virus immunization (exact dose, route of administration, lot# and expiration date were not provided).       On an unknown date the patient experienced scoliosis. The outcome of scoliosis is unknown. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) regarding the event was not applicable.  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the event was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller stated a female patient was 26 years old when she received the first dose in May 2022. Per caller, the patient has not yet received the second dose. Caller had no further details. No permission to con; No adverse event; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in May 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Per caller, the patient has not yet received the second dose (inappropriate schedule of product administration ). No additional adverse event was reported.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Injection site haematoma
Clinical narrative: FBE calling to report AE on behalf of a HCP. Caller reports that a 6 month old boy developed a large hematoma at the injection site 1-2 days after receiving VAXELIS and VAXENEUVANCE at his 6 month visit. The HCP was notified 2 weeks after the hematom; This spontaneous report was received from a physician via company representative and refers to a 6-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in April 2023, the patient was vaccinated pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) strength: 0.5 milliliter, at a dose of 0.5 milliliter once (lot #, expiry date, and route of administration were not provided) and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS), both administered for prophylaxis.   On an unknown date in April 2023 (also reported as "within the past 30 days" or 1-2 after vaccination), the patient experienced a large hematoma at the injection site. The health care professional (HCP) was notified 2 weeks after the hematoma developed and it was unresolved at that time.  The causal relationship between the events and the vaccines was not provided.
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 33-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 24-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 5-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 12-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 5-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 23-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 20-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090,2305USA009091, 2305USA009092, 2305USA009094, 2305USA009095.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 13-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 26-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009095.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 01-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090,2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; HCP called to ask how long she needs to wait between administering of MMR II and VARIVAX? HCP continued to say that the patient was 8 years old received MMR II (3rd or 4th dose) yesterday 5/25/2023. She did not have his full records since he has move; This spontaneous report was received from Consumer and refers to an 8-year-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-MAY-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 25-MAY-2023, HCP called to ask how long she needs to wait between administering of MMR II and VARIVAX? HCP continued to say that the patient was 8 years old received MMR II (3rd or 4th dose) (Extra dose administered). She did not have his full records since he has move. She informed that he needs to receive VARIVAX to attend school. HCP did not have the time to stay on the line to report the AE. HCP did give permission to contact her for additional information. HCP did not wait to get her case#. HCP was in a rush and had to get off the phone. On an unknown date, the patient experienced No additional AE reported.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd Dose 53 Days After First Dose; Initial Report Received on 01-Mar-2023  A nurse  reported that a 67-year-old female received HEPLISAV-B for hepatitis B immunization.    Medical history was reported as unknown.  No concomitant medications were reported.   On 21-Dec-2022 the patient received dose 1 of HEPLISAV-B (Lot #, NDC#, Expiration Date were not provided) via unknown site.   On 11-Feb-2023, the patient received dose 2 of HEPLISAV-B (Lot #, NDC#, Expiration Date were not provided), 53 days after dose 1, via unknown site.  The patient received the second dose of HEPLISAV-B two months after the first dose.  The reporter noted that she had not been informed of any adverse reactions.   No other details were specified.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Received Heplisav-B While Pregnant; Initial Report Received on 18-Apr-2023   A registered nurse manager reported that a 39-year-old pregnant female patient (race and ethnicity unknown) was inadvertently given a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis?B immunization.    Medical history, allergies, and concomitant medications at the time of vaccination were not reported.    On 14-Apr-2023, the pregnant patient received the first dose of HEPLISAV-B vaccine (Lot # 941580, expiration date 29-Nov-2024, and NDC # 43528-0003-05) intramuscularly in the left deltoid from a nurse. The number of weeks gestation was unknown, and the patient's last menstrual period was on 07Oct-2022. The patient came into the facility with immigration paperwork to give vaccines. This incident was discovered upon an audit on 18-Apr-2023. The nurse manager will call to notify the patient and provide the pregnancy registry information. No adverse reactions were reported.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Syncope
Clinical narrative: Third shot he fainted 12 hours after the vaccine was administered; In May 2023 the patient had a third shot of Shingrix (due to a medical clerical error); This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on February 16, 2018 received 1st shot) and Shingrix (on August 06, 2018 received 2nd shot).   In MAY-2023, the patient received the 3rd dose of Shingrix. In MAY-2023, 12 hrs after receiving Shingrix, the patient experienced fainting (Verbatim: Third shot he fainted 12 hours after the vaccine was administered) (serious criteria GSK medically significant) and extra dose administered (Verbatim: In May 2023 the patient had a third shot of Shingrix (due to a medical clerical error)). In MAY-2023, the outcome of the fainting was resolved. The outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fainting to be related to Shingrix.     It was unknown if the company considered the fainting to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAY-2023 and 22-MAY-2023 In 2018 the patient received 2 doses of vaccine On an unspecified day in May 2023 the patient had a third shot of Shingrix (due to a medical clerical error), which led to extra dose administered. The patient stated that he had a stronger reaction to the third shot than the first or second. He stated that first and second shots did not bother him but the third shot he fainted 12 hours after the vaccine was administered.  The patient reported that fainting was the low point.  He said he had no problems after that, after recovering from fainting. The patient asked if there any need to complete 2 shot series of the new dosages and do the vaccine lasted for lifetime The reporter consented to follow up via email or regular mail.   Upon internal review the case was updated on 25-May-2023. summary of changes: Following internal review it was determined initial GSK receipt date was 20-May-2023, which was later than initially reported.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Photopsia
Clinical narrative: seeing stars; felt unwell; This non-serious case was reported by a physician and described the occurrence of visual flashes in a 6-decade-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced visual flashes (Verbatim: seeing stars) and feeling unwell (Verbatim: felt unwell). The outcome of the visual flashes was not reported and the outcome of the feeling unwell was resolved.   The reporter considered the visual flashes to be related to Shingrix. It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     The company considered the visual flashes to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt date: 28-APR-2023 This case was submitted by GlaxoSmithKline employee (doctor) via the online direct entry reporting system. The reporter reported that the patient received a dose of Shingles vaccine and during and IME program on shingles and the moderator asked the audience how many received Shingles vaccine, and if anyone experienced adverse event, then stated that one person shouted out and he felt unwell for a few days and was seeing stars. The room contained over 100 people and the reporter was not able to identify the audience member. The reporter did not consent to follow up.