chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Lethargy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 82-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced dizziness and lethargy. On an unknown date, the outcome of the dizziness and lethargy were unknown. It was unknown if the reporter considered the dizziness and lethargy to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. No further details were provided by the pharmacist. The pharmacist was advised to have the patient follow up with their health care provider.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL, IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who experienced the intended product was DAPTACEL, but ADACEL was administered to the patient instead as the fifth dose in the primary series, a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site and a pretty significant reaction with a 7 cm x 5 cm area warmth, while he received vaccines ADACEL instead of DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation. On 14-Aug-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5898AA via unknown route in unknown administration site instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. The patient developed a non-serious a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious a pretty significant reaction with a 7 cm x 5 cm area warmth following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. It was a case of actual medication error due to wrong vaccine administered. (Other relevant tests included no lab data). Final diagnosis was a pretty significant reaction with a 7 cm x 5 cm area warmth, a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site and the intended product was DAPTACEL, but ADACEL was administered to the patient instead as the fifth dose in the primary series. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site, as Not Applicable for the intended product was DAPTACEL, but ADACEL was administered to the patient instead as the fifth dose in the primary series and as Unknown for a pretty significant reaction with a 7 cm x 5 cm area warmth. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL, IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site warmth, Wrong product administered
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who experienced the intended product was DAPTACEL, but ADACEL was administered to the patient instead as the fifth dose in the primary series, a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site and a pretty significant reaction with a 7 cm x 5 cm area warmth, while he received vaccines ADACEL instead of DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation. On 14-Aug-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5898AA via unknown route in unknown administration site instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. The patient developed a non-serious a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious a pretty significant reaction with a 7 cm x 5 cm area warmth following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. It was a case of actual medication error due to wrong vaccine administered. (Other relevant tests included no lab data). Final diagnosis was a pretty significant reaction with a 7 cm x 5 cm area warmth, a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site and the intended product was DAPTACEL, but ADACEL was administered to the patient instead as the fifth dose in the primary series. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for a pretty significant reaction with a 7 cm x 5 cm area of erythema at the injection site, as Not Applicable for the intended product was DAPTACEL, but ADACEL was administered to the patient instead as the fifth dose in the primary series and as Unknown for a pretty significant reaction with a 7 cm x 5 cm area warmth. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB, RAB
Symptoms: Abnormal loss of weight, Antibody test negative, Asthenia, Blood test, Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Sex: F
Vaccine: RAB, RAB
Symptoms: Colitis, Computerised tomogram abdomen abnormal, Computerised tomogram head, Dizziness, Dysarthria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Sex: F
Vaccine: RAB, RAB
Symptoms: Extra dose administered, Fall, Full blood count, Hypersomnia, Hypertension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypotonia, Hypoxia, Inappropriate schedule of drug administration, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Sex: F
Vaccine: RAB, RAB
Symptoms: Memory impairment, Muscular weakness, Narcolepsy, Nausea, Nuclear magnetic resonance imaging brain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Sex: F
Vaccine: RAB, RAB
Symptoms: Oxygen saturation decreased, Product use issue, Pyrexia, Scan with contrast, Viral titre
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Sex: F
Vaccine: RAB, RAB
Symptoms: Vision blurred, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Sex: F
Vaccine: RAB, RAB
Symptoms: Conversion disorder, Crying, Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an adult female patient who received RABAVERT for prophylaxis. Concurrent medical conditions included animal bite (on finger). On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced feeling unwell, hysteria and crying. On an unknown date, the outcome of the feeling unwell, hysteria and crying were unknown. It was unknown if the reporter considered the feeling unwell, hysteria and crying to be related to RABAVERT. Additional details were provided as follows: The patient used RABAVERT for post-exposure prophylaxis. The age at vaccination was not reported. The patient reported that, she felt sick and felt like she was about to die after receiving an unknown quantity of injections of RABAVERT. The patient's call was transferred from other manufacturer. The patient was hysterical and crying, and even other manufacturer representative could not get any information other than help her. The patient reported that her cat brought a live bat into the house. The bat bite her finger, and she released the bat outdoors. She said she went to the hospital where they gave her 15 shots of vaccine. The representative tried to distinguish which vaccines, and the patient did not know. The patient said she got shots in her thigh, buttocks, and at the site of the bat bite. She was instructed to call and/or go to the emergency room. The representative could not give her any medical advice. The representative had to end the call to get her to contact her health care professional as soon as possible.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Shingrix (batch number G933B, expiry date August 2019) for prophylaxis. The patient's past medical history included shingles (had shingles prior to receiving Shingrix 5 years ago). Concurrent medical conditions included post herpetic neuralgia. On 6th August 2018, the patient received the 1st dose of Shingrix .5 ml. On 8th August 2018, 2 days after receiving Shingrix, the patient experienced shingles, pruritus and skin eruption. On an unknown date, the outcome of the shingles, pruritus and skin eruption were not recovered/not resolved. It was unknown if the reporter considered the shingles, pruritus and skin eruption to be related to Shingrix. Additional details were provided as follows: Patient reported that the last time she had shingles prior to receiving Shingrix was 5 years ago. However, the patient had been battling with post herpetic neuralgia since then. The patient was administered Shingrix in the left deltoid. On 8th August 2018, the patient started having itching and breaking out. By the 9th August 2018, the patient was diagnosed with shingles. The patient had been diagnosed by two different doctors.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Shingrix (batch number G933B, expiry date August 2019) for prophylaxis. The patient's past medical history included shingles (had shingles prior to receiving Shingrix 5 years ago). Concurrent medical conditions included post herpetic neuralgia. On 6th August 2018, the patient received the 1st dose of Shingrix .5 ml. On 8th August 2018, 2 days after receiving Shingrix, the patient experienced shingles, pruritus and skin eruption. On an unknown date, the outcome of the shingles, pruritus and skin eruption were not recovered/not resolved. It was unknown if the reporter considered the shingles, pruritus and skin eruption to be related to Shingrix. Additional details were provided as follows: Patient reported that the last time she had shingles prior to receiving Shingrix was 5 years ago. However, the patient had been battling with post herpetic neuralgia since then. The patient was administered Shingrix in the left deltoid. On 8th August 2018, the patient started having itching and breaking out. By the 9th August 2018, the patient was diagnosed with shingles. The patient had been diagnosed by two different doctors.
Age: 4.0
Sex: F
Vaccine: UNK, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Gait disturbance, Pain, Skin warm, Swelling
Clinical narrative: Swelling, redness, and warm to touch.
Age: 4.0
Sex: F
Vaccine: UNK, DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, and warm to touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Influenza-like symptoms for 24 hours after receiving vaccination.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Chicken pox type rash first appearing on front of hips then massive outbreak in groin area down legs up midline to armpits. There are still spots on the top of his feet but they are not blisters. No fever, no real itchy feeling.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: >10cm of redness, tenderness and induration in the area of the injection site.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative, concerning a 15-year-old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in May 2015, the patient was vaccinated with the first dose of GARDASIL, intramuscularly (dose, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in May 2017, the patient received the second dose of his human papillomavirus (HPV) vaccination with GARDASIL 9, intramuscularly (dose, lot number and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from registered nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB, lot # R012001 (expiry date: 06-NOV-2020) for prophylaxis (strength, route and dosage were not reported) (incorrect product storage). The temperature excursion of the vaccine was 47 degree Fahrenheit to 77 degree Fahrenheit for a time frame of 2 hours. There was no previous temperature excursion. A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Bursitis
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to a 25 year old female patient with drug reactions to Amoxicillin. The patient had not relevant medical history to report. The patient's concurrent conditions was not provided. Concomitant therapies included unspecified vitamins and birth control pills. On 25-JUL-2018, the patient was vaccinated with the third dose of GARDASIL 9 (strength, dose and administration route were not reported) lot number R008165, expiration dose on 12-NOV-2020, for prophylaxis (indication reported as "vaccine"). On 15-AUG-2018, the patient was seen in the office and was diagnosed with bursitis. The patient was being treated with prednisone 20 mg, then, tapering dose schedule, and with acetaminophen (+) hydrocodone bitartrate (VICODIN). Lab diagnostics or studies were not performed. The outcome of bursitis was reported as not resolved. The causality assessment between GARDASIL 9 and the aforementioned event was not provided.
Age: 8.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant, and refers to a 5 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 07-AUG-2009, the patient was vaccinated with the first dose of GARDASIL, second dose on 15-AUG-2011 and third dose on 23-JUL-2012 for prophylaxis (route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Product storage error
Clinical narrative: Information was received from a licensed practical nurse referring to an 18 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On 09-AUG-2018, the patient was vaccinated public funds at a private doctor's office/hospital with improperly stored doses of VAQTA (lot # R006210, expiry date unknown) and MENACTRA (lot # U5917AA, expiry date unknown) intramuscularly in the left deltoid and VARIVAX (lot # R002051, expiry date unknown) subcutaneously in the right arm for prophylaxis. The patient previously received one dose of VARIVAX. No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA007644.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 16-AUG-2018, the patient was vaccinated with a dose of M-M-R II injection, intramuscular route in error (lot# and expiry date not reported) for prophylaxis (inappropriate route of vaccination). No known adverse effects. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age. The medical history, concurrent medications and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # N032747, 20-NOV-2019 which was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. Temperature of 9 degree centigrade to 25 degree centigrade, multiple excursions involved. Time frame of 12 hours and 5 minutes. There was no temperature excursion previously. The data logger was involved.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer regarding her daughter of an unknown age. Information on the patient's pertinent medical history, concomitant medications and drug reactions/ allergies were not reported. On 17-AUG-2018, the patient inadvertently received an additional dose of RECOMBIVAX HB (strength, dose, frequency, route of administration were not reported) (lot # M040422, expiry date: not reported) for prophylaxis (extra dose administered). The patient experienced no adverse effects. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies were not reported. Concomitant therapies included sterile diluent. On 02-AUG-2018, the patient was vaccinated with improperly stored M-M-R II injection, lot # N009800, expiration date 24-MAR-2019 (dose and route of administration were not provided) for prophylaxis. Diluent was stored properly. No adverse effects were reported. The vaccine was stored between 0 and 1 (1.4) Celsius degrees for 4 hours and 18 minutes (multiple excursion). Previous temperature excursion was reported as 9 to 25 (8.7) Celsius degrees for 69.49 hours (multiple excursion). Digital data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a pharmacist via Company representative regarding an unknown age female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 intramuscular route, for prevention of Human Papillomavirus Infection (HPV) (strength, frequency, lot# and expiration date were not provided). On an unknown date, after vaccination, the patient developed seizures and was taken to an unknown hospital. In addition, it was unknown if the patient was admitted to the hospital. It was unknown if the patient received treatment for the event. The patient's present status was unknown. The causal relationship between GARDASIL 9 and the event was not reported. Upon internal review, the event of seizure was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a healthcare professional referring to an adult patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unspecified date in January 2018, the patient  was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). On 15-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (lot number R008165 and expiration date of 12-NOV-2020; however, dosage schedule, route of administration and anatomical location were not reported) (inappropriate schedule of drug administration). No adverse effects were reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 74 year old male patient. The patient's concurrent conditions included hypertension and his concomitant medications included an unspecified blood pressure pill. Not known drug allergies. The patient's medical history was not reported. On 20-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the left arm, lot # N025656 and expiration date: 19-APR-2019, indicated for routine vaccination (dose was not reported). Other suspect therapies included influenza virus vaccine (unspecified) intramuscular in the right arm (dose, lot#, expiration date and indication were not reported). On 20-AUG-2018 after receipt the vaccines, the patient's left arm was beginning to become red. The patient reported that as of 22-AUG-2018, the left arm was swollen from the "shoulder down to the elbow like a cuff". It was reported that the patient sought medical attention by calling the pharmacist and additionally, no treatment had been initiated as of yet. The outcome of injection site erythema, extensive swelling of vaccinated limb and peripheral swelling was reported as not resolved. The causal relationship between injection site erythema, extensive swelling of vaccinated limb and peripheral swelling with the suspect therapies was not reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from a registered nurse referring to infants patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with M-M-R II, via subcutaneous (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The registered nurse reported that it was the practice at her office to administer M-M-R II to infants in the thigh (vaccine administered at inappropriate site). The package insert stated: preferably into the outer aspect of the upper arm. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 17-AUG-2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-DEC-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-NOV-2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. In 2008, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Pruritus, Thermal burn
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 2nd August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema, feeling hot, burn and pruritus. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, feeling hot, burn and pruritus were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, feeling hot, burn and pruritus to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient had a red raised puffy area about 6 inches under where vaccination occurred which was super itchy, burns, and felt hot.
Sex: F
Vaccine: VARZOS
Symptoms: Jaw disorder, Pruritus, Rash, Swelling, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dental fillings. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pruritus, facial swelling and rash. On an unknown date, the outcome of the pruritus, facial swelling and rash were recovered/resolved. It was unknown if the reporter considered the pruritus, facial swelling and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced itching, a rash on her chest and jaw swelling at an unknown time after receiving SHINGRIX. The patient also had a dental filling and the patient reportedly believed that it was related to SHINGRIX. The reporter was not at work at time of call and did not have any other information. The pharmacist stated, dental filling was a routine procedure.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy upper limbs in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX received this shingles vaccine about 8 or 9 years before reporting date in 2008). On 7th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th August 2018, 29 days after receiving SHINGRIX, the patient experienced itchy upper limbs and vesicular rash. The patient was treated with medication unknown (Anti-Itch Medication). On an unknown date, the outcome of the itchy upper limbs and vesicular rash were not recovered/not resolved. It was unknown if the reporter considered the itchy upper limbs and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: About a month after having the vaccination in his left deltoid, the patient noticed an itch in his right arm. There appeared to be a light rash from the bottom of his bicep and the whole length of the tricep from the elbow to the armpit. There was also a silver-sized darker rash under his armpit. He said the rash resembled shingles. The patient was treated with anti-itch medication but it remained itchy. The patient was questioning if he should get the second dose since he had reaction with the first. The patient provided contact detail of the physician.