chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: CSF virus identified, Electrophoresis protein, HIV test negative, Herpes zoster disseminated, Herpes zoster meningoencephalitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of varicella zoster virus infection in a 77-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Aspirin, finasteride, FLOMAX, Lidocaine, HUMALOG and atenolol. In May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 21 days after receiving SHINGRIX, the patient experienced varicella zoster virus infection (serious criteria hospitalization), redness (serious criteria hospitalization), skin scaly (serious criteria hospitalization) and rash (serious criteria hospitalization). In June 2018, the patient experienced confusion. The patient was treated with acyclovir. On an unknown date, the outcome of the varicella zoster virus infection, redness, skin scaly, rash and confusion were unknown. It was unknown if the reporter considered the varicella zoster virus infection, redness, skin scaly, rash and confusion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 3 weeks prior to being hospitalized. The patient experienced rash mostly in C6T1 dermatome and lesions scattered in chest and back. The patient also presented with redness and scaling over thoracic dermatome. The patient presented to the hospital on 6th June 2018. Prior to admission, the patient also presented as being confused. On 6th June 2018, Varicella antibody Ig G and Ig M test results came out positive. On 9th June 2018 lumbar puncture was performed and PCR results showed presence of varicella zoster. The patient was currently still hospitalized, had been put on intravenous Acyclovir in the hospital. No further details were provided by the reporter.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyporeflexia, Immunoglobulins normal, Mental status changes, Muscular weakness, Neck pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of varicella zoster virus infection in a 77-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Aspirin, finasteride, FLOMAX, Lidocaine, HUMALOG and atenolol. In May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 21 days after receiving SHINGRIX, the patient experienced varicella zoster virus infection (serious criteria hospitalization), redness (serious criteria hospitalization), skin scaly (serious criteria hospitalization) and rash (serious criteria hospitalization). In June 2018, the patient experienced confusion. The patient was treated with acyclovir. On an unknown date, the outcome of the varicella zoster virus infection, redness, skin scaly, rash and confusion were unknown. It was unknown if the reporter considered the varicella zoster virus infection, redness, skin scaly, rash and confusion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 3 weeks prior to being hospitalized. The patient experienced rash mostly in C6T1 dermatome and lesions scattered in chest and back. The patient also presented with redness and scaling over thoracic dermatome. The patient presented to the hospital on 6th June 2018. Prior to admission, the patient also presented as being confused. On 6th June 2018, Varicella antibody Ig G and Ig M test results came out positive. On 9th June 2018 lumbar puncture was performed and PCR results showed presence of varicella zoster. The patient was currently still hospitalized, had been put on intravenous Acyclovir in the hospital. No further details were provided by the reporter.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral motor neuropathy, Rash vesicular, Varicella virus test positive
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of varicella zoster virus infection in a 77-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Aspirin, finasteride, FLOMAX, Lidocaine, HUMALOG and atenolol. In May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 21 days after receiving SHINGRIX, the patient experienced varicella zoster virus infection (serious criteria hospitalization), redness (serious criteria hospitalization), skin scaly (serious criteria hospitalization) and rash (serious criteria hospitalization). In June 2018, the patient experienced confusion. The patient was treated with acyclovir. On an unknown date, the outcome of the varicella zoster virus infection, redness, skin scaly, rash and confusion were unknown. It was unknown if the reporter considered the varicella zoster virus infection, redness, skin scaly, rash and confusion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 3 weeks prior to being hospitalized. The patient experienced rash mostly in C6T1 dermatome and lesions scattered in chest and back. The patient also presented with redness and scaling over thoracic dermatome. The patient presented to the hospital on 6th June 2018. Prior to admission, the patient also presented as being confused. On 6th June 2018, Varicella antibody Ig G and Ig M test results came out positive. On 9th June 2018 lumbar puncture was performed and PCR results showed presence of varicella zoster. The patient was currently still hospitalized, had been put on intravenous Acyclovir in the hospital. No further details were provided by the reporter.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Erythema, Lumbar puncture abnormal, Polymerase chain reaction positive, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of varicella zoster virus infection in a 77-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Aspirin, finasteride, FLOMAX, Lidocaine, HUMALOG and atenolol. In May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 21 days after receiving SHINGRIX, the patient experienced varicella zoster virus infection (serious criteria hospitalization), redness (serious criteria hospitalization), skin scaly (serious criteria hospitalization) and rash (serious criteria hospitalization). In June 2018, the patient experienced confusion. The patient was treated with acyclovir. On an unknown date, the outcome of the varicella zoster virus infection, redness, skin scaly, rash and confusion were unknown. It was unknown if the reporter considered the varicella zoster virus infection, redness, skin scaly, rash and confusion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 3 weeks prior to being hospitalized. The patient experienced rash mostly in C6T1 dermatome and lesions scattered in chest and back. The patient also presented with redness and scaling over thoracic dermatome. The patient presented to the hospital on 6th June 2018. Prior to admission, the patient also presented as being confused. On 6th June 2018, Varicella antibody Ig G and Ig M test results came out positive. On 9th June 2018 lumbar puncture was performed and PCR results showed presence of varicella zoster. The patient was currently still hospitalized, had been put on intravenous Acyclovir in the hospital. No further details were provided by the reporter.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin exfoliation, Skin lesion, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of varicella zoster virus infection in a 77-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Aspirin, finasteride, FLOMAX, Lidocaine, HUMALOG and atenolol. In May 2018, the patient received the 1st dose of SHINGRIX. On 6th June 2018, 21 days after receiving SHINGRIX, the patient experienced varicella zoster virus infection (serious criteria hospitalization), redness (serious criteria hospitalization), skin scaly (serious criteria hospitalization) and rash (serious criteria hospitalization). In June 2018, the patient experienced confusion. The patient was treated with acyclovir. On an unknown date, the outcome of the varicella zoster virus infection, redness, skin scaly, rash and confusion were unknown. It was unknown if the reporter considered the varicella zoster virus infection, redness, skin scaly, rash and confusion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 3 weeks prior to being hospitalized. The patient experienced rash mostly in C6T1 dermatome and lesions scattered in chest and back. The patient also presented with redness and scaling over thoracic dermatome. The patient presented to the hospital on 6th June 2018. Prior to admission, the patient also presented as being confused. On 6th June 2018, Varicella antibody Ig G and Ig M test results came out positive. On 9th June 2018 lumbar puncture was performed and PCR results showed presence of varicella zoster. The patient was currently still hospitalized, had been put on intravenous Acyclovir in the hospital. No further details were provided by the reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 14 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Certified pharmacist technician. The health care professional (HCP) reported that the patient received SHINGRIX in the left deltoid. After 2 weeks, the patient experienced rash on her chest, back and her right arm. The patient went to her physician and the physician diagnosed it as shingles.
Sex: F
Vaccine: VARZOS, FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced soreness at her injection site. This case has been linked with case US2018103104, same patient.
Age: 82.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Patient presented to pharmacy today (6/18/18) with a reddened, inflamed, itchy and painful left arm at site of injection. She had already taken Benadryl for several nights. I recommended her to go to her doctor right away and faxed injection information to their office. She was seen immediately and given a course of antibiotics (zpack) which was filled and patient started taking today.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Pain in extremity, Peripheral swelling
Clinical narrative: My upper arm was immediately sore following the administering of the shot, by the next day from my shoulder to my elbow was very sore and swollen. After 48 hours it began to get irritated and I noticed a small red areas in the middle of my upper arm (a few inches below where the shot was administered at the very top of my arm. This red spot grew and by Saturday morning was about 2 inches, lumpy and hot. It was also quite painful, over the next two days the spot grew considerably encompassing the outside half of my upper arm. It burned and hurt quite a lot, even more if I moved my arm to carry something, walk or drive. It was visibly swollen as well. On Monday I went to the doctor who gave ne a shot to counteract the effects.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: My upper arm was immediately sore following the administering of the shot, by the next day from my shoulder to my elbow was very sore and swollen. After 48 hours it began to get irritated and I noticed a small red areas in the middle of my upper arm (a few inches below where the shot was administered at the very top of my arm. This red spot grew and by Saturday morning was about 2 inches, lumpy and hot. It was also quite painful, over the next two days the spot grew considerably encompassing the outside half of my upper arm. It burned and hurt quite a lot, even more if I moved my arm to carry something, walk or drive. It was visibly swollen as well. On Monday I went to the doctor who gave ne a shot to counteract the effects.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Gave patient pediatric dose instead of adult dose.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 23-MAY-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, vial, lot # N011647, expiry date: 17-NOV-2018, orally, for prophylaxis (strength, dose and dosage schedule were not provided) (product storage error). No adverse effects were reported. The temperature excursion and time frame for ROTATEQ was between 47°F to 77°F for a time frame of 36 hours. No previous temperature excursion was reported. No data logger was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-MAR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster the very virus the ZOSTAVAX vaccine was intended to prevent. Later in July 2014 the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX, for 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. During 2016 the patient was treated at a medical facility for symptoms of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for 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: Herpes zoster, Neuralgia, Rash, Rash vesicular, Trigeminal neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JAN-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-NOV-2015 (note that this is before the reported vaccination date), the patient was treated by a physician for a vesicular rash which was diagnosed as trigeminal neuralgia and peripheral neuropathic pain. He was prescribed fentanyl for management of his painful symptoms. On or about 09-FEB-2016, the patient sought subsequent treatment from the same physician for a painful rash which was diagnosed as trigeminal neuralgia and peripheral neuropathic pain. He was prescribed fentanyl for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. The date of vaccination was noted to be after the initial onset of events. Upon receipt of follow-up, this date will be updated/clarified. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2011, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-AUG-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 23-JAN-2016, the patient was treated at a physician's office for a persistent vesicular rash, which was which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as shingles. She was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Sex: F
Vaccine: VARZOS
Symptoms: 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 or about 01-JUL-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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: 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 during 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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: 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 24-NOV-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-DEC-2014, the patient was treated for a vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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: Herpes zoster, Ophthalmic 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 during 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-OCT-2011, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster ophthalmus. On or about 09-NOV-2011, the patient sought subsequent treatment from a physician for a vesicular outbreak, which was diagnosed as herpes zoster keratitis. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Upon internal review, herpes zoster ophthalmus and herpes zoster keratitis were determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine "did" [considered an error] function as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, he was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine "did" [considered an error] function as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 21-JUL-2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, hydrocodone and NORVASC for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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: 68.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a healthcare referring to a 68 year old patient of unknown gender. The patient's had no medical history, concurrent conditions or concomitant medications. On 11-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, lot in the left deltoid, lot number N034525 and expiration date of 13-SEP-2019 for prophylaxis (route of administration was not reported). On 12-JUN-2018, the patient got back to the office with complains of redness, swelling and itching at injection site. The patient was treated with "some OTC medicine" and BENADRYL for itching. There were no laboratory diagnostics or studies performed. At the time of the report, the outcome of redness, swelling and itching at injection site was reported as resolving. Additionally, the reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous
Clinical narrative: Red shingles rash on front of right leg from just below the knee all the way down to the ankle, about 18" long, and width varying from 3 inches down to 1/2 inch.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: High fever began a little over a day after the shot, severe arm pain, approximately 4 days after arm began getting red and swollen, was diagnosed at clinic as cellulitis and KEFLEX 500 mg 4 x a day was prescribed and strarted improving.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Patient reported tingling, burning in nerve endings throughout the body. Patient has HSV and takes valacyclovir at onset of HSV symptoms to prevent outbreak of skin lesions. Symptoms were characteristic of signs of HSV flair except they were all over the body instead of isolated to the lower back and buttock region. Patient took his normal course of valacyclovir. Symptoms went away and he did not experience an outbreak of skin leasions.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms. General body aches and fever.
Age: 0.08
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Blood test, Dehydration, Musculoskeletal stiffness, Respiratory arrest, Screaming
Clinical narrative: Left drs office, baby screaming. Got home, baby screamed until she fell asleep. Put baby in bassinet and clipped Souza on her. About an hour later heard the alarm and baby wasn't breathing. Was able to get her breathing, when she got stiff. Looked it up and was a seizure. Baby continued to seize in hospital and nurse confirmed it was seizures. Baby had no fever. Projectile vomiting, dehydrated from that. I refused to leave baby there in fear of her being vaccinated again while out of my site.
Age: 0.08
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Seizure, Vomiting projectile
Clinical narrative: Left drs office, baby screaming. Got home, baby screamed until she fell asleep. Put baby in bassinet and clipped Souza on her. About an hour later heard the alarm and baby wasn't breathing. Was able to get her breathing, when she got stiff. Looked it up and was a seizure. Baby continued to seize in hospital and nurse confirmed it was seizures. Baby had no fever. Projectile vomiting, dehydrated from that. I refused to leave baby there in fear of her being vaccinated again while out of my site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Pain, Swelling
Clinical narrative: Patient described pain and hard swelling around the lower tricep area. She now states that she can not raise her arm abover parallel due to weakness and pain. She does have redness and swelling in the tricep area. She has seen 2 doctors by her account for this. Her primary doctor, has given her a prescription for Medrol Dose Pack and has advised her to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an expired dose of VAQTA, lot # N005796 for prophylaxis (expired vaccine used) (dosage schedule and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female, age and medical history not provided. The patient was inoculated with ZOSTAVAX by her physician on 03-AUG-2012 for routine adult health maintenance and for the intended purpose of the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus ZOSTAVAX was intended to prevent. On or about 16-JUL-2016 the patient was treated at an urgent care for a blistering vesicular outbreak, which was diagnosed as herpes zoster/shingles. As a direct and proximate result of the ZOSTAVAX 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 suffered and continue to suffer significant medical expenses, and pain and suffering and other damages. Outcome of herpes zoster/shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash generalised, Rash vesicular, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with VARIVAX for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On an unknown date, also reported as "after being vaccinated with VARIVAX", the patient developed chickenpox, described also as a varicella like rash, rash all over his entire body, on his feet, torso, legs, arms and chest. The patient was prescribed an acyclovir by a physician (dose, lot and expiration date unknown by reporter), on an unspecified date to treat the chickenpox. The reporting pharmacist inquired what to put samples in that were taken from rash. It was also reported, that he patient's mother and sister now also have chickenpox and are taking an unspecified anti-viral to treat the chickenpox. The outcome of varicella was unknown. The relatedness between the event and VARIVAX was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 02-JUL-2016, he was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, he was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a hospital as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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: 40.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Erythema, Injection site discolouration, Insomnia, Mobility decreased, Pain
Clinical narrative: Signs/Symptoms as described by patient: Day after injection - Entire shoulder was red and hot to the touch. Arm was very painful, could not lift arm nor sleep on it. Two days after injection - Injection site was dark purple. Three weeks after injection - Pain to arm with movement, unable to sleep on side of injection secondary to pain. Certain movements cause shooting pain from shoulder up to neck on the left side. Patient followed up with PCP.
Age: 40.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Signs/Symptoms as described by patient: Day after injection - Entire shoulder was red and hot to the touch. Arm was very painful, could not lift arm nor sleep on it. Two days after injection - Injection site was dark purple. Three weeks after injection - Pain to arm with movement, unable to sleep on side of injection secondary to pain. Certain movements cause shooting pain from shoulder up to neck on the left side. Patient followed up with PCP.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Diarrhoea, Menstruation irregular, Pain, Vomiting
Clinical narrative: My period started 2 weeks early, the day after the shot, within 4 hours of receiving the shot I began to experience diarrhea that lasted for 48 hours. Within 24 hours of the shot I was in excruciating pain and doubled over with vomiting. I went to the emergency room and was treated with little relief for the pain. The following month the day my period started I was again in excruciating pain and vomiting, again I went to the emergency room and was was treated for pain with no relief. This is my third period since the shot and I find myself again in excruciating pain with no relief in sight. *I was not told that the vaccine contained Latex, if I was told I would have avoided it.*
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Ear infection, Measles post vaccine, Pyrexia, Rash generalised
Clinical narrative: 15 month old female Received MMR and DTap Vaccine at well check up visit on 06/06/18. The pediatrican stated that she had a red ear at time of visit and suspected she may have an ear infection which she later prescribed amoxicillin for on 06/09/18. After being on antibiotics for 6 days she then spiked high fevers 104 degrees and higher (nine days after receiving vaccine). The 15 month old was then brought to pediatrician's office and was examined. Pediatrician stated that she believed it was roseola and suspected a rash would appear after the fevers broke. Fever broke on Sunday June 17 and the 15 month old began a rash that spread to her whole body including her trunk, torso, ears, soles of feet and palms of hands. The 15 month old was then brought back to pediatrician as the rash did not look like roseola pediatrician stated that she agreed that rash did not present at roseola and instead looked like measles that may have been caused by the live vaccine in which she received.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: An area on his LEFT thigh (MMRV) swelled, causing a 3 inch diameter hard, red, raised area that was painful and caused him to limp. This lasted over a week, and I treated it with BENADRYL, cool compress, and oral steroid. After about 12 days, it was no longer hurting and the redness and swelling was subsiding.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Diet refusal, Dizziness, Fatigue, Gait disturbance
Clinical narrative: He fell asleep on our way home from getting his vaccines when he woke up he acted tired and dizzy was having trouble sitting up by himself.. that soon faded but he still has slight trouble sitting up straight or walking straight. This morning he woke up crying and wouldn't eat anything so I looked in his mouth and he had white ulcers on his tongue. I immediately searched what vaccine could cause white ulcers in the mouth and it pulled up the Dtap shot he received yesterday.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Posture abnormal, Somnolence, Tongue ulceration
Clinical narrative: He fell asleep on our way home from getting his vaccines when he woke up he acted tired and dizzy was having trouble sitting up by himself.. that soon faded but he still has slight trouble sitting up straight or walking straight. This morning he woke up crying and wouldn't eat anything so I looked in his mouth and he had white ulcers on his tongue. I immediately searched what vaccine could cause white ulcers in the mouth and it pulled up the Dtap shot he received yesterday.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Discomfort, Dizziness, Injection site bruising
Clinical narrative: Shot was administered in Doctor's office by a medical assistant and/or nurse. The shot was injected into the right shoulder, not into the right arm. Within 15 minutes after shot was administered, symptoms included heart palpitations, diarrhea, vomiting, dizziness, weakness and faintness. Within 12 hours of injection, pain emanating from right shoulder all the way down the arm to the fingers. Unable to sleep the first night due to discomfort from injection. Morning after, rash from right shoulder to right elbow, itchiness, swelling at site of injection and in right biceps/deltoid areas, bruising around injection site, numbness and pain - has received physical therapy to help regain motion in right shoulder/arm. Has taken pain killers including Gabapentin (300 mg X 3 times daily), Extra strength TYLENOL, Prednisone (10mg), CELEBREX, Methylprednisone (4mg dose pack).