chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Chills, Erythema, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient with reaction to ethanol and no drug allergies. The patient had no pertinent medical history. On 11-OCT-2018, the patient received a dose of PNEUMOVAX 23 lot # R006466, expiring on 24-OCT-2019, for immunisation (dose, route and site of administration were not reported). The patient's concomitant medications included blood pressure and thyroid medications. On 11-OCT-2018, the patient's arm where the vaccine was administered became swollen (peripheral swelling), red (erythema), and warm to the touch (skin warm). The patient also experienced chills and pain that radiated to his chest. The pharmacist also reported that when the patient blinked his eyes, objects seemed to be vibrating (visual impairment). The patient went to see the pharmacist for medical attention. Not lab diagnostic test were performed. No treatment was given for the events. On 12-OCT-2018, the pain still persisted, but the eye symptoms had subsided. At the time of the report, the patient had not recovered from skin warm, erythema, peripheral swelling, and chills. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the events.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Skin warm, Visual impairment
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient with reaction to ethanol and no drug allergies. The patient had no pertinent medical history. On 11-OCT-2018, the patient received a dose of PNEUMOVAX 23 lot # R006466, expiring on 24-OCT-2019, for immunisation (dose, route and site of administration were not reported). The patient's concomitant medications included blood pressure and thyroid medications. On 11-OCT-2018, the patient's arm where the vaccine was administered became swollen (peripheral swelling), red (erythema), and warm to the touch (skin warm). The patient also experienced chills and pain that radiated to his chest. The pharmacist also reported that when the patient blinked his eyes, objects seemed to be vibrating (visual impairment). The patient went to see the pharmacist for medical attention. Not lab diagnostic test were performed. No treatment was given for the events. On 12-OCT-2018, the pain still persisted, but the eye symptoms had subsided. At the time of the report, the patient had not recovered from skin warm, erythema, peripheral swelling, and chills. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the events.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy test, Antinuclear antibody, Blister, Contusion, Full blood count
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin bleeding in a adult female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch. The patient was treated with ALLEGRA and Cerave Itch Relief Lotion. On an unknown date, the outcome of the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch were unknown. It was unknown if the reporter considered the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable. The week of 22nd June 2018, the patient broke out with a rash on legs, back and stomach in random locations. Some of the bumps or blisters had been as large as pencil eraser. For the most part, it had been small red bumps. The itching was so severe that the patient had scratched bruises and blood. The patient had seen a dermatologist and an allergist and so far, no one could identify a cause for patient's bumps and itching. For relief, the patient took ALLEGRA allergy medication and Cerave Itch relief Lotion. These did not stop the creation of bumps, but do control the terrible itching. The patient asked whether anyone else reported a prolonged side effect such as theirs. The brochure says the skin rash will go away in a day or two. The patient had it continuously since June 2018. On 27th July 2018, the patient received 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haemorrhage, Liver function test, Metabolic function test, Pruritus, Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin bleeding in a adult female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch. The patient was treated with ALLEGRA and Cerave Itch Relief Lotion. On an unknown date, the outcome of the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch were unknown. It was unknown if the reporter considered the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable. The week of 22nd June 2018, the patient broke out with a rash on legs, back and stomach in random locations. Some of the bumps or blisters had been as large as pencil eraser. For the most part, it had been small red bumps. The itching was so severe that the patient had scratched bruises and blood. The patient had seen a dermatologist and an allergist and so far, no one could identify a cause for patient's bumps and itching. For relief, the patient took ALLEGRA allergy medication and Cerave Itch relief Lotion. These did not stop the creation of bumps, but do control the terrible itching. The patient asked whether anyone else reported a prolonged side effect such as theirs. The brochure says the skin rash will go away in a day or two. The patient had it continuously since June 2018. On 27th July 2018, the patient received 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tryptase
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin bleeding in a adult female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch. The patient was treated with ALLEGRA and Cerave Itch Relief Lotion. On an unknown date, the outcome of the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch were unknown. It was unknown if the reporter considered the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable. The week of 22nd June 2018, the patient broke out with a rash on legs, back and stomach in random locations. Some of the bumps or blisters had been as large as pencil eraser. For the most part, it had been small red bumps. The itching was so severe that the patient had scratched bruises and blood. The patient had seen a dermatologist and an allergist and so far, no one could identify a cause for patient's bumps and itching. For relief, the patient took ALLEGRA allergy medication and Cerave Itch relief Lotion. These did not stop the creation of bumps, but do control the terrible itching. The patient asked whether anyone else reported a prolonged side effect such as theirs. The brochure says the skin rash will go away in a day or two. The patient had it continuously since June 2018. On 27th July 2018, the patient received 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Contusion, Pruritus, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin bleeding in a adult female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch. The patient was treated with ALLEGRA and Cerave Itch Relief Lotion. On an unknown date, the outcome of the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch were unknown. It was unknown if the reporter considered the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable. The week of 22nd June 2018, the patient broke out with a rash on legs, back and stomach in random locations. Some of the bumps or blisters had been as large as pencil eraser. For the most part, it had been small red bumps. The itching was so severe that the patient had scratched bruises and blood. The patient had seen a dermatologist and an allergist and so far, no one could identify a cause for patient's bumps and itching. For relief, the patient took ALLEGRA allergy medication and Cerave Itch relief Lotion. These did not stop the creation of bumps, but do control the terrible itching. The patient asked whether anyone else reported a prolonged side effect such as theirs. The brochure says the skin rash will go away in a day or two. The patient had it continuously since June 2018. On 27th July 2018, the patient received 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scratch, Skin haemorrhage, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin bleeding in a adult female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch. The patient was treated with ALLEGRA and Cerave Itch Relief Lotion. On an unknown date, the outcome of the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch were unknown. It was unknown if the reporter considered the skin bleeding, rash, local swelling, blister, pruritus, contusion and scratch to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable. The week of 22nd June 2018, the patient broke out with a rash on legs, back and stomach in random locations. Some of the bumps or blisters had been as large as pencil eraser. For the most part, it had been small red bumps. The itching was so severe that the patient had scratched bruises and blood. The patient had seen a dermatologist and an allergist and so far, no one could identify a cause for patient's bumps and itching. For relief, the patient took ALLEGRA allergy medication and Cerave Itch relief Lotion. These did not stop the creation of bumps, but do control the terrible itching. The patient asked whether anyone else reported a prolonged side effect such as theirs. The brochure says the skin rash will go away in a day or two. The patient had it continuously since June 2018. On 27th July 2018, the patient received 2nd dose of SHINGRIX.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2014, the patient was treated by a physician for a persistent vesicular rash, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Cough, Fatigue, Hyperhidrosis
Clinical narrative: Night 1: In the evening I started with chills and then slight fever. My arm was painful not at the injection site, but below in all the muscles. Right arm was hot and hard, and red blotches on the skin on the muscle area. Joints in my right hand ached. Had a light cough. The next day I felt better, but still had a painful arm and felt tired all day. Night 2: Mid afternoon I started getting chills again. Then spiked a fever of 102 and sweated through my clothes. Had a light cough when laying down. Took TYLENOL and fever broke. I was fine the next day.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Induration, Myalgia, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Night 1: In the evening I started with chills and then slight fever. My arm was painful not at the injection site, but below in all the muscles. Right arm was hot and hard, and red blotches on the skin on the muscle area. Joints in my right hand ached. Had a light cough. The next day I felt better, but still had a painful arm and felt tired all day. Night 2: Mid afternoon I started getting chills again. Then spiked a fever of 102 and sweated through my clothes. Had a light cough when laying down. Took TYLENOL and fever broke. I was fine the next day.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Night 1: In the evening I started with chills and then slight fever. My arm was painful not at the injection site, but below in all the muscles. Right arm was hot and hard, and red blotches on the skin on the muscle area. Joints in my right hand ached. Had a light cough. The next day I felt better, but still had a painful arm and felt tired all day. Night 2: Mid afternoon I started getting chills again. Then spiked a fever of 102 and sweated through my clothes. Had a light cough when laying down. Took TYLENOL and fever broke. I was fine the next day.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Mobility decreased, Muscular weakness
Clinical narrative: Patient was unable to move arm for nearly 2 days due to significant pain and muscle weakness. On exam 10/17/18, 7 x 8 x 9 cm erythematous raised swollen rhomboidal area spreading distally and medially to injection site which was slightly indurated but not firm/hard.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient was unable to move arm for nearly 2 days due to significant pain and muscle weakness. On exam 10/17/18, 7 x 8 x 9 cm erythematous raised swollen rhomboidal area spreading distally and medially to injection site which was slightly indurated but not firm/hard.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: High fever, shivers, back muscle aches, stomach muscle aches.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pruritus, Rash
Clinical narrative: EDD 12/15/18 Seen in office for prenatal visit on 10/16/18. Given weekly MAKENA injection (hx of preterm labor). Also given Tdap as patient is in third trimester. Patient returns to office the following day (10/17/18) reporting itching and rash that began shortly after her appointment on 10/16/18.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 03-OCT-2018 the patient was vaccinated with PROQUAD (1 dose form, lot # reported as R013125, expiration date: 04-NOV-2019, therapy type: rHA, strength and frequency were unknown) through the route of intramuscular (drug use via unapproved administration route) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown. On 22-MAY-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (therapy type: thimerosal free, lot# N006321, expiration date: 08-NOV-2019; dose, strength, route and frequency unknown) for prophylaxis. No adverse effects was reported. Temperature excursion was reported as below 0 Celsius degrees (C) for time frame 30 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of two cases received from the same reporter. Sender's Comments: US-00950713-1810USA007244.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Information about concurrent condition, concomitant therapy, drug reactions/allergies and medical history was not provided. On an unknown date, the patient received both the PNEUMOVAX 23 (indication: prophylaxis; strength, dose, frequency, route, lot # and expiration date were not reported) and PREVNAR 13 concomitantly (overdose). No adverse effects were reported at the time of the call.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist regarding a 72 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 08-AUG-2018, the patient was administered PREVNAR 13 (strength, dose, frequency, route of administration, lot#, expiration date and indication were not reported). On 08-OCT-2018, the patient was administered PNEUMOVAX 23 (lot# R018735, expiration date 06-APR-2020; strength, dose, frequency and route of administration were not reported) for prophylaxis (product use issue). No adverse effects was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 08-OCT-2018, the patient was vaccinated with a dose of improperly stored vaccine VARIVAX (lot # N034552 with expiration date 05-DEC-2019) (exact dose and route of administration were not provided) for prophylaxis. The VARIVAX was reconstituted with properly stored sterile diluent, (lot # and expiration date not reported). The VARIVAX experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of two reports received from the same reporter (linked to case: #1810USA007227); Sender's Comments: US-009507513-1810USA007227: Original Case: 1810USA004911.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2016, the patient was treated by the 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On an unknown date in 2015, 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 would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
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. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On an unknown date in 2016, the patient was treated 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
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. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On an unknown date in 2012, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
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. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On an unknown date in 2016, the patient was treated by a physician for a vesicular rash, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
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. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On or about 17-OCT-2017, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
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. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On or about 29-AUG-2016, the patient was treated by a physician for a severe vesicular rash, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 18-NOV-2014,  the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On 29-AUG-2016, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster. 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were reported as related to the therapy with ZOSTAVAX.
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. The patient's medical history, concurrent conditions and concomitant medications were not provided. On or about 12-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On or about 29-AUG-2016, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On an unknown date in 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 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2007, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2010, the patient was treated by the physician for a vesicular outbreak accompanied by weakened immune symptoms, 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On or about 19-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) 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 (onset date was not provided). On or about 19-SEP-2013, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VAL ACYCLOVIR and PERCOCET 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2008, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2016, the patient was treated by the physician for a severe vesicular outbreak and decreased immune symptoms which was then diagnosed as severe 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: U
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 patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX 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 an unknown date in 2015, the patient 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 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
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 male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX by a physician 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 2014, the patient 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 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. 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. In 2014, the patient was inoculated with ZOSTAVAX by a physician 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 31-AUG-2016, the patient was treated by a physician's assistant for 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
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 patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX by a physician 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 2014, the patient 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 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
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 patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX by a physician 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, the patient was treated at a medical center for 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
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 patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX 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, the patient 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 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Blindness, Dizziness, Headache, Herpes zoster, Malaise
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. On 13-OCT-2016, the patient went to a pharmacy to receive the influenza virus vaccine (unspecified) (FLU VACCINE). The pharmacy employee recommended that the patient also get the PNEUMOVAX and ZOSTAVAX vaccines. All three vaccines were administered to the patient that day. The patient was not informed of the possible side effects of drug interaction when receiving three vaccinations at the same time. Later that day the patient became violently ill. He developed a painful rash, headache, nausea, loss of vision, dizziness and fever. In response to these complaints the patient presented to his primary care physician, who diagnosed him with shingles, and postherpetic neuralgia.  The outcome of the events was not provided. Upon internal review loss of vision was considered a medically significant event. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Nausea, Post herpetic neuralgia, Pyrexia, Rash
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. On 13-OCT-2016, the patient went to a pharmacy to receive the influenza virus vaccine (unspecified) (FLU VACCINE). The pharmacy employee recommended that the patient also get the PNEUMOVAX and ZOSTAVAX vaccines. All three vaccines were administered to the patient that day. The patient was not informed of the possible side effects of drug interaction when receiving three vaccinations at the same time. Later that day the patient became violently ill. He developed a painful rash, headache, nausea, loss of vision, dizziness and fever. In response to these complaints the patient presented to his primary care physician, who diagnosed him with shingles, and postherpetic neuralgia.  The outcome of the events was not provided. Upon internal review loss of vision was considered a medically significant event. Additional information has been requested.