chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain in extremity, Pityriasis rosea, Pruritus, Scar
Clinical narrative: This case was reported by a consumer and described the occurrence of pityriasis rosea in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included blood pressure high, benign prostatic hyperplasia, genital herpes and chickenpox (as a child). Previously experienced adverse reactions included genital herpes (flare up with anti-flu vaccine). Concomitant products included amlodipine, loratadine, Aspirine, enalapril and alfuzosin. On 19th May 2018, the patient received SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced pain in arm. On 23rd May 2018, the patient experienced tiredness. On 10th June 2018, the patient experienced pityriasis rosea, localized itching and skin ulcer. On an unknown date, the patient experienced scar and skin lesion. The patient was treated with hydrocortisone. On an unknown date, the outcome of the pityriasis rosea, pain in arm, tiredness, localized itching, skin ulcer, scar and skin lesion were unknown. It was unknown if the reporter considered the pityriasis rosea, pain in arm, tiredness, localized itching, skin ulcer, scar and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced sore right arm in 3 days and tiredness on the 4th day. On 10th June 2018, 22 days after receiving SHINGRIX, there appeared small itchy sore like a mosquito bites on left tight. It spread to torso, back, abdomen, buttocks and thigh. On 19th June 2018, the sores was diagnosed as Pityriasis Rosea and was prescribed Hydrocortisone cream 2.5 percent. On 3rd July 2018 at the date of reporting, the patient still have scars from the sores and the lesions itches.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion, Skin ulcer
Clinical narrative: This case was reported by a consumer and described the occurrence of pityriasis rosea in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included blood pressure high, benign prostatic hyperplasia, genital herpes and chickenpox (as a child). Previously experienced adverse reactions included genital herpes (flare up with anti-flu vaccine). Concomitant products included amlodipine, loratadine, Aspirine, enalapril and alfuzosin. On 19th May 2018, the patient received SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced pain in arm. On 23rd May 2018, the patient experienced tiredness. On 10th June 2018, the patient experienced pityriasis rosea, localized itching and skin ulcer. On an unknown date, the patient experienced scar and skin lesion. The patient was treated with hydrocortisone. On an unknown date, the outcome of the pityriasis rosea, pain in arm, tiredness, localized itching, skin ulcer, scar and skin lesion were unknown. It was unknown if the reporter considered the pityriasis rosea, pain in arm, tiredness, localized itching, skin ulcer, scar and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced sore right arm in 3 days and tiredness on the 4th day. On 10th June 2018, 22 days after receiving SHINGRIX, there appeared small itchy sore like a mosquito bites on left tight. It spread to torso, back, abdomen, buttocks and thigh. On 19th June 2018, the sores was diagnosed as Pityriasis Rosea and was prescribed Hydrocortisone cream 2.5 percent. On 3rd July 2018 at the date of reporting, the patient still have scars from the sores and the lesions itches.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 24th March 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The HCP (healthcare professional) reported that the patient received SHINGRIX and had complained of ongoing arm pain.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 24th March 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The HCP (healthcare professional) reported that the patient received SHINGRIX and had complained of ongoing arm pain.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Injection site bruising, Injection site discharge, Injection site discolouration, Injection site pain
Clinical narrative: PATIENT DEVELOPED A SIHNGLES-LOOKING SKIN REACTION - DRAMATIC; REDNESS, BLISTERS, PAIN, THEN DRAMATIC BRUISING.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site scab, Swelling
Clinical narrative: PATIENT DEVELOPED A SIHNGLES-LOOKING SKIN REACTION - DRAMATIC; REDNESS, BLISTERS, PAIN, THEN DRAMATIC BRUISING.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Contusion, Erythema, Pain, Rash vesicular
Clinical narrative: PATIENT DEVELOPED A SIHNGLES-LOOKING SKIN REACTION - DRAMATIC; REDNESS, BLISTERS, PAIN, THEN DRAMATIC BRUISING.
Age: 59.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Back pain, Dizziness, Dyspnoea, Generalised erythema, Immediate post-injection reaction
Clinical narrative: As patient was exiting the room he felt suddenly dizzy with a sharp electric pain radiating down his right arm. He feelt immediately short of breath and began to get red all over. He was examined andf ound to have no wheezing and mild tachycardia. Pulse ox was 93% and he was given 2L of oxygen. Tachypnea gradually resolved. He experienced sharp shooting back pain for less than 1 minute. He had received PNEUMOVAX and SHINGRIX just prior to this episode. He was treated with benadryl IM 25 mg. He improved. Normal blood pressure 122/72, pulse ox 98% on RA and hr 80 prior to leaving the clinic.
Age: 59.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Pain in extremity, Tachypnoea
Clinical narrative: As patient was exiting the room he felt suddenly dizzy with a sharp electric pain radiating down his right arm. He feelt immediately short of breath and began to get red all over. He was examined andf ound to have no wheezing and mild tachycardia. Pulse ox was 93% and he was given 2L of oxygen. Tachypnea gradually resolved. He experienced sharp shooting back pain for less than 1 minute. He had received PNEUMOVAX and SHINGRIX just prior to this episode. He was treated with benadryl IM 25 mg. He improved. Normal blood pressure 122/72, pulse ox 98% on RA and hr 80 prior to leaving the clinic.
Age: 59.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Back pain, Dizziness, Generalised erythema, Immediate post-injection reaction, Pain
Clinical narrative: As patient was exiting the room he felt suddenly dizzy with a sharp electric pain radiating down his right arm. He feelt immediately short of breath and began to get red all over. He was examined andf ound to have no wheezing and mild tachycardia. Pulse ox was 93% and he was given 2L of oxygen. Tachypnea gradually resolved. He experienced sharp shooting back pain for less than 1 minute. He had received PNEUMOVAX and SHINGRIX just prior to this episode. He was treated with benadryl IM 25 mg. He improved. Normal blood pressure 122/72, pulse ox 98% on RA and hr 80 prior to leaving the clinic.
Age: 59.0
Sex: M
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Pain in extremity, Tachycardia, Tachypnoea
Clinical narrative: As patient was exiting the room he felt suddenly dizzy with a sharp electric pain radiating down his right arm. He feelt immediately short of breath and began to get red all over. He was examined andf ound to have no wheezing and mild tachycardia. Pulse ox was 93% and he was given 2L of oxygen. Tachypnea gradually resolved. He experienced sharp shooting back pain for less than 1 minute. He had received PNEUMOVAX and SHINGRIX just prior to this episode. He was treated with benadryl IM 25 mg. He improved. Normal blood pressure 122/72, pulse ox 98% on RA and hr 80 prior to leaving the clinic.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Gait disturbance
Clinical narrative: For 4 straight days patient, who walked over well prior, dragged his entire right side while attempting to get around.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Presyncope
Clinical narrative: Patient experienced near syncopal episode immediately after injection. Patient was placed in the supine position, legs elevated and juice provided. Vitals monitored. Observed in the clinic for an additional 20 minutes and discharged without any further complications.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Very painful, hot  and bumpy red and about 5" x 10".
Age: 22.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test positive
Clinical narrative: Patient came to office on 5/29/2018 for suture removal related to a self inflicted cut to Right Arm.  Health Maintenance regarding the need for BEXSERO and GARDASIL 9 was offered and patient accepted. Patient returned in 2 months, 7/9/2018 after a positive pregnancy test. She then reported that her last menstrual period was in February between Depo Injections. Patient also reported she started taking OCP last month but has since stopped due to the positive pregnancy test.  on 7/9/2018 it is thought that patient was 6/7 weeks along.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Dizziness, Pain, Pyrexia
Clinical narrative: Fever, dizziness, loss of appetite, pain, chills.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Cough, Fatigue, Headache
Clinical narrative: Muscle pain, tiredness, headache, shivering, fever, upset stomach, bad cough, head feels stuffy.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Muscle pain, tiredness, headache, shivering, fever, upset stomach, bad cough, head feels stuffy.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Myalgia
Clinical narrative: Headache, aching muscles (flu-like symptoms), fatigue and a sore upper arm the flu-like symptoms began several hours after the vaccination and by later that evening i felt terrible. The next day the symptoms continued all day and night. The second morning after the vaccination i woke up feeling normal. I did not sense that this reaction was anything but normal adverse reaction. I'm reporting it because it is the socially responsible thing to do.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Headache, aching muscles (flu-like symptoms), fatigue and a sore upper arm the flu-like symptoms began several hours after the vaccination and by later that evening i felt terrible. The next day the symptoms continued all day and night. The second morning after the vaccination i woke up feeling normal. I did not sense that this reaction was anything but normal adverse reaction. I'm reporting it because it is the socially responsible thing to do.
Age: 76.0
Sex: F
Vaccine: RV1
Symptoms: Blister, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Extreme itching on the back of the left hand accompanied by moderate swelling of the left hand. This was followed by numerous (over 100) very small blisters on the back of the left hand. This has continued for a week although the symptoms appear to be subsiding. As of yesterday (July 14, 2018) the back of the left hand is still warm to the touch and still has some slight swelling.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Muscle contusion, Myalgia, Skin warm
Clinical narrative: Deltoid was red, hot to the touch, sore, and had contusion.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Large area of localized swelling, redness, and warmth at injection site and throughout arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Large area of localized swelling, redness, and warmth at injection site and throughout arm.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD recombinant Human Albumin (which had a lot # of N028445 and an expiration date of 09-APR-2019; however, dose, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions on an unknown date: 15F to 46F for 2 hours. There was a previous temperature excursion of 15F to 46F for 23 hours and 30 minutes on an unknown date and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved.
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 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose 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 of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. 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 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. On or about 22-AUG-2009, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose 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 of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 24-SEP-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 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: Blister, 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 19-AUG-2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2015 the patient was treated by a physician for the 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: 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 1-OCT-2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose 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 of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 01-MAR-2016, the patient was treated at an eye facility for a 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: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant/clinical coordinator and refers to a 39 year old patient of an unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD 0.5 ml, once, subcutaneously, lot # N022972, expiration date 19-FEB-2019.5 for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a 26 year old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 05-JUL-2018, the patient was vaccinated with a first dose GARDASIL subcutaneously (dose, lot# and expiration date were not reported) for prophylaxis. The patient wanted to know if she should repeat the injection due to wrong route of administration.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at an urgent care, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2012, the patient was treated at an urgent care for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2007, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a medical center/hospital as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 26-SEP-2015, the patient was treated (by an unspecified healthcare professional) at a medical center/hospital for a blistering vesicular outbreak that was diagnosed as severe 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 direct and proximate result of these malfunctions, 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.  The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-JUL2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical facility/office, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 22-AUG-2016, the patient was treated at a medical facility/office, for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of 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 direct and proximate result of these malfunctions, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A female patient, age unspecified, was inoculated with ZOSTAVAX on 22-MAY-2012 at a medical clinic as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. In 2014  the patient was treated by a physician at a medical clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster,  or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-NOV-2015, the patient was treated by the hospital, for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster. The patient was prescribed hydrocodone and acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of 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 direct and proximate result of these malfunctions, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Post herpetic neuralgia, 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 11-JAN-2016, the patient was treated by a physician, for a blistering vesicular outbreak which was diagnosed as chronic post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of 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 direct and proximate result of these malfunctions, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. 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 2006, 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 of herpes zoster, also known as shingles and other complications. On or about 05-MAY-2015, the patient was treated at a hospital (it was not specified whether she was admitted; therefore, considered Emergency Room visit until follow-up is received) for a blistering vesicular outbreak, which was diagnosed as severe 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: 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 2012, the patient was inoculated with ZOSTAVAX at a pharmacy 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 of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe 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: 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 2016, the patient was inoculated with ZOSTAVAX 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 of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at the same medical center (not specified if admitted; therefore considered an Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-JAN-2013, the patient was inoculated with ZOSTAVAX at a clinic 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. In 2016, the patient was treated at a clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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. 13-JUL-2018. This is a correction. The case was opened to update the general tab with source information. 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2012, 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 12-AUG-2016, the patient was treated at a clinic by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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: 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-MAR-2014, the patient was inoculated with ZOSTAVAX at a doctor's office 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 14-SEP-2015, the patient was treated at a doctor's office by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient was treated with famciclovir (FAMVIR) and amitriptyline hydrochloride (ELAVIL) for management of her painful symptoms and chronic pain. As a direct and proximate result of 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: F
Vaccine: VARZOS
Symptoms: Blister, Death, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and the spouse of a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of persistent strain condition of herpes zoster/shingles and ZOSTAVAX did not prevent shingles as intended 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 significant medical expenses, and pain and suffering, and other damages. The patient died on 07-JAN-2017; cause of death not provided. It is unknown if an autopsy was performed. Upon internal review, death was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: Death.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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: Emotional distress, Herpes zoster, Pain, Physical disability, Quality of life decreased
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 medication use were not provided. On or about 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 11-JUL-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. Shingles outbreak was reported to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion
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 medication use were not provided. On or about 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 11-JUL-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. Shingles outbreak was reported to be disabling. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a nurse, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-JUN-2018, the patient inadvertently received a pediatric/adolescent dose of VAQTA lot # N026997, expiration date on 10-NOV-2018, 0.5 ml, once, intramuscularly (anatomical location was not reported) for prophylaxis. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Sender's Comments: US-009507513-1807USA001764.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 2nd dose of SHINGRIX. On 1st July 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm (The patient did not know lot number, expiration date, or dose of SHINGRIX). The patient had a rash on her neck. The rash was described as itchy. The patient was treated with 1 percent hydrocortisone for rash. Since rash developed it had gotten larger. The patient advised pharmacy and her doctor about the rash. The patient could not provide full contact details for pharmacy and contact details for healthcare professional.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after 1st dose, refer case US2018GSK124969, same reporter). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The pharmacist was the patient. The age at vaccination was not reported. The patient experienced sore arm that lasted for 2 to 3 days. He also stated that the first vaccination was more painful than the second.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal discomfort, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ophthalmic herpes zoster. Concomitant products included amitriptyline and Eye Drops. On 5th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced tiredness, general body pain, fever and muscle discomfort. On an unknown date, the outcome of the tiredness, general body pain, fever and muscle discomfort were recovered/resolved. It was unknown if the reporter considered the tiredness, general body pain, fever and muscle discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he felt the vaccine going into his muscle, that evening he had a little fever and felt tired, was sore all over and after 4 days the events resolved.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Fatigue, Hallucination, Nightmare, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, nightmare, hallucination, pain in arm and abnormal dreams. On an unknown date, the outcome of the fatigue, nightmare, hallucination, pain in arm and abnormal dreams were recovered/resolved. It was unknown if the reporter considered the fatigue, nightmare, hallucination, pain in arm and abnormal dreams to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The patient received the SHINGRIX vaccine at a local pharmacy (different location from reporter). The patient reported 5 days of symptoms and several nights of dreams and hallucinations. The patient experienced fatigue, sore arm, nightmares, and possible hallucinations.