chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-MAR-2010, 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 and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-JUL-2016, the patient was treated by the physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-OCT-2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-DEC-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VALTREX to manage her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-JUN-2014, the patient was inoculated with the ZOSTAVAX vaccine at a drug store 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. On or about 03-FEB-2015, he was treated by a physician for a blistering 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-MAY-2012, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a clinic (by an unspecified healthcare professional) 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 03-NOV-2015, the patient was treated at the clinic (by an unspecified healthcare professional) for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX, prednisone and gabapentin for management of her painful symptoms and chronic pain. On or about 15-NOV-2015, the patient sought subsequent treatment from the clinic for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed ZOSTRIX for management of her painful symptoms and chronic pain. 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 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: 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 2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster.  In 2012, he was treated for a persistent and 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-NOV-2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, she was treated by a physician for a persistent and 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: 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 15-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical center (by an unspecified healthcare professional) 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.  On or about 01-NOV-2014, the patient was treated (by an unspecified health care professional) at the medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. 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, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2013, the patient was treated by the physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-DEC-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 2014, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, she was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested. This is an amended report, a lawyer was added as the primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2014, the patient was treated by the physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-JUL-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-JUL-2016, the patient was treated by the physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-MAY-2013 (conflicting information; the onset date of the patient's symptoms is prior to the vaccination date), the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as shingles. The patient was prescribed prednisone for management of her painful symptoms and chronic pain.  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: HPV9
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unknown date, after receiving GARDASIL 9) the patient's Papanicolaou smear (PAP) test was positive (smear cervix abnormal). It was unknown if the patient received any treatment. At the time of reporting, the outcome of smear cervix abnormal was unknown. The causal relationship between the event and the GARDASIL 9 was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral
Clinical narrative: This initial spontaneous report was received from a 60 year old female patient referring to herself. Concurrent conditions included bipolar disorder. She was allergic to unspecified medications. Concomitant medications were PRISTIQ, lithium, LAMICTAL, and topiramate. On 31-AUG-2016, the patient received ZOSTAVAX, 0.65 ml, subcutaneously for the prevention of shingles (lot # not provided). She also received the sterile diluent (lot # not provided). The patient reported that she has had gradual hearing loss "ever since". She then report the onset to be in approximately February 2017 (reported as about six months after receiving the vaccine). The patient sought medical attention (she saw an audiologist). Her last hearing test conducted on 05-JUN-2018 showed mild to moderate hearing loss on her right side and moderate to severe hearing loss on her left side. No treatment was given. The event was not recovered at the time of the report. Causality assessment was not provided. The patient was requesting compensation. Upon internal review, deafness bilateral was considered medically significant. There was no consent to contact the reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a registered nurse reporting on an adult patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 15-JUN-2018, the patient received a pediatric dose of VAQTA for prophylaxis, lot # N019924, expiration date 02-SEP-2018 (dose and route of administration were not reported). No adverse effects reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 15-JUN-2018, the patient was inadvertently vaccinated with an expire dose of PNEUMOVAX23 via intramuscular (dose and anatomical location were not reported) lot # M042324 and expiration date: 10-JUN-2018, indicated for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, feeling bad and myalgia upper extremities. On an unknown date, the outcome of the fever, feeling bad and myalgia upper extremities were recovered/resolved. It was unknown if the reporter considered the fever, feeling bad and myalgia upper extremities to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a mild fever, muscle pain down her whole arm and she felt bad for 5 days. This was 1 of 4 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a female patient who received SHINGRIX for prophylaxis. On 10th June 2018, the patient received SHINGRIX. On 10th June 2018, several hours after receiving SHINGRIX, the patient experienced flu like symptoms, muscle pain and chills. On an unknown date, the outcome of the flu like symptoms, muscle pain and chills were not recovered/not resolved. It was unknown if the reporter considered the flu like symptoms, muscle pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At around 4 PM, the patient received SHINGRIX. Initially, the patient was fine and at the night the patient started having flu like symptoms, slight chills and her muscles were hurting. The patient did not want to answer any questions to file a report.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received SHINGRIX (batch number A4X57, expiry date 31st July 2020) for prophylaxis. Concomitant products included BOOSTRIX, Calcium Unknown and Vitamin D3. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced swelling arm, injection site erythema, feels awful, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm, injection site erythema, feels awful, pain in arm and injected limb mobility decreased were recovered/resolved. The reporter considered the swelling arm, injection site erythema, feels awful, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included Echinacea. The nurse reported that the patient received the SHINGRIX vaccine in the left deltoid and experienced severe swelling on her left arm that lasted nine days after injection. The patient had pain for 24 hours after injection and where she was unable to move. Two days after immunization the patient felt terrible with redness at the injection site and the patient had an area of redness which was approximately 15 cm x 10 cm. At the time of reporting the redness had resolved.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylactic. Concomitant products included Co Q10 and simvastatin. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site lump and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site lump and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site swelling, injection site lump and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient stated that, after getting her SHINGRIX vaccine in right arm, she had redness, swelling and pain to touch at the injection site. The patient stated there was a lump at the injection site that traveled down to her elbow. The patient stated that, all the symptoms lasted 4 to 5 days. The patient had denied permission to contact their physician. The patient stated, the pharmacy mailed her a letter after her vaccines stating if she had any reaction she should call GlaxoSmithKline and report it. The patient did not have any additional information including street number, or name of pharmacist who administered the vaccine.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 49-year-old female patient who received ENGERIX B (batch number B39CM, expiry date 3rd February 2020) for prophylaxis. Concomitant products included CRESTOR, KEPPRA, Labetalol, Metformin, hydrochlorothiazide, LEXAPRO. On 20th April 2018 16:00, the patient received the 1st dose of ENGERIX B 1 ml. On 20th April 2018, less than a day after receiving ENGERIX B, the patient experienced dizziness and headache. On an unknown date, the outcome of the dizziness and headache were not recovered/not resolved. The reporter considered the dizziness and headache to be probably related to ENGERIX B. Additional details were provided as follows: The patient experienced dizziness when she bend over, sat down and when she got up too fast. She had appointments with her hematologist and general practitioner so far.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 53-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th May 2018, 6 days after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved. The reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: At 13:00, the patient received the SHINGRIX. A week after her vaccination, the patient started to experience fatigue for the last week and a half. The registered pharmacist was transferred to medical information for additional assistance.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of pain in extremity (refer case US2018GSK110165.). On 22nd May 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 22nd May 2018, 30 min after receiving SHINGRIX, the patient experienced pain in arm. On 25th May 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included cholesterol medicine and blood pressure medicine. The soreness was constant but it resolved after 2 to 3 days. The soreness was a little more intense than what he experiences from a flu shot. The patient did not take any medicine for treatment.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 19th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, rash and injection site swelling. In May 2018, the outcome of the injection site erythema, rash and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On the next day of vaccination, the patient experienced redness and swelling at the site that resolved within 2 days. She also had a trunk rash that began the next day after the injection and resolved after 3 days. The pharmacist was referred to the patient's healthcare provider (HCP) to determine appropriateness of 2nd injection.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of varicella-like rash in a 80-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash to be related to SHINGRIX. Additional details were reported as follows: The physician reported that the patient experienced rash in random spots that resembled chicken pox after receiving the SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 31st March 2018, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. She had a headache the next day on 31st March 2018 and her arm was sore for a few days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine (received at the age of 60 years). Concomitant products included calcium carbonate, vitamin d (Calcium With Vitamin D), ciclopirox olamine (Ciclopirox), thyroxine sodium (Levothyroxine), magnesium hydrogen aspartate dihydrate (Magnesium), polyethylene glycol (Miralax), propranolol hydrochloride (Propranolol), cyclosporin (Restasis), simvastatin, acetylsalicylic acid (Baby Aspirin), curcuma longa (Turmeric), raloxifene, zolpidem and mesterolone (Restore). On 30th April 2018, the patient received the 1st dose of SHINGRIX. On 9th June 2018, 40 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she received the SHINGRIX vaccine late in the morning and she was diagnosed with a very mild case of shingles a couple of days ago. The shingles presented itself on her upper right arm and above her right wrist and there are a couple of spots on the base of her thumb on her hand. The patient's physician claims that the case was very mild and possibly a case of shingles but they are treating her accordingly.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure abnormal (receiving blood pressure medication (not specified)). On 5th June 2018 12:30, the patient received the 1st dose of SHINGRIX. In June 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the blister was unknown. It was unknown if the reporter considered the shingles and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the daughter of the patient. The patient received SHINGRIX in the left arm. Two days (couple of days) after receiving SHINGRIX, the patient had 5 shingles blisters.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, Malaise, Mobility decreased, Monoplegia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arm paralysis in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (the patient received vaccine on an unknown date). In June 2018, the patient received SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced arm paralysis (serious criteria GSK medically significant), fever, red blotches, swelling arm, hallucination, mobility decreased, pain in arm, sleepiness and sickness. On an unknown date, the outcome of the arm paralysis, fever, red blotches, swelling arm, hallucination, mobility decreased, pain in arm, sleepiness and sickness were unknown. It was unknown if the reporter considered the arm paralysis, fever, red blotches, swelling arm, hallucination, mobility decreased, pain in arm, sleepiness and sickness to be related to SHINGRIX. Additional details were provided as follows: This adverse event (AE) reported via click to chat. The reporter was a patient. The patient had received many vaccines with no adverse events. The patient received a new Shingles vaccine in the previous week of reporting and sick for two days. The patient also experienced fever and felt like hallucination all night. The patient's arm was paralyzed and he could not lift his arm. The arm was swelled, got red blotches and was so sore. The patient slept most of two days and had a fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rash macular, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arm paralysis in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (the patient received vaccine on an unknown date). In June 2018, the patient received SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced arm paralysis (serious criteria GSK medically significant), fever, red blotches, swelling arm, hallucination, mobility decreased, pain in arm, sleepiness and sickness. On an unknown date, the outcome of the arm paralysis, fever, red blotches, swelling arm, hallucination, mobility decreased, pain in arm, sleepiness and sickness were unknown. It was unknown if the reporter considered the arm paralysis, fever, red blotches, swelling arm, hallucination, mobility decreased, pain in arm, sleepiness and sickness to be related to SHINGRIX. Additional details were provided as follows: This adverse event (AE) reported via click to chat. The reporter was a patient. The patient had received many vaccines with no adverse events. The patient received a new Shingles vaccine in the previous week of reporting and sick for two days. The patient also experienced fever and felt like hallucination all night. The patient's arm was paralyzed and he could not lift his arm. The arm was swelled, got red blotches and was so sore. The patient slept most of two days and had a fever.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Cerebrovascular accident, Chills, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stroke in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, chills and feeling unwell. On 1st June 2018, the patient experienced stroke (serious criteria GSK medically significant) and anxiety. On an unknown date, the outcome of the stroke, headache, chills and feeling unwell were unknown and the outcome of the anxiety was not recovered/not resolved. It was unknown if the reporter considered the stroke, headache, anxiety, chills and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was transferred from GlaxoSmithKline (GSK) Patient Assistance Foundation. The next day after vaccination, she did not feel well. She woke up with headache and chills. She took some medication and went to work. On Friday at 3 PM, 2 days after receiving SHINGRIX, the patient suffered a small stroke and someone told her that SHINGRIX could cause strokes. The patient's physician was baffled by the incident. The patient was left with anxiety from having the stroke. The patient said that there was no reason why she should have had a stroke as she was neither diabetic, nor overweight. She had no blood pressure problems. There was no reason why the patient had a stroke. Further information was not able to collect from the patient. The reporter stated that, she was calling to get an answer and she wanted to know any case of strokes had been reported previously. The patient's husband was a pharmacist, he clarified that he did not administer the vaccine and the call was transferred to medical information (MI) for questions on stroke as an adverse event. The patient provided contact details of the physician.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Anxiety, Cerebrovascular accident, Chills, Computerised tomogram
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stroke in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, chills and feeling unwell. On 1st June 2018, the patient experienced stroke (serious criteria GSK medically significant) and anxiety. On an unknown date, the outcome of the stroke, headache, chills and feeling unwell were unknown and the outcome of the anxiety was not recovered/not resolved. It was unknown if the reporter considered the stroke, headache, anxiety, chills and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was transferred from GlaxoSmithKline (GSK) Patient Assistance Foundation. The next day after vaccination, she did not feel well. She woke up with headache and chills. She took some medication and went to work. On Friday at 3 PM, 2 days after receiving SHINGRIX, the patient suffered a small stroke and someone told her that SHINGRIX could cause strokes. The patient's physician was baffled by the incident. The patient was left with anxiety from having the stroke. The patient said that there was no reason why she should have had a stroke as she was neither diabetic, nor overweight. She had no blood pressure problems. There was no reason why the patient had a stroke. Further information was not able to collect from the patient. The reporter stated that, she was calling to get an answer and she wanted to know any case of strokes had been reported previously. The patient's husband was a pharmacist, he clarified that he did not administer the vaccine and the call was transferred to medical information (MI) for questions on stroke as an adverse event. The patient provided contact details of the physician.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Fear, Headache, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stroke in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 1 days after receiving SHINGRIX, the patient experienced headache, chills and feeling unwell. On 1st June 2018, the patient experienced stroke (serious criteria GSK medically significant) and anxiety. On an unknown date, the outcome of the stroke, headache, chills and feeling unwell were unknown and the outcome of the anxiety was not recovered/not resolved. It was unknown if the reporter considered the stroke, headache, anxiety, chills and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was transferred from GlaxoSmithKline (GSK) Patient Assistance Foundation. The next day after vaccination, she did not feel well. She woke up with headache and chills. She took some medication and went to work. On Friday at 3 PM, 2 days after receiving SHINGRIX, the patient suffered a small stroke and someone told her that SHINGRIX could cause strokes. The patient's physician was baffled by the incident. The patient was left with anxiety from having the stroke. The patient said that there was no reason why she should have had a stroke as she was neither diabetic, nor overweight. She had no blood pressure problems. There was no reason why the patient had a stroke. Further information was not able to collect from the patient. The reporter stated that, she was calling to get an answer and she wanted to know any case of strokes had been reported previously. The patient's husband was a pharmacist, he clarified that he did not administer the vaccine and the call was transferred to medical information (MI) for questions on stroke as an adverse event. The patient provided contact details of the physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of flu like symptoms in a 70-year-old female patient who received SHINGRIX (batch number DK74P, expiry date 6th March 2020) for prophylaxis. On 31st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st April 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms (serious criteria disability), fatigue (serious criteria disability) and fever (serious criteria disability). On an unknown date, the outcome of the flu like symptoms, fatigue and fever were recovered/resolved. The reporter considered the flu like symptoms, fatigue and fever to be related to SHINGRIX. Additional information was received as follows: At 15:35, the patient received SHINGRIX on the right arm. One to two days after receiving SHINGRIX, the patient experienced the flu like symptoms (mostly fatigue and fever) and these resolved three to four days later. The healthcare professional stated that symptoms were disabling in that the patient could not do her job, although the patient went to work, but the patient was not happy. This case is one of 8 cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of flu like symptoms in a 65-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 20th March 2020) for prophylaxis. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms (serious criteria disability), fatigue (serious criteria disability) and fever (serious criteria disability). On an unknown date, the outcome of the flu like symptoms, fatigue and fever were recovered/resolved. The reporter considered the flu like symptoms, fatigue and fever to be related to SHINGRIX. Additional information was received as follows: At 11:40, the patient received SHINGRIX on left arm. The flu like symptoms (mostly fatigue and fever) resolved 10 days later. The healthcare professional stated that symptoms were disabling the patient, who felt like the flu. The patient did not want to come back for the 2nd dose of SHINGRIX. This case is one of 8 cases reported by the same reporter.