chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, FLU3, TD
Symptoms: Neck mass
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 23-JAN-2017, the patient was inoculated with the 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, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. Shortly after receiving the ZOSTAVAX, the patient developed burning, itching, redness and broke out in a rash. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from herpes zoster. As a result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a direct result of the ZOSTAVAX, the patient symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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 outcome of the events was considered to be not recovered. Herpes zoster and vaccination failure were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Herpes zoster, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain
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 early 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. In approximately 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient developed bruising and pain in the arm in which the ZOSTAVAX was administered, accompanied by limited range of motion. The patient also suffered issues with her vision, which has resulted in her not being able to perform every day activities of normal life, as she cannot focus her eyes. In response to these symptoms, the patient presented to a physician and remains under their care. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Issues with her vision/cannot focus her eyes was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vision blurred
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 early 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. In approximately 2016 [reported as "shortly after" receiving ZOSTAVAX], the patient developed bruising and pain in the arm in which the ZOSTAVAX was administered, accompanied by limited range of motion. The patient also suffered issues with her vision, which has resulted in her not being able to perform every day activities of normal life, as she cannot focus her eyes. In response to these symptoms, the patient presented to a physician and remains under their care. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Issues with her vision/cannot focus her eyes was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Pneumonia
Clinical narrative: This spontaneous report was received from a nurse and refers to a 74-year-old female patient. The patient's concurrent conditions were not reported. Relevant medical history was reported as "cardiovascular history". Concomitant medications were reported as "lots of medicines" (not specified). On an unspecified date of 2005 (also reported as when she was 60 years old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufactured unknown) (strength, dose, route of administration, lot # and expiration date were not reported) for pneumococcal prevention. On an unspecified day of December 2018, the patient developed pneumonia that required hospitalization; subsequently, the patient was admitted to the hospital. Some unspecified laboratories and diagnostic studies were performed (details not reported). On an unspecified date, the patient recovered from the event of pneumonia, and, on 02-JAN-2019, she was discharged from the hospital. No further information was provided. Causal relationship between pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and the event of pneumonia was unknown. Upon internal review, the event of pneumonia was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Cerebrovascular accident, Herpes zoster, Vaccination failure
Clinical narrative: Information was received on 08-FEB-2019 from a lawyer and a female consumer  and her husband regarding a case in litigation. On 04-DEC-2014 the patient was inoculated at a pharmacy with ZOSTAVAX (lot number and expiration not reported) for its intended purpose: the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the vaccine the patient suffered a stroke which led to permanent vision loss in one eye. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages and required extensive medical care and treatment. The patient suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result the patient sustained severe and permanent personal injuries. 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 has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Stroke resulting in permanent vision loss in one eye was considered to be a medically significant event. Stroke, herpes zoster and vaccination failure were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2016 (also reported with conflicting information as 06-MAR-2016), the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient developed severe nerve pain, hearing loss and vision loss. As a direct and proximate result of these malfunctions, the plaintiff suffered long-term injuries and damages, and required extensive medical care and treatment. As a further result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a result of ZOSTAVAX, the plaintiff suffered severe and permanent personal injuries. As a further consequence, the plaintiff 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 outcome of the events was considered to be not recovered. The events of severe nerve pain, hearing loss and vision loss were considered medically significant. The events of severe nerve pain, hearing loss and vision loss were considered disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 05-FEB-2019, the patient was vaccinated with a dose of improperly stored VARIVAX lot # N034551, expiration date: 05-DEC-2019 for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 21.7 degrees Fahrenheit for 3 hours 45 minutes and previous temperature excursion of 12.9 degrees Fahrenheit for 30 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA003115: US-009507513-1902USA004130: US-009507513-1902USA004131.
Sex: F
Vaccine: HPV9
Symptoms: Aphthous ulcer, Fibromyalgia, Immune system disorder, Malaise
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 17 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In 2018 (reported as "sometime last year"), the patient was vaccinated with the third dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for routine vaccine. Since the patient received the third dose of GARDASIL 9, she had been getting recurrent aphthous stomatitis, which had not responded to Acyclovir. She also felt always sick and had had some "immune issues mimicking fibromyalgia". The outcome of aphthous ulcer, immune system disorder, malaise and fibromyalgia was not recovered. The patient's mother felt that these symptoms were due to GARDASIL 9. However, the reporter did not reported the causality between the events and GARDASIL 9.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 25-JAN-2019, the patient was vaccinated with an improperly VARIVAX (the dosage regimen information was not reported) lot # N035937 (expiration date: 18-DEC-2019) for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature of -8.16 and -10.96 Celsius degrees for a timeframe of 50 minutes and 13 hours respectively. It was found because of a digital data logger. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1901USA012336; US-009507513-1902USA005477.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 1st dose of SHINGRIX. On 4th February 2019, 15 min after receiving SHINGRIX, the patient experienced weird feeling and blurred vision. On an unknown date, the outcome of the weird feeling was unknown and the outcome of the blurred vision was recovered/resolved. It was unknown if the reporter considered the weird feeling and blurred vision to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. In the morning, the patient received a dose of SHINGRIX. The patient was driving to home about 15 minutes later a vaccination the patient experienced feeling weird. The patient also felt like almost blurred vision and then the patient thought he was going to see double but that did not happen. It was lasted for 10 to 15 seconds. The patient wanted to know, if this events were normal. The medical representative did not see any changes in vision in the literature, therefore it was not something that we would had expected. The medical representative advised the patient to report it to patient's physician. The contact details of the physician was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: This case was reported by a consumer and described the occurrence of back muscle spasms in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included back disorder and muscle tension. Concomitant products included Steroid Injection. On 18th November 2018, the patient received the 2nd dose of SHINGRIX. On 19th November 2018, 1 days after receiving SHINGRIX, the patient experienced back muscle spasms. The patient was treated with diclofenac and cyclobenzaprine. On an unknown date, the outcome of the back muscle spasms was not recovered/not resolved. It was unknown if the reporter considered the back muscle spasms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had been seeing a chronic pain specialist for other back issues. The patient received an epidural steroid injection at his T9/T10 location on 1st November 2018, 3 weeks prior to SHINGRIX vaccine. Since then the patient had received 1 more epidural and 8 trigger point injections, all in his upper back. The patient's physician said his muscles were very tense. The next day, after receiving SHINGRIX, the patient woke up with severe pain in his lower back right side just above the waist line. This turned out to be muscle spasms. The patient finally went to urgent care and was prescribed cyclobenzaprine. The spasms calmed down on the following Sunday. Since then the patient had spasms all over his back not as severe and was taking Diclofenac and cyclobenzaprine to manage it.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. The patient's past medical history included Bell's palsy (experienced twice, the last time it was about 10 years before the date of reporting), bypass surgery, headache and weight loss. On 28th January 2019, the patient received SHINGRIX. On 2nd February 2019, 5 days after receiving SHINGRIX, the patient experienced headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 2nd February 2019, the patient woke up with a headache on the right side in the temple and forehead area. It was a pressure type of headache. The patient inquired if the SHINGRIX shot could have caused this headache. Nothing helped the pain, not even over the counter meds. The patient could not take non-steroidal anti-inflammatory agents due to weight loss or bypass surgery and TYLENOL did not help. The patient was a little concerned and scared.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shivering in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shivering, pain in arm, shivering and pain in arm. On an unknown date, the outcome of the shivering, pain in arm, shivering and pain in arm were unknown. It was unknown if the reporter considered the shivering and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the shivering and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced sore arm and severe shivering. The reporter agreed to follow up from GlaxoSmithKline.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Inappropriate schedule of product administration, Influenza like illness, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For 1st dose, refer case US2018219433). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX. On 3rd February 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain, chills, tremor, fever, pain in arm and drug dose administration interval too long. In February 2019, the patient experienced injected limb mobility decreased, nausea, dizziness and influenza-like symptoms. The patient was treated with ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fever and drug dose administration interval too long were unknown and the outcome of the chills and tremor were recovering/resolving and the outcome of the pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, tremor, fever, pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient received the 2nd dose of SHINGRIX late than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced the same symptoms (pain in arm, injected limb mobility decreased, nausea, dizziness, flu like symptoms), which she had received after receiving the 1st dose of SHINGRIX. Within a couple of hours of receiving the vaccine, she experienced some aching in her left arm in which she received the vaccine in the muscle. She then experienced chills and shakiness throughout her body. Her temperature had gone from 99 to 101 which had lessened the chills and shaking. The patient received treatment with ibuprofen the night before the date of reporting, before she went to bed. She was taking it about for every 5 hours as needed. There was soreness around the injection but the pain was not as with the 1st dose of SHINGRIX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain in extremity, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For 1st dose, refer case US2018219433). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX. On 3rd February 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain, chills, tremor, fever, pain in arm and drug dose administration interval too long. In February 2019, the patient experienced injected limb mobility decreased, nausea, dizziness and influenza-like symptoms. The patient was treated with ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fever and drug dose administration interval too long were unknown and the outcome of the chills and tremor were recovering/resolving and the outcome of the pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, tremor, fever, pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient received the 2nd dose of SHINGRIX late than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced the same symptoms (pain in arm, injected limb mobility decreased, nausea, dizziness, flu like symptoms), which she had received after receiving the 1st dose of SHINGRIX. Within a couple of hours of receiving the vaccine, she experienced some aching in her left arm in which she received the vaccine in the muscle. She then experienced chills and shakiness throughout her body. Her temperature had gone from 99 to 101 which had lessened the chills and shaking. The patient received treatment with ibuprofen the night before the date of reporting, before she went to bed. She was taking it about for every 5 hours as needed. There was soreness around the injection but the pain was not as with the 1st dose of SHINGRIX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For 1st dose, refer case US2018219433). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX. On 3rd February 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain, chills, tremor, fever, pain in arm and drug dose administration interval too long. In February 2019, the patient experienced injected limb mobility decreased, nausea, dizziness and influenza-like symptoms. The patient was treated with ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fever and drug dose administration interval too long were unknown and the outcome of the chills and tremor were recovering/resolving and the outcome of the pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, tremor, fever, pain in arm, injected limb mobility decreased, nausea, dizziness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient received the 2nd dose of SHINGRIX late than the recommended schedule, which led to lengthening of vaccination schedule. The patient experienced the same symptoms (pain in arm, injected limb mobility decreased, nausea, dizziness, flu like symptoms), which she had received after receiving the 1st dose of SHINGRIX. Within a couple of hours of receiving the vaccine, she experienced some aching in her left arm in which she received the vaccine in the muscle. She then experienced chills and shakiness throughout her body. Her temperature had gone from 99 to 101 which had lessened the chills and shaking. The patient received treatment with ibuprofen the night before the date of reporting, before she went to bed. She was taking it about for every 5 hours as needed. There was soreness around the injection but the pain was not as with the 1st dose of SHINGRIX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a 60-year-old female patient who received SHINGRIX (batch number 4Y5KD, expiry date unknown) for prophylaxis. On 30th January 2019, the patient received SHINGRIX. In February 2019, 2 days after receiving SHINGRIX, the patient experienced herpes zoster and eruption. On an unknown date, the outcome of the herpes zoster and eruption were unknown. It was unknown if the reporter considered the herpes zoster and eruption to be related to SHINGRIX. Additional details were provided as follows: The patient experienced herpes zoster without complication. There were 3 distinct areas of eruption on left anterior arm. Rash presented 2 days after vaccine was administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. SHINGRIX was discontinued. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was in his 20's at the time of reporting. The patient had enough pain that he was in bed for nearly 24 hours, and was very painful for 24 hours more. The patient was never in bed for so long over his twenty years and would not receive the 2nd dose of SHINGRIX, nor the several other vaccine recipients had spoken with asking to make something better.
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Malaise
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of malaise in a male patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced malaise and fatigue. On an unknown date, the outcome of the malaise and fatigue were unknown. It was unknown if the reporter considered the malaise and fatigue to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The reporter denied permission for GlaxoSmithKline to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a 76-year-old female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was in bed with flu like symptoms for 4 days. This case has been linked with US2019GSK022777 and US2019GSK022778, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was in bed with flu like symptoms for a few hours. This case has been linked with US2019GSK022777 and US2019GSK022776, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter stated that there were some people who might not be the candidates of receiving SHINGRIX, and he found that their friend was getting sick from the SHINGRIX vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 30th September 2018, the patient received the 1st dose of SHINGRIX. On 30th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The batch number was unknown. The patient experienced injection site soreness after 1st dose of SHINGRIX. The case is linked to case US2019020218, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included degenerative disc disease (discs in neck slightly compromised). 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 injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.  It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had the typical symptoms soreness and redness at injection site. The patient mentioned she had some blood work done recently and would see her primary doctor on 6th February 2019. The patient declined to provide pharmacist's name and did not think there was an issue with technique. This was all the information the patient wished to provide and she would callback to provide additional information after seeing her physician. The patient declined the prescriber's information. For tolerance dose, see case ID US2019020206 reported for 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Discomfort, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, see case US2019GSK027110). Concurrent medical conditions included degenerative disc disease (discs in neck slightly compromised). On 29th January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, shoulder pain and injection site bruising. The patient was treated with paracetamol (Tylenol) and trolamine salicylate (Aspercreme). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, injection site pain, shoulder pain and injection site bruising were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, shoulder pain and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX in the left deltoid. The patient had the typical symptoms she had the first time also, soreness and redness at injection site. This time however, she was getting worse on day 6. The patient was experiencing a sharp pain around her left scapula radiating up to her neck. The patient reported some discs were compromised already before SHINGRIX. The bruise at the injection site still had not gone away. The patient could not get comfortable in bed a night before the date of reporting and so she took one Tylenol which was unusual for her to do. Her husband rubbed some Aspercreme on the affected area. The patient mentioned she had some blood work done recently and would see her primary doctor on 6th February 2019. The patient declined to provide pharmacist's name and did not think there was an issue with technique. This was all the information the patient wished to provide and she would callback to provide additional information after seeing her physician. The patient declined the prescriber's information.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, see case US2019GSK027110). Concurrent medical conditions included degenerative disc disease (discs in neck slightly compromised). On 29th January 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, shoulder pain and injection site bruising. The patient was treated with paracetamol (Tylenol) and trolamine salicylate (Aspercreme). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, injection site pain, shoulder pain and injection site bruising were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, shoulder pain and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX in the left deltoid. The patient had the typical symptoms she had the first time also, soreness and redness at injection site. This time however, she was getting worse on day 6. The patient was experiencing a sharp pain around her left scapula radiating up to her neck. The patient reported some discs were compromised already before SHINGRIX. The bruise at the injection site still had not gone away. The patient could not get comfortable in bed a night before the date of reporting and so she took one Tylenol which was unusual for her to do. Her husband rubbed some Aspercreme on the affected area. The patient mentioned she had some blood work done recently and would see her primary doctor on 6th February 2019. The patient declined to provide pharmacist's name and did not think there was an issue with technique. This was all the information the patient wished to provide and she would callback to provide additional information after seeing her physician. The patient declined the prescriber's information.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Mobility decreased, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number CX5BG, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on 30th September 2018, for tolerance refer case: US2019GSK026941). On 30th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st February 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, mobility decreased, injection site burning and injection site itching. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, mobility decreased, injection site burning and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, mobility decreased, injection site burning and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced injection site burning and had difficulty in lifting arm. The pharmacist reported that, the patient planned to follow-up with her physician on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling bad, fever and sickness. On an unknown date, the outcome of the feeling bad, fever and sickness were unknown.  It was unknown if the reporter considered the feeling bad, fever and sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left deltoid. The pharmacist reported that, the patient told him that, she wanted to delay her 2nd dose of SHINGRIX vaccination because the first vaccination made her feel bad. The patient stated, it knocked her down a little bit. The pharmacist tried to schedule her second SHINGRIX vaccination several times. The patient had a fever and was feeling a little bit sick when the pharmacist spoke to her the last time. The pharmacist stated, he did not note a doctor for the patient.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 58-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 26th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was recovering/resolving. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The patient experienced blisters on her forearm, also up in her shoulder, above an inch or so away from the injection site. The blisters were healing, but could be seen where they were present. This case has been linked with case US2019020324, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Lip blister
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 60-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 31st January 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced blister and lip blister. On an unknown date, the outcome of the blister and lip blister were not recovered/not resolved. It was unknown if the reporter considered the blister and lip blister to be related to SHINGRIX. Additional details were provided as follows: The patient experienced blisters across her upper lip and in her nostril. At the time of reporting the patient still had the symptoms. This case was linked with case US2019020317, reported by the same reporter.
Age: 62.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) (batch number 2MA5F, expiry date 30th June 2019) for prophylaxis. The patient's past medical history included shingles. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular) .5 ml. On 31st January 2019, 122 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced shingles, tingling and rash. On an unknown date, the outcome of the shingles, tingling and rash were unknown. It was unknown if the reporter considered the shingles, tingling and rash to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were received as follows: The patient received SHINGRIX in the left deltoid and Influenza vaccine Quadrivalent 2018-2019 season in the right deltoid. After vaccination, the patient experienced a mild shingles outbreak on his head, which was further described as tingling and a slight rash. The patient was not diagnosed by the physician, but the patient self-diagnosed. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced cold and incomplete course of vaccination. On an unknown date, the outcome of the cold and incomplete course of vaccination were unknown. It was unknown if the reporter considered the cold to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient mentioned briefly that she developed a cold after getting the SHINGRIX vaccine. She stated that it had been more than 9 months since she received her first dose of the SHINGRIX vaccine, till the reporting time she did not receive the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. She wanted to know if she should receive the second dose of the vaccine at the reporting time. No further details were provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Headache, Pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (mild in 2001). On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 28th January 2019, less than a day after receiving SHINGRIX, the patient experienced headache and pain. On 29th January 2019, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On 4th February 2019, the patient experienced bruising of arm. On an unknown date, the outcome of the headache and pain were unknown and the outcome of the erythema of extremities was recovered/resolved and the outcome of the swelling arm, itchy upper limbs and bruising of arm were not recovered/not resolved. It was unknown if the reporter considered the headache, pain, erythema of extremities, swelling arm, itchy upper limbs and bruising of arm to be related to SHINGRIX. Additional details were reported as follows: The first night after the injection, the patient experienced achiness with headache. The following day, the patient had enormous red itchy and puffy left arm that extended 3 inches wide. The patient claimed that the area was red on 31st January 2019 and although the redness had improved at the time of reporting, the itchiness was unresolved. She also reported that, the area was still pink at the time of reporting and it almost looked like bruising on her arm. The reporter gave consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (mild in 2001). On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 28th January 2019, less than a day after receiving SHINGRIX, the patient experienced headache and pain. On 29th January 2019, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On 4th February 2019, the patient experienced bruising of arm. On an unknown date, the outcome of the headache and pain were unknown and the outcome of the erythema of extremities was recovered/resolved and the outcome of the swelling arm, itchy upper limbs and bruising of arm were not recovered/not resolved. It was unknown if the reporter considered the headache, pain, erythema of extremities, swelling arm, itchy upper limbs and bruising of arm to be related to SHINGRIX. Additional details were reported as follows: The first night after the injection, the patient experienced achiness with headache. The following day, the patient had enormous red itchy and puffy left arm that extended 3 inches wide. The patient claimed that the area was red on 31st January 2019 and although the redness had improved at the time of reporting, the itchiness was unresolved. She also reported that, the area was still pink at the time of reporting and it almost looked like bruising on her arm. The reporter gave consent to follow up.