chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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 14-SEP-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 18-SEP-2016, the patient was treated at an urgent care for shingles and zoster-related injuries. On or about 20-SEP-2016, the patient was treated by a physician for zoster-related injuries. The patient suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, 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
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. In or around July 2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around October 2016, the patient was treated by a physician for shingles and zoster related injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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
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. In or around 2014, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In approximately October 2016, the patient was treated for her zoster related symptoms and was diagnosed with shingles. The patient was subsequently treated for shingles and zoster related injuries as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004379:Original Case : 1808USA001261, US-009507513-1808USA004376:Original Case : 1808USA001261, US-009507513-1808USA004377:Original Case : 1808USA001261, US-009507513-1808USA004378:Original Case : 1808USA001261, US-009507513-1808USA004380:Original Case : 1808USA001261, US-009507513-1808USA004381:Original Case : 1808USA001261, US-009507513-1808USA004382:Original Case : 1808USA001261, US-009507513-1808USA004383:Original Case : 1808USA001261, US-009507513-1808USA004384:Original Case : 1808USA001261, US-009507513-1808USA004385:Original Case : 1808USA001261, US-009507513-1808USA004386:Original Case : 1808USA001261, US-009507513-1808USA004362:Original Case : 1808USA001261, US-009507513-1808USA004387:Original Case : 1808USA001261, US-009507513-1808USA004388:Original Case : 1808USA001261, US-009507513-1808USA004363:Original Case : 1808USA001261, US-009507513-1808USA001261:Original Case : 1808USA001261, US-009507513-1808USA004389:Original Case : 1808USA001261, US-009507513-1808USA004390:Original Case : 1808USA001261, US-009507513-1808USA004391:Original Case : 1808USA001261, US-009507513-1808USA004392:Original Case : 1808USA001261, US-009507513-1808USA004365:Original Case : 1808USA001261, US-009507513-1808USA004393:Original Case : 1808USA001261, US-009507513-1808USA004394:Original Case : 1808USA001261, US-009507513-1808USA004395:Original Case : 1808USA001261, US-009507513-1808USA004396:Original Case : 1808USA001261, US-009507513-1808USA004397:Original Case : 1808USA001261, US-009507513-1808USA004366:Original Case : 1808USA001261, US-009507513-1808USA004367:Original Case : 1808USA001261, US-009507513-1808USA004368:Original Case : 1808USA001261, US-009507513-1808USA004398:Original Case : 1808USA001261, US-009507513-1808USA004399:Original Case : 1808USA001261, US-009507513-1808USA004400:Original Case : 1808USA001261, US-009507513-1808USA004369:Original Case : 1808USA001261, US-009507513-1808USA004370:Original Case : 1808USA00126.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376 :Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA001261: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261  US-009507513-1808USA004399: Original Case : 1808USA001261US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261US-009507513-1808USA004370: Original Case : 1808USA001261.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 22-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004379:Original Case : 1808USA001261, US-009507513-1808USA004376:Original Case : 1808USA001261, US-009507513-1808USA004377:Original Case : 1808USA001261, US-009507513-1808USA004378:Original Case : 1808USA001261, US-009507513-1808USA004380:Original Case : 1808USA001261, US-009507513-1808USA004381:Original Case : 1808USA001261, US-009507513-1808USA004382:Original Case : 1808USA001261, US-009507513-1808USA004383:Original Case : 1808USA001261, US-009507513-808USA004384:Original Case : 1808USA001261, US-009507513-1808USA004385:Original Case : 1808USA001261, US-009507513-1808USA004386:Original Case : 1808USA001261, US-009507513-1808USA004362:Original Case : 1808USA001261, US-009507513-1808USA004387:Original Case : 1808USA001261, US-009507513-1808USA004388:Original Case : 1808USA001261, US-009507513-1808USA004363:Original Case : 1808USA001261, US-009507513-1808USA004364:Original Case : 1808USA001261, US-009507513-1808USA004389:Original Case : 1808USA001261, US-009507513-1808USA004390:Original Case : 1808USA001261, US-009507513-1808USA004391:Original Case : 1808USA001261, US-009507513-1808USA004392:Original Case : 1808USA001261, US-009507513-1808USA004365:Original Case : 1808USA001261, US-009507513-1808USA004393:Original Case : 1808USA001261, US-009507513-1808USA004394:Original Case : 1808USA001261, US-009507513-1808USA004395:Original Case : 1808USA001261, US-009507513-1808USA004396:Original Case : 1808USA001261, US-009507513-1808USA004397:Original Case : 1808USA001261, US-009507513-1808USA001261:Original Case : 1808USA001261, US-009507513-1808USA004367:Original Case : 1808USA001261, US-009507513-1808USA004368:Original Case : 1808USA001261, US-009507513-1808USA004398:Original Case : 1808USA001261, US-009507513-1808USA004399:Original Case : 1808USA001261, US-009507513-1808USA004400:Original Case : 1808USA001261, US-009507513-1808USA004369:Original Case : 1808USA001261, US-009507513-1808USA004370:Original Case : 1808USA00126.
Sex: U
Vaccine: MMRV
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, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly dose of PROQUAD (dose, route of administration and anatomical location were not reported) lot # R006218 and expiration date: 28-AUG-2019, indicated for prophylaxis. No adverse symptoms were reported. Administered dose of vaccine experienced a temperature excursion of -8.6 degrees Celsius on unspecified dates for 2 hours and 31 minutes called by a data logger. There were no previous excursions reported.
Age: 0.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant, concerning an approximately 11 month old patient of an unknown gender. The patient's medical history, previously drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date, one day before him/her 1st birthday, the patient was vaccinated with VARIVAX and M-M-R II, reconstituted with sterile diluent (MRK), (strength, doses, routes of administration, anatomical locations, lot numbers and expirations dates were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. It was reported that on 08-AUG-2018, a 9 month old patient was vaccinated with GARDASIL 9 (dose, frequency, lot # and expiry date were not reported) intramuscularly for prophylaxis (drug administered to patient of inappropriate age). No known adverse effects reported. No product quality compliant was involved.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Product preparation error
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a 57-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The healthcare professional reported that, the patient received a dose of SHINGRIX, which was reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Follow up information received from nurse on 2nd August 2018: On 23rd July 2018, the patient received the 1st dose of SHINGRIX. Batch number and expiry date was updated. The healthcare professional (HCP) reported that the patient developed achiness, flu-like symptoms, chills and tiredness the day after administration of the 1st dose of SHINGRIX. These symptoms lasted approximately 1 week, although these symptoms abated, approximately one week after administration of the vaccine, the patient developed a full body rash, described as red and raised but not vesicular or itchy. This patient had a previous case entered for the administration of an improperly reconstituted dose of SHINGRIX. It was unknown if the reporter considered the pain, influenza-like symptoms, chills, tiredness, erythematous rash and raised rash to be related to SHINGRIX. The VAERS details were updated.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in a 57-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The healthcare professional reported that, the patient received a dose of SHINGRIX, which was reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Follow up information received from nurse on 2nd August 2018: On 23rd July 2018, the patient received the 1st dose of SHINGRIX. Batch number and expiry date was updated. The healthcare professional (HCP) reported that the patient developed achiness, flu-like symptoms, chills and tiredness the day after administration of the 1st dose of SHINGRIX. These symptoms lasted approximately 1 week, although these symptoms abated, approximately one week after administration of the vaccine, the patient developed a full body rash, described as red and raised but not vesicular or itchy. This patient had a previous case entered for the administration of an improperly reconstituted dose of SHINGRIX. It was unknown if the reporter considered the pain, influenza-like symptoms, chills, tiredness, erythematous rash and raised rash to be related to SHINGRIX. The VAERS details were updated.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced red blotches. On 27th July 2018, the patient experienced injection site rash, injection site pain, injection site erythema, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder. On an unknown date, the outcome of the injection site rash, injection site pain and injection site erythema were recovering/resolving and the outcome of the red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder were unknown. It was unknown if the reporter considered the injection site rash, injection site pain, injection site erythema, red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder to be related to SHINGRIX. Additional details were provided as follows: At 12:30, the patient received SHINGRIX vaccine in the right arm. The next day after receiving the SHINGRIX vaccine, the patient developed three or four red bumps that looked like mosquito bites at the injection site. When the patient put her finger on them they were sore. They were resolving and had faded into a red blotch. One or two areas in the red blotch were redder than the rest, but there were no longer raised areas. It was still tender if she pressed on the area. Also, the next day after receiving the vaccination, the patient developed a headache at her forehead, the back of her head, and the back of her neck. The pain from her forehead runs up to the crown of her head with the top of her head feeling tight. The patient said the headache had occurred every day since the vaccination but varies in severity. The patient reported that she had issues with temperature control since the next day after receiving the vaccine. The patient got hot and then gets cold. The patient had two occasions where she had experienced bad shivering. One of these shivering episodes was at night and she did not sleep well. The patient said that around the third day after receiving the vaccination she was feeling better, the next day was bad again. Reporter gave permission for her physician to be contacted.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Insomnia, Rash macular, Temperature regulation disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced red blotches. On 27th July 2018, the patient experienced injection site rash, injection site pain, injection site erythema, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder. On an unknown date, the outcome of the injection site rash, injection site pain and injection site erythema were recovering/resolving and the outcome of the red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder were unknown. It was unknown if the reporter considered the injection site rash, injection site pain, injection site erythema, red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder to be related to SHINGRIX. Additional details were provided as follows: At 12:30, the patient received SHINGRIX vaccine in the right arm. The next day after receiving the SHINGRIX vaccine, the patient developed three or four red bumps that looked like mosquito bites at the injection site. When the patient put her finger on them they were sore. They were resolving and had faded into a red blotch. One or two areas in the red blotch were redder than the rest, but there were no longer raised areas. It was still tender if she pressed on the area. Also, the next day after receiving the vaccination, the patient developed a headache at her forehead, the back of her head, and the back of her neck. The pain from her forehead runs up to the crown of her head with the top of her head feeling tight. The patient said the headache had occurred every day since the vaccination but varies in severity. The patient reported that she had issues with temperature control since the next day after receiving the vaccine. The patient got hot and then gets cold. The patient had two occasions where she had experienced bad shivering. One of these shivering episodes was at night and she did not sleep well. The patient said that around the third day after receiving the vaccination she was feeling better, the next day was bad again. Reporter gave permission for her physician to be contacted.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Tension headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced red blotches. On 27th July 2018, the patient experienced injection site rash, injection site pain, injection site erythema, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder. On an unknown date, the outcome of the injection site rash, injection site pain and injection site erythema were recovering/resolving and the outcome of the red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder were unknown. It was unknown if the reporter considered the injection site rash, injection site pain, injection site erythema, red blotches, headache, head tightness, feeling cold, feeling hot, shivering, difficulty sleeping and temperature regulation disorder to be related to SHINGRIX. Additional details were provided as follows: At 12:30, the patient received SHINGRIX vaccine in the right arm. The next day after receiving the SHINGRIX vaccine, the patient developed three or four red bumps that looked like mosquito bites at the injection site. When the patient put her finger on them they were sore. They were resolving and had faded into a red blotch. One or two areas in the red blotch were redder than the rest, but there were no longer raised areas. It was still tender if she pressed on the area. Also, the next day after receiving the vaccination, the patient developed a headache at her forehead, the back of her head, and the back of her neck. The pain from her forehead runs up to the crown of her head with the top of her head feeling tight. The patient said the headache had occurred every day since the vaccination but varies in severity. The patient reported that she had issues with temperature control since the next day after receiving the vaccine. The patient got hot and then gets cold. The patient had two occasions where she had experienced bad shivering. One of these shivering episodes was at night and she did not sleep well. The patient said that around the third day after receiving the vaccination she was feeling better, the next day was bad again. Reporter gave permission for her physician to be contacted.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Malaise, Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 25th July 2018 13:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced tiredness, weakness and sleepiness. On 25th July 2018 22:00, the patient experienced fever, palpitation, sickness and chills. On 26th July 2018, the patient experienced white blood cell increased. On an unknown date, the outcome of the fever, palpitation, sickness, white blood cell increased, tiredness, weakness, sleepiness and chills were unknown. It was unknown if the reporter considered the fever, palpitation, sickness, white blood cell increased, tiredness, weakness, sleepiness and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Around 10:00 pm, 8 hours 30 minutes after receiving the first dose of the SHINGRIX vaccine in left arm, the patient felt sick and experienced fever, chills, and heart palpitations. The patient went to the emergency room at 4 am and was sent home at 8 am. The emergency room physician told him that if his fever went up again he should see his primary care physician. The patient's fever did go up that same day and he went to his primary care office and the nurse practitioner did blood work. He received the results on 30th July 2018, which showed that, patient's white blood cells were elevated (87). He said all of these symptoms resolved within 24 hours. The patient also felt weak, tired, and sleepy all of the time, which he felt was due to the vaccine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 25th July 2018 13:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced tiredness, weakness and sleepiness. On 25th July 2018 22:00, the patient experienced fever, palpitation, sickness and chills. On 26th July 2018, the patient experienced white blood cell increased. On an unknown date, the outcome of the fever, palpitation, sickness, white blood cell increased, tiredness, weakness, sleepiness and chills were unknown. It was unknown if the reporter considered the fever, palpitation, sickness, white blood cell increased, tiredness, weakness, sleepiness and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Around 10:00 pm, 8 hours 30 minutes after receiving the first dose of the SHINGRIX vaccine in left arm, the patient felt sick and experienced fever, chills, and heart palpitations. The patient went to the emergency room at 4 am and was sent home at 8 am. The emergency room physician told him that if his fever went up again he should see his primary care physician. The patient's fever did go up that same day and he went to his primary care office and the nurse practitioner did blood work. He received the results on 30th July 2018, which showed that, patient's white blood cells were elevated (87). He said all of these symptoms resolved within 24 hours. The patient also felt weak, tired, and sleepy all of the time, which he felt was due to the vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. On 23rd July 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 swelling, injection site reaction and arthralgia multiple. On an unknown date, the outcome of the injection site swelling, injection site reaction and arthralgia multiple were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site reaction and arthralgia multiple to be related to SHINGRIX. Additional details were provided as follows: The healthcare (HCP) reported that patient received a dose of SHINGRIX and experienced a severe injection site reaction along with swelling. The patient also experienced hip and knee pain. The patient described these adverse events and coming and going and not resolved at the time of reporting. The HCP mentioned that the dose that was administered was 1 vial after reconstituting with adjuvant, she was not sure if it was 0.5ml, but stated that they gave 1 normal dose. They mentioned it as 1 in their documentation so she was thinking it was 1ml but then stated that it was probably meant as 1 vial for billing purposes.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Pruritus generalised, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included back surgery (3 surgeries in 2017). On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced generalized pruritus. On 24th July 2018, the patient experienced back pain, fever and chills. The patient was treated with ibuprofen, TYLENOL and prednisone. On an unknown date, the outcome of the back pain was recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the generalized pruritus and chills were not recovered/not resolved. It was unknown if the reporter considered the back pain, fever, generalized pruritus and chills to be related to SHINGRIX. Additional information was received as follows: Later that afternoon of the vaccination day, the patient experienced severe back pain and it was unlike any back pain she had ever experienced. The patient stated that the morning after she received the vaccine, she experienced a low-grade fever, that was a little higher than 100 degree F and also experienced chills. The patient also reported that experiencing a fiery itch that was primarily in her back but she felt all over her body. The patient could not recall what day the fiery itch started and she was taking TYLENOL, ibuprofen and prednisone to treat the symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain and fatigue were recovered/resolved. It was unknown if the reporter considered the pain and fatigue to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient who was a physician. The age at vaccination was not reported. The patient experienced aches and fatigue which started the day after the vaccination and persisted for approximately 24 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a 59-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. Co-suspect products included SHINGRIX (batch number 9779K, expiry date 11th October 2020) for an unknown indication. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The caller was a pharmacist who reported that the patient received both doses of SHINGRIX at their pharmacy. The lot numbers provided by reporter are from vials, carton lot numbers were not available to be reported. The caller reported that the patient had history of getting routine MRI scans (Magnetic resonance imaging) for an unknown reason and upon regularly scheduled MRI was noted to have swollen lymph nodes. The caller was unsure if that MRI was after the first or second dose of SHINGRIX. Lab Comments: On an unknown date the patient performed MRI.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pneumonia (hospitalized for pneumonia for 12 days). Previously administered products included Influenza vaccine with an associated reaction of injection site pain (Received Influenza vaccine and experienced injection site pain (refer case US2018GSK144776)). Concurrent medical conditions included chronic obstructive pulmonary disease and emphysema. On 30th July 2018, the patient received the 1st dose of SHINGRIX. On 30th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the headache, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the headache, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The patient experienced pain and swelling at injection site, and also experienced headache, she could feel the pain and swelling immediately as she received the injection. The caller described the pain as worse than a typical flu shot but not bad enough to prevent her from getting the second dose. This case has been linked with case US2018GSK144776 reported by the same reporter for the same patient.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fasciitis, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Mobility decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fasciitis in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced fasciitis, muscle spasm and pain in arm. On an unknown date, the patient experienced numbness in fingers and injected limb mobility decreased. The patient was treated with ibuprofen, TORADOL, FLEXERIL, MEDROL DOSE PAK, DILAUDID and NORCO. On an unknown date, the outcome of the fasciitis and muscle spasm were unknown and the outcome of the pain in arm, numbness in fingers and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the fasciitis, muscle spasm, pain in arm, numbness in fingers and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient's husband reported this case. The patient received SHINGRIX in the left deltoid. The patient experienced severe pain at injection site, which was lasting more than week (8 to 9 days) and was getting worse. Pain was initially in the deltoid area where injection was given. In the evening of 26th July 2018 to the morning of 27th July 2018, pain got to the shoulder blade area, upper arm and forearm. There was a very severe pain and the healthcare professional called their physician on Saturday, 28th July 2018 and the physician advised to give muscle relaxer as the patient might had spasms. The physician gave her FLEXERIL 10 mg every 8 hours and Ibuprofen, pain was not improving so took patient to emergency room (ER) on Sunday, 29th July 2018. The physician in the ER indicated the patient might have mild fasciitis because injection might not have been given the belly of the muscle and might have entered that fascia. The ER physician continued FLEXERIL and added NORCO, in the ER patient received intravenous DILAUDID and TORADOL. Pain improved somewhat on scale of 10 was 4 to 5 and after discharge, there was no improvement in pain. On Monday, 30th July 2018, the physician put the patient on MEDROL DOSE PAK might be due to inflammation. Pain was not getting better and was getting worse in left capillary area. Less than a month after vaccination, the patient experienced could not lift shoulder up and numbness in fingers. The patient could not lift shoulder up, only a little bit. At the time of reporting the patient was saying, she was having numbness in fingers every so often not persistently. The physician stated he reported this to the pharmacist that administered the vaccine and the pharmacist might have reported this event to GlaxoSmithKline.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fasciitis in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced fasciitis, muscle spasm and pain in arm. On an unknown date, the patient experienced numbness in fingers and injected limb mobility decreased. The patient was treated with ibuprofen, TORADOL, FLEXERIL, MEDROL DOSE PAK, DILAUDID and NORCO. On an unknown date, the outcome of the fasciitis and muscle spasm were unknown and the outcome of the pain in arm, numbness in fingers and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the fasciitis, muscle spasm, pain in arm, numbness in fingers and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient's husband reported this case. The patient received SHINGRIX in the left deltoid. The patient experienced severe pain at injection site, which was lasting more than week (8 to 9 days) and was getting worse. Pain was initially in the deltoid area where injection was given. In the evening of 26th July 2018 to the morning of 27th July 2018, pain got to the shoulder blade area, upper arm and forearm. There was a very severe pain and the healthcare professional called their physician on Saturday, 28th July 2018 and the physician advised to give muscle relaxer as the patient might had spasms. The physician gave her FLEXERIL 10 mg every 8 hours and Ibuprofen, pain was not improving so took patient to emergency room (ER) on Sunday, 29th July 2018. The physician in the ER indicated the patient might have mild fasciitis because injection might not have been given the belly of the muscle and might have entered that fascia. The ER physician continued FLEXERIL and added NORCO, in the ER patient received intravenous DILAUDID and TORADOL. Pain improved somewhat on scale of 10 was 4 to 5 and after discharge, there was no improvement in pain. On Monday, 30th July 2018, the physician put the patient on MEDROL DOSE PAK might be due to inflammation. Pain was not getting better and was getting worse in left capillary area. Less than a month after vaccination, the patient experienced could not lift shoulder up and numbness in fingers. The patient could not lift shoulder up, only a little bit. At the time of reporting the patient was saying, she was having numbness in fingers every so often not persistently. The physician stated he reported this to the pharmacist that administered the vaccine and the pharmacist might have reported this event to GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the rash was unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional called and reported that the patient received vaccine and experienced shingles outbreaks since on the arm where the vaccine was administered. The rash seems to be following the nerve line down her arm. The 2nd outbreak was in the crusting over stage at the time of reporting.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a male patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional information was reported as follows: The age at vaccination was not reported. The patient received hepatitis B series in childhood, the vaccine brand for hepatitis B was unknown. The patient had to have his titers done due to matriculating at school, however it was unsure if it was a medical, nursing or a pharmacy school. The serological titers were less than 10mlU/ml. Lab Comments: On an unknown date, the serological test for Hepatitis B were carried out, which showed titers as less than 10 mIU/mL.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of genital herpes in a 66-year-old female patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. Concurrent medical conditions included genital herpes. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown.  It was unknown if the reporter considered the genital herpes and condition aggravated to be related to SHINGRIX. Additional information was received as follows: The health care professional reported adverse event via click to chat forum. The health care professional reported that, they had the patient who just received SHINGRIX and her genital herpes has flared up. No further information was reported.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 74-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, several hours after receiving SHINGRIX, the patient experienced malaise, pain, influenza-like symptoms and fear of death. On an unknown date, the outcome of the malaise, pain, influenza-like symptoms and fear of death were not recovered/not resolved. It was unknown if the reporter considered the malaise, pain, influenza-like symptoms and fear of death to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BENADRYL as concomitant medication. The health care professional stated that by the evening, the patient felt like she was going to die. The patient experienced aching, malaise and flu-like symptoms, but no fever. The symptoms were not resolved at the time of reporting. The patient had not sought out medical attention as of the date of reporting.