chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2017, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the  prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2017, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Biopsy skin abnormal, Lichen striatus, Lymphocytic infiltration, Macule, Papule
Clinical narrative: Information has been received from the authors of the article, and refers to a 63 year old female patient who was seen for a rash on the left arm that had been present for 6 weeks. At the time of presentation, she reported no pain or pruritus. The patient reported an initial development of extremely pruritic red bumps from her left shoulder to her hand, which appeared 2 weeks after receiving an intramuscular hepatitis B vaccination (manufacturer unknown) in the left deltoid (date of vaccination unspecified). Her past medical history was unremarkable. The patient was not taking any medications at the time the rash developed. She was receiving the hepatitis B immunization series owing to negative hepatitis B core and surface antibodies. On physical exam, she had violaceous papules and both hyperpigmented and hypopigmented macules along Blaschko lines. The lesions started on the left lateral shoulder and continued down the medial forearm to the dorsal hand. A punch biopsy was performed on a violaceous papule on the distal forearm for hematoxylin and eosin (H&E) staining. Histologically, the H&E-stained sections were notable for lymphocytic infiltrate and pigment incontinence in the upper dermis and in a perieccrine distribution, consistent with the diagnosis of lichen striatus (LS). Given her lack of symptoms at the time of presentation, treatment was deferred. The authors stated that the patient was administered the second hepatitis B vaccine (manufacturer unknown) in the right deltoid without similar findings. Three months after initial onset, all lesions had resolved with only residual hyperpigmentation remaining. The authors considered LS to be related to hepatitis B vaccine (manufacturer unknown).
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Pigmentation disorder, Rash, Rash erythematous, Rash pruritic, Skin hyperpigmentation
Clinical narrative: Information has been received from the authors of the article, and refers to a 63 year old female patient who was seen for a rash on the left arm that had been present for 6 weeks. At the time of presentation, she reported no pain or pruritus. The patient reported an initial development of extremely pruritic red bumps from her left shoulder to her hand, which appeared 2 weeks after receiving an intramuscular hepatitis B vaccination (manufacturer unknown) in the left deltoid (date of vaccination unspecified). Her past medical history was unremarkable. The patient was not taking any medications at the time the rash developed. She was receiving the hepatitis B immunization series owing to negative hepatitis B core and surface antibodies. On physical exam, she had violaceous papules and both hyperpigmented and hypopigmented macules along Blaschko lines. The lesions started on the left lateral shoulder and continued down the medial forearm to the dorsal hand. A punch biopsy was performed on a violaceous papule on the distal forearm for hematoxylin and eosin (H&E) staining. Histologically, the H&E-stained sections were notable for lymphocytic infiltrate and pigment incontinence in the upper dermis and in a perieccrine distribution, consistent with the diagnosis of lichen striatus (LS). Given her lack of symptoms at the time of presentation, treatment was deferred. The authors stated that the patient was administered the second hepatitis B vaccine (manufacturer unknown) in the right deltoid without similar findings. Three months after initial onset, all lesions had resolved with only residual hyperpigmentation remaining. The authors considered LS to be related to hepatitis B vaccine (manufacturer unknown).
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Skin hypopigmentation
Clinical narrative: Information has been received from the authors of the article, and refers to a 63 year old female patient who was seen for a rash on the left arm that had been present for 6 weeks. At the time of presentation, she reported no pain or pruritus. The patient reported an initial development of extremely pruritic red bumps from her left shoulder to her hand, which appeared 2 weeks after receiving an intramuscular hepatitis B vaccination (manufacturer unknown) in the left deltoid (date of vaccination unspecified). Her past medical history was unremarkable. The patient was not taking any medications at the time the rash developed. She was receiving the hepatitis B immunization series owing to negative hepatitis B core and surface antibodies. On physical exam, she had violaceous papules and both hyperpigmented and hypopigmented macules along Blaschko lines. The lesions started on the left lateral shoulder and continued down the medial forearm to the dorsal hand. A punch biopsy was performed on a violaceous papule on the distal forearm for hematoxylin and eosin (H&E) staining. Histologically, the H&E-stained sections were notable for lymphocytic infiltrate and pigment incontinence in the upper dermis and in a perieccrine distribution, consistent with the diagnosis of lichen striatus (LS). Given her lack of symptoms at the time of presentation, treatment was deferred. The authors stated that the patient was administered the second hepatitis B vaccine (manufacturer unknown) in the right deltoid without similar findings. Three months after initial onset, all lesions had resolved with only residual hyperpigmentation remaining. The authors considered LS to be related to hepatitis B vaccine (manufacturer unknown).
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 30 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (also reported as when the patient was 18 years old), the patient was vaccinated with a dose of GARDASIL, intramuscularly (dose, lot# and expiration date were not reported). On 11-OCT-2018 at age 30, the patient presented in the pharmacy and asked for a dose of GARDASIL 9. A dose had not been given at the time of reporting.
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Balance disorder, Blood pressure decreased, Dizziness, Pallor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dizziness in a 10-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number AL545, expiry date 30th June 2019) for prophylaxis. On 28th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 28th September 2018, 5 min after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness, unsteadiness, blood pressure decreased and pale skin. On 28th September 2018, the outcome of the dizziness, unsteadiness, blood pressure decreased and pale skin were recovered/resolved. The reporter considered the dizziness, unsteadiness, blood pressure decreased and pale skin to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. Five minutes after vaccination, the patient had begun feeling dizzy, looked pale, not stable or wobbly, and his blood pressure was on the on the lower side. The patient had a regular pulse and no dyspnea. The symptoms were transient, as he got up after a few minutes and began walking. The physician sent patient to emergency room just to be evaluated. She followed up with the emergency room doctor and was told the patient was observed and discharged after a couple hours. The healthcare professional informed reporter that she had given 19 other FLUARIX injections from this lot number and no adverse events were reported from the other patients. The reported batch number L545 for FLUARIX did not exist and was updated to AL545 as per the sales database.
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood pressure decreased, Dizziness, Pallor, Presyncope
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of dizziness in a 10-year-old male patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number AL545, expiry date 30th June 2019) for prophylaxis. On 28th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 28th September 2018, 5 min after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness, unsteadiness, blood pressure decreased and pale skin. On 28th September 2018, the outcome of the dizziness, unsteadiness, blood pressure decreased and pale skin were recovered/resolved. The reporter considered the dizziness, unsteadiness, blood pressure decreased and pale skin to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. Five minutes after vaccination, the patient had begun feeling dizzy, looked pale, not stable or wobbly, and his blood pressure was on the on the lower side. The patient had a regular pulse and no dyspnea. The symptoms were transient, as he got up after a few minutes and began walking. The physician sent patient to emergency room just to be evaluated. She followed up with the emergency room doctor and was told the patient was observed and discharged after a couple hours. The healthcare professional informed reporter that she had given 19 other FLUARIX injections from this lot number and no adverse events were reported from the other patients. The reported batch number L545 for FLUARIX did not exist and was updated to AL545 as per the sales database.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cold sweat, Decreased appetite, Fatigue, Headache
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fatigue, appetite lost, injection site pain, clamminess, joint pain, injection site erythema, headache and sweating. On an unknown date, the outcome of the fatigue, appetite lost, injection site pain, clamminess, joint pain, injection site erythema, headache and sweating were recovered/resolved. It was unknown if the reporter considered the fatigue, appetite lost, injection site pain, clamminess, joint pain, injection site erythema, headache and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced severe headache, fatigue, loss of appetite, sweating, clammy skin, joint aches, red painful injection site, all worse for the first 34 hours after vaccination, then began to resolve. The fatigue was the longest lasting symptom, persisted for about 8 days. No further details were provided by the HCP.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 68-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fatigue, appetite lost, injection site pain, clamminess, joint pain, injection site erythema, headache and sweating. On an unknown date, the outcome of the fatigue, appetite lost, injection site pain, clamminess, joint pain, injection site erythema, headache and sweating were recovered/resolved. It was unknown if the reporter considered the fatigue, appetite lost, injection site pain, clamminess, joint pain, injection site erythema, headache and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced severe headache, fatigue, loss of appetite, sweating, clammy skin, joint aches, red painful injection site, all worse for the first 34 hours after vaccination, then began to resolve. The fatigue was the longest lasting symptom, persisted for about 8 days. No further details were provided by the HCP.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival discomfort, Gingival erythema, Oral discomfort, Pain in extremity, Paraesthesia oral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning gum in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced burning gum, burning oral sensation, pain in arm, fever and redness gum. On an unknown date, the patient experienced tingling mouth. On an unknown date, the outcome of the burning gum, burning oral sensation, pain in arm, fever, redness gum and tingling mouth were recovering/resolving. It was unknown if the reporter considered the burning gum, burning oral sensation, pain in arm, fever, redness gum and tingling mouth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that within 24 hours after receiving their initial dose of SHINGRIX the patient developed a sore arm, felt feverish and experienced a burning sensation in mouth with red patches on gums above teeth. At this time the patient stated the symptoms had mostly subsided and was about 98 percentage resolved, however still had a tiny bit of tingling sensation in their mouth. No further details provided regarding the event.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning gum in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced burning gum, burning oral sensation, pain in arm, fever and redness gum. On an unknown date, the patient experienced tingling mouth. On an unknown date, the outcome of the burning gum, burning oral sensation, pain in arm, fever, redness gum and tingling mouth were recovering/resolving. It was unknown if the reporter considered the burning gum, burning oral sensation, pain in arm, fever, redness gum and tingling mouth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that within 24 hours after receiving their initial dose of SHINGRIX the patient developed a sore arm, felt feverish and experienced a burning sensation in mouth with red patches on gums above teeth. At this time the patient stated the symptoms had mostly subsided and was about 98 percentage resolved, however still had a tiny bit of tingling sensation in their mouth. No further details provided regarding the event.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The healthcare professional reported that a few hours after receiving the SHINGRIX, the patient experienced excruciating pain at the injection site which radiated down to her arm. The patient's daughter had given her ibuprofen 800 mg every 8 hours for 2 doses. In the morning after receiving treatment, the patient was feeling better but had some pain, at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis.  On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The physician stated that he had never seen so many patients with severe reactions, it was worse than any vaccine he had ever seen. Attempt was made in order to gather further details from the healthcare professional, but he declined to provide any information and stated that all the stuff that was in the package insert and it should be already known.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 2nd October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the pain in arm, injection site swelling and injection site warmth were unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Less than a week after receiving SHINGRIX vaccine, the patient developed a large, red, raised, hot ring (about 2 inches in diameter) around the injection site. The patient also reported arm soreness in the vaccinated arm right after receiving the injection.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received the 1st dose of SHINGRIX. On 3rd October 2018, 15 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 provided as follows: The reporter did not have lot number or expiry date of the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) for prophylaxis. Previously administered products included ZOSTAVAX (the patient had a reaction to vaccine). On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site erythema, general body pain and injection site pain. On 3rd June 2018, the patient experienced injection site itching. The patient was treated with paracetamol (Tylenol) and crisaborole (Eucrisa). On an unknown date, the outcome of the fever, injection site itching, injection site erythema, general body pain and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, injection site itching, injection site erythema, general body pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a fever, body aches, injection site pain and redness the evening after receiving SHINGRIX. Four days later, the patient experienced severe injection site itching. The patient took Tylenol and Eucrisa to treat her symptoms. Her symptoms lasted about 7 days and resolved. The reporter given permission to contact physician.
Age: 34.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Product complaint, Skin laceration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of laceration in a adult male patient who was preparing SHINGRIX (batch number 539A2, expiry date 30th March 2020) for administration of the patient for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, immediately after receiving SHINGRIX, the patient experienced laceration. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the laceration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. Lot number for adjuvant suspension was unknown. Issue was reported as the base of the vial of the adjuvant suspension was cracked and missing pieces. The reporter's index finger of his right hand was cut when he reached into the carton to pull out the vial and filed related adverse event. The cut has resolved and this occurred approximately three weeks ago. The damage was noted at the time the product was being prepared for administration. The product was not administered to a consumer. The blister tray and or carton were not damaged. No evidence of leakage noted in the carton. No glass pieces were in the vial or in the carton. There were holes of glass pieces missing from the base of the vial. The product was stored on the bottom shelf of the refrigerator. There was no product left in the vial. The package was in good condition upon receipt. The pharmacist threw the vial in the Sharps container after he cut his finger on the vial. The product was not available for return and no picture of the suspect product was available to be emailed. The pharmacist requested to provide credit for one dose of the SHINGRIX.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dehydration, Diarrhoea, Dizziness, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received FLULAVAL QUADRIVALENT for prophylaxis. On 26th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On 27th September 2018, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue. On an unknown date, the outcome of the fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue were not recovered/not resolved. It was unknown if the reporter considered the fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The husband of the patient reported that his wife contacted her physician, but has not been seen by her physician. Upon an internal review the listedness was manually corrected on 4th October 2018.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received FLULAVAL QUADRIVALENT for prophylaxis. On 26th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On 27th September 2018, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue. On an unknown date, the outcome of the fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue were not recovered/not resolved. It was unknown if the reporter considered the fever, dehydration, lightheadedness, muscle pain, nausea, vomiting, diarrhea and fatigue to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The husband of the patient reported that his wife contacted her physician, but has not been seen by her physician. Upon an internal review the listedness was manually corrected on 4th October 2018.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, sleep excessive and tiredness. On an unknown date, the outcome of the general body pain, sleep excessive and tiredness were recovered/resolved. It was unknown if the reporter considered the general body pain, sleep excessive and tiredness to be related to SHINGRIX. Additional details were provided as follows: The reporter was a patient who received SHINGRIX on left arm. The reporter reported that, she experienced whole body aches, felt very tired, and slept a lot and these events resolved about 48 hours after the shot. The patient had denied permission to contact their physician.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received SHINGRIX (batch number D294J, expiry date March 2019) for prophylaxis. On 4th October 2018, the patient received the 2nd dose of SHINGRIX. On 4th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX vaccine in right deltoid. His arm was little sore. The patient expected it would feel better within a day or 2. The physician contact details were provided.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 84-year-old female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 13th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered Shingrix in the deltoid. The patient experienced muscle pain at the injection site and she cannot sleep on the side of the injection due to pain.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Pain, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 75-year-old female patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On 4th October 2018, the patient received SHINGRIX (intramuscular) .5 ml. In October 2018, less than a day after receiving SHINGRIX, the patient experienced facial swelling, general body pain and eye swelling. On an unknown date, the outcome of the facial swelling, general body pain and eye swelling were not recovered/not resolved. It was unknown if the reporter considered the facial swelling, general body pain and eye swelling to be related to SHINGRIX. Additional information received as follows: The pharmacist reported that the patient developed swollen face, achy body and swollen eyes overnight.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, 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 patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX (subcutaneous). In July 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional reported that another pharmacist at their pharmacy vaccinated the patient with SHINGRIX by subcutaneous route instead of intramuscular route, which led to inappropriate route of vaccine administration. The reporter did not have any patient information at the time of reporting, since the vaccine was administered by the other pharmacist, who no longer worked at the facility at the time of reporting. The healthcare professional stated she would need to look up the patient. In July 2018, the healthcare professional called the patient, and stated about the occurred medication error, where the patient stated that only injection site pain was experienced and no other side effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Phantom pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of phantom pain in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included amputee. Concurrent medical conditions included phantom pain. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced phantom pain and condition aggravated. On an unknown date, the outcome of the phantom pain and condition aggravated were unknown. It was unknown if the reporter considered the phantom pain and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: This case was reported via text message to the agency. The age at vaccination was not reported. The physician had an amputee patient with a pre-existent condition of phantom pain.  The phantom pain became severe on the day of the vaccination. The pain was so severe that he had to be put on medication (not specified). No additional details were provided. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK186891.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included IMMUNOSUPPRESSIVE THERAPY (NOS) (unspecified immunosuppressive therapy). On 10th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced shingles, numbness in leg and tingling of extremity. On 3rd October 2018, the patient experienced vesicles. On an unknown date, the outcome of the shingles, numbness in leg, tingling of extremity and vesicles were unknown. It was unknown if the reporter considered the shingles, numbness in leg, tingling of extremity and vesicles to be related to SHINGRIX. Additional details were provided as follows: About 1 week back, from the date of reporting, the patient had numbness and tingling in the legs. Two days back, from the date of reporting, the shingles vesicles appeared and the diagnosis of shingles was made.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 31st July 2019) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The healthcare professional did not know how soon after the vaccine that the patient developed the shingles.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On 17th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on left arm. The patient could not recall the time of day she received the 1st shot. The patient experienced a sore arm with the after the vaccine shot. The soreness lasted for 4 days. The patient's physician was her husband. This case has been linked to the case US2018GSK185723 (2nd dose case for the same patient), reported by same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (in the eye, experienced in 1998) and ischemic optic neuropathy. On 5th October 2018 12:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced headache, pain in arm, nausea, feeling unwell, general body pain and fatigue. On an unknown date, the outcome of the headache, pain in arm, nausea, feeling unwell, general body pain and fatigue were unknown. It was unknown if the reporter considered the headache, pain in arm, nausea, feeling unwell, general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The night after receiving of SHINGRIX, the patient experienced headache, body aches, fatigue and felt somewhat nauseated. His arm was sore in the weekend of reporting date, but it was not as bad as at the time of reporting. The patient at the time of reporting was still not feeling right overall.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included ophthalmic herpes zoster (in the eye, experienced in 1998) and ischemic optic neuropathy. On 5th October 2018 12:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced headache, pain in arm, nausea, feeling unwell, general body pain and fatigue. On an unknown date, the outcome of the headache, pain in arm, nausea, feeling unwell, general body pain and fatigue were unknown. It was unknown if the reporter considered the headache, pain in arm, nausea, feeling unwell, general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The night after receiving of SHINGRIX, the patient experienced headache, body aches, fatigue and felt somewhat nauseated. His arm was sore in the weekend of reporting date, but it was not as bad as at the time of reporting. The patient at the time of reporting was still not feeling right overall.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were recovered/resolved. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, the patient developed a rash and itching that lasted for 10 days after receiving the SHINGRIX. The reporter did not have vaccine information and did not feel comfortable providing all patient details.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm and injection site muscle pain. On an unknown date, the outcome of the pain in arm and injection site muscle pain were recovering/resolving. It was unknown if the reporter considered the pain in arm and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced arm pain. The patient reported that the arm where vaccine was given still hurts at the time of reporting. It was improving everyday but it was still hurting. The patient clarified that the pain was in the muscle where he received the vaccine. It was not just pain at the injection site. At the beginning the patient could not lift his arm straight out or up without pain. Day by day it was getting better.   This case has been linked with the case US2018182666 (patient's wife), reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 25th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 26th September 2018, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. After receiving SHINGRIX, the patient experienced pain at the injection site on the same day. The next day her injection site was red and warm. This case has been linked with the case US2018182664 (patient's husband), reported by same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Herpes zoster, Inflammation, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced 4 times previously). Previously administered products included Valtrex and Acyclovir. Concurrent medical conditions included antiviral treatment. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, pruritus, gastrointestinal disorder, inflammation, pain in hand and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the shingles, pruritus, inflammation, pain in hand and hives were not recovered/not resolved and the outcome of the gastrointestinal disorder was recovered/resolved.  It was unknown if the reporter considered the shingles, pruritus, gastrointestinal disorder, inflammation, pain in hand and hives to be related to SHINGRIX. Additional information was reported as follows: The reporter was the patient. The patient was vaccinated with SHINGRIX and soon after vaccination the patient experienced itching and hives that the patient stated would not go away.  The area was also inflamed. The patient's nurse diagnosed her with shingles. The patient had gastro-intestinal problems for a few weeks, but they had resolved. The pain and itching had radiated from her arm to her hand. She took Benadryl but it had no effect on her condition. The patient's previous bouts with shingles were not on the same location as experienced this time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced 4 times previously). Previously administered products included Valtrex and Acyclovir. Concurrent medical conditions included antiviral treatment. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, pruritus, gastrointestinal disorder, inflammation, pain in hand and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the shingles, pruritus, inflammation, pain in hand and hives were not recovered/not resolved and the outcome of the gastrointestinal disorder was recovered/resolved.  It was unknown if the reporter considered the shingles, pruritus, gastrointestinal disorder, inflammation, pain in hand and hives to be related to SHINGRIX. Additional information was reported as follows: The reporter was the patient. The patient was vaccinated with SHINGRIX and soon after vaccination the patient experienced itching and hives that the patient stated would not go away.  The area was also inflamed. The patient's nurse diagnosed her with shingles. The patient had gastro-intestinal problems for a few weeks, but they had resolved. The pain and itching had radiated from her arm to her hand. She took Benadryl but it had no effect on her condition. The patient's previous bouts with shingles were not on the same location as experienced this time.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old male patient who received SHINGRIX (batch number 3NY5G, expiry date 31st March 2019) for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovering/resolving. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. On an unknown date, the patient developed a rash, described as not blistered, which spread 5-6 inches from the injection site. The healthcare professional (HCP) reported that the rash was improved but not yet resolved.