chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (received 1st dose on 7th November 2018). Concurrent medical conditions included diabetes. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, less than a month after receiving SHINGRIX, the patient experienced injection site burning. In January 2019, the patient experienced skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site itching, injection site abrasion, rash and tiredness. On an unknown date, the patient experienced injection site warmth. The patient was treated with crotamiton, diphenhydramine, glycyrrhizic acid, lidocaine, tocopheryl acetate (Conte Anti-Itching Cream). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness to be related to SHINGRIX. Additional details were provided as follows: After 2nd dose of Shingrix, the patient reports it burned like liquid fire. She thinks the pharmacist hit a nerve or something. Then, the area, about the size of a softball around the injection site, became red, hot, swollen for about a week until it was finally gone 1.5 weeks later. After the redness and swelling went away, the patient started to experience itching so bad that where she has scratched it, she had little sores which concerns her because she has diabetes. She had tried anti itch cream over the counter but it did not help the itching. There was no redness now but a slight rash can be felt on the affected skin. The patient does not feel good further described as tired, exhausted. Reporter did put ice on it about day 3 to 4 when she saw the pharmacist. The patient had no primary physician.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Scratch
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (received 1st dose on 7th November 2018). Concurrent medical conditions included diabetes. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, less than a month after receiving SHINGRIX, the patient experienced injection site burning. In January 2019, the patient experienced skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site itching, injection site abrasion, rash and tiredness. On an unknown date, the patient experienced injection site warmth. The patient was treated with crotamiton, diphenhydramine, glycyrrhizic acid, lidocaine, tocopheryl acetate (Conte Anti-Itching Cream). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness to be related to SHINGRIX. Additional details were provided as follows: After 2nd dose of Shingrix, the patient reports it burned like liquid fire. She thinks the pharmacist hit a nerve or something. Then, the area, about the size of a softball around the injection site, became red, hot, swollen for about a week until it was finally gone 1.5 weeks later. After the redness and swelling went away, the patient started to experience itching so bad that where she has scratched it, she had little sores which concerns her because she has diabetes. She had tried anti itch cream over the counter but it did not help the itching. There was no redness now but a slight rash can be felt on the affected skin. The patient does not feel good further described as tired, exhausted. Reporter did put ice on it about day 3 to 4 when she saw the pharmacist. The patient had no primary physician.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erosion, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (received 1st dose on 7th November 2018). Concurrent medical conditions included diabetes. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, less than a month after receiving SHINGRIX, the patient experienced injection site burning. In January 2019, the patient experienced skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site itching, injection site abrasion, rash and tiredness. On an unknown date, the patient experienced injection site warmth. The patient was treated with crotamiton, diphenhydramine, glycyrrhizic acid, lidocaine, tocopheryl acetate (Conte Anti-Itching Cream). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness to be related to SHINGRIX. Additional details were provided as follows: After 2nd dose of Shingrix, the patient reports it burned like liquid fire. She thinks the pharmacist hit a nerve or something. Then, the area, about the size of a softball around the injection site, became red, hot, swollen for about a week until it was finally gone 1.5 weeks later. After the redness and swelling went away, the patient started to experience itching so bad that where she has scratched it, she had little sores which concerns her because she has diabetes. She had tried anti itch cream over the counter but it did not help the itching. There was no redness now but a slight rash can be felt on the affected skin. The patient does not feel good further described as tired, exhausted. Reporter did put ice on it about day 3 to 4 when she saw the pharmacist. The patient had no primary physician.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Rash, Skin ulcer
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 62-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (received 1st dose on 7th November 2018). Concurrent medical conditions included diabetes. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. On 7th January 2019, less than a month after receiving SHINGRIX, the patient experienced injection site burning. In January 2019, the patient experienced skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site itching, injection site abrasion, rash and tiredness. On an unknown date, the patient experienced injection site warmth. The patient was treated with crotamiton, diphenhydramine, glycyrrhizic acid, lidocaine, tocopheryl acetate (Conte Anti-Itching Cream). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site burning, skin ulcer, injection site induration, injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site abrasion, rash and tiredness to be related to SHINGRIX. Additional details were provided as follows: After 2nd dose of Shingrix, the patient reports it burned like liquid fire. She thinks the pharmacist hit a nerve or something. Then, the area, about the size of a softball around the injection site, became red, hot, swollen for about a week until it was finally gone 1.5 weeks later. After the redness and swelling went away, the patient started to experience itching so bad that where she has scratched it, she had little sores which concerns her because she has diabetes. She had tried anti itch cream over the counter but it did not help the itching. There was no redness now but a slight rash can be felt on the affected skin. The patient does not feel good further described as tired, exhausted. Reporter did put ice on it about day 3 to 4 when she saw the pharmacist. The patient had no primary physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Joint swelling, Local reaction, Product supply issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swollen joints in a 62-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX the patient experienced swollen joints, influenza-like symptoms and product supply issue. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and nsaid's (Non-Steroidal Anti-Inflammatory). On an unknown date, the outcome of the swollen joints and influenza-like symptoms were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the swollen joints and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The healthcare professional (HCP) reported that the patient developed significant swelling of entire left shoulder and flu-like symptoms after initial dose of SHINGRIX which was received 6 to 7 months ago.  The patient treated local reaction with ice packs and non-steroidal anti-inflammatory medications. Symptoms subsided over the course of 3 to 4 days.  The patient had yet to receive the 2nd dose due to vaccine shortage and concerned of possible reoccurring reaction. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Malaise, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th October 2018, 1 days after receiving SHINGRIX, the patient experienced sickness, pain in arm and injection site erythema. In October 2018, the patient experienced injection site itching. On an unknown date, the outcome of the sickness, pain in arm, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the sickness, pain in arm, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were reported as follows: After getting the vaccine, the patient felt sick for 1 to 1.5 days, his arm was sore for a week and the patient had redness at the injection site for a couple weeks. A week and a half (10.5 days) after the vaccine, the redness became itchy. On 23rd January 2019, the got his second dose of SHINGRIX. The reporter consented to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 82-year-old male patient who received SHINGRIX (batch number N79Z5, expiry date 31st January 2020) for prophylaxis. On 17th January 2019, the patient received the 2nd dose of SHINGRIX. On 19th January 2019, 2 days after receiving SHINGRIX, the patient experienced dizziness, balance disorder and headache. On 20th January 2019, the patient experienced tiredness. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the balance disorder and tiredness were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the dizziness, balance disorder, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received his 2nd SHINGRIX dose in right arm. Two days later he experienced headaches that would keep him awake at night, but resolved later in the morning upon awakening. They lasted for 3 days. He also noted he began to feel dizziness that was very bad in the morning, got better throughout the day, but it had not resolved as of this call. He notes his balance is off, he was worried to do his usual things like walking. He also stated he noticed being tired on the 20th, he was out picking up sticks, which was not uncommon, and he continues to be tired as of this call when he exerts himself. The patient had an appointment with his physician. The reporter gave consent to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 82-year-old male patient who received SHINGRIX (batch number N79Z5, expiry date 31st January 2020) for prophylaxis. On 17th January 2019, the patient received the 2nd dose of SHINGRIX. On 19th January 2019, 2 days after receiving SHINGRIX, the patient experienced dizziness, balance disorder and headache. On 20th January 2019, the patient experienced tiredness. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the balance disorder and tiredness were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the dizziness, balance disorder, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received his 2nd SHINGRIX dose in right arm. Two days later he experienced headaches that would keep him awake at night, but resolved later in the morning upon awakening. They lasted for 3 days. He also noted he began to feel dizziness that was very bad in the morning, got better throughout the day, but it had not resolved as of this call. He notes his balance is off, he was worried to do his usual things like walking. He also stated he noticed being tired on the 20th, he was out picking up sticks, which was not uncommon, and he continues to be tired as of this call when he exerts himself. The patient had an appointment with his physician. The reporter gave consent to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 82-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (she received a ZOSTAVAX vaccination 15 years ago). On 28th December 2018, the patient received the 1st dose of SHINGRIX. On 28th December 2018, 1 hr after receiving SHINGRIX, the patient experienced stiff neck and neck pain. On 30th December 2018, the patient experienced tiredness, appetite lost, feeling bad, gait disturbance, loss of energy and shoulder pain. On an unknown date, the patient experienced back pain. On an unknown date, the outcome of the stiff neck, tiredness, appetite lost, feeling bad, gait disturbance, loss of energy, shoulder pain and back pain were recovered/resolved and the outcome of the neck pain was unknown. It was unknown if the reporter considered the stiff neck, tiredness, appetite lost, feeling bad, gait disturbance, loss of energy, shoulder pain, back pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: Two days after receiving the patient experienced tiredness, appetite lost, feeling bad, gait disturbance, loss of energy and shoulder pain. Less than a month, the patient experienced back pain. The patient received SHINGRIX and experienced tired and severe pain for 5 to 6 days. She had loss of appetite for 2 to 3 days. She had lack of energy for 10 to 11 days then felt better. She had mild intermittent neck and back pain that resolved around day 14. Consented to follow up was provided.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 82-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (she received a ZOSTAVAX vaccination 15 years ago). On 28th December 2018, the patient received the 1st dose of SHINGRIX. On 28th December 2018, 1 hr after receiving SHINGRIX, the patient experienced stiff neck and neck pain. On 30th December 2018, the patient experienced tiredness, appetite lost, feeling bad, gait disturbance, loss of energy and shoulder pain. On an unknown date, the patient experienced back pain. On an unknown date, the outcome of the stiff neck, tiredness, appetite lost, feeling bad, gait disturbance, loss of energy, shoulder pain and back pain were recovered/resolved and the outcome of the neck pain was unknown. It was unknown if the reporter considered the stiff neck, tiredness, appetite lost, feeling bad, gait disturbance, loss of energy, shoulder pain, back pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: Two days after receiving the patient experienced tiredness, appetite lost, feeling bad, gait disturbance, loss of energy and shoulder pain. Less than a month, the patient experienced back pain. The patient received SHINGRIX and experienced tired and severe pain for 5 to 6 days. She had loss of appetite for 2 to 3 days. She had lack of energy for 10 to 11 days then felt better. She had mild intermittent neck and back pain that resolved around day 14. Consented to follow up was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse event in an unspecified number of the patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The age group was not reported, but was selected adult as per vaccine indication. The healthcare professional stated that they have noticed that when the patients received the 2nd dose of SHINGRIX closer to the 6 month period the side effects seem to be less severe than when patients were received the 2nd dose at 2 months. The reporter did not give consent to follow up. No specific patients were provided.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 88-year-old female patient who received SHINGRIX (batch number G45LN, expiry date unknown) for prophylaxis. On 24th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tingling of extremity, numbness in fingers and stiff fingers. On an unknown date, the outcome of the tingling of extremity, numbness in fingers and stiff fingers were not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity, numbness in fingers and stiff fingers to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX on left arm in their pharmacy and since then has experienced tingling down the left arm, left hand ring finger was numb and hard to move. The patient reported that these events were not resolved and the expiration date was not available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th September 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and injection site pain. On an unknown date, the outcome of the tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the tiredness and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient planned to continue follow up with her physician on an unknown date. Consented to follow up was provided. This case linked with US2019GSK018566, reported by same reporter for the same patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX. On 20th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site bruising. On 21st December 2018, the patient experienced injection site rash and injection site discoloration. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site bruising, injection site rash and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site bruising, injection site rash and injection site discoloration to be related to SHINGRIX. Additional details were reported as follows: The caller was the patient herself. The patient received SHINGRIX on left arm. The patient experienced swollen arm, bruising and pain at the injection site. The swollen arm lasted for over a week, the bruising lasted for 3 weeks, and pain at injection site lasted for about three to four days. Day after the vaccination she experienced a pink rash at the injection in the front side of the arm which lasted for about 5 days. The reporter did not give consent to follow up. No further details provided. This case has been linked with US2019013627, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and influenza-like symptoms. On an unknown date, the outcome of the erythema of extremities was unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the erythema of extremities and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The caller stated one of her friends received SHINGRIX vaccine on left arm around the end of December 2018. The patient experienced a red band around and underneath the arm. The patient also experienced flu like symptoms which lasted for about 2 days. The patient does not know if the red band had resolved for her friend. No further details were provided. The caller calling in adverse event for herself and her friend. This case has been linked with US2019013718, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Imaging procedure, Laboratory test normal, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a elderly male patient who received SHINGRIX for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX. On 1st January 2019, 5 days after receiving SHINGRIX, the patient experienced weakness of arms (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). In January 2019, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the weakness of arms and walking difficulty were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the weakness of arms, walking difficulty and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's cousin. The patient's concomitant medication included unspecified cholesterol medication. The age at vaccination was not reported but the patient could be 67 or 68 years old. The patient at around 1st January 2019, began to experience weakness in his arms and legs and found it difficult to walk. The patient was seen in the emergency room, and various laboratory and imaging tests were done, but not specified which type. The results were negative. The patient went home and about 2 days later, the symptoms remained, and the patient went back to the emergency department, and was admitted. Nothing remarkable was noted on testing. The physicians thought an unspecified cholesterol medication might be the cause of the weakness and was discontinued, but symptoms did not improve. The patient was limited in daily activities and was in a wheel chair. The reporter consented to follow up. Lab Comments: Various laboratory and imaging tests were done, but not specified which type. The results were negative.
Sex: M
Vaccine: VARZOS
Symptoms: Wheelchair user
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a elderly male patient who received SHINGRIX for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX. On 1st January 2019, 5 days after receiving SHINGRIX, the patient experienced weakness of arms (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). In January 2019, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the weakness of arms and walking difficulty were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the weakness of arms, walking difficulty and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's cousin. The patient's concomitant medication included unspecified cholesterol medication. The age at vaccination was not reported but the patient could be 67 or 68 years old. The patient at around 1st January 2019, began to experience weakness in his arms and legs and found it difficult to walk. The patient was seen in the emergency room, and various laboratory and imaging tests were done, but not specified which type. The results were negative. The patient went home and about 2 days later, the symptoms remained, and the patient went back to the emergency department, and was admitted. Nothing remarkable was noted on testing. The physicians thought an unspecified cholesterol medication might be the cause of the weakness and was discontinued, but symptoms did not improve. The patient was limited in daily activities and was in a wheel chair. The reporter consented to follow up. Lab Comments: Various laboratory and imaging tests were done, but not specified which type. The results were negative.
Age: 88.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 88-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. Co-suspect products included BOOSTRIX (batch number 4P9CL, expiry date 1st December 2020) for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and BOOSTRIX (intramuscular). In August 2018, 2 days after receiving SHINGRIX and BOOSTRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: Two days later the patient developed a rash from the front of her neck down to her legs.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes. On 7th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the left upper arm and had no problem except for some soreness around the injection site for 2 to 3 days. The patient had no primary physician. This case has been linked to the case US2019GSK016957, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient age was 81 years old. The reporter was the pharmacy student. The patient received SHINGRIX vaccine on left arm. The reporter reported that the patient experienced flu like symptoms which lasted for total of 3 days. The reporter wanted to know the efficacy of the vaccine if the patient only received the first dose of SHINGRIX. No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and inflammation. On an unknown date, the outcome of the injection site erythema and inflammation were unknown. It was unknown if the reporter considered the injection site erythema and inflammation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient was experiencing redness at the injection site about 3 by 4 inches in size. The patient was very patient. Because he was very insistent and he probably was a bit repetitive and he wanted to be certain that it was reasonable to not have a reaction for two to three days. The patient did not show up for three days and it was inflamed now and it was not for three days. So patient was very persistent and he was very patient and understanding. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and inflammation. On an unknown date, the outcome of the injection site erythema and inflammation were unknown. It was unknown if the reporter considered the injection site erythema and inflammation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient was experiencing redness at the injection site about 3 by 4 inches in size. The patient was very patient. Because he was very insistent and he probably was a bit repetitive and he wanted to be certain that it was reasonable to not have a reaction for two to three days. The patient did not show up for three days and it was inflamed now and it was not for three days. So patient was very persistent and he was very patient and understanding. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Renal failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of renal failure in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced renal failure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the renal failure was unknown. It was unknown if the reporter considered the renal failure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's husband came into the pharmacy and told that after his wife (patient) received SHINGRIX, she had kidney failure and was hospitalized for a month. Neither reporter could remember the patient's demographic information and they never heard any follow up for how patient was doing at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization). 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 details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction and was hospitalized for 2 days post vaccination.  No further details were available. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included ORENCIA for product used for unknown indication. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer case US2019GSK019571) and XELJANZ. On 4th January 2019, the patient received the 2nd dose of SHINGRIX and ORENCIA. On 5th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, fever and chills. The patient was treated with diclofenac sodium, TYLENOL and BACLOFEN. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site swelling and chills were unknown and the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 4th January 2019, the patient also received ORENCIA. After receiving SHINGRIX, the patient experienced a sore, swollen injection site, fever of 102 degree F and chills. The patient had no rash, difficulty breathing, or signs or symptoms of chest congestion. The patient took one TYLENOL, a diclofenac tablet, and a BACLOFEN but still had fever. She also received TYLENOL 500mg tablets when she was advised to receive one 500 mg tablet but did not receive more TYLENOL for at least 6 hours. The patient was advised if symptoms would not get better by tomorrow contact the ORENCIA prescriber for evaluation of possible infection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Pain, Pulmonary congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 20th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th January 2019, 4 days after receiving SHINGRIX, the patient experienced lung congestion (serious criteria GSK medically significant). On an unknown date, the patient experienced chills, stomach pain, erythema and pain. On an unknown date, the outcome of the chills, stomach pain, erythema and pain were recovered/resolved and the outcome of the lung congestion was not reported. It was unknown if the reporter considered the chills, stomach pain, erythema, pain and lung congestion to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left arm. Chills and stomach ache were lasted for about 2 hours. Redness and soreness were lasted for 4 days. The patient experienced chest congestion. The patient was referred to healthcare professional. The consent to follow up was provided. No further details were provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms and joint pain. On an unknown date, the outcome of the influenza-like symptoms and joint pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient had flu-like symptoms after getting the SHINGRIX. The patient mentioned joint aches specifically. The patient was out of commission for a couple days.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age. On 22-JAN-2019, the patient was vaccinated with a dose of improperly stored PROQUAD injection via subcutaneous route, lot # R017625 with expiration date on 18-DEC-2019. The dose of the vaccine underwent a temperature excursion of 15 to 46 degrees Fahrenheit for 103 days and 47 to 77 degrees Fahrenheit for 10 minutes. The Digital Data Logger was involved in the recording of the excursions. No adverse events were reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of injection site erythema in a 76-year-old female patient who received SHINGRIX for prophylaxis.  On 19th January 2019, the patient received the 1st dose of SHINGRIX .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated that after receiving a dose of SHINGRIX she had redness, swelling and soreness at the injection site of the upper left arm. The reaction was still present as of 25th January 2019.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 16th January 2019, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with neomycin. On an unknown date, the outcome of the cellulitis was recovering/resolving. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced streak and cellulitis. On 18th January 2019, the cellulitis went tore. The outcome of the event was improved 2 to 3 days after. The reporter was agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter pharmacist stated that, other patients experienced pain at the injection site. The reporter consented to follow up. No further information was provided. This case has been linked with case US2019014453, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via other manufacturer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had sore, swollen injection site after receiving SHINGRIX. For tolerance to 2nd dose, refer case US2019GSK019571.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX 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 fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were recovered/resolved. It was unknown if the reporter considered the fever and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter gave consent to follow up. This case was 2 of the 2 cases, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose, refer case ID US2019GSK019668). On 24th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fever, muscle pain and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, muscle pain and nausea were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The reporter gave consent to follow up. This case was 1 of the 2 cases, reported by the same reporter.