chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received at the age of 60 years). On 26th May 2018, the patient received the 1st dose of SHINGRIX. On 8th October 2018, 135 days after receiving SHINGRIX, the patient experienced shingles, discomfort, raised rash, localized erythema, itchy rash and sunburn-like rash. On 12th October 2018, the patient experienced injected limb mobility decreased and painful rash. In October 2018, the patient experienced shooting pain. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles, discomfort, injected limb mobility decreased, itchy rash, painful rash and sunburn-like rash were unknown and the outcome of the raised rash was recovered/resolved and the outcome of the localized erythema and shooting pain were not recovered/not resolved. It was unknown if the reporter considered the shingles, discomfort, injected limb mobility decreased, raised rash, localized erythema, itchy rash, painful rash, sunburn-like rash and shooting pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received SHINGRIX in the right arm. On 8th October 2018, the patient noticed itch on the back of his right shoulder. There were two red spots. This spread to his front right shoulder, the right side of his chest, under his right arm pit, and the right side of his back. These areas were itchy. The patient said that there was a lot of discomfort and it felt like a sunburn. By Monday and Tuesday before the date of reporting, the spots, which he now referred to as a rash, became raised. He went to his family physician on Friday, 12th October 2018 and was prescribed VALTREX. The rash was very painful on Friday, Saturday and Sunday, forcing him to have to sleep upright because he could not lay on the rash and he could not lift his right arm. On 15th October 2018, he has significantly less pain (60-70 percent resolved). On the date of reporting, there was less pain than on Monday, redness was still present but the rash was no longer raised. Every now and then he gets a shooting pain that will last for 2-3 seconds, causing him to flinch and then it was gone.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Erythema, Extensive swelling of vaccinated limb
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In March 2018, 30 min after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad. On an unknown date, the patient experienced extensive swelling of vaccinated limb and incomplete course of vaccination. On an unknown date, the outcome of the extensive swelling of vaccinated limb and incomplete course of vaccination were unknown and the outcome of the pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad to be related to SHINGRIX. Additional details were provided as follows: Within 30 minutes after getting the dose of SHINGRIX vaccine, the patient's arm started swelling and turning red and it was very painful. Her arm was eventually swollen from her shoulder to her elbow and hurt so much that she could not use it. That evening the patient also started feeling feverish, weak, and dizzy and had bad joint pains. The patient stayed in bed for 3 to 4 days after getting the dose of SHINGRIX vaccine because she felt so bad. After 4 to 5 days, the patient felt better, except for her arm was still red swollen and painful. It took at least 10 days for the redness and swelling to resolve and the pain lasted for weeks. The patient had not gotten the 2nd dose and was not sure she ever would, which led to incomplete course of vaccination. The patient had denied permission to contact their physician.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In March 2018, 30 min after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad. On an unknown date, the patient experienced extensive swelling of vaccinated limb and incomplete course of vaccination. On an unknown date, the outcome of the extensive swelling of vaccinated limb and incomplete course of vaccination were unknown and the outcome of the pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema of extremities, fever, dizziness, weakness, injected limb mobility decreased, joint pain and feeling bad to be related to SHINGRIX. Additional details were provided as follows: Within 30 minutes after getting the dose of SHINGRIX vaccine, the patient's arm started swelling and turning red and it was very painful. Her arm was eventually swollen from her shoulder to her elbow and hurt so much that she could not use it. That evening the patient also started feeling feverish, weak, and dizzy and had bad joint pains. The patient stayed in bed for 3 to 4 days after getting the dose of SHINGRIX vaccine because she felt so bad. After 4 to 5 days, the patient felt better, except for her arm was still red swollen and painful. It took at least 10 days for the redness and swelling to resolve and the pain lasted for weeks. The patient had not gotten the 2nd dose and was not sure she ever would, which led to incomplete course of vaccination. The patient had denied permission to contact their physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Blood test abnormal, Fatigue, Lethargy, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of anemia in a 63-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 1 day after receiving SHINGRIX, the patient experienced general body pain. In August 2018, the patient experienced anemia. On an unknown date, the patient experienced lethargy and tiredness. On an unknown date, the outcome of the anemia, lethargy and tiredness were not recovered/not resolved and the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the anemia, lethargy, tiredness and general body pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on Left arm. The patient states that not long, less than a year after receiving the SHINGRIX dose, she experienced tiredness and lethargy. The patient states that she went to the physician and had blood work done in August 2018 and it showed that she was severely anemic. The patient states that in January 2018 her blood work was normal and she was not anemic. The patient states that she was not sure if it was related to the SHINGRIX vaccine or not, she was just trying to figure out what could be causing the anemia. The patient was going to see a hematologist in 2 weeks for the anemia. This case was linked with case US2018188575, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 61-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 30th August 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced allergic reaction, injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the allergic reaction, injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the physician. The patient received SHINGRIX vaccine in left arm. The reporter had a consumer that came into her pharmacy on 13th October 2018 to report that after receiving the SHINGRIX vaccine, the injection site became swollen, hot, red, and painful. The patient had a large red lump at the injection site. The patient's physician told her it was an allergic reaction and advised her not to get the 2nd dose of SHINGRIX vaccine. All symptoms lasted for approximately two weeks and then resolved. The reporter was unable to provide additional details. This case is linked with case US2018188583, reported by the same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 61-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 30th August 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced allergic reaction, injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the allergic reaction, injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the physician. The patient received SHINGRIX vaccine in left arm. The reporter had a consumer that came into her pharmacy on 13th October 2018 to report that after receiving the SHINGRIX vaccine, the injection site became swollen, hot, red, and painful. The patient had a large red lump at the injection site. The patient's physician told her it was an allergic reaction and advised her not to get the 2nd dose of SHINGRIX vaccine. All symptoms lasted for approximately two weeks and then resolved. The reporter was unable to provide additional details. This case is linked with case US2018188583, reported by the same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, headache, stomach pain, nausea, injection site pain and feeling unwell. In May 2018, the patient experienced fatigue. On 7th May 2018, the outcome of the feeling unwell was recovered/resolved. On an unknown date, the outcome of the shivering, headache, fatigue, stomach pain, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the shivering, headache, fatigue, stomach pain, nausea, injection site pain and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: On 4th May 2018 in morning, the patient was vaccinated with her 1st dose of SHINGRIX. The patient experienced soreness at the injection site after the dose was administered. On the same day of the vaccination later, she was not feeling well, she had nausea, terrible stomach, headache and shivering. The patient stayed in bed all over the weekend, and did not feel better until 7th May 2018, Monday. She was not sure, whether she would get vaccinated with the 2nd dose of SHINGRIX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, headache, stomach pain, nausea, injection site pain and feeling unwell. In May 2018, the patient experienced fatigue. On 7th May 2018, the outcome of the feeling unwell was recovered/resolved. On an unknown date, the outcome of the shivering, headache, fatigue, stomach pain, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the shivering, headache, fatigue, stomach pain, nausea, injection site pain and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: On 4th May 2018 in morning, the patient was vaccinated with her 1st dose of SHINGRIX. The patient experienced soreness at the injection site after the dose was administered. On the same day of the vaccination later, she was not feeling well, she had nausea, terrible stomach, headache and shivering. The patient stayed in bed all over the weekend, and did not feel better until 7th May 2018, Monday. She was not sure, whether she would get vaccinated with the 2nd dose of SHINGRIX.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 83-year-old male patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th October 2018, 3 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that his pharmacy gave the patient the first dose of the SHINGRIX. Approximately 3 or 4 days after receiving SHINGRIX, the patient developed a rash on his leg. He thought it was shingles so he went to see his physician. Tests were negative for shingles. The rash was now resolving.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Hallucination, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 months from the date of reporting, refer case US2018GSK194788). On 16th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the sweating, general body pain, influenza like illness, shivering and hallucination were recovered/resolved and the outcome of the exhaustion was recovering/resolving and the outcome of the feeling bad, neck pain and lacrimation were unknown. It was unknown if the reporter considered the pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation to be related to SHINGRIX. Additional details were reported as follows: The patient's arm hurt right after the injection. By 11 PM in the evening of vaccination day, the patient was almost in tears because she felt so bad. The patient was shivering so much her teeth were chattering, she had neck pain, body pain and was almost hallucinating. The patient sweated the symptoms out overnight and was felt a lot better the day of reporting, thought the patient was still wiped out. The patient provided details of physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Lacrimation increased, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 months from the date of reporting, refer case US2018GSK194788). On 16th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the sweating, general body pain, influenza like illness, shivering and hallucination were recovered/resolved and the outcome of the exhaustion was recovering/resolving and the outcome of the feeling bad, neck pain and lacrimation were unknown. It was unknown if the reporter considered the pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation to be related to SHINGRIX. Additional details were reported as follows: The patient's arm hurt right after the injection. By 11 PM in the evening of vaccination day, the patient was almost in tears because she felt so bad. The patient was shivering so much her teeth were chattering, she had neck pain, body pain and was almost hallucinating. The patient sweated the symptoms out overnight and was felt a lot better the day of reporting, thought the patient was still wiped out. The patient provided details of physician.
Age: 62.0
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 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 months from the date of reporting, refer case US2018GSK194788). On 16th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th October 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the sweating, general body pain, influenza like illness, shivering and hallucination were recovered/resolved and the outcome of the exhaustion was recovering/resolving and the outcome of the feeling bad, neck pain and lacrimation were unknown. It was unknown if the reporter considered the pain in arm, sweating, general body pain, influenza like illness, exhaustion, shivering, hallucination, feeling bad, neck pain and lacrimation to be related to SHINGRIX. Additional details were reported as follows: The patient's arm hurt right after the injection. By 11 PM in the evening of vaccination day, the patient was almost in tears because she felt so bad. The patient was shivering so much her teeth were chattering, she had neck pain, body pain and was almost hallucinating. The patient sweated the symptoms out overnight and was felt a lot better the day of reporting, thought the patient was still wiped out. The patient provided details of physician.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Swelling face
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 80-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th October 2018, 2 days after receiving SHINGRIX, the patient experienced pruritus, facial swelling, red face and rash. On an unknown date, the outcome of the pruritus, facial swelling, red face and rash were not recovered/not resolved. It was unknown if the reporter considered the pruritus, facial swelling, red face and rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a medical assistant (MA). The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient developed itching and a rash (unknown location) and her face was swollen and red.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Malaise, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a 66-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. On 15th October 2018, the patient received the 1st dose of SHINGRIX. On 15th October 2018, less than a day after receiving SHINGRIX, the patient experienced sickness, weakness and vomiting. In October 2018, the patient experienced fatigue. On an unknown date, the outcome of the sickness, weakness, vomiting and fatigue were unknown. It was unknown if the reporter considered the sickness, weakness, vomiting and fatigue to be related to SHINGRIX.  Additional details were provided as follows: Within a few hours after vaccination, the patient began to feel sick and slept for 3 hours straight. The patient woke up feeling weak. Same evening of the vaccination, after dinner, the patient experienced vomiting. Less than a week after receiving SHINGRIX, the patient experienced fatigue. The reporter was unsure if symptoms has resolved.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tenderness in a 86-year-old male patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th October 2018, less than a day after receiving SHINGRIX, the patient experienced tenderness. On an unknown date, the outcome of the tenderness was recovered/resolved. It was unknown if the reporter considered the tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. At 14:00 hours, the patient received SHINGRIX in the deltoid. This case has been linked with the case US2018190183, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pruritus, Rash erythematous, Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tenderness in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th October 2018, less than a day after receiving SHINGRIX, the patient experienced tenderness. On 17th October 2018, the patient experienced pruritus, erythematous rash, shivering and tiredness. On an unknown date, the outcome of the tenderness was recovered/resolved and the outcome of the pruritus and erythematous rash were not recovered/not resolved and the outcome of the shivering and tiredness were unknown. It was unknown if the reporter considered the tenderness, pruritus, erythematous rash, shivering and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. At 14:00 hours, the patient received SHINGRIX in the left deltoid. After receiving SHINGRIX, the patient developed a red, flat non-confluent rash on her arm about 24 hours after the vaccination. The next day, the rash had extended to her inner thighs. This case has been linked with the case US2018190180, reported by the same reporter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Injection site pain, Insomnia, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 79-year-old male patient who received Shingrix for prophylaxis. On 16th October 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2018, less than a day after receiving Shingrix, the patient experienced limbs stiffness, fever, feeling hot, general body pain, injection site pain, chills and difficulty sleeping. The patient was treated with Advil. On 17th October 2018, the outcome of the fever and feeling hot were recovered/resolved. On an unknown date, the outcome of the limbs stiffness, general body pain and chills were recovering/resolving and the outcome of the injection site pain and difficulty sleeping were recovered/resolved. It was unknown if the reporter considered the limbs stiffness, fever, feeling hot, general body pain, injection site pain, chills and difficulty sleeping to be related to Shingrix. Additional details were provided as follows: This case was reported by patient's wife. On 16th October 2018 at approximately 5:30 PM, the patient received Shingrix on the right arm. The patient experienced body and leg stiffness and his body was hurting. The patient could not sleep and the next day he was complaining about that. The patient had pain in his arm at the injection site for a few days and then the pain was resolved. The patient also felt feverish for one day. The patient took Advil every six hours or so and the Advil was helping his symptoms. The patient denied permission to contact their physician.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 79-year-old male patient who received Shingrix for prophylaxis. On 16th October 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2018, less than a day after receiving Shingrix, the patient experienced limbs stiffness, fever, feeling hot, general body pain, injection site pain, chills and difficulty sleeping. The patient was treated with Advil. On 17th October 2018, the outcome of the fever and feeling hot were recovered/resolved. On an unknown date, the outcome of the limbs stiffness, general body pain and chills were recovering/resolving and the outcome of the injection site pain and difficulty sleeping were recovered/resolved. It was unknown if the reporter considered the limbs stiffness, fever, feeling hot, general body pain, injection site pain, chills and difficulty sleeping to be related to Shingrix. Additional details were provided as follows: This case was reported by patient's wife. On 16th October 2018 at approximately 5:30 PM, the patient received Shingrix on the right arm. The patient experienced body and leg stiffness and his body was hurting. The patient could not sleep and the next day he was complaining about that. The patient had pain in his arm at the injection site for a few days and then the pain was resolved. The patient also felt feverish for one day. The patient took Advil every six hours or so and the Advil was helping his symptoms. The patient denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th October 2018, several hours after receiving SHINGRIX, the patient experienced injection site wheal, injection site warmth, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 11:00, the patient received SHINGRIX on left deltoid. Later in the evening, the patient experienced welt on her arm at the injection site that was 4 by 5 inches. The area was hot, swollen and itching.
Sex: M
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 70-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a month 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 provided as follows: The age at vaccination was not reported however, the patient was 70 years old at the time of reporting. The patient received a dose of SHINGRIX and it hurted where the shot was given by the pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of double vision in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced double vision. On an unknown date, the outcome of the double vision was unknown. It was unknown if the reporter considered the double vision to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional stated that the patient's doctor would most likely be calling in to do a follow-up report with additional information. No further details were available at the time of reporting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Nausea, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized itching in a 70-year-old male patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 18th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced localized itching, fever, headache, shivering, insomnia and nausea. On an unknown date, the outcome of the localized itching, fever, headache, shivering, insomnia and nausea were recovering/resolving. It was unknown if the reporter considered the localized itching, fever, headache, shivering, insomnia and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient experienced itching on upper torso and arm and extreme shivering. No further details were provided by the pharmacist.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized itching in a 70-year-old male patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 18th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced localized itching, fever, headache, shivering, insomnia and nausea. On an unknown date, the outcome of the localized itching, fever, headache, shivering, insomnia and nausea were recovering/resolving. It was unknown if the reporter considered the localized itching, fever, headache, shivering, insomnia and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient experienced itching on upper torso and arm and extreme shivering. No further details were provided by the pharmacist.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced vesicular rash and blister. On an unknown date, the outcome of the vesicular rash and blister were unknown. It was unknown if the reporter considered the vesicular rash and blister to be related to SHINGRIX. Additional details were provided as follows: The health care professional declined to provide demographics of the patient. The age at the vaccination was not reported. The health care professional reported his patient in their 70s had a rash of 2 inches in diameter with pox like blisters 2 to 3 inches below the injection site that appeared 2 to 3 days after vaccination.
Sex: U
Vaccine: FLU4, MENB
Symptoms: Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a patient who received BEXSERO for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving BEXSERO and FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vomiting, headache, dizziness and fever. On an unknown date, the outcome of the vomiting, headache, dizziness and fever were unknown. It was unknown if the reporter considered the vomiting, headache, dizziness and fever to be related to BEXSERO and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The nurse informed her GSK vaccine representative that the patient received both BEXSERO and FLUARIX at the same time and experienced heavy vomiting, fever, headache and dizziness. This case has been linked with US2018193568, reported by the same reporter.
Sex: U
Vaccine: FLU4, MENB
Symptoms: Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vomiting in a patient who received BEXSERO for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received Bexsero at an unknown dose and FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving BEXSERO and FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vomiting, headache, dizziness and fever. On an unknown date, the outcome of the vomiting, headache, dizziness and fever were unknown. It was unknown if the reporter considered the vomiting, headache, dizziness and fever to be related to BEXSERO and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The nurse informed her Glaxosmithkline vaccine representative that the patient received both BEXSERO and FLUARIX at the same time and experienced heavy vomiting, fever, headache and dizziness. This case has been linked with US2018193567, reported by the same reporter.
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Needle issue, Syringe issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 12-month-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 2D24J, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, 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 FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The nurse administered FLULAVAL QUADRIVALENT to a patient in the thigh. The reported batch number 2024J was corrected to 2D24J as per sales data review. When she withdrew the syringe after vaccination the needle detached from the syringe and fell to the floor. When she went to reattach the needle to the syringe the tip lock part of the prefilled syringe broke off. The reporter also reported that, the patient experienced pain with the vaccination. Clarification has been raised to confirm if this case was associated with pharmaceutical product complaint.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Lethargy, Mobility decreased, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced influenza-like symptoms, fever, general body pain, mobility decreased and lethargy. On an unknown date, the outcome of the influenza-like symptoms, fever, general body pain, mobility decreased and lethargy were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, general body pain, mobility decreased and lethargy to be related to BEXSERO. Additional details were reported as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The patient had flu like symptoms, fever, body aches, couldn't move for an hour and was lethargic. The symptoms were lasted about 2 hours then subsided. The reporter agreed to be contacted by GlaxoSmithKline for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of cold sores in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown. It was unknown if the reporter considered the cold sores to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At the date of reporting, the patient came into the office with 5 to 6 cold sores around her mouth. The reporter agreed to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms, Presyncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of presyncope in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced presyncope and spasms. On an unknown date, the outcome of the presyncope and spasms were unknown. It was unknown if the reporter considered the presyncope and spasms 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 product was SHINGRIX and the reporter said the patient complained of spasms and had syncope like symptoms when driving.
Sex: U
Vaccine: DTP
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received DTP vaccine for prophylaxis. On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to DTP vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient cut their finger five years before the reporting date and needed tetanus shot. The patient received that shot along with DPT vaccine and so was sick. The patient was almost hospitalized from the reaction. The patient would never recommend it but the patient needed the tetanus booster and it was not given alone.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of myalgia in a 63-year-old male patient who received SHINGRIX (batch number DD43M, expiry date unknown) for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On 29th September 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia and fever. On an unknown date, the outcome of the myalgia and fever were unknown. It was unknown if the reporter considered the myalgia and fever to be related to SHINGRIX. Additional details were reported as follows: The patient had myalgias and fever over the next days after receiving SHINGRIX vaccine. The patient described he couldn't get out of bed over the weekend and missed football game on Sunday. The reporter agreed to be followed up. This case was linked with case US2018GSK190867, reported by same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a 77-year-old female patient who received SHINGRIX (batch number 95LX9, expiry date unknown) for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were reported as follows: The reporter described that patient had aches, pains, and fever following SHINGRIX vaccine to the severity that she was reluctant to get 2nd dose. The patient was telling others around her not to get the vaccine. The reporter agreed to be followed up. This case was linked with case US2018GSK190866, reported by same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 2nd dose of SHINGRIX 50 µg. On 18th October 2018, less than a day after receiving SHINGRIX, the patient experienced fever, pain and poor quality sleep. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain was not recovered/not resolved and the outcome of the poor quality sleep was unknown. It was unknown if the reporter considered the fever, pain and poor quality sleep to be related to SHINGRIX. Additional information was reported as follows: The patient experienced fever and body aches overnight vaccination day. The patient inquired how long the adverse effects would last. The patient receive a call back several hours later, after he inquired. On the day of reporting, the patient stated that he had 101 degree F temperature at 8 AM, but his fever was back to normal at the time of reporting. However the patient thought that the fever might go back up again at night when he sleeps. The patient stated that he felt okay at the time of reporting, just had aches fever and pains because he didn't sleep well last night. The contact details of the physician was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. 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 and pain in arm. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. The patient mentioned that he had a sore arm and at the time of receiving 2nd dose of SHINGRIX he had an active case of Shingles. The patient did not want to provide date of birth or physician's contact information or other adverse event information. The patient had denied permission to contact their physician. The patient had provided limited information. For tolerance to next dose, refer case US2018GSK196323.