chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 75-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis and PNEUMOCOCCAL VACCINE for prophylaxis. Concurrent medical conditions included neoplasm malignant. On 29th August 2018, the patient received SHINGRIX (intramuscular), Influenza vaccine Quadrivalent 2017-2018 season and PNEUMOCOCCAL VACCINE. On 29th August 2018, less than a day after receiving SHINGRIX and an unknown time after receiving Influenza vaccine Quadrivalent 2017-2018 season and PNEUMOCOCCAL VACCINE, the patient experienced chills. On an unknown date, the outcome of the chills was recovering/resolving. It was unknown if the reporter considered the chills to be related to SHINGRIX and Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: This case was reported by the patient's wife who was also a nurse. The nurse reported that her husband got SHINGRIX, pneumococcal and flu vaccines a day before reporting and in the evening he started experiencing chills, though he did not have a fever.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The caller was a nurse from healthcare professional office relaying information on behalf of provider. The caller relayed that the patient received SHINGRIX on left deltoid. The caller relayed that the patient complained of redness and hard swelling the size of baseball at the injection site. The caller relayed that the patient stated that the reaction started about a day after administration and had recovered. The caller relayed that the patient received 2nd dose of SHINGRIX (batch number TP5E5, expiry date 15th November 2020) on 17th July 2018 on right deltoid and till the date of reporting the patient had not informed her of any reactions with the 2nd dose of SHINGRIX. No further information provided. This is 1 of the 3 linked cases, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received SHINGRIX (batch number B9739, expiry date November 2020) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm and injection site induration. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved and the outcome of the injection site induration was unknown. It was unknown if the reporter considered the injection site erythema, pain in arm and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The caller was a nurse from healthcare professional office relaying information on behalf of provider. The caller relayed that the patient received SHINGRIX on left deltoid. The caller relayed that the patient complained of redness and hard area at the injection site that was initially about the size of a baseball but went to elbow. The caller also relayed that the patient complained of tenderness to the arm that felt like she ran into a wall. The caller relayed that the patient states the symptoms lasted several days and started the day after administration. The caller relayed that the patient had 2nd dose of SHINGRIX (batch number 7X3EJ, expiry date 13-October 2018) on right arm. No further information provided. This is 1 of the 3 linked cases reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. Concurrent medical conditions included pertussis immunisation. On 18th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th August 2018, 11 days after receiving SHINGRIX, the patient experienced injection site erythema, joint pain, burning hip, fever, feeling hot and injection site swelling. On an unknown date, the outcome of the injection site erythema, joint pain and fever were recovered/resolved and the outcome of the burning hip, feeling hot and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, joint pain, burning hip, fever, feeling hot and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The caller was a nurse from healthcare professional office relaying information on behalf of provider. The caller relayed that the patient received SHINGRIX on left deltoid. The caller relayed that the patient complained of fever (the patient's body temperature was recorded as 103 degrees F), joints aching, joints burning in her knees, elbows, and hips that felt flaming hot. The caller relayed that the patient complained of injection site being red and the size of baseball. The caller relayed that the patient was feeling better on the day of reporting. The caller relayed that the patient stated that the injection site was still red but the swelling, aches, and burning were relieved and the fever subsided. The caller relayed that the patient also stated that she had a similar reaction to TDAP vaccine but is not aware of which product and patient also allergy listed for pertussis vaccine. No further information provided. This is 1 of the 3 linked cases, reported by the same reporter. This case has been linked with US2018GSK161565 (same patient).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. Concurrent medical conditions included pertussis immunisation. On 18th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th August 2018, 11 days after receiving SHINGRIX, the patient experienced injection site erythema, joint pain, burning hip, fever, feeling hot and injection site swelling. On an unknown date, the outcome of the injection site erythema, joint pain and fever were recovered/resolved and the outcome of the burning hip, feeling hot and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, joint pain, burning hip, fever, feeling hot and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The caller was a nurse from healthcare professional office relaying information on behalf of provider. The caller relayed that the patient received SHINGRIX on left deltoid. The caller relayed that the patient complained of fever (the patient's body temperature was recorded as 103 degrees F), joints aching, joints burning in her knees, elbows, and hips that felt flaming hot. The caller relayed that the patient complained of injection site being red and the size of baseball. The caller relayed that the patient was feeling better on the day of reporting. The caller relayed that the patient stated that the injection site was still red but the swelling, aches, and burning were relieved and the fever subsided. The caller relayed that the patient also stated that she had a similar reaction to TDAP vaccine but is not aware of which product and patient also allergy listed for pertussis vaccine. No further information provided. This is 1 of the 3 linked cases, reported by the same reporter. This case has been linked with US2018GSK161565 (same patient).
Sex: F
Vaccine: TDAP
Symptoms: Localised infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of arm infection in a elderly female patient who received dTpa vaccine for prophylaxis. The patient's past medical history included lymph node excision and breast cancer. On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced arm infection. On an unknown date, the outcome of the arm infection was unknown. It was unknown if the reporter considered the arm infection to be related to dTpa vaccine. Additional details were provided as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. The patient received Tdap (unspecified brand) in the deltoid. The patient developed infection in her arm. The reporter did not have any additional information.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Neck pain, Pain in extremity, Tenderness, Ultrasound Doppler normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tenderness in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 26th August 2018, the patient received the 2nd dose of SHINGRIX. On 26th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 28th August 2018, the patient experienced tenderness, influenza-like symptoms and neck pain. On an unknown date, the outcome of the tenderness, influenza-like symptoms, pain in arm and neck pain were unknown. It was unknown if the reporter considered the tenderness, influenza-like symptoms, pain in arm and neck pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. The patient had no issues with the first dose of SHINGRIX. The patient received SHINGRIX in the right arm and 2 days later, experienced tenderness in the artery of the right side of his neck that then traveled to his ear and to his head and flu like symptoms. The patient was seen by his physician, who did an ultrasound of his artery and it was clear. The contact details of the physician was provided.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site rash, Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 59-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included FLUZONE VACCINE. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced skin warm, axillary pain, injection site erythema, nocturnal awakening and injection site rash. On 28th August 2018, the patient experienced enlargement of lymph nodes and injection site pain. On an unknown date, the outcome of the enlargement of lymph nodes, injection site pain, injection site erythema and injection site rash were not recovered/not resolved and the outcome of the skin warm and axillary pain were recovered/resolved and the outcome of the nocturnal awakening was unknown. It was unknown if the reporter considered the enlargement of lymph nodes, skin warm, injection site pain, axillary pain, injection site erythema, nocturnal awakening and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUZONE in the right arm. On that same arm the patient had a large raised red patch at the site of the injection the same day that she received the SHINGRIX vaccine. The patch started being sore at the injection site the next day of the vaccine. The same night of vaccination, she felt hurting underneath the arm where she received the SHINGRIX injection. It felt on fire and it kept waking her up at night. The next day, it was kind of subsided but noticed that the lymph nodes under her arms were swollen and they were still swollen. They were not hurting anymore but were swollen.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Middle insomnia, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 59-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included FLUZONE VACCINE. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th August 2018, less than a day after receiving SHINGRIX, the patient experienced skin warm, axillary pain, injection site erythema, nocturnal awakening and injection site rash. On 28th August 2018, the patient experienced enlargement of lymph nodes and injection site pain. On an unknown date, the outcome of the enlargement of lymph nodes, injection site pain, injection site erythema and injection site rash were not recovered/not resolved and the outcome of the skin warm and axillary pain were recovered/resolved and the outcome of the nocturnal awakening was unknown. It was unknown if the reporter considered the enlargement of lymph nodes, skin warm, injection site pain, axillary pain, injection site erythema, nocturnal awakening and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUZONE in the right arm. On that same arm the patient had a large raised red patch at the site of the injection the same day that she received the SHINGRIX vaccine. The patch started being sore at the injection site the next day of the vaccine. The same night of vaccination, she felt hurting underneath the arm where she received the SHINGRIX injection. It felt on fire and it kept waking her up at night. The next day, it was kind of subsided but noticed that the lymph nodes under her arms were swollen and they were still swollen. They were not hurting anymore but were swollen.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of raised rash in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced raised rash and local swelling. On an unknown date, the outcome of the raised rash and local swelling were unknown. It was unknown if the reporter considered the raised rash and local swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient was out in the garden and came back inside and noted that she had a rash on her back in 3 areas, one of the areas the rash was raised with bumps. The patient was concerned it might be shingles and was planning to see physician as soon as possible. The patient was in a hurry and did not obtain date of birth. The patient had denied permission to contact their physician.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (In April 2018, received 1st dose, refer case US2018GSK160811). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included Flu Seasonal QIV Dresden and methotrexate. On 28th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling. On 29th August 2018, the patient experienced weakness, feeling cold, shivers, headache, injection site erythema and feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the weakness, feeling cold, shivers and headache were recovering/resolving and the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the weakness, injection site swelling, feeling cold, shivers, headache, injection site erythema and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX  day when the patient woke up, she thought she was going to be fine, but began to feel worse as the day progressed. By noon she felt cold, had shivers headache and weakness. She thought she would collapse when getting up yesterday due to weakness. Her arm was also red and swollen. On the date of reporting, she felt 90 percent better, though her arm was red and swollen where she got the shot. She felt much worse after the first shot compared to the 2nd shot. his case has been linked with case US2018158115 and US2018158117, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site swelling, Malaise, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (In April 2018, received 1st dose, refer case US2018GSK160811). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included Flu Seasonal QIV Dresden and methotrexate. On 28th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling. On 29th August 2018, the patient experienced weakness, feeling cold, shivers, headache, injection site erythema and feeling unwell. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the weakness, feeling cold, shivers and headache were recovering/resolving and the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the weakness, injection site swelling, feeling cold, shivers, headache, injection site erythema and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX  day when the patient woke up, she thought she was going to be fine, but began to feel worse as the day progressed. By noon she felt cold, had shivers headache and weakness. She thought she would collapse when getting up yesterday due to weakness. Her arm was also red and swollen. On the date of reporting, she felt 90 percent better, though her arm was red and swollen where she got the shot. She felt much worse after the first shot compared to the 2nd shot. his case has been linked with case US2018158115 and US2018158117, reported by same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (In April 2018, received 1st dose). On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced headache, weakness, shivers and feeling bad. On 2nd August 2018, the outcome of the headache, weakness, shivers and feeling bad were recovered/resolved. It was unknown if the reporter considered the headache, weakness, shivers and feeling bad to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. In April 2018, the patient received SHINGRIX and was fine afterwards. After receiving 2nd dose of SHINGRIX, the patient went to work the next day, but by noon he experienced shivering, a bad headache and weakness. The patient felt bad enough that he thought he should have gone home, though he did not. The next day he felt much improved. This case has been linked with case US2018158113 and US2018158117, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced headache, weakness, shivers and feeling unwell. On an unknown date, the outcome of the headache, weakness, shivers and feeling unwell were recovered/resolved. It was unknown if the reporter considered the headache, weakness, shivers and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was over 50 years old. The coworker of the reporter's husband felt sick for 2 days after getting SHINGRIX. She was unable to get up for 2 days after receiving 2nd dose. She had a severe headache along with shivering and weakness. This case has been linked with case US2018158113 and US2018158115, reported by same reporter.
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Dermatitis acneiform, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash acneiform in a adult male patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. Co-suspect products included ADACEL (batch number C5541AA, expiry date 13th November 2020) for prophylaxis. Previously administered products included Tdap vaccine (received on an unknown date and well tolerated). On 24th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and ADACEL. In August 2018, 3 days after receiving SHINGRIX, the patient experienced rash acneiform, hives and itchy rash. The patient was treated with CLARITIN and BENADRYL. On an unknown date, the outcome of the rash acneiform, hives and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the rash acneiform, hives and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional was not able to provide the patient's initials or birth date. The healthcare professional reported that the patient received both SHINGRIX and ADACEL in opposite deltoids. It was not known that which vaccine was given in which deltoid. Three days after administration of these 2 vaccines, the patient developed an itchy acne-like rash on his back and hives, which do not itch, on his chest. He consulted the pharmacy on 30th August 2018 and the pharmacist recommended BENADRYL or CLARITIN.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. SHINGRIX was discontinued. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient experienced unbearable arm pain for a few days after receiving SHINGRIX, and that they did not want the second dose, the onset of symptoms was unknown. The reporter was not certain if the pharmacist declined to provide patient information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX. On 9th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, nausea and felt faint. On an unknown date, the outcome of the injection site pain and nausea were recovered/resolved and the outcome of the felt faint was unknown. It was unknown if the reporter considered the injection site pain, nausea and felt faint to be related to SHINGRIX. Additional details were provided as follows: The patient experienced extreme pain at the injection site, and nausea on the evening of receiving the SHINGRIX vaccine, due to the nausea, patient felt like she almost passed out but she did not pass out. The patient had now recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult 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, injection site wheal, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site wheal, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, injection site wheal, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The medical assistant reported that, many patients experienced injection area soreness and redness or a welt approximately the size of a quarter after receiving of the SHINGRIX. The purpose of the healthcare professional's call was not to report the adverse events, she mentioned these, as an information, the reporter was asked if she wanted to report any case specifically and she declined, she said many patients have reported more mild reactions. This case has been linked with case US2018GSK161599, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 56-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain, injection site tenderness, injection site swelling, tiredness and injection site erythema. The patient was treated with Diphenhydramine and TYLENOL. On an unknown date, the outcome of the pain, injection site tenderness, injection site swelling, tiredness and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the pain, injection site tenderness, injection site swelling, tiredness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The healthcare professional (HCP) reported that the patient received a dose of SHINGRIX and within 1 to 2 days, experienced pain, tiredness, injection site redness (diameter of half of a grapefruit), swelling, and tender to the touch. The reaction started at 4 AM the following day of vaccination and took about 1 to 2 days to develop. The patient went to visit the doctor and the doctor recommended diphenhydramine 25 mg and TYLENOL 1000 mg three times daily.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Oral herpes, 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 female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th August 2018, 1 days after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, cold sores lip and injection site muscle pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the influenza-like symptoms, cold sores lip and injection site muscle pain were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms, cold sores lip and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. It was not certain that this was a reportable event, and was discussed with GlaxoSmithKline adverse event (GSK AE) Liaison, but the patient reported that her granddaughter was touching her (the patient's) lip (with the cold sore) and experienced pain and blisters on her vaginal area and stomach. The patient's granddaughter was seen by her physician and was diagnosed as having a virus. The patient reported that she followed-up with her pharmacist.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Acupuncture, Hypokinesia, Immediate post-injection reaction, Injection site pain, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 71-year-old male patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX. On 29th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 30th May 2018, the patient experienced neck pain and movements reduced. The patient was treated with Physical Therapy (NOS) and Acupuncture. On an unknown date, the outcome of the neck pain and movements reduced were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the neck pain, injection site pain and movements reduced to be related to SHINGRIX. Additional details were provided as follows: The patient had some soreness at the injection site right after the dose, but it resolved after about 4 days. The caller reported that he had a lot of neck pain starting the day after receiving a dose of SHINGRIX. The patient had seen an orthopedist and had about 20 sessions of physical therapy, but he still had the neck pain. The patient was trying acupuncture at the time of reporting. The patient could not move his head to the full extent either right or left. The patient had a similar problem many years before the reporting date, but it did not last very long.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received SHINGRIX .5 ml. On 30th August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and feeling queasy. On an unknown date, the outcome of the influenza-like symptoms and feeling queasy were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms and feeling queasy to be related to SHINGRIX. Additional details were provided as follows: The reporter was the spouse of the patient. The reporter said that her husband (patient) received the SHINGRIX vaccine. The reporter said that the patient came home an hour earlier from work and was asleep at the time of reporting. The patient's physician said that the patient had flu like symptoms. The reporter said that patient felt a little queasy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass, Pain of skin, Skin mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received SHINGRIX (batch number FZ3ND, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site lump, skin nodule and skin tenderness. On an unknown date, the outcome of the injection site lump was recovered/resolved and the outcome of the skin nodule was not recovered/not resolved and the outcome of the skin tenderness was unknown. It was unknown if the reporter considered the injection site lump, skin nodule and skin tenderness to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported after receipt of SHINGRIX the patient developed a lump at the injection site which went away after rubbing it for a few hours (per patient). The patient then developed a lump on her clavicle a few hours later (same side) approximately a half dollar in size, not red or warm to the touch and only tender if she pressed on it.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included methotrexate. On 21st June 2018, the patient received the 1st dose of SHINGRIX. On 22nd June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, fever and chills. On an unknown date, the outcome of the injection site erythema, injection site pain, fever and chills were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient had a little redness and soreness at the injection site and had chills and fever that lasted may be a day. This case has linked to case US2018GSK162661, reported by same reporter for same patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, pruritus and dermatitis. On 26th May 2018, the patient experienced hives. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pruritus and dermatitis were unknown and the outcome of the hives was not recovered/not resolved.  It was unknown if the reporter considered the pain in arm, pruritus, hives and dermatitis to be related to SHINGRIX. Additional details were provided as follows: On Tuesday, the patient received the 1st dose of SHINGRIX vaccine on the left arm. Her arm was sore for a couple of days after receiving the vaccination. On Saturday, 4 days after receiving SHINGRIX, she noted that she had a hive on the middle finger of one her hands. More hives began to appear which covered the top, sides, and fingers of both hands. They began to fade and new ones began to appear spreading up her arms and around her elbows. Less than a month after receiving SHINGRIX, the patient experienced pruritus and dermatitis. There was intense itching with hives around her elbows. The hives would continuously fade and appear. They have also appeared on her chest, back, legs, neck, and face. On the date of reporting, in the morning, they had reappeared on her elbows and upper arms. She had seen her physician and was initially told that it was dermatitis due to something she had touched. She saw a dermatologist and had been told that, possibly the SHINGRIX might have set off some sort of reaction. Till the date of reporting, there was no diagnosis, but she was prescribed antihistamines. The reporter gave permission for her physician to be contacted. This case was linked to case US2018158198, reported by the same reporter.
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 female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 2nd dose of SHINGRIX. On 29th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was 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 the vaccination was not reported. The patient had pain at site since the day of vaccination. The reporter declined demographics to complete the report.
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sinus infection in a adult female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) and (batch number 2453L, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced sinus infection. The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the sinus infection was unknown. It was unknown if the reporter considered the sinus infection to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The age at the vaccination was not reported. The healthcare professional reported that, the patient developed sinus infection a few days after receiving the SHINGRIX vaccine. The healthcare professional stated, the patient was being treated with antibiotics for sinus infection. The reported expiry date (12th February 2012) for SHINGRIX vaccine was incorrect and was updated to 12th February 2021, according to sales database.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills. On an unknown date, the outcome of the pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. But, it could be 50 or 51 years old. The patient experienced sore arm, fever, body ache, chills, nausea, shakes, headache and diarrhea. The patient recovered from all events about 3 days after the injection. The patient did not report any of this to her physician and that physician was likely unaware that patient received the SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills. On an unknown date, the outcome of the pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, diarrhea, nausea, tremor, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. But, it could be 50 or 51 years old. The patient experienced sore arm, fever, body ache, chills, nausea, shakes, headache and diarrhea. The patient recovered from all events about 3 days after the injection. The patient did not report any of this to her physician and that physician was likely unaware that patient received the SHINGRIX.
Age: 80.0
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 80-year-old female patient who received SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 23rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient arm hurt a little. This case was linked to the case US2018158669, reported by the same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and myalgia. On an unknown date, the outcome of the influenza-like symptoms, fever and myalgia were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, the patient experienced flu-like symptoms, myalgia and fever. The reporter did not have any additional information. The medical representative stated that, this event was reported to him by the healthcare professional on 29th August 2018 and he submitted it on Wednesday however, the report was hung in email and he do not believe it went through. The reporter stated that he noticed, that it had not gone through so wanted to call GRC to report the event. This case was one of the 2 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and myalgia. On an unknown date, the outcome of the influenza-like symptoms, fever and myalgia were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, the patient experienced flu-like symptoms, myalgia and fever. The reporter did not have any additional information. The medical representative sated that, this event was reported to him by the healthcare professional on 29th August 2018 and he submitted it on Wednesday however, the report was hung in email and he do not believe it went through. The reporter stated that he noticed, that it had not gone through so wanted to call agency to report the event. This case was one of the 2 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of 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 pain and feeling unwell. On an unknown date, the outcome of the pain and feeling unwell were unknown. It was unknown if the reporter considered the pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The caller was a consumer who heard from an acquaintance that she received 1st dose of SHINGRIX and experienced feeling very achy and not feeling well. The caller declined to provide address or other identifiers for the patient. No further information was available. The patient had denied permission to contact their physician. This case has been linked with case US2018158685, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult 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. 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. The patient experienced slight injection site pain after receiving 1st dose of SHINGRIX. For tolerance to 2nd dose refer linked case US2018GSK162343, for same patient.