chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a male 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 product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were reported as follows: This case was reported by the former retired GlaxoSmithKline (GSK) employee. The patient did not receive 2nd dose of SHINGRIX by the 6th month and a week deadline. The patient stated that his 6 months period since his first SHINGRIX vaccine was 13th October 2018. The patient had his name on list at several locations as well as his general practitioner (GP). The patient was asking about the supply that was it going to get better. The representative stated to the patient that, to monitor the ongoing safety of our medications. The representative asked the patient to provide his physician's contact details. To address the current high demand, GlaxoSmithKline (GSK) had significantly increased deliveries and accelerated shipments of doses of vaccine for this year, and SHINGRIX was expected to be available throughout 2018 and shipped on a regular basis. Individual medical guidance for patients like himself should be provided by medical professionals and was not something GSK provides to patients. As the patient might know the Food and Drug Administration (FDA) approved dosing schedule for SHINGRIX was the first dose at month 0, followed by a second dose 2 to 6 month after the first dose. The representative stated that he could share with him that the CDC has provided guidance that if it had been more than 6 months since you got the first dose, the patient should get the second dose a soon as possible and you did not need to restart the vaccine series. The patient was advised that he should talk to his doctor or pharmacist about this guidance and your individual situation. If the healthcare provider needs additional information for our products, they can call the GSK Medical Information department. Many of the pharmacist in his were quite frustrated. The locator on the website was not accurate. The patient thought that he would rather see not available than list locations that when he called they did not have any in stock. The patient gave permission to follow up with his healthcare professional (HCP).
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness, Nausea
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (experienced no adverse event after 1st dose). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, injection site erythema, injection site swelling, nausea and lower extremities weakness of. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, nausea and lower extremities weakness of were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, nausea and lower extremities weakness of to be related to BEXSERO. Additional details were provided as follows: The patient was 18 or 19 years old. The reporter reported that no vaccines were administered at same visit as BEXSERO. The patient experienced injection site pain, redness and swelling. Followed over the period of hours, the patient experienced nausea and felt weak in legs. The patient was going for the follow up visit with doctor.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. On 31st October 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia. In November 2018, the patient experienced injection site rash, erythema, skin warm and tenderness. On an unknown date, the outcome of the myalgia, injection site rash, erythema, skin warm and tenderness were unknown. It was unknown if the reporter considered the myalgia, injection site rash, erythema, skin warm and tenderness to be related to SHINGRIX. Additional details were provided as follows: As per PA, the patient complained of myalgia for a day after the vaccine, but came to the clinic a couple days after the vaccine with a itchy rash that was about 1 inch below the presumed injection site. There were about 5 to 6 areas of redness that were warm and tender to the touch. The patient did not have any other systemic symptoms at that time.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash pruritic
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. On 31st October 2018, 1 days after receiving SHINGRIX, the patient experienced myalgia. In November 2018, the patient experienced injection site rash, erythema, skin warm and tenderness. On an unknown date, the outcome of the myalgia, injection site rash, erythema, skin warm and tenderness were unknown. It was unknown if the reporter considered the myalgia, injection site rash, erythema, skin warm and tenderness to be related to SHINGRIX. Additional details were provided as follows: As per PA, the patient complained of myalgia for a day after the vaccine, but came to the clinic a couple days after the vaccine with a itchy rash that was about 1 inch below the presumed injection site. There were about 5 to 6 areas of redness that were warm and tender to the touch. The patient did not have any other systemic symptoms at that time.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. The patient had a Family History of shingles (Patient's wife and father). Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 9th March 2018, refer case US2018042240 for more information) and Shingles vaccine (received couple of years ago and it was about 50 percent effective). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, lower extremities weakness of, sickness, tiredness, influenza-like symptoms, feeling bad and drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, lower extremities weakness of, sickness, tiredness, feeling bad and drug dose administration interval too long were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the fever, chills, lower extremities weakness of, sickness, tiredness, influenza-like symptoms and feeling bad to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient completed his two dose vaccine series. The patient had to wait to wait slightly past the 6 month window to get his second dose because demand was high due to vaccine effectiveness, which led drug dose administration interval too long. The reporter suggested that a lot of doctors did not recommend people to get vaccinated against shingles. The patient experienced fever, chills, legs were weak, tiredness and talks about how sick he felt the whole weekend for most of the segment, repeating some of the symptoms he indicated after receiving his first dose. The patient felt lousy and reaction which were flu like it was only a day or two and then it went away, but said it was better than getting Shingles. The reporter said that they want to not get Shingles, the disease shingles, which was supposedly the most painful thing, which feels like lightening going through your body, so the manufacturer had developed a shingles vaccine. The patient asked if they could do anything to decrease the reaction and was suggested aspirin. The patient encouraged anyone who was had chickenpox to get vaccinated.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Muscular weakness, Product supply issue, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. The patient had a Family History of shingles (Patient's wife and father). Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 9th March 2018, refer case US2018042240 for more information) and Shingles vaccine (received couple of years ago and it was about 50 percent effective). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, lower extremities weakness of, sickness, tiredness, influenza-like symptoms, feeling bad and drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, lower extremities weakness of, sickness, tiredness, feeling bad and drug dose administration interval too long were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the fever, chills, lower extremities weakness of, sickness, tiredness, influenza-like symptoms and feeling bad to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient completed his two dose vaccine series. The patient had to wait to wait slightly past the 6 month window to get his second dose because demand was high due to vaccine effectiveness, which led drug dose administration interval too long. The reporter suggested that a lot of doctors did not recommend people to get vaccinated against shingles. The patient experienced fever, chills, legs were weak, tiredness and talks about how sick he felt the whole weekend for most of the segment, repeating some of the symptoms he indicated after receiving his first dose. The patient felt lousy and reaction which were flu like it was only a day or two and then it went away, but said it was better than getting Shingles. The reporter said that they want to not get Shingles, the disease shingles, which was supposedly the most painful thing, which feels like lightening going through your body, so the manufacturer had developed a shingles vaccine. The patient asked if they could do anything to decrease the reaction and was suggested aspirin. The patient encouraged anyone who was had chickenpox to get vaccinated.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of feeling bad 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, unknown after receiving SHINGRIX, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided a follows: The age at the vaccination was not reported. The reporter reported the patient felt like they were hit by a truck for 2 days. This case was linked with the cases US2018GSK204598 and US2018GSK205480, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was not recovered/not resolved. It was unknown if the reporter considered the adverse reaction to be related to Shingles vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient asked how long did the side effects from a shingles shot last. Follow up would be conducted with the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose). Concurrent medical conditions included type I diabetes mellitus. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced blood glucose increased. On an unknown date, the outcome of the blood glucose increased was unknown. It was unknown if the reporter considered the blood glucose increased to be related to SHINGRIX. Additional details were provided as follows: The patient asked whether it was common for a type 1 diabetic to get an elevated blood glucose after receiving the SHINGRIX vaccine. The patient's blood glucose was elevated much like when she had taken prednisone. The patient assumed it was a stress response and the patient did not remember it getting this after her first dose. Lab Comments: On an unknown date, the patient's blood glucose level was elevated.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema in a 23-year-old female patient who received BEXSERO (batch number 16E901, expiry date unknown) for prophylaxis. On 16th November 2018, the patient received BEXSERO .5 ml. In November 2018, less than a week after receiving BEXSERO, the patient experienced erythema and swelling. The patient was treated with ibuprofen and Warm Packs (Nos). On an unknown date, the outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to BEXSERO. Additional information received as follows: Over the weekend the patient developed redness and swelling that got worsen each day. The reporter asked about giving the second dose of BEXSERO. The reporter stated referred patient's medical information at GlaxoSmithKline. The reporter agreed to follow up from GlaxoSmithKline.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Product label confusion, Pyrexia, Wrong product administered
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 11-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 1 day after receiving BEXSERO, the patient experienced fever, wrong vaccine administered and product label confusion. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the wrong vaccine administered and product label confusion were unknown. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: The patient was to receive MCV4. The vaccine was drawn up by one person, she left the room. Another person came in and administered vaccine (did not confirm which vaccine). BEXSERO was given instead of MCV4 (apparently labeling was unclear), which led to the wrong vaccine administered and product label confusion. Mother was informed and she reported that her daughter experienced one day of low grade fever one day after administration of vaccine. The reporter gave consent to follow up. Lab Comments: The patient experienced one day of low grade fever measured on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 8th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2018 after vaccination, the patient experienced soreness, redness and swelling in the form of a big lump on the injection site. The patient also felt nauseous and feverish. The reporter had given consent for follow up. These events were all same as experienced by her boyfriend (case US2018204717), but were less severe.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 8th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In 2018 after vaccination, the patient experienced soreness, redness and swelling in the form of a big lump on the injection site. The patient also felt nauseous and feverish. The reporter had given consent for follow up. These events were all same as experienced by her boyfriend (case US2018204717), but were less severe.
Age: 64.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Back pain, Dysstasia, Gait disturbance, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer and described the occurrence of difficulty in standing in a 64-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of adverse event (refer case US2018GSK214203). On 16th November 2018 12:15, the patient received FLUARIX QUADRIVALENT2018-2019 season .5 ml. In November 2018, less than a week after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced difficulty in standing and walking difficulty. On 16th November 2018, the patient experienced low back pain and buttock pain. On an unknown date, the outcome of the difficulty in standing and walking difficulty were recovering/resolving and the outcome of the low back pain and buttock pain were not recovered/not resolved. It was unknown if the reporter considered the difficulty in standing, low back pain, walking difficulty and buttock pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient. Immediately afterwards (after vaccination), the patient returned to home and laid down because she usually experience a mild reaction to the flu shot. She dozed off and when she tried to get up appx two hours later, I had excruciating lower back pain (below the kidneys, in the upper right buttock). For the next several days, she could barely walk and had extreme difficulty getting up or sitting down. It seems to be improving as of date of reporting date but was still causing some pain. The patient called the pharmacist who administered the shot to ask if anyone else had reported such a side effect. He said no, not in all his years of giving the flu shot had he heard of anyone having such a reaction, and it must be from something else. But, the patient had done nothing else; no lifting, no twisting, nothing that could hurt her back. The patient did not know if the flu vaccine caused this side effect, but if no one reports it, it would never know. So, she reported it as a possible side effect. The patient received the shot through the program. This case has been linked with case US2018GSK214203, reported by same reporter for same patient.
Age: 64.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of difficulty in standing in a 64-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) for prophylaxis. Previously administered products included Influenza vaccine with an associated reaction of adverse event (refer case US2018GSK214203). On 16th November 2018 12:15, the patient received FLUARIX QUADRIVALENT2018-2019 season .5 ml. In November 2018, less than a week after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced difficulty in standing and walking difficulty. On 16th November 2018, the patient experienced low back pain and buttock pain. On an unknown date, the outcome of the difficulty in standing and walking difficulty were recovering/resolving and the outcome of the low back pain and buttock pain were not recovered/not resolved. It was unknown if the reporter considered the difficulty in standing, low back pain, walking difficulty and buttock pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient. Immediately afterwards (after vaccination), the patient returned to home and laid down because she usually experience a mild reaction to the flu shot. She dozed off and when she tried to get up appx two hours later, I had excruciating lower back pain (below the kidneys, in the upper right buttock). For the next several days, she could barely walk and had extreme difficulty getting up or sitting down. It seems to be improving as of date of reporting date but was still causing some pain. The patient called the pharmacist who administered the shot to ask if anyone else had reported such a side effect. He said no, not in all his years of giving the flu shot had he heard of anyone having such a reaction, and it must be from something else. But, the patient had done nothing else; no lifting, no twisting, nothing that could hurt her back. The patient did not know if the flu vaccine caused this side effect, but if no one reports it, it would never know. So, she reported it as a possible side effect. The patient received the shot through the program. This case has been linked with case US2018GSK214203, reported by same reporter for same patient.
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Back pain, Dysstasia, Gait disturbance, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a 64-year-old female patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. After receiving flu vaccine, the patient experienced mild reaction. This case has been linked with case US2018GSK213171, reported by same reporter for same patient.
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a 64-year-old female patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. After receiving flu vaccine, the patient experienced mild reaction. This case has been linked with case US2018GSK213171, reported by same reporter for same patient.
Sex: M
Vaccine: DTP
Symptoms: Death, Seizure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of death in a male patient who received DTP (A or W not known) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced death (serious criteria death and GSK medically significant) and seizure (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the seizure was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death and seizure to be related to DTP (A or W not known). Additional details were received as follows: The age at vaccination was not reported. The patient's mother reported that, the patient received DPT shot. The patient presented with horrible seizures and he was profoundly handicapped at 2 years of age. The patient died at age of 25 years old (mentally at 16 month). The reporter also stated that the patient's older sister who also received the vaccine was fine. Reported Cause(s) of Death: unknown cause of death.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site swelling
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 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (1st dose received on 10th July 2018, please refer the case US2018164362).  On an unknown date, the patient received the 2nd dose of SHRINGRIX On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema, skin warm and itchy. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, skin warm and itchy were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, skin warm and itchy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not see her physician and called the physician and that was forwarded to the pharmacist where the vaccine got. Basically both shots made her arm below injection site by 3 to 4 inches swell up and red, hot, itchy and it was healing the diameter of the spot was 4 inches in diameter. The patient wanted to know at the time, the patient was concerned about having the second injection. This case has been linked with case US2018164362 reported by the same reporter for the same patient.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pruritus, Skin warm
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 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (1st dose received on 10th July 2018, please refer the case US2018164362).  On an unknown date, the patient received the 2nd dose of SHRINGRIX On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema, skin warm and itchy. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, skin warm and itchy were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, skin warm and itchy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not see her physician and called the physician and that was forwarded to the pharmacist where the vaccine got. Basically both shots made her arm below injection site by 3 to 4 inches swell up and red, hot, itchy and it was healing the diameter of the spot was 4 inches in diameter. The patient wanted to know at the time, the patient was concerned about having the second injection. This case has been linked with case US2018164362 reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb 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, several hours after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema of extremities, limbs stiffness and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities, limbs stiffness and pain in arm were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities, limbs stiffness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported via web form. The age at vaccination was not reported. The patient received SHINGRIX early in the morning and by afternoon her arm was hurting badly and continued throughout the day. By the evening of the day of vaccination, her arm was red and swollen from the hand to the shoulder and she could hardly squeeze her fingers. The patient stated it was painful. It took nearly a week for the pain and stiffness to resolve. The symptoms occurred on her non- dominant arm. The patient consented to follow up. Unable to reach healthcare professional (HCP) for healthcare professional address, information about administration address or the patient and vaccine lot number or information.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Generalised erythema, Pruritus, Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT (batch number GY29L, expiry date 29th June 2019) for prophylaxis. Previously administered products included SHINGRIX (1st dose 0.5 ml via intramuscular route was received on 29th June 2018). On 22nd October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 30th October 2018, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. In October 2018, less than a month after receiving SHINGRIX and less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced generalized erythema, pruritus and raised rash. The patient was treated with prednisone, BENADRYL and Calamine Lotion. On an unknown date, the outcome of the generalized erythema, pruritus and raised rash were unknown. It was unknown if the reporter considered the generalized erythema, pruritus and raised rash to be related to SHINGRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that she received the SHINGRIX vaccine in the left arm. At 10:00 AM Tuesday, the patient received the FLUARIX QUADRIVALENT vaccine in the left arm. The patient reported that during the evening she felt itchy, but it did not bother her. The reporter did not recall where the itchiness was occurring on her body. On 31st October 2018 the next day at 6:00 AM, the patient was eating breakfast and noticed that her inner forearm was getting red and the redness started moving up her arm. The patient went for a walk and when she got back, she noted that the trunk of her body, legs, and arms were red, too. The redness turns to bumps, resolves, and then cycles back to redness and bumps again and her face was very red, too. The patient went to her physician the day before reporting and was prescribed with treatment. In the morning on the reporting date, the patient reported it was not as bad, but notes that her shins are red, too. The patient commented that may be having both vaccinations could possibly have caused this. No more additional information was obtained. The reporter gave permission for her physician to be contacted.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Influenza virus test negative
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th October 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fever, chills, general body pain and myalgia of lower extremities. On 25th October 2018, the patient experienced fatigue, injection site erythema and injection site swelling. The patient was treated with ADVIL and BENADRYL. On 31st October 2018, the outcome of the influenza-like symptoms, headache, fever, chills, general body pain, myalgia of lower extremities, fatigue, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, fever, chills, general body pain, myalgia of lower extremities, fatigue, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The caller has been already informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GlaxoSmithKline (GSK). The reporter had agreed to have GSK's Safety team follow-up with them via postal mail. On the day of getting the vaccine, the patient experienced flu like symptoms, headache, fever, chill, body aches, and muscle pain in legs. The next morning (on 25th October 2018), when the patient woke up she had a temperature of 100.2 degree F, along with headache, and fatigue. The injection site was red and swollen which covered an area of 1.5 by 1.5 inch. On Thursday morning, the patient called her family doctor and she spoke with nurse. She was advised to take ADVIL for fever and pain. Her physician called back and said if the area of swelling increased in size he wanted her to go to the urgent care. She was also advised to take BENADRYL. On Friday 26th October 2018, night the redness and swelling increased in size to 2.5 by 3 inches. On Saturday morning 27th October 2018, she went to the urgent care, she had a nasal swab test done for flu, which was negative. She was advised to continue taking ADVIL and BENADRYL. Her symptoms lasted for total of 7 days and she fully recovered on Wednesday. Consent to follow up was given by the reporter. No further details were provided. The patient was referred to healthcare professional for second dose recommendation. The event did no included product complaint.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th October 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, fever, chills, general body pain and myalgia of lower extremities. On 25th October 2018, the patient experienced fatigue, injection site erythema and injection site swelling. The patient was treated with ADVIL and BENADRYL. On 31st October 2018, the outcome of the influenza-like symptoms, headache, fever, chills, general body pain, myalgia of lower extremities, fatigue, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, fever, chills, general body pain, myalgia of lower extremities, fatigue, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The caller has been already informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GlaxoSmithKline (GSK). The reporter had agreed to have GSK's Safety team follow-up with them via postal mail. On the day of getting the vaccine, the patient experienced flu like symptoms, headache, fever, chill, body aches, and muscle pain in legs. The next morning (on 25th October 2018), when the patient woke up she had a temperature of 100.2 degree F, along with headache, and fatigue. The injection site was red and swollen which covered an area of 1.5 by 1.5 inch. On Thursday morning, the patient called her family doctor and she spoke with nurse. She was advised to take ADVIL for fever and pain. Her physician called back and said if the area of swelling increased in size he wanted her to go to the urgent care. She was also advised to take BENADRYL. On Friday 26th October 2018, night the redness and swelling increased in size to 2.5 by 3 inches. On Saturday morning 27th October 2018, she went to the urgent care, she had a nasal swab test done for flu, which was negative. She was advised to continue taking ADVIL and BENADRYL. Her symptoms lasted for total of 7 days and she fully recovered on Wednesday. Consent to follow up was given by the reporter. No further details were provided. The patient was referred to healthcare professional for second dose recommendation. The event did no included product complaint.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 2nd August 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 3rd August 2018, the patient experienced injection site swelling, fever, injection site erythema and injection site warmth. On 7th August 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site erythema, pain in arm and injection site warmth were recovered/resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site swelling, fever, injection site erythema, pain in arm and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was given the vaccination in the tricep area of her arm intramuscularly, which led to incorrect route of vaccination. The patient noticed the swelling and other side effects took longer to heal than her husband who was given the vaccination intramuscularly. She had pain a couple of hours after the vaccine but the 2nd day (1 day after receiving vaccination), the area was very swollen, red and hot to touch.  The patient also had a systemic fever for 4 days. The patient's arm looked bad for a couple of weeks and the had  a stripe going down her arm from the injections site which took weeks to go away. All symptoms slowly resolved. The reporter consented to follow up. This case was linked to the case US2018201340, reported by the same reporter for her husband.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 2nd August 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 3rd August 2018, the patient experienced injection site swelling, fever, injection site erythema and injection site warmth. On 7th August 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site erythema, pain in arm and injection site warmth were recovered/resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site swelling, fever, injection site erythema, pain in arm and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient was given the vaccination in the tricep area of her arm intramuscularly, which led to incorrect route of vaccination. The patient noticed the swelling and other side effects took longer to heal than her husband who was given the vaccination intramuscularly. She had pain a couple of hours after the vaccine but the 2nd day (1 day after receiving vaccination), the area was very swollen, red and hot to touch.  The patient also had a systemic fever for 4 days. The patient's arm looked bad for a couple of weeks and the had  a stripe going down her arm from the injections site which took weeks to go away. All symptoms slowly resolved. The reporter consented to follow up. This case was linked to the case US2018201340, reported by the same reporter for her husband.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm, joint pain and shoulder pain. On an unknown date, the outcome of the pain in arm, joint pain and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, joint pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The case was reported by the daughter who reported for her mother. The patient received SHINGRIX in the right arm. The reporter reported that she experienced very intense arm and joint and shoulder pain. The pain was not at the injection site but on her right arm which was the same arm that she received the injection. The reporter believed that she has had the pain which started a day or two since she received the injection in October 2018. The reporter could not recall her mother's physician name. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Pneumonia Vaccine for prophylaxis. On 28th September 2018 11:31, the patient received SHINGRIX. On 28th September 2018, the patient received PNEUMONIA VACCINE. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced fever. In October 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site erythema, injection site rash and injection site itching. The patient was treated with Valacyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, injection site erythema, injection site rash and injection site itching were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, fever, injection site erythema, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the left arm and pneumonia vaccine in right arm. That night she had a fever of 103 degree F. The fever lasted for 2 days. Four weeks following the vaccination, the patient reported a red, itchy rash at the injection site. This case was considered as suspected vaccination failure, since the details regarding the details regarding the completion of the primary immunization for influenza and laboratory confirmation for shingles were not provided. On 4th November 2018, it was diagnosed as shingles. She was started on valacyclovir that day to treat the shingles and was on a maintenance dose of 500 mg per day currently. It was unknown if the reporter considered the fever to be related to Pneumonia Vaccine. Consent to follow up was given.