chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythropapular rash in a 73-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (7 years ago had the live shingles). On 11th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced erythropapular rash, erythromacular rash and pruritus. On an unknown date, the patient experienced sleep decreased, discomfort, exhaustion and injection site pain. The patient was treated with prednisone and cetirizine hydrochloride (Zyrtec). SHINGRIX was discontinued. On an unknown date, the outcome of the erythropapular rash and injection site pain were recovered/resolved and the outcome of the erythromacular rash, pruritus and exhaustion were unknown and the outcome of the sleep decreased and discomfort were not recovered/not resolved. The reporter considered the erythropapular rash, erythromacular rash, pruritus, sleep decreased, discomfort, exhaustion and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient described the symptoms as red, itchy bumps everywhere on the body, red splotches on the back and both sides and the newest symptom includes red splotches under the lips. On same day on initial reporting, the reporter provider more details of the events. The reporter stated that the red itch spots were almost every part of her body except from the nose up. She stated that she had been visited to 3 doctors for treatment of events. She was given prednisone and a cream that did not help. Then she went to an allergist and he changed the cream to and told her to take Zyrtec and then last weekend the red spots were bad again so she went to a clinic. She said the ointment helps but it wears off. She said that the redness and itchiness started around her waist, stomach, back and shoulder. She said it was not painful just red and itchy. She said her symptoms were getting worse and that hardly anywhere on her body where she did not have the redness or itchy bumps. She wants to know what could be done to stop this reaction. She said she had not changed detergents, soaps or eaten any different foods. She said that one doctor and one pharmacist had advised her not to get the second shot in the SHINGRIX series. On an unknown date, less tha year after vaccination, the patient experienced sleep decreased, discomfort, exhaustion and injection site pain. The patient stated that, she had only been able to get 3 to 4 hours of sleep per night because she was not comfortable and her legs itch. The patient was wearing herself out (due to lack of sleep). The patient said, she had not much pain or no pain at the injection site and no redness at the injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb
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 65-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to SHINGRIX. Additional details were provided as follows: This case was not reported to anyone previously. At 15: 30 PM, the patient received SHINGRIX on right deltoid. The patient began to experience swelling from their right elbow down to their right hand within two days after receiving the vaccination, which led to extensive swelling of vaccinated limb. The swollen area was not warm to the touch. No issues at the injection site were noted.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site irritation, Injection site pain, Injection site reaction, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site irritation in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site irritation, injection site pain, injection site discomfort and product supply issue. On an unknown date, the outcome of the injection site irritation, injection site pain and injection site discomfort were recovered/resolved and the outcome of the product supply issue was unknown.  It was unknown if the reporter considered the injection site irritation, injection site pain and injection site discomfort to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient stated that, he experienced injection site reaction which included irritation, pain and discomfort which resolved. The patient called due to being upset with the backorder situation with the product and so not all the questions for adverse event report were obtained.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Blood test, Laboratory test
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a elderly female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized joint pain and joint inflammation. The patient was treated with ibuprofen (Advil) and prednisone. On an unknown date, the outcome of the generalized joint pain was recovering/resolving and the outcome of the joint inflammation was recovered/resolved.  It was unknown if the reporter considered the generalized joint pain and joint inflammation to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in unknown arm at 77 years of age. The patient stated that, she experienced pain in joints all over the body. The patient went to the primary physician about her condition, and blood test were performed.  The patient was receiving Advil and it was not helping condition. The patient went to an emergency room. In emergency room, some tests were performed and physician told her that she had inflammation of joints all over the body. The patient prescribed with prednisone for 5 days. The patient went back to her primary physician and she prescribed with low dose prednisone. The patient had denied permission to contact their physician. No further details were provided. Lab Comments: on an unknown, the patient did laboratory test.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th August 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex) and allium sativum (Allicin). On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX in the right deltoid. The patient experienced shingles which were described as a small  patch. On 18th August 2018, patient was seen by the doctor and diagonsed with shingles. The patient was prescribed with Valtrex and Allicin.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of blistery rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown. It was unknown if the reporter considered the blistery rash to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that, the patient experienced a blistery rash either the day or the day after receiving the SHINGRIX. The reporter do not have vaccine information since the patient received at a pharmacy.
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Emotional distress, Extra dose administered, Insomnia, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 6-month-old male patient who received ROTARIX for prophylaxis. Previously administered products included ROTARIX (1st dose received on 9th April 2018). Concomitant products included ROTARIX. On 17th August 2018, the patient received the 3rd dose of ROTARIX. In August 2018, less than a week after receiving ROTARIX, the patient experienced difficulty sleeping and emotional distress. On 17th August 2018, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the difficulty sleeping was not recovered/not resolved and the outcome of the emotional distress, extra dose administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the difficulty sleeping and emotional distress to be related to ROTARIX. Additional information was reported as follows: This case was reported by the patient's mother. On 11th June 2018, the patient received the 2nd dose of ROTARIX at a different clinic other than the 1st dose. The patient received 3rd dose of ROTARIX by mistake at a new clinic, which led to extra dose administered and inappropriate age at vaccine administration.  On the same day, the patient received 3 other vaccines, but the reporter did not have information about the vaccines, they were the standard 6 month appointment vaccines. The reporter did not know if this was due to the additional dose, but the patient had trouble sleeping and woke up every couple of hours inconsolable since vaccination with the 3rd dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Incorrect route of drug administration, Injection site reaction, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extremities hot feeling of in a 65-year-old female patient who received SHINGRIX for prophylaxis.  In April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extremities hot feeling of, pain in arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the extremities hot feeling of and pain in arm were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extremities hot feeling of and pain in arm to be related to SHINGRIX. Additional details were provided as follows: In min April 2018, the pharmacy accidentally administered a dose of SHINGRIX via subcutaneous injection instead of intramuscular injection, which led to incorrect route of drug administration. The patient experienced injection site reaction that was warm and very painful and covered the arm below the injection site to the elbow about 6 to 8 inches and within a week it had resolved.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shingles, fever, sweating, chills and influenza-like symptoms. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown and the outcome of the fever, sweating, chills and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the shingles, fever, sweating, chills and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced flu like symptoms (fever, sweating and chills) within approximately 6 to 12 hours of receiving the SHINGRIX. The event lasted for approximately 12 hours and resolved. The following day, the patient reported an outbreak of Shingles. The patient's doctor prescribed a 7 day course of Valtrex as treatment. The health care professional was not able to provide further specifics at the time of reporting.
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a infant female patient who received MENVEO (batch number M17077, expiry date July 2019) for prophylaxis. On an unknown date, the patient received MENVEO (intramuscular) .5 ml. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 20th February 2018, the patient received the 1st dose of SHINGRIX. On 21st February 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling and injection site bruising. On an unknown date, the outcome of the injection site swelling and injection site bruising were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported the case for one of his patients. The age at vaccination was not reported. The pharmacist said that the symptoms developed at the site of injection and it was a pretty large area. The symptoms went away in about 4 days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number C7B9P, expiry date 16th August 2019) for prophylaxis. On 17th August 2018 09:58, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced shingles and chest pain. On an unknown date, the outcome of the shingles and chest pain were not recovered/not resolved. It was unknown if the reporter considered the shingles and chest pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left deltoid. The pharmacist reported that the consumer who was also a physician called him on the reporting date. The patient reported that he believed he had a shingles after vaccination with SHINGRIX vaccine. The pharmacist did not sure about when the events had started. The patient had a moderate pain in his left chest and it looked like shingles on chest.  The pharmacist stated the patient gave no other description or information. She was calling on his behalf if this could be possible. The call was transferred to medical information system (MIS). The reported batch number was not found in sales data sheet, which changed from C789P to C7B9P.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On 11th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness and shivering. On an unknown date, the outcome of the muscle pain, tiredness and shivering were recovering/resolving. It was unknown if the reporter considered the muscle pain, tiredness and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient experienced muscle aches, shivering, fatigue and tiredness which began 1 day after receiving the SHINGRIX vaccine. The events are improved. This case has been linked with US2018151122, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received SHINGRIX (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 10th August 2018, the patient received the 2nd dose of SHINGRIX. On 11th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness and shivering. On an unknown date, the outcome of the muscle pain, tiredness and shivering were recovering/resolving. It was unknown if the reporter considered the muscle pain, tiredness and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The patient experienced muscle aches, shivering, fatigue and tiredness which began 1 day after receiving the SHINGRIX vaccine. The events are improved. This case has been linked with US2018151119, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 18th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On 18th August 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient was received SHINGRIX on the left arm. The patient reported that she was experiencing a painful injection and then had injection site reaction that included pain, swelling to a circumference of about 1 inch to 1 and ¾ inches and some redness. The patient ended the call before pharmacy information could be gathered or permission to contact prescriber or healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female 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 rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient had rash on whole arm. The healthcare professional unable to provide patient demographics or lot or expiry number.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, headache and debility. On an unknown date, the outcome of the pain, headache and debility were recovered/resolved. It was unknown if the reporter considered the pain, headache and debility to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that her husband had severe aches and pains, headache and debilitation for 3 days after vaccination with SHINGRIX. The patient laid out for 3-4 days with symptoms similar to previous cases of the flu. This case was link with case US2018GSK156342, reported by the same reporter for the same patient (case for 2nd dose).
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and chills to be related to SHINGRIX. Additional details reported as follows: The caller was inquiring about taking prophylaxis TYLENOL prior to receiving the second series of the SHINGRIX vaccine which would be the day after reporting. He received the initial vaccine 4 months before the date of reporting and had flu like symptoms and chills which lasted for several days and then resolved. He was referred back to his physician regarding this question. The patient's physician's name and telephone number could not be obtained secondary to call flow.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 24th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and swelling arm. On an unknown date, the outcome of the injection site pain and swelling arm were unknown. It was unknown if the reporter considered the injection site pain and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on left deltoid at the health department. The patient stated that after the first shot she did not call them because she stated that she "had no side effects after the first shot". She did say that her arm was barely sore (not enough to complain) at the injection site and not red at all (after the first shot) and this was no different than after getting a flu shot, in fact she bumped her arm the second day after the shot and then remembered that she had received the shot. The patient was asked for lot number for SHINGRIX shot but she was not near the paperwork to look. This case has been linked with US2018GSK153694 (2nd dose of SHINGRIX) and US2018GSK153695 (Influenza vaccine Quadrivalent unspecified season) for same patient and US2018GSK152142 for different patient, reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th August 2018, 3 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a shingles rash on the left upper chest. It was a varicella or dermatome type rash. On 20th August 2018 Monday, the patient went to see her physician was a dermatologist and shingles rash was not resolved. The physician stated these types of rashes usually last about 3 weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site bruising, Injection site erythema, Injection site induration, Injection site joint pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site wheal, injection site erythema, injection site bruising, injection site induration and injection site swelling. On 3rd May 2018, the patient experienced lethargy, injection site joint pain, myalgia, injection site pain and fatigue. On 3rd May 2018, the outcome of the injection site pain was recovered/resolved. In May 2018, the outcome of the injection site wheal, injection site erythema, lethargy, injection site joint pain, myalgia, injection site bruising, injection site induration and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injection site wheal, injection site erythema, lethargy, injection site joint pain, myalgia, injection site pain, injection site bruising, injection site induration, injection site swelling and fatigue to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left arm. The patient stated all of the listed events were located around the injection site. She mentioned that she received the injection in morning. The myalgia, fatigue, headache and joint pain were resolved after a few days later. She said that the swelling at the injection site lasted for about 2 weeks and the bruising went away after about 3 weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Lethargy, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site wheal, injection site erythema, injection site bruising, injection site induration and injection site swelling. On 3rd May 2018, the patient experienced lethargy, injection site joint pain, myalgia, injection site pain and fatigue. On 3rd May 2018, the outcome of the injection site pain was recovered/resolved. In May 2018, the outcome of the injection site wheal, injection site erythema, lethargy, injection site joint pain, myalgia, injection site bruising, injection site induration and injection site swelling were recovered/resolved. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injection site wheal, injection site erythema, lethargy, injection site joint pain, myalgia, injection site pain, injection site bruising, injection site induration, injection site swelling and fatigue to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left arm. The patient stated all of the listed events were located around the injection site. She mentioned that she received the injection in morning. The myalgia, fatigue, headache and joint pain were resolved after a few days later. She said that the swelling at the injection site lasted for about 2 weeks and the bruising went away after about 3 weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Excessive eye blinking, Herpes zoster, Herpes zoster oticus, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction, shingles, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased. SHINGRIX was discontinued. On an unknown date, the outcome of the allergic reaction, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, shingles, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased to be related to SHINGRIX. Additional details were provided as follows: At 17:30, the patient received SHINGRIX on left arm. The patient had an allergic reaction. Within a few days the patient experienced low grade fever and all over aches. The patient experienced shingles and stated that hers being worse than her husband (refer case US2018151992). The patient had shingles from bottom of her feet up and had them in her ears that caused her reduced hearing. She had them in her throat and down her esophagus. The patient also had low grade fever. She stated that she was diagnosed by a physician but was not able to give any specifics. She disconnected from call when more specific questions about events was asked. She was threatening law suit against GlaxoSmithKline. The name of the physician was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction, shingles, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased. SHINGRIX was discontinued. On an unknown date, the outcome of the allergic reaction, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased were unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, shingles, fever, general body pain, eye dryness, excessive eye blinking and hearing decreased to be related to SHINGRIX. Additional details were provided as follows: At 17:30, the patient received SHINGRIX on left arm. The patient had an allergic reaction. Within a few days the patient experienced low grade fever and all over aches. The patient experienced shingles and stated that hers being worse than her husband (refer case US2018151992). The patient had shingles from bottom of her feet up and had them in her ears that caused her reduced hearing. She had them in her throat and down her esophagus. The patient also had low grade fever. She stated that she was diagnosed by a physician but was not able to give any specifics. She disconnected from call when more specific questions about events was asked. She was threatening law suit against GlaxoSmithKline. The name of the physician was provided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, 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 77-year-old female patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received SHINGRIX. On 21st August 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain. On 22nd August 2018, the patient experienced sweating. On an unknown date, the outcome of the injection site pain and sweating were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient's husband reported that the patient received SHINGRIX vaccine in left arm at mid morning on the day before reporting (yesterday), and she was sore at the injection site late yesterday and tender. On the date of reporting, the patient was more tender at the site, after rising this morning his wife was experiencing perspiration and she was soaking wet. The patient had denied permission to contact their physician.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Erythema, Eyelid ptosis, Headache
Clinical narrative: This case was reported by a physician via out of hour services and described the occurrence of fever in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache. On an unknown date, the outcome of the fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache were unknown. It was unknown if the reporter considered the fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was reported via after hours voicemail which contacted by staff member from doctor of medicine (MD) office. The reporter did not provide name, calling on behalf of the physician and reported above side effects in regards to one of their patient's experienced with SHINGRIX. The patient experienced tenderness on ear lobe in left side, redness on face in left side, swelling on face in left side, droopy eye lid in left side and headache in left side.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling face
Clinical narrative: This case was reported by a physician via out of hour services and described the occurrence of fever in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache. On an unknown date, the outcome of the fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache were unknown. It was unknown if the reporter considered the fever, chills, ear pain, red face, facial swelling, eyelid ptosis, pain and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was reported via after hours voicemail which contacted by staff member from doctor of medicine (MD) office. The reporter did not provide name, calling on behalf of the physician and reported above side effects in regards to one of their patient's experienced with SHINGRIX. The patient experienced tenderness on ear lobe in left side, redness on face in left side, swelling on face in left side, droopy eye lid in left side and headache in left side.
Sex: U
Vaccine: MENB
Symptoms: Injection site abscess
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site abscess in a patient who received BEXSERO (batch number 166901A, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site abscess. On an unknown date, the outcome of the injection site abscess was unknown. It was unknown if the reporter considered the injection site abscess to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced abscess at the injection site of BEXSERO. This event was occurred in past 6 weeks from the date of reporting. This is 1 of the 3 linked cases reported by the same reporter for different patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain. In August 2018, the outcome of the chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain were recovered/resolved. It was unknown if the reporter considered the chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain to be related to SHINGRIX. Additional information was received as follows: In 2018, the patient experienced chills, feverish, flu like symptoms, nausea, severe stomach pain, injection site swelling and redness, muscle pain in injection arm for a week. The reporter agreed to follow up from GlaxoSmithKline.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain. In August 2018, the outcome of the chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain were recovered/resolved. It was unknown if the reporter considered the chills, fever, influenza-like symptoms, nausea, stomach pain, injection site swelling, injection site erythema and muscle pain to be related to SHINGRIX. Additional information was received as follows: In 2018, the patient experienced chills, feverish, flu like symptoms, nausea, severe stomach pain, injection site swelling and redness, muscle pain in injection arm for a week. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Movement disorder, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy. Concurrent medical conditions included mast cell activation syndrome. On 21st June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced diarrhea, pain in arm, tremor, muscle pain, fever, shivering and movement disorder. On an unknown date, the outcome of the diarrhea, tremor, muscle pain, fever and shivering were recovered/resolved and the outcome of the pain in arm and movement disorder were unknown. It was unknown if the reporter considered the diarrhea, pain in arm, tremor, muscle pain, fever, shivering and movement disorder to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The age at vaccination was not reported. But, it could be 61 or 62 years old. The patient experienced bad diarrhea, fever (body temperature: 100 degree F), shivering, shaking and muscle aches which lasted between 2 and 3 days. The patient also experienced arm soreness such that, she could not use her arm for days. Lab Comments: Lab test was performed on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy. Concurrent medical conditions included mast cell activation syndrome. On 21st June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced diarrhea, pain in arm, tremor, muscle pain, fever, shivering and movement disorder. On an unknown date, the outcome of the diarrhea, tremor, muscle pain, fever and shivering were recovered/resolved and the outcome of the pain in arm and movement disorder were unknown. It was unknown if the reporter considered the diarrhea, pain in arm, tremor, muscle pain, fever, shivering and movement disorder to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The age at vaccination was not reported. But, it could be 61 or 62 years old. The patient experienced bad diarrhea, fever (body temperature: 100 degree F), shivering, shaking and muscle aches which lasted between 2 and 3 days. The patient also experienced arm soreness such that, she could not use her arm for days. Lab Comments: Lab test was performed on an unknown date.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired. On an unknown date, the outcome of the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient did receive SHINGRIX some weeks before the reporting date and the patient became ill the next day of the vaccination day with generalized aches, chills, fever and heavy flu-like symptoms. These were severe enough to disabled the patient for a day but only lasted 24 to 36 hours. The reporter asked if those were the common response. It was interesting that they both (the patient's family member who received SHINGRIX refer case US2018GSK151445) reacted exactly the same. The reporter said that any information could offer here would be appreciated. The reporter said that he was recently retired hospital pharmacist so please do not hesitate to offer him provider information. He understood the pharmacology as well as the supply chain issues. This case was one of the 4 link cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired. On an unknown date, the outcome of the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient did receive SHINGRIX some weeks before the reporting date and the patient became ill the next day of the vaccination day with generalized aches, chills, fever and heavy flu-like symptoms. These were severe enough to disabled the patient for a day but only lasted 24 to 36 hours. The reporter asked if those were the common response. It was interesting that they both (the patient's family member who received SHINGRIX refer case US2018GSK151445) reacted exactly the same. The reporter said that any information could offer here would be appreciated. The reporter said that he was recently retired hospital pharmacist so please do not hesitate to offer him provider information. He understood the pharmacology as well as the supply chain issues. This case was one of the 4 link cases, reported by the same reporter.