chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, 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 feeling bad in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose of SHINGRIX on 30th May 2018.). On 8th January 2019, the patient received the 2nd dose of SHINGRIX. On 8th January 2019, 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 provided as follows: The age at vaccination was not reported. The patient reported that he had his first dose and his second dose was late because the patient unable to get the injection due to supply issue. The patient refused to provide his age or date of birth. Consented to follow up was provided. The patient was request reimbursement. Follow up information received from consumer on 28th January 2019: On 8th January 2019, the patient received the 2nd dose of SHINGRIX which was later the recommended schedule, which led to lengthening of the vaccination schedule. Less than a month after receiving SHINGRIX the patient ended up in bed because it made him feel so lousy. The patient was unwilling to provide any further details as he wanted to get off the phone. The patient stated that he tried to get the 2nd SHINGRIX shot within the 6 month window by calling many pharmacist, and he was finally able to get the second shot in 2019 about 8 months after the first shot. This case has been linked to the US2019GSK021331, reported for the dose 1 of the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Malaise, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired. On an unknown date, the outcome of the sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's mother. The age at vaccination was not reported. About 4 months before the time of reporting, the patient received SHINGRIX on an unknown arm. The patient experienced fever, was sick the next day, missed work, nauseous, felt lousy and his arm was sore and swollen. The symptoms lasted a couple of days. No additional details were available. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired. On an unknown date, the outcome of the sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the sickness, nausea, feeling bad, swelling arm, pain in arm, fever and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's mother. The age at vaccination was not reported. About 4 months before the time of reporting, the patient received SHINGRIX on an unknown arm. The patient experienced fever, was sick the next day, missed work, nauseous, felt lousy and his arm was sore and swollen. The symptoms lasted a couple of days. No additional details were available. The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Nasopharyngitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cough in a 62-year-old male patient who received SHINGRIX (batch number MG42F, expiry date 21st May 2021) for prophylaxis. On 16th January 2019, the patient received SHINGRIX. On 17th January 2019, 1 days after receiving SHINGRIX, the patient experienced cough, cold and tiredness. On an unknown date, the outcome of the cough, cold and tiredness were not recovered/not resolved. It was unknown if the reporter considered the cough, cold and tiredness to be related to SHINGRIX. Additional details were provided as follows: The next day of vaccination, the patient began to feel like he had a cough and cold post vaccination. The patient was also feeling exhausted and tired. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes simplex aggravated in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included herpes simplex. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced herpes simplex aggravated. The patient was treated with Valacyclovir. On an unknown date, the outcome of the herpes simplex aggravated was unknown. It was unknown if the reporter considered the herpes simplex aggravated to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient got SHINGRIX dose and the next day started valacyclovir for a suspect flair of herpes simplex. The patient took 2 doses before stopping. The patient reporter was asking what was your (GSK) recommendation. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tingling tongue in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced tingling tongue and numbness of tongue. On an unknown date, the outcome of the tingling tongue and numbness of tongue were not recovered/not resolved. It was unknown if the reporter considered the tingling tongue and numbness of tongue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced tingling and numbness on the tip of the tongue since vaccination. The reporter did not give consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, fever and general body pain. On an unknown date, the outcome of the shivering, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the shivering, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: Within 24 hours of vaccination, the patient experienced shivering, fever (body temperature of 102 degree F), and generalized body aches. The patient reported that, she took something for the fever. She said these symptoms lasted for 24 hours and then resolved. The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Rotator cuff syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd December 2018, 7 days after receiving SHINGRIX, the patient experienced muscle pain. In December 2018, the patient experienced pain in arm and impingement syndrome. The patient was treated with FLEXERIL (NOS) and (non-proprietary) Cortisone Shot. On an unknown date, the outcome of the pain in arm, muscle pain and impingement syndrome were unknown. The reporter considered the pain in arm, muscle pain and impingement syndrome to be probably related to SHINGRIX. Additional details were provided as follows: The patient experienced sore arm for several weeks. Less than a week after receiving SHINGRIX, the patient experienced pain in arm and impingement syndrome. The patient developed pain in his trapezius muscle and was seen by orthopedist and diagnosed with an impingement syndrome that might be related to injection that made it into the bursa of his shoulder. The patient was receiving cortisone shots and physical therapy to treat the issue. The reporter did not give consent to follow up. Emergency room visit required.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a female patient who received SHINGRIX (batch number ZH5R5, expiry date 18th April 2021) for prophylaxis. On 18th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site lump, injection site erythema, injection site tenderness and injection site warmth. On an unknown date, the outcome of the injection site lump, injection site erythema, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump, injection site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in right deltoid. The patient received SHINGRIX and experienced an injection site reaction that was red, raised, tender, hot to the touch and was 3 inches in diameter. The reporter was unsure if they have resolved. The patient called to report this to office on 22nd January 2019. This case has been linked to the case US2019016623, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling in a adult patient who received SHINGRIX for prophylaxis. In January 2019, the patient received SHINGRIX. In January 2019, less than a month after receiving SHINGRIX, the patient experienced swelling and pain. On an unknown date, the outcome of the swelling and pain were recovered/resolved. It was unknown if the reporter considered the swelling and pain to be related to SHINGRIX. Additional details were provided 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 experienced swelling, soreness, the normal things expected following administration of SHINGRIX earlier this year and she was pretty sure they resolved. This case has been linked to the case US2019016618, reported by same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, weakness and headache. On 1st August 2018, the outcome of the fever, weakness and headache were recovered/resolved. On 13th August 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, weakness and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow up with her physician on 30th January 2019. The patient reported that she heard from friends that people experienced arm pain. No further information was provided. Consent to follow up was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms 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, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms as a result of SHINGRIX use. The patient had SHINGRIX vaccine in the last thirty days and had pain at the injection site and flu like symptoms that were lasted 2 to 3 days. No other information was available.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 57-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 25th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 28th January 2019, 3 days after receiving SHINGRIX, the patient experienced cold sores. The patient was treated with VALTREX. On an unknown date, the outcome of the cold sores was not recovered/not resolved. It was unknown if the reporter considered the cold sores to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient had an adverse reaction. On Monday, the patient broke out with cold sores in her mouth and nose. The patient still had the symptoms. The patient took two doses of VALTREX to treat the symptoms. The patient just told that, she received a prescription, but did not mention visiting physician. The reporter consented to follow up.
Sex: U
Vaccine: PPV
Symptoms: Eye swelling
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer company regarding to an adult patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, strength, frequency, anatomical location, route of administration, lot # and expiration date were unknown by the reporter), for prophylaxis. On an unspecified date, the patient experienced eye swelling. By the reporting time, it was unknown if the patient recovered from the abovementioned event. The causality assessment between eye swelling with PNEUMOVAX 23 was not provided.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lethargy, Myalgia, Pyrexia, Urticaria
Clinical narrative: Hives, Fever. Sore Muscles. Lethargic.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Enuresis, Fatigue, Headache, Lethargy, Local reaction
Clinical narrative: Following day: fatigue, HA, that evening mother reported patient had wet bed. Positive lethargy. Local reaction: arm swelling x one month.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Peripheral swelling
Clinical narrative: Following day: fatigue, HA, that evening mother reported patient had wet bed. Positive lethargy. Local reaction: arm swelling x one month.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Enuresis, Fatigue, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Following day: fatigue, HA, that evening mother reported patient had wet bed. Positive lethargy. Local reaction: arm swelling x one month.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Local reaction, Peripheral swelling
Clinical narrative: Following day: fatigue, HA, that evening mother reported patient had wet bed. Positive lethargy. Local reaction: arm swelling x one month.
Age: 23.0
Sex: F
Vaccine: HEP, MNQ, PNC13
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant at the time of vaccine administration (25w1d).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Headache started evening of injection. Next day sore arm, headache & chills.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: LARGE AREA OF REDNESS APPEARED THIS MORNING (2/7/19) TWO DAYS POST INJECTION. THE PATIENT REPORTED NO PAIN, JUST SWELLING AND A SMALL PATCH OF ITCHINESS. TOLD PATIENT SHE COULD TAKE BENADRYL AND EITHER IBUPROFEN OR TYLENOL AND ALSO CALLED THE PHYSICIAN TO REPORT REACTION.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Disorientation, Eye movement disorder, Fall, Hyperhidrosis, Loss of consciousness
Clinical narrative: Vasovagal Response. Patient fell unconscious on exam table then his eyes rolled in the back of his head and he had began to have seizure like activity and episode of incontinence of urine. Patient was pale excessive sweating and dis oriented upon awakening.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Pallor, Presyncope, Seizure like phenomena, Urinary incontinence
Clinical narrative: Vasovagal Response. Patient fell unconscious on exam table then his eyes rolled in the back of his head and he had began to have seizure like activity and episode of incontinence of urine. Patient was pale excessive sweating and dis oriented upon awakening.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site mass, Irritability, Urticaria
Clinical narrative: Hives on face and both feet, quarter sized redness and lump at injection site, irritable, afebrile, BENADRYL 5 ml.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse, referring to a 25 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 24-JAN-2019, the 25 year old patient was vaccinated with ZOSTAVAX strength reported as 19400 PFU, subcutaneously, lot# R023356 and expiration date 28-JUN-2019, for prophylaxis (strength, dose and frequency were not reported). No adverse effect reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 30-JAN-2019, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB intramuscularly, lot # R021076, expiry date: 11-JUN-2021 (dose and anatomical location were not provided) for prophylaxis. The vaccine was stored in temperature above 47 degrees Fahrenheit (47.3) for 18 minutes. On unknown date in the past, there was one more temperature excursion, the vaccine was stored in temperature above 47 degrees Fahrenheit for 4 minutes. Digital data logger was involved in this case. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA001383.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 89-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 1st October 2018). On 21st January 2019, the patient received the 2nd dose of SHINGRIX .5 ml. In January 2019, less than a day after receiving SHINGRIX, the patient experienced fatigue (serious criteria hospitalization). On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, but it could be 88 or 89 year. Within 24 hours after vaccination with SHINGRIX, patient was hospitalized for extreme fatigue. The reporter agreed to follow up from GSK.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Rhinitis, Sinusitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included sinus infection (recurring). Previously administered products included NUCALA with an associated reaction of alopecia (refer case US2019012862). In January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a month after receiving SHINGRIX, the patient experienced sinus infection, rhinitis, wheezing and difficulty breathing. On an unknown date, the outcome of the sinus infection, rhinitis, wheezing and difficulty breathing were not recovered/not resolved. It was unknown if the reporter considered the sinus infection, rhinitis, wheezing and difficulty breathing to be related to SHINGRIX. Additional details were reported as follows: This call was transferred. The patient stated she had recurring sinus infections and had a sinus infection at the time of reporting. The patient stated she got them all the time. In January 2019 this year, the patient received the SHINGRIX vaccination and was going to get the 2nd dose. The patient stated she saw a top doctor for sinusitis and rhinitis and for her there was no cure. The patient stated they were debilitating with difficult breathing and wheezing. The additional vaccine information was not provided. The reporter gave consent to follow-up. This case has been linked to the US2019012862, reported for the pharma suspect of the same patient.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included sinus infection (recurring). Previously administered products included NUCALA with an associated reaction of alopecia (refer case US2019012862). In January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a month after receiving SHINGRIX, the patient experienced sinus infection, rhinitis, wheezing and difficulty breathing. On an unknown date, the outcome of the sinus infection, rhinitis, wheezing and difficulty breathing were not recovered/not resolved. It was unknown if the reporter considered the sinus infection, rhinitis, wheezing and difficulty breathing to be related to SHINGRIX. Additional details were reported as follows: This call was transferred. The patient stated she had recurring sinus infections and had a sinus infection at the time of reporting. The patient stated she got them all the time. In January 2019 this year, the patient received the SHINGRIX vaccination and was going to get the 2nd dose. The patient stated she saw a top doctor for sinusitis and rhinitis and for her there was no cure. The patient stated they were debilitating with difficult breathing and wheezing. The additional vaccine information was not provided. The reporter gave consent to follow-up. This case has been linked to the US2019012862, reported for the pharma suspect of the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose refer case, US2019015763). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was reporting adverse event for herself and her husband. After receiving the first and second dose of SHINGRIX vaccine the patient experienced redness at the injection site. This lasted for about a week. No further details were provided. The reporter also mentioned that her husband heard from someone that someone had a stroke from SHINGRIX and someone had died from SHINGRIX vaccine. Her husband did not know who the exact person was or any details. The reporter did not consent to follow up. This case has been linked with the case US2019015771, reported her husband.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of painful rash 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, unknown after receiving SHINGRIX, the patient experienced painful rash and vesicular rash. On an unknown date, the outcome of the painful rash and vesicular rash were unknown. It was unknown if the reporter considered the painful rash and vesicular rash to be related to SHINGRIX. Additional details were provided 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 healthcare professional reported that six patients have developed a painful skin rash that resembles Shingles, after receiving the SHINGRIX vaccine. The reporter did not consent to follow-up. The healthcare professional did not have patient information available at this time. This case was 1 of the 6 cases, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Myalgia, Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and ENBREL. On 15th November 2018, the patient received the 2nd dose of SHINGRIX. On 15th November 2018, less than a day after receiving SHINGRIX, the patient experienced rash, facial swelling, neck swelling, red face, feeling of warmth facial and muscle pain. On an unknown date, the outcome of the rash, facial swelling, red face, feeling of warmth facial and muscle pain were not recovered/not resolved and the outcome of the neck swelling was unknown. It was unknown if the reporter considered the rash, facial swelling, neck swelling, red face, feeling of warmth facial and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she experienced rash, swelling, redness, and hotness on her face and neck. The patient reported that she went to the emergency room twice in December 2018. The patient planned to continue follow up with her physician on an unknown date. The reporter consented to follow up. For the tolerability of 1st dose, refer case US2019015781, reported for same patient.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and ENBREL. On 15th November 2018, the patient received the 2nd dose of SHINGRIX. On 15th November 2018, less than a day after receiving SHINGRIX, the patient experienced rash, facial swelling, neck swelling, red face, feeling of warmth facial and muscle pain. On an unknown date, the outcome of the rash, facial swelling, red face, feeling of warmth facial and muscle pain were not recovered/not resolved and the outcome of the neck swelling was unknown. It was unknown if the reporter considered the rash, facial swelling, neck swelling, red face, feeling of warmth facial and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she experienced rash, swelling, redness, and hotness on her face and neck. The patient reported that she went to the emergency room twice in December 2018. The patient planned to continue follow up with her physician on an unknown date. The reporter consented to follow up. For the tolerability of 1st dose, refer case US2019015781, reported for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose received in 2018, for tolerance refer case: US2019015631). On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site pain, injected limb mobility decreased and intramuscular formulation administered by other route. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased were resolved with sequelae and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Before getting the 2nd dose of the SHINGRIX, the administering pharmacist told the patient that she would administer the vaccine subcutaneously and had a short needle attached to the syringe. The reporter told the pharmacist that the product should be administered intramuscularly. The pharmacist said she would administer it intramuscularly but did not change the needle. The reporter felt that the product was administered subcutaneously on the left arm because she did not get any systemic effects like she did with the first dose but experienced significant issues at the injection site. She woke up the next day and she could barely lift her arm. The injection site was red, sore, and hot which measured 3 inches across horizontally and 3.5 inches vertically. It took 5 to 6 days to resolve. The call was transferred to Medical Information.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The pharmacist had another patient who had whelps, but did not have any further information at this time. The pharmacist informed to call back with any additional information. The pharmacist thought that there was something wrong with this lot of SHINGRIX. The pharmacist stated, he was not returned the 1 vial to the GSK but might be returned to his wholesaler. This case has been linked with case US2019009093, reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 51-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, chills, injection site erythema and injection site warmth. On an unknown date, the outcome of the general body pain, chills, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the general body pain, chills, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left arm. The patient experienced little redness and heat at the injection site redness, injection site warmth. The patient had chills and body aches for 1 day. The call was transferred to Medical Information. The reporter gave consent to follow up. For tolerance of 2nd dose, refer case: US2019GSK022646, reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 5th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced nausea, fever and general body pain. On 25th December 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the nausea, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the pain in arm, nausea, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Medical Assistant. The patient experienced severe pain in her left arm. The patient also experienced nausea, body aches, and fever that lasted for approximately 2 days. The reporter did not consent to follow up. The reporter did not want any follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was reporting adverse event for herself and her husband. After receiving the first and second dose of SHINGRIX vaccine the patient experienced redness at the injection site. This lasted for about a week. No further details were provided. The reporter also mentioned that her husband heard from someone that someone had a stroke from SHINGRIX and someone had died from SHINGRIX vaccine. Her husband does not know who the exact person was or any details. The reporter did not give consent to follow up. For tolerance after 2nd dose refer case US2019GSK020713. This case has been linked with the case US2019015771, reported for patient's husband.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Headache, Influenza like illness, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced erythema, pain, fever, nausea, weakness, headache and influenza-like symptoms. On an unknown date, the outcome of the erythema, pain, fever, nausea, weakness, headache and influenza-like symptoms were unknown. It was unknown if the reporter considered the erythema, pain, fever, nausea, weakness, headache and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The caller was reporting adverse event for her husband. The patient received SHINGRIX vaccine on left arm. The patient experienced flu like symptoms, redness, soreness, fever, nausea, weakness and headache. The reporter did not consent to follow up. No further details were provided. This case has been linked with US2019015763 and US2019GSK020713, reported by same reporter.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced erythema, pain, fever, nausea, weakness, headache and influenza-like symptoms. On an unknown date, the outcome of the erythema, pain, fever, nausea, weakness, headache and influenza-like symptoms were unknown. It was unknown if the reporter considered the erythema, pain, fever, nausea, weakness, headache and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The caller was reporting adverse event for her husband. The patient received SHINGRIX vaccine on left arm. The patient experienced flu like symptoms, redness, soreness, fever, nausea, weakness and headache. The reporter did not consent to follow up. No further details were provided. This case has been linked with US2019015763 and US2019GSK020713, reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ENBREL. On 15th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The patient planned to continue follow up with her physician on an unknown date. The reporter did consented to follow up. For the tolerability of 2nd dose, refer case US2019GSK022635 reported for same patient.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine 2017-2018 season for an unknown indication. On 14th December 2018, the patient received the 2nd dose of SHINGRIX and Influenza vaccine 2017-2018 season. On 17th December 2018, 3 days after receiving SHINGRIX and Influenza vaccine 2017-2018 season, the patient experienced shoulder pain, leg pain and headache. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain, leg pain and headache were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the shoulder pain, leg pain and headache to be related to SHINGRIX and Influenza vaccine 2017-2018 season. Additional details were provided as follows: SHINGRIX dose was administered way up on the backside of the patient's right arm, which led to inappropriate site administration; and the Flu vaccine was administered in the patient's left arm. The patient was experiencing excruciating pain in his right shoulder and down his left leg. The patient had an MRI performed but had not received the results yet. The patient had been prescribed a muscle relaxer but was hesitant to take it. The patient was 5 feet 9 and half and weighs 160 pounds. The patient could normally do multiple sets of pushups but could not do 1 at a time. Lab Comments: Lab test performed on unknown date and result not received yet.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine 2017-2018 season for an unknown indication. On 14th December 2018, the patient received the 2nd dose of SHINGRIX and Influenza vaccine 2017-2018 season. On 17th December 2018, 3 days after receiving SHINGRIX and Influenza vaccine 2017-2018 season, the patient experienced shoulder pain, leg pain and headache. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain, leg pain and headache were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the shoulder pain, leg pain and headache to be related to SHINGRIX and Influenza vaccine 2017-2018 season. Additional details were provided as follows: SHINGRIX dose was administered way up on the backside of the patient's right arm, which led to inappropriate site administration; and the Flu vaccine was administered in the patient's left arm. The patient was experiencing excruciating pain in his right shoulder and down his left leg. The patient had an MRI performed but had not received the results yet. The patient had been prescribed a muscle relaxer but was hesitant to take it. The patient was 5 feet 9 and half and weighs 160 pounds. The patient could normally do multiple sets of pushups but could not do 1 at a time. Lab Comments: Lab test performed on unknown date and result not received yet.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Accidental exposure to product, Chills, Exposure via skin contact, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue, general body pain, chills, upset stomach, headache, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the fatigue, general body pain, chills, upset stomach, headache, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the fatigue, general body pain, chills, upset stomach and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient moved her body while getting the injection and it caused some of the liquid to run down her arm, which led to inadvertent exposure to vaccine and exposure via skin contact. The side effects were experienced afterwards. The patient experienced body ache. The reporter did not give consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue, general body pain, chills, upset stomach, headache, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the fatigue, general body pain, chills, upset stomach, headache, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the fatigue, general body pain, chills, upset stomach and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient moved her body while getting the injection and it caused some of the liquid to run down her arm, which led to inadvertent exposure to vaccine and exposure via skin contact. The side effects were experienced afterwards. The patient experienced body ache. The reporter did not give consent to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Discomfort, Platelet count decreased, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: 2-5-2019 @ 4:00pm Low grade fever, a couple small spots by mouth in late evening. 2-6-2019 @ 6:00am Low grade fever, small red spots/rash all over face and upper chest area. Scheduled same day doctor appointment for 8:30am. 2-6-2019 @ 9:00am Rash and symptoms identified as viral infection. 2-6-2019 @ 8:00pm Rash spread from face and trunk to arms and legs. Called pediatrician on call due to symptoms escalating and resembling measles rash. Doctor confirmed diagnosis as reaction to MMRV vaccine on 1-25-2019. 2-7-2019 @ 4:00am Measles rash advanced to complete body coverage. Spots had increased in size drastically. Patient was extremely uncomfortable. Took to emergency room; where diagnosis was confirmed as a vaccine reaction to MMRV. Patient was discharged at approximately 7:00am with no treatment plan (rest, time and TYLENOL as needed).