chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Full blood count normal, Headache, Muscle twitching, Myopathy
Clinical narrative: Bad headaches; Chills; Twitching in legs; Upper extremity myopathy/lower extremity myopathy; Paresthesias/funny sensations; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On 24th June 2020, 6 days after receiving Shingrix, the patient experienced headache, chills, myopathy, paresthesia and twitching of limbs. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, chills, myopathy, paresthesia and twitching of limbs were recovered/resolved.   It was unknown if the reporter considered the headache, chills, myopathy, paresthesia and twitching of limbs to be related to Shingrix.  Additional details were provided as follows: The batch number of Shingrix was reported as 28NDD and was updated to 27N2D as per sales data review. The health care professional was having trouble reading the lot number in his notes, he had given his best guess at the lot number. The reporter stated that after receiving the vaccine, the patient had experienced bad headaches, chills, upper extremity myopathy which eventually also included lower extremity myopathy and paresthesias; twitching in legs and funny sensations. The patient did not get any relief after treatment with Advil. CBC was completed and it came back fine. The events bad headaches, chills, upper extremity myopathy resolved after awhile but the lower extremity myopathy and paresthesias continued 12 days later and into almost 3 weeks later. At the time of reporting, the patient could walk safely and all events were resolved. The reporter consented to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Bad headaches; Chills; Twitching in legs; Upper extremity myopathy/lower extremity myopathy; Paresthesias/funny sensations; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2ZN2D, expiry date 16th September 2022) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On 24th June 2020, 6 days after receiving Shingrix, the patient experienced headache, chills, myopathy, paresthesia and twitching of limbs. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, chills, myopathy, paresthesia and twitching of limbs were recovered/resolved.   It was unknown if the reporter considered the headache, chills, myopathy, paresthesia and twitching of limbs to be related to Shingrix.  Additional details were provided as follows: The batch number of Shingrix was reported as 28NDD and was updated to 27N2D as per sales data review. The health care professional was having trouble reading the lot number in his notes, he had given his best guess at the lot number. The reporter stated that after receiving the vaccine, the patient had experienced bad headaches, chills, upper extremity myopathy which eventually also included lower extremity myopathy and paresthesias; twitching in legs and funny sensations. The patient did not get any relief after treatment with Advil. CBC was completed and it came back fine. The events bad headaches, chills, upper extremity myopathy resolved after awhile but the lower extremity myopathy and paresthesias continued 12 days later and into almost 3 weeks later. At the time of reporting, the patient could walk safely and all events were resolved. The reporter consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles, Rash vesicular
Clinical narrative: two small blisters / injection site.; blisters appear like shingles blister; This case was reported by a physician via call center representative and described the occurrence of injection site blisters in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prolia injection (several months ago). Concurrent medical conditions included osteoporosis and allergy. Concomitant products included benadryl (nos) (Benadryl).   On 11th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th September 2020, 1 days after receiving Shingrix, the patient experienced injection site blisters and vesicular rash. On an unknown date, the outcome of the injection site blisters was not recovered/not resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the injection site blisters and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and the next day noticed two small blisters one on each side of the injection site.  The reporter stated the blisters appear like shingles blister, but they are not red or oozing, only tan.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Dysphagia, Dyspnoea, Herpes zoster, Injection site pain
Clinical narrative: lip is swelling; big sore on the top of her lip; oral herpes / cold sores; tongue swelling; shortness of breath; difficulty swallowing; sores/herpes zoster on her lips; sore where the shot was administered; This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included denosumab (Prolia Injection) for an unknown indication.   Concurrent medical conditions included the patient stated she has bad allergies. Illness at time of vaccination included the patient had a prolia injection several months ago..   On 9th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Prolia Injection at an unknown dose and frequency. In September 2020, less than a week after receiving Shingrix, the patient experienced lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain. The action taken with Prolia Injection was unknown. On an unknown date, the outcome of the lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain were unknown.   It was unknown if the reporter considered the lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the first dose of Shingrix last Wednesday. She took some Benadryl before getting the shot. She now stated her lip is swelling and she had a big sore on the top of her lip. The patient had never had oral herpes before and was wondering whether it could be because of the shot.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Oral herpes, Swollen tongue
Clinical narrative: lip is swelling; big sore on the top of her lip; oral herpes / cold sores; tongue swelling; shortness of breath; difficulty swallowing; sores/herpes zoster on her lips; sore where the shot was administered; This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included denosumab (Prolia Injection) for an unknown indication.   Concurrent medical conditions included the patient stated she has bad allergies. Illness at time of vaccination included the patient had a prolia injection several months ago..   On 9th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Prolia Injection at an unknown dose and frequency. In September 2020, less than a week after receiving Shingrix, the patient experienced lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain. The action taken with Prolia Injection was unknown. On an unknown date, the outcome of the lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain were unknown.   It was unknown if the reporter considered the lip swelling, sores lip, oral herpes, swollen tongue, shortness of breath, swallowing difficult, herpes zoster and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the first dose of Shingrix last Wednesday. She took some Benadryl before getting the shot. She now stated her lip is swelling and she had a big sore on the top of her lip. The patient had never had oral herpes before and was wondering whether it could be because of the shot.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Get the flu shot / Prior to getting the flu/ Suspected Vaccination failure; flu; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for injection for product used for unknown indication and mepolizumab autoinjector device administration system for product used for unknown indication.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season, Nucala 300 mg cyclically and mepolizumab autoinjector device. In November 2019, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after starting Nucala and mepolizumab autoinjector device, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the influenza to be related to Nucala and mepolizumab autoinjector device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received Nucala in February or March 2019, 300 miligram monthly injected at an infusion center and experienced flu in November 2019. The reporter stated that, the patient did get the Flu shot the stronger one for older patients, prior to getting the flu, which led to Vacciantion failure and influenza. The reporter consented to follow up. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Influenza like illness, Injection site pain, Nervousness, Pain, Pain in extremity
Clinical narrative: Skin sensitivity going up her rib cage; Nerves are on edge; Painful to touch and painful when she moves the wrong way; Site of injection issues of sore arm; flu-like symptoms; Site of injection issues of sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 2nd September 2020, the patient received Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 2nd September 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the patient experienced injection site pain, sensitive skin, nervous and tenderness. On 3rd September 2020, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the sensitive skin, nervous and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site pain, influenza-like symptoms, sensitive skin, nervous and tenderness to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had site of injection issues of sore arm for 1 day.  Flu-like symptoms for 24 hours. Those aforementioned effects have resolved.  The following had not resolved. She has skin sensitivity going up her rib cage; it goes to the center of her torso and wraps around.  Her nerves were on edge. She painful to touch and painful when she moves the wrong way. Caller got Shingrix and flu shot at the same time.  The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Sensitive skin, Tenderness
Clinical narrative: Skin sensitivity going up her rib cage; Nerves are on edge; Painful to touch and painful when she moves the wrong way; Site of injection issues of sore arm; flu-like symptoms; Site of injection issues of sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 2nd September 2020, the patient received Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 2nd September 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the patient experienced injection site pain, sensitive skin, nervous and tenderness. On 3rd September 2020, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the sensitive skin, nervous and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site pain, influenza-like symptoms, sensitive skin, nervous and tenderness to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had site of injection issues of sore arm for 1 day.  Flu-like symptoms for 24 hours. Those aforementioned effects have resolved.  The following had not resolved. She has skin sensitivity going up her rib cage; it goes to the center of her torso and wraps around.  Her nerves were on edge. She painful to touch and painful when she moves the wrong way. Caller got Shingrix and flu shot at the same time.  The reporter did not consent to follow up.
Sex: M
Vaccine: MENB
Symptoms: Paroxysmal nocturnal haemoglobinuria
Clinical narrative: Hemoglobinuria (PNH); This case was reported by a nurse via call center representative and described the occurrence of paroxysmal nocturnal hemoglobinuria in a male patient who received Men B NVS (Bexsero) for prophylaxis.   In February 2019, the patient received the 1st dose of Bexsero. On an unknown date, 2 weeks after receiving Bexsero, the patient experienced paroxysmal nocturnal hemoglobinuria (serious criteria GSK medically significant). The patient was treated with ravulizumab. On an unknown date, the outcome of the paroxysmal nocturnal hemoglobinuria was unknown.   It was unknown if the reporter considered the paroxysmal nocturnal hemoglobinuria to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. 2 weeks after receiving Bexsero, the patient started receiving infusions of Ravulizumab for hemoglobinuria (PNH).  The patient had been receiving infusions every 2 months.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: myalgia; fever; fatigue; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced myalgia, fever, fatigue and influenza-like symptoms. On an unknown date, the outcome of the myalgia, fever, fatigue and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fever, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix and two days after experienced myalgia, fatigue, fever and flu like symptons ongoing for 8 days.  The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Blood pressure decreased, Dizziness, Fatigue, Headache
Clinical narrative: been sick / malaise; muscles pain in her entire body; Headache; blisters on her left arm; Fatigue; Decreased Blood Pressure; dizziness; Pain; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced malaise, myalgia, headache, blister, fatigue, blood pressure decreased, dizziness and pain. On an unknown date, the outcome of the malaise and pain were unknown and the outcome of the myalgia, blister and fatigue were not recovered/not resolved and the outcome of the headache, blood pressure decreased and dizziness were recovered/resolved.   It was unknown if the reporter considered the malaise, myalgia, headache, blister, fatigue, blood pressure decreased, dizziness and pain to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine and flu vaccine on the same day and did not know the lot number or expiration date of either and cannot confirm if the flu vaccine she received was a GSK product.  The patient stated that she has been sick and had muscles pain in her entire body, headache, decreased blood pressure, blisters on her left arm, where she was given the unknown flu vaccine, and dizziness, all of which had resolved.  The reporter was still experiencing some malaise, fatigue and did not go see her HCP while she was sick because she said the symptoms began to resolve. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Malaise, Myalgia, Pain
Clinical narrative: been sick / malaise; muscles pain in her entire body; Headache; blisters on her left arm; Fatigue; Decreased Blood Pressure; dizziness; Pain; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced malaise, myalgia, headache, blister, fatigue, blood pressure decreased, dizziness and pain. On an unknown date, the outcome of the malaise and pain were unknown and the outcome of the myalgia, blister and fatigue were not recovered/not resolved and the outcome of the headache, blood pressure decreased and dizziness were recovered/resolved.   It was unknown if the reporter considered the malaise, myalgia, headache, blister, fatigue, blood pressure decreased, dizziness and pain to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine and flu vaccine on the same day and did not know the lot number or expiration date of either and cannot confirm if the flu vaccine she received was a GSK product.  The patient stated that she has been sick and had muscles pain in her entire body, headache, decreased blood pressure, blisters on her left arm, where she was given the unknown flu vaccine, and dizziness, all of which had resolved.  The reporter was still experiencing some malaise, fatigue and did not go see her HCP while she was sick because she said the symptoms began to resolve. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Immediate post-injection reaction, Oral herpes
Clinical narrative: blisters; cold sores on her lips; This case was reported by a other health professional via call center representative and described the occurrence of blister in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date unknown) for prophylaxis.   The patient's past medical history included cold sores (cold sores in her 20's).   On 3rd March 2020, the patient received the 1st dose of Shingrix. On 3rd March 2020, immediately after receiving Shingrix, the patient experienced blister and cold sores lip. On an unknown date, the outcome of the blister and cold sores lip were recovering/resolving.   It was unknown if the reporter considered the blister and cold sores lip to be related to Shingrix.  Additional details were provided as follows:  The reporter did not had the expiry date till the time of reporting.  The patient had history of cold sores when she was in her 20's was treated with a series of small pox shots and it was resolved  around 1968/69.  The patient received the dose of shingrix on and experienced blister and cold sores lip.  The patient did not had any other cold sore breakouts until she received Shingrix, treatment for this breakout was unknown.  The patient was suffering from cold sores and blisters are ongoing but the frequency was less.  The patient stated that would she get the 2nd dose.  The reporter consented to follow up
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Fatigue / her legs feel tired; Myalgia; pain; her legs feel tired and sore/Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fatigue, myalgia, pain, injection site warmth and leg pain. On an unknown date, the outcome of the injection site pain, fatigue and myalgia were not recovered/not resolved and the outcome of the pain, injection site warmth and leg pain were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, myalgia, pain, injection site warmth and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that her left arm, where she received the injection, was hurting, pain, and she had been icing the area. She also stated that she felt tired, fatigue and her legs feel tired and sore, myalgia.  The reporter consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Muscular weakness
Clinical narrative: arm was red around the injection site about 2 inches; muscle weakness in the arm/ arm felt weak; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 13th August 2020, the patient received Shingrix. On 13th August 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and muscle weakness upper limb. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the muscle weakness upper limb was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and muscle weakness upper limb to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had muscle weakness in the arm. The arm was red around the injection site about 2 inches and then it felt weak. The patient can use arm and was able to do everything with her arm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swelling / in the lymph node in the injection arm; This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received Shingrix (intramuscular). In September 2020, 24 hrs after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported.  The patient received Shingrix in deltoid muscle. After receiving dose of Shingrix, the patient experienced swelling of the size of a golf ball in the lymph node in the injection arm. The reporter reported that, she was not sure if the symptoms were resolved. She did not provide more details. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Tinea cruris
Clinical narrative: rash in his groin area; jock-itch; shingles; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced rash, tinea cruris and shingles. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the tinea cruris and shingles were unknown.   It was unknown if the reporter considered the rash, tinea cruris and shingles to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported.  The patient received 1st dose of Shingrix in left arm. After receiving 1st dose of Shingrix, the patient experienced rash in his groin area, jock itch or shingles. The reporter did not consent to follow up.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: developed hives.; This case was reported by a physician via call center representative and described the occurrence of hives in a 36-year-old female patient who received HBV (Engerix B) for prophylaxis.   In August 2020, the patient received the 1st dose of Engerix B (intramuscular). On an unknown date, less than a month after receiving Engerix B, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Engerix-B vaccine 4 weeks ago and developed hives.  The reporter reported that the dose was given by the patient's primary care doctor and not by the caller. The reporter did not consent to follow up. The reporter had very limited information about the event and did not know the lot number or expiration date of the vaccine given.  The reporter was an allergist and said the patient was referred to him by the primary care physician who gave the first dose.  The patient did not give permission to follow up with HCP.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: sore arm; first Shingrix shot date November 2018/did not receive the second shot within the 6 month time frame; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had pain in arm. The patient did not receive the second shot within the 6 month time frame, which led to incomplete course of vaccination. Limited information was available. The reporter consented to follow up. Lot and expiration date was unavailable.
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Prostate cancer
Clinical narrative: prostate cancer; This case was reported by a other health professional via call center representative and described the occurrence of prostate cancer in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received the 1st dose of Shingrix. In May 2020, between 1 and 3 months after receiving Shingrix, the patient experienced prostate cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the prostate cancer was not recovered/not resolved.   It was unknown if the reporter considered the prostate cancer to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported but it could be 71 or 72 years. The patient reported that a patient got 1st dose of Shingrix and was diagnosed with prostate cancer in May 2020. As a measure, the patient received chemotherapy. This condition was ongoing.  The patient's 2nd dose was planned for 12th September 2020, but the patient was on chemo treatment until last week. His oncology suggested to not get Shingrix and wait for 4-6 weeks after last day of treatment.  The patient would receive his 2nd dose would be then on 10th October 2020. He did not receive the 2nd dose within the recommended 2-6 month period.  No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: Pain at the injection site; malaise; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and malaise. On an unknown date, the outcome of the injection site pain and malaise were recovered/resolved.   It was unknown if the reporter considered the injection site pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 2nd dose of Shingrix he experienced pain at the injection site and malaise for 3 days.  No additional information provided. The reporter consent to follow up. This case has been linked with case US2020186287reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186287:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash; looked like a shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and vesicular rash. On an unknown date, the outcome of the rash and vesicular rash were unknown.   It was unknown if the reporter considered the 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 an adult per the vaccine indication. HCP could not provide and patient demographics, lot number, or expiration date. The patient experienced rash following 1st dose  of Shingrix.  The rash looked like a shingles rash. HCP noted the patient received the dose from their Doctors office and not from the pharmacy.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles in Feb 2020 / in June of 2020 / now has shingles for a third time; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st February 2020, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in summer of 2019 in left arm. After receiving 2nd dose of Shingrix, the patient experienced his first case of shingles in February 2020, his second case in June 2020 and at the time of reporting he had shingles for a third time. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since laboratory confirmation for herpes zoster were not provided.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD Quadrivalent was inadvertently administered to a 64 year old patient, no AE; Fluzone HD Quadrivalent was inadvertently administered to a 64 year old patient, no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64-year-old male patient who was inadvertently administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ443AA, expiry date: 30-Jun-2021) (product administered to patient of inappropriate age and overdose) on an unknown date as prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  This was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a Menactra vaccine which was exposed to negative 1.8 Celsius for about 18 hours and was non viable/No AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 11-years-old female patient who was mistakenly vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (single dose vials) (lot U6596AB and expiry date 24-MAY-2021) via intramuscular route at the left deltoid for prophylactic vaccination on an unknown date which was exposed to negative 1.8 Celsius for about 18 hours and was non viable (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and Human Papilloma Virus (HPV) VACCINE VLP RL1 9V (YEAST) for prophylactic vaccination.  It was an actual medication error case due to product storage error temperature too low.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: a dose of Fluzone Quadrivalent given to a patient from a shipment that arrived late, No AE; a dose of Fluzone Quadrivalent given to a patient from a shipment that arrived late, No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via phone.  This case involves an INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] which had temperature excursion as its shipment arrived late hence not viable to use and a six months old patient (gender was not reported) who was vaccinated with a 0.5 ml dose of this vaccine (batch number and other dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was an actual medication error case due to incorrect product storage.  It was a case of Product shipment delay.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Fluzone High-Dose from last season was administered to a patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 74 year old male patient who was vaccinated with a 0.5 ml once dose of an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot  number UJ311AB and expiration date 30-Jun-2020) via an intramuscular route in the right deltoid on 03-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive any concomitant vaccine.  It was an actual medication error case due to expired vaccine used (latency was same day).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of Menactra was administered to the patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17 year old female patient who was administered an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not pregnant.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 03-Sep-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6208AD, expiry date 08-Jul-2020, vial) once via unknown route in the left deltoid for prophylactic vaccination.  It was reported that the clinician may vaccinate right away and another clinician wanted to wait on her second dose of Varicella in a month.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: large amount of liquid ran down arm during vaccination with FLUZONE HIGH-DOSE QUADRIVALENT, No AE; large amount of liquid ran down arm during vaccination with FLUZONE HIGH-DOSE QUADRIVALENT, No AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 74-years-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination, and large amount of liquid ran down arm during vaccination on 09-Sep-2020 for prophylactic vaccination.  The patient's past medical treatment included ENBREL for last 12 years. The patient's medical history, past vaccination(s) and family history were not provided.  Concomitant medications included SECUKINUMAB (COSENTYX).  It was a case of exposure via skin contact and vaccine underdose (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: female patient received the vaccine which started leaking down her arm/ NO AE; female patient received the vaccine which started leaking down her arm/ NO AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves female patient (age not reported) who received vaccine 0.5 mL INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (batch number, expiry date, route and site of administration not reported) which started leaking down her arm (exposure via skin contact and underdose) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to exposure via skin contact and vaccine underdose (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.