chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: vaccination failure; shingles on his right forehead, scalp, and temple; Body aches; Fatigue; flu like; Body aches; Fatigue; flu like; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles two years before the date of reporting). Previously administered products included Shingles vaccine (had a shingles vaccination sometime before that outbreak).   In March 2018, the patient received the 1st dose of Shingrix. In September 2018, the patient received the 2nd dose of Shingrix. In March 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, fatigue and influenza-like symptoms. In September 2018, the patient experienced general body pain, fatigue and influenza-like symptoms. In August 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, general body pain, fatigue and influenza-like symptoms were unknown and the outcome of the general body pain, fatigue and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, general body pain, fatigue and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, general body pain, fatigue and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: At the time of reporting, the patient experienced shingles on his right forehead, scalp, and temple. Within a few hours after receiving both the doses of Shingrix, the patient experienced flu-like symptoms which included body aches and fatigue. The symptoms lasted for 1.5 days after receiving 1st dose of Shingrix.  The reporter gave permission for his physician to be contacted. The reporter was unable to obtain additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-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, less than 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 67 years or 68 years. The case was reported by patient's ex husband. The reporter stated that the patient had pain at injection site with first dose. The reporter was unable to give consent for follow up but will ask patient to contact GSK to provide more information. The case has been linked to the case US2019154030, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling and itching at the injection site; redness, swelling and itching at the injection site; redness, swelling and itching at the injection site; fever; body aches; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (for 1st dose refer case US2019GSK107242).   On 2nd June 2019 12:00, the patient received the 2nd dose of Shingrix. On 2nd June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, fever, general body pain, shivering and headache. The patient was treated with non-drug therapy (Cold Compress). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovering/resolving and the outcome of the fever, general body pain, shivering and headache were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, fever, general body pain, shivering and headache to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix at noon and that night he experienced shivering, headache, body aches and fever.  The shivering, headache and body aches resolved the next day but the fever lasted all day Monday. Also on Sunday night, he experienced redness, swelling and itching at the injection site.  The injection site reactions became worse on Monday and severe by Tuesday. It was at its worse last night. It was treated with a cold compress and is a little better today but not resolved. The reporter Consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: redness, swelling and itching at the injection site; redness, swelling and itching at the injection site; redness, swelling and itching at the injection site; fever; body aches; shivering; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (for 1st dose refer case US2019GSK107242).   On 2nd June 2019 12:00, the patient received the 2nd dose of Shingrix. On 2nd June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, fever, general body pain, shivering and headache. The patient was treated with non-drug therapy (Cold Compress). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovering/resolving and the outcome of the fever, general body pain, shivering and headache were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, fever, general body pain, shivering and headache to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix at noon and that night he experienced shivering, headache, body aches and fever.  The shivering, headache and body aches resolved the next day but the fever lasted all day Monday. Also on Sunday night, he experienced redness, swelling and itching at the injection site.  The injection site reactions became worse on Monday and severe by Tuesday. It was at its worse last night. It was treated with a cold compress and is a little better today but not resolved. The reporter Consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscular weakness, Pain in extremity
Clinical narrative: arm sore at the injection site pain that goes down from bicep above elbow and down to wrist; arm feels weak when he moves it in certain ways; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm and weakness of arms. On an unknown date, the outcome of the pain in arm and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and weakness of arms to be related to Shingrix.  Additional details were provided as follows: In mid of May 2019, the patient received Shingrix in an unknown arm. The patient's arm was sore for 3 days afterwards at the injection site, but then he started experiencing pain that went down from his bicep above his elbow and down to his wrist. The patient was still experiencing that pain and his arm felt weak when he moved it in certain ways.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Tremor
Clinical narrative: shaking; myalgia; joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of tremor in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number N4C23, expiry date 15th November 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th June 2019, with no issues arising).   On 13th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th August 2019, less than a day after receiving Shingrix, the patient experienced tremor, myalgia and joint pain. On 14th August 2019, the outcome of the tremor, myalgia and joint pain were recovered/resolved.   The reporter considered the tremor, myalgia and joint pain to be related to Shingrix.  Additional details were provided as follows: Emergency room visit required.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Blister, Blood urine present, Dysphagia, Fatigue
Clinical narrative: difficulty swallowing; spots on throat; blood in urine; allergic reaction to the vaccine; all over rash; fatigue; blisters that looks like shingles; shingles/looks like shingles; This case was reported by a pharmacist via call center representative and described the occurrence of allergy to vaccine in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th June 2019 without incidence).   On 6th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th August 2019, 2 days after receiving Shingrix, the patient experienced allergy to vaccine, generalized rash and fatigue. On 11th August 2019, the patient experienced hematuria. In August 2019, the patient experienced vesicular rash and blister. On 18th August 2019, the patient experienced swallowing difficult and throat lesion. The patient was treated with prednisone. On an unknown date, the outcome of the allergy to vaccine, vesicular rash, fatigue, blister, swallowing difficult and throat lesion were not recovered/not resolved and the outcome of the generalized rash was recovering/resolving and the outcome of the hematuria was unknown.   It was unknown if the reporter considered the allergy to vaccine, vesicular rash, generalized rash, fatigue, blister, hematuria, swallowing difficult and throat lesion to be related to Shingrix.  Additional information was provided as follows: The reporter was the son of the patient. The patient did not have history of Shingles. The patient received Shingrix in left deltoid in another pharmacy. The patient experienced an all over rash and fatigue.   On 9th August 2019, she saw her physician.  The patient's labs were drawn, which showed a normal CBC but she did have blood in her urine. The reporter thought, the patient might had a viral infection.  On 11th August 2019, the patient was seen at urgent care and given a prednisone dose pack and told it was an allergic reaction to the vaccine. Somewhere in there, the patient also developed blisters on both arms which looked like shingles, as per the reporter. These Blisters were in clusters and had gotten worse. On the day before the reporting date, the patient had difficulty swallowing and spots on her throat, so she went back to her primary care physician, who sent her to the local emergency room.   The rash appeared a little better, the fatigue was the same and the blisters were worse. At the time of reporting, the reporter did not know if the patient would be admitted or not. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Haematuria, Rash, Rash vesicular, Throat lesion
Clinical narrative: difficulty swallowing; spots on throat; blood in urine; allergic reaction to the vaccine; all over rash; fatigue; blisters that looks like shingles; shingles/looks like shingles; This case was reported by a pharmacist via call center representative and described the occurrence of allergy to vaccine in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th June 2019 without incidence).   On 6th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th August 2019, 2 days after receiving Shingrix, the patient experienced allergy to vaccine, generalized rash and fatigue. On 11th August 2019, the patient experienced hematuria. In August 2019, the patient experienced vesicular rash and blister. On 18th August 2019, the patient experienced swallowing difficult and throat lesion. The patient was treated with prednisone. On an unknown date, the outcome of the allergy to vaccine, vesicular rash, fatigue, blister, swallowing difficult and throat lesion were not recovered/not resolved and the outcome of the generalized rash was recovering/resolving and the outcome of the hematuria was unknown.   It was unknown if the reporter considered the allergy to vaccine, vesicular rash, generalized rash, fatigue, blister, hematuria, swallowing difficult and throat lesion to be related to Shingrix.  Additional information was provided as follows: The reporter was the son of the patient. The patient did not have history of Shingles. The patient received Shingrix in left deltoid in another pharmacy. The patient experienced an all over rash and fatigue.   On 9th August 2019, she saw her physician.  The patient's labs were drawn, which showed a normal CBC but she did have blood in her urine. The reporter thought, the patient might had a viral infection.  On 11th August 2019, the patient was seen at urgent care and given a prednisone dose pack and told it was an allergic reaction to the vaccine. Somewhere in there, the patient also developed blisters on both arms which looked like shingles, as per the reporter. These Blisters were in clusters and had gotten worse. On the day before the reporting date, the patient had difficulty swallowing and spots on her throat, so she went back to her primary care physician, who sent her to the local emergency room.   The rash appeared a little better, the fatigue was the same and the blisters were worse. At the time of reporting, the reporter did not know if the patient would be admitted or not. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash surrounding injection site; Red rash; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX771AA, expiry date 31st July 2020) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Bexsero. On 7th July 2019, 6 days after receiving Bexsero, the patient experienced injection site rash and injection site erythema. On 11th July 2019, the outcome of the injection site rash and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero on left arm and developed a rash. The reporter described rash as surrounding injection site and red. The reporter consented to follow up. This case has been linked with case US2019151262, same reporter.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered, Fatigue, Muscular weakness, Nausea
Clinical narrative: nausea; fatigue; muscle weakness; Inappropriate schedule of vaccine; Inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA150A, expiry date 31st May 2020) for prophylaxis.   Previously administered products included Menveo (1st dose received on 31st July 2015).   On 15th July 2019, the patient received the 2nd dose of Menveo. On 16th August 2019, the patient received the 3rd dose of Menveo (intramuscular) .5 ml. On 15th July 2019, unknown after receiving Menveo and not applicable after receiving Menveo, the patient experienced extra dose administered. In August 2019, the patient experienced nausea, fatigue and muscle weakness. On 16th August 2019, the patient experienced extra dose administered. On an unknown date, the outcome of the nausea, fatigue and muscle weakness were not recovered/not resolved and the outcome of the extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the nausea, fatigue and muscle weakness to be related to Menveo.  Additional details were provided as follows: The batch number of Menveo was updated as AMVA150A from AMAVA150A, as per sales data sheet. The nurse reported that, after 1st dose of Menveo, the patient received booster dose on 15th July 2019 and repeat dose on 16th August 2019, which led to extra dose administered. Less than a week after vaccination with 3rd dose, the patient experienced nausea, fatigue and muscle weakness. The reporter reported that, the patient still have symptoms.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash on his chest, back, both legs, both arms, groin area; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th August 2019, 4 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient started to develop a red rash on his chest, back, both legs, both arms, groin area at the time of reporting. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Heart Palpitations; Shortness of Breath; This case was reported by a nurse via call center representative and described the occurrence of palpitation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2018, the patient received the 1st dose of Shingrix. In May 2018, 1 day after receiving Shingrix, the patient experienced palpitation and shortness of breath. On an unknown date, the outcome of the palpitation and shortness of breath were unknown.   It was unknown if the reporter considered the palpitation and shortness of breath to be related to Shingrix.  Additional details were provided as follows: This case was reported via chat. The age of the patient could be 68 or 69 years old. 24 hours after vaccination with dose of Shingrix, the patient experienced palpitation and shortness of breath. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Psoriasis
Clinical narrative: Plaque psoriasis; This case was reported by a pharmacist via call center representative and described the occurrence of psoriatic plaque 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, less than 2 years after receiving Shingrix, the patient experienced psoriatic plaque. The patient was treated with ixekizumab (Taltz). On an unknown date, the outcome of the psoriatic plaque was unknown.   It was unknown if the reporter considered the psoriatic plaque to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist reported that the patient received their first dose of Shingrix a few months ago and in the meantime, has started Taltz for plaque psoriasis. This patient was new to the caller, but she assumed the patient had plaque psoriasis prior to receiving the first dose of Shingrix. The reporter has no other information. No further information captured.
Sex: F
Vaccine: VARZOS
Symptoms: Corneal abrasion, Eye disorder, Hyperkeratosis, Vision blurred
Clinical narrative: keratosis of the cornea; corneal abrasions; blurred vision; This case was reported by a consumer via call center representative and described the occurrence of keratosis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 2nd dose of Shingrix (intramuscular). In February 2019, less than 2 months after receiving Shingrix, the patient experienced keratosis, corneal abrasion and blurred vision. The patient was treated with valaciclovir hydrochloride (Valtrex) and ophthalmologicals (Eye Drops (Nos)). On an unknown date, the outcome of the keratosis, corneal abrasion and blurred vision were unknown.   It was unknown if the reporter considered the keratosis, corneal abrasion and blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced eye problems in Feb 2019 and in April 2019 was diagnosed with keratosis of the cornea and subsequently diagnosed with corneal abrasions with associated blurred vision. The patient was on Valtrex and other eye drops to treat the issue. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypersomnia, Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: itching at injection site; redness at injection site; swelling at injection site; malaise; lethargy; not feeling himself; discomfort at the injection site; sleeping more; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix. On 17th August 2019, 1 days after receiving Shingrix, the patient experienced malaise, lethargy, feeling abnormal, injection site discomfort and hypersomnia. On 18th August 2019, the patient experienced injection site itching, injection site erythema and injection site swelling. On an unknown date, the outcome of the malaise, lethargy and feeling abnormal were recovered/resolved and the outcome of the injection site discomfort, hypersomnia, injection site itching, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the malaise, lethargy, feeling abnormal, injection site discomfort, hypersomnia, injection site itching, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced just not feeling himself. This lasted for a couple days along with discomfort at injection the injection site and he was sleeping more. About 48 hours after the vaccination, he developed redness, itching and swelling at the injection site and it extend a couple of inches below the site. The reporter did not consent to follow-up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Malaise
Clinical narrative: itching at injection site; redness at injection site; swelling at injection site; malaise; lethargy; not feeling himself; discomfort at the injection site; sleeping more; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th August 2019, the patient received the 1st dose of Shingrix. On 17th August 2019, 1 days after receiving Shingrix, the patient experienced malaise, lethargy, feeling abnormal, injection site discomfort and hypersomnia. On 18th August 2019, the patient experienced injection site itching, injection site erythema and injection site swelling. On an unknown date, the outcome of the malaise, lethargy and feeling abnormal were recovered/resolved and the outcome of the injection site discomfort, hypersomnia, injection site itching, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the malaise, lethargy, feeling abnormal, injection site discomfort, hypersomnia, injection site itching, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced just not feeling himself. This lasted for a couple days along with discomfort at injection the injection site and he was sleeping more. About 48 hours after the vaccination, he developed redness, itching and swelling at the injection site and it extend a couple of inches below the site. The reporter did not consent to follow-up.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 47-year-old male patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 17th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient developed Shingles after the first dose of Shingrix. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Fatigue, Malaise, Nasopharyngitis
Clinical narrative: Feeling Sick; lightheaded; tired; leg pain; Cough; Sneezing; Cold; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2019, the patient received the 1st dose of Shingrix. On 18th August 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell, light headedness, tiredness, leg pain, cough, sneezing and cold. On an unknown date, the outcome of the feeling unwell, light headedness and tiredness were not recovered/not resolved and the outcome of the leg pain, cough, sneezing and cold were unknown.   It was unknown if the reporter considered the feeling unwell, light headedness, tiredness, leg pain, cough, sneezing and cold to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. On Sunday, the patient experienced feeling sick with cough, sneezing, and cold, lightheaded, tired and leg pain. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sneezing
Clinical narrative: Feeling Sick; lightheaded; tired; leg pain; Cough; Sneezing; Cold; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2019, the patient received the 1st dose of Shingrix. On 18th August 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell, light headedness, tiredness, leg pain, cough, sneezing and cold. On an unknown date, the outcome of the feeling unwell, light headedness and tiredness were not recovered/not resolved and the outcome of the leg pain, cough, sneezing and cold were unknown.   It was unknown if the reporter considered the feeling unwell, light headedness, tiredness, leg pain, cough, sneezing and cold to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. On Sunday, the patient experienced feeling sick with cough, sneezing, and cold, lightheaded, tired and leg pain. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: did not sleep for 4 nights; This case was reported by a nurse via call center representative and described the occurrence of sleep loss in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autoimmune thyroiditis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced sleep loss. On an unknown date, the outcome of the sleep loss was unknown.   It was unknown if the reporter considered the sleep loss to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was a nurse. The patient given an unspecified dose number of Shingrix and did not sleep for 4 nights. No other events were reported. It was reported that very uncooperative reporter and patient would not participate in a safety report or provide any demographics. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Supraventricular tachycardia
Clinical narrative: Supra-ventricular Tachycardia; This case was reported by a pharmacist via call center representative and described the occurrence of supraventricular tachycardia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced supraventricular tachycardia. On an unknown date, the outcome of the supraventricular tachycardia was unknown.   It was unknown if the reporter considered the supraventricular tachycardia 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 as per the vaccine indication. The reporter stated that, the patient experienced supraventricular tachycardia after receiving Shingrix. The reporter did not consent to follow up. The reporter declined to provide details.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, developed rash after receiving dose of Shingrix. The patiet did not provide any further information and abruptly ended call.  No other information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In July 2019, between 2 and 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter stated that, the patient received 1st dose of Shingrix 3 months before the reporting date but developed shingles 1 month before the reporting date. The reporter was unsure if patient actually received the shingles vaccination or not because it is not documented in their system and also he did not provide patients initials and date of birth. The reporter did not consent to follow-up.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Product administered at inappropriate site
Clinical narrative: pain at injection site; redness at injection site; Circumstance or information capable of leading to medication error; Vaccine administered at inappropriate site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 20th September 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site erythema, circumstance or information capable of leading to medication error and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site erythema, circumstance or information capable of leading to medication error and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix and experienced pain and redness at injection site. The patient might get the 2nd dose at either the gluteal or anterolateral thigh site, which led to circumstance or information capable of leading to medication error and vaccine administered at inappropriate site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain; Swelling; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis.   On 10th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacy intern stated that the night after getting Shingrix the patient experienced pain and swelling on the right upper arm and the site of injection.  The patient at the time of reporting had recovered. No further details were provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Lack of effect/ Suspected Vaccination failure; Shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a elderly 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. On an unknown date, less than 2 years after receiving Shingrix and unknown 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were received as follows: The patient completed the 2 dose series of Shingrix and then developed a case of Shingles. The reporter consented to follow up. The reporter did not vaccinate the patient and they did not have the data at the time of the call.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Headache, Injection site pain
Clinical narrative: shivering; soreness at injection site; warm feeling; tired; headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received the 2nd dose of Shingrix. On 21st August 2019, less than a day after receiving Shingrix, the patient experienced shivering, injection site pain, feeling of warmth, tiredness and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the shivering, injection site pain, feeling of warmth, tiredness and headache were unknown.   It was unknown if the reporter considered the shivering, injection site pain, feeling of warmth, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine and she had soreness at the injection site. Later the patient experienced shivering, warm feeling but without fever, tiredness and a headache. The patient had taken tylenol and she was feeling better. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia, Tremor
Clinical narrative: fever; shaking; flu-type soreness all over; This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, tremor and flu-like aching. On an unknown date, the outcome of the fever, tremor and flu-like aching were recovered/resolved.   It was unknown if the reporter considered the fever, tremor and flu-like aching to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received Shingrix and experienced fever, shaking, and flu-type all over soreness.These events fully resolved within 48-72 hours. The vaccine was administered at a pharmacy.  The reporter believes that she was around 82 years old. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field (recovered) and the outcome reported in the source document (recovered with sequel).
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to chemicals, Parosmia, Perfume sensitivity
Clinical narrative: sensitivity to smells; sesnsivity to fragances; sensitivity to chemicals; This case was reported by a other health professional via call center representative and described the occurrence of hyperosmia in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced hyperosmia, fragrance sensitivity and chemical sensitivity. On an unknown date, the outcome of the hyperosmia, fragrance sensitivity and chemical sensitivity were unknown.   It was unknown if the reporter considered the hyperosmia, fragrance sensitivity and chemical sensitivity to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and reports a sensitivity to smells, fragrances, and chemicals.  The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Corrective lens user, Pain in extremity, Vision blurred
Clinical narrative: blurred vision in left eye; sore arm; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced blurred vision and pain in arm. On an unknown date, the outcome of the blurred vision was recovering/resolving and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the blurred vision and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced sore arm for about one week and that resolved.  The caller reported that she experienced blurred vision in her left eye and has been seen by ophthalmologist and another eye specialist. The caller reported that blurry vision has improved some but still present and wears corrective lens glasses. The reporter consented to follow up.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain, Condition aggravated, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: syncope; was unconscious; Headache; dizziness; extreme fatigue; increased occurrence in hypotension; decreased heart rate; stabbing abdominal pain; vomiting; nausea; hands/feet feel asleep; feels like in a fog; This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 47-year-old female patient who received HAB (Twinrix) (batch number 53AT5, expiry date 28th November 2020) for prophylaxis.   The patient's past medical history included syncope. Concurrent medical conditions included psoriatic arthritis and hypotension. Concomitant products included adalimumab (Humira), methotrexate and methocarbamol.   On 16th August 2019, the patient received the 3rd dose of Twinrix (intramuscular). On 20th August 2019, 4 days after receiving Twinrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, abdominal pain, vomiting, nausea, numbness of extremities and foggy feeling in head. On an unknown date, the outcome of the syncope, unconscious, headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, numbness of extremities and foggy feeling in head were not recovered/not resolved and the outcome of the abdominal pain, vomiting and nausea were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, abdominal pain, vomiting, nausea, numbness of extremities and foggy feeling in head to be related to Twinrix.  Additional details were provided as follows: The case was reported by patient for herself. The patient received Twinrix on left deltoid. On 20th August 2019, in the morning, the patient experienced stabbing abdominal pain and nausea.  She went to the restroom and vomited and after vomiting she experienced a syncopal episode. The patient did not knew how long she was unconscious.  Following the syncopal episode she checked her blood pressure and it was 80/50mm hg, her heart rate was in 50's.  The syncopal episodes were continued with the most recent episode being experienced on 22nd August 2019 that left the patient with a feeling of being in a fog, extreme fatigue, headaches, the feeling of her hands and feet being asleep, increased occurrence of hypotension and decreased heart rate. The patient did not seek medical attention and had driven to work. The reporter consented to follow up. Till the time of reporting, the patient had not received any medical treatment.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Headache, Heart rate decreased, Hypoaesthesia, Hypotension, Loss of consciousness
Clinical narrative: syncope; was unconscious; Headache; dizziness; extreme fatigue; increased occurrence in hypotension; decreased heart rate; stabbing abdominal pain; vomiting; nausea; hands/feet feel asleep; feels like in a fog; This case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 47-year-old female patient who received HAB (Twinrix) (batch number 53AT5, expiry date 28th November 2020) for prophylaxis.   The patient's past medical history included syncope. Concurrent medical conditions included psoriatic arthritis and hypotension. Concomitant products included adalimumab (Humira), methotrexate and methocarbamol.   On 16th August 2019, the patient received the 3rd dose of Twinrix (intramuscular). On 20th August 2019, 4 days after receiving Twinrix, the patient experienced syncope (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, abdominal pain, vomiting, nausea, numbness of extremities and foggy feeling in head. On an unknown date, the outcome of the syncope, unconscious, headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, numbness of extremities and foggy feeling in head were not recovered/not resolved and the outcome of the abdominal pain, vomiting and nausea were recovered/resolved.   It was unknown if the reporter considered the syncope, unconscious, headache, dizziness, fatigue, hypotension aggravated, heart rate decreased, abdominal pain, vomiting, nausea, numbness of extremities and foggy feeling in head to be related to Twinrix.  Additional details were provided as follows: The case was reported by patient for herself. The patient received Twinrix on left deltoid. On 20th August 2019, in the morning, the patient experienced stabbing abdominal pain and nausea.  She went to the restroom and vomited and after vomiting she experienced a syncopal episode. The patient did not knew how long she was unconscious.  Following the syncopal episode she checked her blood pressure and it was 80/50mm hg, her heart rate was in 50's.  The syncopal episodes were continued with the most recent episode being experienced on 22nd August 2019 that left the patient with a feeling of being in a fog, extreme fatigue, headaches, the feeling of her hands and feet being asleep, increased occurrence of hypotension and decreased heart rate. The patient did not seek medical attention and had driven to work. The reporter consented to follow up. Till the time of reporting, the patient had not received any medical treatment.