chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13, TDAP
Symptoms: Erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Patient 9-10-18 at 12:00 PM presented to the pharmacy to request ranitidine. Patient asked me to look at her left arm. It presented red, swollen and warm to touch but it was localized, she said it had begun the evening after the vaccine and had not gotten worse. I advised to keep an eye in case any signs of infection. I followed up 6 hrs later and there was no change. Patient had an existing doctor's visit on 9-11-18 and she will ask MD to advise on the swelling. I explained to the patient that one of the known adverse effects of BOOSTRIX was redness and swelling at injection site. Patient stated there was mild pain at injection site but no other side effects or adverse effects and no fever.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Left arm inflammation, redness (deltoid muscle), soreness, heat sensation.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cardiac flutter, Heart rate increased, Hypertension, Nasopharyngitis
Clinical narrative: Three days post injection pt became weak, shaking, cold, runny nose mild fever, HTN increased, heart flutter increased, HR increased, then all 3 fluctuated. Pt. was seen on 8-6-18 by regular physician and advised to not take second SHINGRIX.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: Three days post injection pt became weak, shaking, cold, runny nose mild fever, HTN increased, heart flutter increased, HR increased, then all 3 fluctuated. Pt. was seen on 8-6-18 by regular physician and advised to not take second SHINGRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, HIBV, MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 37.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Cold sweat, Dyspnoea, Eye movement disorder, Hypopnoea, Loss of consciousness
Clinical narrative: As soon as 2nd vaccine given (HAVRIX) pt's head slumped forward on his chest with labored/shallow breathing then head went backwards eye moving around then pt had mild convulsions-had lasted 15 secs 911 called but Pt became conscious before they arrived. Pt got pale and clammy.
Age: 37.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pallor, Posture abnormal, Seizure
Clinical narrative: As soon as 2nd vaccine given (HAVRIX) pt's head slumped forward on his chest with labored/shallow breathing then head went backwards eye moving around then pt had mild convulsions-had lasted 15 secs 911 called but Pt became conscious before they arrived. Pt got pale and clammy.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm is red, swollen, extremely sore and somewhat itchy. I cannot raise arm above my head without pain. I have had PREVNAR 13 previously w/mild reaction, but PREVNAR 23 produced symptoms that are moderate to severe.
Age: 17.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Expired product administered
Clinical narrative: Administered vaccine 1 day past expiration. (Hep B).
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient complained of pain in the arm - was taken to urgent care and was given antibiotic.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: Rash up the arm into the neck. Itching throughout the body. No previous history of reaction to ZOSTAVAX. Patient called doctor and he said it might be an allergic reaction to the shot.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: He had a syncopal episode that lasted a few seconds. He laid down for a few minutes and drank water and was back to baseline.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Patient reported to pharmacy on 9-10-18 that starting on 9-2-18 she had a redness on side of arm opposite injection site and a rash that spread to her chest.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: MD started it was cellulitis (red, warm to touch) txt'ed w/Amox.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Chest X-ray, Laboratory test, Respiratory failure
Clinical narrative: Severe anaphylaxis, Respiratory failure.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Palpitations
Clinical narrative: During the first 72 hours massive headaches with high fevers and cardiac arrhythmias. Continuing since the vaccination, photo and auditory sensitivity, dizziness, vertigo, muscle and joint weakness and pain, stiffness and pain in the back of the neck. Liquid diarrhea, nausea and no appetite. No endurance for completing tasks such as washing dishes, walking short distances without becoming short of breath. Treatment: Homeopathic hot and cold therapy, homeopathic remedy: dermatophytosis of nail, tinea unguium. I am trying everything I can to recover so I don't have to apply for disability.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia
Clinical narrative: During the first 72 hours massive headaches with high fevers and cardiac arrhythmias. Continuing since the vaccination, photo and auditory sensitivity, dizziness, vertigo, muscle and joint weakness and pain, stiffness and pain in the back of the neck. Liquid diarrhea, nausea and no appetite. No endurance for completing tasks such as washing dishes, walking short distances without becoming short of breath. Treatment: Homeopathic hot and cold therapy, homeopathic remedy: dermatophytosis of nail, tinea unguium. I am trying everything I can to recover so I don't have to apply for disability.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Arrhythmia, Arthralgia, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: During the first 72 hours massive headaches with high fevers and cardiac arrhythmias. Continuing since the vaccination, photo and auditory sensitivity, dizziness, vertigo, muscle and joint weakness and pain, stiffness and pain in the back of the neck. Liquid diarrhea, nausea and no appetite. No endurance for completing tasks such as washing dishes, walking short distances without becoming short of breath. Treatment: Homeopathic hot and cold therapy, homeopathic remedy: dermatophytosis of nail, tinea unguium. I am trying everything I can to recover so I don't have to apply for disability.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Dyspnoea exertional, Headache, Hyperacusis, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: During the first 72 hours massive headaches with high fevers and cardiac arrhythmias. Continuing since the vaccination, photo and auditory sensitivity, dizziness, vertigo, muscle and joint weakness and pain, stiffness and pain in the back of the neck. Liquid diarrhea, nausea and no appetite. No endurance for completing tasks such as washing dishes, walking short distances without becoming short of breath. Treatment: Homeopathic hot and cold therapy, homeopathic remedy: dermatophytosis of nail, tinea unguium. I am trying everything I can to recover so I don't have to apply for disability.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Photosensitivity reaction
Clinical narrative: During the first 72 hours massive headaches with high fevers and cardiac arrhythmias. Continuing since the vaccination, photo and auditory sensitivity, dizziness, vertigo, muscle and joint weakness and pain, stiffness and pain in the back of the neck. Liquid diarrhea, nausea and no appetite. No endurance for completing tasks such as washing dishes, walking short distances without becoming short of breath. Treatment: Homeopathic hot and cold therapy, homeopathic remedy: dermatophytosis of nail, tinea unguium. I am trying everything I can to recover so I don't have to apply for disability.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia, Vertigo
Clinical narrative: During the first 72 hours massive headaches with high fevers and cardiac arrhythmias. Continuing since the vaccination, photo and auditory sensitivity, dizziness, vertigo, muscle and joint weakness and pain, stiffness and pain in the back of the neck. Liquid diarrhea, nausea and no appetite. No endurance for completing tasks such as washing dishes, walking short distances without becoming short of breath. Treatment: Homeopathic hot and cold therapy, homeopathic remedy: dermatophytosis of nail, tinea unguium. I am trying everything I can to recover so I don't have to apply for disability.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Monoplegia
Clinical narrative: Severe arm/shoulder pain. Pain resolved by next day but patient described paralysis of shoulder. I followed up several days later and was told the "paralysis" had moved to the throat and she could not swallow.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Musculoskeletal pain, Pain in extremity, Paralysis
Clinical narrative: Severe arm/shoulder pain. Pain resolved by next day but patient described paralysis of shoulder. I followed up several days later and was told the "paralysis" had moved to the throat and she could not swallow.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received SHINGRIX (batch number E927Z, expiry date 27th February 2021) for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash. On 29th August 2018, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site rash and injection site blisters were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site blisters to be related to SHINGRIX. Additional details were reported as follows: Around 4:00 pm, the patient received the SHINGRIX vaccine and within 1 to 2 hours after vaccination, the patient had a circle at the injection site. On the date of reporting (morning), 1 day after receiving the SHINGRIX, she experienced blisters at the site of injection. The circle on her arm was four inches in diameter and has blisters all over it at the time of reporting.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received SHINGRIX (batch number E927Z, expiry date 27th February 2021) for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash. On 29th August 2018, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site rash and injection site blisters were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site blisters to be related to SHINGRIX. Additional details were reported as follows: Around 4:00 pm, the patient received the SHINGRIX vaccine and within 1 to 2 hours after vaccination, the patient had a circle at the injection site. On the date of reporting (morning), 1 day after receiving the SHINGRIX, she experienced blisters at the site of injection. The circle on her arm was four inches in diameter and has blisters all over it at the time of reporting.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt had SHINGRIX vaccine at a local pharmacy-- the next day had swelling of her arm-- went down with topical steroid but swelling came back-- arm with induration.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Induration, Peripheral swelling
Clinical narrative: Pt had SHINGRIX vaccine at a local pharmacy-- the next day had swelling of her arm-- went down with topical steroid but swelling came back-- arm with induration.
Age: 65.0
Sex: F
Vaccine: PNC13, FLUA3, PNC13
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to Pharmacy on Monday 9/10/18 after receiving immunization on 9/7/18. Pt reported having an adverse effect to vaccine starting on Friday evening at immunization site which was swollen, red, hot to touch, pt had fever, weakness, and fatigue. Symptoms lasted until Sunday morning and site reaction still present on Monday. Pt was seen by primary MD and given antibiotic for the reaction as well as local reaction and told to monitor symptoms and report if not improved.
Age: 65.0
Sex: F
Vaccine: PNC13, FLUA3, PNC13
Symptoms: Local reaction, Pyrexia
Clinical narrative: Patient presented to Pharmacy on Monday 9/10/18 after receiving immunization on 9/7/18. Pt reported having an adverse effect to vaccine starting on Friday evening at immunization site which was swollen, red, hot to touch, pt had fever, weakness, and fatigue. Symptoms lasted until Sunday morning and site reaction still present on Monday. Pt was seen by primary MD and given antibiotic for the reaction as well as local reaction and told to monitor symptoms and report if not improved.
Age: 65.0
Sex: F
Vaccine: PNC13, FLUA3, PNC13
Symptoms: Local reaction, Pyrexia, Vaccination complication
Clinical narrative: Patient presented to Pharmacy on Monday 9/10/18 after receiving immunization on 9/7/18. Pt reported having an adverse effect to vaccine starting on Friday evening at immunization site which was swollen, red, hot to touch, pt had fever, weakness, and fatigue. Symptoms lasted until Sunday morning and site reaction still present on Monday. Pt was seen by primary MD and given antibiotic for the reaction as well as local reaction and told to monitor symptoms and report if not improved.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pain
Clinical narrative: Patient reported severe headache and full body pain, resolved the next day without medical attention.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Dermatitis contact, Ear swelling, Erythema, Injection site pain
Clinical narrative: During the vaccine administration vaccine administered too quickly; muscle aches at the site the site of the injection. After 1 month used Nasacort more because of slight bother then stopped using it. At 2 months poison ivy symptoms (scabbing, ears swollen, red patches on face, red hands) came back with a vengeance all over body, went to Urgent Care and given antibiotic (Prednisone), steroid (cephalexin). Problems improving after only 1 day of medication but still in recovery.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: During the vaccine administration vaccine administered too quickly; muscle aches at the site the site of the injection. After 1 month used Nasacort more because of slight bother then stopped using it. At 2 months poison ivy symptoms (scabbing, ears swollen, red patches on face, red hands) came back with a vengeance all over body, went to Urgent Care and given antibiotic (Prednisone), steroid (cephalexin). Problems improving after only 1 day of medication but still in recovery.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Taking Benadryl otc for itching and cortisone cream for rash.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adolescent male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, 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 BEXSERO. Additional details were provided as follows: The patient was 16 or 17 years of age at the time of reporting. The age at vaccination was not reported. The patient experienced severe pain at the injection site. The patient refused to receive the second dose because of this event. The pain lasted for two weeks after the shot. The reporter agreed for follow up.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter of unknown age who was trying to get into School at the reporting time. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date (reported as some years ago), the patient was vaccinated with a first dose of M-M-R II (dose, route of administration, #lot and expiration date were unspecified). On an unknown date in November 2017, the patient was vaccinated with a second dose of M-M-R II (dose, route of administration, #lot and expiration date were unspecified). On an unknown date, the reporter stated that the patient failed to seroconvert to the vaccination because she showed a negative titer. Approximately on 06-AUG-2018, the patient was vaccinated with the third dose of M-M-R II (dose, route of administration, #lot and expiration date were unspecified). The outcome of antibody test negative was unknown. The relatedness between and the event and M-M-R II was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare Worker and refers to a patient of unknown age and gender. No pertinent medical history,  or drug reactions / allergies were reported. On unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (which had a lot # of R006753 and an expiration date of 06-MAR-2020; however, dosage number and route of administration were not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 6 F degrees to 14 F degrees (9.5 F degrees) for 1 hour and 6 F degrees to 14 F degrees (6.4 F degrees) multiple excursion for 50 minutes. Reportedly, there had been previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Limb mass, Pruritus, Swelling
Clinical narrative: Information has been received from a nurse via a field representative referring to a 17 year old female patient who had no pertinent medical history or drug reactions/allergies. The patient's concomitant medication included pantoprazole sodium (PROTONIX). On 22-JAN-2018 the patient received the first dose of her human papillomavirus (HPV) vaccination series with GARDASIL 9 (intramuscular, strength, dose, frequency, batch/lot # and expiration date were not reported) for HPV vaccination. On 25-APR-2018 the same patient received the second dose of her HPV vaccination series with GARDASIL 9 (intramuscular, strength, dose, frequency, batch/lot # and expiration date were not reported). On 29-AUG-2018 the same patient returned to the physician's office for medical attention and reported that she had a lump in her arm that itched. The start date, extent, and duration of swelling were unspecified. No lab diagnostics/studies were performed. The treatment given for the events was unknown. There was no intervention to prevent serious criteria. The outcome of the events was unknown. The causality between the events and GARDASIL 9 was unknown.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a female consumer of unknown age, referring to herself. Information of the patient's medical history, concomitant therapy and current condition was not provided. In August 2013, the patient received PREVNAR (lot number, expiration date, dose, frequency and route unknown) for prophylaxis. In August 2016, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose, frequency and route unknown) for prophylaxis (inappropriate schedule of vaccine administered). No clinical adverse event was reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 54-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on an unspecified date for tolerance see case US2018GSK162339). On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering were unchanged. It was unknown if the reporter considered the generalized muscle aches, influenza-like symptoms, fatigue, injection site pain and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient received the SHINGRIX vaccine before the day of reporting. The patient was experiencing muscle ache all over the body, pain at the injection site, shivering, fatigue, and flu like symptoms. The patient gave permission to contact her health care provider. No further details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Headache, Injection site rash, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received SHINGRIX (batch number N7H72 ?, expiry date 8th February 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, fever and headache. On 23rd August 2018, the patient experienced injection site rash, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the nausea, fever, headache, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis were unknown. It was unknown if the reporter considered the injection site rash, nausea, fever, headache, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis to be related to SHINGRIX. Additional details were provided as follows: The case reported via medical assistant. At 11:05 am, the patient received SHINGRIX and the following day, she experienced a headache with nausea and a low grade fever. Two days later (or 3 days after vaccination), she developed a rash that started at the injection site and over her entire trunk and dorsal back area running down into her left groin. The rash looks like dermatitis and was red, swollen and systemic and the rash was located everywhere on the patient's body except her face. The rash did not hurt but it was severely itchy. The patient visited a medi clinic and they put her on a steroid and it made the rash worse. On 22nd August 2018, the patient started to receive Steroids. Medical assistant indicated to medical information that the rash was similar to a hypersensitivity rash, not a shingles like rash (no vesicles).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received SHINGRIX (batch number N7H72 ?, expiry date 8th February 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, fever and headache. On 23rd August 2018, the patient experienced injection site rash, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the nausea, fever, headache, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis were unknown. It was unknown if the reporter considered the injection site rash, nausea, fever, headache, erythematous rash, raised rash, generalized rash, itchy rash and allergic dermatitis to be related to SHINGRIX. Additional details were provided as follows: The case reported via medical assistant. At 11:05 am, the patient received SHINGRIX and the following day, she experienced a headache with nausea and a low grade fever. Two days later (or 3 days after vaccination), she developed a rash that started at the injection site and over her entire trunk and dorsal back area running down into her left groin. The rash looks like dermatitis and was red, swollen and systemic and the rash was located everywhere on the patient's body except her face. The rash did not hurt but it was severely itchy. The patient visited a medi clinic and they put her on a steroid and it made the rash worse. On 22nd August 2018, the patient started to receive Steroids. Medical assistant indicated to medical information that the rash was similar to a hypersensitivity rash, not a shingles like rash (no vesicles).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site reaction, Skin lesion, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin lesion in a 64-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th August 2018, 3 days after receiving SHINGRIX, the patient experienced skin lesion, localized erythema and local swelling. On an unknown date, the outcome of the skin lesion was not recovered/not resolved and the outcome of the localized erythema and local swelling were unknown. It was unknown if the reporter considered the skin lesion, localized erythema and local swelling to be related to SHINGRIX. Additional information was reported as follows: Approximately 3 days after vaccination with SHINGRIX, the patient had noticed a red lesion on the front of his left shoulder. The lesion was red and swollen and approximately 4 inches from the injection site. The patient thought that this lesion might be related to the vaccine, however the reporter stated that it could be something else.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included anaphylactic reaction to drug (for THYROGEN injection). On 22nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, palmar erythema, axillary lymph nodes enlarged, injection site erythema, skin warm, hypersensation skin, injection site warmth and pain in hand. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, axillary lymph nodes enlarged and injection site warmth were not recovered/not resolved and the outcome of the palmar erythema, injection site erythema, skin warm, hypersensation skin and pain in hand were unknown. It was unknown if the reporter considered the injection site pain, palmar erythema, axillary lymph nodes enlarged, injection site erythema, skin warm, hypersensation skin, injection site warmth and pain in hand to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on left arm. The patient experienced injection site reactions that included redness, pain and it was very sensitive to even clothing sleeves that touched the injected site area. The patient was unable to sleep on the injected arm. The palm of her left hand was red and hot to the touch and that her armpit lymph nodes were swollen. She used BENADRYL and that it helped relieve the pain somewhat. The patient had declined to provide her phone number. The patient had denied permission to contact their physician.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain in extremity, Palmar erythema, Skin warm, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included anaphylactic reaction to drug (for THYROGEN injection). On 22nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, palmar erythema, axillary lymph nodes enlarged, injection site erythema, skin warm, hypersensation skin, injection site warmth and pain in hand. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, axillary lymph nodes enlarged and injection site warmth were not recovered/not resolved and the outcome of the palmar erythema, injection site erythema, skin warm, hypersensation skin and pain in hand were unknown. It was unknown if the reporter considered the injection site pain, palmar erythema, axillary lymph nodes enlarged, injection site erythema, skin warm, hypersensation skin, injection site warmth and pain in hand to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on left arm. The patient experienced injection site reactions that included redness, pain and it was very sensitive to even clothing sleeves that touched the injected site area. The patient was unable to sleep on the injected arm. The palm of her left hand was red and hot to the touch and that her armpit lymph nodes were swollen. She used BENADRYL and that it helped relieve the pain somewhat. The patient had declined to provide her phone number. The patient had denied permission to contact their physician.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injected limb mobility decreased, Injection site irritation, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 50-year-old female patient who received SHINGRIX (batch number M77B4, expiry date August 2019) for prophylaxis. On 19th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 4 days after receiving SHINGRIX, the patient experienced injection site rash, injection site irritation, injection site swelling and injection site warmth. On 19th August 2018, the patient experienced malaise, flu symptoms, pain and pain in arm. On 20th August 2018, the patient experienced injected limb mobility decreased. The patient was treated with ibuprofen and benadryl (nos) (Benadryl Cream). On 21st August 2018, the outcome of the malaise, flu symptoms, pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the injection site rash, injection site irritation, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the malaise, flu symptoms, pain, pain in arm, injected limb mobility decreased, injection site rash, injection site irritation, injection site swelling and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist was the patient herself. The patient experienced flu symptoms, felt achy and also had arm pain on the same night of vaccination and the events worsened the next day following the vaccination. The next day after the vaccination, the patient could not lift her arm. The patient took ibuprofen and these symptoms resolved after 48 hours. As the arm pain resolved the patient developed a patch of rash, irritation, swelling that felt hot on her left deltoid, she applied Benadryl cream, however this events were resolving till the date of reporting.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 50-year-old female patient who received SHINGRIX (batch number M77B4, expiry date August 2019) for prophylaxis. On 19th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 4 days after receiving SHINGRIX, the patient experienced injection site rash, injection site irritation, injection site swelling and injection site warmth. On 19th August 2018, the patient experienced malaise, flu symptoms, pain and pain in arm. On 20th August 2018, the patient experienced injected limb mobility decreased. The patient was treated with ibuprofen and benadryl (nos) (Benadryl Cream). On 21st August 2018, the outcome of the malaise, flu symptoms, pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the injection site rash, injection site irritation, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the malaise, flu symptoms, pain, pain in arm, injected limb mobility decreased, injection site rash, injection site irritation, injection site swelling and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist was the patient herself. The patient experienced flu symptoms, felt achy and also had arm pain on the same night of vaccination and the events worsened the next day following the vaccination. The next day after the vaccination, the patient could not lift her arm. The patient took ibuprofen and these symptoms resolved after 48 hours. As the arm pain resolved the patient developed a patch of rash, irritation, swelling that felt hot on her left deltoid, she applied Benadryl cream, however this events were resolving till the date of reporting.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Muscle spasms, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back surgery (had some time ago before the date of reporting and her back has not bothered her in 1.5 years). Previously administered products included Influenza vaccine Quadrivalent unspecified season (received on an unknown date, refer case ID US2018GSK162474). Concurrent medical conditions included back disorder. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced muscle spasm. On 27th August 2018, the patient experienced headache and pain in arm. On 28th August 2018, the patient experienced localized erythema, local swelling and localized feeling of warmth. On an unknown date, the outcome of the muscle spasm, localized erythema, local swelling, headache and pain in arm were not recovered/not resolved and the outcome of the localized feeling of warmth was unknown. The reporter considered the muscle spasm to be possibly related to SHINGRIX. It was unknown if the reporter considered the localized erythema, local swelling, localized feeling of warmth, headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: In the evening after receiving SHINGRIX, the patient started experiencing a headache and pain in her left arm. The patient used ice on her arm to help with the pain. On 28th August 2018, Tuesday, 1 days after receiving SHINGRIX, the patient noticed redness and swelling on her left arm and that her left arm felt hot. The pain, redness and swelling that the patient experienced following the SHINGRIX vaccine was located below the injection site. In August 2018, less than a week after vaccination, the patient experienced muscle spasms in her lower left leg. The patient felt the spasms from below the knee down to the foot. The patient stated that it was possible that the spasms could be related to the vaccine but could also possibly be related to her back problems.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back surgery (had some time ago before the date of reporting and her back has not bothered her in 1.5 years). Previously administered products included Influenza vaccine Quadrivalent unspecified season (received on an unknown date, refer case ID US2018GSK162474). Concurrent medical conditions included back disorder. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced muscle spasm. On 27th August 2018, the patient experienced headache and pain in arm. On 28th August 2018, the patient experienced localized erythema, local swelling and localized feeling of warmth. On an unknown date, the outcome of the muscle spasm, localized erythema, local swelling, headache and pain in arm were not recovered/not resolved and the outcome of the localized feeling of warmth was unknown. The reporter considered the muscle spasm to be possibly related to SHINGRIX. It was unknown if the reporter considered the localized erythema, local swelling, localized feeling of warmth, headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: In the evening after receiving SHINGRIX, the patient started experiencing a headache and pain in her left arm. The patient used ice on her arm to help with the pain. On 28th August 2018, Tuesday, 1 days after receiving SHINGRIX, the patient noticed redness and swelling on her left arm and that her left arm felt hot. The pain, redness and swelling that the patient experienced following the SHINGRIX vaccine was located below the injection site. In August 2018, less than a week after vaccination, the patient experienced muscle spasms in her lower left leg. The patient felt the spasms from below the knee down to the foot. The patient stated that it was possible that the spasms could be related to the vaccine but could also possibly be related to her back problems.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The reporter received this information via chat. The age at vaccination was not reported. The healthcare professional (HCP) reported that they had a provider stated that the patient had a reaction of flu like symptoms, chills and shivering.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arthritis aggravated in a 74-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (ganglion cyst surgery on left wrist and tendon eroded performed on 9th December 2017.), rotator cuff repair (carried out twice), diverticulitis (diagnosed on 30th April 2018) and constipation (diagnosed on 30th April 2018). Previously administered products included ZOSTAVAX and ciprofloxacin. Concurrent medical conditions included reactive arthritis (possibly related to previous ganglion cyst occurred in 2018), osteoarthritis, tendon rupture (possible side effect to ciprofloxacin, started on 1st July 2018) and arthritis. On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and skin warm. On an unknown date, the patient experienced arthritis aggravated. On an unknown date, the outcome of the arthritis aggravated was not recovered/not resolved and the outcome of the pain in arm and skin warm were recovered/resolved. It was unknown if the reporter considered the arthritis aggravated, pain in arm and skin warm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. But, it could be 73 or 74 years old. The patient received the SHINGRIX on the left arm. The patient experienced a warm and sore arm for three days and on 4th day the symptoms faded away. The patient claimed that his arthritis worsened after receiving the SHINGRIX for some days and was on and off. The patient claimed that, the arthritis was systemic but noted specifically in the left wrist, second digit, first knuckle, right wrist, knee and hip area. The patient claimed that, he was a set up for reactive arthritis.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. In April 2018, the outcome of the erythema of extremities and swelling arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient had swelling and redness of the whole arm following injection of SHINGRIX which were resolved within 3 days. The batch number reported for SHINGRIX (9XC595) did not exist and was updated to 9XC39, as per sales database.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th August 2018, several hours after receiving SHINGRIX, the patient experienced light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm. On an unknown date, the outcome of the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm were unchanged. It was unknown if the reporter considered the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm to be related to SHINGRIX. Additional details were reported as follows: At 4:30 PM, the patient received a dose of SHINGRIX. After vaccination, that night, the patient experienced lightheadedness, pain in arm, pain in shoulder, runny nose, loss of appetite and head hurts. The patient reported that, on an unknown date with the 1st dose of SHINGRIX, did not experience these events as strongly. This case was linked with case US2018GSK162719, reported by same reporter for the same patient.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th August 2018, several hours after receiving SHINGRIX, the patient experienced light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm. On an unknown date, the outcome of the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm were unchanged. It was unknown if the reporter considered the light headedness, headache, shoulder pain, runny nose, appetite lost and pain in arm to be related to SHINGRIX. Additional details were reported as follows: At 4:30 PM, the patient received a dose of SHINGRIX. After vaccination, that night, the patient experienced lightheadedness, pain in arm, pain in shoulder, runny nose, loss of appetite and head hurts. The patient reported that, on an unknown date with the 1st dose of SHINGRIX, did not experience these events as strongly. This case was linked with case US2018GSK162719, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dermatitis allergic, Pain, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of allergic skin reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic skin reaction, swelling arm, general body pain and blister. On an unknown date, the outcome of the allergic skin reaction, swelling arm, general body pain and blister were unknown. It was unknown if the reporter considered the allergic skin reaction, swelling arm, general body pain and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Physician assistant. The age at vaccination was not reported. The patient experienced an epidermal allergic reaction which consisted of arm swelling and blisters forming around the elbow; additionally the patient experienced intense body aches.