chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irrigation, Lacrimation increased, Pain, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included asthma and eczema. On 17th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced rash, pain and watering eyes. On 17th August 2018, the patient experienced pain in arm. On 21st August 2018, the patient experienced pustular rash and itchy rash. The patient was treated with boric acid. On an unknown date, the outcome of the rash, pustular rash, pain and itchy rash were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the watering eyes was not recovered/not resolved. It was unknown if the reporter considered the rash, pustular rash, pain in arm, pain, itchy rash and watering eyes to be related to SHINGRIX. Additional information was received as follows: The patient stated that she did not have any other immunizations 4 weeks prior to or on the day of her SHINGRIX administration. At 10:26 AM, the patient received SHINGRIX on the left arm at a local pharmacy. The patient stated that it was uncertain of whom actually administered the injection and it was the most painful shot she ever received. The patient experienced the rash on face along with the bumps underneath the skin. On Saturday, 18th August 2018, within 12 to 20 hours after receiving the vaccine, her left arm had a 4 inch rash patch and was also very sore, to where she could not sleep on that side. On Tuesday, 4 days after receiving the SHINGRIX vaccine, the patient noticed a pustular, itchy rash on her left cheek. On Wednesday, 22nd August 2018, she then had a rash develop on her right cheek. The patient stated she self treated at the time of reporting as she had a history of eczema and the rashes were recovering. The patient stated that the rash was clearing up. She had been treating it with prescription eczema cream. On 22nd August 2018, the rash on her arm was resolved. However, the rash on her face was still recovering. On the left side of her face where the rash was the worst, her eye had been watering constantly. She had been flushing her eye with over the counter Boric acid solution, but it kept tearing and weeping. She had an appointment to see her eye physician next week of reporting date for a follow up from a laser surgery to treat cataracts, so she would have him look at her eye. The patient was unable to provide lot number or expiry date. The patient was concerned to get the 2nd dose of SHINGRIX. The patient initially called the Regulatory Authority during after-hours. The patient later stated that, she called and reported this information to the Vaccine Service Center but was not asked as many questions for reporting the adverse event. The patient gave the information of vaccination location and the physician who prescribed the SHINGRIX. No further information was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included asthma and eczema. On 17th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced rash, pain and watering eyes. On 17th August 2018, the patient experienced pain in arm. On 21st August 2018, the patient experienced pustular rash and itchy rash. The patient was treated with boric acid. On an unknown date, the outcome of the rash, pustular rash, pain and itchy rash were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the watering eyes was not recovered/not resolved. It was unknown if the reporter considered the rash, pustular rash, pain in arm, pain, itchy rash and watering eyes to be related to SHINGRIX. Additional information was received as follows: The patient stated that she did not have any other immunizations 4 weeks prior to or on the day of her SHINGRIX administration. At 10:26 AM, the patient received SHINGRIX on the left arm at a local pharmacy. The patient stated that it was uncertain of whom actually administered the injection and it was the most painful shot she ever received. The patient experienced the rash on face along with the bumps underneath the skin. On Saturday, 18th August 2018, within 12 to 20 hours after receiving the vaccine, her left arm had a 4 inch rash patch and was also very sore, to where she could not sleep on that side. On Tuesday, 4 days after receiving the SHINGRIX vaccine, the patient noticed a pustular, itchy rash on her left cheek. On Wednesday, 22nd August 2018, she then had a rash develop on her right cheek. The patient stated she self treated at the time of reporting as she had a history of eczema and the rashes were recovering. The patient stated that the rash was clearing up. She had been treating it with prescription eczema cream. On 22nd August 2018, the rash on her arm was resolved. However, the rash on her face was still recovering. On the left side of her face where the rash was the worst, her eye had been watering constantly. She had been flushing her eye with over the counter Boric acid solution, but it kept tearing and weeping. She had an appointment to see her eye physician next week of reporting date for a follow up from a laser surgery to treat cataracts, so she would have him look at her eye. The patient was unable to provide lot number or expiry date. The patient was concerned to get the 2nd dose of SHINGRIX. The patient initially called the Regulatory Authority during after-hours. The patient later stated that, she called and reported this information to the Vaccine Service Center but was not asked as many questions for reporting the adverse event. The patient gave the information of vaccination location and the physician who prescribed the SHINGRIX. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included 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, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, swelling and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown and the outcome of the swelling was recovered/resolved. It was unknown if the reporter considered the injection site pain and swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The age at vaccination was not reported. In 2018, the patient received the first dose of the SHINGRIX series about 4 months ago and the shot hurt, caused a lot of pain. Less than a year after receiving SHINGRIX, the patient had a bump that lasted a week. The patient was also concerned that she would be late for the second dose of the SHINGRIX series due to the current backorder. The patient did not want to provide contact information.
Age: 1.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythematous rash in a 18-month-old male patient who received KINRIX (batch number E72T3, expiry date 25th April 2020) for prophylaxis. On 15th August 2018, the patient received KINRIX. On 15th August 2018, unknown after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On 16th August 2018, the patient experienced erythematous rash, papular rash and itchy rash. On an unknown date, the outcome of the erythematous rash, papular rash, itchy rash and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the erythematous rash, papular rash, itchy rash and inappropriate age at vaccine administration to be related to KINRIX. Additional details reported as follows: The patient received KINRIX which was given to an 18 month old, which led to inappropriate age at vaccine administration. One day after vaccination, the patient experienced red bumpy, itchy rash on his legs, trunk and diaper area.
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Nausea, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a female patient who received BEXSERO (batch number 16B701A, expiry date 28th February 2019) for prophylaxis. On 21st August 2018, the patient received BEXSERO. In August 2018, less than a week after receiving BEXSERO, the patient experienced injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm. On an unknown date, the outcome of the injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm were unknown. It was unknown if the reporter considered the injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm to be related to BEXSERO. Additional details reported as follows: The age at vaccination was not reported however it could be 18 or 19 years old. The patient had developed injection site reaction that includes red, hard site about 4 by 6 cm with space of white skin and then blotchy red rash that is warm to touch, all on upper arm on site of injection. The patient also had nausea and had an area of rash on chest that was 2 by 3 cm but not warm to touch and an area of rash on the back that was 3 by 4 cm and not warm to touch.
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Rash macular, Skin warm
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a female patient who received BEXSERO (batch number 16B701A, expiry date 28th February 2019) for prophylaxis. On 21st August 2018, the patient received BEXSERO. In August 2018, less than a week after receiving BEXSERO, the patient experienced injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm. On an unknown date, the outcome of the injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm were unknown. It was unknown if the reporter considered the injection site erythema, nausea, injection site induration, injection site discoloration, rash, blotchy rash, erythematous rash and skin warm to be related to BEXSERO. Additional details reported as follows: The age at vaccination was not reported however it could be 18 or 19 years old. The patient had developed injection site reaction that includes red, hard site about 4 by 6 cm with space of white skin and then blotchy red rash that is warm to touch, all on upper arm on site of injection. The patient also had nausea and had an area of rash on chest that was 2 by 3 cm but not warm to touch and an area of rash on the back that was 3 by 4 cm and not warm to touch.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included egg allergy. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, swelling arm and fever. On an unknown date, the outcome of the pain and swelling arm were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the pain, swelling arm and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the certified management accountant (CMA). The healthcare professional (HCP) was reporting on behalf of the physician. The patient was a relative of the physician and did not receive SHINGRIX within their facility. The patient had a history of egg allergies but no other medical history noted. The patient developed severe reactions after receiving a dose of SHINGRIX. The patient reportedly had a fever of 104 degree F, achiness, severe arm swelling and pretty much every symptom listed by the company. The fever lasted for several days. The HCP did not want to be contacted further regarding the reported adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza, Injection site pain, Listless, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of listless in an elderly male 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 day after receiving SHINGRIX, the patient experienced listless, fever, injection site pain and influenza. On an unknown date, the outcome of the listless, fever, injection site pain and influenza were recovered/resolved. It was unknown if the reporter considered the listless, fever, injection site pain and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 83 or 84 years. Within approximately two hours after receiving SHINGRIX, the patient experienced pain at the injection site. The evening after receiving SHINGRIX, the patient began to feel listless like he had a mild flu, and a low-grade fever. All of the symptoms were resolved within two to three days. The reporter gave permission to contact their physician. The reporter was unable to provide additional information. This case has been linked with cases US2018153593 and --, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly 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 day after receiving SHINGRIX, the patient experienced pain and injection site pain. On an unknown date, the outcome of the pain and injection site pain were recovered/resolved. It was unknown if the reporter considered the pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 83 or 84 years. The patient could not remember what arm she received the first injection. The patient experienced achiness and a dull throbbing at the injection site that started within one hour of receiving the vaccination. Achiness and throbbing at the injection site were resolved within two to three days. The reporter gave permission to contact their physician. The reporter was unable to provide additional information. This case has been linked with cases US2018153589 and US2018GSK158507, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be unlikely related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician's assistant via chat. The age at vaccination was not reported. The healthcare professional (HCP) reported that after receipt of SHINGRIX, the patient developed a rash on her abdomen. The healthcare professional (HCP) had no information other than gender of the patient. The patient did not receive the SHINGRIX vaccine at a pharmacy and not at the reporter's facility.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingles several times). Previously administered products included ZOSTAVAX. Concomitant products included SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 20th August 2018, less than a month after receiving SHINGRIX, the patient experienced painful rash, itchy rash and shingles. On an unknown date, the outcome of the painful rash, itchy rash and shingles were not recovered/not resolved. It was unknown if the reporter considered the painful rash, itchy rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in the left arm intramuscularly in May 2018 and 2nd dose in her right arm. The patient did not provide the exact vaccination dates for the 1st or 2nd dose of SHINGRIX. The patient stated that since Monday she had a painful, itchy rash on her buttocks that she believed to be Shingles. The patient had not been seen by healthcare professional or formally diagnosed with Shingles. The patient had denied permission to contact their physician.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th August 2018, 11 days after receiving SHINGRIX, the patient experienced shingles and pain. On an unknown date, the patient experienced post herpetic neuralgia. The patient was treated with LYRICA and antivirals for systemic use. On an unknown date, the outcome of the shingles, pain and post herpetic neuralgia were not recovered/not resolved. The reporter considered the shingles, pain and post herpetic neuralgia to be related to SHINGRIX. Additional details reported as follows: The physician reported to the sales representative that the patient experienced left thoracic shingles on her T-11 area. The patient went to the emergency room, was prescribed an antiviral, and was discharged home. Also, the patient was prescribed LYRICA by her physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received SHINGRIX. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unchanged. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient had a rash at the injection site after receiving the SHINGRIX vaccine in the left arm. The patient stated that, the rash was getting worse.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included stem cell transplant. Concomitant products included acyclovir.  On 6th June 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a year after receiving SHINGRIX, the patient experienced shingles, numbness and tingling. On an unknown date, the outcome of the shingles, numbness and tingling were unknown. It was unknown if the reporter considered the shingles, numbness and tingling to be related to SHINGRIX. Additional details were provided as follows: The patient did not specify why acyclovir was being taken or for what the stem cell transplant was for. The patient stopped acyclovir the day after her SHINGRIX injection, by doctor's order. The patient reported that during the last week in July 2018, she experienced shingles, primarily on the lower back and abdomen, near the navel. The patient reported that the shingles also consisted of some numbness and tingling. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a adult female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, several hours after receiving SHINGRIX, the patient experienced injected limb mobility decreased, pain in arm and activities of daily living impaired. On an unknown date, the patient experienced injection site bruising. On an unknown date, the outcome of the injected limb mobility decreased, injection site bruising and activities of daily living impaired were recovered/resolved and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased, injection site bruising, pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. The patient was unable to give the exact date and time, but the date was towards the end of June 2018, in the afternoon. The patient reported that after receiving the injection, she felt fine but later that same evening, her left arm became very sore to a point where you could not lift her arm, Her husband had to assist her with dressing and undressing over the next few days and she had to use her right arm to lift her left arm when she was at work. She also had difficulty showering and could not use her left arm for several days. She reported she was able to at least move her left arm after several days, but the left arm remained very sore over the course of several weeks and did have a small bruise at the injection site. The patient reported she did notify her physician about the symptoms and he was not concerned. The patient was scheduled to have her next injection in September which was scheduled in her doctor's office along with receiving a Hepatitis B vaccine. She was concerned she would have to go through similar arm pain with the second injection.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX (batch number 9349T, expiry date 7th March 2021) for prophylaxis. 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 fever, pain and headache. On an unknown date, the outcome of the fever, pain and headache were unknown. It was unknown if the reporter considered the fever, pain and headache to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX yesterday (the day before reporting) and on the date of reporting reported adverse events as headache, fever, and general aches.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included latex allergy. 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 rash. On an unknown date, the outcome of the rash was not recovered/not resolved. 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. In 2018, the patient was given SHINGRIX 4 months ago and experienced ongoing rash on her trunk for the last 4 months. The healthcare professional (HCP) did not know that how long after the patient received SHINGRIX that she developed a rash on her trunk. The HCP also stated that the patient had a latex sensitivity so HCP confirmed there was no latex in the formulation of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a adult female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) 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 fatigue, influenza-like symptoms, pain in toe, general malaise, general body pain and wrist pain. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the influenza-like symptoms, pain in toe, general malaise, general body pain and wrist pain were unknown. It was unknown if the reporter considered the fatigue, influenza-like symptoms, pain in toe, general malaise, general body pain and wrist pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had severe fatigue, ached all over, her wrists and toes hurt, felt like flu, totally wiped out, generalized malaise. The reporter stated that the main thing was aching all over. This case has been linked with US2018GSK158114, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a adult female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) 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 fatigue, influenza-like symptoms, pain in toe, general malaise, general body pain and wrist pain. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the influenza-like symptoms, pain in toe, general malaise, general body pain and wrist pain were unknown. It was unknown if the reporter considered the fatigue, influenza-like symptoms, pain in toe, general malaise, general body pain and wrist pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had severe fatigue, ached all over, her wrists and toes hurt, felt like flu, totally wiped out, generalized malaise. The reporter stated that the main thing was aching all over. This case has been linked with US2018GSK158114, reported by the same reporter.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received MENVEO for prophylaxis. On 27th July 2018, the patient received the 1st dose of MENVEO. On 27th July 2018, less than a day after receiving MENVEO, the patient experienced injection site pain. On 31st July 2018, the patient experienced tremor of hands, loose stools, fatigue and headache. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the tremor of hands and loose stools were unknown and the outcome of the fatigue was unchanged and the outcome of the headache was recovering/resolving. It was unknown if the reporter considered the injection site pain, tremor of hands, loose stools, fatigue and headache to be related to MENVEO. Additional details were provided as follows: This case was previously reported to physician. The patient received MENVEO on an unknown arm. The patient experienced pain at the injection site which resolved. About 4 to 5 days after receiving MENVEO, the patient began to experience fatigue, headache, loose stools, and hands trembling.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Paraesthesia oral, Tongue ulceration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling tongue in a 78-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX. On 23rd July 2018, immediately after receiving SHINGRIX, the patient experienced tingling tongue. On an unknown date, the patient experienced tongue ulceration. On 30th July 2018, the outcome of the tingling tongue was recovered/resolved. On an unknown date, the outcome of the tongue ulceration was recovered/resolved. It was unknown if the reporter considered the tingling tongue and tongue ulceration to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that immediately following vaccination with SHINGRIX, the patient reported that her tongue felt funny and was tingling. The tingling never progressed to anything else and resolved 1 week later. On an unknown date, less than a year after receiving SHINGRIX, the patient also reported that small ulcers appeared on one side of her tongue and also resolved. The patient's primary care physician (PCP) instructed the patient to not get the second dose based off of these reactions to dose 1.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The caller was the patient who received SHINGRIX approximately 2 months ago on left arm. The caller reported that he was still experiencing sore arm muscle at injection site since that dose was given. This case has been linked with US2018154149, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever 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 fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The caller mentioned during conversation that a friend's wife had gotten SHINGRIX and experienced fever afterwards. No further details available. This case has been linked with US2018154148, reported by same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included HUMIRA. On 17th May 2018, the patient received SHINGRIX. On 17th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site pain, fever, chills, headache, stomach pain and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain, fever, chills, headache, stomach pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, fever, chills, headache, stomach pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The evening of vaccination date, the patient began to experience injection site reactions in the arm. The events all resolved in about 2 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included HUMIRA. On 17th May 2018, the patient received SHINGRIX. On 17th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site pain, fever, chills, headache, stomach pain and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain, fever, chills, headache, stomach pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, fever, chills, headache, stomach pain and fatigue to be related to SHINGRIX. Additional details were reported as follows: The evening of vaccination date, the patient began to experience injection site reactions in the arm. The events all resolved in about 2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a adult 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 swelling. On an unknown date, the outcome of the swelling was recovered/resolved. It was unknown if the reporter considered the swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. A pharmacist reported that the patient had a huge amounts of swelling after a dose of SHINGRIX. The event lasted for about 7 days. The health care professional was not sure if this was reported previously.   The basis of her call was to determine if 2nd dose could be given if severe adverse event were experienced after 1st dose. The pharmacist was asked, if there was anything to report but he was unable to provide much information. No patient or vaccine information was available. This case was link with US2018154154, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult 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 adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The pharmacist reported that the patient had severe adverse events after a dose of SHINGRIX, no knowledge of anaphylaxis. The event did not last as long or was not more severe as compared to other patient (refer case US2018154153). The health care professional was not sure if this case was reported previously. The basis of her call was to determine if 2nd dose could be given if severe adverse event were experienced after 1st dose. The pharmacist was asked, if there was anything to report but he was unable to provide much information. No patient or vaccine information was available.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient experienced sore arm and it was so insignificant that the patient could not remember how long it took to resolve. The contact details of the physician was provided. For tolerance to next dose, refer case US2018GSK159188.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced twice about six years before the reporting date). On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 25th July 2018, 85 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the pharmacist who herself was the patient. The patient had an outbreak of Shingles. On 6th August 2018, the patient was seen in urgent care where the diagnosis was confirmed and the patient was prescribed VALTREX.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Shingrix for an unknown indication. Co-suspect products included Shingrix for an unknown indication. In March 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and 45 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm and pain in arm. On an unknown date, the outcome of the vaccination failure, shingles and pain in arm were unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles about 1 and 1/2 months to 2 months after the vaccination. The patient also experienced arm pain after the 1st Shingrix dose and worse arm pain after the 2nd Shingrix dose. The healthcare professional did not have all of the details of the event because she was working at a different location. The patient received 2nd dose 2 months later than 1st dose. Shingles was diagnosed with shingles by the healthcare professional.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced fever and aches after the first dose of the SHINGRIX series. The healthcare professional did not had all the details because she was working in a different location.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, muscle pain, fever and activities of daily living impaired. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fatigue, muscle pain, fever and activities of daily living impaired were recovering/resolving. It was unknown if the reporter considered the fatigue, muscle pain, fever and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: At 12:00 hours, the patient received SHINGRIX on left arm. The patient stated that, she woke up today (on the date of reporting) with fatigue and muscle ache all over the body. At 10:15 am, she went swimming and once she got home she checked to see that she had fever of 102 degree F. She took a Tylenol and napped for a while. She also had to cancel going to work today (on the date of reporting). The patient had denied permission to contact their physician. No further details were provided.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and injection site tenderness. On an unknown date, the outcome of the pain in arm and injection site tenderness were recovering/resolving. It was unknown if the reporter considered the pain in arm and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient stated that he had tenderness at the injection site, and the entire arm was sore. The patient was 80 percent better at the time of reporting. The patient had denied permission to contact their physician. No further details were provided.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Eye discharge, Eye irritation, Nasal discomfort, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of runny nose in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 22nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 23rd August 2018, 1 days after receiving SHINGRIX, the patient experienced runny nose, appetite absent, burning in eyes, eye discharge and nasal burning. On an unknown date, the outcome of the runny nose, appetite absent, burning in eyes, eye discharge and nasal burning were not recovered/not resolved. It was unknown if the reporter considered the runny nose, appetite absent, burning in eyes, eye discharge and nasal burning to be related to SHINGRIX. Additional detail were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow-up with her physician on an unknown date.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome 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 month after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After receiving SHINGRIX vaccine, within 2 weeks the patient was presented with Guillain Barre Syndrome. The physician did not know if the condition was related to SHINGRIX, but could not attribute it to anything else. The physician advised to the patient to not receive 2nd dose of SHINGRIX vaccine. The caller did not have any additional information to provide regarding the event.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the doctor. The age at vaccination was not reported. The patient experienced a sore arm which had not resolved in 2 months since the injection.