chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 02-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 25-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 08-MAR-2018 the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Age: 22.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 22 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 07-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Age: 22.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 22 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 29-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 5 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Age: 22.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 22 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 07-JUN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 2 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash generalised, Swelling face
Clinical narrative: This spontaneous report as received from patient's mother referring to a 1 year old male patient with attention deficit/hyperactivity disorder, developmental delay and drug hypersensitivity to sulfa medications. Concomitant therapies included HAVRIX and unspecified Varicella vaccine. On 09-JUL-2009 the patient was vaccinated with a dose of M-M-R II, 0.5 ml  injection in the right arm for prophylaxis. On 10-JUL-2013 or 11-JUL-2013 the patient experienced swelling in his face, a full body rash and had a high fever (Estimated at 103 degrees) that lasted approximate 7 days. The patient was seen at Hospital Urgent Care but not admitted. No treatment was given. The outcome of the events was reported as resolved. Action taken was not applicable. Causality was not reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included BOOSTRIX. On 5th July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever. In July 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: On 2nd July 2018, the patient received a dose of BOOSTRIX. The fever lasted a couple of days. The healthcare professional could not access SHINGRIX or BOOSTRIX lot numbers or expiry dates at the time of call.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 16-year-old male patient who received BEXSERO (batch number 16E601, expiry date 1st March 2019) for prophylaxis. On 5th June 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 7th July 2018, 32 days after receiving BEXSERO, the patient experienced injection site pain, injection site erythema and strength loss of. On an unknown date, the outcome of the injection site pain, injection site erythema and strength loss of were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and strength loss of to be related to BEXSERO. Additional details were provided as follows: The patient stated he had pain and redness in his left arm at the site of injection, even though his strength was diminished, there was no weakness. The mother of the patient was supposed to be call the HCP (healthcare professional) with an update. The reference number was provided to the HCP for reference when she calls back.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Hypoaesthesia, Neuralgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes and post herpetic neuralgia (but the patient never had episode of Shingles.). Concomitant products included gabapentin. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 6th July 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, nerve pain, tingling of extremity, numbness of upper extremities and skin lesion. On 11th July 2018, the patient experienced skin plaque and erythema of extremities. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the nerve pain, tingling of extremity, numbness of upper extremities, skin plaque and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the shingles, nerve pain, tingling of extremity, numbness of upper extremities, skin plaque, erythema of extremities and skin lesion to be related to SHINGRIX. Additional details were received as follows: The patient was seen by pain Neurologist for potential Shingles outbreak in the past with continued (Postherpetic neuralgia) PHN. The patient reported either PHN or possible diabetic nerve pain in the area of T 7 to T 8 that ran from back to front, this pain was present before receiving a dose of SHINGRIX vaccine. The patient received the SHINGRIX vaccine in the left arm. About 4 or 5 days after SHINGRIX vaccination, the patient noted nerve pain on the opposite side of her left side of injection. Later the patient reported that 4 days after a dose of SHINGRIX vaccine, she woke up in the middle of the night with terrible stinging under her skin, skin lesions. The patient noted, the pain took her breath away at times, it was a sharp pain and more of a stinging than a dull pain. It started on her right side, under her arm area, close to her breast area. In the morning of reporting day, the patient woke up to find a dime size, raised thickened plaque feeling, red area that was just below her shoulder but still on her arm and toward the underarm area. It was bumpy in appearance. The patient was referred to physician and she planned to discuss with her pain management and Primary Care Provider (PCP). The patient called back and reported that she was seen by the internal medicine physician. The physician confirmed that the patient had a case of shingles. The patient was unsure if the events was related to SHINGRIX vaccine or not. The patient provided contact details of the physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Skin lesion, Skin plaque
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes and post herpetic neuralgia (but the patient never had episode of Shingles.). Concomitant products included gabapentin. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 6th July 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, nerve pain, tingling of extremity, numbness of upper extremities and skin lesion. On 11th July 2018, the patient experienced skin plaque and erythema of extremities. On an unknown date, the outcome of the shingles and skin lesion were unknown and the outcome of the nerve pain, tingling of extremity, numbness of upper extremities, skin plaque and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the shingles, nerve pain, tingling of extremity, numbness of upper extremities, skin plaque, erythema of extremities and skin lesion to be related to SHINGRIX. Additional details were received as follows: The patient was seen by pain Neurologist for potential Shingles outbreak in the past with continued (Postherpetic neuralgia) PHN. The patient reported either PHN or possible diabetic nerve pain in the area of T 7 to T 8 that ran from back to front, this pain was present before receiving a dose of SHINGRIX vaccine. The patient received the SHINGRIX vaccine in the left arm. About 4 or 5 days after SHINGRIX vaccination, the patient noted nerve pain on the opposite side of her left side of injection. Later the patient reported that 4 days after a dose of SHINGRIX vaccine, she woke up in the middle of the night with terrible stinging under her skin, skin lesions. The patient noted, the pain took her breath away at times, it was a sharp pain and more of a stinging than a dull pain. It started on her right side, under her arm area, close to her breast area. In the morning of reporting day, the patient woke up to find a dime size, raised thickened plaque feeling, red area that was just below her shoulder but still on her arm and toward the underarm area. It was bumpy in appearance. The patient was referred to physician and she planned to discuss with her pain management and Primary Care Provider (PCP). The patient called back and reported that she was seen by the internal medicine physician. The physician confirmed that the patient had a case of shingles. The patient was unsure if the events was related to SHINGRIX vaccine or not. The patient provided contact details of the physician.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old female patient who received for prophylaxis. Previously experienced adverse reactions included rash (in the past from a band aid). Concurrent medical conditions included shingles (the patient had mild shingles at the age 50 years). On 26th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 26th April 2018, the patient experienced muscle pain, erythematous rash, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache, pain of skin and injection site pain. On an unknown date, the outcome of the muscle pain, erythematous rash, fever, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache and pain of skin were recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the muscle pain, erythematous rash, fever, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache, pain of skin and injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient reported that she was petite and received SHINGRIX in right deltoid at 2 pm. The patient's side effects with previous vaccinations lasted a couple of days and then fade away.  The patient experienced muscle ache within a few hours with a headache on the same day of vaccination. The patient had a rash later in the evening with an itchy arm. The patient reported that most of her side effects occurred in the evening of the vaccination. The patient also reported that SHINGRIX vaccine affected her more strongly than previous vaccinations. She reported a headache, low grade fever for a couple of days with body aches and sore skin like a flu. The patient had muscle soreness, her whole arm hurt and she had no full range of motion and couldn't raise her arm all the way up. The patient reported that the vaccine hurt like heck when she initially got vaccination and the it went away. The patient was feeling icky and she had a rash on the side of her arm near the dent in her arm or muscle. The patient described the rash as a half bend around her right arm that was red and itchy and didn't spread and it took one week to resolve all the symptoms. The rash never moved or spread. They put a band aid on her arm after vaccination and she had previously experienced a rash from a band aid in the past.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pain of skin, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old female patient who received for prophylaxis. Previously experienced adverse reactions included rash (in the past from a band aid). Concurrent medical conditions included shingles (the patient had mild shingles at the age 50 years). On 26th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 26th April 2018, the patient experienced muscle pain, erythematous rash, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache, pain of skin and injection site pain. On an unknown date, the outcome of the muscle pain, erythematous rash, fever, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache and pain of skin were recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the muscle pain, erythematous rash, fever, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache, pain of skin and injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient reported that she was petite and received SHINGRIX in right deltoid at 2 pm. The patient's side effects with previous vaccinations lasted a couple of days and then fade away.  The patient experienced muscle ache within a few hours with a headache on the same day of vaccination. The patient had a rash later in the evening with an itchy arm. The patient reported that most of her side effects occurred in the evening of the vaccination. The patient also reported that SHINGRIX vaccine affected her more strongly than previous vaccinations. She reported a headache, low grade fever for a couple of days with body aches and sore skin like a flu. The patient had muscle soreness, her whole arm hurt and she had no full range of motion and couldn't raise her arm all the way up. The patient reported that the vaccine hurt like heck when she initially got vaccination and the it went away. The patient was feeling icky and she had a rash on the side of her arm near the dent in her arm or muscle. The patient described the rash as a half bend around her right arm that was red and itchy and didn't spread and it took one week to resolve all the symptoms. The rash never moved or spread. They put a band aid on her arm after vaccination and she had previously experienced a rash from a band aid in the past.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old female patient who received for prophylaxis. Previously experienced adverse reactions included rash (in the past from a band aid). Concurrent medical conditions included shingles (the patient had mild shingles at the age 50 years). On 26th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 26th April 2018, the patient experienced muscle pain, erythematous rash, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache, pain of skin and injection site pain. On an unknown date, the outcome of the muscle pain, erythematous rash, fever, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache and pain of skin were recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the muscle pain, erythematous rash, fever, general body pain, itchy rash, pain in arm, injected limb mobility decreased, feeling abnormal, headache, pain of skin and injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient reported that she was petite and received SHINGRIX in right deltoid at 2 pm. The patient's side effects with previous vaccinations lasted a couple of days and then fade away.  The patient experienced muscle ache within a few hours with a headache on the same day of vaccination. The patient had a rash later in the evening with an itchy arm. The patient reported that most of her side effects occurred in the evening of the vaccination. The patient also reported that SHINGRIX vaccine affected her more strongly than previous vaccinations. She reported a headache, low grade fever for a couple of days with body aches and sore skin like a flu. The patient had muscle soreness, her whole arm hurt and she had no full range of motion and couldn't raise her arm all the way up. The patient reported that the vaccine hurt like heck when she initially got vaccination and the it went away. The patient was feeling icky and she had a rash on the side of her arm near the dent in her arm or muscle. The patient described the rash as a half bend around her right arm that was red and itchy and didn't spread and it took one week to resolve all the symptoms. The rash never moved or spread. They put a band aid on her arm after vaccination and she had previously experienced a rash from a band aid in the past.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin irritation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 90-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 5th November 2020) for prophylaxis. On 9th July 2018, the patient received SHINGRIX (intramuscular). On 10th July 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities and skin irritation. On 12th July 2018, the patient experienced swelling arm. On an unknown date, the outcome of the erythema of extremities, skin irritation and swelling arm were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin irritation and swelling arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The healthcare professional (HCP) reported that, the patient had redness and irritation on her arm. The next day, the redness became bigger to about 2 inches, and then the day after that, the redness was 3 to 4 inches in diameter and had swelling.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 9th April 2018 16:00, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, fatigue and pain in arm. On an unknown date, the outcome of the muscle pain, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue and pain in arm to be related to SHINGRIX. Additional information was received as follows: The case was reported by the patient's wife. The patient received SHINGRIX on the left arm. At evening, the patient started to experienced arm pain which progressed. The reporter also reported that the patient felt fatigue. The symptoms resolved approximately after a week. This case has been linked to the case US2018GSK129717, reported by the same reporter for the same patient.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity, Tendon pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 9th April 2018 16:00, the patient received the 1st dose of SHINGRIX. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, fatigue and pain in arm. On an unknown date, the outcome of the muscle pain, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue and pain in arm to be related to SHINGRIX. Additional information was received as follows: The case was reported by the patient's wife. The patient received SHINGRIX on the left arm. At evening, the patient started to experienced arm pain which progressed. The reporter also reported that the patient felt fatigue. The symptoms resolved approximately after a week. This case has been linked to the case US2018GSK129717, reported by the same reporter for the same patient.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Herpes zoster SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced tendon pain and fatigue. On an unknown date, the patient experienced muscle pain and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the muscle pain and tendon pain were unknown and the outcome of the fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the muscle pain, tendon pain, fatigue and pain in arm to be related to SHINGRIX. Additional information was received as follows: On 9th April 2018, the patient received the 1st dose of SHINGRIX on the left arm. The patient received the 2nd dose of SHINGRIX on an unknown arm. The patient experienced the muscle pain, fatigue, arm pain as well as pain in the tendons of the back of his ankles. The pain lasted for 6 to 7 days and was also in the arm where the dose was administered but the reporter did not known which arm that was. The fatigue lasted approximately a month before resolving. This case has been linked to the case US2018124946, reported by the same reporter for the same patient.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity, Tendon pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included Herpes zoster SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced tendon pain and fatigue. On an unknown date, the patient experienced muscle pain and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the muscle pain and tendon pain were unknown and the outcome of the fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the muscle pain, tendon pain, fatigue and pain in arm to be related to SHINGRIX. Additional information was received as follows: On 9th April 2018, the patient received the 1st dose of SHINGRIX on the left arm. The patient received the 2nd dose of SHINGRIX on an unknown arm. The patient experienced the muscle pain, fatigue, arm pain as well as pain in the tendons of the back of his ankles. The pain lasted for 6 to 7 days and was also in the arm where the dose was administered but the reporter did not known which arm that was. The fatigue lasted approximately a month before resolving. This case has been linked to the case US2018124946, reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm. At the time of reporting, as of 3 months after vaccination, the patient still had arm pain at the injection site. The pharmacist had limited information at the time of reporting.
Age: 83.0
Sex: F
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 injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 12th July 2018, the patient received the 1st dose of SHINGRIX. On 12th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In July 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved. The reporter considered the injection site pain and pain in arm to be probably related to SHINGRIX. Additional information was reported as follows: The patient was the reporter's mother. The patient received her first SHINGRIX vaccination last night, to the date of reporting, in her left arm. The patient complained of pain in her right arm after the vaccination and complained of pain at the injection site in the morning of reporting day.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On 12th July 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In July 2018, the patient experienced chills. The patient was treated with Aspirin With Vitamin C. On an unknown date, the outcome of the injection site pain and chills were recovering/resolving. It was unknown if the reporter considered the injection site pain and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that adverse reactions to a SHINGRIX that he experienced injection site soreness immediately, but later in the middle of the night around 2 PM (on 13th July 2018), the patient developed chills. The patient denied any fever. On the day of reporting, the patient took an aspirin with Vitamin C for the injection site soreness and was inquiring if this would affect the efficacy of the vaccine and the patient also inquired that how long the side effects would be last. Unable to obtain the physician's name and phone number due to call flow. As the patient asked, reviewed PI information regarding timeframe for the adverse reactions according to the PI and the clinical trials and found that advised taking an anti-inflammatory would not affect the efficacy of the vaccine. The patient was offered a copy of the PI (product information), but declined.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Skin discolouration, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 65-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 18th May 2018, less than a year after receiving SHINGRIX, the patient experienced localized erythema and tenderness. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the localized erythema, tenderness and skin discoloration were unknown. It was unknown if the reporter considered the localized erythema, tenderness and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had red spot and this spot was described as tender and red. After a month, the spot changed to a color of purple but no increase of tenderness. The caller reported prior to her second vaccine for advice.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain, muscle pain and chills. On an unknown date, the outcome of the influenza-like symptoms, pain, muscle pain and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, pain, muscle pain and chills to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient reported that, on the same day after vaccination with SHINGRIX, the patient experienced flu-like symptoms, achiness, muscle aches and chills. The events were resolved in one day. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in an unspecified number of adult patients 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 swelling arm, erythema of extremities, skin warm and pain in arm. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The pharmacist reported that she had administered 26 doses of SHINGRIX since May 2018 and that 50 to 80 percent of the patients experienced swelling and redness on the arm and the area was hot to the touch and painful. This case has been linked with the case US2018125497, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in an unspecified number of adult patients 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 swelling arm, erythema of extremities, skin warm and pain in arm. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and pain in arm were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The pharmacist reported that she had administered 26 doses of SHINGRIX since May 2018 and that 50 to 80 percent of the patients experienced swelling and redness on the arm and the area was hot to the touch and painful. This case has been linked with the case US2018125497, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
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. 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 fever, malaise and chills. On an unknown date, the outcome of the fever, malaise and chills were unknown. It was unknown if the reporter considered the fever, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The pharmacist reported that she had administered 26 doses of SHINGRIX since May 2018. This case has been linked with the cases US2018125495 and US2018GSK130784, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Malaise, 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. 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 fever, malaise and chills. On an unknown date, the outcome of the fever, malaise and chills were unknown. It was unknown if the reporter considered the fever, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The pharmacist reported that she had administered 26 doses of SHINGRIX since May 2018. This case has been linked with the cases US2018125495 and US2018GSK130784, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
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. 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 fever, malaise and chills. On an unknown date, the outcome of the fever, malaise and chills were unknown. It was unknown if the reporter considered the fever, malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The pharmacist reported that she had administered 26 doses of SHINGRIX since May 2018. This case has been linked with the cases US2018125495 and US2018125497, reported by the same reporter.