chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Death
Clinical narrative: This spontaneous report as received from a consumer and refers to her mother's aunt, a 91-year-old female patient. The patient had a medical history of Epstein-Barr virus infection. The patient's concurrent conditions, concomitant medications and drug reactions/ allergies were not reported. On an unspecified date, the patient was vaccinated with a dose of an unspecified pneumonia vaccine (manufacturer unknown) (captured as PNEUMOVAX23) and a dose of an influenza virus vaccine at the same time for prophylaxis (dose number, route, and lot # were not reported). On the same day at night, the patient passed away. The cause of death was not reported. It was unknown, if an autopsy was performed. The reporter's causality assessment was not provided. This was one of two reports received from a same reporter.; Sender's Comments: US-009507513-1809USA010075:; Reported Cause(s) of Death: Unknown cause of death.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Cough, Tremor, Urinary tract disorder
Clinical narrative: This spontaneous report was received from medical assistant and refers to a currently 77 years old female patient. The patient concurrent conditions were right lung non-small cell lung cancer and chronic obstructive pulmonary disease. The patient's medical history included right lung lobectomy. The patient was vaccinated with PREVNAR 13 on 19-FEB-2016. The patient's concomitant therapies included VENTOLIN, QVAR, PLAVIX, DUONEB, lisinopril, lovastatin, propranolol hydrochloride, sertraline hydrochloride, spironolactone, trazodone hydrochloride and ROBAXIN. On 20-OCT-2017, the patient was vaccinated with PNEUMOVAX 23, lot # M023460, expiration date: 12-NOV-2017 for prophylaxis. On 21-SEP-2018, the patient presented in physician's assistant office for cough, unspecified tremors, and unspecified urinary problems experienced since unknown dates. The patient had routine chest x-rays performed however no results were provided. The patient received unspecified treatment for the events. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Erythema, Injection site discolouration
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's medical history included pneumonia in 2012. The patient had no drug reactions or allergies. On 13-SEP-2018, the patient was vaccinated with PNEUMOVAX 23, lot # N022703, expiration date 27-FEB-2019, intramuscularly in arm for prophylaxis. Other suspect therapies included FLUZONE administered on the same day in the same arm. On 20-SEP2018 the patient came back to pharmacy complaining on redness, soreness radiating over her back, and black discoloration around injection site, she was experienced since unknown date in September 2018. The patient saw her unspecified physician and was told that the reaction was probably due to receiving both vaccines in the same arm. No treatment was given for an adverse events. The outcome of the events was unknown. Causality assessment between the events and suspect vaccines was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medication, drug reactions and allergies provided. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023952, expiration date 12-JUL-2020, for prophylaxis. The vaccine dose was improperly stored for 12 minutes in temperature of -26.5 degrees Fahrenheit. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a patient's mother who was also a company representative and refers to a 9-year-old female patient. The patient had an allergy to amoxicillin. The patient's concurrent condition included 18 to 20 small warts on her hands for over a year. There was no concomitant therapies reported. In April 2018, the patient was vaccinated with the first dose of GARDASIL 9 (route of administration, lot # and expiration date were not provided) for prevention of HPV. In approximately August 2018 (reported as sometime within the past month which was about 4 to 5 months after receiving the vaccine), the patient's warts started to disappear and currently had almost completely disappeared. The reporter considered this adverse event as an unexpected therapeutic benefit. The patient had an appointment to receive second dose of GARDASIL 9 in October 2018.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 08-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N035941 with expiration date on 18-DEC-2018 and M-M-R II lot # R002930 with expiration date on 31-JAN-2019 (reported as 30-JAN-2019) (doses, route and site of administration were not reported) for prophylaxis. It was unknown if the sterile diluent used for reconstitution was properly stored. Administered dose of VARIVAX experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 72 hours. Administered dose of M-M-R II experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 72 hours. Digital data logger was involved. There were no previous temperature excursions reported. No adverse effect was reported. Additional information is not expected.; Sender's Comments: US-009507513-1809USA008879:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Depressed mood, Feeling abnormal, Herpes zoster
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. Concurrent medical conditions included cold sore (herpetic). On 21st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. In August 2018, less than 2 weeks after receiving SHINGRIX, the patient experienced feeling sad, difficulty sleeping, fever and foggy feeling in head. On 30th August 2018, the patient experienced shingles, blister and pustule. On an unknown date, the patient experienced general body pain. The patient was treated with lidocaine hydrochloride, antibiotics nos, anti-inflammatory/antirheumatic products, antivirals for systemic use and hydrocodone. On an unknown date, the outcome of the shingles, blister, feeling sad, difficulty sleeping, fever, foggy feeling in head, pustule and general body pain were recovering/resolving. It was unknown if the reporter considered the shingles, blister, feeling sad, difficulty sleeping, fever, foggy feeling in head, pustule and general body pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's husband. At 15:00 pm, the patient received SHINGRIX on the right arm. The patient experienced body pain from upper leg to shoulder on right side of the body. On 27th August 2018, the patient was taken to an emergency room. She was given antibiotics and anti-inflammatory medication and discharged on the same day. The event arthritis was ruled out. The patient experienced blisters and pus. The blisters were present on upper right leg joint and back. She had fever, fogginess, trouble sleeping and sadness due to prolonged period of pain. On 31st August 2018, she went to her primary care physician. The physician said that it was Shingles like viral infection, and therefore the physician started treatment for Shingles. She was started on antiviral medication, and hydrocodone for the pain. She also applied lidocaine patch for the pain. On 13th September 2018, the patient underwent blood test and she was waiting for test results at the reporting time. The reporter gave permission to contact the patient's physician. No further details were provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pyrexia, Rash pustular
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. Concurrent medical conditions included cold sore (herpetic). On 21st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. In August 2018, less than 2 weeks after receiving SHINGRIX, the patient experienced feeling sad, difficulty sleeping, fever and foggy feeling in head. On 30th August 2018, the patient experienced shingles, blister and pustule. On an unknown date, the patient experienced general body pain. The patient was treated with lidocaine hydrochloride, antibiotics nos, anti-inflammatory/antirheumatic products, antivirals for systemic use and hydrocodone. On an unknown date, the outcome of the shingles, blister, feeling sad, difficulty sleeping, fever, foggy feeling in head, pustule and general body pain were recovering/resolving. It was unknown if the reporter considered the shingles, blister, feeling sad, difficulty sleeping, fever, foggy feeling in head, pustule and general body pain to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's husband. At 15:00 pm, the patient received SHINGRIX on the right arm. The patient experienced body pain from upper leg to shoulder on right side of the body. On 27th August 2018, the patient was taken to an emergency room. She was given antibiotics and anti-inflammatory medication and discharged on the same day. The event arthritis was ruled out. The patient experienced blisters and pus. The blisters were present on upper right leg joint and back. She had fever, fogginess, trouble sleeping and sadness due to prolonged period of pain. On 31st August 2018, she went to her primary care physician. The physician said that it was Shingles like viral infection, and therefore the physician started treatment for Shingles. She was started on antiviral medication, and hydrocodone for the pain. She also applied lidocaine patch for the pain. On 13th September 2018, the patient underwent blood test and she was waiting for test results at the reporting time. The reporter gave permission to contact the patient's physician. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of migraine in a adult female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, 2 days after receiving SHINGRIX, the patient experienced migraine. In September 2018, the patient experienced vomiting and nausea. On an unknown date, the outcome of the migraine, vomiting and nausea were not recovered/not resolved. It was unknown if the reporter considered the migraine, vomiting and nausea to be related to SHINGRIX. Additional details were provided as follows: The health care professional did not administer the vaccine and was given in a different state and did not have any additional details about patient or batch number and expiry date. The health care professional was also uncertain of her work address, so address provided was from internet search by pharmacy name. The patient reported a terrible migraine which started 2 days after receiving her 1st dose of SHINGRIX and was persisting till the time of reporting (day 7). The patient's husband was vaccinated at same time with no problems. This case has been linked with case US2018171044 reported by the same reporter. The reporter did plan to instruct the patient to follow up and provide a more detailed report.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising, 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 an unspecified number of adult patients who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and contusion. On an unknown date, the outcome of the injection site pain and contusion were unknown. It was unknown if the reporter considered the injection site pain and contusion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that typically after receiving SHINGRIX, the patients complained of some soreness at the injection site and mild bruising. The reporter included these non specific reports of events she heard of from patients in the past following SHINGRIX vaccine. This case has been linked with US2018171041, reported by the same reporter in which a specific patient presented with a completely different adverse event profile than these, which this reporter considers typical. No specific patient details were available about these more typical events.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 17th September 2018 12:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, less than a week after receiving SHINGRIX, the patient experienced pain in hip. On 17th September 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and pain in hip were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and pain in hip to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The physician did not have lot or expiration date of SHINGRIX. About 5 hours after vaccination, the patient experienced arm pain and tenderness in his left arm. The patient experienced severe hip pain in his right hip, which felt almost like bursitis.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperaesthesia, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th April 2018, 2 hrs after receiving SHINGRIX, the patient experienced headache and fever. In April 2018, the patient experienced itchy skin, hypersensation skin, tiredness and pain. The patient was treated with Cortisone Topical Cream and medication unknown (Over The Counter Medication (Unknown)). On an unknown date, the outcome of the itchy skin and hypersensation skin were not recovered/not resolved and the outcome of the headache, tiredness, fever and pain were recovered/resolved. It was unknown if the reporter considered the itchy skin, headache, hypersensation skin, tiredness, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that she had the a of SHINGRIX at 1:00 pm. She had a fever and she stayed in bed the following day and she had a headache and a lot of pain. Started in April 2018, the patient experienced itchy skin. The itching was incessant and she had tried cortisone creams, and over the counter products (OTC) and the only relief she could get was with scalding hot water which provided temporary relief and had a fever and she stayed in bed the following day and she had a headache and a lot of pain. The patient was reporting a sensitivity to her skin after the vaccination. For example, she had a mosquito bite that was super itchy and the site is red, thick and nasty at the time of reporting. The patient also had an electrocardiogram monitor on her chest and within one week, they had to move the leads for the monitor to her back and her chest was itching from April where the monitor electrodes were placed, back of her shoulders were also itching as well. Headache, pain, and fever resolved within 24 hours as well as tiredness. By Saturday (15th April 2018) the patient spent the day in bed and she felt okay other than the itching which was worse at the time of reporting. The contact details of physician was provided. For tolerance see case US2018GSK173824.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th April 2018, 2 hrs after receiving SHINGRIX, the patient experienced headache and fever. In April 2018, the patient experienced itchy skin, hypersensation skin, tiredness and pain. The patient was treated with Cortisone Topical Cream and medication unknown (Over The Counter Medication (Unknown)). On an unknown date, the outcome of the itchy skin and hypersensation skin were not recovered/not resolved and the outcome of the headache, tiredness, fever and pain were recovered/resolved. It was unknown if the reporter considered the itchy skin, headache, hypersensation skin, tiredness, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that she had the a of SHINGRIX at 1:00 pm. She had a fever and she stayed in bed the following day and she had a headache and a lot of pain. Started in April 2018, the patient experienced itchy skin. The itching was incessant and she had tried cortisone creams, and over the counter products (OTC) and the only relief she could get was with scalding hot water which provided temporary relief and had a fever and she stayed in bed the following day and she had a headache and a lot of pain. The patient was reporting a sensitivity to her skin after the vaccination. For example, she had a mosquito bite that was super itchy and the site is red, thick and nasty at the time of reporting. The patient also had an electrocardiogram monitor on her chest and within one week, they had to move the leads for the monitor to her back and her chest was itching from April where the monitor electrodes were placed, back of her shoulders were also itching as well. Headache, pain, and fever resolved within 24 hours as well as tiredness. By Saturday (15th April 2018) the patient spent the day in bed and she felt okay other than the itching which was worse at the time of reporting. The contact details of physician was provided. For tolerance see case US2018GSK173824.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 62 years or 63 years. In May 2018, on Tuesday, the patient received SHINGRIX on an unknown arm. The patient experienced some soreness in her arm after the injection. In 2018, on Saturday, 4 days after vaccination, the patient noticed 3 red spots on her arm by the injection site about the size of a 50 cent coin. The patient stated that the spots looked like she was going to get shingles, but they resolved after about 2 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received SHINGRIX. On 18th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fever, joint pain and nausea. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the fever, joint pain and nausea were recovered/resolved. It was unknown if the reporter considered the pain in arm, fever, joint pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiry date were not reported. Within one day after receiving SHINGRIX, the patient experienced soreness in arm, nausea, joint aches, joint pain and a low grade fever. In September 2018, nausea, joint aches, joint pain and a low grade fever were resolved. Health care professional was not able to provide any further details on the SHINGRIX product administered. Event onset date of low grade fever, joint ache/joint pain and nausea were reported as 19th September 2018 (with latency of 1 day), clarification has been raised for the confirmation of latency.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Cyst, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of back pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cyst removal (had surgery in July 2017 to remove the cysts and it was successful). In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 28 days after receiving SHINGRIX, the patient experienced back pain, cyst and fever. On an unknown date, the outcome of the back pain, cyst and fever were unknown. It was unknown if the reporter considered the back pain, cyst and fever to be related to SHINGRIX. Additional details were provided as follows: The patient did mention that she was going on a mission trip back in December 2017 and had to take a lot of vaccines and medications beforehand. The patient mentioned hepatitis, malaria and typhoid. The patient had to spend one week in the surgical unit and was transferred to rehabilitation for two weeks. The patient was unsure if those vaccines and medications have anything to do with her condition. Four weeks after receiving the 1st dose of SHINGRIX, the patient started to experience the back ache and fever and the back ache was causing excruciating pain. She went to the emergency room for treatment and she was sent home only to go back to the hospital two days later because of the pain. After running tests, it was noticed that she had developed three cysts on her spine which might be sitting on nerves. The patient was unsure if the vaccine was the cause but now she is looking into finding out if that was a possibility.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On 19th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm and injection site erythema were unchanged and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The reporter was the nurse and patient herself. At 13:00, the patient received SHINGRIX subcutaneously instead of intramuscular route, which led to incorrect route of vaccine administration. On the day of reporting, in the morning, she noticed she had a sore arm and redness at injection site covering 2 by 2 inch area. No further details were provided. The reporter gave permission to contact their healthcare provider. The case was transferred to medical information team for further information on subcutaneous administration of vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received the 2nd dose of SHINGRIX. On 19th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and red blotches. On an unknown date, the outcome of the injection site swelling and red blotches were unchanged and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site pain and red blotches to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient received a dose of SHINGRIX vaccine at a pharmacy in left arm. The reporter put the patient on the phone, the patient stated that she experiencing swelling and pain at the injection site, along with red blotches covering area of 2 by 3 inches right below the injection site. On 19th September 2018, the patient noticed all of the symptoms. The pain at the injection site was better than the day before reporting. Swelling and red blotches are still unchanged.
Sex: F
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 female patient who received SHINGRIX (batch number 293AT, expiry date 27th February 2021) for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 2 months 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 details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in left deltoid. The reporter had a consumer that received the SHINGRIX vaccine and was still experiencing soreness and pain at the injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis, injection site erythema, injection site pain and pain. On 19th September 2018, the patient experienced injection site itching. On 20th September 2018, the patient experienced injection site swelling and injection site warmth. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site cellulitis and pain were unknown and the outcome of the injection site erythema, injection site swelling, injection site itching and injection site warmth were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site pain, injection site swelling, injection site itching, pain and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine on the left arm. The patient experienced pain and redness at the injection site for two days. On the day of reporting, the patient woke up with a raised red area and swelling at the injection site. The area was warm and she described the area as a bull's eye on her arm that is very swollen with itching at the injection site. The reporting nurse treated the area like it was cellulitis. The nurse also reported that the patient had itching a day before the reporting date and she had to put ice on the injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis, injection site erythema, injection site pain and pain. On 19th September 2018, the patient experienced injection site itching. On 20th September 2018, the patient experienced injection site swelling and injection site warmth. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site cellulitis and pain were unknown and the outcome of the injection site erythema, injection site swelling, injection site itching and injection site warmth were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site pain, injection site swelling, injection site itching, pain and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine on the left arm. The patient experienced pain and redness at the injection site for two days. On the day of reporting, the patient woke up with a raised red area and swelling at the injection site. The area was warm and she described the area as a bull's eye on her arm that is very swollen with itching at the injection site. The reporting nurse treated the area like it was cellulitis. The nurse also reported that the patient had itching a day before the reporting date and she had to put ice on the injection site.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Musculoskeletal pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (had many surgeries in life and prior to getting SHINGRIX). Concomitant products included hydrocodone. In April 2018, the patient received SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain. On an unknown date, the outcome of the pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain were not recovered/not resolved. The reporter considered the pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported to VAERS by the patient's pharmacist. The patient received SHINGRIX vaccine in the end of April 2018 in the left arm. The patient could not specify exactly when the events happened. However, soon after the SHINGRIX injection his whole arm where he received the injection was sore. The muscles of arms started getting sore. The patient started noticing that when he was sitting in a reclining chair and was resting his left arm on the arm chest, the pain from his arm was radiating up to his neck and shoulder. If the patient was in bed sleeping and he was side sleeping, it did not matter which side he slept on, he would get throbbing pain from bicep area of his left arm. The patient was on 3 pills of 5 mg hydrocodone a day. Even with that dose, he was still feeling the pain that he had as a result of getting the SHINGRIX. The patient had provided the contact details of his physician.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, 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 53-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (had many surgeries in life and prior to getting SHINGRIX). Concomitant products included hydrocodone. In April 2018, the patient received SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain. On an unknown date, the outcome of the pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain were not recovered/not resolved. The reporter considered the pain in arm, throbbing pain, shoulder pain, muscle soreness and neck pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported to VAERS by the patient's pharmacist. The patient received SHINGRIX vaccine in the end of April 2018 in the left arm. The patient could not specify exactly when the events happened. However, soon after the SHINGRIX injection his whole arm where he received the injection was sore. The muscles of arms started getting sore. The patient started noticing that when he was sitting in a reclining chair and was resting his left arm on the arm chest, the pain from his arm was radiating up to his neck and shoulder. If the patient was in bed sleeping and he was side sleeping, it did not matter which side he slept on, he would get throbbing pain from bicep area of his left arm. The patient was on 3 pills of 5 mg hydrocodone a day. Even with that dose, he was still feeling the pain that he had as a result of getting the SHINGRIX. The patient had provided the contact details of his physician.
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received FLULAVAL QUADRIVALENT 2017-2018 season (batch number 354H9, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced injection site rash and fever. On an unknown date, the outcome of the injection site rash and fever were recovered/resolved. It was unknown if the reporter considered the injection site rash and fever to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were reported as follows: This case was reported by the patient's mother. The patient received a flu shot last year and had a reaction on his arm at the injection site. The reporter called as a rash and said it was all around the injection site and down the arm as well. The rash was resolved after 4 days. She also reports that her son had a fever for 24-48 hours after the flu shot last year. This case was linked with case US2018GSK176589, reported by the same reporter for the same patient.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Rash, Rash pruritic, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced feeling unwell. In August 2018, the patient experienced itchy rash and varicella-like rash. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the itchy rash and varicella-like rash were not recovered/not resolved. It was unknown if the reporter considered the feeling unwell, itchy rash and varicella-like rash to be related to SHINGRIX. Additional information received as follows: The patient did not feel well. The reporter was asked if she could describe what she meant by that, she said she could not explain it, just not feeling well. A couple of days after getting SHINGRIX, the patient started seeing a few spots, like a rash on the lower abdomen area. The rash in the lower abdomen was almost gone. However, she started having another rash showing up on her breast area. She said that the rash looked like the chickenpox. The reporter also mentioned that she was getting an inner itching sensation on the rash. The reporter did say that she travelled a lot internationally with her husband. The contact details of the physician were provided. The case has been linked to the case US2018171895, reported by the same reporter (husband's case).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced feeling unwell. In August 2018, the patient experienced rash. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the rash was recovering/resolving. It was unknown if the reporter considered the feeling unwell and rash to be related to SHINGRIX. Additional information received as follows: The case was reported by the spouse of the patient. The patient did not feel well. The reporter was asked if she could describe what she meant by that, she said she could not explain it, just not feeling well. A couple of days after getting SHINGRIX, the patient started seeing a few spots, like a rash on the lower abdomen area. The patient was a lot better than his spouse. The rash in the lower abdomen was almost gone. The reporter did say that the patient travelled a lot internationally with her. The contact details of the physician were provided. The case has been linked to the case US2018171894, reported by the same reporter (spouse's case).
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction but was not sure if it was from the PEDIARIX. The reporter denied providing any information regarding the patient or reaction the patient had.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of injection site pain in a adult male patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 3 weeks after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient was the reporting pharmacist who reported adverse event on GRC after hours voicemail. The patient experienced severe pain at the injection site for 3 days. The patient reported it that it felt like someone hit him with a baseball bat. No other information was provided.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (10 years before the date of reporting). On 14th September 2018, the patient received the 2nd dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 17th September 2018, the patient experienced upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced soreness at the injection site the day of the vaccination. Three days after the vaccination date the patient experienced muscle aches all over and upset stomach presented. The aches were in shoulders, all joints, ankles and back. The soreness at the injection site lasted for 2 to 3 days. This case has been linked to the US2018172508, reported by the same reporter.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (10 years before the date of reporting). On 14th September 2018, the patient received the 2nd dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 17th September 2018, the patient experienced upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced soreness at the injection site the day of the vaccination. Three days after the vaccination date the patient experienced muscle aches all over and upset stomach presented. The aches were in shoulders, all joints, ankles and back. The soreness at the injection site lasted for 2 to 3 days. This case has been linked to the US2018172508, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient was a neighbor of the reporter. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter mentioned that the patient had experienced a headache following the SHINGRIX shot. No additional details were reported. This case is linked with US2018172507, reported by the same reporter.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX. On 26th August 2018, 3 days after receiving SHINGRIX, the patient experienced erythematous rash and raised rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the erythematous rash and raised rash were recovering/resolving. It was unknown if the reporter considered the erythematous rash and raised rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at another pharmacy and not the pharmacy that was reporting about him, so, the batch number and expiry date were not reported. After receiving SHINGRIX, the patient developed a rash that appeared red and raised, spread from his torso to back to stomach. The patient was treated at an urgent care, received BENADRYL which the reporter calling said did help.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, 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 78-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, the patient experienced pain in her arm following the 1st dose (received in an unknown arm) and therefore put off getting the 2nd dose beyond 6 months. Till the time of reporting, the patient had not received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination.