chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 11-MAY-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot# N035173, expiration date 09-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of PROQUAD was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1805USA010447.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Swollen tongue, Throat irritation
Clinical narrative: 6/29/18 Felt like tongue was swollen and noticed itchy throat. The injection site was reddened and sore. Patient's mother stated she had already been in contact with her daughter's allergist and was following their instructions. I instructed Patient's mother to take Patient to the ED if symptoms did not resolve or if worsened. 7/3/19 - Patient reports on issues are reddened and sore injection site.  7/5/18 - Patient reports no issues. Arm is no longer reddened or sore at injection site and no additional symptoms.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Injection site hypoaesthesia, Injection site pain, Pain in extremity, Ultrasound scan
Clinical narrative: Initially symptoms included massive pain and loss of strength in right arm. After several months the pain subsided, but was replaced by numbness at the site of the injection and slight intermittent pain at the site of injection. Currently (over 5 months later), loss of strength and slight numbness in right arm still persists. Occasionally, the site of injection is painful to the touch. Treatment included visiting 3 doctors to try to alleviate pain. Pain medications were prescribed and taken to try to mitigate the pain.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-APR-2016 the patient was treated (by an unspecified health care professional) at a medical center (hospital and ER) for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX by a certified physician assistant (PA-C) at a healthcare facility/clinic as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-FEB-2014 the patient was treated by the certified physician assistant (PA-C) at the healthcare facility/clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-SEP-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-MAY-2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-APR-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-JUN-2012, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated by a hospital for a severe vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a health department, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2013, the patient was treated by a physician for a vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2015, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 22-DEC-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated by a nurse practitioner at a family practice center for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, fever, nausea, injection site rash and injection site erythema. In June 2018, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the injection site swelling, fever and injection site erythema were unknown and the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, fever, nausea, injection site rash and injection site erythema to be related to SHINGRIX. Additional detail were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received vaccine on Thursday and experienced swollen red arm with rash at injection site, a fever of 101 degrees F and was nauseated for one day. The reporter stated that rash did not go away and was getting larger. No other details were provided. The callback was attempted to patient without success and limited report was filed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 23rd June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On 24th June 2018, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were recovering/resolving. The reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling and soreness at the injection site and about 2 inches below the injection site. No emergency room or doctor visit was required.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Coccydynia, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX vaccine (received other vaccine around October 2017). Concurrent medical conditions included osteoporosis (had the condition for about 2 years) and intervertebral disc protrusion (disk sites at L4, L5 and S1). Concomitant products included PROLIA and vitamin D. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. On 22nd June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 23rd June 2018, the patient experienced headache, muscle pain, appetite lost, back pain, fatigue, injection site erythema, injection site warmth, fever, influenza like illness, buttock pain, coccydynia and feeling bad. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, injection site erythema and injection site warmth were recovering/resolving and the outcome of the muscle pain, appetite lost, pain in arm, back pain, fatigue, fever, influenza like illness, buttock pain, coccydynia and feeling bad were not recovered/not resolved. The reporter considered the headache, muscle pain, appetite lost, pain in arm, back pain, fatigue and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth, fever, influenza like illness, buttock pain, coccydynia and feeling bad to be related to SHINGRIX. Additional details reported as follows: The patient reported that she decided herself to get the vaccine. The time of administration of the SHINGRIX was sometime between 11:00 AM and 1:00 PM. In the evening the day of vaccination, the patient noticed the soreness in the arm, when she was nudged in the arm. The patient had flu like symptoms (headache, fever, muscle ache and fatigue) first on Saturday morning. The patient looked at her arm at the injection site, the spot was very red and felt like the skin had a fever. The size of the redness on the arm looked like a big circle that covered her upper arm that has spread all around. When the patient went to go to the bathroom that same morning, she could hardly get out of the bed because of the pain she was experiencing. She said the pain was located lower back in the middle of her buttocks and her tail bone. The patient was still experiencing the pain, at the time of reporting. The patient had never felt pain like this before. The patient said that she felt bad on Saturday, but the symptoms got worse on Sunday. She did take some TYLENOL on the reporting morning for her headache and BENADRYL as treatment for possible for more reactions. A suggestion was made to contact her physician about her side effects. The patient had contacted VAERS and left a message for a call back. The patient was asked to make VAERS aware that she had already spoken to the company and filed a report.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site warmth, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX vaccine (received other vaccine around October 2017). Concurrent medical conditions included osteoporosis (had the condition for about 2 years) and intervertebral disc protrusion (disk sites at L4, L5 and S1). Concomitant products included PROLIA and vitamin D. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. On 22nd June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 23rd June 2018, the patient experienced headache, muscle pain, appetite lost, back pain, fatigue, injection site erythema, injection site warmth, fever, influenza like illness, buttock pain, coccydynia and feeling bad. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, injection site erythema and injection site warmth were recovering/resolving and the outcome of the muscle pain, appetite lost, pain in arm, back pain, fatigue, fever, influenza like illness, buttock pain, coccydynia and feeling bad were not recovered/not resolved. The reporter considered the headache, muscle pain, appetite lost, pain in arm, back pain, fatigue and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth, fever, influenza like illness, buttock pain, coccydynia and feeling bad to be related to SHINGRIX. Additional details reported as follows: The patient reported that she decided herself to get the vaccine. The time of administration of the SHINGRIX was sometime between 11:00 AM and 1:00 PM. In the evening the day of vaccination, the patient noticed the soreness in the arm, when she was nudged in the arm. The patient had flu like symptoms (headache, fever, muscle ache and fatigue) first on Saturday morning. The patient looked at her arm at the injection site, the spot was very red and felt like the skin had a fever. The size of the redness on the arm looked like a big circle that covered her upper arm that has spread all around. When the patient went to go to the bathroom that same morning, she could hardly get out of the bed because of the pain she was experiencing. She said the pain was located lower back in the middle of her buttocks and her tail bone. The patient was still experiencing the pain, at the time of reporting. The patient had never felt pain like this before. The patient said that she felt bad on Saturday, but the symptoms got worse on Sunday. She did take some TYLENOL on the reporting morning for her headache and BENADRYL as treatment for possible for more reactions. A suggestion was made to contact her physician about her side effects. The patient had contacted VAERS and left a message for a call back. The patient was asked to make VAERS aware that she had already spoken to the company and filed a report.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX vaccine (received other vaccine around October 2017). Concurrent medical conditions included osteoporosis (had the condition for about 2 years) and intervertebral disc protrusion (disk sites at L4, L5 and S1). Concomitant products included PROLIA and vitamin D. On 22nd June 2018, the patient received the 1st dose of SHINGRIX. On 22nd June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On 23rd June 2018, the patient experienced headache, muscle pain, appetite lost, back pain, fatigue, injection site erythema, injection site warmth, fever, influenza like illness, buttock pain, coccydynia and feeling bad. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, injection site erythema and injection site warmth were recovering/resolving and the outcome of the muscle pain, appetite lost, pain in arm, back pain, fatigue, fever, influenza like illness, buttock pain, coccydynia and feeling bad were not recovered/not resolved. The reporter considered the headache, muscle pain, appetite lost, pain in arm, back pain, fatigue and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth, fever, influenza like illness, buttock pain, coccydynia and feeling bad to be related to SHINGRIX. Additional details reported as follows: The patient reported that she decided herself to get the vaccine. The time of administration of the SHINGRIX was sometime between 11:00 AM and 1:00 PM. In the evening the day of vaccination, the patient noticed the soreness in the arm, when she was nudged in the arm. The patient had flu like symptoms (headache, fever, muscle ache and fatigue) first on Saturday morning. The patient looked at her arm at the injection site, the spot was very red and felt like the skin had a fever. The size of the redness on the arm looked like a big circle that covered her upper arm that has spread all around. When the patient went to go to the bathroom that same morning, she could hardly get out of the bed because of the pain she was experiencing. She said the pain was located lower back in the middle of her buttocks and her tail bone. The patient was still experiencing the pain, at the time of reporting. The patient had never felt pain like this before. The patient said that she felt bad on Saturday, but the symptoms got worse on Sunday. She did take some TYLENOL on the reporting morning for her headache and BENADRYL as treatment for possible for more reactions. A suggestion was made to contact her physician about her side effects. The patient had contacted VAERS and left a message for a call back. The patient was asked to make VAERS aware that she had already spoken to the company and filed a report.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (completed chemotherapy 4 months before the reporting date and also had radial therapy). On 24th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced chills. On 24th June 2018, the patient experienced muscle pain and upset stomach. On an unknown date, the outcome of the muscle pain, chills and upset stomach were not recovered/not resolved. The reporter considered the muscle pain, chills and upset stomach to be related to SHINGRIX. Additional information was received as follows: The patient stated that he experienced upset stomach and muscle aches. At the time of reporting, the patient was experiencing previous symptoms and also experienced chills and shivering.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX (batch number L7F7E, expiry date June 2019) for prophylaxis. Concurrent medical conditions included blood pressure high. Concomitant products included amlodipine, Clobetasol Ointment and PROCTOSOL-HC. On 21st June 2018 17:30, the patient received the 1st dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. In June 2018, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. After receiving SHINGRIX, the patient experienced pain, redness, soreness, and swelling at the injection site. The pain lasted for about 2 days, the redness lasted for about 4 days along with the soreness and swelling lasted for total of 3 days. The redness was circular and 4 inches in diameter. The patient was now recovered. The reporter gave permission to contact his health care physician.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. The reporter considered the sickness to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter was the wife of the patient. The age at vaccination was not reported. The patient experienced sick. The reporter wanted to report the event that she would call GlaxoSmithKline. The patient had denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male 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 pain in arm. On an unknown date, the outcome of the pain in arm 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 age at vaccination was not reported. The reporter reported that when she was getting SHINGRIX, the pharmacist who was administering the vaccine commented that her husband (the pharmacist's husband) complained about his arm hurting after the vaccination. No other information was provided. Clarification has been raised for the confirmation of the patient involved with same reporter.
Age: 75.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, 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 75-year-old patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cancer. Concomitant products included ASA, acyclovir, Calcium (Unknown), dexamethasone, omeprazole, LANTUS, NINLARO, Cranberry Pill and TOPROL. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site pain and fatigue to be related to SHINGRIX. Additional details reported as follows: The patient received vaccine on left, upper arm on outside area. The patient experienced pain, soreness, fatigue which lasted for two days. The pain and soreness from the first shot were located at the location of the injection. The caller did not report to any healthcare professional and did not seek any medical attention after either shot. The patient had denied permission to contact their physician. No additional information was available. This case has been linked with US2018GSK118633, reported by the same reporter for same patient.
Age: 75.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, 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 75-year-old patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cancer. Concomitant products included ASA, acyclovir, Calcium (Unknown), dexamethasone, omeprazole, LANTUS, NINLARO, Cranberry Pill and TOPROL. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site pain and fatigue to be related to SHINGRIX. Additional details reported as follows: The patient received vaccine on left, upper arm on outside area. The patient experienced pain, soreness, fatigue which lasted for two days. The pain and soreness from the first shot were located at the location of the injection. The caller did not report to any healthcare professional and did not seek any medical attention after either shot. The patient had denied permission to contact their physician. No additional information was available. This case has been linked with US2018GSK118633, reported by the same reporter for same patient.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old patient who received SHINGRIX (batch number Z9RR4, expiry date 30th November 2018) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of fatigue (On 14th April 2018, after 1st dose the patient experienced pain, soreness (refer case US2018113409)). Concurrent medical conditions included cancer. Concomitant products included ASA, acyclovir, Calcium Unknown, Cranberry Pill, dexamethasone, LANTUS, NINLARO, omeprazole and TOPROL. On 23rd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and pain in arm. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovering/resolving and the outcome of the injection site pain and pain in arm were recovered/resolved. The reporter considered the injection site erythema, injection site pain, injection site warmth and pain in arm to be related to SHINGRIX. Additional details reported as follows: The patient received vaccine on left, upper arm on outside area. The patient experienced redness, soreness, hot to touch and a red ring appeared three inches from the injection location. The red ring went half way around the arm and was 2 inches wide. The caller stated the second injection was more painful during the injection, than the first dose. The caller did not know how quickly after the injections the symptoms started. The patient had denied permission to contact their physician. No additional information was available. The reported batch number ZPRR4 for SHINGRIX did not exist and was updated to Z9RR4 as per the sales database.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old patient who received SHINGRIX (batch number Z9RR4, expiry date 30th November 2018) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of fatigue (On 14th April 2018, after 1st dose the patient experienced pain, soreness (refer case US2018113409)). Concurrent medical conditions included cancer. Concomitant products included ASA, acyclovir, Calcium Unknown, Cranberry Pill, dexamethasone, LANTUS, NINLARO, omeprazole and TOPROL. On 23rd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and pain in arm. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovering/resolving and the outcome of the injection site pain and pain in arm were recovered/resolved. The reporter considered the injection site erythema, injection site pain, injection site warmth and pain in arm to be related to SHINGRIX. Additional details reported as follows: The patient received vaccine on left, upper arm on outside area. The patient experienced redness, soreness, hot to touch and a red ring appeared three inches from the injection location. The red ring went half way around the arm and was 2 inches wide. The caller stated the second injection was more painful during the injection, than the first dose. The caller did not know how quickly after the injections the symptoms started. The patient had denied permission to contact their physician. No additional information was available. The reported batch number ZPRR4 for SHINGRIX did not exist and was updated to Z9RR4 as per the sales database.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site scab
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site scab in a 68-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site scab and injection site itching. On an unknown date, the outcome of the injection site scab and injection site itching were recovered/resolved. The reporter considered the injection site scab and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that a patient developed small scabs around the injection site 1 to 2 days after receiving the SHINGRIX. The scabs were itchy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Joint range of motion decreased, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of localized erythema in a 60-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On 5th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema, joint range of motion decreased, local swelling and discomfort. On an unknown date, the outcome of the localized erythema, joint range of motion decreased, local swelling and discomfort were recovered/resolved. The reporter considered the localized erythema, joint range of motion decreased, local swelling and discomfort to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the pharmacy student. The patient received SHINGRIX in the right deltoid. The healthcare professional did not have expiration date. In 2018, the patient experienced a localized reaction, which included redness, discomfort, decreased range of motion and swelling. The adverse events were resolved after 4 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 a 64-year-old female patient who received Shingrix for prophylaxis. On 18th April 2018, the patient received the 1st dose of Shingrix. On 18th April 2018, less than a day after receiving Shingrix, the patient experienced skin warm. On 19th April 2018, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm and skin warm were recovered/resolved. The reporter considered the swelling arm and skin warm to be probably related to Shingrix. Additional details were provided as follows: The patient's arm felt warm after receiving the Shingrix vaccination on right arm. The next day of vaccination, the patient developed swelling in her arm that lasted about a week.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved. The reporter considered the fever and shivering to be related to Shingrix. Additional details were provided as follows: The reporter was a friend of the patient. This case was not previously reported to anyone. The age at vaccination was not reported. The patient received the vaccine on an unknown arm. The reporter stated that the patient experienced chills, shivering, and a fever of 102 degree F. The reporter stated that the patient's symptoms resolved after 1 day. The reporter had limited information at the time of reporting. The reporter also had limited details regarding the patient's healthcare professional information. Lab Comments: On an unknown date, the lab test was performed.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of unexpected therapeutic effect in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included post herpetic neuralgia. 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 unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was an acquaintance of the patient but did not have her initials, DOB (date of birth) (believed she was in her late seventies or early eighties). The reporter did not have any of the product specific information. The HCP healthcare professional (reporter) reported that a patient with post herpetic neuralgia received a dose of SHINGRIX and subsequently noticed a marked reduction in symptoms and the patient was able to open her hand(s) for the first time in a year and a half. The reporter was eager, however, to provide information to safety and requests that the GSK (GlaxoSmithKline) was sending a form for reporter (or the patient) to fill out.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 71-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced swelling (serious criteria other: as per reporter) and pain (serious criteria other: as per reporter). On an unknown date, the outcome of the swelling and pain were unknown. It was unknown if the reporter considered the swelling and pain to be related to SHINGRIX. Additional details were provided as follows: As per the reporting pharmacist, the patient complained of pain and swelling that was the size of a goose egg following the dose of SHINGRIX received in the right deltoid.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever (serious criteria other: as per reporter) and chills (serious criteria other: as per reporter). The patient was treated with TYLENOL. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by healthcare professional (HCP) on live television for himself in the morning of the reporting date. The age at vaccination was not reported. When the patient got SHINGRIX, he stated it was such potent vaccine that night he had a little bit of a fever and chills. The patient felt it. The patient had TYLENOL and he felt better. It was unsure if these adverse events were reported previously.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: PATIENT IS COMPLAINING OF ON GOING INJECTION SITE PAIN THAT SHE DESCRIBED AS VERY PAINFUL AND TENDS TO WAKE HER UP AT NIGHT. SHE HAS NOT HAD ANY TREATMENT FOR THE PAIN AND IS MAKING AN APPOINTMENT TO SEE HER DOCTOR TO DISCUSS A REMEDY.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: PATIENT IS COMPLAINING OF ON GOING INJECTION SITE PAIN THAT SHE DESCRIBED AS VERY PAINFUL AND TENDS TO WAKE HER UP AT NIGHT. SHE HAS NOT HAD ANY TREATMENT FOR THE PAIN AND IS MAKING AN APPOINTMENT TO SEE HER DOCTOR TO DISCUSS A REMEDY.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Flushing, Hypoaesthesia, Oropharyngeal pain, Pain in jaw
Clinical narrative: I had numbness in my lower jaw, pain in the jaw hinges, and facial flushing in about 30 minutes or less. I called 911". The paramedics ran an EKG without finding problems. I declined transport to a hospital after talking to the paramedics. In their view, this was a side affect rather than an allergic reaction. At 12:24 PM, the facial flushing is essentially gone. I still have the jaw pain and numbness and a now a pain in the lower part of my throat.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt. got shingles 8 days after receiving vaccine, on 6/20/18.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Immediate post-injection reaction, Pain in extremity, Pallor
Clinical narrative: During administration of vaccine patient grabbed left arm and stated "my whole arm hurts!". Immediately after administration of HPV vaccine, patient turned pale, eyes rolled backwards, and he began to sway his body. Immediately laid patient down with feet elevated.Patient ate PEDIALYTE popsicle. After 15 minutes observation in office, patient's color returned to face, reported no longer felt dizzy. Ambulated out of office with steady gait.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Headache, Injection site pain, Pyrexia
Clinical narrative: Injection sight pain onset soon after shot lasted 2 days, fever and headache occurred that evening had subsided by next morning, trouble swallowing occurred a few minutes after vaccination lasted for 1/2 hour.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Expired medication given on July 2, 2018. Expiration date 6/29/2018. Lot Number: M046008 Expiration Date: 6/29/2018 Manufacturer and NDC: Merck & Co Inc and 0006-4047-41 Brand Name of Product:  ROTATEQ Rotavirus pentavalent.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation at injection site. Large area of the arm and it was given 1 week ago at this point.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: UNSURE IF ENERGIX B or RECOMBIVAX and UNSURE OF LOT, ROUTE, and DOSE - this shot was supposed to be a booster, patient would have had the series as an infant or child based on state requirements.