chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Lymphadenopathy, Myalgia, Oedema peripheral
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 3rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced chills, pain in arm, pain, facial flushing and swelling of feet. In September 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the pain, facial flushing and swelling of feet were recovering/resolving. It was unknown if the reporter considered the chills, pain in arm, pain, facial flushing and swelling of feet to be related to SHINGRIX. Additional details were reported as follows: The reporting nurse was the patient who received a dose of SHINGRIX in right arm. The patient reported that about 12 hours after the vaccination with SHINGRIX, she awoke with shaking chills which lasted about 10 minutes. The patient did not have a fever. On 5th September 2018, after 60 hours, the patient noted right axillary area tenderness. The next evening, the patient noted that her upper arm was tender to the touch. The events subsequently progressed to her lower arm being tender. The patient also began experiencing achiness, flushing of her face, and puffy feet. The axillary and arm tenderness lasted for approximately three days and it was resolving. The symptoms related to the achiness, flushing, and puffy feet were unchanged. The patient called back and stated that she changed her mind and did not want her physician to be contacted.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Weight increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 3rd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, 12 hrs after receiving SHINGRIX, the patient experienced chills, pain in arm, pain, facial flushing and swelling of feet. In September 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the pain, facial flushing and swelling of feet were recovering/resolving. It was unknown if the reporter considered the chills, pain in arm, pain, facial flushing and swelling of feet to be related to SHINGRIX. Additional details were reported as follows: The reporting nurse was the patient who received a dose of SHINGRIX in right arm. The patient reported that about 12 hours after the vaccination with SHINGRIX, she awoke with shaking chills which lasted about 10 minutes. The patient did not have a fever. On 5th September 2018, after 60 hours, the patient noted right axillary area tenderness. The next evening, the patient noted that her upper arm was tender to the touch. The events subsequently progressed to her lower arm being tender. The patient also began experiencing achiness, flushing of her face, and puffy feet. The axillary and arm tenderness lasted for approximately three days and it was resolving. The symptoms related to the achiness, flushing, and puffy feet were unchanged. The patient called back and stated that she changed her mind and did not want her physician to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes, Lymphadenopathy, Myalgia, Vulvovaginal pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of genital herpes in a 63-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. The patient's past medical history included genital herpes (since 1980). On 25th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 1 day after receiving SHINGRIX, the patient experienced muscle soreness. On 28th August 2018, the patient experienced genital herpes, vaginal itching and lymphadenopathy inguinal. On an unknown date, the outcome of the genital herpes and lymphadenopathy inguinal were not recovered/not resolved and the outcome of the muscle soreness was recovered/resolved and the outcome of the vaginal itching was recovering/resolving.  It was unknown if the reporter considered the genital herpes, muscle soreness, vaginal itching and lymphadenopathy inguinal to be related to SHINGRIX. Additional details were reported as follows: This case was not previously reported to the physician. The patient received SHINGRIX vaccine in left deltoid. On 28th August 2018 or 29th August 2018, the patient started to experienced really bad genital herpes outbreak. The patient had not an outbreak this bad in years. The patient stated that she had itching on her right labia and swollen glands in her groin area. The patient starting to have the symptoms in her left labia as well at the reporting time. The patient stated that she also experienced muscle soreness in her left arm one day after receiving the SHINGRIX injection. The physician's details were by the reporter. This case was link to case US2018GSK167364, reported by the same reporter for the same patient.
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Hypersensitivity, Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of asthmatic attack in a female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. The patient's past medical history included asthma. Concurrent medical conditions included egg allergy. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, several minutes after receiving Flu trivalent vaccine, the patient experienced asthmatic attack, wheezing and documented hypersensitivity to administered product. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the asthmatic attack and wheezing were recovered/resolved and the outcome of the documented hypersensitivity to administered product was unknown. The reporter considered the asthmatic attack and wheezing to be related to Flu trivalent vaccine. Additional details were provided as follows: The patient received flu vaccine in an unknown arm. The patient stated that approximately 15 years ago she received a flu vaccine (unknown manufacturer) and a few minutes after receiving the injection, she experienced wheezing and had an asthma attack. The patient stated that she was allergic to eggs and believed that it was the egg component of the vaccine that caused the asthma attack. The patient stated that prior to this incident, she did not have an asthma attack for 30 years. The patient stated that she no longer gets the flu shot. The patient had denied permission to contact their physician. The patient had limited information regarding the event. The patient did not want to provide age or date of birth.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 5th September 2018, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the headache and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, the injection hurt going in yesterday (on the day before reporting/on the day of vaccination) and she woke with a severe headache in the morning on the date of reporting. The patient refused to provide her contact information. The patient had denied permission to contact their physician.
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Headache, Nausea, Pruritus
Clinical narrative: This case was reported by a nurse via out of hour services and described the occurrence of pruritus in a adult female patient who received BOOSTRIX (batch number 2T923, expiry date unknown) for prophylaxis. On 5th September 2018, the patient received BOOSTRIX. On 5th September 2018, less than an hour after receiving BOOSTRIX, the patient experienced pruritus and several minutes after vaccination, the patient experienced headache and nausea and less than a day after vaccination, the patient felt flushed. The patient was treated with antihistamine. On an unknown date, the outcome of the pruritus, headache, flushing and nausea were unknown. It was unknown if the reporter considered the pruritus, headache, flushing and nausea to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is a nurse who was patient. A female patient reported that within 20 minutes after receiving a BOOSTRIX injection, she experienced itching. After 45 minutes, the patient said the itching became worse. Ninety minutes later, she reported nausea. Minutes later, the patient reported headache. The patient also said, she felt flushed. The patient took an antihistamine and itching improved. She reported that, she had never had any reaction of this type to any previous vaccination in her life.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes, Paraesthesia oral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sores. On 30th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th September 2018, 5 days after receiving SHINGRIX, the patient experienced cold sores. On 5th September 2018, the patient experienced tingling lips. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the tingling lips was unknown. It was unknown if the reporter considered the cold sores and tingling lips to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 69 or 70 years old. The patient received the SHINGRIX on an unknown arm. The patient stated she had a cold sore on the side of her mouth. She had no tingling before it appeared. The night before the date of reporting, 6 days after receiving the SHINGRIX, the patient felt a tingling in her lips and experienced another two cold sores on her lips. The patient sought reimbursement.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Lethargy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 17th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site rash and skin warm. On 18th June 2018, the patient experienced lethargy and pain. On an unknown date, the patient experienced product supply issue. In July 2018, the outcome of the injection site erythema, injection site pain, pain, injection site swelling and injection site rash were recovered/resolved. On an unknown date, the outcome of the lethargy and skin warm were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, lethargy, pain, injection site swelling, injection site rash and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left deltoid. The next day, after SHINGRIX injection the patient did have lethargy and was achy but lethargy passed within the first 24 hours. The patient stated that her arm was warm to touch. She had soreness at the injection site which developed within 48 hours of getting the vaccination. The area got bigger with swelling and a rash developed after the erythema. The entire episode took 3 to 4 weeks to completely resolve. The patient planned to obtain the second part of the SHINGRIX series despite the side effects, however, was unable to locate any providers who had the product in her area (product supply issue).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product supply issue, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 17th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site rash and skin warm. On 18th June 2018, the patient experienced lethargy and pain. On an unknown date, the patient experienced product supply issue. In July 2018, the outcome of the injection site erythema, injection site pain, pain, injection site swelling and injection site rash were recovered/resolved. On an unknown date, the outcome of the lethargy and skin warm were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, lethargy, pain, injection site swelling, injection site rash and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left deltoid. The next day, after SHINGRIX injection the patient did have lethargy and was achy but lethargy passed within the first 24 hours. The patient stated that her arm was warm to touch. She had soreness at the injection site which developed within 48 hours of getting the vaccination. The area got bigger with swelling and a rash developed after the erythema. The entire episode took 3 to 4 weeks to completely resolve. The patient planned to obtain the second part of the SHINGRIX series despite the side effects, however, was unable to locate any providers who had the product in her area (product supply issue).
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 55-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date unknown) for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX(intramuscular). On 31st August 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the erythema, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that patient experienced "significant erythema," injection site swelling, and injection site warmth the day of vaccine administration. The duration was unknown, but symptoms had resolved. The reporter did not have expiration date.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 57-year-old male patient who received SHINGRIX (batch number L9CS4, expiry date unknown) for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash and rash. The patient was treated with diphenhydramine and hydrocortisone. On 3rd August 2018, the outcome of the injection site rash and rash were recovered/resolved. It was unknown if the reporter considered the injection site rash and rash to be related to SHINGRIX. Additional detail were provided as follows: The pharmacist reported that patient experienced a rash which was spread from their injection site to their chest and back. The patient was treated with diphenhydramine and hydrocortisone. The reporter did not have expiration date.
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Laboratory test normal, Mobility decreased, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of polymyalgia in a adult female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, 3 days after receiving SHINGRIX, the patient experienced polymyalgia and mobility decreased. On 5th September 2018, 8 days after vaccination, the patient experienced walking difficulty. The patient was treated with prednisone. On 6th September 2018, the outcome of the polymyalgia was not recovered/not resolved. On an unknown date, the outcome of the walking difficulty and mobility decreased were unknown. The reporter considered the polymyalgia, walking difficulty and mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. All the laboratory values were found to be normal for the patient. The patient was vaccinated with the 1st dose of SHINGRIX at a local pharmacy and not at the physician office. Approximately 3 days after vaccination with SHINGRIX, the patient reported that it was an effort to lift her feet. On 5th September 2018, the patient was seen in the office and was noted that she could hardly walk or move. At the time of reporting, the healthcare professional stated that the patient had not turned to be worsened and seemed to be a little better. The healthcare professional reported that the event was due to temporal relationship between SHINGRIX administration and the onset of symptoms and also due to the lack of evidence for any other cause of patient's symptoms. Lab Comments: On an unspecified date, the patient carried out some unspecified laboratory test that showed the values as normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included genital herpes. On 31st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, less than a day after receiving SHINGRIX, the patient experienced headache. On 5th September 2018, the patient experienced nasal congestion, tiredness, fever and chills. The patient was treated with TYLENOL and Aspirin. On an unknown date, the outcome of the headache was unknown and the outcome of the nasal congestion and tiredness were not recovered/not resolved and the outcome of the fever and chills were recovering/resolving. It was unknown if the reporter considered the headache, nasal congestion, tiredness, fever and chills to be related to SHINGRIX. Additional detail were provided as follows: The patient started having a headache that day and it had been off and on since the day of vaccination. At the time of the call, the patient had taken some TYLENOL and did not have a headache. The patient reported she has felt different ever since the injection, but yesterday 5 day after receiving vaccination, the patient felt very tired had fever, chills and started to feel some congestion. The patient took some aspirin and TYLENOL to treat the symptoms. The patient does not have a fever, but does still feel some chills and was still tired. The patient was also more congested. The patient was not sure if the symptoms were related to the vaccine, or if she was getting sick with something else.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram abnormal, Culture negative, Hyperhidrosis, Malaise
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pneumonia in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included bronchiectasis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant), fever, chills, malaise, widespread rash, sweating and nausea. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the pneumonia, fever, chills, malaise, widespread rash, sweating and nausea were recovering/resolving. It was unknown if the reporter considered the pneumonia, fever, chills, malaise, widespread rash, sweating and nausea to be related to SHINGRIX. Additional details were provided as follows: his case was reported by Medical liaison. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced intermittent wide spread rash. The patient had been experiencing all the events since one month. The patient visited the doctor and had full body work up done. Test results showed cultures were negative. Other labs noted inflammatory process was present such as elevated white blood cells (WBC) count. The patient also went through a computerised tomogram (CAT) scan, which showed presence of Pneumonia. The patient was put on antibiotics and patient was doing little better as per the physician. No further details were provided. As per the medical liaison the previous field representative had reported this event to them and wanted to provide add on information to previous report. However, no duplicate case was identified.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pneumonia, Pyrexia, Rash generalised, White blood cell count increased
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pneumonia in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included bronchiectasis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant), fever, chills, malaise, widespread rash, sweating and nausea. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the pneumonia, fever, chills, malaise, widespread rash, sweating and nausea were recovering/resolving. It was unknown if the reporter considered the pneumonia, fever, chills, malaise, widespread rash, sweating and nausea to be related to SHINGRIX. Additional details were provided as follows: his case was reported by Medical liaison. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced intermittent wide spread rash. The patient had been experiencing all the events since one month. The patient visited the doctor and had full body work up done. Test results showed cultures were negative. Other labs noted inflammatory process was present such as elevated white blood cells (WBC) count. The patient also went through a computerised tomogram (CAT) scan, which showed presence of Pneumonia. The patient was put on antibiotics and patient was doing little better as per the physician. No further details were provided. As per the medical liaison the previous field representative had reported this event to them and wanted to provide add on information to previous report. However, no duplicate case was identified.
Age: 62.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Diabetic foot, Infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diabetic ulcer in a 62-year-old male patient who received MENVEO (batch number M16199, expiry date August 2018) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included TRUMENBA and eculizumab (Soliris). On 12th June 2018, the patient received the 1st dose of MENVEO. In July 2018, less than a year after receiving MENVEO, the patient experienced diabetic ulcer (serious criteria GSK medically significant) and infection. On an unknown date, the outcome of the diabetic ulcer and infection were recovering/resolving. The reporter considered the diabetic ulcer and infection to be unlikely related to MENVEO. Additional details were provided as follows: The patient was diabetic. The patient was also on soliris. On 12th June 2018, the patient was administered MENVEO in the right deltoid and TRUMENBA. The patient experienced a diabetic ulcer on the foot at the end of July 2018. The health care professional stated that the patient was due for 2nd dose of MENVEO in August 2018. The health care professional wanted to delay the vaccine for a few months and wanted to know what the efficacy would be. Also, the health care professional stated that the ulcer was infected and the patient might need surgery. No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Incorrect dose administered, Myalgia, Nausea, Neck pain
Clinical narrative: This case was reported by a physician via patient support programs and described the occurrence of blistery rash in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date but did not experienced any adverse event). In August 2018, the patient received the 2nd dose of SHINGRIX 1.5 ml. In August 2018, unknown after receiving SHINGRIX, the patient experienced overdose. On an unknown date, the patient experienced blistery rash, hives, fever, myalgia, neck pain, tremor, nausea and pruritus. On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the hives, fever, myalgia and neck pain were recovered/resolved and the outcome of the tremor, nausea, pruritus and overdose were unknown. It was unknown if the reporter considered the blistery rash, hives, fever, myalgia, neck pain, tremor, nausea and pruritus to be related to SHINGRIX. Additional details were reported as follows: This case was received from the physician via the vaccine patient assistant program. The reporting physician was a patient and who was also the physician for the facility. The age at vaccination was not reported. The patient did not experienced any events with 1st dose of SHINGRIX. Less than a year after vaccination with 2nd dose, the patient experienced rash with blisters, hives, fever, myalgia including significant neck pain, the shakes many times uncontrollable, nausea, significant itching which lasted for 2 and half weeks. The patient received 1.5 ml of SHINGRIX vaccine, which led to overdose. At the time of reporting, rash was fading. The symptoms would go away and fire back up. The patient missed significant time from work. The caller informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. This report did not include a product complaint.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash vesicular, Tremor, Urticaria
Clinical narrative: This case was reported by a physician via patient support programs and described the occurrence of blistery rash in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date but did not experienced any adverse event). In August 2018, the patient received the 2nd dose of SHINGRIX 1.5 ml. In August 2018, unknown after receiving SHINGRIX, the patient experienced overdose. On an unknown date, the patient experienced blistery rash, hives, fever, myalgia, neck pain, tremor, nausea and pruritus. On an unknown date, the outcome of the blistery rash was recovering/resolving and the outcome of the hives, fever, myalgia and neck pain were recovered/resolved and the outcome of the tremor, nausea, pruritus and overdose were unknown. It was unknown if the reporter considered the blistery rash, hives, fever, myalgia, neck pain, tremor, nausea and pruritus to be related to SHINGRIX. Additional details were reported as follows: This case was received from the physician via the vaccine patient assistant program. The reporting physician was a patient and who was also the physician for the facility. The age at vaccination was not reported. The patient did not experienced any events with 1st dose of SHINGRIX. Less than a year after vaccination with 2nd dose, the patient experienced rash with blisters, hives, fever, myalgia including significant neck pain, the shakes many times uncontrollable, nausea, significant itching which lasted for 2 and half weeks. The patient received 1.5 ml of SHINGRIX vaccine, which led to overdose. At the time of reporting, rash was fading. The symptoms would go away and fire back up. The patient missed significant time from work. The caller informed that they have reported an experience with a GlaxoSmithKline product that needs to be shared with GSK. This report did not include a product complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms and soreness at injection site. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 29th August 2018, 28 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the physician for for himself. Four weeks after receiving SHINGRIX, the patient experienced mild case of shingles.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Lip swelling, Swelling face
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of lip swelling in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX. On 19th August 2018, 2 days after receiving SHINGRIX, the patient experienced lip swelling, facial swelling and lip blister. The patient was treated with Acyclovir Ointment and BENADRYL. On an unknown date, the outcome of the lip swelling, facial swelling and lip blister were recovered/resolved. The reporter considered the lip swelling, facial swelling and lip blister to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Two days after vaccination with SHINGRIX vaccine, the patient experienced swollen lips, facial swelling, blisters on lips. This symptoms were lasted for 7 days. The physician thought that, this events were related to SHINGRIX. The patient was given acyclovir ointment and BENADRYL for treatment. The reporter agreed to follow up from GlaxoSmithKline.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pain
Clinical narrative: Aches, pains. Flu like feeling. Nausea.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Swelling face
Clinical narrative: Patient experienced swelling in the face. The swelling decreased after patient took BENADRYL.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Influenza like illness, Pain, Swelling
Clinical narrative: Swelling, Headache, diarrhea, aches, pain. Flu like symptoms.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Child in for routine PCV13 vaccine. Placed in side saddle position on mother's lap, technique indicated/described by CDC. Mom was instructed on how to hold child during this technique. During the injection of the vaccine into the left thigh child moved leg enough that the needle came out of the left before the entire vaccine could be injected, only about 1/2 given. Following the incident a small second puncture site noted just next to the vaccine injection site which must have happened during incident. Area wiped clean and Band-Aid applied. Mom instructed that this dose could not be counted as valid as it was not the complete amount. Mother was very understanding and did schedule another appointment in 1 month to get the dose repeated. She was instructed on aftercare and the child was kept for the 15 minute post immunization observation period. Notification sent to local nurse supervisor, immunization nurse program coordinator and the immunization program chief.
Age: 66.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: Painful right shoulder has persisted for 2 weeks, and has shown no sign of going away.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Skin warm, Vaccination site swelling
Clinical narrative: Swelling in left arm up to 5 inches below vaccination site. Arm is very itchy and hot to touch. We will refer patient to doctor to follow up with treatment and outcome.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 1 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 20-AUG-2018 the patient was inadvertently administered one dose of PROQUAD (strength and route were not reported; lot # N019249 and expiration date 20-DEC-2018) and one dose of VARIVAX (strength, route, batch/ lot # and expiration date were not reported) for prophylaxis(overdose). No adverse effects were reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician refers to an 18 year old patient (gender unknown). Information about medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 injection (dose, strength, route, lot# and expiration date unknown) for prophylaxis. On an unknown date in March 2018, the patient was vaccinated with the third dose of GARDASIL 9 injection (dose, strength, route, lot# and expiration date unknown) for prophylaxis. On 22-AUG-2018, the patient was vaccinated with the fourth dose of GARDASIL 9 (indication prophylaxis; dose, strength, route, lot# and expiration date unknown). No adverse effects reported.
Sex: M
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months, in approximately 2018. The patient was 4 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810; US-009507513-1809USA004055; US-009507513-1809USA004057; US-009507513-1809USA004058; US-009507513-1809USA004059; US-009507513-1809USA004060; US-009507513-1809USA004061.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Influenza like illness, Injection site pain
Clinical narrative: I rec'd the 1st of the series of SHINGRIX last Fri. and had a pretty miserable 48 hours thereafter. My symptoms can best be described as flu like; total body aches, fever, extreme fatigue (I probably slept 15 hours, on and off) and nausea, as well s severe pain at the injection site. I'm pretty much back to normal today (9.17.18).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I rec'd the 1st of the series of SHINGRIX last Fri. and had a pretty miserable 48 hours thereafter. My symptoms can best be described as flu like; total body aches, fever, extreme fatigue (I probably slept 15 hours, on and off) and nausea, as well s severe pain at the injection site. I'm pretty much back to normal today (9.17.18).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: I rec'd the 1st of the series of SHINGRIX last Fri. and had a pretty miserable 48 hours thereafter. My symptoms can best be described as flu like; total body aches, fever, extreme fatigue (I probably slept 15 hours, on and off) and nausea, as well s severe pain at the injection site. I'm pretty much back to normal today (9.17.18).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: I rec'd the 1st of the series of SHINGRIX last Fri. and had a pretty miserable 48 hours thereafter. My symptoms can best be described as flu like; total body aches, fever, extreme fatigue (I probably slept 15 hours, on and off) and nausea, as well s severe pain at the injection site. I'm pretty much back to normal today (9.17.18).
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Upper chest and neck itching and developing hives. No respiratory symptoms. No treatment required.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema, induration, warmth to touch at injection site approximately 2.5 inches in length and 2 inches in width. Lasting from day of vaccination to full day after vaccination. Slight ecchymosis at bottom of reaction site/2 inches below injection site, day after injection.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event noted.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Patient reported swelling of her lips and left eye within 2 hours of administration. She took 25 mg of BENADRYL at that time and repeated the dose two hours later. She never experienced difficulty breathing. She felt better after the 1st dose of BENADRYL, but took a second dose to be safe. No other treatment was required.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Unable to lift arm above head for about 2 weeks; throbbing pain for 2-3 days.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Altered state of consciousness, Flushing, Pallor, Tremor
Clinical narrative: Patient started he has never fainted for a vaccine before during the questionnaire. When he was paying for his vaccine he got pale and his arms started shaking. I asked if he's going to pass out and he said yes. We laid him on the floor and elevated his feet. Later he stated this happens before when he gave blood. We gave him orange juice and he sat for 20 minutes then said he feels fine and wanted to leave. He didn't want us to call EMS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Still unable to raise arm above head; throbbing pain upon movement; diffficulty getting out of bed and putting on bra. NOTE: Pt. says that 2nd dose was in Right arm and not Left arm, however documentation states that both were given in Left arm.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male patient. The patient's concurrent condition and medical history were not reported. On 04-SEP-2018, the patient was vaccinated with VARIVAX (lot # R006753, Expiration Date: 06-MAR-2020) (dose, unit not provided) dose 1, subcutaneously and PROQUAD (lot # R004440, Expiration Date: 12-AUG-2019) (dose, unit and therapy type not provided) dose 1, subcutaneously for prophylaxis. The patient was concomitantly vaccinated with PREVNAR 13. He was vaccinated in a private doctor's office/hospital using private funds. The patient was to receive MMR plus varicella vaccines. Measles, PROQUAD was drawn up thinking it was MMR not realizing the varicella was in the vaccine as well. Varicella was also given separately, so patient technically got an extra dose of varicella. Mother of the child was notified that day of error and advised on any reactions/symptoms to watch out for. As of the reporting, no adverse reaction had been noted. No prescription drug treatment was required for the experience. The patient had no illnesses at the time of vaccination and had a birth weight of 3.728 kg.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received by a pharmacist and concerns a pregnant female patient (age not provided). There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 29-AUG-2018 the patient was vaccinated with M-M-R II for immigration purposes (prophylaxis), (dose, frequency, route of administration, lot number and expiration date were not reported) and according to the reporter the patient was pregnant at the moment of vaccination. It was unknown if the patient sought medical attention, or if any laboratory diagnostic studies were performed.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 07-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006747 and an expiration date of 03-SEP-2019; however, dosage number and route of administration were not reported), for prophylaxis and was reconstituted with properly stored sterile diluent (MERCK). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: 6° F to 14°F for 6 minutes. Reportedly, there had been no previous temperature excusions and the aformentioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter; Sender's Comments: US-009507513-1809USA006757: US-009507513-1809USA006756.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes ophthalmic, Herpes zoster, Pain, 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-OCT-2010, the patient was inoculated at a medical center/hospital with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-SEP-2015, the patient was treated by the medical center/hospital for a blistering vesicular outbreak which was diagnosed as ocular shingles. The patient was prescribed codeine for management of his painful symptoms and chronic pain. 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, persistent strain condition of herpes zoster/ blistering vesicular outbreak, which was diagnosed as ocular shingles was determined to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 20-AUG-2018, the patient was vaccinated with a improperly stored PROQUAD recombinant Human Albumin (rHA) (which had a lot # of R006747 and an expiration date of 03-SEP-2019; however, dosage number and route of administration were not reported), for prophylaxis and was reconstituted with properly stored Merck sterile diluent. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: 6 degrees F to 14 degrees F for 6 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1809USA006757; US-009507513-1809USA004794.