chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included rheumatoid arthritis (patient takes prednisone for this). Concomitant products included prednisone. On 28th July 2018, the patient received the 1st dose of SHINGRIX. On 2nd August 2018, 5 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the erythematous rash was unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the pain in arm and chills to be related to SHINGRIX. The reporter considered the erythematous rash to be possibly related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who herself was patient. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced sore arm and chills. On 2nd August 2018 in morning, the patient woke up and found four or five red bumps on her abdomen that look similar to bug bites but did not itch and on the same day she was seen by her gastroenterologist for a regular appointment, and the physician noted it appeared to be a reaction to the SHINGRIX. The patient declined to provide physician and noted she was willing to answer any follow up questions or details needed for the report. The patient had denied permission to contact their physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Alendronate. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, 6 hrs after receiving SHINGRIX, the patient experienced shivering, and pain. On 26th July 2018, less than a day after receiving SHINGRIX, the patient experienced stomach pain, fever, loose stools, dizziness and headache. On 27th July 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the shivering, fatigue, dizziness, stomach pain, fever, loose stools, pain and headache were recovered/resolved. It was unknown if the reporter considered the shivering, fatigue, dizziness, stomach pain, fever, loose stools, pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 26th July 2018, 6 hours after receiving SHINGRIX, the patient experienced achiness and shivering and on the same day, less than a day after vaccination, the patient experienced headache, stomach ache, fever, loose stool and dizziness. On 27th July 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue. The patient reported that, the representative nurse was very, very kind, and sympathetic for her side effects that she had with the SHINGRIX vaccine, and the only thing that did not get resolved knew whether she was going to have another reaction when she had the second shot. So, it was not a good experience, as far as her shot, but the patient's experience with the representative nurse was excellent. The patient planned to follow-up with her physician on an unknown date. This case has been linked to the US2018139538 and US2018139534, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pancreatic disorder, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Alendronate. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, 6 hrs after receiving SHINGRIX, the patient experienced shivering, and pain. On 26th July 2018, less than a day after receiving SHINGRIX, the patient experienced stomach pain, fever, loose stools, dizziness and headache. On 27th July 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the shivering, fatigue, dizziness, stomach pain, fever, loose stools, pain and headache were recovered/resolved. It was unknown if the reporter considered the shivering, fatigue, dizziness, stomach pain, fever, loose stools, pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 26th July 2018, 6 hours after receiving SHINGRIX, the patient experienced achiness and shivering and on the same day, less than a day after vaccination, the patient experienced headache, stomach ache, fever, loose stool and dizziness. On 27th July 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue. The patient reported that, the representative nurse was very, very kind, and sympathetic for her side effects that she had with the SHINGRIX vaccine, and the only thing that did not get resolved knew whether she was going to have another reaction when she had the second shot. So, it was not a good experience, as far as her shot, but the patient's experience with the representative nurse was excellent. The patient planned to follow-up with her physician on an unknown date. This case has been linked to the US2018139538 and US2018139534, reported by the same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Hyperhidrosis, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included losartan. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain, headache, sweating and erythema. On an unknown date, the outcome of the pain, headache, sweating and erythema were recovered/resolved. It was unknown if the reporter considered the pain, headache, sweating and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX on right arm. This case has been linked to the US2018139533 and US2018139538, reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Insomnia
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 male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine with an associated reaction of injection site pain (received 2 years ago without incident). On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, headache and fatigue. In August 2018, the patient experienced difficulty sleeping, fever and chills. On an unknown date, the outcome of the injection site pain and fatigue were recovering/resolving and the outcome of the difficulty sleeping, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, difficulty sleeping, headache, fever, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. This case was not reported to anyone previously. The patient received the ZOSTAVAX vaccine 2 years ago without incident; accept for soreness at the injection site. In the early afternoon, the patient received SHINGRIX in the left deltoid. The patient began to have pain at the injection site in the early evening and became extremely fatigued after dinner. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, fatigue and developed a headache prior to going to bed. In August 2018, 12 hours after vaccination, the patient experienced fever and chills in the middle of the night and had difficulty sleeping. The fever and chills and difficulty sleeping have resolved, but the patient continued to feel tired and had soreness at the injection site.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
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 male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine with an associated reaction of injection site pain (received 2 years ago without incident). On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, headache and fatigue. In August 2018, the patient experienced difficulty sleeping, fever and chills. On an unknown date, the outcome of the injection site pain and fatigue were recovering/resolving and the outcome of the difficulty sleeping, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, difficulty sleeping, headache, fever, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. This case was not reported to anyone previously. The patient received the ZOSTAVAX vaccine 2 years ago without incident; accept for soreness at the injection site. In the early afternoon, the patient received SHINGRIX in the left deltoid. The patient began to have pain at the injection site in the early evening and became extremely fatigued after dinner. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain, fatigue and developed a headache prior to going to bed. In August 2018, 12 hours after vaccination, the patient experienced fever and chills in the middle of the night and had difficulty sleeping. The fever and chills and difficulty sleeping have resolved, but the patient continued to feel tired and had soreness at the injection site.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 31st July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the patient experienced injection site pain, injection site warmth, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site swelling were not recovered/not resolved and the outcome of the fatigue was recovered/resolved and the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, fatigue, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: At afternoon, the patient received SHINGRIX on the right arm. On 2nd July 2018, the patient called the pharmacist and reported that he had pain, redness and swelling in the injection site area. It was also hot to the touch. The patient described the redness and swelling area to be the circumference of a baseball. It was not known when these symptoms presented. The patient also said he felt the blahs on the day before the reporting date, which the pharmacy interpreted as fatigue.
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain 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, less than a year after receiving SHINGRIX, the patient experienced pain, pain in arm and lethargy. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain, pain in arm and lethargy were recovered/resolved. It was unknown if the reporter considered the pain, pain in arm and lethargy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt achy, had a sore arm, and was lethargic after receiving the SHINGRIX vaccine. She took TYLENOL and went to bed to sleep it off. The events aches, soreness, and lethargy resolved within six hours. Limited information was reported, the reporter did not wish to complete the safety report and hence a follow up was discouraged. The reporter also stated that, she did not complain about the SHINGRIX and was very happy with her experience with the SHINGRIX vaccine. For tolerance after 2nd dose of SHINGRIX, refer US2018GSK144911.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis viral
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of viral conjunctivitis in a 70-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. On 18th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 30 days after receiving SHINGRIX, the patient experienced viral conjunctivitis. On an unknown date, the outcome of the viral conjunctivitis was resolved with sequelae. It was unknown if the reporter considered the viral conjunctivitis to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that patient experienced viral pink eye. It was not resolved with treatment. The reported batch number 9A539 for SHINGRIX did not exist and was updated to 9AS39 as per the sales database.
Sex: M
Vaccine: MENB
Symptoms: Muscular weakness, Neck pain, Paraesthesia, Peripheral coldness, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of neck pain in a 18-year-old male patient who received BEXSERO (batch number 16A301, expiry date 1st January 2019) for prophylaxis. On 17th July 2018, the patient received BEXSERO. In July 2018, 2 days after receiving BEXSERO, the patient experienced neck pain and rash. On an unknown date, the patient experienced coldness of lower extremities, tingling of extremity and weakness in extremity. On an unknown date, the outcome of the neck pain, coldness of lower extremities, tingling of extremity and weakness in extremity were not recovered/not resolved and the outcome of the rash was recovering/resolving. It was unknown if the reporter considered the neck pain, coldness of lower extremities, tingling of extremity, rash and weakness in extremity to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported, but it could be 17 years or 18 years. At the time of reporting, the patient was still experiencing neck pain and new symptoms have developed. Less than a month after receiving vaccination, the patient experienced weakness and tingling in the left leg and weakness and tingling in the right arm, and left leg also felt cold to the touch. The healthcare professional would not provide the patient information.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 11th July 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, 2 days after receiving SHINGRIX, the patient experienced fatigue, nausea, shivering, headache, chest pressure and difficulty breathing. On an unknown date, the outcome of the fatigue, nausea, shivering, headache, chest pressure and difficulty breathing were recovered/resolved. It was unknown if the reporter considered the fatigue, nausea, shivering, headache, chest pressure and difficulty breathing to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The healthcare professional reported that the events fatigue, nausea, shivering and headache resolved in 2 days. The next night, the patient also experienced trouble in breathing and felt heavy pressure on his chest which led to an emergency room visit.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 11th July 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular). In July 2018, 2 days after receiving SHINGRIX, the patient experienced fatigue, nausea, shivering, headache, chest pressure and difficulty breathing. On an unknown date, the outcome of the fatigue, nausea, shivering, headache, chest pressure and difficulty breathing were recovered/resolved. It was unknown if the reporter considered the fatigue, nausea, shivering, headache, chest pressure and difficulty breathing to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The healthcare professional reported that the events fatigue, nausea, shivering and headache resolved in 2 days. The next night, the patient also experienced trouble in breathing and felt heavy pressure on his chest which led to an emergency room visit.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown. Additional details were provided as follows: This case came via email into Medical Information's queue. The age at vaccination was not reported. The patient had SHINGRIX vaccine approximately 1 month before the reporting date. On 7th August 2018, the patient was scheduled for breast cancer chemotherapy, and had been advised by her oncologist to avoid any vaccines. The healthcare professional reported it as a possible adverse event. The timing of breast cancer diagnosis was unspecified in relation to when the patient received SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown. The reporter considered the breast cancer to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with breast cancer about 1 month after receiving the first dose of SHINGRIX and would be undergoing treatment during the recommended time frame of the second dose of SHINGRIX. The healthcare professional inquired about the best time to give the patient their second dose of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife and was previously not reported to anyone. The patient experienced pain at the injection site. Limited information was provided. No follow up would be conducted due to refusal to complete the safety report because, the reporter stated that, it was not necessary and the patient had already improved. This case has been linked to case US2018GSK141425, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received SHINGRIX (batch number T5242, expiry date March 2019) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the arm. The healthcare professional reported that the patient had redness on arm basically a big rectangle from shoulder to elbow along with pain at the injection site. The redness lasted for 1 week with a slightly pinkish discoloration that resolved fully a few weeks later.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included allergic reaction to antibiotics and drug allergy. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and muscle pain. On an unknown date, the outcome of the rash and muscle pain were unknown. It was unknown if the reporter considered the rash and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a localized rash and muscle pain, with a severity of 5 by 10. The healthcare professional called from an internal medicine office, to obtain a list of ingredients to check for cross-sensitivity between patient allergies. The patient was given the vaccine at a pharmacy and not at the physician office. The healthcare professional had no further information.
Sex: F
Vaccine: TDAP
Symptoms: Nasal congestion
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of nasal stuffiness in a 29-year-old female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced nasal stuffiness. On an unknown date, the outcome of the nasal stuffiness was unknown. It was unknown if the reporter considered the nasal stuffiness to be related to BOOSTRIX. Additional details were provided as follows: The initial information received by other manufacturer on an adverse event report associated with GlaxoSmithKline's BOOSTRIX. The age at vaccination was not reported. No additional information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arthritis aggravated in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 27th June 2018, the patient received SHINGRIX 50 mcg/mg. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced arthritis aggravated and injection site pain. On an unknown date, the outcome of the arthritis aggravated and injection site pain were unknown. It was unknown if the reporter considered the arthritis aggravated and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the staff pharmacist who himself was patient. In 2018, the patient experienced increase in arthritis; he had increase in pain in several joints that already had arthritis. The patient also had severe pain at the injection site, but that was a known side effect. The patient had not read that the arthritis pain increase was a known side effect.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Recently from the reporting date, the patient had SHINGRIX and experienced pretty severe side effects, but these side effects were past in a few days. The patient was asking if it was likely that he/she would experience the same side effects with the second shot of SHINGRIX or would the side effects be less.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of nausea in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient ate shrimp after receiving a dose of SHINGRIX and experienced nausea and vomiting. The reporter agreed to be followed up. This case was linked with US2018GSK138896, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter agreed to be followed up. The case US2018GSK138898 was identified as duplicate of case US2018GSK138896. Case US2018GSK138898 would be deleted and all future correspondence will be added in the case US2018GSK138896 which stands as case of record for this patient. This case was also linked with US2018GSK138801, reported by the same reporter.
Sex: F
Vaccine: MNQ
Symptoms: Laceration, Product container issue, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of laceration of finger in a 62-year-old female patient who intended to administer MENVEO for prophylaxis. On 31st July 2018, the patient received MENVEO. On 31st July 2018, immediately after receiving MENVEO, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to MENVEO. Additional details were provided as follows: This case was reported by a medical assistant (MA). There was no previous contact done to GlaxoSmithKline about any adverse event for the patient. The vaccine was not administered. The age at vaccination was not applicable for this report. This case was associated with product complaint. Medical assistant reported that a colleague opened a box of MENVEO and one vial had the top broken off when she opened the box and she dumped out the box to remove any glass and she cut her finger on the broken vial. The MENVEO vaccine was stored in their refrigerator and there was no damage to the box, however, the MA believed that the MENVEO vial was possibly damaged in shipment. There was no product remaining in the vial as it had leaked in the box. The pictures would be sent to the QA email address. The product was available for return to GSK for investigation. A Credit Request Template would be completed to arrange credit. It was related QA reported to Quality. No further details were available. The reporter had given permission to contact for follow up.
Sex: F
Vaccine: MEN
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Meningococcal B vaccine for prophylaxis. On 2nd August 2018, the patient received the 1st dose of Meningococcal B vaccine. On 2nd August 2018, less than a day after receiving Meningococcal B vaccine, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were unknown. It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, her arm was pretty much useless. She could not lift it hardly at all without sending pain up and down the entire arm. The patient stated that, this experience was not supposed to be pleasant, but she must admit, she did not want to do this again. Like any other teenager, she had scoured the internet looking for a reason as to why she must went for a second does.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Immediate post-injection reaction, Injection site erythema, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 64-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis. The patient's past medical history included shingles (experienced in her 40's and again). Previously administered products included ZOSTAVAX (received on 16th October 2014). Concomitant products included ADACEL. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th July 2018, the patient received dTpa vaccine. On 31st July 2018, immediately after receiving SHINGRIX and 1 days after receiving SHINGRIX and dTpa vaccine, the patient experienced muscle pain and pain in arm. On 1st August 2018, the patient experienced feeling unwell, fever, stomach pain and headache. On 2nd August 2018, the patient experienced injection site erythema. The patient was treated with MOTRIN. SHINGRIX was continued with no change. DTpa vaccine was continued with no change. On an unknown date, the outcome of the muscle pain and pain in arm were unknown and the outcome of the injection site erythema, feeling unwell, fever, stomach pain and headache were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, pain in arm, injection site erythema, feeling unwell, fever, stomach pain and headache to be related to SHINGRIX. The reporter considered the muscle pain, pain in arm and injection site erythema to be unrelated to dTpa vaccine. It was unknown if the reporter considered the feeling unwell, fever, stomach pain and headache to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Tdap vaccine on the left deltoid. The patient received SHINGRIX on right deltoid. The caller stated that immediately after receiving SHINGRIX, the patient experienced the soreness and muscle pain of her arm. One day after receiving SHINGRIX and 2 days after receiving Tdap in the morning, the patient woke and experienced fever (the patient's body temperature was recorded as 99.4 degree F), stomach ache, really bad headache and not feeling well. Two day after receiving SHINGRIX, the patient experienced area of injection was red and a large area of 4 inches by 3 inches. The patient had been treated with MOTRIN. The caller noted that she received Tdap but did not contribute the issues to this product. The caller referred to health care provider for management of symptoms. This case has been linked with A0709984A (same patient).
Age: 64.0
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 muscle pain in a 64-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis. The patient's past medical history included shingles (experienced in her 40's and again). Previously administered products included ZOSTAVAX (received on 16th October 2014). Concomitant products included ADACEL. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th July 2018, the patient received dTpa vaccine. On 31st July 2018, immediately after receiving SHINGRIX and 1 days after receiving SHINGRIX and dTpa vaccine, the patient experienced muscle pain and pain in arm. On 1st August 2018, the patient experienced feeling unwell, fever, stomach pain and headache. On 2nd August 2018, the patient experienced injection site erythema. The patient was treated with MOTRIN. SHINGRIX was continued with no change. DTpa vaccine was continued with no change. On an unknown date, the outcome of the muscle pain and pain in arm were unknown and the outcome of the injection site erythema, feeling unwell, fever, stomach pain and headache were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, pain in arm, injection site erythema, feeling unwell, fever, stomach pain and headache to be related to SHINGRIX. The reporter considered the muscle pain, pain in arm and injection site erythema to be unrelated to dTpa vaccine. It was unknown if the reporter considered the feeling unwell, fever, stomach pain and headache to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Tdap vaccine on the left deltoid. The patient received SHINGRIX on right deltoid. The caller stated that immediately after receiving SHINGRIX, the patient experienced the soreness and muscle pain of her arm. One day after receiving SHINGRIX and 2 days after receiving Tdap in the morning, the patient woke and experienced fever (the patient's body temperature was recorded as 99.4 degree F), stomach ache, really bad headache and not feeling well. Two day after receiving SHINGRIX, the patient experienced area of injection was red and a large area of 4 inches by 3 inches. The patient had been treated with MOTRIN. The caller noted that she received Tdap but did not contribute the issues to this product. The caller referred to health care provider for management of symptoms. This case has been linked with A0709984A (same patient).
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site rash in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site rash, rash papular and rash vesicular. On an unknown date, the outcome of the injection site rash, rash papular and rash vesicular were recovered/resolved. It was unknown if the reporter considered the injection site rash, rash papular and rash vesicular to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 77 or 78 years. The patient experienced papular vesicular confluent rash at injection site (from elbow to upper shoulder and neck area). The rash resolved within 3 weeks. The reporter was agree for follow up.
Sex: U
Vaccine: MENB
Symptoms: Fatigue
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of tiredness in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced tiredness and fatigue. On an unknown date, the outcome of the tiredness and fatigue were unknown. It was unknown if the reporter considered the tiredness and fatigue to be related to BEXSERO. Additional details were provided as follows: The age at the vaccination was not applicable for this report. The physician reported some patients were tired and fatigued after receiving BEXSERO. The reporter said he was not sure if it was vaccine related.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 24th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and rash. On an unknown date, the outcome of the pain in arm and rash were recovered/resolved. It was unknown if the reporter considered the pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rash on her left arm for a week as well as painful to touch. The reactions disappeared after a week. The patient had a concern regarding 2nd dose of SHINGRIX. The patient stated that, she understand that there was a national shortage on SHINGRIX. She had been told that the pharmacy might not get their shipment until next January.
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received BOOSTRIX for prophylaxis. Concurrent medical conditions included meat allergy (the patient was Alpha-gal positive). On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be possibly related to BOOSTRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was Alpha-gal positive and believed that was why she reacted to BOOSTRIX. The patient received her vaccination with BOOSTRIX about a year ago and after receiving the vaccine, she literally felt as if she had broke her arm. The patient sought medical attention and ultimately took predispose to help resolve the issue. On an unknown date, the patient did have an x-ray as well to ensure she did not have a broken bone. Lab Comments: LAB test done on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Neuropathy peripheral, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neuropathy peripheral in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included numbness in feet (for years). On 3rd August 2018, the patient received the 2nd dose of SHINGRIX. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced neuropathy peripheral (serious criteria GSK medically significant) and foot pain. On an unknown date, the outcome of the neuropathy peripheral and foot pain were unknown. It was unknown if the reporter considered the neuropathy peripheral and foot pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he received SHINGRIX and experienced severe neuropathy in feet. The patient also reported that he never had pain before though he had numbness in feet for years. The pain kept the patient up virtually all night long. The patient wondered if this event would resolve in a day or two or if this was totally unrelated to the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported by a consumer and described the occurrence of unresponsive to stimuli in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unresponsive to stimuli (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the unresponsive to stimuli was unknown. It was unknown if the reporter considered the unresponsive to stimuli to be related to SHINGRIX. Additional information was reported as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was unknown. The case was reported to seek indemnification for claims, regarding the events experienced by the patient after administration of SHINGRIX. It was stated that the patient became unresponsive after vaccination with SHINGRIX, and was further transported to the hospital. The reporter had requested claim from GlaxoSmithKline for the consequences suffered by the patient. The reporter further stated that, based on the available information, they had tendered this claim to GlaxoSmithKline for handling and denying liability.  They had requested to acknowledge their tender as soon as possible and confirm that GlaxoSmithKline or its liability insurance arrier will investigate the matter and thereafter advise the reporter's office as well as the involved pharamcy store. They had also requested to provide a copy of release to them for their records.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: 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 55-year-old female patient who received Influenza vaccine for prophylaxis. The patient's past medical history included pneumonia (hospitalized for pneumonia for 12 days). Concurrent medical conditions included chronic obstructive pulmonary disease and emphysema. On an unknown date, the patient received the 1st dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had denied permission to contact their physician. This case has been linked with case US2018139480 reported by the same reporter for the same patient.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: On 5/8/18 patient had febrile seizure lasting 5-10 minutes. Parents took to Emergency Department. Only treatment was antipyretics.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Reported right upper arm swollen, warm to touch, and tender on 08-10-2018. Child came home from school with arm swollen. No doctor appointment made per grandmother or urgent care visit needed. Vaccines where given on 08/07/2018.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Ear infection, Ear tube insertion, Eye movement disorder, Injection site pain, Injection site swelling
Clinical narrative: At 4 months of age my sons left eye turned sharply inward toward his nose. I brought this up at the next Dr. visit and was told this was common in infants and that it should correct itself with time. Because my son was sick at his 6 month visit he did not receive shots on this day. I thought nothing of it until looking back at pictures. I found several pictures that clearly show my sons left eye turned inward within 48 hours of his 4 month shots. All pictures previous to this day his eyes are perfectly aligned. I realized at that time my son must have had a reaction to the shots and the scope of damage is unknown. On the day of his shots, my sons legs were very swollen and remained so for several days. He was very fussy but particularly if you touched or moved his legs to pick him up he would scream. The colic resolved around 7-8 months. His eyes corrected themselves around 10 months. He has had chronic ear infections and had surgery (at 11 months) to insert tubes. He has not received any further immunizations due to the fact that it could further compromise his health and well being.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Irritability, Screaming
Clinical narrative: At 4 months of age my sons left eye turned sharply inward toward his nose. I brought this up at the next Dr. visit and was told this was common in infants and that it should correct itself with time. Because my son was sick at his 6 month visit he did not receive shots on this day. I thought nothing of it until looking back at pictures. I found several pictures that clearly show my sons left eye turned inward within 48 hours of his 4 month shots. All pictures previous to this day his eyes are perfectly aligned. I realized at that time my son must have had a reaction to the shots and the scope of damage is unknown. On the day of his shots, my sons legs were very swollen and remained so for several days. He was very fussy but particularly if you touched or moved his legs to pick him up he would scream. The colic resolved around 7-8 months. His eyes corrected themselves around 10 months. He has had chronic ear infections and had surgery (at 11 months) to insert tubes. He has not received any further immunizations due to the fact that it could further compromise his health and well being.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Patient presented to the pharmacy with a site reaction that spread down her arm and up her neck towards her lymph nodes.