chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with (wistar ra 27-3) M-M-R II, lot #N031294 with expiration date 21-AUG-2019 and LIQUID PEDVAXHIB, lot #N024570, with expiration date 01-MAY-2020, both for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccines experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccines had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011006: US-009507513-1808USA011007:US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with M-M-R II, lot #N031294 with expiration date 21-AUG-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II, lot #N031294 with expiration date 21-AUG-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccines had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA006003: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of M-M-R II, lot #N031294 with expiration date 21-AUG-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored doses of M-M-R II, lot #N031294 with expiration date 21-AUG-2019  and PEDVAXHIB, lot #N024570, with expiration date 01-MAY-2020, both for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored doses of M-M-R II (lot #N031294 with expiration date 21-AUG-2019) and VARIVAX (lot # N031002 with expiration date 03-NOV-2019), both for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered dose of M-M-R II experienced a temperature excursion in the range between 47 degrees F to 77 degrees F (52.7 degrees F) during 2 hours and 15 minutes. While the administered dose of VARIVAX experienced a temperature excursion in the range between 6 degrees F to 14 degrees F (7.2 degrees F) during 5 hours and 10 minutes. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005; US-009507513-1808USA011006; US-009507513-1808USA011007; US-009507513-1808USA011008; US-009507513-1808USA011009; US-009507513-1808USA011011; US-009507513-1808USA011012; US-009507513-1808USA011013; US-009507513-1808USA011014; US-009507513-1808USA006003.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (lot #N024570, with expiration date 01-MAY-2020), for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47 degrees F to 77 degrees F (52.7 degrees F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005; US-009507513-1808USA011006; US-009507513-1808USA011007; US-009507513-1808USA011008; US-009507513-1808USA011009; US-009507513-1808USA011010; US-009507513-1808USA011012; US-009507513-1808USA011013; US-009507513-1808USA011014; US-009507513-1808USA006003.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of GARDASIL 9, lot # M041212 with expiration date 21-JUN-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007:  US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of GARDASIL 9, lot # M041212 with expiration date 21-JUN-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011014: US-009507513-1808USA006003:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of VARIVAX, lot # N031002 with expiration date 03-NOV-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 6°F to 14°F (7.2°F) during 5 hours and 10 minutes. The vaccine had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA006003.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-JUN-2013, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided), for its intended purpose the prevention of shingles. On 09-JAN-2017, the patient suffered from a shingles outbreak; in addition to chronic pain, rash and lesions to various parts of her body as a direct result of the ZOSTAVAX. As a direct result of ZOSTAVAX vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient has sustained severe and permanent personal injuries, suffered serious, progressive, and incurable injuries, as well as conscious pain and suffering, mental and emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of ZOSTAVAX use. The outcome of the event was unknown. Causality assessment was related. The event of shingles outbreak was considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received on 24-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 23-SEP-2011, the patient received the ZOSTAVAX (lot number and expiration unknown) unknown route for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of "his" body (in conflict, the patient is female.) The patient did not have a shingles outbreak until 05-JAN-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of use of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: HEP, HPV9, MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB strength 10/1.0 microgram/ml, (lot # M044032 with expiry date of 03-JUL-2019) (lot# N020613 with expiry date of 05-MAY-2020), GARDASIL 9 (lot #N022583 with expiry date of 20-JUN-2020), M-M-R II (lot #N020925 with expiry date of 01-AUG-2019), PROQUAD) (lot #R002935 with expiry date of 29-JUL-2019) and VARIVAX (lot #M046926 with expiry date of 28-NOV-2018) (lot #M046004 with expiry date of 18-NOV-2018) (dose, frequency, strength and route of administration were not reported for any of the vaccines) for prophylaxis. All the vaccines were administered to the patients after temperature excursions (product storage error). No adverse effects were reported. The temperature/time frame were 15 Fahrenheit(F) to 46 fahrenheit (-9 celsius to 8 celsius) (45.5F) for 24 hours for VARIVAX and PROQUAD 47 fahrenheit to 77 fahrenheit (9 celsius to 25 celsius) (53.4F) for 6 days and below 32 F/0 celsius(15 fahrenheit) for 3 hours 50 minutes for remaining vaccines. No previous temperature excursion were reported. The call was due to data logger. No product quality complaint was filed. This is a non-valid case due to lack of patient identifiers.
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 male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 reported as follows: The age at vaccination was not reported. The patient stated that SHINGRIX shot was painful. The pain was resolved within 48 hours.   The patient declined demographic details and any other questions. Only information given was that reported. For tolerance after 2nd dose refer case US2018GSK152775.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chest burning in a adult male patient who received SHINGRIX for prophylaxis. On 14th August 2018 11:00, the patient received SHINGRIX. On 15th August 2018, 1 days after receiving SHINGRIX, the patient experienced chest burning. On an unknown date, the outcome of the chest burning was recovered/resolved. It was unknown if the reporter considered the chest burning to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife The age at vaccination was not reported. The patient felt burning in his chest the night before last and last night from the date of reporting and it had resolved. No additional details were provided. This case has been linked with US2018149804, reported by same reporter for herself.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of axillary pain in a 53-year-old female patient who received SHINGRIX (batch number 4F7K7, expiry date 5th December 2020) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th August 2018, 1 days after receiving SHINGRIX, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain was unchanged. It was unknown if the reporter considered the axillary pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The pharmacist stated that the patient experienced tenderness and pain under the left armpit closer to the breast area. The patient described tenderness as bruise like feeling. No further details were provided by the pharmacist.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a 58-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included sumatriptan succinate (Imitrex). On 5th June 2018, the patient received the 1st dose of SHINGRIX. On 5th June 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia upper extremities, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the myalgia upper extremities was recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced a sore arm (muscle pain) which lasted for 7 days. The patient also reported that he did not see the pharmacist mix the liquid and powder together as she did at time of 2nd dose vaccination and thought that she might have just received the adjuvant suspension without the powder being mixed. This led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was instructed to contact her pharmacist to discuss. The permission to send letter asking for doctor information was given. For tolerance to 2nd dose refer linked case US2018GSK154592.
Age: 70.0
Sex: F
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 71-year-old female patient who received SHINGRIX for prophylaxis. On 5th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX 3 months ago. Since then she had intermittent pain right where she received the injection. Most of the time she was fine but then all of a sudden she could feel where the shot was given. This did not happen every day. It was usually not a bad pain but last night, on 17th August 2018, it was much more severe. The patient had denied permission to contact their physician.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hyperhidrosis, Joint swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swollen joints, sweating, fatigue, joint pain and fever. On an unknown date, the outcome of the swollen joints, sweating, fatigue, joint pain and fever were recovered/resolved. It was unknown if the reporter considered the swollen joints, sweating, fatigue, joint pain and fever to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient stated she has had arthritis but she experienced increased joint swelling and pain in her right ankle, and both wrists which lasted for about a month. She had a fever the same evening post vaccination which lasted for 12 hours. She also experienced severe fatigue and sweating which lasted for total of 18 hours. The patient gave consent to contact her physician. No further details provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Feeling abnormal, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Enbrel).  On 31st May 2018, the patient received the 1st dose of SHINGRIX. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain and bone pain. On 1st June 2018, the patient experienced feeling bad. On an unknown date, the outcome of the muscle pain, bone pain and feeling bad were recovered/resolved. It was unknown if the reporter considered the muscle pain, bone pain and feeling bad to be related to SHINGRIX. Additional details reported as follows: The patient received the vacine in the left arm. The patient reported same day as first SHINGRIX dose she had soreness but by the 2nd day she felt like she had been beaten, the soreness was worse and she in general felt bad. She reported the soreness was muscle and felt like bone also. She stated the events resolved within 36 hours in 2018. The healthcare professional was not asked.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 14th May 2018, refere case US2018GSK154593).  On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 17th August 2018, the patient experienced weakness, sniffles, dizziness, headache and nausea. On an unknown date, the outcome of the pain in arm, weakness, sniffles, dizziness, headache and nausea were recovering/resolving. It was unknown if the reporter considered the pain in arm, weakness, sniffles, dizziness, headache and nausea to be related to SHINGRIX. Additional information was received as follows: The case was reported by the physician for himself. The patient received SHINGRIX on the left deltoid. With the second shot of the SHINGRIX vaccine, he experienced a sore arm on a scale of 8 out of 10. After 48 hours it was 70 percent better and the soreness was on a scale of 3 out of 10. He also experienced headache, weakness, nausea, sniffles and dizziness which started on day 2 post vaccination. No further details were provided.This case has been linked to the case US2018GSK154593, reported by the same reporter for the same patient.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 14th May 2018, refere case US2018GSK154593).  On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 17th August 2018, the patient experienced weakness, sniffles, dizziness, headache and nausea. On an unknown date, the outcome of the pain in arm, weakness, sniffles, dizziness, headache and nausea were recovering/resolving. It was unknown if the reporter considered the pain in arm, weakness, sniffles, dizziness, headache and nausea to be related to SHINGRIX. Additional information was received as follows: The case was reported by the physician for himself. The patient received SHINGRIX on the left deltoid. With the second shot of the SHINGRIX vaccine, he experienced a sore arm on a scale of 8 out of 10. After 48 hours it was 70 percent better and the soreness was on a scale of 3 out of 10. He also experienced headache, weakness, nausea, sniffles and dizziness which started on day 2 post vaccination. No further details were provided.This case has been linked to the case US2018GSK154593, reported by the same reporter for the same patient.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 10th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, neck pain, shoulder pain and ear pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, neck pain, shoulder pain and ear pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, neck pain, shoulder pain and ear pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on unknown deltoid and later on in August 2018, experienced pain at the injection site, pain behind the ear and down the side of the neck and shoulder of the arm where the vaccine was given. These events had not resolved till the time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 68-year-old female patient who received SHINGRIX (batch number 2453L, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced erythematous rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The health care professional reported that the patient experienced torso rash which was red with no hives or itching that lasted for about a week. The patient received Benadryl and the rash resolved with out any further intervention. The health care professional was unable to provide the vaccine date. The health care professional stated that she called previously on the day of reporting and reported the patient had a rash reaction to a high dose flu vaccine, FLUZONE HD, and the ZOSTAVAX.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX (batch number 3374S, expiry date 22nd November 2020) for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site tenderness and injection site erythema were unknown. It was unknown if the reporter considered the injection site swelling, injection site tenderness and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that her patient received SHINGRIX 7 days before the reporting date and her arm was still red, swollen, and tender around the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No other information was provided.
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal distension
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of bloating in a female patient who received ENGERIX B for prophylaxis. Concurrent medical conditions included allergy to grains. On an unknown date, the patient received the 1st dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced bloating and stomach discomfort. On an unknown date, the outcome of the bloating and stomach discomfort were unknown. It was unknown if the reporter considered the bloating and stomach discomfort to be related to ENGERIX B. Additional details reported as follows: The age at vaccination was not reported. The patient had an allergy to corn.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Headache, Muscle twitching
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of facial paralysis in a 50-year-old male patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 10th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 5 days after receiving SHINGRIX, the patient experienced facial paralysis (serious criteria GSK medically significant), headache and muscle twitching. On an unknown date, the outcome of the facial paralysis was unchanged and the outcome of the headache and muscle twitching were unknown. It was unknown if the reporter considered the facial paralysis, headache and muscle twitching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by certified medical assistant. No further information was reported regarding the event.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details reported as follows: This case was reported by medical assistant (MA). The age at vaccination was not reported. Two months after first dose SHINGRIX, the patient received 2nd dose. The patient experienced fever of 102 degree F, which lasted for 24 hours. The medical assistant talked on phone with the patient during first 24 hours to see how she was feeling and told her to drink water and take fever reducing medicine. The patient also self-reported this case with Centers for Disease Control and Prevention (CDC). Lab Comments: On an unknown date, lab test were performed.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of activities of daily living impaired in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the registered nurse for her coworker. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient was unable to do activities over the weekend after receiving SHINGRIX.  The reporting nurse had encouraged the patient to report what they experienced. The reporter did not agree to be followed up. This case has been linked with US2018GSK149759, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (experienced after 1st dose, refer case US2018149792). On 16th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. 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 SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient stated that SHINGRIX shot was painful. The pain was resolved within 48 hours. The patient declined demographic details and any other questions. Only information given was that reported. For tolerance after 2nd dose refer case US2018GSK152775.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Influenza like illness, Migraine
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of migraine aggravated in a 58-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of myalgia (1st dose received and other medication error events after receiving 1st dose, refer linked case US2018149815). Concurrent medical conditions included migraine headache. Concomitant products included sumatriptan succinate (Imitrex). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced migraine aggravated, influenza-like symptoms and fatigue. On an unknown date, the outcome of the migraine aggravated, influenza-like symptoms and fatigue were unknown. It was unknown if the reporter considered the migraine aggravated, influenza-like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced flu like symptoms consisting of fatigue and tiredness. The patient reported that since dose 2 was given, she had an increase in migraine headache. The permission to send letter asking for doctor information was given.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. 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 information was received as follows: This case was reported by the physician for himself. The patient received SHINGRIX on the left deltoid. He experienced soreness at the injection with the first dose of SHINGRIX vaccine which lasted for about 2 days. No further details were provided. This case has been linked to the case US2018149833, reported by the same reporter for the same patient.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood iron normal, Muscle twitching, Neurological examination normal, Streptococcus test negative, Tic
Clinical narrative: Tics (eyes, nose, head and neck) and twitches (shoulder, arm, leg, body all on right side only) began occurring during times of rest daily. 2 months later, during an hour of rest, the tics and twitches would occur the entire hour with maybe a minute of rest the entire hour. They have become non stop.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site paraesthesia, Injection site warmth
Clinical narrative: Reddened area after vaccine, line placed seems bigger, seems tingly in area localized, right arm seemed more involved, left arm as well more so today, hurt to touch, feels warm, no fever no chills. On PE: right upper arm not well demarcated erythematous area firm to touch warm to touch mild tender 9 1/2 x 8 1/2 cm in diameter; right well demarcated slight raised erythematous warm to touch nontender 7 x 6 1/2 cm in diameter. TX: Cephalexin 250 mg Oral Capsule (Cephalexin) ..... 1 capsule 3 times a day x 7 days
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of the flu shot (one of 8/15 and one on 8/22). Patient did not report any adverse events.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site swelling, Laboratory test normal
Clinical narrative: Patient went to physician's office complaining of swelling in the upper left arm. The physician diagnosed the patient with cellulitis and gave her an IM antibiotic and oral antibiotic. The patient believes the pharmacist gave her an infection. The patient presented to me to what seemed to be an adverse reaction to the injection. According to the physician documents given to the patient, the patient was afebrile and other signs were shown to be in the normal ranges. Patient was discharged with self-care instruction. Her outcome is unknown at this time.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Chills, Headache
Clinical narrative: Within 1 hour of receiving vaccine developed chills, headache and abdominal pain went to Urgent Care. Advised to push fluids and take Ibuprofen or Tylenol.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shignles, V1 distribution diagnosed one month after second dose of SHINGRIX given.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous
Clinical narrative: T12 distribution erythematous rash present in right low back/flank, wraps around side to RLQ region. Appears as vesicles that have ruptured, non-tender, no streaking, no exudate, no other sings of infection or trauma. Started valcyclovir 1000 mg TID x 7 days. Started lidocaine ointment 5% x 7 days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Patient called to report she had chills, fever, body aches, injection site was fire red and hot to the touch and hard.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient called to report she had chills, fever, body aches, injection site was fire red and hot to the touch and hard.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Pt states he had a rash all over his back start 24AUG after receiving vaccine on 22AUG 2018. Rash spread all over back as flat red, splotchy rash. Rash began to subside within 48hrs. Pt followed up 2 days after rash subsided.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain and unable to move in left arm.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Within 3 hours patient had severe debilitating arm pain which lasted for about 48 hours. She claims she could not use her arm at all.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose was administered to an adult patient.
Age: 18.0
Sex: F
Vaccine: MENB, VARCEL
Symptoms: Asthenia, Deafness unilateral, Dizziness, Injection site induration, Injection site mass
Clinical narrative: 6 hrs. after receiving BEXSERO vaccine (on 8/17/18) in left deltoid patient started having a lot of swelling and pain at the site. She could not hear from her left ear. The hearing loss dissipated overnight. On 8/18/18 she was seen at Hospital. Her swelling measured 5 cm x 6 cm and she was having left sided pain from her neck to her fingers. She could not move her arm at all. She was so dizzy she needed assistance with walking. She felt weak and heart rate at hospital was 130. On 8/27/18 patient was seen in our office. She had a raised lump at the injection site measuring 2.5 cm x 2.5 cm. There was no redness and area was semi-firm to touch. She had no pain with touch and she could move and use her arm normally. No signs of infection.
Age: 18.0
Sex: F
Vaccine: MENB, VARCEL
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: 6 hrs. after receiving BEXSERO vaccine (on 8/17/18) in left deltoid patient started having a lot of swelling and pain at the site. She could not hear from her left ear. The hearing loss dissipated overnight. On 8/18/18 she was seen at Hospital. Her swelling measured 5 cm x 6 cm and she was having left sided pain from her neck to her fingers. She could not move her arm at all. She was so dizzy she needed assistance with walking. She felt weak and heart rate at hospital was 130. On 8/27/18 patient was seen in our office. She had a raised lump at the injection site measuring 2.5 cm x 2.5 cm. There was no redness and area was semi-firm to touch. She had no pain with touch and she could move and use her arm normally. No signs of infection.
Age: 18.0
Sex: F
Vaccine: MENB, VARCEL
Symptoms: Walking aid user
Clinical narrative: 6 hrs. after receiving BEXSERO vaccine (on 8/17/18) in left deltoid patient started having a lot of swelling and pain at the site. She could not hear from her left ear. The hearing loss dissipated overnight. On 8/18/18 she was seen at Hospital. Her swelling measured 5 cm x 6 cm and she was having left sided pain from her neck to her fingers. She could not move her arm at all. She was so dizzy she needed assistance with walking. She felt weak and heart rate at hospital was 130. On 8/27/18 patient was seen in our office. She had a raised lump at the injection site measuring 2.5 cm x 2.5 cm. There was no redness and area was semi-firm to touch. She had no pain with touch and she could move and use her arm normally. No signs of infection.