chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to a currently 16 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of R001262 and an expiration date of 10-NOV-2001; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following potential temperature excursion: Unknown temperature for 1 day. Reportedly, there had been no previous temperature excursions and the aforementioned one were not  identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1807USA011814; US-009507513-1807USA011815; US-009507513-1807USA008554.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to a currently 13 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of R001262 and an expiration date of 10-NOV-2001; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following potential temperature excursion: Unknown temperature for 1 day. Reportedly, there had been no previous temperature excursions and the aforementioned one were not  identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to a currently 15 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of R001262 and an expiration date of 10-NOV-2001; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following potential temperature excursion: Unknown temperature for 1 day. Reportedly, there had been no previous temperature excursions and the aforementioned one were not identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1807USA011814.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 79-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (and flu like symptoms after receiving 1st dose received on 2nd May 2018, refer case US2018GSK130831). On 13th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth. On 15th July 2018, the patient experienced erythematous rash. On an unknown date, the outcome of the injection site warmth and erythematous rash were unknown. It was unknown if the reporter considered the injection site warmth and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient did not receive any concomitant medications. At 2:30 pm, the patient received SHINGRIX in left deltoid. The pharmacist reported that the patient experienced a hot feeling at the injection site the morning of the day after her injection. In the morning of 15th July 2018, 2 days after vaccination, she also noticed a red, rough rash area along with the hotness from the day before, that began below the injection site that followed the tricep muscle down to her elbow but ended about 1 to 2 inches above her elbow. The whole area was said to be large, about 3 to 5 inches in size. This case has been also linked to case US2018GSK130832 (unspecified number of patients), reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Influenza vaccine Quadrivalent for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to Influenza vaccine Quadrivalent. Additional information reported as follows: The patient was 65 years old at the time of reporting. The age at vaccination was not reported. The patient reported that she had a flu shot in the past (unknown date, unknown manufacturer) and also experienced redness (red spot) on her arm at the injection site. This case has been linked with US2018125484 reported for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and injection site pain. On an unknown date, the outcome of the injection site reaction and injection site pain were unknown. It was unknown if the reporter considered the injection site reaction and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the pharmacy intern. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported that the patient experienced a bad reaction, clarified as a severe injection site reaction which was sore. No additional information was available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX in the left arm at a local pharmacy. The patient stated that, in the evening after receiving the SHINGRIX vaccine, the injection site was red, sore, painful and warm to touch. Due to the soreness he could not lay down on that arm. It resolved within 3 days. The patient stated, he was not been able to find any pharmacy which had SHINGRIX available for the 2nd shot. The patient was told, it should be administered in the next 2 months. No further details were provided. The patient gave permission to contact their healthcare provider.
Age: 47.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 48 year old female patient who received BOOSTRIX (batch number 4BN7L, expiry date 2019) for prophylaxis. Concomitant products included TWINRIX. On 21st June 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved. It was unknown if the reporter considered the injection site tenderness to be related to BOOSTRIX. Additional details were reported as follows: The patient received BOOSTRIX on left arm. The pharmacist said that one of their patient's was still having tenderness at the injection site. The patient was also given TWINRIX on that same day. However, the patient's symptoms were on the same arm where the patient received BOOSTRIX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020) for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and fever. On 16th July 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and fever were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema and fever to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) were unsure if the SHINGRIX injection was actually administered via intramuscular route and stated there was possibility that it was administered subcutaneous route, which led to incorrect route of vaccination. No further information was reported.
Sex: U
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 adult patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved. 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 healthcare professional reported that the patient had pain and a red spot at the injection site after vaccination with SHINGRIX. No other details were given. The healthcare professional did not provide patient or vaccine information.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Back pain, Burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 62-year-old male patient who received ENGERIX B (batch number ET5TE, expiry date unknown) for prophylaxis. Previously administered products included LIPITOR, Shingles vaccine (received shingles live vaccine in 2017), ENGERIX B (1st dose received on an unknown date without any symptoms), ENGERIX B (2nd dose received on an unknown date without any symptoms) and SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, for tolerance refer case US2018130314). On 11th July 2018, the patient received the 3rd dose of ENGERIX B. On 13th July 2018, 2 days after receiving ENGERIX B, the patient experienced lower extremities weakness of, leg pain, burning leg and unable to walk. On 14th July 2018, the patient experienced rectal bleeding (serious criteria GSK medically significant). On 15th July 2018, the patient experienced epistaxis. In July 2018, the patient experienced weakness and pain localized. On 19th July 2018, the patient experienced back pain, abdominal pain and burning in abdomen. On 18th July 2018, the outcome of the rectal bleeding was recovered/resolved. On an unknown date, the outcome of the epistaxis was recovered/resolved and the outcome of the lower extremities weakness of, leg pain, burning leg and unable to walk were recovering/resolving and the outcome of the weakness, pain localized, back pain, abdominal pain and burning in abdomen were unknown. It was unknown if the reporter considered the rectal bleeding, epistaxis, lower extremities weakness of, leg pain, burning leg, unable to walk, weakness, pain localized, back pain, abdominal pain and burning in abdomen to be related to ENERIX B. Additional details were reported as follows: The patient experienced nosebleed. Starting on 13th July 2018, the patient's his legs were weak and painful (no cramping) but burning at the top of patient's legs and in his hips after walking half a block. It was on the sides of his legs and to stop walking. The patient's rectal bleeding started on 14th July 2018 and peaked on 16th July 2018. These symptoms reached their peak on 14th July 2018 and 15th July 2018. The patient was asked if these symptoms are resolved completely for which the patient stated, he felt a tinge but it had moved to his waist, upper back, trunk which he would feel if he tried to bend over. The patient also said he woke up on 19th July 2018 with these symptoms in his back and abdomen. The patient stated he had not reported his symptoms to his physician office but he had reported them to the pharmacy and they provided him with the lot number.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Epistaxis, Gait inability, Muscular weakness, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 62-year-old male patient who received ENGERIX B (batch number ET5TE, expiry date unknown) for prophylaxis. Previously administered products included LIPITOR, Shingles vaccine (received shingles live vaccine in 2017), ENGERIX B (1st dose received on an unknown date without any symptoms), ENGERIX B (2nd dose received on an unknown date without any symptoms) and SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, for tolerance refer case US2018130314). On 11th July 2018, the patient received the 3rd dose of ENGERIX B. On 13th July 2018, 2 days after receiving ENGERIX B, the patient experienced lower extremities weakness of, leg pain, burning leg and unable to walk. On 14th July 2018, the patient experienced rectal bleeding (serious criteria GSK medically significant). On 15th July 2018, the patient experienced epistaxis. In July 2018, the patient experienced weakness and pain localized. On 19th July 2018, the patient experienced back pain, abdominal pain and burning in abdomen. On 18th July 2018, the outcome of the rectal bleeding was recovered/resolved. On an unknown date, the outcome of the epistaxis was recovered/resolved and the outcome of the lower extremities weakness of, leg pain, burning leg and unable to walk were recovering/resolving and the outcome of the weakness, pain localized, back pain, abdominal pain and burning in abdomen were unknown. It was unknown if the reporter considered the rectal bleeding, epistaxis, lower extremities weakness of, leg pain, burning leg, unable to walk, weakness, pain localized, back pain, abdominal pain and burning in abdomen to be related to ENERIX B. Additional details were reported as follows: The patient experienced nosebleed. Starting on 13th July 2018, the patient's his legs were weak and painful (no cramping) but burning at the top of patient's legs and in his hips after walking half a block. It was on the sides of his legs and to stop walking. The patient's rectal bleeding started on 14th July 2018 and peaked on 16th July 2018. These symptoms reached their peak on 14th July 2018 and 15th July 2018. The patient was asked if these symptoms are resolved completely for which the patient stated, he felt a tinge but it had moved to his waist, upper back, trunk which he would feel if he tried to bend over. The patient also said he woke up on 19th July 2018 with these symptoms in his back and abdomen. The patient stated he had not reported his symptoms to his physician office but he had reported them to the pharmacy and they provided him with the lot number.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Rectal haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 62-year-old male patient who received ENGERIX B (batch number ET5TE, expiry date unknown) for prophylaxis. Previously administered products included LIPITOR, Shingles vaccine (received shingles live vaccine in 2017), ENGERIX B (1st dose received on an unknown date without any symptoms), ENGERIX B (2nd dose received on an unknown date without any symptoms) and SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, for tolerance refer case US2018130314). On 11th July 2018, the patient received the 3rd dose of ENGERIX B. On 13th July 2018, 2 days after receiving ENGERIX B, the patient experienced lower extremities weakness of, leg pain, burning leg and unable to walk. On 14th July 2018, the patient experienced rectal bleeding (serious criteria GSK medically significant). On 15th July 2018, the patient experienced epistaxis. In July 2018, the patient experienced weakness and pain localized. On 19th July 2018, the patient experienced back pain, abdominal pain and burning in abdomen. On 18th July 2018, the outcome of the rectal bleeding was recovered/resolved. On an unknown date, the outcome of the epistaxis was recovered/resolved and the outcome of the lower extremities weakness of, leg pain, burning leg and unable to walk were recovering/resolving and the outcome of the weakness, pain localized, back pain, abdominal pain and burning in abdomen were unknown. It was unknown if the reporter considered the rectal bleeding, epistaxis, lower extremities weakness of, leg pain, burning leg, unable to walk, weakness, pain localized, back pain, abdominal pain and burning in abdomen to be related to ENERIX B. Additional details were reported as follows: The patient experienced nosebleed. Starting on 13th July 2018, the patient's his legs were weak and painful (no cramping) but burning at the top of patient's legs and in his hips after walking half a block. It was on the sides of his legs and to stop walking. The patient's rectal bleeding started on 14th July 2018 and peaked on 16th July 2018. These symptoms reached their peak on 14th July 2018 and 15th July 2018. The patient was asked if these symptoms are resolved completely for which the patient stated, he felt a tinge but it had moved to his waist, upper back, trunk which he would feel if he tried to bend over. The patient also said he woke up on 19th July 2018 with these symptoms in his back and abdomen. The patient stated he had not reported his symptoms to his physician office but he had reported them to the pharmacy and they provided him with the lot number.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Asthenia, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rectal bleeding in a 62-year-old male patient who received ENGERIX B (batch number ET5TE, expiry date unknown) for prophylaxis. Previously administered products included LIPITOR, Shingles vaccine (received shingles live vaccine in 2017), ENGERIX B (1st dose received on an unknown date without any symptoms), ENGERIX B (2nd dose received on an unknown date without any symptoms) and SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, for tolerance refer case US2018130314). On 11th July 2018, the patient received the 3rd dose of ENGERIX B. On 13th July 2018, 2 days after receiving ENGERIX B, the patient experienced lower extremities weakness of, leg pain, burning leg and unable to walk. On 14th July 2018, the patient experienced rectal bleeding (serious criteria GSK medically significant). On 15th July 2018, the patient experienced epistaxis. In July 2018, the patient experienced weakness and pain localized. On 19th July 2018, the patient experienced back pain, abdominal pain and burning in abdomen. On 18th July 2018, the outcome of the rectal bleeding was recovered/resolved. On an unknown date, the outcome of the epistaxis was recovered/resolved and the outcome of the lower extremities weakness of, leg pain, burning leg and unable to walk were recovering/resolving and the outcome of the weakness, pain localized, back pain, abdominal pain and burning in abdomen were unknown. It was unknown if the reporter considered the rectal bleeding, epistaxis, lower extremities weakness of, leg pain, burning leg, unable to walk, weakness, pain localized, back pain, abdominal pain and burning in abdomen to be related to ENERIX B. Additional details were reported as follows: The patient experienced nosebleed. Starting on 13th July 2018, the patient's his legs were weak and painful (no cramping) but burning at the top of patient's legs and in his hips after walking half a block. It was on the sides of his legs and to stop walking. The patient's rectal bleeding started on 14th July 2018 and peaked on 16th July 2018. These symptoms reached their peak on 14th July 2018 and 15th July 2018. The patient was asked if these symptoms are resolved completely for which the patient stated, he felt a tinge but it had moved to his waist, upper back, trunk which he would feel if he tried to bend over. The patient also said he woke up on 19th July 2018 with these symptoms in his back and abdomen. The patient stated he had not reported his symptoms to his physician office but he had reported them to the pharmacy and they provided him with the lot number.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Back pain, Burning sensation
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of muscle pain in a 62-year-old male patient who received ENGERIX B adult (batch number ET5TE, expiry date unknown) for prophylaxis. On 12th July 2018, the patient received the 3rd dose of ENGERIX B adult. On 12th July 2018, less than a day after receiving ENGERIX B adult, the patient experienced muscle pain and leg pain. On an unknown date, the patient experienced weakness. On an unknown date, the outcome of the muscle pain and leg pain were not recovered/not resolved and the outcome of the weakness was unknown. The reporter considered the muscle pain and leg pain to be probably related to ENGERIX B adult. It was unknown if the reporter considered the weakness to be related to ENGERIX B adult. Additional details were reported as follows: The patient received ENGERIX B adult prefilled syringe on deltoid muscle. The patient stated that it had caused weakness and pain in upper legs and back muscle group. The patient stated that any physical activity such as walking triggered a sore like pain after a workout. The health care professional did not consider the events to be life threatening and hospital overnight or prolong an existing hospitalization. It was unknown if the reporter considered the events to result in persistent or significant disability/incapacity.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Epistaxis, Gait inability, Muscular weakness, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of muscle pain in a 62-year-old male patient who received ENGERIX B adult (batch number ET5TE, expiry date unknown) for prophylaxis. On 12th July 2018, the patient received the 3rd dose of ENGERIX B adult. On 12th July 2018, less than a day after receiving ENGERIX B adult, the patient experienced muscle pain and leg pain. On an unknown date, the patient experienced weakness. On an unknown date, the outcome of the muscle pain and leg pain were not recovered/not resolved and the outcome of the weakness was unknown. The reporter considered the muscle pain and leg pain to be probably related to ENGERIX B adult. It was unknown if the reporter considered the weakness to be related to ENGERIX B adult. Additional details were reported as follows: The patient received ENGERIX B adult prefilled syringe on deltoid muscle. The patient stated that it had caused weakness and pain in upper legs and back muscle group. The patient stated that any physical activity such as walking triggered a sore like pain after a workout. The health care professional did not consider the events to be life threatening and hospital overnight or prolong an existing hospitalization. It was unknown if the reporter considered the events to result in persistent or significant disability/incapacity.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Rectal haemorrhage
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of muscle pain in a 62-year-old male patient who received ENGERIX B adult (batch number ET5TE, expiry date unknown) for prophylaxis. On 12th July 2018, the patient received the 3rd dose of ENGERIX B adult. On 12th July 2018, less than a day after receiving ENGERIX B adult, the patient experienced muscle pain and leg pain. On an unknown date, the patient experienced weakness. On an unknown date, the outcome of the muscle pain and leg pain were not recovered/not resolved and the outcome of the weakness was unknown. The reporter considered the muscle pain and leg pain to be probably related to ENGERIX B adult. It was unknown if the reporter considered the weakness to be related to ENGERIX B adult. Additional details were reported as follows: The patient received ENGERIX B adult prefilled syringe on deltoid muscle. The patient stated that it had caused weakness and pain in upper legs and back muscle group. The patient stated that any physical activity such as walking triggered a sore like pain after a workout. The health care professional did not consider the events to be life threatening and hospital overnight or prolong an existing hospitalization. It was unknown if the reporter considered the events to result in persistent or significant disability/incapacity.
Age: 62.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Asthenia, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of muscle pain in a 62-year-old male patient who received ENGERIX B adult (batch number ET5TE, expiry date unknown) for prophylaxis. On 12th July 2018, the patient received the 3rd dose of ENGERIX B adult. On 12th July 2018, less than a day after receiving ENGERIX B adult, the patient experienced muscle pain and leg pain. On an unknown date, the patient experienced weakness. On an unknown date, the outcome of the muscle pain and leg pain were not recovered/not resolved and the outcome of the weakness was unknown. The reporter considered the muscle pain and leg pain to be probably related to ENGERIX B adult. It was unknown if the reporter considered the weakness to be related to ENGERIX B adult. Additional details were reported as follows: The patient received ENGERIX B adult prefilled syringe on deltoid muscle. The patient stated that it had caused weakness and pain in upper legs and back muscle group. The patient stated that any physical activity such as walking triggered a sore like pain after a workout. The health care professional did not consider the events to be life threatening and hospital overnight or prolong an existing hospitalization. It was unknown if the reporter considered the events to result in persistent or significant disability/incapacity.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction and pain in arm. The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the adverse reaction and pain in arm were unknown. It was unknown if the reporter considered the adverse reaction and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter only stated that a patient had a bad reaction and had to be put on antibiotics. The patient had pain that would not go away around the arm. The patient might had received the injection in May 2018 based when the reporter spoke with the reporter saying it was a month ago when he was told about in June 2018. There were no specifics given to the sales representative. The sales representative was a new employee and was not aware that adverse events were required to be reported within 24 hours of acknowledgement and the type of information at a minimum to ask when he heard an adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthralgia in a female patient who received SHINGRIX for prophylaxis. On 12th May 2018, the patient received SHINGRIX. In June 2018, 42 days after receiving SHINGRIX, the patient experienced arthralgia, leg pain and general body pain. On an unknown date, the outcome of the arthralgia, leg pain and general body pain were not recovered/not resolved. It was unknown if the reporter considered the arthralgia, leg pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician stated that the patient still had pain down her legs and lower body 6 to 8 weeks after the vaccine. The sales representative was not provided with any other information about the patient. The sales representative was not aware that adverse event reports must be filed within 24 hours of acknowledgement.
Sex: M
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 23-month-old male patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (1st dose received) and BEXSERO (2nd dose received). On an unknown date, the patient received the 3rd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient missed the booster dose of BEXSERO (which should have it at 12-15 months), which led to incomplete course of vaccination. The patient was arranged to get the booster dose of BEXSERO soon. The reporter just read that the patient cannot have it at aged over 24 months. The reporter asked to let know why this was. He would hopefully be having it a week or two before 24 months but the reporter was worried as it is so close the 24 months stipulated in the leaflet. The reporter would like to know what the implications are of having the 3rd injection this late.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Fear, Feeling hot, Insomnia, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, difficulty sleeping, feeling hot, anxiety, nervous, fear and activities of daily living impaired. The patient was treated with Sleeping Pill. On an unknown date, the outcome of the general body pain, difficulty sleeping, feeling hot, anxiety, nervous, fear and activities of daily living impaired were unknown. It was unknown if the reporter considered the general body pain, difficulty sleeping, feeling hot, anxiety, nervous, fear and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient had the SHINGRIX injection on Monday and day of reporting was Wednesday. The patient reported that she had to take a sleeping pill to sleep, she could not even take a nap.  The patient felt like she had fever and was afraid to take her temperature because then she would be even more worried. Her body hurt all over and her activities had come to a standstill. At the time of reporting, the patient was extremely anxious, nervous, jumpy and scared. The patient thought that GSK should have done more research on side effects. She was a very small person and regret having started the series of SHINGRIX injections and would never recommend it to anyone.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, difficulty sleeping, feeling hot, anxiety, nervous, fear and activities of daily living impaired. The patient was treated with Sleeping Pill. On an unknown date, the outcome of the general body pain, difficulty sleeping, feeling hot, anxiety, nervous, fear and activities of daily living impaired were unknown. It was unknown if the reporter considered the general body pain, difficulty sleeping, feeling hot, anxiety, nervous, fear and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient had the SHINGRIX injection on Monday and day of reporting was Wednesday. The patient reported that she had to take a sleeping pill to sleep, she could not even take a nap.  The patient felt like she had fever and was afraid to take her temperature because then she would be even more worried. Her body hurt all over and her activities had come to a standstill. At the time of reporting, the patient was extremely anxious, nervous, jumpy and scared. The patient thought that GSK should have done more research on side effects. She was a very small person and regret having started the series of SHINGRIX injections and would never recommend it to anyone.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received BEXSERO for prophylaxis. Co-suspect products included MENVEO for prophylaxis. Previously administered products included BEXSERO (received 1st dose 6 months prior to 2nd dose). On an unknown date, the patient received the 2nd dose of BEXSERO and MENVEO at an unknown dose. On an unknown date, unknown after receiving BEXSERO and MENVEO, the patient experienced pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO and MENVEO. Additional details were reported as follows: The age at vaccination was not reported. At the speaker program the reporter presented at last night, several nurses shared that they had attended an Immunization Conference and were told that BEXSERO should be given at 0 and 6 months so they had been administering BEXSERO on this schedule, which led to lengthening of the vaccination schedule. A different nurse reported that her son reported that his arm hurt with both MENVEO and BEXSERO. The nurse was not concerned and reported that the pain did not last very long. The reporter did not agree to follow up from GlaxoSmithKline. This was 1 of 3 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This case was reported by a consumer and described the occurrence of red blotches in a adult female patient who received SHINGRIX for prophylaxis. On 11th July 2018, the patient received the 1st dose of SHINGRIX. On 12th July 2018, 1 days after receiving SHINGRIX, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was unknown. It was unknown if the reporter considered the red blotches to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. About 1 to 2 days after vaccination, a large light pink blotch appeared on the patient's skin several inches below the injection site.  Over the last 6 days additional blotches have appeared closer to the injection site and all of the blotches have become a darker red. The patient wanted to know if this was a normal side effect.
Sex: M
Vaccine: MENB
Symptoms: Feeling hot, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a male patient 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 swelling arm and extremities hot feeling of. On an unknown date, the outcome of the swelling arm and extremities hot feeling of were unknown. The reporter considered the swelling arm and extremities hot feeling of to be related to BEXSERO. Additional details reported as follows: This case was reported by a medical assistant. The age at vaccination was not reported. For 3 to 4 days the patient's arm was swelled and was hot. The patient did believe it was due to the vaccine. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced swelling arm, chills, fatigue and headache. On an unknown date, the outcome of the swelling arm, chills, fatigue and headache were recovered/resolved. It was unknown if the reporter considered the swelling arm, chills, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist in the office for herself. The age at vaccination was not reported, but it could be either 53 or 54 year of age. The patient experienced major arm swelling and intense chills, fatigue and severe headache symptoms which lasted for 24 hours. This case has been linked with US2018GSK132748, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
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 SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extreme pain, redness, and swelling on her arm. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms 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 experienced moderate flu like symptoms. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 79-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. In 2018, the events were resolved. For tolerance to next dose, refer case US2018126941. This case has been also linked to case US2018GSK130832 (unspecified number of patients), reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was selected as adult as per vaccine indication. The pharmacist stated that she had 50 percent of the patients returning for the 2nd dose stating they had flu like symptoms with the 1st dose. She did not have any patients who refused the 2nd dose due to those events but she had not been reporting those to GlaxoSmithKline, as they were known events listed in the product information (PI). No specific number was shared with specific identifiers.
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of multiple sclerosis in a female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced multiple sclerosis (serious criteria GSK medically significant). The patient was treated with DECADRON and AUBAGIO. On an unknown date, the outcome of the multiple sclerosis was unknown. It was unknown if the reporter considered the multiple sclerosis to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had been diagnosed with multiple sclerosis and would be taking 5 days of DECADRON intravenous followed 2 weeks later with oral AUBAGIO daily. The reporter wanted to know would this impact her taking the second SHINGRIX in September.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fatigue and general body pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient states that after receiving the 1st dose of the SHINGRIX vaccine, she experienced flu-like symptoms that included body aches and fatigue. The patient stated that the symptoms started approximately 48 hours after receiving the injections. The patient stated that the symptoms lasted for a few days then resolved. This case has been linked with case US2018126866 same patient for 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Feeling hot, Gastrointestinal disorder, Headache
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced swelling arm, gastrointestinal disorder, feeling hot, clamminess, headache, skin discoloration and felt faint. On an unknown date, the outcome of the swelling arm, gastrointestinal disorder, feeling hot, clamminess, headache, skin discoloration and felt faint were recovered/resolved. It was unknown if the reporter considered the swelling arm, gastrointestinal disorder, feeling hot, clamminess, headache, skin discoloration and felt faint to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist in the office for herself. The age at vaccination was not reported, but it could be either 53 or 54 year of age. The patient experienced less arm swelling, gastrointestinal issues, hot and clammy and severe headache and feeling like going to pass out and the family members said the patient was gray and green in color, which was lasted for 48 hours. This case has been linked with US2018GSK130129, reported by same reporter.