chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Started with neck pain/stiffness that progressed to transit joint pain, especially hips, knees, hand plus some myalgia & abdominal discomfort about 4-5 hours after injections; 2 ADVIL taken before bed that helped decrease symptoms. The next day, joint pain, especially neck, knees, shoulders and abdominal discomfort continued and then worsened significantly by 12:00 PM, at which time significant fatigue and myalgia was noted at which time I was unable to complete ADLs. About 2:00, chills set in and by 5:00 I was found to have a fever of 100.3 F. At this time, 4 ADVIL were taken and the symptoms decreased. Today is day 3 and I still have neck & hip pain (worst) and mild generalized joint discomfort. SHINGRIX injection site remains somewhat painful at use of left arm and is tender to touch. MMR site (R arm) is non-tender.
Age: 50.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Pyrexia
Clinical narrative: Started with neck pain/stiffness that progressed to transit joint pain, especially hips, knees, hand plus some myalgia & abdominal discomfort about 4-5 hours after injections; 2 ADVIL taken before bed that helped decrease symptoms. The next day, joint pain, especially neck, knees, shoulders and abdominal discomfort continued and then worsened significantly by 12:00 PM, at which time significant fatigue and myalgia was noted at which time I was unable to complete ADLs. About 2:00, chills set in and by 5:00 I was found to have a fever of 100.3 F. At this time, 4 ADVIL were taken and the symptoms decreased. Today is day 3 and I still have neck & hip pain (worst) and mild generalized joint discomfort. SHINGRIX injection site remains somewhat painful at use of left arm and is tender to touch. MMR site (R arm) is non-tender.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Significant flu-like symptoms with severe fatigue, lower extremity myalgias, rigors, chills, brain fog, decreased appetite.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Myalgia
Clinical narrative: Significant flu-like symptoms with severe fatigue, lower extremity myalgias, rigors, chills, brain fog, decreased appetite.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Injection site erythema, Injection site induration
Clinical narrative: 2nd day had a red hard spot at place of shot that was warm and tender to touch, it was about the size of the palm of my hand and got a little bigger the 3rd day. 2nd day I had diarrhea, I ached all over, and I was very tired. I ran a low grade fever and had chills. It is the 3rd day now, the area on my arm is still very red and itches a little and it is a little bigger than the 2nd day, (it is hard and warm), but I do not have diarrhea anymore. I have taken TYLENOL for the muscle aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Myalgia, Pain
Clinical narrative: 2nd day had a red hard spot at place of shot that was warm and tender to touch, it was about the size of the palm of my hand and got a little bigger the 3rd day. 2nd day I had diarrhea, I ached all over, and I was very tired. I ran a low grade fever and had chills. It is the 3rd day now, the area on my arm is still very red and itches a little and it is a little bigger than the 2nd day, (it is hard and warm), but I do not have diarrhea anymore. I have taken TYLENOL for the muscle aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 2nd day had a red hard spot at place of shot that was warm and tender to touch, it was about the size of the palm of my hand and got a little bigger the 3rd day. 2nd day I had diarrhea, I ached all over, and I was very tired. I ran a low grade fever and had chills. It is the 3rd day now, the area on my arm is still very red and itches a little and it is a little bigger than the 2nd day, (it is hard and warm), but I do not have diarrhea anymore. I have taken TYLENOL for the muscle aches.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUN-2018, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB, lot # reported as L014426, expiration date: 08-MAR-2018, intramuscularly for prophylaxis. No adverse effects were reported. Lot number L014426 is an invalid lot number for hepatitis b vaccine (recombinant).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cataract, Cataract operation, Cerebrovascular accident, Computerised tomogram head, Eye operation
Clinical narrative: Information has been received on 22-JUN-2018 from a consumer concerning herself. The patient was a 63 years old female with a history of thyroid removal and hysterectomy. The patient also reported treatment with AMBIEN ("years ago") and another unspecified sleep medication because AMBIEN "did not really work anymore." Concomitant medications included biotin, calcium, CLARITIN, FLONASE, LIPITOR, lisinopril (mfr. unk), and SYNTHROID. The patient reported that in August 2012, she was vaccinated with ZOSTAVAX for the prevention of shingles. In 2013 she experienced "difficulty seeing" (no further clarifying information was provided). The patient was seen by an eye doctor in 2014 and was diagnosed as "having a stroke in the back of her left eye." It was not specified how the diagnosis was made. The eye doctor directed her to see an eye specialist (date not specified). On an unspecified date, the patient had a CT scan of both eyes (results not provided). The patient reported that she had cataracts removed from both eyes in 2014. After having the cataracts removed (date not specified) she starting using moisturizing drops (NOS) in both eyes; using the drops anywhere from two to five times per day, in each eye. The patient also reported that she had fat removed from both eyes in 2015. The patient reported that she has not recovered from the adverse events. She also reported that she was pursuing legal action regarding the adverse events she experienced after being vaccinated with ZOSTAVAX. Upon internal review having a stroke in the back of her left eye and cataracts removed from both eyes were considered medically significant events. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Information has been received on 22-JUN-2018 from a consumer concerning herself. The patient was a 63 years old female with a history of thyroid removal and hysterectomy. The patient also reported treatment with AMBIEN ("years ago") and another unspecified sleep medication because AMBIEN "did not really work anymore." Concomitant medications included biotin, calcium, CLARITIN, FLONASE, LIPITOR, lisinopril (mfr. unk), and SYNTHROID. The patient reported that in August 2012, she was vaccinated with ZOSTAVAX for the prevention of shingles. In 2013 she experienced "difficulty seeing" (no further clarifying information was provided). The patient was seen by an eye doctor in 2014 and was diagnosed as "having a stroke in the back of her left eye." It was not specified how the diagnosis was made. The eye doctor directed her to see an eye specialist (date not specified). On an unspecified date, the patient had a CT scan of both eyes (results not provided). The patient reported that she had cataracts removed from both eyes in 2014. After having the cataracts removed (date not specified) she starting using moisturizing drops (NOS) in both eyes; using the drops anywhere from two to five times per day, in each eye. The patient also reported that she had fat removed from both eyes in 2015. The patient reported that she has not recovered from the adverse events. She also reported that she was pursuing legal action regarding the adverse events she experienced after being vaccinated with ZOSTAVAX. Upon internal review having a stroke in the back of her left eye and cataracts removed from both eyes were considered medically significant events. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold in a 68-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included CRESTOR. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced cold, influenza-like symptoms and muscle ache. On an unknown date, the outcome of the cold, influenza-like symptoms and muscle ache were unchanged. It was unknown if the reporter considered the cold, influenza-like symptoms and muscle ache to be related to SHINGRIX. Additional information was received as follows: At 14:30, the patient received SHINGRIX on the left arm. The patient gave permission to contact his health care provider. No further details were provided by the caller. Referred the patient to his health care provider for further follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included triamterene and Bupropion XL. On 16th June 2018, the patient received the 1st dose of SHINGRIX. On 16th June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 18th June 2018, the patient experienced eye swelling, facial swelling and skin warm. On 19th June 2018, the patient experienced itchy upper limbs. On an unknown date, the outcome of the eye swelling, itchy upper limbs, pain in arm, erythema of extremities, facial swelling and skin warm were not recovered/not resolved. The reporter considered the eye swelling, facial swelling and skin warm to be almost certainly related to SHINGRIX. The reporter considered the itchy upper limbs, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient stated that a couple of hours after receiving the injection on left arm, she experienced pain in her left arm and a big red circle on her left arm. The patient stated that the day before reporting (2 days after vaccination), when she woke up, she noticed swelling under her eyes and on her cheeks. The patient's face was warm to the touch and it looked like sunburn. The patient stated that at the day of reporting (3 days after vaccination), her left arm was itchy. The patient had denied permission to contact their physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included triamterene and Bupropion XL. On 16th June 2018, the patient received the 1st dose of SHINGRIX. On 16th June 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 18th June 2018, the patient experienced eye swelling, facial swelling and skin warm. On 19th June 2018, the patient experienced itchy upper limbs. On an unknown date, the outcome of the eye swelling, itchy upper limbs, pain in arm, erythema of extremities, facial swelling and skin warm were not recovered/not resolved. The reporter considered the eye swelling, facial swelling and skin warm to be almost certainly related to SHINGRIX. The reporter considered the itchy upper limbs, pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient stated that a couple of hours after receiving the injection on left arm, she experienced pain in her left arm and a big red circle on her left arm. The patient stated that the day before reporting (2 days after vaccination), when she woke up, she noticed swelling under her eyes and on her cheeks. The patient's face was warm to the touch and it looked like sunburn. The patient stated that at the day of reporting (3 days after vaccination), her left arm was itchy. The patient had denied permission to contact their physician.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Pain, Pyrexia, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 17-year-old female patient who received BEXSERO for prophylaxis. Concomitant products included MENVEO. On 19th June 2018, the patient received the 1st dose of BEXSERO .5 ml. In June 2018, less than a week after receiving BEXSERO, the patient experienced fever, weakness, general body pain and swelling. On an unknown date, the outcome of the fever, weakness, general body pain and swelling were unknown. The reporter considered the fever, general body pain and swelling to be probably related to BEXSERO. It was unknown if the reporter considered the weakness to be related to BEXSERO. Additional details were provided as follows: The batch number was not known by sales representative. The patient received two vaccinations on the same date but in different arms. It was unknown which arm the BEXSERO was given and if it was given in the deltoid area. It was also unknown by the representative if the vaccine was administered intramuscular. The patient was also received MENVEO on the same date but the reporter did not relate the adverse events to that vaccine.  The reporter basically wanted to know if these adverse reactions that are listed in the label for BEXSERO could be expected with the 2nd dose. The patient did visit the doctor's office with a low grade fever of 99.7 along with pain, swelling body aches and weakness.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingles twice). Previously administered products included ZOSTAVAX (received 2 years ago). On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 14th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 15th June 2018, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 14th June 2018, Thursday, the patient received SHINGRIX on unknown arm and the injection was painful and arm continued to be sore. Next day after receiving SHINGRIX, the patient noticed baseball size redness and swelling about 4 inches below injection site. The patient was asked to if she could get the 2nd dose in 2 to 6 months. The patient was also scheduled for a cervical epidural on Tuesday. The patient was asking if there were any contraindications due to injection from getting the epidural. Clarification has been raised for the confirmation of latency and anatomical location for the adverse events (if erythema and swelling was at injection site or away from injection site).
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingles twice). Previously administered products included ZOSTAVAX (received 2 years ago). On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 14th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 15th June 2018, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 14th June 2018, Thursday, the patient received SHINGRIX on unknown arm and the injection was painful and arm continued to be sore. Next day after receiving SHINGRIX, the patient noticed baseball size redness and swelling about 4 inches below injection site. The patient was asked to if she could get the 2nd dose in 2 to 6 months. The patient was also scheduled for a cervical epidural on Tuesday. The patient was asking if there were any contraindications due to injection from getting the epidural. Clarification has been raised for the confirmation of latency and anatomical location for the adverse events (if erythema and swelling was at injection site or away from injection site).
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received SHINGRIX. On 16th June 2018, 1 days after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received shot 1 of SHINGRIX vaccine. The patient noticed some raised redness. On 17th June 2018, the raised redness continued to get worse to a size of about 5 by 3 inches. On 18th June 2018, the size was slightly less red and raised and slightly smaller.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Erythema, Inflammation, Initial insomnia, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of inflammation localized in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose, see case US2018GSK114430) and ZOSTAVAX. On 14th June 2018, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and wrong injection technique. On 15th June 2018, the patient experienced inflammation localized, erythema of extremities, skin warm and injected limb mobility decreased. In June 2018, the patient experienced itchy upper limbs, trouble falling asleep, diarrhea and churning of stomach. On an unknown date, the outcome of the inflammation localized, injection site pain, erythema of extremities, itchy upper limbs, skin warm, trouble falling asleep, injected limb mobility decreased, diarrhea and churning of stomach were not recovered/not resolved and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the inflammation localized, injection site pain, erythema of extremities, itchy upper limbs, skin warm, trouble falling asleep, injected limb mobility decreased, diarrhea and churning of stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received second SHINGRIX at pharmacy. It definitely hurt much more than the first time and soon, realized that perhaps the injection had been incorrectly given. Thus, it might had led to possible wrong injection technique. By the next day, the patient's arm was inflamed and the patient could not (still could not) raise it above my head. The red area seems warmer than the other arm also. At the reporting date, three days later, it was much better, still red and intensely itching and painful when anything touches it, even a sleeve or the like. It was hard to sleep also. The patient asked how long would the reaction last, if anything she could put on it to lessen the sensitivity and especially the itching (cortisone or triamcinalone cream) which was the worst feeling. The patient did not seem to have a fever but did have diarrhea and churning stomach. All in all, this unexpected reaction was scary, the patient hope to see a general physician or urgent care document. The patient was part of the original clinical study for ZOSTAVAX many years before the reporting date and was given it at the end. The patient got it again once it became generally available. The patient had received two SHINGRIX shots, for a grand total of four shots, not many could, and she said as might be it was overdone.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Nausea, Pruritus, Skin warm, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer and described the occurrence of inflammation localized in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose, see case US2018GSK114430) and ZOSTAVAX. On 14th June 2018, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and wrong injection technique. On 15th June 2018, the patient experienced inflammation localized, erythema of extremities, skin warm and injected limb mobility decreased. In June 2018, the patient experienced itchy upper limbs, trouble falling asleep, diarrhea and churning of stomach. On an unknown date, the outcome of the inflammation localized, injection site pain, erythema of extremities, itchy upper limbs, skin warm, trouble falling asleep, injected limb mobility decreased, diarrhea and churning of stomach were not recovered/not resolved and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the inflammation localized, injection site pain, erythema of extremities, itchy upper limbs, skin warm, trouble falling asleep, injected limb mobility decreased, diarrhea and churning of stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received second SHINGRIX at pharmacy. It definitely hurt much more than the first time and soon, realized that perhaps the injection had been incorrectly given. Thus, it might had led to possible wrong injection technique. By the next day, the patient's arm was inflamed and the patient could not (still could not) raise it above my head. The red area seems warmer than the other arm also. At the reporting date, three days later, it was much better, still red and intensely itching and painful when anything touches it, even a sleeve or the like. It was hard to sleep also. The patient asked how long would the reaction last, if anything she could put on it to lessen the sensitivity and especially the itching (cortisone or triamcinalone cream) which was the worst feeling. The patient did not seem to have a fever but did have diarrhea and churning stomach. All in all, this unexpected reaction was scary, the patient hope to see a general physician or urgent care document. The patient was part of the original clinical study for ZOSTAVAX many years before the reporting date and was given it at the end. The patient got it again once it became generally available. The patient had received two SHINGRIX shots, for a grand total of four shots, not many could, and she said as might be it was overdone.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of inflammation localized in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after receiving 1st dose, see case US2018GSK114430) and ZOSTAVAX. On 14th June 2018, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and wrong injection technique. On 15th June 2018, the patient experienced inflammation localized, erythema of extremities, skin warm and injected limb mobility decreased. In June 2018, the patient experienced itchy upper limbs, trouble falling asleep, diarrhea and churning of stomach. On an unknown date, the outcome of the inflammation localized, injection site pain, erythema of extremities, itchy upper limbs, skin warm, trouble falling asleep, injected limb mobility decreased, diarrhea and churning of stomach were not recovered/not resolved and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the inflammation localized, injection site pain, erythema of extremities, itchy upper limbs, skin warm, trouble falling asleep, injected limb mobility decreased, diarrhea and churning of stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received second SHINGRIX at pharmacy. It definitely hurt much more than the first time and soon, realized that perhaps the injection had been incorrectly given. Thus, it might had led to possible wrong injection technique. By the next day, the patient's arm was inflamed and the patient could not (still could not) raise it above my head. The red area seems warmer than the other arm also. At the reporting date, three days later, it was much better, still red and intensely itching and painful when anything touches it, even a sleeve or the like. It was hard to sleep also. The patient asked how long would the reaction last, if anything she could put on it to lessen the sensitivity and especially the itching (cortisone or triamcinalone cream) which was the worst feeling. The patient did not seem to have a fever but did have diarrhea and churning stomach. All in all, this unexpected reaction was scary, the patient hope to see a general physician or urgent care document. The patient was part of the original clinical study for ZOSTAVAX many years before the reporting date and was given it at the end. The patient got it again once it became generally available. The patient had received two SHINGRIX shots, for a grand total of four shots, not many could, and she said as might be it was overdone.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Erythema, Inflammation, Initial insomnia, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. 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 unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the vaccination hurt less than the 2nd time. This case has been linked with US2018GSK109508, reported by the same patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Nausea, Pruritus, Skin warm, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. 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 unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the vaccination hurt less than the 2nd time. This case has been linked with US2018GSK109508, reported by the same patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. 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 unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the vaccination hurt less than the 2nd time. This case has been linked with US2018GSK109508, reported by the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fatigue in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccination about 2 to 3 months before the reporting date. For a day or two afterward, the patient felt fatigue, something which he never felt after vaccinations, even after vaccination with the earlier formulation. On the reporting day, the patient received his second dose of SHINGRIX. The patient was asking, could he expect the same reaction. For the answer, the patient was transferred to the Medical Information Scientist who worked with SHINGRIX closely.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a male patient who received SHINGRIX for prophylaxis. On 11th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown. It was unknown if the reporter considered the atrial fibrillation to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. The age at vaccination was not reported. The patient received initial SHINGRIX dose and less than 24 hours later his heart rate was 250 beats per minute. The reporter asked if there was any information indicating that the vaccine could have triggered this episode of atrial fibrillation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: The day after the patient received SHINGRIX dose 2 she complained of weakness in arm where vaccination occurred. This weakness spread up and down the arm and continued to bother patient even 1 week after injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Incomplete course of vaccination, Insomnia, Pain, Pyrexia
Clinical narrative: Patient receives SHINGRIX vaccine Thursday and comes back Monday saying she is still experiencing side effects. Diarrhea on and off for 3 days and is better now 6/27 after 6 days. Pain and swelling, hot to touch for 4 nights creating difficulty sleeping. Fever on and off for 3 days as well. Taking OTC to treat symptoms. Had denied the 2nd dose of SHINGRIX due to severe reaction to 1st dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Vaccination complication
Clinical narrative: Patient receives SHINGRIX vaccine Thursday and comes back Monday saying she is still experiencing side effects. Diarrhea on and off for 3 days and is better now 6/27 after 6 days. Pain and swelling, hot to touch for 4 nights creating difficulty sleeping. Fever on and off for 3 days as well. Taking OTC to treat symptoms. Had denied the 2nd dose of SHINGRIX due to severe reaction to 1st dose.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Deafness, Dizziness, Eye swelling, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient expressed concern about pain associated with injection prior to vaccination, she was visibly nervous. Mother insisted that patient had shots before and that this [receiving injection] is not something new. I offered to delay injection, however mother insisted to have the vaccination done, and physically held patient's face away so that the patient does not look at the needle. After injection given, patient immediately complained about injection site pain, and complained about not able to hear. Patient's mother and sibling was at her side, talking to patient saying "but you can hear us," patient was able to respond to mother/sibling. Few minutes later, patient started to complain about not able to see well, and she states that her eyes are swollen. She requested to have some water to drink and cold bottled water was provided to her. Patient denied experiencing any shortness of breath. She had held her ears several times throughout the incident. Patient remained seated and her lower extremities were elevated on another chair the whole time after the injection was given. Patient complained about being lightheaded, however did state that the vision and hearing problem got "a little better" after 15-20 minutes post-injection but that they are still present. We offered to call 911 several times, however patient's mother declined. We offered that there's an urgent care clinic nearby and if the patient wanted to be seen by the clinic - patient's mother agreed. Patient states she wanted to "get some fresh air." Motorized wheelchair was offered to escort the patient to the clinic- declined by patient's mother. Patient was escorted by her mother and was able to walk out the store on her feet.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Nervousness, Visual impairment
Clinical narrative: Patient expressed concern about pain associated with injection prior to vaccination, she was visibly nervous. Mother insisted that patient had shots before and that this [receiving injection] is not something new. I offered to delay injection, however mother insisted to have the vaccination done, and physically held patient's face away so that the patient does not look at the needle. After injection given, patient immediately complained about injection site pain, and complained about not able to hear. Patient's mother and sibling was at her side, talking to patient saying "but you can hear us," patient was able to respond to mother/sibling. Few minutes later, patient started to complain about not able to see well, and she states that her eyes are swollen. She requested to have some water to drink and cold bottled water was provided to her. Patient denied experiencing any shortness of breath. She had held her ears several times throughout the incident. Patient remained seated and her lower extremities were elevated on another chair the whole time after the injection was given. Patient complained about being lightheaded, however did state that the vision and hearing problem got "a little better" after 15-20 minutes post-injection but that they are still present. We offered to call 911 several times, however patient's mother declined. We offered that there's an urgent care clinic nearby and if the patient wanted to be seen by the clinic - patient's mother agreed. Patient states she wanted to "get some fresh air." Motorized wheelchair was offered to escort the patient to the clinic- declined by patient's mother. Patient was escorted by her mother and was able to walk out the store on her feet.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site reaction, Pain, Rash
Clinical narrative: Px reported receiving shot at approximately 630pm 6/25/18 and at approx 10pm she reported the following SX's: Large Rash on chest and neck, body aches/chills that lasted thru the next morning, large, painful welt at injection site that extended to armpit area. This is her second shot in the series. She did not exhibit any of these same SX's after receiving the first shot in April. She reported to her PCP by phone who instructed her to take IBU and to try BENADRYL prn. Pt reported to pharmacy 6/27. I asked the px if she was otherwise OK, and she said yes. PCP instructed her to follow up in approximately 3 days, and to come into office if no improvement.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Px reported receiving shot at approximately 630pm 6/25/18 and at approx 10pm she reported the following SX's: Large Rash on chest and neck, body aches/chills that lasted thru the next morning, large, painful welt at injection site that extended to armpit area. This is her second shot in the series. She did not exhibit any of these same SX's after receiving the first shot in April. She reported to her PCP by phone who instructed her to take IBU and to try BENADRYL prn. Pt reported to pharmacy 6/27. I asked the px if she was otherwise OK, and she said yes. PCP instructed her to follow up in approximately 3 days, and to come into office if no improvement.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called our Pharmacy on 06/27/2018 at 1:40 PM and said his left arm swollen and redness a little bit two days after he was given a vaccine. Stated that the redness and swollen went away after two days. But now and for a couple of two days he feels pain in his left arm. He stated that he went to a doctor and he was told that the pain will go away after a couple of days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Patient has a greenish/yellow mark above where vaccine was administered. Mark appeared about 2 to 3 days after vaccine. Reports no pain, itching, irritation, or discomfort.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea, Pain
Clinical narrative: Severe injection site soreness & local swelling; swollen neck on left side; headache; nausea; vomiting; severe body pain, myalgia.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vomiting
Clinical narrative: Severe injection site soreness & local swelling; swollen neck on left side; headache; nausea; vomiting; severe body pain, myalgia.
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Bradycardia, Hypoglycaemia, Hypotension, Slow response to stimuli, Somnolence
Clinical narrative: Patient became bradycardic, hypotensive, hypoglycemic despite just eating a full meal, drowsy, slow to respond and incontinent of urine.
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Urinary incontinence
Clinical narrative: Patient became bradycardic, hypotensive, hypoglycemic despite just eating a full meal, drowsy, slow to respond and incontinent of urine.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site discolouration, Pyrexia, Rash generalised, Skin lesion
Clinical narrative: We were not the facility giving the vaccine. The vaccine was provided by the pediatrician. The patient was seen by us about 2 weeks after giving the vaccine and reported these events. I am unsure how the vaccines were given (combined MMR and Varicella or separate). The parents reported a high fever of 40C on 6/21-6/22. On 6/24-6/25, patient developed a generalized body rash consisting of diffuse red lesions (unclear if macular or papular). There were no remaining lesions at the time of the pulmonary visit. Patient also had a hyperpigmented lesion at the site of the vaccination.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: Dizziness, Fall
Clinical narrative: Patient was given three immunizations, and then got in line and she just fell down while in line. I had patient come sit down on the bench. Patient states that she felt a little light headed. Her mom said her daughter has not eaten anything all day.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen and painful right upper arm, per patient symptoms appeared after receiving vaccine. Treated with BENADRYL and BACTRIM.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Epistaxis
Clinical narrative: The patient had a nosebleed that lasted more than 12 hours starting a few hours after getting the SHINGRIX.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dizziness, Swelling
Clinical narrative: Patient had an anaphylactic reaction to the vaccine. She had to a local emergency room for treatment. She described feeling dizzy, sweeling around the throat area and having to use an Epipen. She stated the reaction started approximately 45 minutes after the injection.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient requested a HAVRIX (Hep A) injection and after she received the vaccine she left the IMZ booth and she collapsed on the floor in front of pharmacy. No medication was given, she felt better after a few minutes and I let her go with her consent.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Swelling
Clinical narrative: Pain and swelling, headache, shivering, fever (101F).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Malaise, Vomiting
Clinical narrative: Patient stated that she was not feeling well yesterday evening (day vaccine was given) and was vomiting all night. She had a prescription at home, Dicyclomine, that she is currently prescribed and took that to aid the abdominal cramping.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient received 1st dose of SHINGRIX on 5-29-18.  By 5-31-18, patient states she was broken out in an itchy rash all over her body. Her home health nurse recommended CLARITIN and to apply hydrocortisone 1% three times daily. The patient came to the pharmacy 6-25-18 to let us know of the reaction. Pharmacy has called her healthcare provider for follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site pain, Neck pain
Clinical narrative: Patient experienced stomach/intestine discomfort, and neck, injection site, legs, and feet ache non-stop. Patient claims very fatigued and have a headache. Patient treated with MOTRIN and rest. Symptoms lasted 2 and 1/2 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient experienced stomach/intestine discomfort, and neck, injection site, legs, and feet ache non-stop. Patient claims very fatigued and have a headache. Patient treated with MOTRIN and rest. Symptoms lasted 2 and 1/2 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder starting 3 to 4 hours after vaccination continuing to date - still unresolved. Pain is severe - patient cannot lift arm to shoulder height or swing backwards.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Severe body aches, fatigue, vertigo, headaches, severe intermittent back pain. Local arm pain at injection site.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Severe body aches, fatigue, vertigo, headaches, severe intermittent back pain. Local arm pain at injection site.
Age: 70.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Injection site warmth, Pain
Clinical narrative: For the first 24-48 hours, the patient reported chills and pain near the injection site.  Over the course of the first 48 hours, these symptoms diminished. On the morning of the 3rd day post-vaccination, the patient awoke with redness on the upper arm that was injected as well as describing it as warm/hot. Over the course of today, the 3rd day post-vaccination, those symptoms also began to diminish.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain at injection site, fever and chills the evening of injection. Body aches and pain in the legs the morning after the vaccine.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Flank pain, Malaise, Mobility decreased, Nausea
Clinical narrative: Day after her shot pt woke up with intense pain in the arm; "I could hardly move my arm". Pain mostly over the deltoid. Entire arm felt like a deep ache down to the fingers and up into her neck. General ill feeling, some nausea, no energy, no vomiting, no fever or chills, no hives or itching, stayed in bed all day. Today she's less ill than yesterday but still has a deep ache in the arm and it's going into her L side. She did not receive any routine vaccinations in childhood. At about age 10 she did get some type of tetanus shot; not known whether it was a Td or DTap, because she lived in an old house and her parents were concerned. She had not had any tetanus shots since that time.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Day after her shot pt woke up with intense pain in the arm; "I could hardly move my arm". Pain mostly over the deltoid. Entire arm felt like a deep ache down to the fingers and up into her neck. General ill feeling, some nausea, no energy, no vomiting, no fever or chills, no hives or itching, stayed in bed all day. Today she's less ill than yesterday but still has a deep ache in the arm and it's going into her L side. She did not receive any routine vaccinations in childhood. At about age 10 she did get some type of tetanus shot; not known whether it was a Td or DTap, because she lived in an old house and her parents were concerned. She had not had any tetanus shots since that time.
Age: 46.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Nausea
Clinical narrative: Severe abdominal pain and nausea.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Lethargy, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Patient reports a spreading rash on his neck, face, scalp and today 6/27 starting to spread downward and outward to his chest and back. The rash itches and burns, particularly on his scalp. He also reports severe left arm soreness for 3 days and general myalgia, low grade fever and lethargy for about 24 hours after receiving SHINGRIX. The rash has resulted in the need for a KENALOG 40 injection and a clobetasol scalp solution for itching (from a dermatologist).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient reports a spreading rash on his neck, face, scalp and today 6/27 starting to spread downward and outward to his chest and back. The rash itches and burns, particularly on his scalp. He also reports severe left arm soreness for 3 days and general myalgia, low grade fever and lethargy for about 24 hours after receiving SHINGRIX. The rash has resulted in the need for a KENALOG 40 injection and a clobetasol scalp solution for itching (from a dermatologist).