chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (For tolerance to 1st dose please refer case US2019001666). In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema, pruritus, swelling arm, shoulder pain, vomiting, shivering, headache, dizziness and fatigue. The patient was treated with Ginger. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the erythema and pruritus were unknown and the outcome of the swelling arm was recovering/resolving and the outcome of the shoulder pain, shivering, headache, dizziness and fatigue were not recovered/not resolved and the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the erythema, pruritus, swelling arm, shoulder pain, vomiting, shivering, headache, dizziness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however, it could be 62 or 63 years. The patient received SHINGRIX vaccine in left arm, approximately 8 days ago before the date of reporting. Next day the patient started vomiting. The patient has been eating ginger to help and has now recovered. The patient experienced swollen arm which was better than before but it was still swollen. The patient was still experiencing shivering, headache, dizziness, shoulder pain, redness, itching, and fatigue. The reporter did not consent to follow-up. No further details were provided. The reporter would follow up with her physician as required.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Peripheral swelling, Pruritus, Vaccine positive rechallenge, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (For tolerance to 1st dose please refer case US2019001666). In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema, pruritus, swelling arm, shoulder pain, vomiting, shivering, headache, dizziness and fatigue. The patient was treated with Ginger. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the erythema and pruritus were unknown and the outcome of the swelling arm was recovering/resolving and the outcome of the shoulder pain, shivering, headache, dizziness and fatigue were not recovered/not resolved and the outcome of the vomiting was recovered/resolved. It was unknown if the reporter considered the erythema, pruritus, swelling arm, shoulder pain, vomiting, shivering, headache, dizziness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however, it could be 62 or 63 years. The patient received SHINGRIX vaccine in left arm, approximately 8 days ago before the date of reporting. Next day the patient started vomiting. The patient has been eating ginger to help and has now recovered. The patient experienced swollen arm which was better than before but it was still swollen. The patient was still experiencing shivering, headache, dizziness, shoulder pain, redness, itching, and fatigue. The reporter did not consent to follow-up. No further details were provided. The reporter would follow up with her physician as required.
Age: 65.0
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 pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported, however patient could be either 65 or 66 years old. The patient experienced sore arm for about 4 days. The reporter consented to follow up. This case has been linked with case US2019001678 for the same patient reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: This case was reported by a other health professional 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 the 1st dose of SHINGRIX .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Both immunizations given at same pharmacy. Lot number was not known. Arm began to hurt immediately upon immunization of both doses. Immunized person reported never being so aware of where arm was even if the patient was not moving. With both doses, side effects lasted about 2 days. The patient thought experienced events were related to immunization. For tolerance after 2nd dose refer case US2019GSK002321. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Middle insomnia, Tremor
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of tremor in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in September 2018, see case US2019GSK002329). On 14th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced tremor, shivering, malaise and nocturnal awakening. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the tremor, shivering and nocturnal awakening were unknown and the outcome of the malaise was recovered/resolved. It was unknown if the reporter considered the tremor, shivering, malaise and nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was over 50 years old. The patient with the dose of SHINGRIX, awoke in the night, shaking or shivering, continued malaise that lasted about 24 hours. The patient took ibuprofen or TYLENOL and started feeling better within about 24 hours. The reporter agreed to be followed up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Depressed mood, Influenza like illness, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, pain, feeling down, chills, nausea and influenza-like symptoms. On an unknown date, the outcome of the fever, pain, feeling down, chills, nausea and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, pain, feeling down, chills, nausea and influenza-like symptoms to be related to SHINGRIX. Additional details were reported 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 consumer reported the following via online chat the patient had side effects after 1st shingle shot fever, ache, down several days. The reporter asked should they expect them with the second dosage. Yes, it was and the patient had flu like symptoms including fever chills and nausea. It was confirmed that the patient received SHINGRIX. The reporter did not consent to follow up.  The reporting consumer declined to provide more information.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, pain, feeling down, chills, nausea and influenza-like symptoms. On an unknown date, the outcome of the fever, pain, feeling down, chills, nausea and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, pain, feeling down, chills, nausea and influenza-like symptoms to be related to SHINGRIX. Additional details were reported 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 consumer reported the following via online chat the patient had side effects after 1st shingle shot fever, ache, down several days. The reporter asked should they expect them with the second dosage. Yes, it was and the patient had flu like symptoms including fever chills and nausea. It was confirmed that the patient received SHINGRIX. The reporter did not consent to follow up.  The reporting consumer declined to provide more information.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Metastasis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of metastasis in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cancer. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced metastasis (serious criteria GSK medically significant). On an unknown date, the outcome of the metastasis was unknown. It was unknown if the reporter considered the metastasis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was informed that her cancer had metastasized. The patient did not provide any contact information, but she would have her physician contact medical information.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) 0.5 ml. On 5th January 2019, 1 days after receiving SHINGRIX, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved. It was unknown if the reporter considered the vertigo to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On Saturday evening, the patient started to experience vertigo every time she changed her position from lying down to getting up. The reporter gave consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blood sugar increased in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus. On 9th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 7 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the patient experienced blood sugar increased (serious criteria hospitalization). On an unknown date, the outcome of the blood sugar increased and rash were recovered/resolved. It was unknown if the reporter considered the blood sugar increased and rash to be related to SHINGRIX. Additional details were provided as follows: A week after vaccination, the patient developed some spots on her hands, arms and abdominal region. The patient believed that, she had chicken pox, but the pharmacist had not heard any official diagnosis from the patient's physicians. Sometime after getting the SHINGRIX, the patient also ended up in the hospital due to very high blood sugar. Lab Comments: On an unknown date, the patient's blood sugar was increased.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Illness at time of vaccination included pruritus (About 1 month before the vaccination with SHINGRIX). On 19th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: About 7 months after the case of shingles, the patient vaccinated with the SHINGRIX vaccine. About 1 month before vaccination with SHINGRIX, the patient had some itching. But since the patient never had itching with shingles before, the patient did not associate it with shingles. The pharmacist reported that the patient presented with shingles one week after vaccination with SHINGRIX. One week after getting SHINGRIX, the shingles vesicles broke out where she had the itching.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had pain in her shoulder following dose of SHINGRIX. The pharmacist had no further details regarding the patient or vaccine administration.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (past 2 to 3 years ago). Previously administered products included ZOSTAVAX. Concurrent medical conditions included pruritus (itching was present on the top of his head, and the left side of the face and top of the eye). On 27th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain and pruritus aggravated. On an unknown date, the outcome of the injection site pain and pruritus aggravated were recovered/resolved. It was unknown if the reporter considered the injection site pain and pruritus aggravated to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. He had Shingles in the past 2 to 3 years from the date of reporting, and he was left with itching from the Shingles that he had. The itching was present on the top of his head, and the left side of the face and top of the eye. After receiving SHINGRIX the itching got aggravated. As of the day of reporting he had recovered from the itching. The patient also experienced pain at the injection site which lasted for total of 3 days. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain and injection site muscle reaction. On an unknown date, the outcome of the injection site muscle pain and injection site muscle reaction were not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain and injection site muscle reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX vaccine on an unknown deltoid. The patient was due for 2nd dose of SHINGRIX vaccine but at the time of reporting had intermittent muscle pain and weakness at the site of 1st dose of SHINGRIX vaccine. The reporter consented to follow up. The healthcare professional did not have immediate access to lot number or expiry date.
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Erythema, Loss of consciousness, Migraine, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blackout 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, unknown after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), nausea, difficulty in standing, migraine, erythema, pruritus, swelling arm and pain. On an unknown date, the outcome of the blackout, nausea, difficulty in standing, migraine, erythema, swelling arm and pain were recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the blackout, nausea, difficulty in standing, migraine, erythema, pruritus, swelling arm and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced nausea, had hard time standing up, and migraine post vaccination. This lasted for one day and she had to take medicine for her migraine.  The patient blacked out for about a minute. The patient experienced redness, itching, pain and swollen arm which lasted for total of 3 days. The reporter did not consent to follow-up. No further details were provided. The reporter would follow up with her physician as required. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK003476.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blackout 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, unknown after receiving SHINGRIX, the patient experienced blackout (serious criteria GSK medically significant), nausea, difficulty in standing, migraine, erythema, pruritus, swelling arm and pain. On an unknown date, the outcome of the blackout, nausea, difficulty in standing, migraine, erythema, swelling arm and pain were recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the blackout, nausea, difficulty in standing, migraine, erythema, pruritus, swelling arm and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced nausea, had hard time standing up, and migraine post vaccination. This lasted for one day and she had to take medicine for her migraine.  The patient blacked out for about a minute. The patient experienced redness, itching, pain and swollen arm which lasted for total of 3 days. The reporter did not consent to follow-up. No further details were provided. The reporter would follow up with her physician as required. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK003476.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. 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 reporter and her husband were both on the phone. They mentioned that, they had several friends who got the SHINGRIX vaccine and that the side effects of fever and flu-like symptoms were worse after the second dose vs. the first. They tried to get specifics. The only specific they could got was one male friend was in bed for several days with flu like symptoms after dose 2. This case was linked with case US2019GSK005444, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Pain, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX (batch number 2AH5M, expiry date 31st May 2021) for prophylaxis. On 29th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, stomach pain, headache, general body pain and rash. On an unknown date, the outcome of the fever, stomach pain, headache, general body pain and rash were recovered/resolved.  It was unknown if the reporter considered the fever, stomach pain, headache, general body pain and rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever, stomach ache, headache, body ache and arm rash for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date 22nd February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient developed shingles approximately 2 months after receiving SHINGRIX. The reporter consented to follow up and the healthcare professional was unsure about the exact time the patient developed shingles, but approximately 2 months after the 1st dose.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Fluid retention, Heart rate increased, Hyperaesthesia, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 3rd November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 14 days after receiving SHINGRIX, the patient experienced heart rate increased. In December 2018, the patient experienced swelling of legs, water retention and hyperesthesia. The patient was treated with diuretics nos (Diuretic). On an unknown date, the outcome of the heart rate increased was recovered/resolved and the outcome of the swelling of legs, water retention and hyperesthesia were not recovered/not resolved. It was unknown if the reporter considered the heart rate increased, swelling of legs, water retention and hyperesthesia to be related to SHINGRIX. Additional details were provided as follows: The patient recevied SHINGRIX vaccine on left arm. It was reported that, two weeks after the vaccination, the patient experienced increased heart rate. In the beginning of December 2018, the patient began to experience swelling and water retention in both legs and had increased sensitivity at the tips of all of his fingers. The patient was kept on diuretic three weeks ago and had lost 8lbs of fluid. The reporter had consented to follow up and gave permission for his physician to be contacted.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site pain, Injection site rash, Product administered at inappropriate site, Wrong product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site stinging in a adult female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number ZA72G, expiry date 31st May 2019) for prophylaxis. On 7th January 2019, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (subcutaneous) .1 ml. On 7th January 2019, unknown after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced wrong vaccine administered and intramuscular formulation administered by other route. On 8th January 2019, the patient experienced injection site stinging and injection site rash. On an unknown date, the outcome of the injection site stinging and injection site rash were recovering/resolving and the outcome of the wrong vaccine administered and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site stinging and injection site rash to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The medical administered a dose of FLULAVAL rather than a Tuberculosis shot to an adult female patient, which led to wrong vaccine administered. The patient received 0.1 ml dose of injected FLULAVAL subcutaneously into the left forearm, which led to intramuscular formulation administered by other route. After a day, the patient reported that the injection site burned and stung. The patient developed rash around the injection site, about 1 and a half inches in diameter. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, 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 injection site pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (2 years ago from the reporting). On 3rd January 2019, the patient received the 1st dose of SHINGRIX. On 4th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain. In January 2019, the patient experienced injection site swelling, injection site erythema and injection site discoloration. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site swelling, injection site erythema and injection site discoloration were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site discoloration to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine last Thursday in left arm. About 24 hours after vaccination, the patient noticed pain at the site. She also noted redness from the site down to elbow, but she was unsure when this started and might had slight swelling at the site. At the time of reporting the site slight pink but no pain and just a small bump about the size of a pencil eraser if that at the site. The patient went to show these side effects to the pharmacist. No medications or advice gave by the pharmacist to the patient. The pharmacist only noted the day when the patient received SHINGRIX. The pharmacist commented that he wished they would have changed the needle after drawing the vaccine up before he gave it. No healthcare professional information asked.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Injection site joint movement impairment, Injection site pain
Clinical narrative: Immediate intense pain at the time of the injection. The pain instantly spread from the injection site throughout left arm down to fingertips. Very limited arm movement since the time of injection (11 weeks ago). Arm aches while at rest, but the pain greatly intensifies and is severe when arm is in motion. Decreased range of motion of left shoulder. Decreased strength in left arm. Excruciatingly painful to lift anything with left arm. Numbness and tingling in fingers of left hand.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediate intense pain at the time of the injection. The pain instantly spread from the injection site throughout left arm down to fingertips. Very limited arm movement since the time of injection (11 weeks ago). Arm aches while at rest, but the pain greatly intensifies and is severe when arm is in motion. Decreased range of motion of left shoulder. Decreased strength in left arm. Excruciatingly painful to lift anything with left arm. Numbness and tingling in fingers of left hand.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt had red swollen upper L arm with bruising in the center of the red area, fever, low grade x 3 days controlled with TYLENOL.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, CSF protein increased, Culture negative, Depressed level of consciousness, Electromyogram abnormal
Clinical narrative: Patient received flu vaccine at 0835 on 11/28/2018. On 11/29/2018 patient does not follow any commands. Barely able to move all the extremities. Does not withdraw to pain. All cultures remain negative. Start spiking fever up to 103. MRI was ordered and later on reviewed. It showed no acute brain abnormalities. Weakness, obtunded state resp failure raising concern for GBS with elevated CSF protein. Diagnosis of GBS confirmed with lab and EMG - with severely prolonged F waves.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Mobility decreased, Nuclear magnetic resonance imaging brain normal, Pyrexia, Respiratory failure
Clinical narrative: Patient received flu vaccine at 0835 on 11/28/2018. On 11/29/2018 patient does not follow any commands. Barely able to move all the extremities. Does not withdraw to pain. All cultures remain negative. Start spiking fever up to 103. MRI was ordered and later on reviewed. It showed no acute brain abnormalities. Weakness, obtunded state resp failure raising concern for GBS with elevated CSF protein. Diagnosis of GBS confirmed with lab and EMG - with severely prolonged F waves.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received flu vaccine at 0835 on 11/28/2018. On 11/29/2018 patient does not follow any commands. Barely able to move all the extremities. Does not withdraw to pain. All cultures remain negative. Start spiking fever up to 103. MRI was ordered and later on reviewed. It showed no acute brain abnormalities. Weakness, obtunded state resp failure raising concern for GBS with elevated CSF protein. Diagnosis of GBS confirmed with lab and EMG - with severely prolonged F waves.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pruritus, Urticaria
Clinical narrative: Hives presented at home after the 15 minute evaluation period. They have been subsiding...patient is well enough to have walked in the pharmacy though. Patient also reported itching, headache, chills & muscle aches/pains. These all resolved on their own.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site irritation, Nausea
Clinical narrative: Woke up the next day with nausea, headache, dizziness, fatigue that lasted a full day. She also had irritation at injection site that continued to get worse throughout for the next 3 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Terrible chills and shivering with a massive headache. Headache lasted two days.....shivering for a few hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pain, Pyrexia
Clinical narrative: Patient states that within about 24 hours of having the vaccine she developed and low fever and body aches. Then on about the second day her bottom lip was swollen. She said she didn't develop swelling or itching in the throat or body.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: A few hours after the shot, arm got fairly red and started swelling. It was very sore. For several days, half of my upper arm and slightly below my elbow was red and my arm was swollen. It lasted about 9 days. There were no symptoms of extreme nature that required medical attention. I had a slight reaction over 6 years ago when I had this vaccine. This was much worse. Am concerned if any components of this vaccine are in any other vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Embolic stroke, Retinal artery occlusion, Retinal detachment, Retinal tear, Sudden visual loss
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient received ZOSTAVAX, (lot# and route unknown) on 06-OCT-2016 for its intended purpose: the prevention of shingles. Shortly after receiving ZOSTAVAX the patient suffered sudden acute loss of vision with temporal arteritis, an embolic accident, and retinal detachment. The patient was then diagnosed with central retinal artery occlusion of the right eye. The patient also suffered and was diagnosed with a vitreous hemorrhage in her right eye and a retinal tear in her left eye. As a direct and proximate result of ZOSTAVAX the patient suffered painful injuries and damages,  and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further as a tragic consequence the patient suffered serious progressive permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Sudden acute loss of vision with temporal arteritis, embolic accident, retinal detachment, central retinal artery occlusion of the right eye, vitreous hemorrhage in her right eye, retinal tear in her left eye were reported to be disabling. Upon internal review, sudden acute loss of vision with temporal arteritis, embolic accident, retinal detachment, central retinal artery occlusion of the right eye, vitreous hemorrhage in her right eye, retinal tear in her left eye were considered medically significant events. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Temporal arteritis, Vitreous haemorrhage
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient received ZOSTAVAX, (lot# and route unknown) on 06-OCT-2016 for its intended purpose: the prevention of shingles. Shortly after receiving ZOSTAVAX the patient suffered sudden acute loss of vision with temporal arteritis, an embolic accident, and retinal detachment. The patient was then diagnosed with central retinal artery occlusion of the right eye. The patient also suffered and was diagnosed with a vitreous hemorrhage in her right eye and a retinal tear in her left eye. As a direct and proximate result of ZOSTAVAX the patient suffered painful injuries and damages,  and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further as a tragic consequence the patient suffered serious progressive permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Sudden acute loss of vision with temporal arteritis, embolic accident, retinal detachment, central retinal artery occlusion of the right eye, vitreous hemorrhage in her right eye, retinal tear in her left eye were reported to be disabling. Upon internal review, sudden acute loss of vision with temporal arteritis, embolic accident, retinal detachment, central retinal artery occlusion of the right eye, vitreous hemorrhage in her right eye, retinal tear in her left eye were considered medically significant events. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Seizure
Clinical narrative: Seizures that night.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Cellulitis, Injection site inflammation, Vaccination complication
Clinical narrative: 12/13/2018 8:00 am Inflamed lower right thigh.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUX, MMRV
Symptoms: Gastroenteritis, Immediate post-injection reaction, Influenza, Malaise, Respiratory tract infection
Clinical narrative: He has been sick ever since getting the flu shot. Stomach bug immediately followed by respiratory infection immediately followed by what appears to be the flu or possibly just a nasty viral infection. Waiting to be seen by PCP.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Pyrexia, Vomiting
Clinical narrative: Saturday around midnight my daughter woke up vomiting and had a fever. Sunday morning from about 5am-830am she would not stop vomiting, everything that went in came right out and she had a high fever. I gave her gripe water and the vomiting stopped but the fever continues. Sunday night the fever was as high as 103. Throughout today (Monday) her fever has been up and down.
Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Eye pruritus, Lacrimation increased, Sneezing
Clinical narrative: Severe watering of the eyes, especially in the morning, accompanied by itchy eyes and also sneezing.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient received all 3 vaccines listed above and tolerated well. He was released to front waiting area to wait for his certificate of immunization 5 minutes after vaccine was given. Once he walked to the front lobby he had a syncopal episode. Patient did not lose consciousness and was alert and oriented x 3.  He was pale and diaphoretic. He was set up in chair with feet elevated, cool rag applied to neck, and was monitored by RN. RN gave him a lollipop and a can of cola and monitored patient x 15 minutes.   His color returned and diaphoresis resolved so RN released patient in the care of his mother and a friend that accompanied them that was a nurse.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Lethargy, Myalgia
Clinical narrative: Lethargy, slight muscle soreness all over in addition to site of injection, tired mostly the day following the injection, but still a bit for the next several days. Slight occasional dizziness still on 4th day after shot.
Age: 45.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Injection site bruising, Peripheral swelling, Skin warm
Clinical narrative: Warmth, redness and swelling in right arm 2"x2". Bruised area at injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Upper arm, shoulder area very sore and stiff. Chills for about 24 hours.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Asthenia, Chills, Feeling abnormal, Inflammation
Clinical narrative: Pt reports receiving shot in her LD around noon on 01/09/2019, and pretty much on the dot at 3 PM 01/09/2019 she started getting an intense, "excruciating pain" building in her left arm. Within seconds, her pain level had reached a 9/10 on 0-10 pain scale and she felt weak, shaky and that she was going to pass out. She was at a local business, but had to lay on the floor and request help. They brought her water (she drank about 90 oz within a few minutes), gave her some ibuprofen and sat with her until a relative came. She thought about going to ER but says that after about one hour laying down there she felt okay to go to home. That evening, she developed some mild fever and chills. She reported minimal swelling at injection site and minimal redness but states she has very limited movement and strength in her arm. She describes it pretty much as an "arm paralysis". She denies any airway involvement nor rash. But even after two days (she reported to me on 01/11/2019) she still doesn't feel very good, still has little movement in her arm and almost no strength. She is taking ibuprofen 800 mg every six hours and Benadryl about the same schedule. She reports with medications, her pain is tolerable at a 2-3 pain level, but without medication and resting it is around a 4-5. If she tries to lift or move her arm, the pain quickly becomes 8-9 on 0-10 pain scale. I spoke with pt again on 01/14/19 and she feels she is on the mend but still only has about 80% normal range of motion and 60% strength in her arm. If she tries to lift her arm, it quickly becomes a 7-8 on pain scale. She spoke with a Dr. over the weekend who told her she likely had an anaphylactic reaction and should not receive any future doses. She spoke with an NP today and was Rx'd prednisone x 5 days to see if there was any benefit. Both providers agreed that she has nerve involvement from the inflammation process in her arm. She doesn't feel shaky, chilled or any other symptoms at this time besides her arm pain and limited movement. She does plan to potentially follow up with her PMD, Dr especially if no further improvement from the prednisone. Again, she denies any respiratory involvement, no rash, no major swelling or redness. Her arm is very tender to the touch at the injection site. Pt is a long practice RN who is a professor with local university nursing program, so does feel she has pretty good medical background. She reports she anticipated some pain and potential reaction, but nothing to this severity, length and involvement.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Nervousness
Clinical narrative: Pt reports receiving shot in her LD around noon on 01/09/2019, and pretty much on the dot at 3 PM 01/09/2019 she started getting an intense, "excruciating pain" building in her left arm. Within seconds, her pain level had reached a 9/10 on 0-10 pain scale and she felt weak, shaky and that she was going to pass out. She was at a local business, but had to lay on the floor and request help. They brought her water (she drank about 90 oz within a few minutes), gave her some ibuprofen and sat with her until a relative came. She thought about going to ER but says that after about one hour laying down there she felt okay to go to home. That evening, she developed some mild fever and chills. She reported minimal swelling at injection site and minimal redness but states she has very limited movement and strength in her arm. She describes it pretty much as an "arm paralysis". She denies any airway involvement nor rash. But even after two days (she reported to me on 01/11/2019) she still doesn't feel very good, still has little movement in her arm and almost no strength. She is taking ibuprofen 800 mg every six hours and Benadryl about the same schedule. She reports with medications, her pain is tolerable at a 2-3 pain level, but without medication and resting it is around a 4-5. If she tries to lift or move her arm, the pain quickly becomes 8-9 on 0-10 pain scale. I spoke with pt again on 01/14/19 and she feels she is on the mend but still only has about 80% normal range of motion and 60% strength in her arm. If she tries to lift her arm, it quickly becomes a 7-8 on pain scale. She spoke with a Dr. over the weekend who told her she likely had an anaphylactic reaction and should not receive any future doses. She spoke with an NP today and was Rx'd prednisone x 5 days to see if there was any benefit. Both providers agreed that she has nerve involvement from the inflammation process in her arm. She doesn't feel shaky, chilled or any other symptoms at this time besides her arm pain and limited movement. She does plan to potentially follow up with her PMD, Dr especially if no further improvement from the prednisone. Again, she denies any respiratory involvement, no rash, no major swelling or redness. Her arm is very tender to the touch at the injection site. Pt is a long practice RN who is a professor with local university nursing program, so does feel she has pretty good medical background. She reports she anticipated some pain and potential reaction, but nothing to this severity, length and involvement.