chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling and pain, redness, dizziness,  warm/hot at injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pain, Rash pruritic, Swelling
Clinical narrative: Swelling/Pruritic rash. Swelling and pain. Ice-Tylenol Elocon 0.1-1 topical cream
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Arthralgia, Fatigue, Mobility decreased, Pyrexia
Clinical narrative: Extreme soreness at site of administration the same evening of administration 11/22/19. On 11/23/19 woke up with fatigue, joint pain all over body that limited her movement. Did not take her temperature but felt like she had a fever.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Congenital skin dimples, Immediate post-injection reaction, Pain in extremity, Ultrasound scan normal
Clinical narrative: (L) arm pain, soreness, began immediately after vaccination, persisting, 2 meds for swelling, went to ER on 11/14/2019 Improved, still having pain
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Flushing
Clinical narrative: Flushed/red/burning face
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: none noted
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Patient says he can not raise his arm above his head. Started after vaccine
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: School did not accept Engerix-B peds 0.5 ml dose as indicated in package insert and built into EMR
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash pruritic
Clinical narrative: Red 5.5" x 2" area surroundings - not cellulitic - itchy rash - topical Ice/Zyrtec
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Tremor
Clinical narrative: Body shaking (thought it was my vehicle) 45 mins. After injection. Stopped Shaking 9:30 pm, same day. Injection site was sore for 2 days
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Patient was given vaccine Boostrix in Dr. office (L) deltoid. Patient came back to office 2 days later for a quarter size raised rash at inj site
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: flu like symptoms  body aches, headache, nausea  abdominal & back pain  Both patients had reaction  Contacted Dr. after hours at Health dept & Dr Family practice about symptoms  This letter is to give you a better idea of whats happened and the adverse reaction to the Vague Hep A vaccine we both had on Feb 12, 2019 and Aug 12th 2019. Husband's adverse reaction was worse than mine. He started 4-5 days after the last dose was given became sick, Headaches, dizziness and weakness and back pain, nausea, abdominal pain. It started after we both got this last dose. I had headache, nausea and felt tired. The first dose we also had reaction that I reported to County Health Dept. Whether it was reported I can't tell you. Staff at the health Dept when I called several times said this last dose had been reported I find it quite odd that the waitresses at the restaurant here whom also recieved the vaccine Hep A at the same place said they all had reactions each different, Headaches, shoulder pain nausea etc. First dose Feb 12, 2019 We both had white colored bowels. My shoulder hurt really bad! He decided to call the Health dept to ask about his symptoms the Dr whom works for them said you can have a reaction a week after the vaccine. He also called his primary care doctor at Family practice he also said it could be the vaccine he can have a reaction a week after. He still is suffering from Headaches and dizziness. I looked it up on your website the Hep A vaccine is listed on the drug page for adverse reactions. He recently saw a Neurologist he said he doesn't think the headaches are from Neuropathy. We don't understand why he feels bad. But he has alot
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain, Paraesthesia
Clinical narrative: I went into to severe neuropathy type symptom within 12 hours of receiving the vaccination that are still persistent. I have never in my life been allergic or sensitive to foods and chemicals prior to the vaccination. I have extreme sensitivities to most foods. This shot has totally ruined my everyday life. My  doctors are only recommending drugs to treat the symptoms of neuropathy. I am living with this 24 hours a day since the vaccination. If I walk into a public place such as a movie theater my extremities immediately react with burning and tingling. I am living a nightmare since this shot.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Burning sensation, Food allergy, Nerve conduction studies normal, Neuropathy peripheral
Clinical narrative: I went into to severe neuropathy type symptom within 12 hours of receiving the vaccination that are still persistent. I have never in my life been allergic or sensitive to foods and chemicals prior to the vaccination. I have extreme sensitivities to most foods. This shot has totally ruined my everyday life. My  doctors are only recommending drugs to treat the symptoms of neuropathy. I am living with this 24 hours a day since the vaccination. If I walk into a public place such as a movie theater my extremities immediately react with burning and tingling. I am living a nightmare since this shot.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: I went into to severe neuropathy type symptom within 12 hours of receiving the vaccination that are still persistent. I have never in my life been allergic or sensitive to foods and chemicals prior to the vaccination. I have extreme sensitivities to most foods. This shot has totally ruined my everyday life. My  doctors are only recommending drugs to treat the symptoms of neuropathy. I am living with this 24 hours a day since the vaccination. If I walk into a public place such as a movie theater my extremities immediately react with burning and tingling. I am living a nightmare since this shot.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: 7/12/2019: Sharp chest pains - to ER / Medical Center / Chest x-Ray, Heart Test / Observed overnight 7/13/2019: Start pain upper left shoulder and upper left arm/Severe. Has continued to get worse and now includes both sides, across back, neck, severe in wrists and hands/fingers/arthritis-like (?) no sleep for three months 10/21/2019: Internist / Dr / PA / Ordered blood tests Dr./ Chiropractor for pain/no disagnosis /  Dr./PA again, no diagnosis...Dr saw her, no diagnosis./referral to rheumatologist Dec. 21 Urgent Care 2x. neither time diagnosis or help  Dr walk in. also calls. finally got referral to neurologist, Dec 2 Symptoms of daytime bad aching in shoulders, arms, wrists/hands/fingers. Cannot use hands well or bend fingers barely. NEck pain and headache. Nights: as soon as I lie down. sever ache/pain begins in all areas. crushing and like on fire. tingling. unbearable, I cry out. Advil not helpful at all. take .5 ativan/ day and now .5 /night. no help sleep average 3.5 hours restless. overall feel weak and very ill. had felt great before shot! miserable and scared.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Cardiac function test normal, Chest X-ray, Chest pain
Clinical narrative: 7/12/2019: Sharp chest pains - to ER / Medical Center / Chest x-Ray, Heart Test / Observed overnight 7/13/2019: Start pain upper left shoulder and upper left arm/Severe. Has continued to get worse and now includes both sides, across back, neck, severe in wrists and hands/fingers/arthritis-like (?) no sleep for three months 10/21/2019: Internist / Dr / PA / Ordered blood tests Dr./ Chiropractor for pain/no disagnosis /  Dr./PA again, no diagnosis...Dr saw her, no diagnosis./referral to rheumatologist Dec. 21 Urgent Care 2x. neither time diagnosis or help  Dr walk in. also calls. finally got referral to neurologist, Dec 2 Symptoms of daytime bad aching in shoulders, arms, wrists/hands/fingers. Cannot use hands well or bend fingers barely. NEck pain and headache. Nights: as soon as I lie down. sever ache/pain begins in all areas. crushing and like on fire. tingling. unbearable, I cry out. Advil not helpful at all. take .5 ativan/ day and now .5 /night. no help sleep average 3.5 hours restless. overall feel weak and very ill. had felt great before shot! miserable and scared.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site pain, Malaise, Pain, Paraesthesia
Clinical narrative: 7/12/2019: Sharp chest pains - to ER / Medical Center / Chest x-Ray, Heart Test / Observed overnight 7/13/2019: Start pain upper left shoulder and upper left arm/Severe. Has continued to get worse and now includes both sides, across back, neck, severe in wrists and hands/fingers/arthritis-like (?) no sleep for three months 10/21/2019: Internist / Dr / PA / Ordered blood tests Dr./ Chiropractor for pain/no disagnosis /  Dr./PA again, no diagnosis...Dr saw her, no diagnosis./referral to rheumatologist Dec. 21 Urgent Care 2x. neither time diagnosis or help  Dr walk in. also calls. finally got referral to neurologist, Dec 2 Symptoms of daytime bad aching in shoulders, arms, wrists/hands/fingers. Cannot use hands well or bend fingers barely. NEck pain and headache. Nights: as soon as I lie down. sever ache/pain begins in all areas. crushing and like on fire. tingling. unbearable, I cry out. Advil not helpful at all. take .5 ativan/ day and now .5 /night. no help sleep average 3.5 hours restless. overall feel weak and very ill. had felt great before shot! miserable and scared.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Restlessness, White blood cell count increased, X-ray limb abnormal
Clinical narrative: 7/12/2019: Sharp chest pains - to ER / Medical Center / Chest x-Ray, Heart Test / Observed overnight 7/13/2019: Start pain upper left shoulder and upper left arm/Severe. Has continued to get worse and now includes both sides, across back, neck, severe in wrists and hands/fingers/arthritis-like (?) no sleep for three months 10/21/2019: Internist / Dr / PA / Ordered blood tests Dr./ Chiropractor for pain/no disagnosis /  Dr./PA again, no diagnosis...Dr saw her, no diagnosis./referral to rheumatologist Dec. 21 Urgent Care 2x. neither time diagnosis or help  Dr walk in. also calls. finally got referral to neurologist, Dec 2 Symptoms of daytime bad aching in shoulders, arms, wrists/hands/fingers. Cannot use hands well or bend fingers barely. NEck pain and headache. Nights: as soon as I lie down. sever ache/pain begins in all areas. crushing and like on fire. tingling. unbearable, I cry out. Advil not helpful at all. take .5 ativan/ day and now .5 /night. no help sleep average 3.5 hours restless. overall feel weak and very ill. had felt great before shot! miserable and scared.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Blood glucose normal, Blood pressure decreased, Confusional state, Dizziness postural, Eye movement disorder
Clinical narrative: Patient received the Flu vaccine in office and was discharged with parents. As described by mom, while in the elevator, the patient fell to the elevator floor and had seizure like activity. She reports that the patient became stiff and his eyes rolled back. The patient was carried into the office by father and was directly taken to an exam room for evaluation. Blood pressure, heart rate and blood glucose were all taken. BP was 80/52, HR was 55/min and Glucose was 100. Patient was given apple juice and crackers to snack on. Patient was placed on left side and evaluated. Attempts were made to change patient position to sitting and eventually standing with assistance. Once patient was able to tolerate position changes, about 30 min duration, BP was re-evaluated and measured at 92/54. Patient was discharged with mother and father and able to ambulate to car. Patient had eaten breakfast and did not seem anxious about receiving vaccine per mom.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Fall, Generalised tonic-clonic seizure, Hyperhidrosis, Musculoskeletal stiffness, Somnolence
Clinical narrative: Patient received the Flu vaccine in office and was discharged with parents. As described by mom, while in the elevator, the patient fell to the elevator floor and had seizure like activity. She reports that the patient became stiff and his eyes rolled back. The patient was carried into the office by father and was directly taken to an exam room for evaluation. Blood pressure, heart rate and blood glucose were all taken. BP was 80/52, HR was 55/min and Glucose was 100. Patient was given apple juice and crackers to snack on. Patient was placed on left side and evaluated. Attempts were made to change patient position to sitting and eventually standing with assistance. Once patient was able to tolerate position changes, about 30 min duration, BP was re-evaluated and measured at 92/54. Patient was discharged with mother and father and able to ambulate to car. Patient had eaten breakfast and did not seem anxious about receiving vaccine per mom.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Tremor
Clinical narrative: Patient received the Flu vaccine in office and was discharged with parents. As described by mom, while in the elevator, the patient fell to the elevator floor and had seizure like activity. She reports that the patient became stiff and his eyes rolled back. The patient was carried into the office by father and was directly taken to an exam room for evaluation. Blood pressure, heart rate and blood glucose were all taken. BP was 80/52, HR was 55/min and Glucose was 100. Patient was given apple juice and crackers to snack on. Patient was placed on left side and evaluated. Attempts were made to change patient position to sitting and eventually standing with assistance. Once patient was able to tolerate position changes, about 30 min duration, BP was re-evaluated and measured at 92/54. Patient was discharged with mother and father and able to ambulate to car. Patient had eaten breakfast and did not seem anxious about receiving vaccine per mom.
Age: 11.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Blood glucose normal, Eye movement disorder, Fall, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: Patient received the Flu vaccine in office and was discharged with parents. As described by mom, while in the elevator, the patient fell to the elevator floor and had seizure like activity. She reports that the patient became stiff and his eyes rolled back. The patient was carried into the office by father and was directly taken to an exam room for evaluation. Blood pressure, heart rate and blood glucose were all taken. BP was 80/52, HR was 55/min and Glucose was 100. Patient was given apple juice and crackers to snack on. Patient was placed on left side and evaluated. Attempts were made to change patient position to sitting and eventually standing with assistance. Once patient was able to tolerate position changes, about 30 min duration, BP was re-evaluated and measured at 92/54. Patient was discharged with mother and father and able to ambulate to car. Patient had eaten breakfast and did not seem anxious about receiving vaccine per mom.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain
Clinical narrative: Wrong Route of Administration; Soreness; Redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 12th November 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In November 2019, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient was administered the dose of Shingrix subcutaneously under the skin, which led to incorrect route of vaccine administration.  She experienced soreness and redness around the injection site covering 3 inches by 3 inches area. It is continuing to spread. The reporter consented to follow up. No further details were provided.  She did not have a zip code for her physician.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: Wrong Route of Administration; Soreness; Redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 12th November 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In November 2019, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient was administered the dose of Shingrix subcutaneously under the skin, which led to incorrect route of vaccine administration.  She experienced soreness and redness around the injection site covering 3 inches by 3 inches area. It is continuing to spread. The reporter consented to follow up. No further details were provided.  She did not have a zip code for her physician.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eye contusion, Face injury, Headache, Malaise
Clinical narrative: Body ache, headache first night Dizziness, passed out before breakfast. Badly bruised right eye. Still blue!
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Syncope, Vertigo
Clinical narrative: Body ache, headache first night Dizziness, passed out before breakfast. Badly bruised right eye. Still blue!
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Eye contusion, Headache, Loss of consciousness, Pain
Clinical narrative: Body ache, headache first night Dizziness, passed out before breakfast. Badly bruised right eye. Still blue!
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration
Clinical narrative: Body ache, headache first night Dizziness, passed out before breakfast. Badly bruised right eye. Still blue!
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site reaction, Joint stiffness, Muscle spasms, Vaccination site erythema
Clinical narrative: Extreme tenderness, hot to the touch, redness in vaccination area radiating up toward collarbone, and down arm but not past elbow.  Joint stiffness, foot spasms (1X), general feeling of aching in joints.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Extreme tenderness, hot to the touch, redness in vaccination area radiating up toward collarbone, and down arm but not past elbow.  Joint stiffness, foot spasms (1X), general feeling of aching in joints.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pt developed worsening muscle pain at the site of injection over the past several weeks. This has required referral to Orthopedist.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; a dose of GARDASIL 9 was inadvertently administered, that was expired; This spontaneous report was received from the office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition, previous drug allergies or reactions, and concomitant medication were not reported.  On 05-NOV-2019, the patient was inadvertently administered with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (route of administration, anatomical location and dose number were not reported, and lot number R024264 has been verified to be a valid lot number, expiration date reported and validated as 29-OCT-2019) as prophylaxis, that was expired (expired product administered). No adverse effect reported.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: permanent hearing loss; Information has been received from lawyers referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In or around 2013, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On an unknown date, the patient experienced permanent hearing loss. The patient did not recover from the event. As per the reporter, 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 event was disabling.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Patient received an improperly stored dose of PNEUMOVAX 23; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis (lot number R009408 with expiration date in 07-MAR-2020 or lot number R005345 with expiration date in 01-MAR-2020) (route of administration, strength and anatomical location were not reported).  The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at the lowest temperature below36°F (34.5°F) for the time frame of 35 hours and 37 minutes. There was another temperature excursion below 36°F (34.4°F) for 83 hours and 11 minutes. The call was because of a data logger.
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin discolouration
Clinical narrative: Extreme pain; Adverse symptoms following administration; arm turned color and it was a full month before the patient was over it; This spontaneous report as received from a other refers to a female patient of unknown age.    On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.       On an unknown date the patient experienced pain, skin discolouration and adverse event following immunisation.    The outcome of pain, skin discolouration and adverse event following immunisation was reported as recovered/resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for one of her friend. The patient received Shingrix and had sore arms.  No other details were provided. This case linked with US2019AMR206160, US2019205723 and US2019205719, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had got hit with bad flu symptoms. The patient asked would feel the same after second shot.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Frequent bowel movements
Clinical narrative: multiple bowel movements; This case was reported by a consumer via call center representative and described the occurrence of frequent bowel movements in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced frequent bowel movements. On an unknown date, the outcome of the frequent bowel movements was unknown.   It was unknown if the reporter considered the frequent bowel movements to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and having multiple bowel movements common.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; pain; heaches; This case was reported by a physician via sales rep and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced chills, pain and headache. On an unknown date, the outcome of the chills, pain and headache were recovered/resolved.   It was unknown if the reporter considered the chills, pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had chills, pain and headache for 2days. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles in the same dermatome where the injection was given; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient was return within 3 months with a case of shingles in the same dermatome where the injection was given. At the time of reporting, the reporter did not have specific patient information. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with case US2019AMR208349, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Migraine
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (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 migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of the 6 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sensitive skin
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (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 migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of the 6 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Flank pain, Headache, Hyperaesthesia
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (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 migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of the 6 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Myalgia
Clinical narrative: migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (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 migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of the 6 linked cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy kidney abnormal, Herpes zoster, Renal disorder, Vaccination failure
Clinical narrative: Suspected vaccination fialure; Shingles on both feet; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included kidney transplant.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. At the time of reporting, the patient was struggling with shingles on both feet. The physician performed a biopsy on his kidney and the biopsy came back positive for shingles. The patient was advised he would need a new kidney in the next 12 to 24bmonths. The reporter did not call on this clinic nor did know these providers.  This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset for target disease were unknown at the time of reporting.      Lab Comments: On an unknown date, a biopsy was performed on kidney and the biopsy came back positive for shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Sexual dysfunction
Clinical narrative: Sexual dysfunction; This case was reported by a consumer via call center representative and described the occurrence of sexual dysfunction in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sexual dysfunction. On an unknown date, the outcome of the sexual dysfunction was unknown.   It was unknown if the reporter considered the sexual dysfunction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not know it was a side effect but when the patient laying with a woman and could not keep it up got to wonder.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: felt like he got hit by a truck; Sore arm; was very tired requiring he nap; achy; This case was reported by a other health professional via sales rep and described the occurrence of feeling abnormal in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix .5 ml. On 16th November 2019, 1 days after receiving Shingrix, the patient experienced feeling abnormal, pain in arm, tiredness and pain. On an unknown date, the outcome of the feeling abnormal, pain in arm, tiredness and pain were unknown.   It was unknown if the reporter considered the feeling abnormal, pain in arm, tiredness and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, however the patient could be 88 or 89 years old. The patient received a dose of Shingrix in left arm. The patient felt like he got hit by a truck and his symptoms included sore arm, was very tired and required nap. The patient was achy. The reporter did not give consent to follow up.
Sex: F
Vaccine: RV1
Symptoms: Pruritus
Clinical narrative: Pruritus; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 2534R, expiry date 30th November 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On an unknown date, less than 9 months after receiving Rotarix lyophilized formulation, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Rotarix lyophilized formulation.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced pruritus after receiving first dose of Rotarix. The reporter consented to follow-up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Malaise, Vomiting, Weight decreased
Clinical narrative: Vomit; Fatigued; Weak; Not feeling well; Lost three pounds; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix. On 8th November 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell. On 9th November 2019, the patient experienced vomiting, fatigue and asthenia. In November 2019, the patient experienced weight loss. On 9th November 2019, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the feeling unwell and weight loss were unknown and the outcome of the fatigue and asthenia were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, vomiting, fatigue, asthenia and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she went to bed that night not feeling well, but she did not provide details.  She woke and began to vomit. She continued to vomit. She went to her doctor who gave her a shot to stop the vomiting and told her not to eat anything for 48 hours. She lost three pounds. She still feels fatigued and weak but did go to work. Emergency room visit required. This case linked with US2019AMR206160 and US2019AMR206161, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches in both hips and both knees; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. In November 2019, 8 days after receiving Shingrix, the patient experienced myalgia. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine on left arm, approximately two weeks ago. Six days ago he began to experience muscle aches in both hips and both knees.   The patient was continuing to have the aches and they occurred all day till the day of reporting. The reporter was unable to provide any additional details.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced shingles about a week and a half later; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   The patient's past medical history included shingles.   On 19th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks 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 patient received Shingrix and experienced shingles about a week and a half later. The patient had a history of shingles as well. The patient had notified the doctor but no treatment has been recommended.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Pain upon administration; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain and flu-like symptoms. On an unknown date, the outcome of the injection site pain and flu-like symptoms were unknown.   It was unknown if the reporter considered the injection site pain and flu-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix, and it was painful upon administration. Also the patient had flu-like symptoms. The reporter did not consented to follow-up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel vaccine on 22Oct2019 that was not reconstituted with the Hib portion; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves Child patient who received who received DTAP-IPV portion HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] only and Hib portion was not administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number was not reported.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested
Sex: F
Vaccine: FLUR4
Symptoms: Adverse reaction
Clinical narrative: bad reaction; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 80 years old female patient who experienced bad reaction(Unevaluable event), while she received vaccine influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient's past medical history included Hypersensitivity with allergic to egg and latex.  On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine with unknown lot number not reported in unknown administration site.  The patient developed a non-serious bad reaction (unevaluable event) following the administration of influenza quadrivalent recombinant vaccine.  Information on the batch number was requested .  (Other relevant tests included no lab data.)  Final diagnosis was bad reaction.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for unevaluable event.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Daptacel, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3-year-old female patient who was received an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation.  On 29-Oct-2019, the patient received a third dose (0.5 mL) of expired diphtheria-15/tetanus/5 ac pertussis vaccine (lot number: lot C523LAA; expiry date: 05-Oct-2019) via intramuscular route in the left anterior thigh.  It was a case of actual medication error due to expired vaccine administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient under age 18 had received Flublok, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age who received a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.