chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no adverse effects reported; Patient was administered GARDASIL 9 while pregnant; Patient was administered GARDASIL 9 while pregnant; This spontaneous prospective pregnancy report was received from nurse concerning a 36-year-old female pregnant patient, with a pregnancy gestation of 21 weeks and 5 days.  The patient's concurrent conditions included genital herpes, and papilloma viral infection (HPV). The patient had past drug reactions / allergies to latex and metronidazole benzoate (FLAGYL). The patient did not take concomitant medications.  On 08-APR-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose not provided) lot # reported as R024264, date of expiration: 29-OCT-2019, intramuscular as routine vaccine, while pregnant (exposure during pregnancy, product use issue. The patient did not received treatment for the event, and she did not seek medical attention. There were no diagnostic / studies performed. No adverse effects were reported. There was no additional information at that time. Product quality complaint (PQC) was not filed. At the time of report, the pregnancy outcome was pending.
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Mobility decreased, Movement disorder
Clinical narrative: This spontaneous report was received from a physician via company representative regarding to a 83 year old female patient. The patient's concurrent conditions were not reported. Patient's medical history included penicillin allergy and sulfa allergy. Concomitant medications included unspecified diabetic medications and hypertension medications. On 08-APR-2019 the patient was vaccinated with PNEUMOVAX 23 (lot # R030140 and expiry date: 07-AUG-2020), (strength and dose were not provided) via intramuscular route for prophylaxis. The reporter stated that, on 09-APR-2019, patient woke up and was unable to move arm or get out of bed (movement disorder). On 10-APR-2019, the patient was hospitalized for the event. It was reported the patient was discharged from hospital on 14-APR-2019. The patient had sought medical attention. On an unknown date in April 2019, lab tests included Chest X-Ray for which no results were reported. On an unknown date in April 2019, the patient recovered from movement disorder. The causality between PNEUMOVAX 23 and event was not provided. The reporter did not consider the event as significant disability.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; patient was administered his first dose of GARDASIL 9 around 24-OCT-2018 and had just received the second dose on 24-APR-2019; This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications.  On 24-OCT-2018, the patient was vaccinate with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly, lot# N035957 (expiration date: 10-OCT-2020) for prophylaxis (strength and frequency were not reported). Then on 24-APR-2019, the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported)(inappropriate schedule of product administration). The patient was on the three dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) schedule. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; one dose of improperly stored VARIVAX was administered to one patient; Information has been received from a medical assistant referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 24-APR-2019, the patient received one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: R029518; expiration date: 14-OCT-2020; strength and dose were not reported), subcutaneously for prophylaxis. No adverse effect reported. The temperature of storage was -9 degrees centigrade to 8 degrees centigrade (2.5C), the time frame was 5 hours and 23 minutes. The previous temperature excursion was 9 degrees centigrade to 25 degrees centigrade (9C) for 17 hours. Data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter knew the 3 people who got shingles days after getting the vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked to the case US2019AMR070828 and US2019AMR070829, reported by same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: arm became sore at the injection site; Fever; Body aches; 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 6th September 2018, the patient received the 1st dose of Shingrix. In September 2018, several hours after receiving Shingrix, the patient experienced injection site pain, fever and general body pain. On an unknown date, the outcome of the injection site pain, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The reporter indicated that a couple of hours after receiving the Shingrix vaccine her arm became sore at the injection site that lasted for three days. She also started with a fever around that same day of vaccination. She woke up during the night that same night with body aches. These symptoms lasted for a couple of days. For tolerance to 2nd dose, refer case US2019071195.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: stabbing pains in leg muscles and hip and knee joints; stabbing pains in leg muscles and hip and knee joints; upset stomach; chills; headache; sore shoulder; tired; queasy; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2019, 1 days after receiving Shingrix, the patient experienced shoulder pain, tiredness and queasy. On 24th March 2019, the patient experienced muscle pain, joint pain, upset stomach, chills and headache. On an unknown date, the outcome of the shoulder pain, tiredness, queasy, muscle pain, joint pain, upset stomach, chills and headache were recovered/resolved.   It was unknown if the reporter considered the shoulder pain, tiredness, queasy, muscle pain, joint pain, upset stomach, chills and headache to be related to Shingrix.  Additional information was reported as below: On the next day, the patient's shoulder was sore and he felt tired and queasy.  The symptoms lasted for about 3 days before he started feeling better.  4 days after receiving Shingrix, the patient suddenly started having stabbing pains in his leg muscles and hip and knee joints. The pain would come in wave, getting stronger the ebbing again and then returning again sometime later. The muscle and joint pains occurred only below his waist.  He would also have waves of upset stomach, chills and headache, though these were not as severe as the muscle and joint pains.  He had been feeling better for the past day and a half, so he hopes he was past these symptoms. The patient consented to follow up but declined to provide his address.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Nausea
Clinical narrative: stabbing pains in leg muscles and hip and knee joints; stabbing pains in leg muscles and hip and knee joints; upset stomach; chills; headache; sore shoulder; tired; queasy; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2019, 1 days after receiving Shingrix, the patient experienced shoulder pain, tiredness and queasy. On 24th March 2019, the patient experienced muscle pain, joint pain, upset stomach, chills and headache. On an unknown date, the outcome of the shoulder pain, tiredness, queasy, muscle pain, joint pain, upset stomach, chills and headache were recovered/resolved.   It was unknown if the reporter considered the shoulder pain, tiredness, queasy, muscle pain, joint pain, upset stomach, chills and headache to be related to Shingrix.  Additional information was reported as below: On the next day, the patient's shoulder was sore and he felt tired and queasy.  The symptoms lasted for about 3 days before he started feeling better.  4 days after receiving Shingrix, the patient suddenly started having stabbing pains in his leg muscles and hip and knee joints. The pain would come in wave, getting stronger the ebbing again and then returning again sometime later. The muscle and joint pains occurred only below his waist.  He would also have waves of upset stomach, chills and headache, though these were not as severe as the muscle and joint pains.  He had been feeling better for the past day and a half, so he hopes he was past these symptoms. The patient consented to follow up but declined to provide his address.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness
Clinical narrative: Flu-like Symptoms; Weakness; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male 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 influenza-like symptoms and weakness. On an unknown date, the outcome of the influenza-like symptoms and weakness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and weakness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient experienced weakness and flu-like symptoms for 2 days after receiving Shingrix.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: swollen injection site; painful injection site; red streaks from injection site running down under his arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 15th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced swollen and painful injection site and red streaks from injection site running down under his arm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX) for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In April 2019, unknown after receiving SHINGRIX and less than a year 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 and SHINGIRX. Additional details were reported as follows: Initial information reported by the patient's husband. The patient received SHINGRIX and diagnosed with Shingles early in the week of reporting. The patient had no outbreaks of shingles since June 2018 when the patient received most recent dose. The reporter was driving during the report, so as much information was captured. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac monitoring, Discomfort, Injection site pain, Malaise, Palpitations
Clinical narrative: not feel well; soreness at injection site; Heart Palpitations; Uncomfortable; 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.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 6th September 2018, refer case US2019GSK074706).   On 5th February 2019, the patient received the 2nd dose of Shingrix. On 5th February 2019, 2 hrs after receiving Shingrix, the patient experienced feeling unwell. In February 2019, the patient experienced injection site pain, palpitation and discomfort. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, palpitation and discomfort were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the injection site pain, discomfort and feeling unwell to be related to Shingrix. The reporter considered the palpitation to be related to Shingrix.  Additional details were provided as follows: Approximately two hours after receiving Shingrix vaccine she reported that she started to not feel well and took Advil. This did not last very long.  She also, again, experienced soreness at the injection site that lasted for a couple of days.  Two days after receiving the 2nd dose she started to have heart palpitations. She went to her physician on 13th February 2019 and was given a heart monitor that she wore until 17th February 2019. It was noted that she was having occasional heart palpitations. She was still having these palpitations and she described them as being uncomfortable. She felt that the heart palpitations are related to the product.  The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: not feel well; soreness at injection site; Heart Palpitations; Uncomfortable; 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.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 6th September 2018, refer case US2019GSK074706).   On 5th February 2019, the patient received the 2nd dose of Shingrix. On 5th February 2019, 2 hrs after receiving Shingrix, the patient experienced feeling unwell. In February 2019, the patient experienced injection site pain, palpitation and discomfort. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, palpitation and discomfort were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the injection site pain, discomfort and feeling unwell to be related to Shingrix. The reporter considered the palpitation to be related to Shingrix.  Additional details were provided as follows: Approximately two hours after receiving Shingrix vaccine she reported that she started to not feel well and took Advil. This did not last very long.  She also, again, experienced soreness at the injection site that lasted for a couple of days.  Two days after receiving the 2nd dose she started to have heart palpitations. She went to her physician on 13th February 2019 and was given a heart monitor that she wore until 17th February 2019. It was noted that she was having occasional heart palpitations. She was still having these palpitations and she described them as being uncomfortable. She felt that the heart palpitations are related to the product.  The reporter consented to follow up.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Pyrexia
Clinical narrative: inappropriate schedule of vaccine administered; arm pain; fever; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number H7JY4, expiry date 1st July 2021) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 17th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain in arm and fever. On 17th April 2019, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the pain in arm, fever and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were reported as follows: On 23rd February 2019, the patient received the 1st dose of Shingrix. On 17th April 2019, the patient received the 2nd dose of Shingrix on left deltoid, which led to shortening of the vaccination schedule. The patient was concerned because she got the 2nd dose 6 days early.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossodynia, Tongue ulceration
Clinical narrative: Painful sore on the back side of the tongue; This case was reported by a pharmacist via call center representative and described the occurrence of tongue pain in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On 3rd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th April 2019, 1 days after receiving Shingrix, the patient experienced tongue pain. On an unknown date, the outcome of the tongue pain was not recovered/not resolved.   It was unknown if the reporter considered the tongue pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the left deltoid. The pharmacist stated that the patient received Shingrix vaccine and on next day patient experienced a painful sore on the back side of her tongue, and she was still experiencing the painful sore. No further details were provided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness at injection site; swelling at injection site; achy/ body aches; headache; warm at injection site; fatigue; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On 16th April 2019, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, general body pain, headache, injection site warmth, fatigue and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, general body pain, headache, injection site warmth, fatigue and fever were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, general body pain, headache, injection site warmth, fatigue and fever to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient received Shingrix on left arm and about 2 hours later the patient experienced swelling at injection site of left arm, hot to touch at the injection site, redness which was described as 3 inches in diameter, fever, body aches, headache and fatigue.  Symptoms were improving but not resolved. The reporter did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: redness at injection site; swelling at injection site; achy/ body aches; headache; warm at injection site; fatigue; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On 16th April 2019, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, general body pain, headache, injection site warmth, fatigue and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, general body pain, headache, injection site warmth, fatigue and fever were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, general body pain, headache, injection site warmth, fatigue and fever to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient received Shingrix on left arm and about 2 hours later the patient experienced swelling at injection site of left arm, hot to touch at the injection site, redness which was described as 3 inches in diameter, fever, body aches, headache and fatigue.  Symptoms were improving but not resolved. The reporter did not consent to follow-up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Had Trumenba vaccine in left arm, next day had large red area on left upper arm. that seemed to worsen for a few days, today woke up and is less red and faded from the top of the shoulder and only on the lower part of the arm, is a little sore and can move the arm fine
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: PATIENT REPORTED CHILLS BEGINNING DURING NIGHT 4/26/19, THEN DEVELOPED FEVER 100.2, BODY ACHES.  PATIENT ADVISED TO CONTACT PCP FOR TREATMENT.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling, Tenderness
Clinical narrative: Slight swelling, tenderness, bright red rash Treatment is ongoing with a pain reliever of choice, hydrocortisone cream, ice, and anti-histamine(s)
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Redness at site of injection, painful arm, pruritis at injection site fever, chills, weakness, dizzyness, fatigue, nausea, general achiness and malaise
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: Redness at site of injection, painful arm, pruritis at injection site fever, chills, weakness, dizzyness, fatigue, nausea, general achiness and malaise
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness at site of injection, painful arm, pruritis at injection site fever, chills, weakness, dizzyness, fatigue, nausea, general achiness and malaise
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Chest discomfort, Cough, Pharyngeal swelling, Throat tightness
Clinical narrative: Almost immediate right sided throat swelling, followed by throat tightness, chest tightness with wheezing/coughing and abdominal cramping - all reported to physicians office as having been a previous reaction to the flu vaccine. Treated at home with oral Benadryl and steroid.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Almost immediate right sided throat swelling, followed by throat tightness, chest tightness with wheezing/coughing and abdominal cramping - all reported to physicians office as having been a previous reaction to the flu vaccine. Treated at home with oral Benadryl and steroid.
Age: 1.42
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Pt returned to the clinic 2 hours after administration of vaccines with hives on her Right thigh/leg. No fever, no respiratory distress noted. PA in house at the time assessed the patient and instructed the pt's mom to give Benadryl and zyrtec. Also instructed pt's mom to take pt to nearest ER if symptoms persist.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mom stated that leg was warm to touch, thigh was swollen 2x the size of the other leg, redness around the injection site and hardness around the injection site as well.
Age: 51.0
Sex: M
Vaccine: JEV1, PPV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: The individual vaccinated reported to his clinic to treat symptoms. He reported aches, general malaise, and a fever of 102.9F that presented the following day after immunizations, lasting through Thursday until treatment was provided.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Swelling
Clinical narrative: Swollen , Red, Sick feeling
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Employee developed redness, swelling and rash on her arms (all the way to wrists and hands) bilaterally.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter know the 3 people who got shingles days after getting the vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked to the case US2019AMR070827 and US2019AMR070829, due to reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter knew the 3 people who got shingles days after getting the vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked to the case US2019AMR070828 and US2019AMR070827, reported by same reporter.
Sex: U
Vaccine: HEP
Symptoms: False positive investigation result, Hepatitis B antigen positive
Clinical narrative: Engerix B antigens positive; This case was reported by a other health professional via call center representative and described the occurrence of hepatitis b antigen positive in a patient who received HBV (Engerix B) for prophylaxis.   On 3rd April 2019, the patient received Engerix B. On 5th April 2019, 2 days after receiving Engerix B, the patient experienced hepatitis b antigen positive. On an unknown date, the outcome of the hepatitis b antigen positive was unknown.   It was unknown if the reporter considered the hepatitis b antigen positive to be related to Engerix B.  Additional details were provided as follows: The batch number was not reported. The medical assistant reported that the patient completed Engerix B series and blood work was drawn and revealed false positives.  The blood work drawn again and revealed false positive. The health care professional noted that the antigens were showing positive but she felt this was a false reading caused by Engerix-B.  The health care professional did not provide patient demographics details.      Lab Comments: Blood work was drawn on 5th April2018 and revealed false positives. Blood work drawn again on 8th April2019 and again revealed false positive.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Red at injection site; Warm to touch at injection site; Tender at injection site; Nausea; Vomiting; Diarrhea; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AB, expiry date 31st August 2020) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Bexsero (intramuscular). On 9th April 2019, less than a day after receiving Bexsero, the patient experienced nausea, vomiting and diarrhea. On 10th April 2019, the patient experienced injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the nausea, vomiting and diarrhea were recovered/resolved and the outcome of the injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, injection site erythema, injection site warmth and injection site tenderness to be related to Bexsero.  Additional information was reported as below: The patient received Bexsero in the left deltoid. At the evening, the patient experienced nausea, vomiting and diarrhea.   The next day on 10th April 2019, the patient presented in the office with local reaction of red, warm to touch and incredibly tender at the injection site (area of 4 by 5cm). The events nausea, vomiting and diarrhea were self-resolved.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Red at injection site; Warm to touch at injection site; Tender at injection site; Nausea; Vomiting; Diarrhea; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AB, expiry date 31st August 2020) for prophylaxis.   On 9th April 2019, the patient received the 1st dose of Bexsero (intramuscular). On 9th April 2019, less than a day after receiving Bexsero, the patient experienced nausea, vomiting and diarrhea. On 10th April 2019, the patient experienced injection site erythema, injection site warmth and injection site tenderness. On an unknown date, the outcome of the nausea, vomiting and diarrhea were recovered/resolved and the outcome of the injection site erythema, injection site warmth and injection site tenderness were unknown.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, injection site erythema, injection site warmth and injection site tenderness to be related to Bexsero.  Additional information was reported as below: The patient received Bexsero in the left deltoid. At the evening, the patient experienced nausea, vomiting and diarrhea.   The next day on 10th April 2019, the patient presented in the office with local reaction of red, warm to touch and incredibly tender at the injection site (area of 4 by 5cm). The events nausea, vomiting and diarrhea were self-resolved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of blindness in a 72-year-old female patient who received SHINGRIX (batch number 27KF5, expiry date 10th June 2021) for prophylaxis. On 2nd April 2019, the patient received the 2nd dose of SHINGRIX. On 6th April 2019, 4 days after receiving SHINGRIX, the patient experienced blindness (serious criteria GSK medically significant). On an unknown date, the outcome of the blindness was not recovered/not resolved. It was unknown if the reporter considered the blindness to be related to SHINGRIX. Additional details were reported as follows: The reporting healthcare professional stated that the patient had no known history of blindness or eye disease. The patient received SHINGRIX and 4 days after vaccination, the patient was completely blind. The patient has been seen by her primary care physician for this issue. The blindness was still ongoing. The reporter did not know which arm the patient received injection.
Age: 73.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Gastric disorder, Pruritus, Rash, Urticaria
Clinical narrative: Hives; Rash; Itching; Stomach issues; This case was reported by a consumer via call center representative and described the occurrence of hives in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fexofenadine hydrochloride (Allegra) for rash.   The patient's past medical history included blood glucose normal (under control), hypertension (controlled with diet and exercise) and benign prostatic hyperplasia. Previously administered products included Thyroid medication. Concurrent medical conditions included drug hypersensitivity. Concomitant products included tamsulosin hydrochloride (Flomax).   In March 2019, the patient received the 1st dose of Shingrix. In April 2019, the patient started Allegra at an unknown dose and frequency. In April 2019, less than a year after receiving Shingrix, the patient experienced gastric disorder. On 17th April 2019, the patient experienced rash and pruritus. On an unknown date, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl), cortisone (non-proprietary) (Cortisone Cream) and homeopathic medication (nos) (Homeopathic Medication). The action taken with Allegra was unknown. On an unknown date, the outcome of the hives, rash, pruritus and gastric disorder were unknown.   It was unknown if the reporter considered the hives, rash, pruritus and gastric disorder to be related to Shingrix.  Additional case details were reported as follows: The patient received first dose of Shingrix vaccine about 5 to 6 weeks ago. Patient not sure of the dates. The patient developed hives around the time of receiving Shingrix. Less than a year after receiving Shingrix patient developed rash and itching on his back and shoulder the night before.  It went away and comes back. He also had rash on his waist and belly.  The patient stated today that he had the rash with severe itch on his right lower leg towards the ankle.  The patient stated that the rash went away and comes back somewhere else.  The patient discontinued the Allegra as he could not tolerate it due to stomach issues.  The patient stated that he was very sensitive to medication and this situation was bad. The patient did not have any additional information. The patient did not consent to follow up. The reporter considered the gastric disorder to be related to Allegra.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incorrect route of product administration, Product administered at inappropriate site, Pyrexia
Clinical narrative: Vaccine Administered at Inappropriate Site; fever; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 17th April 2019, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced fever and chills. On 17th April 2019, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the fever, chills and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously instead of intramuscularly in left arm, which led to vaccine administered at inappropriate site. The patient was complaining of fever and chills. The patient did not consent to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmological examination, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: Vision worsened; Blurred vision in right eye / cloudy vision; Floaters in right eye; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th January 2019, 4 hrs after receiving Shingrix, the patient experienced blurred vision and eye floaters. On an unknown date, the patient experienced vision decreased. On an unknown date, the outcome of the blurred vision and eye floaters were not recovered/not resolved and the outcome of the vision decreased was unknown.   It was unknown if the reporter considered the blurred vision, eye floaters and vision decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in the left arm. The patient reported that she had an eye examination just prior to receiving Shingrix, approximately 2 weeks prior. The patient reported that 4 hours after the injection, her right eye became blurred and she experienced floaters in the eyes, described as web-like. The patient reported that the vision in that eye is becoming worse and more cloudy. She had a follow up with the physician and nothing remarkable was noted with her eye health. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid arthritis
Clinical narrative: Initial unsolicited report received from the literature (abstract article) on 24-Apr-2019. This case is linked to cases 2019SA114648 and 2019SA114647 (same literature article). This case involves a female patient (middle-aged) who experienced chronic rheumatoid arthritis, while she received vaccine Influenza Vaccine (Trivalent). The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Vaccine (Trivalent) produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious chronic rheumatoid arthritis (rheumatoid arthritis) with unknown latency following the administration of Influenza Vaccine (Trivalent). This event was assessed as medically significant. Lab data was not provided. Final diagnosis was chronic rheumatoid arthritis. An unknown corrective continuous standard treatment was received. The patient outcome is reported as Unknown for chronic rheumatoid arthritis. The reporter assessed the causal relationship as association exists between immunization and the onset of RA. List of documents held by sender: none. Sender's Comments: This literature article reports about adult female patient who presented with rheumatoid arthritis with chronic presentation after vaccination with Trivalent Influenza vaccine. The time to onset is unknown. There is no information regarding patients condition at the time of vaccination, nor are any lab/radiological results provided refuting alternate causes. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 0.92
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh red, hot and raised area.  No fever. No drainage. Redness not spread much since first appeared same day of immunization (4/23).  Use ice packs, Motrin & Benadryl. If no improvement or worsens call & then will treat for cellulitis.
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Pyrexia, Tremor, Vomiting
Clinical narrative: 11:30pm constant body shaking and shivering. Midnight fever of 102.6 degrees with vomiting. This lasted for 4 hours. Fever rise to 102.8 and constant with TYELENOL unit 9:30am.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: On 4/22 she developed R side facial weakness - Bell's palsy diagnosed in clinic on 4/26 when she sought medical treatment. Started on prednisolone and valacyclovir as well as lubricating eye drops/ointment. Told to follow-up in 2 weeks.
Age: 15.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: After receiving vaccinations pt became lightheaded, pale and nauseated.
Age: 1.08
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccination Error
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Oedema, Pruritus, Urticaria
Clinical narrative: initially local reaction with erythema and edema, developed into itching and whole body uriticaria. Improved with q4-6 hour dosing of benedryl x 3 days
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Bradyphrenia, Fatigue, Lethargy, Muscular weakness
Clinical narrative: fatigue, muscle weakness, lethargy, mental sluggishness started the next day
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site reaction, Pain, Pyrexia
Clinical narrative: 101 degree fever, aches, headache, big red welt at site
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 101 degree fever, aches, headache, big red welt at site
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised skin from injection site to top of elbow.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen, red & warm to touch. -4 inches in size -Prescribed.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received extra dose of Hep B vaccine--patient had no adverse reaction noted; no treatment needed;  Health Dept notified and stated no side effects would be expected and that it will not harm him
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Injection site pain, Injection site vesicles, Swelling
Clinical narrative: 1 week Redness with swelling, Pain to the area with blisters. No fever mom putting ice pack daily.    Treatment given benadryl and steroid cream.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Throat irritation
Clinical narrative: pt complained of itching and scratchy throat after injection
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: patient  was given adult dose of Hep A
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: Reaction with 5cm of redness around injection site.  Treatment, cold compresses and Benadryl prn.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Shortness of breath, weakness, and redness and swelling near injection site on left deltoid  Symptoms started approximately 12 hours after vaccination and lasted about 24-48 hours with symptoms dissipating over time. Symptoms had resolved within 72 hours.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site urticaria, Skin discolouration, Urticaria
Clinical narrative: Per NP hive on lower extremities spreading to abdomen, following immunizations, reported change in color of extremities, not observed by provider following Benadryl hives resolving, infant sleeping advised to monitor and wake in 3 hours to feed. Will refer to allergist to determine a plan for the following set of shots.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Cardiac monitoring, Heart rate decreased, Pallor, Syncope
Clinical narrative: PT DEVELOPED SYNCOPE WITHIN 15 MINUTES OF BEING GIVEN VACCINE. PT RECOGNIZED THE SYMPTOMS PLACED HER HEAD BETWWEN HER KNEES. THEN WANTED TO LAY DOWN ON THE COOL FLOOR. 911 WAS CALLED. PT WAS ON HER SIDE.SHE NEVER LOST COSCIOUSNESS. PT BECAME PALE.. PULS WAS LOW. PT RESPONDED WELL WITH NO MEDICAL TREATMENT GIVEN.   PT STATED SHE ONLY ATE A BANANA AND PEANUT BUTTER AND A CUP OF TEA AND A BOTTLE OF WATER ALL DAY BEFORE THE VACCINE.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Gait disturbance, Pain in extremity
Clinical narrative: Got sore arm same day, not bad.  Towards bedtime I got chills, went to bed. Got up during night to use bathroom, no problem. At 6:30 am the next day, I went to bathroom, got extremely dizzy. Had to crawl on floor to get to bed. Otherwise I would have passed out.