chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Soreness at the injection site; Headache; Generally achy; Joint pain; Fatigue; sick; Cold; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 8th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, headache, pain, arthralgia, fatigue, sickness and cold. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the headache, pain, arthralgia, fatigue, sickness and cold were unknown.   The reporter considered the injection site pain, headache, pain, arthralgia, fatigue, sickness and cold to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had soreness at the injection site, but that was at the time of reporting gone. The patient had headache, joint pain and generally achy and fatigued. The patient thought it might be a cold but did not had any of those symptoms like congestion, sore throat, fever, just the aches and headache.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Soreness at the injection site; Headache; Generally achy; Joint pain; Fatigue; sick; Cold; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 8th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, headache, pain, arthralgia, fatigue, sickness and cold. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the headache, pain, arthralgia, fatigue, sickness and cold were unknown.   The reporter considered the injection site pain, headache, pain, arthralgia, fatigue, sickness and cold to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had soreness at the injection site, but that was at the time of reporting gone. The patient had headache, joint pain and generally achy and fatigued. The patient thought it might be a cold but did not had any of those symptoms like congestion, sore throat, fever, just the aches and headache.
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Infection, Pertussis
Clinical narrative: DPT shot it left her vulnerable to getting Whooping Cough which she did get; terrible allergic reaction; Infectious disease; This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced whooping cough (serious criteria hospitalization and GSK medically significant), allergic reaction (serious criteria hospitalization) and infection (serious criteria hospitalization). The patient was treated with oxygen (Oxygen Therapy) and medication unknown (Intravenous Therapy (Nos)). On an unknown date, the outcome of the whooping cough, allergic reaction and infection were unknown.   It was unknown if the reporter considered the whooping cough, allergic reaction and infection to be related to DTPa vaccine.  Additional information was received as follows: Age at vaccination was not reported. This was a social media report. The patient got her 1st DPT shot and had a terrible allergic reaction which put her in the hospital. But by the patient not being able to get her DPT shot it left her vulnerable to getting Whooping Cough which she did get. She ended up in the hospital, in an oxygen tent in infectious disease where she was hooked up to so many IV's and machines.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Myalgia
Clinical narrative: Muscle pain/Myalgia; Hot flash; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 10th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). In December 2019, less than a day after receiving Shingrix, the patient experienced muscle pain and hot flashes. On an unknown date, the outcome of the muscle pain and hot flashes were recovering/resolving.   It was unknown if the reporter considered the muscle pain and hot flashes to be related to Shingrix.  Additional information was received as follows: The patient stated that around 2:30 am on the date of reporting she developed myalgia and muscle pains.  She was also having what feels like hot flashes.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Oedema mucosal, Pyrexia, Rash maculo-papular, Rash pruritic
Clinical narrative: Severe generalized  pruritic maculopapular rash, fever (101.6) and  mucosal swelling
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Computerised tomogram, Fall, Seizure
Clinical narrative: Pt received injections and was sitting on the table, I turned around to talk with mom ,asked her if she needed anything ,and then the mom started screaming stating pt was having a seizure, the next thing pt was on the floor, I ran to pt and asked mom to go get a doctor, pt was laughing and talking right after I gave shots.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Syncope and Seizure
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: large red area mreasuring 3x2 inches; This spontaneous report as received from a Physician Assistant refers to a 40-year-old female patient.    The patient's medical history included anxiety, depression, asthma and hypothyroidism.    The patient had received unspecified asthma, anxiety, depression and hypothyroidism medications. The patient had drug allergy to mood medications. On 30-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S012246, expiry date: 10-FEB-2021) via intramuscular route for prophylaxis. The patient had sought medical attention.       On 02-OCT-2019, the patient was seen for a large red patch measuring 3x2 inches (injection site erythema). The patient was treated with ice and Ibuprofen (MOTRIN) and did not contact the office with any additional concerns. It was not known if the symptoms completely resolved or when they did resolve. No additional information provided.  The outcome of injection site erythema was reported as recovering/resolving. Causality was not reported.
Age: 0.33
Sex: F
Vaccine: TDAP
Symptoms: Febrile convulsion, Kawasaki's disease
Clinical narrative: symptoms of Kawasaki syndrome; reacted with febrile convultions; This case was reported by a consumer via interactive digital media and described the occurrence of kawasaki's disease in a 25-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced kawasaki's disease (serious criteria hospitalization and GSK medically significant) and febrile convulsion (serious criteria hospitalization and GSK medically significant). DTPa vaccine was discontinued. On an unknown date, the outcome of the kawasaki's disease and febrile convulsion were recovered/resolved.   It was unknown if the reporter considered the kawasaki's disease and febrile convulsion to be related to DTPa vaccine.  Additional details were provided as follows: The patient reacted with febrile convulsions. The reporter stated, during her 4 day hospital stay, someone recognized symptoms of Kawasaki syndrome and the patient was treated accordingly. It saved the her life. The reporter stated, they might never know if this was a coincidence but she had not received any more pertussis vaccines thereafter. The patient was 25 now and healthy.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: vaccine was administered too high on the deltoid; Extreme pain at the injection site; Difficulty raising arm/Weight bearing difficulty; Sirva; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 42-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional information was received as follows: The patient reported extreme pain at the injection site which remained at the time of reporting. The patient has difficulty raising his arm and lifting objects. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms. Consented to follow up. Emergency Room Visit Required. This was 1 out of 8 cases reported by same reporter.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: Titers came negative/ lack of effect; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 19-year-old patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.  Additional information were received as follows: The age at vaccination was not reported. The patient completed the series of Hepatitis B vaccine and the titers came negative. The patient asked about the information regarding booster Twinrix dose. No further data from patient or vaccine was provided.      Lab Comments: on an unknown dat e, hepatitis B test was performed
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Pain in deltoid; This case was reported by a other health professional via call center representative and described the occurrence of localized muscle pain in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 3D57E, expiry date 11th December 2021) for prophylaxis.   On 10th December 2019, the patient received Shingrix. On 10th December 2019, less than a day after receiving Shingrix, the patient experienced localized muscle pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the localized muscle pain was unknown.   It was unknown if the reporter considered the localized muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in deltoid after receiving Shingrix. The patient was treated with icepack and Tylenol, with some relief. The reporter consented to follow up. This case has been linked with case US2019226008 reported by the same reporter. The batch number was changed from 3D538 to 3D57E as per sales data sheet.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness at injection site; hot to touch at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th December 2019, 2 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were received as follows: The patient experienced redness at the injection site, described as about a two inch circle. The patient also noted the site was hot to the touch, and painful.  At time of report, the patient did notice some minor improvement in symptoms. The patient did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: FLU4, HEPA, VARZOS
Symptoms: Angiogram normal, Biopsy artery normal, C-reactive protein increased, Ear discomfort, Headache
Clinical narrative: Elevated CRP- C reactive protein; left ear pressure; loss of left upper field  of vision, in the left eye; Bilateral Ischemic Optic Neuropathy; headache; This case was reported by a nurse via call center representative and described the occurrence of ischemic optic neuropathy in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9227H, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number MB9YJ, expiry date 6th June 2020) for prophylaxis.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml, the 2nd dose of Havrix (intramuscular) 1 ml and FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, 1 days after receiving Shingrix, Havrix and FluLaval Tetra 2019-2020 season, the patient experienced ischemic optic neuropathy (serious criteria GSK medically significant) and headache. On 12th October 2019, the patient experienced sensation of pressure in ear and visual field defect. On 14th October 2019, the patient experienced c-reactive protein increased. On an unknown date, the outcome of the ischemic optic neuropathy and headache were recovering/resolving and the outcome of the sensation of pressure in ear and visual field defect were not recovered/not resolved and the outcome of the c-reactive protein increased was unknown.   It was unknown if the reporter considered the ischemic optic neuropathy, headache, sensation of pressure in ear, visual field defect and c-reactive protein increased to be related to Shingrix, Havrix and FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The patient experienced headache and left ear pressure. The patient experienced bilateral ischemic optic neuropathy. The patient began to have eye symptoms of loss of left upper field of vision, in the left eye.  On 14th October 2019,The patient had an elevated C reactive protein of 6.770.  On 15th October 2019, the patient was seen at the opthalmologist. The patient underwent CT angiogram of the head and neck , brain MRI which were normal. On 18th October 2019,the patient also underwent left temporal artery biopsy and was found negative for arteritis.
Age: 56.0
Sex: F
Vaccine: FLU4, HEPA, VARZOS
Symptoms: Magnetic resonance imaging brain normal, Optic ischaemic neuropathy, Visual field defect
Clinical narrative: Elevated CRP- C reactive protein; left ear pressure; loss of left upper field  of vision, in the left eye; Bilateral Ischemic Optic Neuropathy; headache; This case was reported by a nurse via call center representative and described the occurrence of ischemic optic neuropathy in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9227H, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis and Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number MB9YJ, expiry date 6th June 2020) for prophylaxis.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml, the 2nd dose of Havrix (intramuscular) 1 ml and FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, 1 days after receiving Shingrix, Havrix and FluLaval Tetra 2019-2020 season, the patient experienced ischemic optic neuropathy (serious criteria GSK medically significant) and headache. On 12th October 2019, the patient experienced sensation of pressure in ear and visual field defect. On 14th October 2019, the patient experienced c-reactive protein increased. On an unknown date, the outcome of the ischemic optic neuropathy and headache were recovering/resolving and the outcome of the sensation of pressure in ear and visual field defect were not recovered/not resolved and the outcome of the c-reactive protein increased was unknown.   It was unknown if the reporter considered the ischemic optic neuropathy, headache, sensation of pressure in ear, visual field defect and c-reactive protein increased to be related to Shingrix, Havrix and FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The patient experienced headache and left ear pressure. The patient experienced bilateral ischemic optic neuropathy. The patient began to have eye symptoms of loss of left upper field of vision, in the left eye.  On 14th October 2019,The patient had an elevated C reactive protein of 6.770.  On 15th October 2019, the patient was seen at the opthalmologist. The patient underwent CT angiogram of the head and neck , brain MRI which were normal. On 18th October 2019,the patient also underwent left temporal artery biopsy and was found negative for arteritis.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Mild rash in the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient that received the first dose of Shingrix a month ago, experienced mild rash in the injection site for 2 days. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Accidental exposure to product
Clinical narrative: Parent was offered all four vaccines, declined to have HPV and Bexsero.  A nursing change during the patients visit resulted in a miscommunication to the covering nurse, and all four vaccines were given.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient given 0.5 mL pediatric dose of Havrix. Error noted after patient had left the office and we were unable to give her the additional 0.5 mL needed for a full dose.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Injection site papule, Rash erythematous, Rash papular
Clinical narrative: shingles behind his ear on his hairline near his scalp; red dots with white heads on the abdomen; tiny bumps; bumps; Skin lesion; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 4 days after receiving Shingrix, the patient experienced shingles, red rash, injection site papule, papular rash and skin lesion. On an unknown date, the outcome of the shingles, red rash, injection site papule, papular rash and skin lesion were recovered/resolved.   It was unknown if the reporter considered the shingles, red rash, injection site papule, papular rash and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection and four days later he developed shingles behind his ear on his hairline near his scalp. He went to the dermatologists and they did a scraping and it was confirmed it was shingles. A few days later he went to urgent care because the lesions had gotten worst and he was prescribed an antibiotic. A week later he went to his primary doctor for a regular visit and blood was drawn the next day he developed tiny bumps at the insertion site where the blood was drawn and had seven tiny red dots with white heads on his abdomen. His physician stated that they were either shingles or chicken pox. The lesions have all healed and was told he can get his 2nd injection in December.
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: shingles behind his ear on his hairline near his scalp; red dots with white heads on the abdomen; tiny bumps; bumps; Skin lesion; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 4 days after receiving Shingrix, the patient experienced shingles, red rash, injection site papule, papular rash and skin lesion. On an unknown date, the outcome of the shingles, red rash, injection site papule, papular rash and skin lesion were recovered/resolved.   It was unknown if the reporter considered the shingles, red rash, injection site papule, papular rash and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection and four days later he developed shingles behind his ear on his hairline near his scalp. He went to the dermatologists and they did a scraping and it was confirmed it was shingles. A few days later he went to urgent care because the lesions had gotten worst and he was prescribed an antibiotic. A week later he went to his primary doctor for a regular visit and blood was drawn the next day he developed tiny bumps at the insertion site where the blood was drawn and had seven tiny red dots with white heads on his abdomen. His physician stated that they were either shingles or chicken pox. The lesions have all healed and was told he can get his 2nd injection in December.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscle swelling, Pain
Clinical narrative: extreme swelling in deltoid; extreme redness; extreme pain; This case was reported by a physician via sales rep and described the occurrence of muscle swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced muscle swelling, localized erythema and pain. On an unknown date, the outcome of the muscle swelling, localized erythema and pain were recovered/resolved.   It was unknown if the reporter considered the muscle swelling, localized erythema and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received first dose of shingrix and experienced extreme redness, pain and swelling in deltoid which lasted a few days. The reporter refused additional information.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pruritus
Clinical narrative: tired; nausea; headache; Upper arm rash; pain; itching; Puckering of skin; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2019, 2 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced tiredness, nausea and headache. In November 2019, the patient experienced rash zosteriform, pain in arm, itchy upper limbs and skin wrinkling. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the tiredness, nausea and headache were resolved with sequelae and the outcome of the rash zosteriform, pain in arm and itchy upper limbs were recovering/resolving and the outcome of the skin wrinkling was unknown.   It was unknown if the reporter considered the tiredness, nausea, headache, rash zosteriform, pain in arm, itchy upper limbs and skin wrinkling to be related to Shingrix.  Additional details were received as follows: The patient received the 1st dose of vaccine and was very tired and had slight nausea and headaches. The symptoms lasted a couple days before resolving.  The patient also noticed horrendous rash on most of her upper arm. The patient arm was painful so she  could not touch it and it itched. The patient thought the rash looks like shingles. The patient sent a picture to her physician and he prescribed valacyclovir, but she did not actually go to the physician's office. The patient stated that rash has improved, it was lighter and a little smaller and the pain was leaving her arm.  The patient noticed some puckering of the skin on her arm. The patient consented to follow up. This case has been linked to US2019205795 and US2019GSK206553 reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Skin wrinkling, Tenderness
Clinical narrative: tired; nausea; headache; Upper arm rash; pain; itching; Puckering of skin; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2019, 2 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced tiredness, nausea and headache. In November 2019, the patient experienced rash zosteriform, pain in arm, itchy upper limbs and skin wrinkling. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the tiredness, nausea and headache were resolved with sequelae and the outcome of the rash zosteriform, pain in arm and itchy upper limbs were recovering/resolving and the outcome of the skin wrinkling was unknown.   It was unknown if the reporter considered the tiredness, nausea, headache, rash zosteriform, pain in arm, itchy upper limbs and skin wrinkling to be related to Shingrix.  Additional details were received as follows: The patient received the 1st dose of vaccine and was very tired and had slight nausea and headaches. The symptoms lasted a couple days before resolving.  The patient also noticed horrendous rash on most of her upper arm. The patient arm was painful so she  could not touch it and it itched. The patient thought the rash looks like shingles. The patient sent a picture to her physician and he prescribed valacyclovir, but she did not actually go to the physician's office. The patient stated that rash has improved, it was lighter and a little smaller and the pain was leaving her arm.  The patient noticed some puckering of the skin on her arm. The patient consented to follow up. This case has been linked to US2019205795 and US2019GSK206553 reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain, Wrong product administered
Clinical narrative: Pain after each injection; Extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on December 2018) and Shingrix (2nd dose received on February 2019).   In October 2019, the patient received the 3rd dose of Shingrix. In October 2019, less than 3 months after receiving Shingrix, the patient experienced pain and extra dose administered. On an unknown date, the outcome of the pain and extra dose administered were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient came for a pneumonia vaccine in October 2019 but was accidentally given a third dose of Shingrix, which led to extra dose administered. The reporter stated that the patient had pain after each injection. The reporter did not have more specific details available at the time of reporting. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea
Clinical narrative: Diarrhea, chills, abdominal cramping
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient first dose of HPV vaccine. Patient passed out for 2 minutes after receiving vaccine. Patient's vitals were stable and denied dizziness or headaches.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: rash to entire upper arm
Age: 0.5
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Erythema, Erythema of eyelid
Clinical narrative: Patient had mile left sided facial and redness under bilateral eyes.  Pts symptoms resided after a few minutes.  Pt was monitored for 30 minutes following resolution of symptoms and was released by provider.  No interventions/treatments performed.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Start of December (cannot remember exact date) patient came and reports that he may have some pain in his left shoulder/upper arm  in the same arm as flu shot he received.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Diplegia, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Procedural failure
Clinical narrative: Patient reports tremors a few hours after the vaccine, then she became numb and both legs were paralyzed (Monday and Tuesday following immunization), she spent a couple of days in the hospital. she underwent 5 unsuccessful spinal taps. Dr. gave her a pre-diagnosis of Guillan-Barre since they couldn't perform the spinal tap.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Tremor
Clinical narrative: Patient reports tremors a few hours after the vaccine, then she became numb and both legs were paralyzed (Monday and Tuesday following immunization), she spent a couple of days in the hospital. she underwent 5 unsuccessful spinal taps. Dr. gave her a pre-diagnosis of Guillan-Barre since they couldn't perform the spinal tap.
Sex: F
Vaccine: FLUN4
Symptoms: Cellulitis, Eye pain, Rash, Rhinalgia, Swelling
Clinical narrative: EYE PAIN; SWELLING; NASAL PAIN; RASH; CELLULITIS; A spontaneous report has been received from the regulatory authority (MA). The report concerns a female patient of Unknown ethnic origin (age 11 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for routine childhood immunisation on 24-Oct-2019.     On 08-Nov-2019, the patient experienced cellulitis (preferred term: Cellulitis). On an unknown date, the patient experienced eye pain (preferred term: Eye pain), swelling (preferred term: Swelling), nasal pain (preferred term: Rhinalgia) and  rash (preferred term: Rash).     The outcome of the events of eye pain, swelling, nasal pain, cellulitis and rash was unknown.     The events eye pain, swelling, nasal pain, cellulitis and rash were considered serious (hospitalised) by reporter.     ; Sender's Comments: Eye pain, swelling, rhinalgia and cellulitis are not listed in the company core data sheet for Q/LAIV (Fluenz Tetra). Reported cellulitis could be contributory for swelling, eye pain and rhinalgia. Due to limited information on exact location of swelling and cellulitis, exact onset date of events, concurrent diseases, concomitant medication, relevant medical history, risk factors (injury, weakened immune system, skin condition, obesity), etiologic and diagnostic workup, it is not possible to make conclusive assessment of causal relationship of events with suspect drug.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This spontaneous report was received from a 45-year-old male patient consumer and refers to himself. The patient concomitantly received several unspecified medication and had allergies to bee stings and adhesive bandages. No information regarding pertinent medical history was provided.   On an unspecified date in September 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscular (dose, site of administration, lot # and expiration date were not provided) for prophylaxis. The patient reported that he has missed his second scheduled vaccination by over a month and on unspecified date in September 2019, he experienced injection site soreness.The patient sought medical attention and visited to physician. There was no treatment given for the event. On an unspecified date in 2019 (reported as couple days after receiving the vaccine), the patient recovered.   The relatedness between the event and the therapy with pembrolizumab (KEYTRUDA) was not provided.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse effects reported; inadvertently administered one dose of MMRII and one dose of PRQOUAD simultaneously; This spontaneous report was received from a nurse prescriber and refers to a 12-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-DEC-2019, the patient was vaccinated with dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) and with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (exact dose, dose number, route and site of administration, lot# and expiration date were not reported). A healthcare provider accidentally administered both vaccines to this patient (inappropriate schedule of vaccine administered). No additional adverse effects were reported. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Suffered from a bad case of the shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 02-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the vaccine, the patient suffered a bad case of shingles. It was also specified that 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.  At the reporting time, the outcome of shingles was unkwnon. The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Herpes zoster was considered to be disabling due to permanent injuries.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Rash pruritic, Skin warm
Clinical narrative: Tenderness @ injection site. Hot, itchy rash developed on 2nd day after injection. Lasted 15 or more days with decreasing intensity.
Age: 3.83
Sex: F
Vaccine: FLU4, HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pt presented with flu form filled out in front and back - As new employee. I asked her to sign the back of the form in the wright place which she did. I gave her the flu shot and recalled Admin had not given me a vaccine record to fill out for her so I called the front desk requesting it. This took longer than expected & I went with Pt to the front and was handed the form which I signed. The Pt then told me she was here for Hepatitis - Not flu which she had gotten last month. The Pharmacist was asked to see if there could be adverse reaction to 2 flu shots. But I still fill out an incident report. Pt mistakenly given a flu dose rather than a Hepatitis B #2 dose. Pt filled out front and back page of flu form; didn't say anything about Hep B dose until after shot record handed to her. Shot received not included in until after flu shot given. Pt didn't get flu shot #1 at MD - so this was not on record. I gave Hepatitis B vaccine after this mistake noted and apologized to Pt. Not sure why she would fill out Flu form in the 1st place and not say something.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediately after receiving influenza vaccination on Dec 7, 2019, felt pain in the arm (left) and felt numbness in the face on the left. Symptoms resolved within 24 hours.
Age: 55.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Rash
Clinical narrative: Patient has had the flu shot many times in the past but has never had the shingles shot. Pretty sure her reaction is related to the Shingrix vaccination. She broke in a rash on her whole body.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: Patient noted 1 hour after injection left arm became painful. She complains of pain and decreased strenght
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dizziness, Headache, Injected limb mobility decreased
Clinical narrative: Extreme pain -left arm, cannot move left arm, 100.9 temperature,chills, dizziness, headache
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Extreme pain -left arm, cannot move left arm, 100.9 temperature,chills, dizziness, headache
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Varicella vaccine inadvertently administered in pregnancy, EDC 5/22/20
Age: 25.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Eye inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, swelling  and warmth at SQ site where Varicella was administered.  Bilateral eye inflammation .  Pt was seen yesterday at PCP and given prednisone and dose of epi in the office.  The area of redness was measured at 13.5 cm X 10 cm per the PCP.  Line of demarcation drawn on 12/19/19 and on 12/20/19 the redness was expanded beyond the mark.  Photos taken by pt per the PCP.  Provider is continuing to follow up on pt as of 12/20/19.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin reaction
Clinical narrative: Minor skin reaction must likely secondary to needle Injection/break in skin barrier.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Localized redness at injection site approx 48 hrs after administration Follow up w/patient on 12/16 & she states redness is self resolving
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Dyskinesia, Dyspnoea, Headache, Laboratory test abnormal, Liver function test abnormal
Clinical narrative: Pain in muscle, loss of control of muscles, difficulty breathing, excessive swelling , headache, nausea
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Myositis, Nausea, Pneumonitis, Swelling
Clinical narrative: Pain in muscle, loss of control of muscles, difficulty breathing, excessive swelling , headache, nausea
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Muscle contractions involuntary, Muscle tightness, Somnolence, Tremor, Unresponsive to stimuli
Clinical narrative: On 12/20/2019, 1 day following vaccination, patient had a 30 second episode of closing eyes and rapidly shaking arms and legs with generalized muscle tension and toes curled downward.  Also would not open eyes to parent's voice during episode.  Appeared sleepy after episode for 20 minutes and then took a nap.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: White blood cells urine positive
Clinical narrative: On 12/20/2019, 1 day following vaccination, patient had a 30 second episode of closing eyes and rapidly shaking arms and legs with generalized muscle tension and toes curled downward.  Also would not open eyes to parent's voice during episode.  Appeared sleepy after episode for 20 minutes and then took a nap.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Culture throat, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Rash, fever, runny nose, sore throat.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rhinorrhoea, X-ray
Clinical narrative: Rash, fever, runny nose, sore throat.
Age: 22.0
Sex: F
Vaccine: FLU4, HEPA, TD
Symptoms: Rash pruritic, Swelling face, Tuberculin test negative, Urticaria
Clinical narrative: Pt reported facial swelling followed by itchy rash (hives) on bilateral arms and body.  Pt states that symptoms lasted for the rest of the day and subsided with use of Benadryl.  Pt states that this was her first hepatitis A vaccine and that she had never had a reaction from a vaccine previously.  She also received PPD in left arm which resulted as a negative reading.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: Pain with raising injected arm with episodic pain and tingling down lateral arm to the elbow area for 30 days.
Age: 75.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site bruising, Injection site pain, Musculoskeletal pain
Clinical narrative: SORENESS AT SITE DAY AFTER, BRUISIN G THE SIZE OF HALF A BASEBALL AFTERWARDS, STILL HAS SHOULDER PAIN ALMOST TWO MONTHS AFTERWARDS
Age: 75.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site bruising, Pain, Pain in extremity
Clinical narrative: SORENESS AT SITE DAY AFTER, BRUISIN G THE SIZE OF HALF A BASEBALL AFTERWARDS, STILL HAS SHOULDER PAIN ALMOST TWO MONTHS AFTERWARDS
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeding disorder, Nasal dryness
Clinical narrative: Arm was sore all the time. Chills started in middle of night and kept patient awake.  Today in the morning, patient has body aches and feels tired--has no energy at all.    Patient feels nauseous and can't eat anything. Chills continue.    Patient contacted doctor but was told they were expected symptoms. Patient took Ibuprofen last night and in the morning but did not help much.  Patient continues to drink liquids.  Patient specifies nose is very dry.   Patient received Flu vaccine from same facility.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Arm was sore all the time. Chills started in middle of night and kept patient awake.  Today in the morning, patient has body aches and feels tired--has no energy at all.    Patient feels nauseous and can't eat anything. Chills continue.    Patient contacted doctor but was told they were expected symptoms. Patient took Ibuprofen last night and in the morning but did not help much.  Patient continues to drink liquids.  Patient specifies nose is very dry.   Patient received Flu vaccine from same facility.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Arm was sore all the time. Chills started in middle of night and kept patient awake.  Today in the morning, patient has body aches and feels tired--has no energy at all.    Patient feels nauseous and can't eat anything. Chills continue.    Patient contacted doctor but was told they were expected symptoms. Patient took Ibuprofen last night and in the morning but did not help much.  Patient continues to drink liquids.  Patient specifies nose is very dry.   Patient received Flu vaccine from same facility.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Peripheral swelling, Tenderness
Clinical narrative: Significant erythema and swelling of (R) upper extremity with tenderness from shoulder to mid forearm which began a couple of hours after PPSV23 injection on 12/18/19. Symptoms continue 48 hours after injection with little to no improvement. Patient seen in clinic 12/20/19 for further evaluation. Benadryl 50mg IM administered and ACE bandage compression applied to (R) arm.   Pt ordered to keep ACE in place 12 hours on/ 12 hours off for the next 2 days. PCV13 vaccine completed 11/2018 with no adverse effects. Pharmacy contacted regarding adverse event.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Induration
Clinical narrative: area of induration at 7 cm
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Back pain, Dysstasia
Clinical narrative: Client received a Stamaril vaccine at the Department of Health on 12/16/2019 and later traveled. Hecalled me, (principal investigator for Stamaril clinical trials) on 12/17/2019 advising that he was having severe lower back pain that began that day and he was having difficulty standing. He was referred to ER where he advised them of the vaccine administration the previous day. He received a discharge diagnosis of back pain and placed him on Ibuprofen 800mg and Methocarbamol 750mg. Follow up on 12/18/2019 he was not feeling better.On 12/20/2019 client stated that he went to Urgent Care and was given another prescription and is feeling better, they mentioned that they believe his symptoms are not related to the vaccine ; they thought it was due to extended travel time on plane.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives with itching on chest which appeared day following vaccine.  No cough, wheezing, N/V/D,  Benadryl prescribed