chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Vaccination site pain, Wrong product administered
Clinical narrative: administered Gardasil 9 while being 28 weeks pregnant; mistakenly admonistered gardasil 9 instead of T-DAP; the vaccine hurt; This spontaneous prospective pregnancy report as received from a physician refers to a 31-year-old female patient. The patient's current condition included asthma. The patient had drug allergy due to augmentin (hives). Concomitant therapies included albuterol(ALBUTEROL), budesonide(PULMICORT) and prenatal vitamins (vitamins (unspecified)  On 04-NOV-2019, the patient was mistakenly administered with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R026716, expiry date: 30-MAY-2021) via intramuscular route for prophylaxis instead of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) (wrong product administered). The patient was 27 weeks pregnant (reported as 28 weeks still pregnant) at the time of vaccination (exposure during pregnancy). The patient became pregnant with last menstrual period (LMP) of 28-APR-2019 and estimated due date (EDD) of 02-FEB-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 27 week(s). The pregnancy outcome was pending. The physician reported that the patient stated that the vaccine was hurting (vaccination site discomfort).  No other adverse effects were reported. It was the first time the patient had vacccine. No additional information. No product quality complaint (PQC).  The outcome of vaccination site discomfort, wrong product administered and exposure during pregnancy was unknown. The reporter considered pain to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported for the patient; administration of one dose of an improperly stored vaccine, VAQTA, to one patient on 11/6/2019; This spontaneous report was received from  a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 06-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) injection at a dose of 0.5 milliliter, one dose of lot # S009943 with expiry date 26-JUL-2020 (frequency and route of administration were unknown) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed to 58.6 Fahrenheit temperature for 10 minutes. There was no previous temperature excursion. Digital data logger was involved. The office manager also reported a possible malfunction of the data logger, but does not know if the data logger malfunctioned or not. No adverse effects reported.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Musculoskeletal pain, Pyrexia
Clinical narrative: swelling at injection site; Fever; Fatigue; Shoulder pain; This case was reported by a consumer and described the occurrence of injection site swelling in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019, the patient received the 2nd dose of Shingrix. On 2nd November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, fever, fatigue and shoulder pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site swelling, fever, fatigue and shoulder pain were unknown.   The reporter considered the injection site swelling, fever, fatigue and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient complained of fever, fatigue, shoulder pain, and swelling at injection site. The patient spoke to pharmacist who advised to take Tylenol to manage and rest. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received Shingrix. On 25th October 2019, 9 days after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient started having almost all of the side effects. The patient asked whether it was possible that the side effects would take 9 days to start. The patient assumed, that she had some sort of virus, but when she looked up the side effects she wondered if the vaccine could affect her that long after she received it.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out what appears to be shingles; This case was reported by a consumer and described the occurrence of shingles in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received first shot and due for the second. According to day of reporting this weekend patient broke out what appears to be shingles and enquired should patient still get the vaccine shot. The reporter consent to follow up.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at the injection site; Swelling at the Injection site; This case was reported by a other health professional and described the occurrence of injection site erythema in a adolescent male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than a month after receiving Bexsero, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Medical Assistant (MA). The age at vaccination was not reported. Couple of weeks back from the date of reporting, the patient was administered of Bexsero and experience swelling and redness at the injection site that lasted 1.5 weeks.  The patient explained to her that the PI details a rate of localized adverse event at the injection site.
Sex: M
Vaccine: HEP
Symptoms: Patient isolation
Clinical narrative: Hepatitis B surface antigen positive; This case was reported in a literature article and described the occurrence of hepatitis b surface antigen positive in a 65-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Concurrent medical conditions included end stage renal disease, diabetes and diabetic foot ulcer.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 14 days after receiving Hepatitis B vaccine, the patient experienced hepatitis b surface antigen positive (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis b surface antigen positive was unknown.   The reporter considered the hepatitis b surface antigen positive to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of hepatitis B surface antigen positive in a 65-year-old male patient who was vaccinated with unspecified hepatitis B vaccine (manufacturer unknown) for prophylaxis. The case corresponds to patient 2 reported in this literature article. The patient had underlying condition of end-stage kidney disease (EKSD), diabetes and diabetic foot ulcer. No information on patient's family history or concomitant medication was provided. On an unspecified date, 2 weeks prior to admission, the patient received booster dose of unspecified hepatitis B vaccine (administration route and site unspecified; dosages unknown; batch number not reported). It was reported that, detailed information on administration vaccination revealed by patient's dialysis unit. [The current advisory committee on immunization practices guidelines recommend hepatitis B vaccination series for All ESKD patient's preceded by serologic testing and followed by post vaccination confirmation of immunity]. The age at vaccination was not provided, but it could be 64 or 65 years. On an unspecified date, 2 weeks after receiving the booster dose of vaccination, the patient with ESKD was admitted to the hospital for a diabetic foot ulcer. Patient's routine hospital testing for hepatitis B surface antigen (HBsAg) was positive, and the patient was dialyzed with isolation practice while awaiting results of an acute hepatitis B panel. The patient was irate about faulty vaccination, stating that he was told his recent vaccination would help to prevent hepatitis B infection, not cause it. Treatment was unknown. The outcome was not reported. The authors did not comment on relationship between the event hepatitis B surface antigen positive and unspecified hepatitis B vaccine. The authors stated "The current advisory committee on immunization practices guidelines recommend hepatitis B vaccination series for all ESKD patient's preceded by serologic testing and followed by post vaccination confirmation of immunity'' This is 1 of the 2 valid cases reported in the same literature article. This article is not available for regulatory submission due to copyright restriction.      Lab Comments: Lab test done on an unknown date.
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Upper respiratory tract infection
Clinical narrative: fatigue; upper respiratory infection; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   On 30th October 2018, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular) .5 ml. On 1st November 2018, 2 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced fatigue. In November 2018, the patient experienced upper respiratory tract infection. On 21st November 2018, the outcome of the upper respiratory tract infection was recovered/resolved. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue and upper respiratory tract infection to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received a dose of Fluarix last year. The patient started feeling fatigued and it took several weeks to resolve.  The patient developed an upper respiratory infection on 2nd November 2018. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Fatigue, Injection site pain, Tinnitus
Clinical narrative: Ringing in left ear; Bone pain; joint pain; tired; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2022) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st October 2019, 1 days after receiving Shingrix, the patient experienced ringing in ears, bone pain, joint pain, tiredness and injection site pain. On an unknown date, the outcome of the ringing in ears, bone pain, joint pain, tiredness and injection site pain were recovering/resolving.   It was unknown if the reporter considered the ringing in ears, bone pain, joint pain, tiredness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient experienced ringing in ears, bone pain, joint pain, tiredness and injection site pain after vaccination. The reporter consented to follow up. This case has been linked with case US2019199338, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Emotional distress, Nausea, Pyrexia
Clinical narrative: Broke up all over body / Has at this moment one in her eye, arm and one on her back; nausea; felt bummed; Feverish; weak; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 8th October 2019, less than a day after receiving Shingrix, the patient experienced nausea, emotional distress, fever, weakness and blister. On an unknown date, the outcome of the nausea and weakness were recovered/resolved and the outcome of the emotional distress and fever were resolved with sequelae and the outcome of the blister was recovering/resolving.   It was unknown if the reporter considered the nausea, emotional distress, fever, weakness and blister to be related to Shingrix.  Additional details were provided as follows: The patient stated that after vaccination had nausea, felt bummed, feverish, weak. The patient also broke up all over her body and that has not gone away. The patient usually gets one single red pop that turns into a water blister and then it goes away. At the time of reporting patient had one in her eye, arm and one on her back. The patient said it was not a lot of them but they show up randomly at different places since she got the vaccine. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Somatic reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female 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. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced influenza-like symptoms with Shingrix. No further details were provided. The reporter consented to follow up. This case has been linked with case US2019199353, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Somatic reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 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. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced influenza-like symptoms with Shingrix. No further details were provided. The reporter consented to follow up. This case has been linked with case US2019199353, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Condition aggravated, Ear pain, Headache
Clinical narrative: body aches; nausea; knee pain intensified; ear ache intensified; knee pain intensified/ ear ache intensified; Chills; Headache; low grade fever; This case was reported by a physician via call center representative and described the occurrence of pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included JAPANESE ENCEPHALITIS VACCINE for prophylaxis.   Concurrent medical conditions included knee pain and ear pain.   On 25th October 2019, the patient received the 2nd dose of Shingrix. On 10th October 2019, the patient received JAPANESE ENCEPHALITIS VACCINE. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain, low grade fever, nausea, headache, knee pain, ear pain, condition aggravated and chills. On an unknown date, the outcome of the pain, nausea, knee pain, ear pain, condition aggravated and chills were unknown and the outcome of the low grade fever and headache were recovered/resolved.   It was unknown if the reporter considered the pain, low grade fever, nausea, headache, knee pain, ear pain, condition aggravated and chills to be related to Shingrix.  Additional case details were reported as follows: The patient did not have lot number and expiration date of vaccine, as it was given elsewhere. The patient reported chills, low grade fever, body aches, nausea. The knee pain intensified and earache( preexisting issue). The headache and low grade fever, intermittent lasting over 7 days.  The patient also stated that she had Japanese encephalitis immunization on 10th October 2019. The reporter consent to follow up. It was unknown if the reporter considered the pain, low grade fever, nausea, headache, knee pain, ear pain, condition aggravated and chills to be related to JAPANESE ENCEPHALITIS VACCINE .
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: body aches; nausea; knee pain intensified; ear ache intensified; knee pain intensified/ ear ache intensified; Chills; Headache; low grade fever; This case was reported by a physician via call center representative and described the occurrence of pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included JAPANESE ENCEPHALITIS VACCINE for prophylaxis.   Concurrent medical conditions included knee pain and ear pain.   On 25th October 2019, the patient received the 2nd dose of Shingrix. On 10th October 2019, the patient received JAPANESE ENCEPHALITIS VACCINE. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain, low grade fever, nausea, headache, knee pain, ear pain, condition aggravated and chills. On an unknown date, the outcome of the pain, nausea, knee pain, ear pain, condition aggravated and chills were unknown and the outcome of the low grade fever and headache were recovered/resolved.   It was unknown if the reporter considered the pain, low grade fever, nausea, headache, knee pain, ear pain, condition aggravated and chills to be related to Shingrix.  Additional case details were reported as follows: The patient did not have lot number and expiration date of vaccine, as it was given elsewhere. The patient reported chills, low grade fever, body aches, nausea. The knee pain intensified and earache( preexisting issue). The headache and low grade fever, intermittent lasting over 7 days.  The patient also stated that she had Japanese encephalitis immunization on 10th October 2019. The reporter consent to follow up. It was unknown if the reporter considered the pain, low grade fever, nausea, headache, knee pain, ear pain, condition aggravated and chills to be related to JAPANESE ENCEPHALITIS VACCINE .
Age: 57.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Nausea; Fever; Achy; Achy/ achy from tips to fingers to toes; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 57-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season and the 1st dose of Shingrix. On 31st October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season and Shingrix, the patient experienced general body pain and pain in fingers. On 1st November 2019, the patient experienced nausea and feverish. On 1st November 2019, the outcome of the general body pain, pain in fingers, nausea and feverish were recovered/resolved.   It was unknown if the reporter considered the general body pain, pain in fingers, nausea and feverish to be related to Influenza vaccine Quadrivalent 2019-2020 season and Shingrix.  Additional case details were reported as follows: The reporter was the patient's wife. The patient received Shingrix vaccine in unknown arm and Flu vaccine in the opposite arm. Within the night after vaccination the patient was extremely achy from tips to fingers to toes. The patient woke up the next morning after vaccination feeling nauseous and feverish although he did not want to check his temperature. He went to work for approximately 3 hours. The patient felt better after returning from work where he ate. The patient did not have symptoms afterwards. The reporter consent to follow up. This is 2 of the 2 linked cases reported by the same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: muscle aches; headache; did not feel well; pain during injection; fever; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included genital herpes.   On 8th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced muscle pain, headache, feeling unwell, pain during injection and fever. On an unknown date, the outcome of the muscle pain, headache, feeling unwell and pain during injection were resolved with sequelae and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the muscle pain, headache, feeling unwell, pain during injection and fever to be related to Shingrix.  Additional details were reported as follows: The reporter was a patient.  Sometime after receiving the 1st dose of Shingrix, the patient developed severe muscle aches, fever, headache and did not feel well.  The patient could not remember how long the symptoms lasted.  The patient states that he also experienced pain during the injection.  The patient states that the patient had not had the 2nd dose of the vaccine till the time of reporting and it had been almost 8 months since he received the 1st dose.  The patient states that he had not yet received the 2nd dose because of the side effects he experienced with the 1st dose.  The patient was planning to get the 2nd dose soon. Caller had to get off of the phone and get to work, so he did not have time to provide HCP information or any additional details regarding this event.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; nausea; fever; shivering; headache; muscle pain; tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix. On 3rd November 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness. On an unknown date, the outcome of the influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter. The reporter stated that the patient experienced influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness. The daughter of the patient stated that her mother planned to follow up with her physician on an unknown date. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: flu like symptoms; nausea; fever; shivering; headache; muscle pain; tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix. On 3rd November 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness. On an unknown date, the outcome of the influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter. The reporter stated that the patient experienced influenza-like symptoms, nausea, fever, shivering, headache, muscle pain and tiredness. The daughter of the patient stated that her mother planned to follow up with her physician on an unknown date. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Feeling hot, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Cellulitis; Swelling in 2/3 of her arm; Arm was hot; Arm was tender; Patient's arm developed several indurations that were overlapping circles of 3 to 6 cm in size; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a female 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 cellulitis (serious criteria GSK medically significant), swelling arm, extremities hot feeling of, pain in arm and induration. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, swelling arm, extremities hot feeling of, pain in arm and induration were unknown.   It was unknown if the reporter considered the cellulitis, swelling arm, extremities hot feeling of, pain in arm and induration to be related to Shingrix.  Additional case details were provided as follows: This case was reported by the family nurse practitioner. The age at vaccination was not reported. The patient experienced swelling in 2/3 of her arm, which was also hot and tender, after the Shingrix vaccination.  The patient's arm developed several indurations that were overlapping circles of 3 to 6 cm in size. The patient went to the emergency room, was diagnosed with cellulitis, and given antibiotics. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Cellulitis; Swelling in 2/3 of her arm; Arm was hot; Arm was tender; Patient's arm developed several indurations that were overlapping circles of 3 to 6 cm in size; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a female 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 cellulitis (serious criteria GSK medically significant), swelling arm, extremities hot feeling of, pain in arm and induration. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, swelling arm, extremities hot feeling of, pain in arm and induration were unknown.   It was unknown if the reporter considered the cellulitis, swelling arm, extremities hot feeling of, pain in arm and induration to be related to Shingrix.  Additional case details were provided as follows: This case was reported by the family nurse practitioner. The age at vaccination was not reported. The patient experienced swelling in 2/3 of her arm, which was also hot and tender, after the Shingrix vaccination.  The patient's arm developed several indurations that were overlapping circles of 3 to 6 cm in size. The patient went to the emergency room, was diagnosed with cellulitis, and given antibiotics. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Bad reaction; This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in a 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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that almost every patient who has received shingrix in her clinic has complained of a bad reaction. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia
Clinical narrative: Injection Site tenderness / Injection Site Achy; Low grade fever; Malaise; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a female 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 injection site tenderness, low grade fever and malaise. On an unknown date, the outcome of the injection site tenderness, low grade fever and malaise were unknown.   It was unknown if the reporter considered the injection site tenderness, low grade fever and malaise to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Nurse for herself. The age at vaccination was not reported. The patient experienced site tenderness that was achy, a low grade fever and malaise after receiving vaccine. This case is 1 of the 4 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Swollen Lips; Tingling of the tongue; This case was reported by a other health professional via call center representative and described the occurrence of lip swelling in a 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, unknown after receiving Shingrix, the patient experienced lip swelling and tingling tongue. On an unknown date, the outcome of the lip swelling and tingling tongue were unknown.   It was unknown if the reporter considered the lip swelling and tingling tongue to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The reporter stated that, after vaccination with 1st dose of Shingrix, the patient experienced swollen lips and tingling of the tongue. The reporter asked for 2nd dose recommendation, if the patient experienced adverse reaction after 1st dose. No additional details available at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Pain at the site of injection; shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 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, unknown after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On an unknown date, the outcome of the injection site pain and shoulder pain were unknown.   It was unknown if the reporter considered the injection site pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not provided. The age at vaccination was not reported. The patient received dose of Shingrix and experienced injection site pain and shoulder pain. No further details were provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: red injection site; indurated at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2019) for prophylaxis.   On 2nd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site induration. On an unknown date, the outcome of the injection site erythema and injection site induration were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site induration to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that the patient received Shingrix and developed a red, indurated area 3 inches by 2 inches at the injection site. She states that this has resolved at the time of reporting and unsure of the date of resolution. The reporter did not consent to follow up. The health care professional did not consent to follow up for this adverse event.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular
Clinical narrative: Rash; Itching; This case was reported by a physician via call center representative and described the occurrence of papular rash in a 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, 28 days after receiving Shingrix, the patient experienced papular rash and pruritus. On an unknown date, the outcome of the papular rash and pruritus were unknown.   It was unknown if the reporter considered the papular rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vacciantion was not reported. The reporter asked if anyone could get a chicken pox or shingles rash from the vaccine 4 to 6 weeks out. The patient had a non blister but papular rash bilaterally inner arms, itchy a few days timing was 4 weeks out from injection. The reporter consented to follow up. Probed for administration date and dose number but visitor disconnected from the chat.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: soreness; swelling; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2019, less than a day after receiving Shingrix, the patient experienced pain and swelling. The action taken with Shingrix was unknown. On an unknown date, the outcome of the pain and swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient stated she was only experiencing some pain and a little swelling. The reporter consent to follow up.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave Fluzone instead of Shingrix - no known adverse reactions
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Fatigue, Headache, Myalgia
Clinical narrative: achy muscles, fatigue, dehydration, chills and nausea, sore arm and headache
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: achy muscles, fatigue, dehydration, chills and nausea, sore arm and headache
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Migraine, Myalgia, Nausea
Clinical narrative: APPROX 2 HRS AFTER RECEIVING SECOND SHINGRIX VACCINATION, PT STARTED HAVING MYALGIAS, NAUSEA AND VOMITING WITH SEVERE HEADACHE.   PROGRESSED TO CHILLS, MORE SEVERE HEADACHE WITH EXTREME PHOTOSENSITIVITY  AND FEVER.   PT DESCRIBED HEADACHE AS A 10 OUT OF 10 WITH PHOTOSENSITIVITY SO SEVERE PT COULD NOT OPEN HER EYES.   PT WAS SEEN FIRST IN URGENT CARE AND WAS GIVEN ODANSETRON 1 MG FOR THE NAUSEA AND WAS ADVISED TO GO TO ER.   PT WENT TO HOSPITAL AND EVALUATED, DIAGNOSES: MIGRAINE HEADACHE BROUGHT ON BY ADVERSE VACCINE REACTION AND ADVERSE REACTION TO SHINGLES VACCINE.   WAS GIVEN BENADRYL, REGLAN, TORADOL AND ATIVAN IN ER AND WAS FEELING BETTER AFTER WITH NO HEADACHE AND LESSENED BODY ACHES.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Photosensitivity reaction, Pyrexia, Vomiting
Clinical narrative: APPROX 2 HRS AFTER RECEIVING SECOND SHINGRIX VACCINATION, PT STARTED HAVING MYALGIAS, NAUSEA AND VOMITING WITH SEVERE HEADACHE.   PROGRESSED TO CHILLS, MORE SEVERE HEADACHE WITH EXTREME PHOTOSENSITIVITY  AND FEVER.   PT DESCRIBED HEADACHE AS A 10 OUT OF 10 WITH PHOTOSENSITIVITY SO SEVERE PT COULD NOT OPEN HER EYES.   PT WAS SEEN FIRST IN URGENT CARE AND WAS GIVEN ODANSETRON 1 MG FOR THE NAUSEA AND WAS ADVISED TO GO TO ER.   PT WENT TO HOSPITAL AND EVALUATED, DIAGNOSES: MIGRAINE HEADACHE BROUGHT ON BY ADVERSE VACCINE REACTION AND ADVERSE REACTION TO SHINGLES VACCINE.   WAS GIVEN BENADRYL, REGLAN, TORADOL AND ATIVAN IN ER AND WAS FEELING BETTER AFTER WITH NO HEADACHE AND LESSENED BODY ACHES.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site rash, Rash
Clinical narrative: Patient was at the Center on 11/6/2019 for an office visit and at the time she received a flu and PPSV vaccine.  The patient presented to the clinic on 11/8/2019 with a rash at both injections sites she claimed that started the day after receiving.  The rash had spread to her torso and upper back.  She was treated with Depo-Medrol 80mg.
Age: 25.0
Sex: F
Vaccine: FLUA3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Severe shoulder pain that has persisted 11 days after vaccine with little improvement. Limited range of motion of left arm. Lifting my left arm up or across my body causes severe pain.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood test, Chest X-ray, Chills, Dizziness
Clinical narrative: Prior to receiving the shot on 11/5 and the days leading up to I was healthy and feeling perfectly fine. Around 1:00 I began to notice a funny painful feeling in my left arm, so I walked over to one of my pharmacist to be informed my arm was swollen. That same day as I laid down for bed my body felt off.  However, on 11/6 I woke up for work but I could not make my body get up because it felt really week. Once I was able to get up I began to walk towards the bathroom and I became really dizzy so I immediately laid down and called into to work. During that same day I began experience muscle pains, and body sweats. On 11/7 as I woke up for work I woke up with a really bad headache, so I decided to just call into work again. I went back to sleep and I began to experience chills and fever, but not once did I feel sick it was more like I was just having weird symptoms. On 11/8 I woke up and I was still dealing with my same symptoms, but I was managing to move around okay. It was about 5:30pm that night and my voice just left. I could barely get a word out clear enough or loud enough to be understood. Thats when I googled and read up on my symptoms and they were all listed under a severe reaction to the shot. On 11/9 I went to the ER and they told me I had the flu as well as pneumonia which I never had before. And last year after receiving the shot it caused me to be sick as well
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Influenza, Malaise
Clinical narrative: Prior to receiving the shot on 11/5 and the days leading up to I was healthy and feeling perfectly fine. Around 1:00 I began to notice a funny painful feeling in my left arm, so I walked over to one of my pharmacist to be informed my arm was swollen. That same day as I laid down for bed my body felt off.  However, on 11/6 I woke up for work but I could not make my body get up because it felt really week. Once I was able to get up I began to walk towards the bathroom and I became really dizzy so I immediately laid down and called into to work. During that same day I began experience muscle pains, and body sweats. On 11/7 as I woke up for work I woke up with a really bad headache, so I decided to just call into work again. I went back to sleep and I began to experience chills and fever, but not once did I feel sick it was more like I was just having weird symptoms. On 11/8 I woke up and I was still dealing with my same symptoms, but I was managing to move around okay. It was about 5:30pm that night and my voice just left. I could barely get a word out clear enough or loud enough to be understood. Thats when I googled and read up on my symptoms and they were all listed under a severe reaction to the shot. On 11/9 I went to the ER and they told me I had the flu as well as pneumonia which I never had before. And last year after receiving the shot it caused me to be sick as well
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Pneumonia, Pyrexia
Clinical narrative: Prior to receiving the shot on 11/5 and the days leading up to I was healthy and feeling perfectly fine. Around 1:00 I began to notice a funny painful feeling in my left arm, so I walked over to one of my pharmacist to be informed my arm was swollen. That same day as I laid down for bed my body felt off.  However, on 11/6 I woke up for work but I could not make my body get up because it felt really week. Once I was able to get up I began to walk towards the bathroom and I became really dizzy so I immediately laid down and called into to work. During that same day I began experience muscle pains, and body sweats. On 11/7 as I woke up for work I woke up with a really bad headache, so I decided to just call into work again. I went back to sleep and I began to experience chills and fever, but not once did I feel sick it was more like I was just having weird symptoms. On 11/8 I woke up and I was still dealing with my same symptoms, but I was managing to move around okay. It was about 5:30pm that night and my voice just left. I could barely get a word out clear enough or loud enough to be understood. Thats when I googled and read up on my symptoms and they were all listed under a severe reaction to the shot. On 11/9 I went to the ER and they told me I had the flu as well as pneumonia which I never had before. And last year after receiving the shot it caused me to be sick as well
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Speech disorder
Clinical narrative: Prior to receiving the shot on 11/5 and the days leading up to I was healthy and feeling perfectly fine. Around 1:00 I began to notice a funny painful feeling in my left arm, so I walked over to one of my pharmacist to be informed my arm was swollen. That same day as I laid down for bed my body felt off.  However, on 11/6 I woke up for work but I could not make my body get up because it felt really week. Once I was able to get up I began to walk towards the bathroom and I became really dizzy so I immediately laid down and called into to work. During that same day I began experience muscle pains, and body sweats. On 11/7 as I woke up for work I woke up with a really bad headache, so I decided to just call into work again. I went back to sleep and I began to experience chills and fever, but not once did I feel sick it was more like I was just having weird symptoms. On 11/8 I woke up and I was still dealing with my same symptoms, but I was managing to move around okay. It was about 5:30pm that night and my voice just left. I could barely get a word out clear enough or loud enough to be understood. Thats when I googled and read up on my symptoms and they were all listed under a severe reaction to the shot. On 11/9 I went to the ER and they told me I had the flu as well as pneumonia which I never had before. And last year after receiving the shot it caused me to be sick as well
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea
Clinical narrative: Patient reports onset of diarrhea on 11/6/2019.  She had 4 loose stools.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Speech disorder, Urticaria
Clinical narrative: Within 20 minutes of vaccination, I began wheezing and having difficulty speaking/breathing. I took a Benadryl and albuterol. Within 2 hours of taking those medications, I had hives, a severe headache and numbness in the arm I received the vaccination in.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Wheezing
Clinical narrative: Within 20 minutes of vaccination, I began wheezing and having difficulty speaking/breathing. I took a Benadryl and albuterol. Within 2 hours of taking those medications, I had hives, a severe headache and numbness in the arm I received the vaccination in.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Laboratory test, Tinnitus
Clinical narrative: Tinnitus.  Ongoing, currently unresolved.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Vaccination site pain, X-ray limb normal
Clinical narrative: persistent pain at vaccination location, nearly 1 month post vaccination. Pain is now more of a stiffness quality
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: patient in due to having a swollen arm from the vaccines given on 11/5/19, pt mother stated she noticed redness yesterday and it was more red and swollen yesterday as well, visual exam done pt left arm is warm to touch, hard with redness and raised, pt states it does not hurt. Nurse and I reassured mother it is normal localized reaction from mostly the DTAP vaccine and to continue with warm compress and to give child Tylenol/ibuprofen if he starts to complain of discomfort. Measured the redness of patient arm it is 10 cm in width  and 17cm in length informed pt to take patient to pediatrician if it spreads or discoloration appears.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Nurse states she did not mix both vials of the adjuvant suspension component and the lyophilized gE antigen component.  Adjuvant Suspension Component was given only. Nurse states she realized she had not mixed them after administering the adjuvant only. Nurse contacted GSK and reported her error and informed this writer and PCP of patient. GSK states patient should wait 4 weeks before coming in for the correct immunization dose. PCP updated patient.