chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: PATIENT REPORTED CLASSIC SYMPTOMS OF BRUSITIS - UNABLE TO LIFT LEFT ARM & SHOULDER ABOVE HEAD FOR ABOUT 5-7 DAYS AFTER IMMUNIZATION. HAS BETTER RANGE OF  MOVEMENT NOW BUT STILL SORE AT SHOULDER
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: The day after vaccination, patient developed arm soreness at injection site, headache, nausea, diarrhea, myalgias, chills, and fatigue.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea
Clinical narrative: The day after vaccination, patient developed arm soreness at injection site, headache, nausea, diarrhea, myalgias, chills, and fatigue.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Within 12 hours developed tiredness, muscle and joint pain.  No fever or nausea.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: High fever 103, Shaking/tremors/Muscle aches Lasted through the night, then disappeared with Tylenol
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient was given immunization in right arm.  Over the next 48 hours she experienced increasing pain in the injection site radiating down the arm.  The pain is worse with movement.  Patient seen in office on 10/9/20 for pain.  Decreased ROM.  Patient unable to raise arm over head.  Pain 1/10 at rest and 10/10 with movement.  Dr. diagnosed as possible frozen arm continue OTC pain medication will reevaluate on 10/12/20 may need physical therapy.  On 10/12/20 patient reported the arm was starting to feel better ROM coming back doesn't think she'll need PT.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Urticaria
Clinical narrative: patient explained that after the she received her shot, the following day she had a large welt and red area the size of a baseball
Sex: M
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Patient's arm swelled immediately after injection to the size of approximately a golf ball.  Patient reported swelling has gone down but still pain at the injection site.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: vomiting x1, finger swelling per Mom which resolved with 5 ml of benadryl
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 year old patient received GARDASIL 9 in error; This spontaneous report as received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 07-OCT-2020 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe (1 dose, lot # S023475, expiration date 26-MAR-2022; route was not reported) for prophylaxis (product administered to patient of inappropriate age) in error. Device was not available for evaluation (obtain was reported as false). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: experienced syncope following administration of GARDASIL 9; This spontaneous report was received from a physician via Company representative and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 02-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular injection (dose, anatomical location, lot # and expiration date were not reported) for human papillomavirus (HPV) prevention.  On the same day, after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient was advised to wait for 15 minutes, before leaving the clinic, but she decided to leave immediately. She experienced syncope when she got in her car to drive away, and went back inside the clinic. She was examined by the physician. It was unknown if any laboratory diagnostics or studies were performed. The patient recovered quickly on the same day without any treatment, and was able to go home without further event.  The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was determined to be medically significant.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash pustular
Clinical narrative: blisters on both arms, both legs, and trunk of body; pustules and blisters on both arms, both legs, and trunk of body; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3F3FP, expiry date 30th April 2022) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 5 days after receiving Shingrix, the patient experienced blister, pustular rash and rash. On an unknown date, the outcome of the blister, pustular rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the blister, pustular rash and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix vaccine in the left arm. The pharmacist reported that 5 days after receiving the vaccine the patient had a rash, pustules and blisters on both arms, both legs, and trunk of the body and this was still ongoing till the time of reporting. The reporter did not consent to follow up. The patient did not give consent to follow up with health care provider. This is 1 of the 5 link cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201575:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020201578:same reporter US-GLAXOSMITHKLINE-US2020AMR202100:same reporter
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Overdose, Pain in extremity
Clinical narrative: pain in his arm; the patient received 0.7 mL dose; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 79 years old male patient who experienced pain in his arm (pain in extremity), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On 24-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ499AA, expiry date: 30-Jun-2021) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious pain in his arm (pain in extremity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was also a case of overdose.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for pain in extremity.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Contraindication to vaccination
Clinical narrative: I gave a vaccine and according to the vaccine checklist she has a latex allergy.
Age: 61.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Chills, Cough, Fatigue, Malaise, Oropharyngeal pain
Clinical narrative: Fever (99 degrees F), aches, chills, coughing, fatique, malaise starting day after vaccines, sore throat
Age: 61.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (99 degrees F), aches, chills, coughing, fatique, malaise starting day after vaccines, sore throat
Age: 89.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Pt experienced arm and shoulder pain, some discomfort under the arm and into the upper breast area.  She tried treating it with Biofreeze, heating pad and Tylenol.  Then tried Aleve bid after speaking to Rph and reported marked improvement in pain and mobility.  Pt reported problems with picking up coffee pot and after Aleve was able to do so.
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt noted pain in his left shoulder worsening around Saturday which has led to difficulty sleeping and limiting his range of motion.  Pt has tried using ibuprofen with limited success.  Pt notes that vaccine seemed to have been given higher in arm than usual.  He did note the typical arm soreness for the first 2 days after injection but then the left arm worsened and continues to linger today (day 6)
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Malaise, Nausea
Clinical narrative: Fever, moderate chills, Severe  nausea, giddiness, vomitings X 2, diarrhea X 2, Moderate fatigue and malaise.  Had to leave work before noon to rest.  Self-treated with appropriate supportive measures
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, moderate chills, Severe  nausea, giddiness, vomitings X 2, diarrhea X 2, Moderate fatigue and malaise.  Had to leave work before noon to rest.  Self-treated with appropriate supportive measures
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Death
Clinical narrative: Death
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Friend of patient cam to inform us on her behalf that she was in the hospital with Guillain-Barre Syndrome
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: Vision disturbance
Age: 57.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: The patient called  the office 10/13/20 at 8:37am to report that she had hives and was concerned it was related to the flu vaccine she received 10/12/20. The patient stated the area around the injection site looked normal, there was only a small red spot where the injection was given. She did however have hives all over her body and reported they were very pruritic. The patient had been taking Benadryl since the symptoms began and felt the hives were improving.  The patient was advised to continue Benadryl every 4-6 hours and to call if she is not improving.
Age: 57.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site erythema, Urticaria
Clinical narrative: The patient called  the office 10/13/20 at 8:37am to report that she had hives and was concerned it was related to the flu vaccine she received 10/12/20. The patient stated the area around the injection site looked normal, there was only a small red spot where the injection was given. She did however have hives all over her body and reported they were very pruritic. The patient had been taking Benadryl since the symptoms began and felt the hives were improving.  The patient was advised to continue Benadryl every 4-6 hours and to call if she is not improving.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Patient received PPSV 23 at her visit on 10/12/2020 at 10:45am, by dinner time that day the injection site was itchy and sore with rash on inferior upper arm. The rash then continued to spread to back, abdomen and chest. Was seen in office on 10/14/2020 for evaluation.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Pt sts that evening after administration she noted a large red area around injection site. She put ice on it, no pain associated with it. Redness went away in couple of days, bruising formed at base of redness area.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Nausea, Pyrexia
Clinical narrative: I have selected the first flu vaccine, but did not get information about the specific type other than iiv4. Felt hot at night and had a 99.4 fever, but in the middle of the night, woke feeling nauseous and had a fever of 102.4. Tylenol brought it down to 100.6, but after four hours it was back to 102.4. He has a fine appetite and mental state.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Palpitations
Clinical narrative: Prior to flu vaccine administration, pt will take 80mg of DepoMedrol. This year she did not. Pt started to get flushed and heart palpitations approx. 1 hr after administration of flu vaccine. Pt was given 80mg of DepoMedrol, 25mg Bendaryl, and Pepcid. At 0900 she was starting to feel better, heart palpitation resolved, flushed face improving. At 1130 pt had completed resolved symptoms of reaction.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Paraesthesia
Clinical narrative: Client given dose of flu vaccine and client told nurse she was anxious about getting the flu vaccine.  Injection given and client felt fine. Around 20 minutes later ,nurse was notified that client was laying on the floor of an office.  Nurse went to client,she said she felt dizzy, sweaty and her left arm was tingling.  Denied SOB, no wheezing, no hives, no rash.  Client said she gets anxious, she said she did not faint but laid down when she felt dizzy.  She refused to have her BP taken.  Nurse sat her up and had her stand with no further dizziness.
Sex: U
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling abnormal, Lymph node pain, Pain, Productive cough
Clinical narrative: Sore gland and down hill from there; Breathing / has been awful; Buildup of phlegm has been awful; Feeling absolutely horrible after the flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. In 2020, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain, difficulty breathing, phlegm and feeling bad. On an unknown date, the outcome of the pain, difficulty breathing, phlegm and feeling bad were unknown.   It was unknown if the reporter considered the pain, difficulty breathing, phlegm and feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient will not going to get the flu vaccine again.  It never fails, the patient feel so bad for about 5 or 6 days afterward, and that couldn't be right, the patient had gotten it because breathing was somewhat compromised. However after the patient received the flu vaccine again this year breathing and buildup of phlegm has been awful.  The patient felt great the day of getting it and next day, it started with a sore gland, and down hill from there.  For tolerance in other shot of Flu vaccine refer case US2020AMR199564.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199564:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: little tempeture; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had little temperature and Headache.  The reporter asked how long these affect would last.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient received Shingrix and experienced sore arm. The reporter did not consent to follow up. The reporter declined to provide any HCP information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202284:wife's case
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: pain; persistent pain that interfered with daily activities; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and activities of daily living impaired. On an unknown date, the outcome of the pain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient was vaccinated with 3 vaccines on the same arm by pharmacist of which one of the vaccines was Shingrix.  The patient returned to the pharmacy later complaining of persistent pain that interfered with daily activities.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Incomplete course of vaccination
Clinical narrative: Anaphylaxed to her first dose / allergic reaction; Vaccine was given 3/20/2020 / 6 month window / has already passed; This case was reported by a physician and described the occurrence of anaphylactic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the anaphylactic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for 1st dose of vaccine. The age at vaccination was not applicable for 2nd dose of vaccine. The patient was anaphylaxed to her first dose of Shingrix.  The reporter planned to do allergy testing to the vaccine and then give the vaccine in an incremental challenge. The reporter inquired about the non irritating concentration of the vaccine. The reporter asked since the 6 month window for getting the 2nd vaccine has already passed whether there was need to get 2 more vaccinations. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: achy body; fever; This case was reported by a consumer via call center representative and described the occurrence of general body pain in an unspecified patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were unknown.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Shingrix had an achy body and fever within twenty four hours. The reporter did not consent to follow up. The reporter declined to provide any additional information for this case.  The reporter abruptly hung up. This case linked with US2020202277, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202277:Same reporter
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: got a flu shot I almost died.; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received flu shot and experinced almost died.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Injection site became red; Received a dose of Flulaval on 10/1/2020 subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 1st October 2020, the patient received FluLaval Tetra 2020-2021 season (subcutaneous) .5 ml. On 1st October 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. HCP was reporting her own experience with Flulaval.  The patient received a dose of Flulaval Quadrivalent 2020-2021 season on 1st October 2020 subcutaneously instead of the indicated intramuscular route which led to intramuscular formulation administered by other route.  The reporter stated that the injection site became red on 1st October 2020 and this continued. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles appears 1 month later the second dose of Shingrix / suspected vaccination failure; shingles appears; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7X743, expiry date 22nd May 2021) for prophylaxis.   On 20th December 2018, the patient received the 1st dose of Shingrix. On 25th February 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and 1 month after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was resolved with sequelae.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The shingles appeared 1 month later the second dose of Shingrix to a patient.  This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200020:same reporter
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of redness of legs in a adult female patient who received FLUARIX QUADRIVALENT 2019-2020 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2019-2020 season. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2019-2020 season, the patient experienced redness of legs. On an unknown date, the outcome of the redness of legs was recovered/resolved. It was unknown if the reporter considered the redness of legs to be related to FLUARIX QUADRIVALENT 2019-2020 season. Additional details were reported as follows: The age at vaccination was not reported. Last year, the patient developed erythema bilaterally in both legs after a dose of FLAURIX which resolved after 14 days. The reporter consented to follow up. Sender's Comments:  US-GLAXOSMITHKLINE-US2020202326: Same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Life support
Clinical narrative: had the flu vaccine 2 hours later in hospital 5 hours later life support; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 hrs after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hospitalization (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter's friend granddaughter had the flu vaccine 2 hours later in hospital 5 hours later life support for 3 weeks million dollars hospital bill and at the time of reporting had other problems.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Myelitis transverse
Clinical narrative: Transverse mylitious
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Eye movement disorder, Mydriasis, Pallor, Tremor
Clinical narrative: Patient was lying on exam table when given vaccination. He sat up after receiving it and a few seconds after stated that he felt dizzy. He laid back down then a few seconds after lying down his eyes turned toward the right and the pupils dilated then he had tremors in his arms, he was not responsive but his eyes remained opened. He had tremors approximately 30-45 seconds then became responsive. His color was pale during the unresponsive period then returned to normal when he became responsive.  Treatment: Elevated feet, cold compress to back of neck, wet cloth to forehead.  Blood pressure and pulse were taken (100/60, 60 bpm). He was oriented x3. He was given juice when he sat up. His PCP was called by his mother to notify her. This nurse spoke to nurse at PCP's office and informed of event. PCP directed mom to take him to ER to follow up.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was lying on exam table when given vaccination. He sat up after receiving it and a few seconds after stated that he felt dizzy. He laid back down then a few seconds after lying down his eyes turned toward the right and the pupils dilated then he had tremors in his arms, he was not responsive but his eyes remained opened. He had tremors approximately 30-45 seconds then became responsive. His color was pale during the unresponsive period then returned to normal when he became responsive.  Treatment: Elevated feet, cold compress to back of neck, wet cloth to forehead.  Blood pressure and pulse were taken (100/60, 60 bpm). He was oriented x3. He was given juice when he sat up. His PCP was called by his mother to notify her. This nurse spoke to nurse at PCP's office and informed of event. PCP directed mom to take him to ER to follow up.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Anticoagulant therapy, Asthenia, Atrial fibrillation, Cardiomegaly, Chest X-ray abnormal
Clinical narrative: Patient was admitted to the hospital for 2 days. Admitting diagnoses were weakness, SIRS, and Sepsis without acute organ dysfunction due to unspecified organism. Final diagnosis on discharge were: Final Diagnosis: 1.)  SIRS, though no infection found, this is likely due to the flu injection 2.)  Pulmonary fibrosis, on chronic mycophenolate 3.)  Mild NIDDM, stable 4.)  Cor pulmonale secondary to his lung disease, on aggressive diuretics at home 5.)  CKD, stage 3, stable 6.)  AFIB, on rivaroxaban 7.)  History of alcoholic cirrhosis, stable
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Chronic kidney disease, Cirrhosis alcoholic, Condition aggravated, Cor pulmonale, Laboratory test
Clinical narrative: Patient was admitted to the hospital for 2 days. Admitting diagnoses were weakness, SIRS, and Sepsis without acute organ dysfunction due to unspecified organism. Final diagnosis on discharge were: Final Diagnosis: 1.)  SIRS, though no infection found, this is likely due to the flu injection 2.)  Pulmonary fibrosis, on chronic mycophenolate 3.)  Mild NIDDM, stable 4.)  Cor pulmonale secondary to his lung disease, on aggressive diuretics at home 5.)  CKD, stage 3, stable 6.)  AFIB, on rivaroxaban 7.)  History of alcoholic cirrhosis, stable
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Lung disorder, Pulmonary fibrosis, Pulmonary oedema, Pulmonary vascular disorder, Sepsis
Clinical narrative: Patient was admitted to the hospital for 2 days. Admitting diagnoses were weakness, SIRS, and Sepsis without acute organ dysfunction due to unspecified organism. Final diagnosis on discharge were: Final Diagnosis: 1.)  SIRS, though no infection found, this is likely due to the flu injection 2.)  Pulmonary fibrosis, on chronic mycophenolate 3.)  Mild NIDDM, stable 4.)  Cor pulmonale secondary to his lung disease, on aggressive diuretics at home 5.)  CKD, stage 3, stable 6.)  AFIB, on rivaroxaban 7.)  History of alcoholic cirrhosis, stable
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Systemic inflammatory response syndrome, Type 2 diabetes mellitus, Vaccination complication
Clinical narrative: Patient was admitted to the hospital for 2 days. Admitting diagnoses were weakness, SIRS, and Sepsis without acute organ dysfunction due to unspecified organism. Final diagnosis on discharge were: Final Diagnosis: 1.)  SIRS, though no infection found, this is likely due to the flu injection 2.)  Pulmonary fibrosis, on chronic mycophenolate 3.)  Mild NIDDM, stable 4.)  Cor pulmonale secondary to his lung disease, on aggressive diuretics at home 5.)  CKD, stage 3, stable 6.)  AFIB, on rivaroxaban 7.)  History of alcoholic cirrhosis, stable
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Grip strength decreased, Myalgia
Clinical narrative: Patient having muscle ache to elbow & around shoulder area for over a week.  He went to chiropractor saying it was bothering him & chiropractor stated he was out of alignment but that he had heard flu shot was causing more muscle pain.  He is also having issues gripping things very well.  It has not worsened but is not getting better very quickly per his wife.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis
Clinical narrative: Cellulitis of right arm after injection after Flu vaccine. Vaccine was given at a walk in clinic, so unsure of any of the vaccine information.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Flu shot 10/18..unsure of exact date..Rcvd flu shot  Immediately after flu shot had pain and then begin having other symptoms such as muscle spasms decreased range of motion and pain in my arm.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Ultrasound scan
Clinical narrative: Flu shot 10/18..unsure of exact date..Rcvd flu shot  Immediately after flu shot had pain and then begin having other symptoms such as muscle spasms decreased range of motion and pain in my arm.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, FLU4, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Pentacel was expired when give.  Dose expired 10/11/2020, was given on 10/14/2020.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Fall, Feeling abnormal, Gaze palsy, Loss of consciousness
Clinical narrative: Patient was given their flu vaccine. The medical assistant left the exam room to collect his lab orders. The medical assistant and the patient walked to the lab down the hall. The medical assistant attempted to draw his blood and missed. She began to dress the area and the patient stated, "I'm starting to feel fuzzy." The medical assistant stated his eyes rolled back in his head and he fell forward and she had caught him before he fell. Nurse was walking in the hall and saw and helped assist right as the patient started to have a seizure. 911 was notified and responded. Patient regained consciousness and was taken to the local ED.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Patient was given their flu vaccine. The medical assistant left the exam room to collect his lab orders. The medical assistant and the patient walked to the lab down the hall. The medical assistant attempted to draw his blood and missed. She began to dress the area and the patient stated, "I'm starting to feel fuzzy." The medical assistant stated his eyes rolled back in his head and he fell forward and she had caught him before he fell. Nurse was walking in the hall and saw and helped assist right as the patient started to have a seizure. 911 was notified and responded. Patient regained consciousness and was taken to the local ED.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: BY THE NEXT MORNING, THE INJECTION SITE WAS RED, RAISED, QUITE TENDER AND THE SIZE OF MY PALM.   THIS LASTED ABOUT A WEEK.  AS THIS ABATED, THE MUSCLE ITSELF BECAME QUITE TENDER AND MY RANGE OF MOTION AT THE SHOULDER WAS LIMITED BY PAIN AT THE EXTREMES.   IF I PERSISTED IN PUSHING IT?, THE PAIN WOULD RADIATE DOWN ALONG THE RADIAL NERVE AND INTO THE WRIST AND THUMB.  ALL OF THIS HAS PERSISTED TO THIS TIME.  THE PAIN IS SOMEWHAT RELIEVED BY NAPROXEN AND ACETAMINOPHEN AND LOCAL APPLICATION OF HEAT.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia, Pain, Pain in extremity
Clinical narrative: BY THE NEXT MORNING, THE INJECTION SITE WAS RED, RAISED, QUITE TENDER AND THE SIZE OF MY PALM.   THIS LASTED ABOUT A WEEK.  AS THIS ABATED, THE MUSCLE ITSELF BECAME QUITE TENDER AND MY RANGE OF MOTION AT THE SHOULDER WAS LIMITED BY PAIN AT THE EXTREMES.   IF I PERSISTED IN PUSHING IT?, THE PAIN WOULD RADIATE DOWN ALONG THE RADIAL NERVE AND INTO THE WRIST AND THUMB.  ALL OF THIS HAS PERSISTED TO THIS TIME.  THE PAIN IS SOMEWHAT RELIEVED BY NAPROXEN AND ACETAMINOPHEN AND LOCAL APPLICATION OF HEAT.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given to patient on Left Thigh. Vaccine had expired on 10/04/2020. Informed Provider of incident and informed patient guardian of incident and patient stayed for 20 minutes to make sure no side affects were notices. Patient did not show any symptoms while waiting in clinic so they left.
Age: 58.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: The morning after pt received her shots she woke up with a sore arm and a fever. Her arm became increasingly more swollen over the next several days with the fever persisting, going as high as 102.8 but maintaining around 101, mostly in the evening time. Today, 10/14, pt is still experiencing a red swollen arm and is having trouble lifting her arm. She went to a health clinic and was diagnosed with Cellulitis. She informed the doctor she received the shot on 10/8, the doctor instructed her to call us and report the event.
Age: 58.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: The morning after pt received her shots she woke up with a sore arm and a fever. Her arm became increasingly more swollen over the next several days with the fever persisting, going as high as 102.8 but maintaining around 101, mostly in the evening time. Today, 10/14, pt is still experiencing a red swollen arm and is having trouble lifting her arm. She went to a health clinic and was diagnosed with Cellulitis. She informed the doctor she received the shot on 10/8, the doctor instructed her to call us and report the event.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Starting the evening after vaccination patient developed redness and swelling starting about 1&1/2 inches below injection site and expanded to about 5 inches in length and width over the next day.  Patient had fever (99F) for about 24 hours but has resolved.   Redness and swelling still present but has stabilized over the last 8 hours.  Patient took 2 Benadryl the night of 10/13/2020.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: Patient received flu vaccine for the first time. While being monitored after vaccine she began to feel nauseated. She had 2 episodes of vomiting. No hives, rash or shortness of breath. Glucose fingerstick was 92. She rested in Health Center and observed for 45 minutes and felt much better. Upon follow up the next day she stated she had a slight headache the night of the vaccine that resolved. States she was feeling well with only minimal soreness at the injection site.
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Diarrhoea, Fatigue, Palpitations
Clinical narrative: Patient experienced within an hour of flu vaccination: palpitations, fatigue, and diarrhea
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: RED LEFT ARM FORM SHOULDER TO ELBOW, CAME ON AFTER LESS THAN 24 HRS TREATED WITH TYLENOL AND ICE OFFICE VISIT ON 10/14/2020 TO REVIEW NO PREVIOUS REACTIONS TO FLU VACCINE
Age: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Diarrhoea
Clinical narrative: Patient complained of Diarrhea on 10/14/2020.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Headache, Pain in extremity, Sneezing
Clinical narrative: Less than 24 hours, very, very sore arm.  Very bad headache, shivering.  Less than 48 hours later, diarrhea and sneezing.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood pressure increased, Dizziness, Dyspnoea, Headache
Clinical narrative: Within 30-60 minutes post injection, I started feeling nauseated, became pale and dizzy with a rapid heart rate, B/P elevated, shaky, weak and developed a headache.  I drove myself home leaving work at approximately 1 hour 20 minutes.  Took acetaminophen 1000mg  was able to sleep fairly well through the night.  Awoke the next morning with a headache, runny nose and minor difficulty breathing.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Nausea, Nervousness, Pallor, Rhinorrhoea
Clinical narrative: Within 30-60 minutes post injection, I started feeling nauseated, became pale and dizzy with a rapid heart rate, B/P elevated, shaky, weak and developed a headache.  I drove myself home leaving work at approximately 1 hour 20 minutes.  Took acetaminophen 1000mg  was able to sleep fairly well through the night.  Awoke the next morning with a headache, runny nose and minor difficulty breathing.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Fatigue, Headache, Impaired work ability, Neck pain
Clinical narrative: Within 1 hour of the vaccination, the soreness in my left arm was traveling to my neck and back. By evening I was having whole body aches, headache, neck pain, and fatigue. This persisted into the next day - causing me to miss work.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Within 1 hour of the vaccination, the soreness in my left arm was traveling to my neck and back. By evening I was having whole body aches, headache, neck pain, and fatigue. This persisted into the next day - causing me to miss work.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Pneumonia
Clinical narrative: pneumonia; hearing loss; vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 17-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: pneumonia, hearing loss and vision loss. The outcome of pneumonia, hearing loss and vision loss were unknown.   Upon internal review, pneumonia, hearing loss and vision loss were determined to be medically significant.
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Circulatory collapse, Confusional state, Fatigue, Headache
Clinical narrative: collapsed. He awoke confused; fatigue and feeling main in his head and joints; He awoke confused; Feeling pain in his head and joints; Feeling pain in his head and joints; collapsed. He awoke confused; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown). On an unknown date, 5 days after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant), circulatory collapse (serious criteria GSK medically significant), fatigue, confusion, headache and joint pain. On an unknown date, the outcome of the passed out, circulatory collapse, fatigue, confusion, headache and joint pain were recovered/resolved.   The reporter considered the passed out, circulatory collapse, fatigue, confusion, headache and joint pain to be related to Bexsero.  Additional details provided as follows: The age at vaccination was not reported, however the patient could be of 15 or 16 years old at a time of vaccination. The patient received Bexsero and experienced several adverse event. The patient was about 5 days post dose and symptoms lasted about 4 days. It started when he collapsed, he awoke confused, very fatigue and feeling main in his head and joints. The patient was unsure of the root cause of these symptoms because it was in late summer during the very intense football workout. However Nurse quickly concluded that the events were consequential to his first dose of Bexsero.
Sex: M
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: collapsed. He awoke confused; fatigue and feeling main in his head and joints; He awoke confused; Feeling pain in his head and joints; Feeling pain in his head and joints; collapsed. He awoke confused; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown). On an unknown date, 5 days after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant), circulatory collapse (serious criteria GSK medically significant), fatigue, confusion, headache and joint pain. On an unknown date, the outcome of the passed out, circulatory collapse, fatigue, confusion, headache and joint pain were recovered/resolved.   The reporter considered the passed out, circulatory collapse, fatigue, confusion, headache and joint pain to be related to Bexsero.  Additional details provided as follows: The age at vaccination was not reported, however the patient could be of 15 or 16 years old at a time of vaccination. The patient received Bexsero and experienced several adverse event. The patient was about 5 days post dose and symptoms lasted about 4 days. It started when he collapsed, he awoke confused, very fatigue and feeling main in his head and joints. The patient was unsure of the root cause of these symptoms because it was in late summer during the very intense football workout. However Nurse quickly concluded that the events were consequential to his first dose of Bexsero.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: had a flu shot / got the flu/ suspected vaccination failure; flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 57-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by patient him/herself on interactive digital media. The age at vaccination was not reported. The patient received flu vaccine and had flu. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.