chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature decreased, Fall, Head injury, Loss of consciousness, Tremor
Clinical narrative: The shot was given to the patient around 8:30 A.M. After she was finished she waited in the room about 5 minutes and than walked to the waiting room.  She was standing up in the front about to leave but she passed out and her head hit the floor. She lost concussion and was shaking according to witnesses in the front. Doctor gave the patient .half cc of benadryl and her temperature  dropped to 94.5 ,911 was called and the ambulance arrived around 8:50 A.M.
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Pain in extremity
Clinical narrative: Arm was bruised and sore
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Muscular weakness
Clinical narrative: I felt fatigue, then overall muscle weakness.   About 2 hours later I felt very warm and then chills.  Later my abdomen became very warm and a slight reddening started at my abdomen and covered my body.  I did not feel I needed to call my doctor.  The following 3 days the fatigue and overall muscle weakness stayed with me.  I am fine now *;}
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: I felt fatigue, then overall muscle weakness.   About 2 hours later I felt very warm and then chills.  Later my abdomen became very warm and a slight reddening started at my abdomen and covered my body.  I did not feel I needed to call my doctor.  The following 3 days the fatigue and overall muscle weakness stayed with me.  I am fine now *;}
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Feeling cold, Influenza like illness, Neuralgia
Clinical narrative: PATIENT RECEIVED DOSE AT 11:11AM ON 8/31/19 BY EVENING TIME AROUND 9PM SHE STATES THAT SHE WAS VERY COLD AND GOT A BLANKET TO WARM UP. SHE HAD INVOLENTARY MOVENTS OF HER ARMS AND JERKING OF HER NECK/HEAD. SHE PROCEEDED TO GO TO SLEEP AND WOKE UP THE NEXT MORNING WITH FLU-LIKE SYMPTOMS FOR THE NEXT DAY AND IMPROVED ON DAY 2. **PATIENT ALSO REPORTED ON 1ST DOSE SHE HAD  NERVE PAIN DOWN HER ARM WITH FLU LIKE SYMPTOMS FOR 3 DAYS.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Hyperhidrosis, Laboratory test, Myalgia
Clinical narrative: High fever of 102.3, severe headache and muscle pain. Dizziness and sweats. For 48 hours
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: High fever of 102.3, severe headache and muscle pain. Dizziness and sweats. For 48 hours
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Syncope
Clinical narrative: episode of syncope
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Rash
Clinical narrative: Rashes on arms and knees. Headache, tired
Age: 18.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse effects; pregnant patient received VARIVAX; a pregnant patient received VARlVAX; This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to an 18-year-old female patient. Her pertinent medical history included asthma and obesity. The patient did not have any concomitant medications, drug reactions or allergies. On 15-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot # R034392 has been verified to be a valid lot number, expiration date 27-NOV-2020) for prophylaxis (exact dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent diluent (STERLIE DILUENT) injection (lot # has been verified to be a valid lot number, expiration date 04-AUG-2020 (formulation, strength, dose, frequency and route of administration were not reported).  On an unknown date, the patient had unspecified pregnancy test performed (result not provided). On an unspecified date in 2019, the patient became pregnant with last menstruation period (LMP) of 21-JUL-2019 and estimated due date (EDD) of 26-APR-2020. The patient was vaccinated at 3 weeks of gestation. The patient sought medical attention and visited an unspecified office. She did not receive any treatment.  At the time of the report, the pregnancy outcome was pending and the fetal outcome was unknown. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Headache, Herpes zoster, Post herpetic neuralgia, Vertigo
Clinical narrative: bilateral sensorineural sloping hearing loss; vertigo; post herpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 05-DEC-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after vaccination), the patient suffered a sharp pain in her head and was diagnosed with herpes zoster. As further result of herpes zoster, the patient suffered and was diagnosed with bilateral sensorineural sloping hearing loss, vertigo, and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt suffered severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of bilateral sensorineural sloping hearing loss was determined to be medically significant. The events were considered to be disabling.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Injection site pain, Myalgia, Nausea
Clinical narrative: Muscle aches; Felt warm; nausea; Sore Injection Site; Shivers / Chills / Severe Shivering; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on 11th March 2019, refer linked case US2019GSK045802).   On 27th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and shivers. On 28th August 2019, the patient experienced muscle pain, feeling of warmth and nausea. The patient was treated with paracetamol (Tylenol). On 29th August 2019, the outcome of the injection site pain, shivers, muscle pain, feeling of warmth and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, shivers, muscle pain, feeling of warmth and nausea to be related to Shingrix.  Additional information received were as follows: The patient was a physician who received both doses of the Shingrix vaccine. The lot number was unknown. The patient received Shingrix on left deltoid in the evening. The patient experienced sore injection site that resolved the next morning of vaccination date. The patient experienced shivers and was treated with Tylenol every 6 hours and was fine until 11:00 am. At that time, the patient began to experience chills, muscle aches, and severe shivering which lasted approximately 45 minutes.  At 7:00 pm that evening, the patient again had chills and felt warm, but he did not take his temperature.  On 28th August 2019, the patient went to bed at 9:30 pm and woke up on 29th August 2019 with all symptoms resolved.  The reporter was unable to provide any additional details and unable to locate case number for first case. The caller stated that all symptoms had resolved, however, he still had a little soreness in his left arm. The patient also mentioned that he had experienced soreness at the injection site following previous flu shots (unknown manufacturer).  The caller did not provide any additional details. This was 1 of the 3 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash papular, Urticaria
Clinical narrative: Developed 3 smaller bumps resembling hives; This case was reported by a other health professional via interactive digital media and described the occurrence of papular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received Shingrix. In August 2019, less than 3 weeks after receiving Shingrix, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown.   It was unknown if the reporter considered the papular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced 3 smaller bumps resembling hives. The patient asked could this be a side effect and is it safe to be around my pregnant daughter-in-law.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site; Pain, redness, swelling at injection site; Pain, redness, swelling at injection site; This is a spontaneous report from a contactable other healthcare professional (HCP) via company representative. A female patient of an unspecified age (65+, Unit: unknown) started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain, redness, swelling at injection site on an unspecified date after vaccination. Pain lasted 2 weeks. The outcome of events was unknown.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Nausea, Night sweats
Clinical narrative: Fever-like symptoms started in the afternoon/evening, including uneasy stomach, headache, aches and chills. Sweat profusely during the night and difficulty sleeping. Felt much better in morning and all symptoms were gone by end of day.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever-like symptoms started in the afternoon/evening, including uneasy stomach, headache, aches and chills. Sweat profusely during the night and difficulty sleeping. Felt much better in morning and all symptoms were gone by end of day.
Age: 13.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Rash
Clinical narrative: Patient was given bexero on 9/4/19 and on 9/6/19 mother called in patient broke out in rash on 9/5/19 small bumps on face, arms and legs , sore at injection site.
Age: 13.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Rash, Rash papular
Clinical narrative: Patient was given bexero on 9/4/19 and on 9/6/19 mother called in patient broke out in rash on 9/5/19 small bumps on face, arms and legs , sore at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urticaria
Clinical narrative: Mom noted hive like rash from waist to feet that started on Tuesday after school that persisted through Sunday 9/8/19.  Administered Children's Benadryl as directed.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: PT developed rash thigh, right axilla and face.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd Dose of Shingrix given when unneeded
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Fatigue (2+ days) Slight headache Slight nausea Soreness at site of injection (more than expected)
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: PT HAD 3 VACCINES AND HAD RASH ON ARMS, FACE , BACK AND NECK.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Neck pain, Pyrexia
Clinical narrative: fever, chills, neck soreness, fatigue, dizziness
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site mass
Clinical narrative: 1 week after vaccination still has "knot" at vaccination site and arm is still sore
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Burning sensation, Chills, Decreased appetite, Fatigue, Ill-defined disorder
Clinical narrative: Experienced illness and symptoms of the following:  temporary loss of appetite and redness/tenderness where the shot was given.  Experienced a high fever over 103.  Additionally, experienced fatigue, ear burning sensation, severe headache and chills.   Note:  I didn't notify my primary physician.  Too ill during that time.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Experienced illness and symptoms of the following:  temporary loss of appetite and redness/tenderness where the shot was given.  Experienced a high fever over 103.  Additionally, experienced fatigue, ear burning sensation, severe headache and chills.   Note:  I didn't notify my primary physician.  Too ill during that time.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Fatigue, Fear of falling, Feeling jittery, Gait disturbance
Clinical narrative: Immunized on 8/9/2019 (Friday).  Very fatigued over the weekend and spent most of the day in bed.  8/12/2019 c/o legs feeling shaky, unsteady gait, fear of falling, "jitteriness in the legs."  .  Symptoms progressed through the week.  Fear of falling increased especially with going down steps or walking down incline.  The 3rd week after immunization, symptoms became worse and contacted family doctor.  Physician exam on 9/3/2019 - c/o sweaty several times/day, heart beating funny but relieved with Valsalva, gait more unsteady.  Today (9/9/2019) unsteady gait continues, reflexes - ok, no foot drop, no falls, denies muscle weakness, most unsteady when going from sitting to standing position, fear of falling continues - especially with downward incline.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate abnormal, Hyperhidrosis, Muscular weakness
Clinical narrative: Immunized on 8/9/2019 (Friday).  Very fatigued over the weekend and spent most of the day in bed.  8/12/2019 c/o legs feeling shaky, unsteady gait, fear of falling, "jitteriness in the legs."  .  Symptoms progressed through the week.  Fear of falling increased especially with going down steps or walking down incline.  The 3rd week after immunization, symptoms became worse and contacted family doctor.  Physician exam on 9/3/2019 - c/o sweaty several times/day, heart beating funny but relieved with Valsalva, gait more unsteady.  Today (9/9/2019) unsteady gait continues, reflexes - ok, no foot drop, no falls, denies muscle weakness, most unsteady when going from sitting to standing position, fear of falling continues - especially with downward incline.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: April 10th I received the first dose of Shingrix vaccine. By April 21st I had a full on outbreak of shingles including severe derm pain on head and forehead. Nowhere in labeling is this reported as a side effect of this vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Difficulty breathing and wheezing developing within 5-10 minutes of receiving vaccines
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blister, Malaise, Pruritus
Clinical narrative: Patient states she started forming blisters on face and extremities and had itching 1 day after receiving vaccines. States she also did not feel well.  I instructed patient to seek medical attention to have blisters looked at.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Severe swelling spreading from deltoid to elbow.  no fever.  normal range of motion.  Reaction site resolved after 24 hours.  Parents and I have pictures
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received second dose in Varivax series that was improperly stored.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions, and concurrent conditions were not disclosed.  On 23-JUL-2019, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, frequency, anatomical injection site and route of administration were not disclosed), lot # R020650 and expiration date 18-JUL-2020, for prophylaxis. This vaccine was diluted with a properly stored sterile diluent.  It was reported that this vaccine had been on a temperature excursion that started in April 2019, and was stored at 7.7 °F during 30 minutes. It was also noted that there had been a previous temperature excursion, and the vaccine had been stored between 6 °F and 14 °F, for 188 minutes.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Effect; administered PROQUAD & VARIVAX concomitantly; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 03-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, frequency, site and route of administration, lot# and expiration date were not reported for both), concomitantly for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: fatigued; little pinkness / red; swelling of arm; arm pain; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th August 2019, the patient received the 2nd dose of Shingrix. On 29th August 2019, 1 days after receiving Shingrix, the patient experienced fatigue, erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the fatigue, erythema of extremities, swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the fatigue, erythema of extremities, swelling arm and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient was told that he/she might be contagious to people who never had measles. The patient was very fatigued a day before reporting, but seem almost normal on day of reporting, with the exception of a little pinkness and swelling of arm (It was red a day before reporting, but did not hurt patient to the point that he/she couldn't sleep on it. The reporter did not give permission to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Vaccine positive rechallenge
Clinical narrative: Inappropriate schedule of vaccine; Pain at injection site/painful; This case was reported by a consumer and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in January 2018, refer case US2019AMR159031).   On 29th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 29th August 2019, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were provided as follows: The patient had an opportunity to move to and forgot to go back for my 2nd followup vaccination, which patient finally did the day before reporting, which led to which led to lengthening of the vaccination schedule. The reaction to my second dose was much more painful than initial one, in terms of second-day pain at injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site/painful; This case was reported by a consumer and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported but could be 66 or 67 years. The patient experienced injection site pain. For tolerance after 2nd dose refer case US2019AMR159021.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site warmth, Nausea
Clinical narrative: Nauseous; Very tired; Felt like I had a bit of a fever; Feel little nervous; Very large red circle around the injection site; Injection site hot to the touch; Itchy; Arm is Painful; This case was reported by a consumer and described the occurrence of injection site erythema in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site itching, pain in arm, fever and nervous. On 28th August 2019, the patient experienced nausea and tiredness. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching, pain in arm, nausea, tiredness and nervous were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site itching, pain in arm, nausea, tiredness, fever and nervous to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with the dose of Shingrix, had very large red area around the inejction site which was still hot to touch and it was itchy. The patient's arm was painful and was very tired. The first day after vaccination, the patient was nauseous. After vaccination, the patient felt like had fever, but at the time of reporting, did not feel like have fever anymore. The patient felt little nervous. There was discrepancy in the name of suspect given in the source document and that reported in system.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Nervousness, Pain in extremity, Pyrexia
Clinical narrative: Nauseous; Very tired; Felt like I had a bit of a fever; Feel little nervous; Very large red circle around the injection site; Injection site hot to the touch; Itchy; Arm is Painful; This case was reported by a consumer and described the occurrence of injection site erythema in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site itching, pain in arm, fever and nervous. On 28th August 2019, the patient experienced nausea and tiredness. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching, pain in arm, nausea, tiredness and nervous were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site itching, pain in arm, nausea, tiredness, fever and nervous to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with the dose of Shingrix, had very large red area around the inejction site which was still hot to touch and it was itchy. The patient's arm was painful and was very tired. The first day after vaccination, the patient was nauseous. After vaccination, the patient felt like had fever, but at the time of reporting, did not feel like have fever anymore. The patient felt little nervous. There was discrepancy in the name of suspect given in the source document and that reported in system.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Product preparation issue
Clinical narrative: Arm is red; Arm is sore; Inappropriate preparation of medication; Inappropriate dose of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on 26th June 2019 refer case, US2019159135). Concomitant products included Herpes zoster (Shingrix).   On 28th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th August 2019, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 29th August 2019, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovering/resolving and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received only the adjuvant of Shingrix, as the pharmacist forgotten to reconstitute the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. After being administered, the patient's arm  was red and sore after receiving only the adjuvant. The patient did not consent to follow-up.
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Feeling very tired; Feeling achy / Pain; Headache; Fever; Numbness of my arm; Weakness throughout my body; Stomachache; nightmare; This case was reported by a consumer and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 26th August 2019 12:00, the patient received the 1st dose of Shingrix. On an unknown date, the patient received TETANUS VACCINE at an unknown dose. In August 2019, 15 hrs 33 min after receiving Shingrix and unknown after receiving TETANUS VACCINE, the patient experienced headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare. On 26th August 2019, the patient experienced tiredness and pain. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare were unknown.   It was unknown if the reporter considered the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare 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 reporter just wanted to report the horrible experience had with vaccination.  The patient's physician told to the patient that the patient would experience some swelling at the site, might be some chills.  The patient received Shingrix at about noon time and started feeling very tired and achy that evening. The patient went to sleep. On 27th August 2019 at 3:33 am, the patient woke up living the worst nightmare of life. The pain, the headache, fever, numbness of my arm, weakness throughout body and stomachache.  The patient spent two days out of work, in bed recovering with Motrin. The patient reported that its first shingles vaccination and my last. The reporter was not informed of returning for a second part of the shot and was also given a tetanus vaccination and asked could that have compounded the reactions. The reporter was just curious why the side effects were so severe. It was unknown if the reporter considered the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare to be related to tetanus vaccine.
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Impaired work ability, Nightmare, Pain, Pyrexia
Clinical narrative: Feeling very tired; Feeling achy / Pain; Headache; Fever; Numbness of my arm; Weakness throughout my body; Stomachache; nightmare; This case was reported by a consumer and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 26th August 2019 12:00, the patient received the 1st dose of Shingrix. On an unknown date, the patient received TETANUS VACCINE at an unknown dose. In August 2019, 15 hrs 33 min after receiving Shingrix and unknown after receiving TETANUS VACCINE, the patient experienced headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare. On 26th August 2019, the patient experienced tiredness and pain. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare were unknown.   It was unknown if the reporter considered the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare 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 reporter just wanted to report the horrible experience had with vaccination.  The patient's physician told to the patient that the patient would experience some swelling at the site, might be some chills.  The patient received Shingrix at about noon time and started feeling very tired and achy that evening. The patient went to sleep. On 27th August 2019 at 3:33 am, the patient woke up living the worst nightmare of life. The pain, the headache, fever, numbness of my arm, weakness throughout body and stomachache.  The patient spent two days out of work, in bed recovering with Motrin. The patient reported that its first shingles vaccination and my last. The reporter was not informed of returning for a second part of the shot and was also given a tetanus vaccination and asked could that have compounded the reactions. The reporter was just curious why the side effects were so severe. It was unknown if the reporter considered the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare to be related to tetanus vaccine.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Severe Pain; Redness (large wheel); Swelling in her right arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Bexsero .5 ml and MENACTRA. In August 2019, less than a week after receiving Bexsero, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero in right deltoid muscle and also received Menactra in her left arm at the same visit. The reporter stated that, the patient experienced severe pain, redness (large wheel), and swelling in her right arm.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore; Difficulty moving arm/difficulty lifting his arm up and down; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reportered by patient's wife. The patient received Shingrix in his left arm. Within 1.5 hours of receiving the Shingrix, the patient's arm became sore and he had difficulty lifting his arm up and down. These symptoms resolved 3 days later. The reporter would not provide any additional details.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Have an hypersensitivity reaction to a pneumococcal vaccine; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunization.  Medical history included post splenectomy.  The patient's concomitant medications were not reported. The patient had a hypersensitivity reaction to a pneumococcal vaccine on an unspecified date with outcome of unknown.    Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site nodule
Clinical narrative: Have a knot on arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for pneumonia (immunization).  The patient's medical history and concomitant medications were not reported. The patient had a knot on arm at the injection site on an unspecified date. The outcome of event was unknown.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Have a knot on arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for pneumonia (immunization).  The patient's medical history and concomitant medications were not reported. The patient had a knot on arm at the injection site on an unspecified date. The outcome of event was unknown.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: arm is red and hot from shoulder to elbow
Age: 0.75
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Alopecia, Anaemia, Aphasia, Fine motor skill dysfunction, Motor dysfunction
Clinical narrative: Seizures (non-febrile) beginning within hours of the injection. He had dozens of seizures each day for weeks. 4 years later he is still having subclinical and absence seizures daily. He lost all previously gained speech and didn't speak for 3 years. He lost gross and fine motor skills and began losing weight, losing his hair and became severely anemic.
Age: 0.75
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Petit mal epilepsy, Seizure, Weight decreased
Clinical narrative: Seizures (non-febrile) beginning within hours of the injection. He had dozens of seizures each day for weeks. 4 years later he is still having subclinical and absence seizures daily. He lost all previously gained speech and didn't speak for 3 years. He lost gross and fine motor skills and began losing weight, losing his hair and became severely anemic.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient reported a fever of 101 F and redness on arm around injection sites that took up a large space on her upper arm. These symptoms began on the day after her vaccinations.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Sore arm, red, swollen, itchy, red blotch on skin from injection towards elbow - 3" by 6" - began 4 hours after injection and lasted 5 days Low grade fever (99.4), full body aches, chills, lethargic -began 8 hours after injection and lasted 48 hours
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Pain, Pyrexia, Rash macular
Clinical narrative: Sore arm, red, swollen, itchy, red blotch on skin from injection towards elbow - 3" by 6" - began 4 hours after injection and lasted 5 days Low grade fever (99.4), full body aches, chills, lethargic -began 8 hours after injection and lasted 48 hours
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Rash, Urticaria
Clinical narrative: wide-spread rash, hives, and itching.  Swelling and feeling of warmth around injection site.  Taking diphenhydramine otc to help resolve symptoms
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Balance disorder, Conjunctivitis, Dizziness, Lymphadenopathy, Pyrexia
Clinical narrative: Fever, red bumpy rash all over body, swollen lymph nodes, dizziness, loss of balance, conjunctivitis, and possible loss of hearing.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash erythematous
Clinical narrative: Fever, red bumpy rash all over body, swollen lymph nodes, dizziness, loss of balance, conjunctivitis, and possible loss of hearing.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of 50 units was given to 13 year old patient instead of the ped/adolescent dose of 25 units.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Severe flu like symptoms with fever
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reports redened area, warm to the touch surrounding area of vaccination to left upper arm. Patient reports pain and discomfort at injection site. Denies fever started 9/6/19, the day after vaccination.
Age: 10.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Rash on the face and torso.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: patient states her arm & shoulder are still painful & is unable to lift her arm
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Skin reaction, Skin warm
Clinical narrative: Heated Red Patch that continued to expand. Arm Soreness that lasted more than a week. Extreme Fatigue that continued past a week.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received Tdap/Boostrix and MCV4/Menveo at our office on 08-20-2019 in his left deltoid. Presented to office today 08-26-19 with redness and heat to left deltoid. Area is flat, no hardness noted. Will treat with ice pack to area. Started 08-25-19. Per Dad: put ice on it 08-30-19 and it went right away.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Papule, Rash vesicular
Clinical narrative: Pt seen on 9/7 with multiple chicken like spots (papules) on torso, arms, leg
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: six months old patient received a dose of pneumovax23; no adverse effect; This spontaneous report was received from a registered nurse referring to a 6-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. No product quality(PQC) complaint was filed.; Sender's Comments:  US-009507513-1909USA002286:
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: suspected vaccination failure; flu; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in an unknown number of patients who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, unknown after receiving Fluarix Tetra, 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 Fluarix Tetra.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that in his experience patients had come down with the flu after being vaccinated with Fluarix. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and dose number were not provided. The reporter did not give permission for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The pain shoots down the arm all the way to the fingers; Disables the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In March 2019, the patient received the 2nd dose of Shingles vaccine. In April 2019, 30 days after receiving Shingles vaccine, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that about a month after receiving the vaccine began experiencing extreme pain at the injection site if raised arm above the shoulder. The patient stated that, the pain shoots down the arm all the way to the fingers and disables the arm for a period of 1 minute. The patient did some research on side effects of the shot and have found that approximately 1 in 6 people who get the shot experience a similar reaction.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Asthenia, Dizziness, Injection site warmth, Night sweats, Pain
Clinical narrative: Night injections in both arms had heat at injection site, fever, aches and pains.  Has lasted for two weeks with arms itching and overall weakness, dizzyness and night sweats.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Pruritus, Pyrexia
Clinical narrative: Night injections in both arms had heat at injection site, fever, aches and pains.  Has lasted for two weeks with arms itching and overall weakness, dizzyness and night sweats.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Injection site mass, Pyrexia
Clinical narrative: woke up after the vaccines with a fever and large and hot bump on her upper right arm. Resolved the next day
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Cold sweat, Pain in extremity, Pyrexia
Clinical narrative: patient had cold sweats, chills, low grade fever of approx 99. Her arm is sore, symptoms occurred the following day
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness, Rash
Clinical narrative: Received vaccine after rubella titer came back not immune.  Vaccine given on 8/23/19.  Developed rash and stiffness to joints on 9/6/19.  Report incident to our office 9/9/19.  Her rash and stiffness to joints have diminished from initial encounter but wanted to report incident to our employee health office .
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Parent reported 2 days after vaccination :   On the afternoon after vaccination, patient exhibited shortness of breath, dizziness and nausea.  No action was taken at the time of the symptoms.  Nausea, fever and fatigue continued for the following 2 days.  Appointment  was recommended but declined by parent (father).
Sex: M
Vaccine: HEP
Symptoms: Apnoea, Cyanosis, Electroencephalogram, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Stopped Breathing - turned Blue - started having Seizures. Transferred to a Hospital - had uncontrollable seizures and apnea for 20 days.  Was put on two anti seizure meds.
Sex: M
Vaccine: HEP
Symptoms: Respiratory arrest, Seizure, Ultrasound scan
Clinical narrative: Stopped Breathing - turned Blue - started having Seizures. Transferred to a Hospital - had uncontrollable seizures and apnea for 20 days.  Was put on two anti seizure meds.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Syncope
Clinical narrative: Syncopal episode approximately 10-15 minutes after the vaccine. Patient starting to fall. Mom grabbed her and together we had her lie down on the exam table. I elevated her legs and began taking her vitals.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient presented with a rash on her chest, neck, and face that occurred 5 days after the Shingrix shot. She went to the Dr and it was 75% resolved. She had not SOB, wheezing, etc.  She declined treatment for the rash at that time. She was given prednisone to take with the 2nd shot.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Deafness unilateral
Clinical narrative: L ear hearing loss
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Pain in extremity, Pyrexia
Clinical narrative: pt had low fever on 09/07 and gone on 09/08 AM, but left arm was red and pain. on 09/09 AM pt feel nausea and fever again, arm still pain and red.