chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: General malaise with headache starting about an hour after injection. Eight hours after injection muscle and joints ache and started to run a fever. Took naproxen 220 mg at 1800 hrs. Woke up next day feeling like I had the flu and running a temp. of 101F. Took Acetaminophen 500mg. 0800 hr and 1400 hr and remained in bed still running a fever. By 1700 hr fever gone and felt much better. Injection site remains painful and warm to touch at 1000 hr 8/17/18. (No signs of infection).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Almost immediate pain in area of injection. Pt states was a 10/10 for one week. Has taken ALEVE PRN. Still cannot raise left arm fully. Suspects was given too high on left arm. Limiting use, pain with use of arm. No prior history of any problems with left arm or shoulder.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Loss of consciousness, Pallor
Clinical narrative: Patient was given Tdap, HPV, Meningococall vaccines. After the vaccines where given patient was instructed to sit on the table for 5min before raising. Patient did as instructed. Once the patient stood she was instructed to stand for a few minute because her color was pale. Patient denies any light-headedness or dizziness. Patient and guardian walked to the front counter. Once the patient was standing at the front desk she told her guardian that she felt funny. Guardian started to walk the patient back to the nurses desk and the patient passed out. The guardian slide the patient down the wall calling for help so the patient would not hit her head. The nurses came over to the patient she had come to. We gave her juice and a cool rage. Patient was helped off the ground and placed in a chair. Once in the chair patient denies any dizziness or light headedness. We had the patient sit for about 30-45 minute before leaving the clinic.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Eosinophil count increased, Injection site erythema, Injection site pain, Neutrophil count increased, Pyrexia
Clinical narrative: Pt. running a temp after recent pneumococcal vaccination. CBC done and neutrophils and Eosinophils elevated. 2/23 she developed soreness, redness, and pain in her right arm at the site of the shot. She also developed a fever with highs of 103's.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Dizziness, Rash, Rash macular, Respiratory tract congestion
Clinical narrative: Approx. 15 minutes after receiving the ZOSTAVAX vaccine with congestion, sneezing and tightness in his chest. -also felt dizzy. Trunk with progressing erythemic blotching as time progress.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: Approx. 15 minutes after receiving the ZOSTAVAX vaccine with congestion, sneezing and tightness in his chest. -also felt dizzy. Trunk with progressing erythemic blotching as time progress.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, historical condition and concomitant medications were not reported. On 22-JUN-2018, the patient was vaccinated with a dose each of both VARIVAX and PROQUAD subcutaneously for prophylaxis (overdose). No known adverse effects. This is a non-valid case due to lack of patient identifier. Upon receipt of follow-up information, it was determined that this case is now valid because patient identifier was received. Follow-up information was received from a registered nurse on 13-AUG-2018. The 12 month old male patient received both the vaccines VARIVAX (lot # N019600) and PROQUAD (lot # N028444) intramuscularly using public funds at a public health clinic/hospital during the same visit. The patient was concomitantly administered HAVRIX, PREVNAR 13 and a Hib conj vaccine (unspecified carrier). No prescription drug treatment was required for the experience. The patient had no illnesses at the time of vaccination and had a birth weight of 5lb. 14oz. The patient's guardian was contacted. No medical event occurred.
Age: 20.0
Sex: F
Vaccine: HEP, HPV9, MMR
Symptoms: Anxiety, Disorientation, Dizziness, Dyspnoea, Myoclonus
Clinical narrative: This spontaneous report was received from a company representative and registered nurse and refers to a 20-year-old female patient. The patient's medical history and concomitant therapies were not reported. The patient did not have any pre-existing physician-diagnosed allergies, birth defects and medical conditions. The patient's vaccine history included vaccination with a first dose of MENACTRA intramuscular in the right deltoid, lot# reported as U59116AA on 14-JUN-2018 and a first dose of TDAP intramuscular in the right deltoid, lot# reported as 9GM3R on the same day. The patient's measles, mumps, and rubella (wistar ra 27-3) virus titer status was not known. On 12-JUL-2018, the patient received three vaccines at a private doctor's office in the following order: firstly she was vaccinated with a first dose of GARDASIL 9 injection, intramuscular in the left deltoid, lot# N035955, expiration date: 09-OCT-2020 (exact dose was not reported) for human papillomavirus infection (HPV) vaccination, then with a first dose of M-M-R II subcutaneous in the right arm, lot# N027781, expiration date: 08-AUG-2019 (albumin status and exact dose were not specified) (it was reported she needed to receive it for a job) and with a first dose of ENGERIX-B intramuscular in the left deltoid, lot# reported as GR55T (exact dose and expiration date were not reported). On the same day, after receiving GARDASIL 9, the patient experienced a reaction which was described as vasovagal syncope. The patient became nauseated and had mild myoclonic jerks. Her blood pressure (BP) was reported as 110/70 (units not provided). The patient was also reported to be disoriented and was observed in the office for 20 minutes then went home. Shortly after, she experienced dizziness, shortness of breath (SOB) and anxiety and came back to the clinic later that day at an unspecified time. She was reported to be still disoriented. Her BP was 90/58 (units not provided) and her heart rate (HR) was 77 (units not provided). She was again observed for an unspecified period of time and left that same day and was believed to be recovered on an unknown date in July 2018. It was believed that the patient had the reaction after receiving the GARDASIL 9 and then went on to receive M-M-R II and ENGERIX-B after the reaction but that could not be confirmed. There was no illness at the time of vaccination. There was no treatment given for vasovagal syncope and disorientation. The patient received prescription for ZOFRAN 4 mg as a treatment for nausea. There was no hospitalization. There was no digital data logger involved and no product quality complaint involved. The outcome of the events was reported as recovered on an unspecified date in July 2018. The relatedness between GARDASIL 9, M-M-R II, ENGERIX-B and the events was not provided.
Age: 20.0
Sex: F
Vaccine: HEP, HPV9, MMR
Symptoms: Nausea, Syncope
Clinical narrative: This spontaneous report was received from a company representative and registered nurse and refers to a 20-year-old female patient. The patient's medical history and concomitant therapies were not reported. The patient did not have any pre-existing physician-diagnosed allergies, birth defects and medical conditions. The patient's vaccine history included vaccination with a first dose of MENACTRA intramuscular in the right deltoid, lot# reported as U59116AA on 14-JUN-2018 and a first dose of TDAP intramuscular in the right deltoid, lot# reported as 9GM3R on the same day. The patient's measles, mumps, and rubella (wistar ra 27-3) virus titer status was not known. On 12-JUL-2018, the patient received three vaccines at a private doctor's office in the following order: firstly she was vaccinated with a first dose of GARDASIL 9 injection, intramuscular in the left deltoid, lot# N035955, expiration date: 09-OCT-2020 (exact dose was not reported) for human papillomavirus infection (HPV) vaccination, then with a first dose of M-M-R II subcutaneous in the right arm, lot# N027781, expiration date: 08-AUG-2019 (albumin status and exact dose were not specified) (it was reported she needed to receive it for a job) and with a first dose of ENGERIX-B intramuscular in the left deltoid, lot# reported as GR55T (exact dose and expiration date were not reported). On the same day, after receiving GARDASIL 9, the patient experienced a reaction which was described as vasovagal syncope. The patient became nauseated and had mild myoclonic jerks. Her blood pressure (BP) was reported as 110/70 (units not provided). The patient was also reported to be disoriented and was observed in the office for 20 minutes then went home. Shortly after, she experienced dizziness, shortness of breath (SOB) and anxiety and came back to the clinic later that day at an unspecified time. She was reported to be still disoriented. Her BP was 90/58 (units not provided) and her heart rate (HR) was 77 (units not provided). She was again observed for an unspecified period of time and left that same day and was believed to be recovered on an unknown date in July 2018. It was believed that the patient had the reaction after receiving the GARDASIL 9 and then went on to receive M-M-R II and ENGERIX-B after the reaction but that could not be confirmed. There was no illness at the time of vaccination. There was no treatment given for vasovagal syncope and disorientation. The patient received prescription for ZOFRAN 4 mg as a treatment for nausea. There was no hospitalization. There was no digital data logger involved and no product quality complaint involved. The outcome of the events was reported as recovered on an unspecified date in July 2018. The relatedness between GARDASIL 9, M-M-R II, ENGERIX-B and the events was not provided.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a 76 year old female patient referring herself. The patients current condition included chronic lymphocytic leukemia (also reported as diagnosed years before). Concomitant medications included immunotherapy medication (unspecified). The patient's medical history and rug reactions/allergies was not reported. On an unknown date in 2011, the patient was vaccinated with 1st dose of PNEUMOVAX 23 injection (strength, dose, route of administration, lot # and expiry date were not reported) and 2nd dose injection possibly in 2016 or 2017 to avoid pneumococcal disease. It was reported that the patient was "in remission for CLL" (chronic lymphocytic leukaemia) (unspecified when remission occurred). The patient's physician recommended her to receive another revaccination with PNEUMOVAX 23 (circumstance or information capable of leading to medication error). It was reported that the No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Syncope
Clinical narrative: After 12 hours, patient was at home and had a syncopal episode; mom reported to the on-call doctor. Patient had become queasy. Denied nausea, vomiting, diarrhea. No cardiovascular disease history.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Eye pruritus, Eye swelling, Eyelid oedema, Rhinorrhoea
Clinical narrative: At 10:00 PM started to cough, breathing became wheezy with runny nose, itchy eyes. By 10:10 PM area of both eyes and eyelids very swollen. I took over the counter BENADRYL tablets and symptoms eased but eyes remained swollen for a day and a half...took additional BENADRYL tablet to deal with this.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: At 10:00 PM started to cough, breathing became wheezy with runny nose, itchy eyes. By 10:10 PM area of both eyes and eyelids very swollen. I took over the counter BENADRYL tablets and symptoms eased but eyes remained swollen for a day and a half...took additional BENADRYL tablet to deal with this.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test, Seizure
Clinical narrative: My son received this vaccination at the clinic. We were not asked to wait after the vaccination and 7 min from the time the vaccine was given he had a seizure in the front seat of my vehicle in the parking lot of the facility.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Severe swelling of entire upper arm, difficulty moving arm, pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arrhythmia, Blindness, Blindness unilateral, Chest X-ray, Electrocardiogram
Clinical narrative: Approx 5pm on 7/27/2018 had self reported funny heart rhythm. On 8/1/2018 pt went to emergency room (traveling) where they did EKG which was normal (he thinks?) (he is getting records transferred). Pt saw Dr. on 8/16/2018 to follow-up. Per pt MD didn't find anything abnormal. Per pt he also on Tuesday night 7/31/2018 had experienced total vision loss in left eye for approximately 10 minutes.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Fever and local erythema, pain, and induration at injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous
Clinical narrative: Presented for appt on 11/16/12 and received the ZOSTAVAX vaccination. On 11/19/12 patient presented to ER with painful red rash which was diagnosed as shingles. Rash. Acyclovir 800 mg; Other, Acetaminophen/hydrocodone one tab QID.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash and red, uticaria. Sulfamethoxazole/Trimethoprim 1 tab BID.
Age: 63.0
Sex: M
Vaccine: DT, VARZOS
Symptoms: Erythema
Clinical narrative: And erythematous patch.
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Visual impairment
Clinical narrative: And visual disturbance.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm - red, swollen, hot to touch, tender to the touch 5 cm x 5 cm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site reaction, Rash, Rash papular, Skin lesion
Clinical narrative: Woke this AM with rash. Rash - large, erythematous papules on back, several lesions 2-3 large erythematous papules on thigh around injection site 1 lesion in scalp. No fever, irritability feeding changes or other signs of illness.
Age: 62.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, C-reactive protein increased, Full blood count normal, Musculoskeletal pain, Pain in extremity
Clinical narrative: Completed series of 5 injections, and HRIG. Within hours developed painful shoulder then knees, arms, legs, feet. Slight amelioration with NSAIDS.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Headache, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: Patient was seen on 08/08/2018 received 2 vaccines MENACTRA and Tdap on each deltoid. Patient had large local reaction and tenderness. Fever off and on up 103 F, headache and abdominal pain.
Age: 33.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Unevaluable event
Clinical narrative: Patient did not have any symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Client was sitting in chair during administration of vaccines. Client turned pale immediately following the 3rd vaccine. Client verbalized that everything started looking weird at 3:58pm. Client was transferred to exam table, briefly lost consciousness, less than 1 minute. Started talking, answering questions at 4:00pm. Vital signs were stable every 5 minutes x3. Client tried sitting up at 4:15pm, but felt lightheaded and laid back down, resting until 4:45pm. No difficulty breathing, no rash, no hives observed during episode. Client sipped orange juice and left the clinic ambulatory with parent at 4:54pm.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: Pt had flu like symptoms, and redness and swelling on arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red swollen injection reaction measuring 15.5 cm X 12 cm in size 72 hour after shot and still enlarging. Also warm to touch.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Extreme injection site pain lasting for 48 hours+, low grade fever, maculopapular rash on torso, arthralgia.
Age: 58.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Incorrect product formulation administered
Clinical narrative: DTaP was given instead of TDaP. TDaP should have been given due to patient's age. Health Department was contacted and instructed me to fill out VAERS form. Attempting to contact patient to inform. Patient has not yet called back.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Liver function test abnormal
Clinical narrative: Patient had abnormal liver results come back 1 day after receiving vaccine and wanted to know if this was caused by the SHINGRIX vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Extra dose administered, Sunburn
Clinical narrative: Left arm "sun burn" and general joint aches. 70yo and was not billed for PNEUMOVAX so dispensed. Now find patient did get PNEUMOVAX when turned 65. Administered 3/26/13 more than 5 years ago. Patient states on day 3 the reaction is improving. No expected treatment.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash, Rash vesicular, Urticaria, Vaccination complication
Clinical narrative: Pt had hives/rash after first SHINGRIX vaccine 8/16/18. Administered about 12pm and pt reported rash started in the evening, started on arms and abdomen, moved to groin and elbows "shingles-like" rash that waxes and wanes (gets better and then worse on its own). Pt went to urgent care and the providers determined it was likely an allergic reaction to the vaccine.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Vaccine induced Varicella, initial encounter. Rash - lesions on Arms, back and torso of body.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient was complaining of fever, headache and shivering.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Neuralgia, Rash, Rash pustular
Clinical narrative: One week after vaccine, patient complained of muscle soreness and some nerve pain at injection site that radiated up to her neck. It lasted two days then left. Nine days after vaccine, patient reports a rash with small pustules at injection site that extended sporadically down to her forearm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dysphagia, Dysphonia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: On 7/24/18, pt started having bilateral lower extremity numbness and tingling and some pain. This progressed to hand numbness and tingling, then gait instability. 8/15/18, pt developed perioral numbness and trouble swallowing. He has a change in his voice as well. Pt being treated at hospital for presumed Guillian Barre. LP pending. Starting IVIG 8/17/18.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia oral, Immunoglobulin therapy, Pain in extremity, Paraesthesia
Clinical narrative: On 7/24/18, pt started having bilateral lower extremity numbness and tingling and some pain. This progressed to hand numbness and tingling, then gait instability. 8/15/18, pt developed perioral numbness and trouble swallowing. He has a change in his voice as well. Pt being treated at hospital for presumed Guillian Barre. LP pending. Starting IVIG 8/17/18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient is experiencing redness and itching from her shoulder to elbow. It presented 2 days after the vaccine was given and started at the injection site. There was more swelling than redness for the day or two. By day 4 after administration, the swelling had decreased and redness was moving down her arm. By day 6, the swelling was all but gone, but the redness is now approaching her elbow. It has been itching all throughout the present symptoms. We advised her to start diphenhydramine 25mg every 4-6 hours as needed for itching starting on day 4. Patient reports this has helped tremendously and has maintained that therapy until day 6 (date of reporting). She will continue it until all the redness and itching stops.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site muscle pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The date of birth of patient was unknown. The age at the vaccination was not reported. The patient experienced pain at injection site. The pain was described as myalgia in the upper arm where the vaccine shot was administered. It was unknown if the reporter agreed for follow up contact.
Age: 1.42
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # N013884, expiration date on 05-DEC-2018 (anatomical location and administration route were not reported) (Or) M-M-R II lot # N001532, expiration date on 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) which was properly stored. No adverse effects were reported. The vaccines were stored at 47°Fahrenheit to 77°F (61.7°F) for 2 hours 30 minutes; and 32°F to 35°F (33F) for 6 hours 51 minutes. The  previous temperature excursion was reported as  47°F to 77°F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This case was considered Non-valid due to lack of patient identifiers. Follow-up information has been received from the reporting office manager on 07-AUG-2018. This report concerns to a 17 month old patient of an unknown gender. On 04-APR-2018, the patient was vaccinated with improperly stored M-M-R II (Incorrect product storage). This is one of several reports received from same reporter. This case is considered valid due to availability of patient identifiers.; Sender's Comments: US-009507513-1808USA007353: US-009507513-1808USA007354: US-009507513-1808USA007355: US-009507513-1808USA007351: US-009507513-1808USA007352:
Age: 14.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant via company representative and refers to a 14-year-old female patient. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions or illness at the time of vaccination. On 19-JUL-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 one intramuscular injection in the deltoid muscle of right arm, lot # R002354 and expiration date 17-DEC-2019 (indication was not reported). Concomitantly on 19-JUL-2018, the patient was vaccinated with the second dose of VAQTA (reported as Hep A) intramuscular injection in the left arm. The PNEUMOVAX 23 was given in error, because patient should have been vaccinated with GARDASIL 9. The reporter stated that the label on the vaccine bottle was not checked before given to the patient. There were no any other vaccinations within 4 weeks prior to the 19-JUL-2018. The medical assistant stated that there was no harm to the patient. There were no side effects or reactions and there was no prescription drug treatment given.
Age: 6.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The medical assistant reported that on 18-AUG-2016 and on 30-AUG-2017, patient was intramuscularly vaccinated with GARDASIL 9 (dose, lot# and expiration date were not reported). No known adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 12 month old patient of unknown gender. The patients' medical history and concurrent conditions were not reported. On 29-MAR-2018, the patient was vaccinated with an improperly stored M-M-R II lot # N001532, expiration date 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. Concomitant medications included properly stored sterile diluent. No adverse effects were reported. The vaccine was stored at 47 degree Fahrenheit to 77 degree F (61.7 degree F) for 2 hours 30 minutes and 32 degree F to 35 degree F (33F) for 6 hours 51 minutes. The previous temperature excursion was reported as 47 degree F to 77 degree F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116: US-009507513-1808USA007351: US-009507513-1808USA007352: US-009507513-1808USA007354: US-009507513-1808USA007355.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager referring to a 12 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 07-MAY-2018, the patient was vaccinated with an improperly stored M-M-R II, lot # N001532, expiration date 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis (Incorrect product storage). Concomitant medications included properly stored Sterile Diluent. No adverse effects were reported. The vaccine was stored at 47 degrees Fahrenheit to 77 degrees F (61.7 degrees F) for 2 hours 30 minutes and 32 degrees F to 35 degrees F (33F) for 6 hours 51 minutes. The  previous temperature excursion was reported as 47 degrees F to 77 degrees F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116; US-009507513-1808USA007353; US-009507513-1808USA007351; US-009507513-1808USA007352; US-009507513-1808USA007355.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-OCT-2016, the patient was treated by the same physician for herpes zoster, or shingles. The outcome of the events is unknown. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, fatigue and muscle pain. On an unknown date, the outcome of the chills, fatigue and muscle pain were recovered/resolved. It was unknown if the reporter considered the chills, fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received her 1st dose of SHINGRIX on 21st June 2018. On Sunday, 5th August 2018, she received the 2nd dose because she was at the pharmacy where they were administering it and she could not remember when she got the 1st dose. For tolerance to next dose, refer case US2018GSK148701.
Age: 81.0
Sex: U
Vaccine: VARZOS
Symptoms: Joint swelling, Mobility decreased, Peripheral swelling, Rash, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of peripheral swelling in a 81-year-old patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 2nd August 2018, the patient received SHINGRIX (intramuscular) 50 ug. On 4th August 2018, 2 days after receiving SHINGRIX, the patient experienced peripheral swelling and mobility decreased. On 5th August 2018, the patient experienced ankle swelling. In August 2018, the patient experienced erythromacular rash. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the peripheral swelling, ankle swelling, erythromacular rash and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the peripheral swelling, ankle swelling, erythromacular rash and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: On the morning of 4th August 2018, the patient's arms were swollen from her elbows down. Her hands were so severely swollen that she could not close them. She took some Benedryl and ibuprofen to try and treat the swelling. From 5th August 2018 to 6th August 2018, the swelling migrated to her legs so her feet ankles and lower legs were all swollen as well. She developed a rash of bright red spots on her legs up to her mid thigh and also had some spots on her arms. It looked like someone had put random dots with a bright red marker on her. It did not look like shingles. The patient had been to the physician and gotten a prescription for prednisone.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Extensive swelling of vaccinated limb, Headache, Induration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. The patient's past medical history included bee sting hypersensitivity (history of delayed allergic response to bee stings). On 31st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, headache, chills, induration and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache, chills, induration and erythema of extremities were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, induration and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swollen arm about the size of a softball, hard and red and about halfway down the arm between shoulder and elbow.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The event lasted a few days, and then resolved. The reporter was from the GlaxoSmithKline outbound vaccines service center. He was notified last night during an outbound sales call to the pharmacist. There was no QA to report. This case has been linked with US2018GSK148719, reported by same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX (batch number 33745 ?, expiry date 22nd November 2020 GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th August 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right ram. On 9th August 2018, the patient woke up with a chest rash. However, the latency for chest rash was reported several hours. Clarification has been raised for batch number.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin striae
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. The patient also experienced skin striae. In August 2018, the outcome of the pain in arm and skin striae were recovered/resolved. It was unknown if the reporter considered the pain in arm and skin striae to be related to SHINGRIX. Additional details were provided as follows: The physician called to report an adverse event for himself. The patient was administered SHINGRIX in the left arm 2 weeks before the reporting date. The patient stated that he experienced pain in the left arm. One day after receiving vaccination, the patient experienced striae in the left arm. Both the events lasted for approximately 1 week before going away.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX (batch number N77EY ?, expiry date 8th February 2021) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd August 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain and headache. In August 2018, the outcome of the injection site pain and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX around noon and she experienced serious pain at the injection site and headache which started at night on the day of her vaccination. The symptoms remained for 4 to 5 days and then resolved. The clarification was raised for the correct batch number, however the reply was not received.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 52-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced fever and itchy rash. On an unknown date, the outcome of the fever and itchy rash were unknown.  It was unknown if the reporter considered the fever and itchy rash to be related to SHINGRIX.  Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The patient had red circle in axillae and white pimple like bumps that were itchy.