chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness around injection site about 3 inches long and 1.5 inches wide; hot injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (received 1st dose on an unknown date).   On 18th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was complaining about redness around injection site about 3 inches long and 1.5 inches wide and injection site was hot to the touch. The reporter stated that the patient took Bendryl which seemed to minimally help. The patient stated that she forgot but this happened during the first shot but went away after the first 1 -2 days. This case has been linked with case US2019GSK118068, reported by the same reporter.
Patient reported right arm deltoid swelling, tenderness, redness, and heat at site of injection on 11/8/17 at 0840.
Very sore arm at injection site. Approximately 16 hours later developed 101 fever, severe body aches. Bed ridden most of day. Temp fluctuated between 101 and 100.  Took Ibuprophen. Temp droped to 98 but jumped back to101 when it wore off. Next day, Thursday 02/25, temp fluctuated between 99 and 100.  Body aches not as bad. Slept most of day.  Today, Friday 02/26,temp 97,  no aches but very tired.
He say he needs oxygen; Flu-like symptoms; Restless; Nausea; Chills; he is very angry; Body ache; sleeps for couple of hour; This is a spontaneous report from a contactable consumer or other non hcp.  A 39-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 13Jul2021 (at the age of 39-years-old) as a single dose for covid-19 immunisation. Medical history included tobacco user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Thursday (15Jul2021) afternoon he got the side effects from it, they were like the flu symptoms and reporter stated that the patient was very angry, he was just restless. The patient he had a long sleep. It was like on and off, he sleeps for couple of hours and he had some little bit of nausea today (17Jul2021). The patient did not go to a doctor except MD urgent care because he had sick and got Antibiotic. The patient had chills and body ache. The patient was taking Tylenol or Advil one or two tablets (not sure). The patient stated that he needs oxygen. The reporter wanted him to get to an urgent care doctor and he was resisting. The reporter was asking what are they going to do and she wanted to find out what else she can do or what else he can do. The patient underwent lab tests and procedures which included body height: 5 feet 6 inches or 5 feet 7 inches on 5 feet 6 inches or 5 feet 7 inches, no I am not sure, physical examination: unknown results on. Therapeutic measures were taken as a result of he says he needs oxygen (hypoxia), flu-like symptoms, restless, nausea, chills, he is very angry, body ache, sleeps for couple of hours. The outcome of the events was hypoxia, nausea, chills, anger, pain, Somnolence was unknown flu-like symptoms, restless, was not recovered.   Information about the Lot/batch number has been requested.
Arm I still red; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities (Verbatim: Arm I still red). The outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingles vaccine.     It was unknown if the company considered the erythema of extremities to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient had his or her first shingles shot exactly 7 days ago and his or her arm was still red. The patient asked that anyone did know why. The follow-up could not be possible as no contact details were available.
Severe chills, fever, headache, body aches, severe fatigue lasting 24 hours, gradually diminishing over next 24 hours, finally disappearing after 3 days.
Patient received vaccine waited the 15 minutes. As he was leaving became dizzy, nausea, severe headache. Clinic staff escorted him to the ER for evaluation.
Patient contracted COVID-19 while traveling, but not experiencing any symptom; Patient contracted COVID-19 while traveling, but not experiencing any symptom; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "Patient contracted COVID-19 while traveling, but not experiencing any symptom". Consumer male in 40s, weight and height unknown. Consumer has been vaccinated with Comirnaty and received booster. Patient contracted COVID-19 while traveling, but not experiencing any symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
experienced a striking decrease of my diabetes since my shots; This is a spontaneous report received from a contactable physician (reporting for herself) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an un-specified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that have you noticed decreases in blood sugar levels after Covid shots. Patient have experienced a striking decrease of her diabetes since her shots. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
On Aug 9th had crying and bloody stool noted by parent.  Brought to emergency department, diagnosed with ileocolic intussusception. Reduced with air enema.  8/21/07 Received vax record from provider which confirms RO dose & lost # as reported.  10/16/07 Received hospital medical records which reveal patient experienced irritability & bloody stool x 1 day.  Admitted 8/8-8/9/2007. FINAL DX: Ileocolic intussusception, enema reduced.  Records faxed to CDC.
Received DT on 09/12/2005.  DT had expiration date of 09/03/2005.
This spontaneous report as received from a 55 year old female patient who was also a registered nurse refers to herself. The patient had no allergies. On 04-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). On 05-AUG-2014 the patient experienced the injection site reaction. The injection site was red, approximately 8 cm wide, with a hard lump. The patient visited physician, but no treatment was given. Moreover approximately on 12-AUG-2014 (reported as a week after the ZOSTAVAX was administrated) the patient experienced hair loss. The patient recovered from the injection site was red, approximately 8 cm wide, with a hard lump. The outcome of hair loss was reported as not recovered. The relatedness between all events and ZOSTAVAX was not specified. Additional information is not expected as there was no consent for contact.
11jan90 pt vax hepta B. pt devel. vomiting, h/a, chills, fever, fatigue, and diarrhea. sx persisted for 2 weeks during which time he was incapacitated for several days.  seen by doctor and treated for sx. pt recovered.
11/21/21 - 11/30/21 Visible facial swelling on bridge of nose, forehead, eyes and chin. Very sore face, hot to the touch and flushed. Swelling most intense around areas treated with HA dermal filler. 12/1/21 - present (01/12/22) _ symptoms not resolved. Emergence of many small painful sores on fingers and hands. Sores persistent for weeks and ooze clear fluid. Symptoms are novel and not related to a pre-existing condition.
Post herpetic neuralgia; alleviate the pain; Nerve damage; Shingles; Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia), pain (Verbatim: alleviate the pain), nerve damage (Verbatim: Nerve damage), shingles (Verbatim: Shingles) and product supply issue (Verbatim: Inappropriate schedule of vaccine).The outcome of the post herpetic neuralgia, pain and shingles were not reported and the outcome of the nerve damage was not resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the post herpetic neuralgia, pain, nerve damage and shingles to be related to Shingrix.     It was unknown if the company considered the post herpetic neuralgia, pain, nerve damage and shingles to be related to Shingrix.   Additional Information: The age at vaccination was not applicable for this report.  The age group was not reported but it was selected as adult as per vaccine indication. The patient inquired about the inability for him to obtain the second vaccine of Shingrix in the allotted time frame secondary to lack of availability in his area.  The six month window of time had come and gone.  He was provided with the CDC guidance statement that he did not have to re-start the series but felt that was not appropriate guidance when it comes to the efficacy of the series.  He was on a waiting list but the longer time went by, he was losing interest and was probably not going to get the second vaccine. The patient was unhappy with the CDC guidance after the 6 month window and felt that there was a schedule of time it should be adhered to.  The patient provided limited information and declined to provide demographics.  Unable to obtain the physician's name and phone number secondary to call flow.   Follow-up information received on 27-Sep-2023. The reporter wanted to know if you had Post Herpetic Neuralgia (PCN) if he should still get the Shingrix shot. The reporter wanted to know would it help protect from getting Shingles again. The reporter wanted to know would it help alleviate the pain and current damage to the nerves on the one side of the head from the PCN. Summary of changes: product details, event details and narrative details were updated.
Patient received 2nd dose of Moderna covid 19 vaccine on 4/2/21. Patient did not advise staff that she had received a prior moderna vaccine from a different site and also a prior Pfizer vaccine for a total of 4 covid 19 vaccines in the last 26  days.
10:10 am - 15 minutes post vaccine, patient felt dizzy and light headed with tingling at the back of her neck. BP 128/84, P 78, R 14. No headache, no chest pain, no s/s of anaphylaxis.   10:40  am - Patient recovered,  symptoms resolved.
Swollen ulcerated tongue, bleeding out of tongue. After applying pressure and 24 hours, tongue stopped bleeding. Swelling ended after 48 hours. Nausea, 2/8 in morning, 2/9 in morning Headache, 2/9 in morning Crawling skin on chest, 2/10 afternoon
Several afib episodes in afternoon but heart did correct itself (meaning done lasted long enough to go to hospital, mostly were feeling like heart was hiccuping); early on 2nd evening after shot soreness from arm which had been slightly achy and not persistent/constant had become constant and severe. Pain radiated across lower neck to other shoulder and then had severe achy pain on both sides.  Pain was so severe that became nauseated and then had become clammy. Was unsure if it was actually a heart attack due to severity of symptoms.  Felt extremely sick. Took 2 Tylenol and tried to rest for evening. Felt better in am.
Female patient on 05/18/2005 was vaccinated with a fourth dose of hepatitis B virus vaccine.  It was reported that the series was completed many years ago.  Subsequently, on 05/18/2005, the patient said she felt sick.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (strength, dose# and route of administration were not reported) for prophylaxis. Properly stored sterile diluent (MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature of 15 to 46 Fahrenheit for 2 hours and 50 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1710USA007379: US-009507513-1709USA007245: US-009507513-1710USA007381: US-009507513-1710USA007382: US-009507513-1710USA007383.
Received immunization in area, using phone no issues, then fell in chair, black out for 20 seconds, began to talk and felt nausea.  set onto floor then wanted to set up to vomit. did not vomit stated to talk. held up in setting position then moved to chair. wanted water and ice pack on back of neck. missed lunch and was going to eat afterwards.
PER PARENT LEFT DELTOID SWOLLEN AFTER VACCINE GIVE ON 08/05/2008.
Vestibular signs, mild dizzyness as if sea sick, not debilitating but definately annoying going around corners started day after first vaccine then progressed for about 2 weeks then started to fade.  signs went away for 2 days after the second vaccine, then signs recurred to about same level then faded, normal approximately 5 weeks after 2nd vaccine
Presented with AMS/confusion x2 days; Covid + in ED; Admit ICU 9/15 Covid PNA; tx 9/16 zinc, singulair, merrem, steroids, eliquis,     9/17 vanc,; with High K+ and AKI with admit..not candidate for remdesivir or baricitinib; O2 initially on 6 LPM NC; transitioned to HF O2 within 24 hours; 9/20 pt intubated; 10/2 CRRT started; 10/7 Currently; pt on 1 pressor, 100% FiO2, High CO2 values and unresponsive >24 hours off sedation and paralytics; Discussing comfort measures with family. Patient has been made DNR by family members,and was pronounced dead on 10/15/2021
Information has been received from a currently 38 year old female consumer reporting on herself with no pertinent medical history or drug reactions/allergies who received all three doses of GARDASIL (route, dose and lot # not provided) "between 2008 - 2009" when she was approximately 35 years old. There was no concomitant medication. The consumer reported that a couple of months after she had the GARDASIL in 2009, she was diagnosed with Human Papilloma Virus (HPV) and was hospitalized (dates not provided). The physician did not tell she what kind of HPV. She indicated that she got the vaccine because her boyfriend at the time had HPV. She was 36 years old at the time. She stated that since then, she had to get surgeries and acid treatment for the HPV, she had "even lost nerve damage", because they had to remove so much skin. At the time of the report, the patient had not recovered from HPV, she stated "you are always considered contagious". The consumer sought unspecified medical attention. Additional information has been requested.
Extreme soreness in left arm - to the point raising arm to remove clothing was difficult, migraine, sharp lower back pain, full body chills, feverish, loss of appetite, dizziness, full body fatigue.
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #24 of 32, a 35 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 35 year old female on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. One day after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02348, WAES # 1004USA02350 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Woke up hoarse on 8/31 and a few days later began coughing and it is not getting any better. Saw Dr. 9/14/11 got x-Ray, lungs clear and was put on Antibiotics and Steroids. Nothing has helped.
Patient received vaccine on Monday Sept 23, did not feel well the next day (Sept 24). On September 27 developed headache on left side of head, sinus and teeth aching. Some visual distortion. Saw physician on October 1, 2 and 3 eye doctor on Oct 2, and had emergency visit for CT scan on Oct 3.
Around 9:00 pm. Syncopal episode. Lasted approximately 30 sec to 1:00 minute. Onset over about 5 minutes. Felt "fuzzy headed", vision got narrow. Then passed out. Leaning on counter at time talking to people. Normal day. No increased physical activity. No dehydration. Reported by people there that I was white as a sheet with weak pulses. Woke up knew everyone there taking care of me. Blood glucose 77. No confusion other than the event. OK after event.
Pt recvd vax & devel a welt in the area of inject accompanied by warmth; reaction lasted a day; pt devel the flu;
Fever (101.5 F), chills, tiredness, redness and pain at injection site.
Severe Vertigo with vomiting started 12:30PM. Tried to take Meclizine and Zofran at home but kept vomiting.  Was unable to walk due to balance issues from vertigo. Called ambulance at 5:30pm to go to ER. Phenergan was given in the ambulance. CT-Scan and MRI showed no signs of stroke. Was given valium, zofran, ativan, meclizine and prednisone for dizziness and nausea. Was diagnosed with Central Vertigo. An ultrasound on the carotid arteries was done on 5/1  and a thrombus was found in the left carotid. Started on Heparin and Coumadin. The doctors did not think that the thrombus was related to the vertigo.
Within ~3 minutes became lightheaded with cognitive impairment, followed by adverse perspiration. Nurse acknowledged pale skin tone, EMS arrived and checked vitals, all were satisfactory. Followed by an ongoing vibrating neurological sensation of the hands, (hands were stationary, but felt as if they were vibrating.) Vibration sensation carried on for 30 minutes or so, followed by regaining normality at approximately 1 hour of elapsed time from initial inoculation.
had 2 dose and still get Shingles/ suspected Vaccination failure; Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the 2 dose Shingrix vaccine and still get Shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Employee states feeling  flushed and dizzy approxiamtely 15-20 minutes after vaccination was given. Employee was provided with ice packs and instructed to sit in examination bed. After approximately 20 minutes flushing was no longer present, however still presented with dizziness.
I am experiencing what is known as Lhemeritte's Sign. It is a common MS symptom, but I have never experienced it until now. In fact, I was displaying no MS symptoms for years.
A report has been received from a Health Professional concerning multiple patients who had been receiving Nasal FLUMIST, INTRANASAL), 0.2 Millilitres, Unknown, which was given when it was out of temperature range which was off label. The FLUMIST was out of temperature range on different occasions between 02-Nov-2015 and 02-Dec-2015. FLUMIST (INTRASNASAL) started on an unknown date. FLUMIST (INTRANASAL) was continued. The outcome of the event TEMPERATURE EXCURSION and OFF LABEL is unknown. The report was considered to be non-serious.
Pt was mistakenly given this MMRV and Adult Varicella on 5/28/22.  I called Pt Pt 6/30/22 and she said she was very well and not having any problems from the shot.