chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizures; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In 2011, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long term-term prevention of shingles and zoster-related conditions. subsequent to inoculation, on an unknown date, the pt experienced seizures and was treated by a physician.  As a direct and proximate result of use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain, medical care and treatment. Also had significant medical and related expenses including but not limited to medical losses, and costs included care for hospitalization, physician care, monitoring treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages. At the reporting time, the pt was not recovered from seizure and it was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, seizure was considered a medically significant event.
Pain, fever, redness, swelling, itchy. Tx in ER w/ steroids. Better as of 10/25/12.
October 12, 2015, flu vaccine. On Oct 14 I became very ill, unable to get out of bed for a week. Went to ER for I.V./dehydration at this time my arm and shoulder started aching very badly. This frozen shoulder has never quit hurting.
On 1/27, awoke w/flu-like symptoms, by afternoon, L/arm swollen w/purplish discoloration from elbow to hand (lasted 6-7 hrs). Went to ER, later that evening & swellin & discoloration had subsided. Arm felt tingly through 1/29/00.
I woke up 4 days later 2/12, with both ear clogged or ear fullness. I felt out of balanced and a little light headed. I also felt like my hearing was less. Next day 2/13 I only felt ear fullness on my left ear. 2/15 I woke up feeling fine. A week later 2/19 I woke up with the injection site hurting along with my leg ear clogged again. Again I felt out of balanced and light headed. I went to see an audiologist on the third day 2/21 while my ear was still clogged. They didn't see any wax or ear infection. They did a hearing test which showed normal hearing but worse on the left ear than the right. They told me I should see an ENT. 2/22 I woke up feeling fine. 2/24 I was asymptomatic when I went to see the ENT and my hearing test was normal but when they did a videonystagmography it showed significant positional nystagmus.
titres were drawn on an unknown date, producing an IgG reading of 114. IgM antibodies were not asses due to lab oversight/ titres drawn; second VARIVAX dose recommended but not administered at patient's request/ varicella titres/ Negative titers; patient received a dose of VARIVAX on 7/1/2020. On 7/14/2020, the patient developed "less than 12 varicella-like lesions" on her skin, and developed a low grade fever.; developed a low grade fever; This spontaneous report as received from a nurse practitioner, who refers to a female patient of unknown age. The patient had no pertinent medical history, no drug reactions/allergies and she did not administer any concomitant medication. On 01-JUL-2020 the patient was received first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, subcutaneously, for vaccination (strength, dose, frequency, indication, lot # and expiry date were not reported). Other suspect therapies included sterile diluent (STERILE DILUENT) 0.5 ml (no further details provided). On 14-JUL-2020, the patient developed "less than 12 varicella-like lesions" on her skin and a low grade fever. On an unknown date, titres were drawn and results showed immunoglobulin G (IgG) was 114 (units not provided) and immunoglobulin M (IgM) antibodies were not assessed due to lab oversight. The second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was recommended, but was not administered at patient's request. No product quality complaint (PQC) involved. Varicella Zoster Virus (VZV) packet due to Program was sent per request. The outcome of the events was reported as not recovered. The action taken with varicella virus vaccine live (oka/merck) (VARIVAX) was not applicable. The causality assessment between the suspect therapy and all events was not provided.
The symptoms began to kick in 2 to 3 days after the first vaccine and include but at not limited to ? Headache/Migraine ?Double Vision ?Neck Pain ?Fever ?Chills ?Loss Of Smell ?Earache ?Tinnitus  (I've since made a recovery, but after receiving the second dose, I believe (some of) the symptoms are starting to come up again)
Swollen glands in armpit of the arm where I received the injection; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 11Mar2021 at 12:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient previously received clindamycin (MANUFACTURER UNKNOWN) on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021, the patient experienced swollen glands in armpit of the arm where she had received the injection. Injection was on Thursday and swollen gland felt on Saturday. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen glands in armpit of the arm where the patient received the injection was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sore arm and then high fever by 11:00pm. The fever continued for the next few days and on 1/10/13 at 10:00 a 3-4 inch area of redness around the injection site was noticed.  I called the ask a nurse and primary care physician and was told to take my daughter to the ER for a reaction to the Pneumovax 23 shot.  The ER doctor said she had Cellulitis and needed to take Keflex for the next 10 days.
Patient woke up at 3AM Wednesday 7/22/15 with moderate pain at injection site, hard, red 1/2 dollar size area which increased to softball size. Patient also had nausea, dizziness and felt "out of it". Felt better in afternoon, saw Dr at 3PM, was given doxycycline, redness area has softened but is increasing in size down to elbow, patient felt that it was disseminating but improving.
Woke up with chills and slight body aches. Fever started a little later. Fever fluctuated from 101-104? throughout the day. Bad headaches accompanied with the fever and more chills throughout the day. All the symptoms lasted throughout the duration of the entire day into the night and early next morning (3:00am).
No additional AE/PQC; the patient received 0.5 ml of VAQTA instead of 1 ml of VAQTA; This spontaneous report was received from a Medical Assistant referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 30-AUG-2023, the patient was vaccinated with a pediatric first dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (incorrect dose administered). No additional adverse event was provided
sick; low-grade fever; has a bad cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick, low-grade fever. On 16Mar2021, has a bad cold. Caller stated she was so confused, stated the reason she called because she was sick, states have a bad cold, has appointment for second shot tomorrow which she thinks she needs to cancel. States she got a cold two days ago. The 2nd dose will be (19Mar2021) but could not makes it tomorrow for her 2nd dose because she was experiencing low-grade fever and colds now. The clinical outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report was received from a physician and refers to two patients of unknown demographics. The physician was told about the event by other patient. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL or GARDASIL 9 (lot #, dose and route were not provided). On unknown dates, the patients died. The causes of death were not reported. The relatedness between the event and suspect vaccine was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.
Sore arm, fever, body aches and chills, sore lymph nodes in armpit of shot arm
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 29-month-old male patient who experienced seizure. At 29 months of age, the patient received a dose on 29-Jun-2010 along with a second dose of VAQTA (Merck) and a dose of TRIPACEL (Aventis-Pasteur) on 29-Jun-2010. On 29-Jun-2010, at 3:00 PM, the patient experienced a seizure. The patient was taken to the emergency room, where (unspecified) blood work was performed (no results available). No treatment was reported. The patient was discharged to home. The outcome was not reported. No additional information was available at the time of this report.
BROKE OUT IN FULL BODY BLISTERS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced broke out in full body blisters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out in full body blisters was not reported. This report was non-serious. This case, from the same reporter is linked to 20210858509.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is considered non serious.
Information has been received from a physician concerning a 7 year old female patient who on 30-JAN-2008 was vaccinated with her second dose of VARIVAX (Merck) (Lot# 658586/1272U) by SQ route. On 01-FEB-2008 the patient developed a small area of red around the site of vaccination. Significantly increased in size through the day to 5x3 1/2 cm area of induration and warmth increased. The patient started on KEFLEX and recovered on 03-FEB-2008. The physician considered the patient's experiences to be Other Important Medical Events. No further information is available.
First dose of pfizer on 1/6/21. Second dose of pfizer on 1/21/21 Second dose was 15 days after first dose, instead of the recommended 21 days No adverse reaction was noted in patient after administration No adverse reaction has been reported by the patient since administration
Mom RTC 6 days after vaccination stating child started having whole body rash 3 hours after vaccination with itching. She gave child ibuprofen & BENADRYL. Child was seen by APN at clinic & diagnosed with breakthrough varicella per APN's notes, with multiple red papulovesicular lesions - some with scabs on cheeks, arms & legs and mild on trunk & abdomen.
INFECTION VIA VACCINEE; COUGH; A spontaneous report has been received from the regulatory authority. The report concerns a female patient (age 8 years, height 128 cm).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) (batch number 2019) once/single administration, via nasal route, during 2019.     On 23-Oct-2019, the patient experienced cough (preferred term: Cough). On an unknown date, the patient experienced infection via vaccinee (preferred term: Infection via vaccinee).     The patient recovered with sequelae from the event of cough after 3 weeks on 15-Nov-2019. The outcome of the event of infection via vaccinee was unknown.     The events were considered serious (disability and important medical event) by reporter.     ; Sender's Comments: Cough and infection via vaccine are not listed in the company core data sheet for Q/LAIV (Fluenz Tetra). Due to limited information on the exact start date of drug, exact onset date of infection via vaccine, concurrent diseases, concomitant medication, relevant medical history, risk factors, etiologic and diagnostic workup, it is not possible to make conclusive assessment of causal relationship of events with suspect drug.
Headache, Chills, fever, R arm Red & warm to the touch x 2day.  11/4/08 date of injection.
8 hours after receiving the shot at 5 pm, shivering and chills began.  Then total fatigue.  I bundled up and dragged myself to bed where I shivered until 11 pm.  I was extremely thirsty and sleeping in occasional 5 minute intervals.  After 11 pm, the chills were gone but not fatigue or thirst and I slept in 10 minute intervals.  I had no treatment.  It is morning and my only symptom is exhaustion.
pt recvd 1st dose of Hep B vax on 15MAY92 & 48 hrs later pt tried to give blood & was told that was HBsAg pos; prior to pts 2nd vax testing revealed HBsAg neg;
pt recvd flu vax; pt states inject was given directly into ax nerve; pt exp instant severe pain that has persisted over 8 wks; atrophy of the posterior deltoid & impaired function & persistent pain in the lt deltoid & trapezius; poss GBS;
Hives on the upper arm close to the injection site. Warm to the touch and itchy. I sent a picture to my dermatologist and she told me that similar reactions were reported to Moderna and that it would go away after 24 hours. The tenderness lasted for 5 days. I did not take any medicine for it. On the 6th day the tenderness went away.
Flu shot on 10/24/12. Noticed on 10/25/12 when removed band-aid. Quarter size redness, warm to touch, slightly swollen. Took BENADRYL Thurs night 10/25 and arm was fine on AM of 10/26.
This case was reported by a consumer via call center representative and described the occurrence of autistic behavior in a male patient who received HAVRIX for prophylaxis. Previously administered products included Hepatitis A vaccine (received on 31st October 2012) and Hepatitis A vaccine (booster dose received on 24th July 2013). On 22nd August 2016, the patient received HAVRIX. On 22nd August 2016, less than a day after receiving HAVRIX, the patient experienced autistic behavior (serious criteria GSK medically significant), behavior abnormal, generalized rash and fever. On an unknown date, the patient experienced hyperacusis and asocial behavior. On an unknown date, the outcome of the autistic behavior, behavior abnormal, hyperacusis and asocial behavior were not recovered/not resolved and the outcome of the generalized rash and fever were recovered/resolved. It was unknown if the reporter considered the autistic behavior, behavior abnormal, hyperacusis, generalized rash, asocial behavior and fever to be related to HAVRIX. Additional details were provided as follows: The reporter (mother of the patient) was calling on behalf of her son (patient). The age at vaccination was not reported. The reporter stated that on the same day when the patient received the vaccine, the mother of the patient noticed some behavioral changes in the patient (stated that the patient would not look at her or her husband) and that same night he also had a high fever and a rash all over his body. The reporter stated that he was usually a very compassionate person but that he all of a sudden he was not (she observed on the same day). The reporter stated that they were so concerned that they took him back to the doctor the next day, and the doctor did not think his symptoms (behavioral) had anything to do with the vaccine. The reporter stated that at the time of reporting the patient was not better and that he basically exhibits autistic behaviors, as he continues to suffer socially. They were taking him to evaluate his behaviors. The reporter also stated that the patient did not like noise, at the time of reporting. The reporter mentioned that the patient received this vaccine after being informed by her doctor's office that he needed the vaccine but it was determined that he had already received another Hepatitis A vaccine (different manufacturer, she believed it was Merck) and the booster as well and wondered if this could be the reason why he was having problems. The mother of the patient was informed that GSK did not have any information on this inquiry and that also could not find any information in the PI (product information) that lists similar side effects. The reporter did not state if the patient received a booster dose of HAVRIX. Lab Comments: On an unknown date, the patient was took to evaluate his behavior.
Patient is a 28-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. Patient denies having adverse reaction with first dose of Pfizer. Patient has no known allergies. Patient given 15-minute observation time with EMTs. At 1:53 pm, the patient received her second dose of Pfizer (lot number EW0187, expires on 08/2021) on right deltoid. At 2:22 pm, patient reports ?5/10? numbness of tongue and throat. Patient denies shortness of breath. Patient requesting IM Benadryl. EMT responded by taking patient's vitals while lead RN drew up IM Benadryl. At 2:24 pm: BP 145/93, SPO2 99%, HR 86. Patient was placed in anti-gravity chair and given water. Patient states she has ?a little? trouble swallowing. At 2:29 pm, RN gave patient 50 mg/1mL of IM Benadryl in left deltoid. At 2:33 pm: BP 160/109, SPO2 98%, HR 75. Patient denies SOB. Patient states numbness in throat and tongue is now a ?3/10?. At 2:38 pm: BP 159/105, SPO2 99%, HR 73. Patient describes numbness as a ?2/10? and her mouth feels ?almost back to normal?. At 2:44 pm: BP 164/98, SPO2 99%, HR 70. Patient states she is ?feeling fine? and denies symptoms of high blood pressure, such as dizziness and seeing spots. At 2:50 pm: BP 170/94, SPO2 99%, HR 83. Patient continues to deny symptoms of high blood pressure. At 2:57 pm, patient states her numbness is ?1/10?. Patient denies additional symptoms of adverse reaction. Patient states she would like to leave facility. Lead RN provided patient with education related to when to seek medical attention, such as seeing spots and feeling faint. RN advised the patient to stay at facility to continue to monitor blood pressure. At 3:04 pm: BP 159/106, SPO2 97%, HR 75. Patient states she will follow up with PCP about reaction and elevated blood pressure readings. Patient states her mother will drive her home. At 3:09: BP 144/90. Patient stood up from anti-gravity chair, denies dizziness and lightheadedness. Patient walked with steady, balanced gait to parking lot.
Rash and severe itching at injection site approximately 7 days after the injection.  After about 48 hours the itching is subsiding but rash redness is still there.
Due to my history of past transient autoimmune incidents and low semi quant spike protein AB levels I received my booster shot 5 months  after my second shot. However, I received the Moderna after getting Pfizer for doses 1 and 2. Reaction was normal for first 3 days (fatigue, sore arm) then those symptoms disappeared and may forearms felt swollen with pressure and hand s and face numbness and tingling. Hands alternate from cold to warm and clammy. Feet are  cold.  Pins and needles come and go throughout body. BP elevated . Tomorrow is day 6 since receiving the shot
Severe H/A, metallic taste, BP 252/104, HR 104, Her BP returned to normal in a very short time.
Minor pregnant at the time of vaccine administration. Estimated delivery date 06/29/2023.
had pains in my hands(hands are swollen),in my knee,in my arm,in my shoulder and in the joints of my arm/joint pain in hands/ joint pain in knee/pain in elbow/joint pain in feet/joint pain in shoulder; hands are swollen/Hand swelling; This is a spontaneous report from a contactable consumer (patient himself). An 87-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 at 14:00 (Batch/Lot Number: EN6198) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Sep2020 to an unknown date, joint pains from Sep2020 to an unknown date. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) included the shingles vaccine on 12Feb2021 with no after effects. The patient stated when I had the COVID, had some joint pains and so forth; it somewhat subsided over the month. After I got my first Pfizer shot, (on an unspecified date in Mar2021) I had pains in my hands (hands are swollen), in my knee, in my arm, in my shoulder and in the joints of my arm. He had previously had COVID 19 infection on Sep2020. When he had COVID 19 infection, he had pain in his joints, which has subsided over the months. Since getting the shot he has had pain in his joints, especially his hands and his hands are swollen. He is asking is that a standard side effect, he notices the pain in the elbow and shoulder when he moves. The feet and knee are not as bad as the hands. He is scheduled 31Mar2021 but that is another thing he wants to ask if he should get the second dose. He is unsure when after the shot his joint pain started but it is all persisting. Upon additional information received on 26Mar2021, he reported since he had his shot, he started experiencing joint pains especially on his hands and on his right arm which is still going on until today. He is concerned that he might have a permanent joint pain and wants to know if he should get his 2nd shot. The outcome of all the events was not recovered, at the time of this report.  No follow-up attempts are possible. No further information is expected.
Developed lump and rash at injection site 2 weeks and 3 days post injection.  Discovered during sleep cycle due to itching sensation.  Lump and rash still evident.  Please be advised I have bilateral lymphedema.
Client received a Tdap, IPV, MMRV, MCV4, and HPV9.  Immediately receiving the HPV9 the client drew his hands up toward his face staring with no response to stimuli for approximately 10 to 15 seconds. Then he responded saying, "what just happened?"  He was alert and drank some cold water.  After he gained his composure he was assisted by the nurse to the waiting room for observation.  After approximately 20 minutes he was accompanied by his Mother to his car.  Instructions were given for them to take the elevator down walking close to Mother, and if he began to feel faint to sit or lay down until the feeling passed.