chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a male who on 05-NOV-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) and did not experience any symptoms following this dose. The patient was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) on 16-APR-2007. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and ibuprofen (MOTRIN). The physician reported that the patient came in to the office on 16-MAY-2007 with a fever, headache, and sore throat. There were also 4 lesions on the patient's left forearm with an itch. The physician believed it was breakthrough chicken pox. The onset of the adverse events was reported as unknown. No further information was provided. No laboratory or diagnostic tests were provided. No laboratory or diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested.
A report has been received from a Physician concerning a 7 year old, female subject, who hs been receiving nasal FLUMIST. FLUMIST started on an unknown date. The reporter said that within 2 minutes after giving FLUMIST the child had running nose and sneezing which started on 13-SEP-2013. The patient recovered from the event of running nose and sneezing 2 minutes after FLUMIST on an unspecified date. The report was considered to be non-serious by the company physician.
About one week after the first inoculation, I had back pain similar to the pain I had 25 years ago.  At the suggestion of my doctor I saw a chiropractor.  I received acupuncture which helped some what.  About one week after the second inoculation the back pain became the same as one month previously including for the first time pain in my neck, right hip and right leg.  I do not have arthritis.  I have an appointment on March 29 to see my doctor who hopefully will provide advice on how to treat this pain.
PATIENT APPROACHED PHARMACY WITH A RASH ON RIGHT ARM, APPROXIMATELY 1.5 INCHES IN WIDTH. AND APPROXIMATELY 2 INCHES IN LENGTH (LIKE A BAND ON THE ARM). RXN WAS RED AND SLIGHTLY INFLAMMED. PATIENT SAID SHE FELT PAIN LAST NIGHT BUT DID NOT NOTICE A RASH UNTIL THIS MORNING. MD WAS IMMEDIATELY NOTIFIED. MD TO CALL PATIENT AND PROVIDE MEDICAL DIRECTION/ADVICE.
Patient presented with 3cmx3cm soft, mildly reddened swelling around injection site; he was very fussy and area appeared to be tender. Given acetaminophen and applied warm compresses in clinic.
pt recvd vax; on 12apr94 pt had a clonic tonic sz; to hosp via ambulance;
11-6-13 10 am grand daug noticed red area on (L) arm. Pt c/o burning sensation to area. 9 - 10 pm at bath time area very irritated and burning sensation. 11-7-13 2 am pt awakened felt clammy and warm. States she took her temp. orally and it was 103! She drank some water and returned to bed. At 815 while getting dress noted area remains very irritated and sensitive to touch. Burning continues and feels as if getting worse.
Presented 48  hrs after vaccination at office with complaint of red swollen ankle with stiffness for several hours. Rash also present on ankles. Occurred that evening along with swelling and tingling of the lips; which resolved and symptoms now subsided. MD advised BENADRYL that night. T/C client day- states improvement.
This case was reported by a physician via sales rep and described the occurrence of chills in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, nausea and vomiting. On an unknown date, the outcome of the chills, nausea and vomiting were recovered/resolved. It was unknown if the reporter considered the chills, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: GSK case number US2018GSK072329 is a duplicate of US2018GSK072330. Case US2018GSK072329 will be deleted and all future correspondence will be submitted to US2018GSK072330 which stand as case of record for this patient. Within 12 hours of vaccination, the patient had chills, nausea and vomiting which resolved by 24 hours. The call came in as part of Medical Science Liaison on demand. The physician stated that he would prefer to submit the information by himself for HIPPA reasons and would do so if he received a link to the portal. Thus no other patient data was given and the report might be a duplicate of a report that would be put in by the doctor himself. However, no more duplicate case was identified. The reporter did not agree upon follow up from GlaxoSmithKline.
Dose 1 Apr2021 + Dose 2 Apr2021; Onset of acute Tachycardia after second dose of Pfizer vaccine; hypertensive; diagnosed with "Sinus Tachycardia".; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on Apr2021 (at the age of 62 years), (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration, administered in Arm Right on Apr2021 (at the age of 62 years), (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation in hospital. The patient was not pregnant at the time of vaccination. Medical history included hypertension, obesity, Mitral Valve Prolaspe from an unknown date and unknown if ongoing, Known allergies: Sulfa. Concomitant medication included atenolol, hctz and lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 08:00 the patient experienced, Onset of acute Tachycardia after second dose of Pfizer vaccine. Heart rate sustaining at 100 and over. Also, hypertensive. Acute episode of Tachycardia not responding to new medications to help (Norvasc 5mg/day, Lisinopril 40mg/day, HCTZ 25mg/day, Metoprolol ER 25mg/day had been to the local Emergency Room and diagnosed with "Sinus Tachycardia". The events resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of onset of acute tachycardia after second dose of Pfizer vaccine, diagnosed with "sinus tachycardia" as Lopressor and Metoprolol. The clinical outcome of the event Onset of acute Tachycardia after second dose of Pfizer vaccine was unknown and remaining all other events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Day after vaccine patient went to er with cp, cough, myalgias and fever, he was sent home.  (No known covid exposure) The following day sent to the er with same symptoms and bedside echo normal.  the third day came back to the er and labs were done with an elevated troponin to 2.7  increased to 12.  Still currently monitoring.
At 7:40 pm on 04/27 I received my second Pfizer COVID19 shot. I felt okay for the rest of the night and went to bed around 2am that night. The next day, I woke up around 10:30am and was sore until about 12pm when I began to feel completely awful. I was tired and no pain reliever helped with the muscle aches in my shoulders and back. I felt like my chest was being weighed down and it felt like a horrible chore to even breathe. About 24 hours after the shot, under my jaws began to hurt terribly and ice didn't do much to help it. I finally fell asleep on 04/28 around 2am and woke up on 04/29 without any pain.
fever of 102 degrees F; felt like he was dying; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75 years old male patient who experienced fever of 102 degrees F and felt like he was dying, while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2019 at 12:30, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ282AA, expiry date:  via unknown route in the left deltoid.  On 09-Oct-2019, the patient developed a non-serious felt like he was dying (chest pain) same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient developed a non-serious fever of 102 degrees f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient had chest pain, felt like he was dying, and went to the ER (Emergency Room) around 20:30. He has been running a fever of 102 degrees F ever since and is still at the ER.   Other relevant tests were not reported.  Final diagnosis was felt like he was dying and fever of 102 degrees F.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for both the events.
I got extremely hypothermic & my joints froze up to where I could not move or be touched. I was in extreme amounts of pain lasting for about 48 hours after the Johnson & Johnson shot was administered.
breakthrough covid case. Filling out this form as directed by pfizer occupational health.; breakthrough covid case. Filling out this form as directed by pfizer occupational health.; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Oct2021 11:00 (Lot number: FF8841) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "breakthrough covid case"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "breakthrough covid case". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 25Dec2021, outcome "not recovered" and all described as "breakthrough covid case. Filling out this form as directed by pfizer occupational health."; IMMUNISATION (non-serious) with onset 20Oct2021, outcome "unknown", described as "Dose number=3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) negative, notes: Nasal Swab; (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure. No follow-up attempts are possible. No further information is expected.
Malaise: began 3 hrs after injection  Nausea: 36hrs Fever: 50 hrs (ranging from 99 to 103.2) 103.2 was for 10 hrs. Fatigue: began 3hrs after injection (ongoing) Heartburn: 48hrs Chills: 40 hrs Difficulty breathing: 3 hrs  Injection site soreness: immediately
patient received 0.5 mcg instead of booster dose of 0.25 mcg Patient has been notified and advised to contact office if adverse reactions occur
pt recvd vax & had feb sz; onset of sz w/in 12 hrs after vax; rash 10 days later;
Case number PHEH2015US019967, is an initial spontaneous report from a consumer received on 05 Oct 2015. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX (batch number: not reported) intramuscularly on 16 Sep 2015. On 01 Oct 2015, the patient experienced flu. The patient started to recover from the event on 05 Oct 2015. Seriousness of the events was not reported. Seriousness of the events was upgraded based on information available in the source document. Causality was not reported. No consent to contact and reporter's details were not provided.
Blistering pururitic rash in left facial dermatome with isolated other hemorrhagic macules with overlying vesicles.
Received first Covid vaccine and his dementia got worse.  After the booster on January 2, 2022, his vocal cord was damaged,.....now they do not touch when he talks.  This was checked by an Ear, Eyes, Nose and Throat doctor.  Now his voice is very raspy and he is difficult to understand.  This change in his voice happened about two hours after he received the booster shot.  It is still raspy and difficult for him to talk and difficult   to understand him, even now, three months after he received the booster.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Topical Steroid Withdrawal" (unspecified if ongoing). Concomitant medication(s) included: CEFDINIR, start date: 16Jun2022, stop date: 06Jul2022; GABAPENTIN, start date: Jul2018; METFORMIN, start date: Nov2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200935085 Same patient, different drug, different event;
4/3/03 discoloration and dimpling with scarring on Rt lateral thigh observed-follow up scheduled with surgeon. Follow up on 08/05/2002: "Exact adverse event onset date is unknown.  It's unclear when parents first noticed the scar at the injection site."
I have rapid heart beat, high blood pressure, weakened heart muscle, loss of energy.   Feels like my head wants to explode.  On 2 meds now to keep blood pressure down.   metoprolol and losartan    Always ran around 100/70 to 110/70   After this second shot I went up to 198/100, 168/98 etc etc...
Delayed rash (hives) stomach, legs, back of arms, back and buttocks; Delayed rash (hives) stomach, legs, back of arms, back and buttocks; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 16:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included pcos (polycystic ovarian syndrome) and high blood pressure. The patient had known allergies to sulfa, tea tree oil and detergent. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Mar2021 at 16:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 14Apr2021 at 08:00, the patient experienced delayed rash (hives) on stomach, legs, back of arms, back and buttocks. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported event which included treatment with a round of prednisone (MANUFACTURER UNKNOWN) of 40mg. The clinical outcome of events delayed rash (hives) on stomach, legs, back of arms, back and buttocks was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
The day after the vaccination, my arm hurt so bad. I have had pain in my elbow before but it was going away. After the shot it increased significantly. It was so painful. I saw my acupuncturist for the pain. After acupuncture treatment its better.
About hour after injection had low grade temp 99.0, nausea, fatigue, red and hot localized where injection given. Pt used ice and it's improving.
pt recv vax 2JAN96 & 12hr p/vax pt exp sever abd cramps & passed out d/t pain;
Initial case received from a consumer on 14 August 2014. A female patient, age not reported, received MENINGOCOCCAL VACCINE on an unspecified date and subsequently experienced " a serious allergic reaction". According to the reporter, the patient would not be able to have a booster injection due to the reaction. Additional information, including symptoms, treatment, and outcome, were not reported. Documents held by sender: None.
Pt. reported developing a persistent cough a week after receiving the vaccine that lasted multiple weeks. The patient states that he still is experiencing a minor cough at the time of reporting the event.
Initial and follow up information has been received from a registered nurse and a physician concerning a 52 year old male (previously reported as 51 years old) with no adverse events following prior vaccinations reported. On 6/14/05 at 4pm, the patient was vaccinated intramuscularly with Pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). The patient had asthma at the time of vaccination. On 6/15/2005 in the PM, within 24 hours, the patient developed swelling and erythema of the left arm (previously reported that on 6/17/05 the patient developed an injection site reaction that included the following, redness, swelling, local heat and pain. The patient sought unspecified medical attention. On 6/20/05, the patient had recovered from the swelling and erythema of the left arm. No further information is available.
Wednesday morning at 2 am, I broke out into itching hives all over my chest, stomach and under arm pits.  I took a Claritin and applied Benadryl cream.  They were gone when I woke up that morning.  Around 3pm that afternoon,  my neck started itching.  By the time I got off of work at 5pm, my entire neck had broken out in hives and there were hives forming near both of my eyes. When I got home, my face had swelled and I was also breaking out on my arms, chest, stomach and upper thighs.  I went to the hospital where they treated me for an allergy.  I was given prednisone and Pepcid, a prescription for an EpiPen, and then told to take Benadryl and apply hydrocortisone cream which I had to purchase myself.  I took two Benadryls that night and applied the cream and the hives were gone by the morning.  Thursday, around 4 pm, my chest and stomach started itching.  I came home and took 2 Benedryls, and a cold shower to help relieve the itch.  I applied the hydrocortisone cream and took a nap.  I woke up 3 hours later, itching again, this time all over my arms, face, thighs and back.  My lips had swollen and my ears were itchy and red.  I called the urgent care number and was instructed by a doctor to come into the facility since my lips were swollen.  When I arrived, I was given a steroid (name unknown), Pepcid and Benadryl through IV.  The hives did not respond right away and in fact because to spread further after treatment.  After 2 steroid shots, they finally went away, though my lips were still  slightly swollen.   I was given a prescription for Prednisone and sent home.  Saturday morning, my arms and chest began to itch and turn red.  I applied hydrocortisone cream, took 2 Benadryls and the Prednisone as prescribed.  The itching subsided after an hour, but the redness remained the rest of the day.  As I am typing this on Sunday morning, I still have redness over my chest, stomach and arms, but no itching.
Pt. reported pain in right leg that then became pins and needles in the right leg and then she stated that the pins and needles feeling started in the right forearm.
After 3rd shot, pt complained of stiffness in elbows, pain in legs and irritability. Spoke with doctor who recommended discontinuing series.
On 04/09/2002, the pt was given Varivax and MMR. On 04/16/2002 fever of 103 deg. F. On 04/17-20/2002 rash on trunk, no blistering lesions, some noticed. On 04/19/2002 pt's grandmother got a rash on her back which was very painful. On 04/22/2002 the pt's mother got a similar rash on her face. She states that "this week both of us were on Acyclovir for these rashes as they were most likely herpes related according to our respective doctors. I wanted to report this as it seems to be possible that our rashes arose from exposure to my daughter after her chicken pox vaccine."
Pt in a chair called out to nurse saying he was going to pass out.  Pt started to roll his head back, arms & legs were stiffening.  He quickly came too stating that he had a seizure 8 yrs ago when he was in a "choke hold".  Pts A & O x4 was good, & aware of surroundings.  Lead nurse let him leave with a friend.    After pt left, nurse called pt to follow-up with his primary doctor immediately about seizure symptoms & discuss to have 2nd covid vaccine with his Dr.
Patient experienced no adverse event as described by caretakers. However, patient was given an undiluted dose of pediatric pfizer.
NEW PATIENT TO PRACTICE, RECORDS NOT COMLPLETE. PT GIVEN BOOSTRIX IN 2008, ADACEL GIVEN HERE 8/16/2010
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.