chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker via field representative referring to a 18 year and 7 months old male patient. Information about medical history and concurrent conditions were unspecified. On 16-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot number, dose and route were unknown) (drug administered to patient of inappropriate age). No adverse experience has been reported. The reporter declined to provide patient identifiers and discussed Health Insurance Portability and Accountability Act (HIPAA). No PQC involved. Additional information has been requested.
Extreme soreness, pain in injection arm, patient complains that can't raise her arm!! No redness or swelling at injection site according to pt. via phone conversation. Patient said pain started approx. 1 hr after receiving injection and has persisted since. Pt. advised to take APAP and apply ice to site to relieve pain. Questioned pt. regarding her delay in contacting the pharmacy regarding this issue...she said she thought pain would go away.
Pt. was to have her 2nd COVID Pfizer vaccine, but instead received the COVID Pfizer Bivalent vaccine. Pt. had no reaction to the vaccine
I received a flu vaccine on 10/20/15 in my left shoulder. On 10/21/15 the left shoulder was very painful, limited mobility and lost strength. Sleepless night on 10/21/15 so went to urgent care 10/22/15.
About 1hr 45 min post vaccination, pt complained of flushing and slight tingling sensation in arms. Torso blotchiness was noted soon afterward. Patient took 50mg BENADRYL and showed improvement with 30 minutes.
I have had a low level tinnitus for approx 10 years?2/10 volume. I received my 2nd dose of the Pfizer vaccine on January 20,2021.on February 25, I woke to a LOUD screeching in my ears.  It has not returned to my original volume. It is blaring at 6-8/10 EVERY waking second since the 25th of February.
Registered nurse accidentally diluted 1 vial of  pfizer covid 19 vaccine with sterile water instead of 0.9% normal saline and administered it to the patient.
This spontaneous report as received from a physician refers to a 58 year old male patient. Current conditions of patient were immunosuppressed, diabetes, anemia, toxoplasmosis and orthostatic hypotension. The patient's medical history included cramping with statins and allergy to certain blood pressure medication (unknown date, manufacturer and drug name were unknown). On 02-DEC-2013 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included BENICAR and cinnamon. On 02-DEC-2013 the patient experienced sharp spike in blood sugar level right after receiving the vaccine, since then the blood sugar level had remained elevated. In December 2013 the patient experienced losing vision in right eye (medically significant). On an unknown date in December 2013 (reported as starting a few days after the ZOSTAVAX injection), the patient experienced headache, sleepiness, and weakness. On an unknown date in December 2013 (unspecified date), after the ZOSTAVAX injection, the patient began to feel that he was "losing vision in the right eye". He also stated that his "right eyelid became puffy and the right eye looked red. On 17-DEC-2013 (reported as about "a week ago"), the patient went to an unspecified HCP who stated it was "an infection". The patient was reported to be legally blind, and stated that his right eye is "pucked up", with bumps on the inside of the eye. In the same eye he has decreased vision, along with brightness in vision. It was also reported that the patient had a reddish tint, a "maybe pink or orange glow" in right eye. It was further reported that the patient may have been immunosuppressed at time of receiving shot since he was anaemic and diabetic. The outcome of all the events were reported to be recovering. The patient sought medical attention (reported as went to see the physician). The relationship between the ZOSTAVAX and the events were not reported. Upon internal review, the event "Blindness unilateral" was considered as medically significant. Additional information has been requested.
anaphylactic reaction to first dose of the COVID-19 Pfizer vaccine; tomato allergy has become increasingly sensitive, and developed new allergies to other foods; tomato allergy has become increasingly sensitive, and developed new allergies to other foods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tomato" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic reaction to first dose of the COVID-19 Pfizer vaccine"; FOOD ALLERGY (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "tomato allergy has become increasingly sensitive, and developed new allergies to other foods". The events "anaphylactic reaction to first dose of the covid-19 pfizer vaccine" and "tomato allergy has become increasingly sensitive, and developed new allergies to other foods" required emergency room visit.  Addition inoraamtion: Patient experienced anaphylactic reaction to first dose of the COVID-19 Pfizer vaccine. Ever since the described event, the patient's tomato allergy has become increasingly sensitive, and developed new allergies to other foods. Covid prior vaccination was unknown. Covid tested post vaccination was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Given client expired Rotavirus; had client to wait 15 min after meds was given; no problem noted. Informed Dr & supervisor will call or send letter to revaccinate.
Indurated, redness, warmth, with liquid and pus.  No fever/nausea/vomiting.  Some diarrhea reported. Drainage require for treatment to elevate pus.
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Adverse events after 2nd shot on 6/15/2021 Severe dizziness, no balance to walk  Began 6/27 to present
This spontaneous report as received from a medical assistant and a physician refers to a patient of unknown age. The patient had no pertinent medical history and no known allergies. ON 17-FEB-2014 the patient was vaccinated with a dose of ROTATEQ (dose, lot # not reported), oral. No concomitant medications. On 17-FEB-2014, patient proceeded to "vomit" the dose up along with breast milk at the office visit. No treatment was given for the event. The outcome of the event was unknown. It was unknown if the patient sought medical attention. The reporter did not provide causality assessment. Additional information has been requested.
Headaches, chills, dizziness/lightheadedness, body aches, nausea started around 0530 AM 28JULY22, and began worsening from 0830 AM to 1030 AM, and have continued to worsen (specifically headaches and dizziness/lightheadedness)
dizziness; She lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy; This is a spontaneous report from a contactable nurse. A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot Number: N6201) via an unspecified route of administration in Left arm on 14Feb2021 17:00 as single dose for COVID-19 immunization (66-year age at Vaccination). The patient medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer and experienced dizziness on 15Feb2021 6:15 am at the gym, the patient had to stop and drink water. The patient doesn't see that listed unless a side effect of severe allergic reactions. She is wondering if this is a side effect. On an unspecified date in 2021 she lifted her head and the room was spinning. It as weird. It has abided somewhat. She is a little foggy. She has a friend who is a nurse who said her fellow nurse had her first dose of the vaccine and had dizziness as well. She doesn't have that nurses information but will pass on that she should call in and report as well. Outcome of the events was not recovered.
The patient's daughter came in to report that her mother, Patient arm was red and swollen after getting the shingrix (rx 7032907, lot 394kf, exp 09/23/2022) and pneumovax 23 (rx7037906, lot t022294, exp 3/26/2022) on 1/19/21 which as administered into the left deltoid. The daughter reported that the redness and swelling was on the right side. RPH, advised to ice the area for swelling and take OTC Benadryl to reduce redness/itching for 3-5 days before seeing a primary care doctor. She was also advised to keep an eye on the area to make sure it doesnt spread up the shoulder or to the forearm. No allergy was reported on the patient's profile or patient questionnaire. Patient's daughter did not request anything from pharmacy. This event was also reported to VAERS.
Doesn't feel right.  Hot all over at upper chest and right shoulder and then allover.  No pain at injection site.
3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), COVID-19 (medically significant), outcome "unknown" and all described as "3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: reported a positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After a family gathering at the , 3 family members, all who had received the bivalent COVID vaccine, reported a positive COVID test. The two family members over the age of 50 have been prescribed Paxlovid. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201333384 same product and event, different patient;US-PFIZER INC-202201333385 same product and event, different patient;
Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; Jynneos vaccine had a temperature excursion; Affected Jynneos was administered; Case reference number US-BN-2022-002048 is a spontaneous case report initially received on 23-Aug-2022 from a nurse via Communications (reference number: USBAV22-1123) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 18-Aug-2022, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003) had a temperature excursion (explicitly coded as 'product storage error').  On 22-Aug-2022, the patient was vaccinated with the affected Jynneos vaccine (batch number: FDP00003), at dose reported as 0.1 mL, administered intradermally (explicitly coded as 'underdose', 'inappropriate route of vaccination' and 'product administration error'), for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from on 24-Aug-2022 included the local case ID.  Case is linked to cases US-BN-2022-002030, US-BN-2022-002045, US-BN-2022-002046, US-BN-2022-002047, US-BN-2022-002028 and US-BN-2022-002049 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, incorrect route of product administration, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the Jynneos vaccine, at dose reported as 0.1 mL, administered intradermally for monkeypox prophylaxis, and Jynneos vaccine had a temperature excursion prior the vaccination, which is considered as underdose, inappropriate route of vaccination, product storage error and product administration error. No associated adverse events have been reported with the reported medication error. The events of underdose, incorrect route of product administration, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose, inappropriate route of vaccination, product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
within 45 minutes of vaccine administration, patient felt very fatigued, she developed hot flashes, then would get cold, had a headache , upset stomach and dizziness. Patient took ibuprofen. Symptoms resolved within 36 hours.
2 vaccines administered. Client sat on exam table while VARIVAX given. Client laid down on (R) side while GARDASIL given. Face color pink, warm to touch. Eyes rolled back and when asked client stated he was dizzy. He remained responsive, answering questions. BP 124/85, steady pulse. When sat up was lethargic and weak, not sitting well without support. Had not eaten much. Gave apple juice. Remained weak, unsteady with VS normal. Dad helped to car 12:50 PM. Event reported to supervisor. Discussed ER, Urgent Care, call to family Dr. Mother said she would call Dr. for f/u. T.C. to Mom 2:15. Client ate lunch, feels nauseated, tired and is lying down. She called Dr. office and is waiting for return call. States client continues to be unsteady, weak. 12-6-12 T/C with Mother. R/T F/U care. Mother states con't to act "spacey and stoned", sleepy, minimal eye contact, speech slur. Mother states Dr. office has not returned call for appt. Encouraged mother to contact PMD again or take to E.R. if symptoms do not improve.
jul87 pt vax hepta B. after vax pt did not feel well. pt vax 2nd hepta B. aug87.  pt wiped out w/ nausea & fever 104 F.  14feb90 pt vax 3rd hepta B. temp 101 f> 16feb90 pt ex lack of energy. pt recovered.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that, starting on or after 30-AUG-2016, patients' were vaccinated with improperly stored VARIVAX (dose and route unknown) from lot # M000757 with expiry date of 06-JAN-2018. The vaccines were exposed to a temperature excursion of 10.4 F for a time frame of 2 hours. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Had a severe reaction; could not get up; an irregular heart beat; Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up), HEART RATE IRREGULAR (an irregular heart beat) and INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine). On 15-Sep-2021, the patient experienced VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up) and HEART RATE IRREGULAR (an irregular heart beat). At the time of the report, VACCINATION COMPLICATION (Had a severe reaction), MOBILITY DECREASED (could not get up) and HEART RATE IRREGULAR (an irregular heart beat) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Got the 2 doses of the Pfizer vaccine. Then, last Tuesday 14-Sep-2021 got a dose of the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) irregular heart beat.         No concomitant medication were reported. No treatment information was provided by the reporter.  Patient received first 2 doses of Pfizer vaccine the last one was around 4 months ago.patient does not take any medication regularly and that not aware of the patient having a previous diagnose of myocarditis or pericarditis and state the patient did not get covid-19.
Within 24 hours having memory loss, foggy headedness, forgetful, now we realize she had at least two seizures that week. 10/12/19 was taken my ambulance after grand mal seizure; no history of seizures prior. Dr. put on anti-seizure meds 3/13/20 had another convulsive seizure 11/19/20 severe seizure episode, status epilepticus, put on ventilator, 3 days in ICU, IV anti-seizure drugs
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 15:30 (Lot number: FC3184) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "fertility issues" (unspecified if ongoing), notes: Fertility issues prior to the vaccine which causes me to not ovulate and rarely bleeding. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product=COVID 19, lot number=FC3184, lot unknown=False, dose number=1), administration date: 30Aug2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "spotting".The following information was reported: VULVOVAGINAL DISCOMFORT (non-serious) with onset 24Sep2021, outcome "unknown", described as "a lot of pressure in both of my ovaries but especially on my left side"; VAGINAL HAEMORRHAGE (non-serious) with onset 24Sep2021, outcome "unknown", described as "spotting"; ARTHRITIS (non-serious) with onset 24Sep2021, outcome "unknown", described as "joint pain in my wrist elbow's meals"; NAUSEA (non-serious) with onset 24Sep2021, outcome "unknown", described as "a little nauseous"; HEADACHE (non-serious) with onset 24Sep2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 24Sep2021, outcome "unknown", described as "fatigue"; BREAST TENDERNESS (non-serious) with onset 24Sep2021, outcome "unknown", described as "breast tenderness as well as being able  able to fill my blood pump through my body".No follow-up attempts are possible. No further information is expected.
Patient presented to my office 11/3/22 for an appointment due to the development of hives to bilateral legs, bilateral arms, and anterior and posterior trunk.  Patient reported getting the pfizer bivalent vaccine 11/1/22 at pharmacy.  Then, that evening, developed hives to the legs which continued to spread over the next 36 hours.  Patient reported tolerating all prior doses of pfizer vaccine.  Patient prescribed steroid course and antihistamine for treatment and told to seek care in the ER if she developed more serious signs of reaction such as shortness of breath.
Information regarding Prevnar was received from a healthcare professional regarding a female patient who experienced fever of >103F. The patient received the second dose on an unspecified date. A physician reported that his daughter experienced fever of >103F after receiving her second dose of Prevnar on an unspecified date. The outcome was not reported. See related case (s): HQWYE456022MAR06 (adverse event, non-expedited) and HQWYE517624MAR06 (adverse event, non-expedited).
This spontaneous report as received from a nurse refers to a 21 year old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 06-JUL-2018, the patient was vaccinated with a fourth dose of GARDASIL 9, lot # N025428, expiration date: 19-JUN-2020, intramuscularly for prophylaxis. There was no adverse event reported.
pt recv vax 11JAN99 & 18JAN99 temp of 106, sz taken to ER by ambulance;pt was given IV valium, APAP unresponsive 45min per ER report on 20JAN99;sparse rash on abd;
This spontaneous report was received from a nurse and refers to a 4 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-OCT-2017, the patient was vaccinated with improperly stored  VAQTA lot # N017094 with expiration date on 31-AUG-2018 for prophylaxis (strength, dose and route were not reported). On an unknown date, the VAQTA was stored in temperature of 48.9 Fahrenheit degrees for 6 minutes. Previous temperature excursions were reported as 48.9 Fahrenheit degrees for 24 minutes and 47.4 Fahrenheit degrees for 15 minutes. No adverse effect was provided. Data logger was involved. No product quality complaint was reported. This is the one of several case reports received from the same reporter.; Sender's Comments: US-009507513-1710USA013033: US-009507513-1711USA004813: US-009507513-1711USA004811:
Patient was given second pediatric Pfizer vaccine and felt fine immediately after. Sibling was also administered vaccine without any issues. About 5 minutes after receiving the vaccine the patient fainted. Patient was nervous and anxious before receiving vaccine which most likely led to this presentation. Patient made a full recovery after about 20 minutes. Patient's parents also denied any issues receiving the first vaccine.