chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial solicited report received from a consumer (online market research respondent) in the study on 04 December 2015. The subject (gender and age were not reported) experienced an adverse event on an unspecified date, after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. During a prompted discussion the subject experienced an adverse reaction "last year" after the subject received the vaccination. And so the subject did not receive the same vaccine this year. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
According to mother, this 13 year old was vaccinated at school and, within minutes, developed significant swelling in her fingers and hand. Her hand was also apparently discolored (purplish color). Her palms were sweaty and her hand also turned white (washed out color in her hand) and had a cold sensation going up her left arm (same arm as vaccine site). She was taken into the emergency room because she couldn't move her left hand. At some point she was also taken to her pediatrician. The vaccine was administered as part of the Flu campaign in schools and the Flu staff was there but was not made aware of any reactions to any vaccines on the day of the clinic.  The Flu staff were notified on November 7, 2018 by the child's pediatrician. The Flu staff contacted mom on 11/8/18 and mom said that the child is okay now.
Pt became dizzy about 15" after injection. assited to lie horizontal on table. B/P 78/46 P-45. Didn't lose consciousness. O2 sats remained 95-100%. Pt says she does this with shots and sat in chair "over-thinking" the shot. B/P remained low although pulse then increased to 113. Seen by physician who recommended evaluation in ED
I received alarm on baby's diary because he is doing the study, but reaction was on NON-IP thigh, right side, located where my PI injected the MMR vaccine, the Varicella Zoster vaccine was injected lower on the thigh area, mom reported mild irritibility to 3, moderate pain to 5 and severe swelling to 15, mom gave Tylenol that night, the next morning when I assessed the situation, mom sent photo to clinic, I reported to my  PI, Dr. , my monitor and submitted Adverse Event to the study on NON-IP reaction form in system.
SHORTNESS OF BREATH; SWEATS; COUGH; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included copd.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced shortness of breath. On 14-MAR-2021, the subject experienced sweats. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 14-MAR-2021, was recovering from sweats, and fatigue, and had not recovered from shortness of breath, cough, and headache. This report was non-serious.
Low grade fever; fatigue; dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 17:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 11:00, the patient experienced low grade fever, fatigue and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, fatigue and dizziness was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 3 month old patient who was vaccinated with the first dose of Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. Intussusception was considered to be immediately life-threatening and an other important medical event. The outcome was not reported. Additional information has been requested. 4/6/07 Received medical records from both hospitals today which reveal: Hospital #1 ER - seen 3/10/07 for blood in stool night before & that AM.  Also vomited that AM.  Was seen by PCP on 3/9 & thought to be possible allergy, tx w/benadryl.  After second bloody stool, went to ER.  Dx w/acute GI bleed.  Tx w/IVF & transferred to higher level of care.   Hospital #2 Admission 3/10/07-3/13/07.  Received into PICU & surg consult obtained.  Exam revealed patient to be lethargic & mildly dehydrated despite prior IVFs.  Abdomen was soft, nondistended w/+BS but also with a palpable mass along the left side of the abdomen, LLQ.  Rectal exam revealed mucosal mass almost protruding from rectum.  Air contrast enema x2 failed to reduce. Patient taken to OR for exp lap, reduction of  right colon-ileocecal IS w/difficulty due to edematous & ischemic cecum & appendectomy.  Patient progressed well & was able to tolerate oral diet prior to d/c on 3/13/07. FINAL DX: Ileocecal intussusception, surgically reduced.
redness and swelling around injection site; redness and swelling around injection site; redness and swelling around injection site; Initial information received on 19-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves Infant male patient of unknown age who experienced redness and swelling around injection site, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, following the vaccination the patient experienced vaccination site inflammation with symptoms (vaccination site erythema and vaccination site swelling).  (Other relevant tests included no lab data.)  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
Grey bivalent given upon charting realized that orange should have been given. Provider and family notified.
Patients arm started to swell up on 09/12/2018 evening. Ice packs and Ibuprofen were given to help reduce swelling. However swelling got worse on 09/13/2018 and was very warm to the touch. Patient complained of itchiness and 3/4 of the circumference of the arm was red and swollen. Spot was also very hard to the touch. Patient was prescribed cephalexin suspension 250mg/5ml 10ml TID for 10 days and Orapred ODT 15mg 1 tab BID for 5 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid as treatment drug from 28Apr2023 to 03May2023.  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-202300183755 same patient, different drug and different event;
This case was reported by a physician via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain and fatigue. On an unknown date, the outcome of the pain and fatigue were recovered/resolved. It was unknown if the reporter considered the pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician did not have lot number or expiration date, as it was administered at another facility. The patient received her dose of SHINGRIX with her husband. This case was linked with US2018096041, reported by the same reporter for the patient's husband.
she hurt her back after getting the first dose of the covid vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The reporter stated that patient hurt her back after getting the first dose of the covid vaccine on an unspecified date and patient has not had any side effects even after her second dose. The outcome of the event was unknown.  Information on lot number/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL8982), on 12Mar2021 as dose 2, single (Lot number: EN6108), in right arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Sulfer drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Jul2022) Negative, notes: negative For seven day; (Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No any Seriousness criteria (results in death, Life threatening, prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect). Anti-viral product, brand was Paxlovid, started on 04Jul2022 and stopped on 08Jul2022 for treatment of COVID-19. Other medication in 2 weeks was famotidine, Claritin. The patient was take other medications/products within 2 weeks of starting COVID-19 treatment. She was previously received a COVID-19 Vaccine. She was positive and day 5 tested negative for seven days, now testing positive again. Device Date was reported as, 17Jul2022.  No follow-up attempts are possible. No further information is expected.
PT REPORTED AND SHOWED REDNESS, SWELLING, AND PAIN AT SITE.
Information has been received from the mother of a consumer concerning her 8 weeks old infant son who on 08-JAN-2010, was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). Concomitant therapy included Hib conj vaccine (manufacturer unknown), PENTACEL (unspecified) and TYLENOL. The consumer stated that her son had an adverse event after receiving ROTATEQ. "Immediately after" he was fine at 11AM on 08-JAN-2010. The infant felt asleep and was still fine. At 9 PM the consumer reported that they gave him on dose of TYLENOL. He was not responding and did not bubble or coo and he did not take eye contact with him or interact. The consumer called her physician about the TYLENOL. On the 6th day (on 14-JAN-2010), he started eye contact again. The consumer stated that her son was fully resolved after three weeks (on approximately 29-JAN-2010). The consumer stated that at the fourth month vaccine series, he did not had the TYLENOL and had no symptoms. It was unknown if the patient sought medical attention. The patient did not receive any treatment for the event. At the time of the report the patient had recovered. Additional information has been requested.
Fatigue; muscle soreness; headache; fuzzy headiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 16:15 (Lot number: EP6955) at the age of 25 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D; 5 HTP [OXITRIPTAN]. Past drug history included: Ciprofloxacin for Known allergies: Ciprofloxacin, notes: Known allergies: Ciprofloxacin. Vaccination history included: Bnt162b2 (Dose number: 1, Batch/lot number: EP6955, Anatomical Location: Arm Left), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "muscle soreness"; HEADACHE (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "headache"; FEELING ABNORMAL (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "fuzzy headiness". Therapeutic measures were not taken as a result of fatigue, myalgia, headache, feeling abnormal.  Follow up (20Apr2021): This is a follow-up spontaneous report received in response to the mail trail regarding the confirmation below mention Query the response included:  Query: The Pfizer Drug safety unit recently received the attached report submitted by via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events.  Please also help to confirm the primary reporter of the report (the patient of others) and provided relevant information for the reporter.  This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  Response: Patient   confirm became aware of this event the evening of 14Apr2021. the patient of is my son.   No follow-up attempts are possible. No further information is expected.
After the 1st my entire face went numb, felt hot and tingly.  After the second shot - two days later I woke up in the middle of the night and could not see. It felt like I was looking through a white washed window. All of my limbs (arms and legs  - left and right) went numb and tingly. Had trouble feeling them. After that it progressed to vison problems, vertigo, I lost my ability to read, balance issues, jumpy vision, problems with vestibular system, extreme nausea, extremes fatigue.
This spontaneous report was received from healthcare student referring to an unspecified female patient of unknown age, who on an unknown date, was vaccinated with an unspecified vaccine that contained albumin. The healthcare student reported that the patient had an allergic reaction to an unspecified vaccine that contained albumin. The healthcare student did not knew the name of the vaccine, however there was no information that identified the albumin containing vaccine as M-M-R II, or when the patient might had been administered the vaccine that contained albumin. Additional information has been requested.
Systemic: Exhaustion / Lethargy-Mild, Systemic: 20% decrease (shrinkage) of male genitalia-Severe
pt recv vax 5OCT98 & exp reappearance of wheezing on 6OCT98;pt exp one further episode of wheezing on 9OCT98;tx w/med;
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Alcoholic (1 drink/month). Concurrent medical conditions included Migraine (worsening) since 2014, Hypothyroidism since 2016 and Bipolar disorder since 2006. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), TRAZODONE and ACETAMINOPHEN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 20-Nov-2020 and the estimated date of delivery was 25-Aug-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2020, Pregnancy test: positive (Positive) Positive. On 15-Jan-2021, Ultrasound foetal: abnormal (abnormal) fetal tachycardia. On 27-Jan-2021, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Estimated conception date of patient was on 02 Dec 2020. No of fetus was found to be one.   Treatment information was not provided.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-JAN-2016 the patient was vaccinated with an improperly stored dose of VAQTA 10Pk 50U/1ml (lot # L017757, expiration date 08-APR-2018, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 240 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received on a pt who was vaccinated on 11/13/00, post vaccination the pt experienced redness, warmth, baseball size area and difficulty raising arm.
Received vaccine at 1030, My arm instantly began to hurt. Pain radiating to my neck. I had the same painful feeling that I had with the first vaccine dose, Unable to lay down on that arm and unable to push myself up. I would say pain with weakness. My chills, body aches and exhaustion began much sooner this time. Vaccine at 1030 symptoms began by 4pm and lasted over 24 hours. I slept for most of the next day and had a fever to 100.9 at 9pm nearly 36 hours post injection. It's almost 48 hours since I received the vaccine, I am back to work today but not 100% for sure. Taking Motrin helps. Dose #2 was worse then #1. Just a reminder I did have covid 18 in April of 2020.
Vasovagal syncope. Patient fell to floor and hit R orbial area and had two lacerations that needed stitches.
Patient was given her 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose.  Patient has been notified of the vaccine administration error.