chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of VAQTA (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of VAQTA improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Was told by phone call to report positive COVID here. Booster received in Oct 2021. Tested positive for COVID Jan 19, 2022. Went to Urgent Care twice. Very sore throat, unable to speak, coughing, head congestion. X-ray clear. Symptoms lasted bad two weeks, lingering minor symptoms 4-5 weeks. Received Steroid pack first visit, Received Z-pack second visit one week later.
Came to clinic at 22:00 01/13/04.  Complained of fever and left arm swelling and redness.  Temperature 102 F.
23NOV chills, HA, general malaise seen by MD who prescribed Amoxil; had sem reaction to prev flu shot;
Very sore arm, persistent. After 2-3 after shot given. From shoulder to elbow.
Moderna on 2/4 and 3/4. Positive on 9/12
Cheeks started swelling, no sign of difficulty breathing, patient coming in-and-out of it, PROAIR used, BENADRYL given, 911 called and taken to the hospital, no other signs of anaphylaxis, EPIPEN offered and refused.
Positive test 14 days after symptom; Positive test 14 days after symptom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 16:45 as dose 1, single (Lot number: EN6205), in left arm, on 24Mar2021 at 16:15 as dose 2, single (Lot number: ER8727), in left arm and on 22Sep2021 at 16:45 as dose 3 (booster), single (Lot number: FF2588) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medication in 2weeks product=asthma steroid; "Ankylosing Spondylitis" (unspecified if ongoing); "Known allergies: Avocado" (unspecified if ongoing); "Birth control" (unspecified if ongoing); "vesovagal" (unspecified if ongoing); "Known allergies: food" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing); "known allergies: wheat" (unspecified if ongoing); "Known allergies: red dye" (unspecified if ongoing); "known allergies: black tea" (unspecified if ongoing); "known allergies: vodka" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: Sep2018, stop date: 10Apr2022; DAYSEE taken for contraception, start date: Jan2010, stop date: 14Apr2022; SUCRALFATE, start date: Dec2019; SYMBICORT taken for asthma, start date: Aug2008, stop date: 18Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Apr2022, outcome "unknown" and all described as "Positive test 14 days after symptom". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19.
An area (approximately the size of a medium orange) of itchy bumps came up on my chest several hours after the injection.  It is not painful and I did not notice it anywhere else, just the area on the upper right side of my sternum.
Breakthrough COVID infection. The day after my booster I started feeling under the weather. Left work early. The next morning I had a cough and runny nose and hard to breathe. It got worse over the weekend. Learned that everyone at work tested positive and I then tested positive for Covid. I continue to have bad headaches and fatigue and numbness in my left leg.
Pt recvd 3 doses Hep B vax 18OCT90, 6JAN91 & 14FEB91 & 8MAY91 it was determined that titer was neg; Booster dose #1 given 17MAY91 & 8JUL91 titer neg; Booster #2 given 15JUL91 & 4SEP91 titer neg; Booster #3 given 3OCT91 & 2DEC91 titer neg
Information has been received from a physician concerning a 34 year old white female patient with Hashimoto's thyroiditis, no known allergies, and a history of 1 pregnancy and 1 live birth, who on 9/18/02, was vaccinated with MMR (second generation) (lot # 638598/1305L). Concomitant therapy included 100 micrograms of levothyroxine Na (SYNTHROID), 1200 milligrams daily of calcium (unspecified) and vitamins (unspecified). The administration of the vaccine on 9/18/02 occurred 4 weeks after her LMP: 8/18/02. In approximately 9/02 a serum human chorionic gonadotropin test confirmed pregnancy. Follow up information received from a physician reports the patient had a spontaneous abortion 7 weeks from her last menstrual period (approximately 10/7/02). It was noted the patient did not have a miscarriage, stillbirth, or birth defects with her prior pregnancy.
6 days after receiving the vaccination, I started to display symptoms related to COVID.  I was tested 8 days after receiving the vaccination and was positive for COVID. The symptoms I had in order of appearance were chills, fever, body aches, fatigue, chest heaviness,  diarrhea, loss of smell, loss of taste, congestion,  sore throat,  and cough.  I never experienced headache, nausea, or a drop in oxygen levels.  Approximately 12 days after receiving the vaccination I had a raised, red, irregularly-shaped rash around the sit of the injection.  The rash was warm and firm to the touch.  It disappeared about 4 days after I first noticed it.
caller tested positive on covid a week after taking the 1st dose of vaccine; caller tested positive on covid a week after taking the 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Pfizer First Connect.   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history was and concomitant medications were not reported.  The patient was tested positive for Covid a week after taking the 1st dose of vaccine on an unspecified date. The outcome of events was unknown. Patient wanted to know if she can get the second dose.  Information on the lot/batch number has been requested.
Patient returned for second dose of Pfizer COVID 19 vaccine. Patient noted by immunizer for second dose to be underage per current EUA authorization. No reported adverse reactions. Second dose not administered due to age.
Systemic: Flushed / Sweating-Mild, Additional Details: resolved under 15 minutes. patient was given a bottle of water.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1896 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient says that 5 days after the vaccine, he developed urinary symptoms. He thinks it was related to H1N1 vaccine. His primary care provider tested his urine (normal) and prostate (normal). His primary care provider referred him to a urologist.
Hives on face on 8/28/01. Hives on the hand and bottom of her feet on 8/30/01. Mom spoke to doctor first and he told her to start pt on Benadryl. The mother had a call into doctor about the rash spreading to the pt's feet and hands and was waiting on a call back from the doctor.
5 days after vaccine had hives appear on both hands and legs with intense itching. Lasted 2 + days
Right after getting the shot, I felt dizzy, had a sore arm, and my heart was beating too fast, for about an hour. At 9:30 the next morning, I developed a fever of 100.5 and body aches. Around 2 pm, I got a headache which felt like it was because blood was hitting the veins in my head really hard- I think that's high blood pressure? My blood pressure was 126/85. I read not to take medicine because it would make the vaccine less effective, but I had to take an aspirin at 8 pm because I couldn't handle the headache any more, and ever since, I've just had a sore arm and a headache when I walk too fast (it's been two days after the shot now).
dizziness; diarrhea; vomiting; I have hard time hearing; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318) via unknown route of administration on 31Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included pressure was a little high not much high but little high. Concomitant medications were not reported. Patient stated she had her first covid vaccine shot 12 days ago and experienced dizziness, diarrhea and vomiting on 11Feb2021. Patient was asking if this was a normal side effect people has experienced when they got the covid vaccine. Patient have hard time hearing on an unknown date in 2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), on 07Apr2021 as dose 2, single (Lot number: EW0150) and on 21Oct2021 as dose 3 (booster), single (Lot number: FF2582) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Antihistamine" (unspecified if ongoing); "Anti-acid" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; NEXIUM [ESOMEPRAZOLE SODIUM] taken for gastrooesophageal reflux disease; ZYRTEK taken for antiallergic therapy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative, notes: By 13May2022 I was testing negative,; (May2022) Negative, notes: testing twice daily on Antigen tests for the next full week; (10May2022) positive, notes: on 10May2022 I tested positive and began Paxlovid that evening; (20May2022) positive, notes: On first text 20May2022, I began to test positive again for Covid. Been testing positive for Covid since 20May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Conclusion- The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine lot EN6207 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Clinical course- The patient started exhibiting Covid symptoms on 08May2022, on 10May2022  tested positive and began Paxlovid that evening. By 13May2022 the patient was testing negative, testing twice daily on Antigen tests for the next full week. The patient completed Paxlovid dose the morning 15May2022. On first text 20May2022, the patient began to test positive again for Covid. The patient receive other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications the patient received within 2 weeks of vaccination.   No follow-up attempts are needed. No further information is expected.
Sudden onset of pain in injection site, radiating to neck.  Decreased range of motion without severe pain.  Arm is extremely heavy and unable to be moved very much. Increased with movement and palpation.  Unable to work.
25 MM RAISED WHELP; PINK IN COLOR AND SLIGHTLY WARM; PATIENT DENIES DISCOMFORT OR ITCHING; ADVISED TO APPLY COOL/ICE COMPRESSES AND TYLENOL PRN
Pentacel being administered to a 5 year old/No AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5 year old patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of potential medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Lg area of bumps at injection site going down into underarm & side of back started date of injection & still present on 4-2-09
Headache started same day as dose given. Following day still had headache. Also began to have bad body aches and was extremely tired.
Emergency room 1/25/21 HPI patient is a 66 y.o. female who presents with dizziness, nausea, and vomiting.  Patient reports that she began having acute episodic dizziness and vertigo early this morning when she rolled over in bed.  She states the dizziness became so bad it made her nauseous and she began vomiting.  Patient reports she tried to take a Dramamine but was unable to keep it down, and thus it did not help.   Patient denies any ringing in the ears, decreased hearing, or ear pain.  Patient does report she has had episodes of dizziness and vertigo like this in the past.  Patient denies any fevers or chills.  Patient does report mild frontal headache.  Patient denies any chest pain, palpitations, or shortness of breath.
Chills; 101.1 temperature; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Severe shoulder wrist neck aches; Chest pains; Shortness of breath; Anxiety; Fatigue; Jaw pain; Teeth pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164, Expiration date: Aug2021) via an unspecified route of administration in the left arm on 16Apr2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The medical history included chronic back leg pain and allergy to ACE inhibitors. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included hydrocodone bitartrate/ paracetamol (VICODIN), tramadol (MANUFACTURER UNKNOWN), alprazolam (XANAX), hydrochlorothiazide/ triamterene (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN); all for an unspecified indications from an unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730, Expiration date:Jul2021) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 19:00, the patient experienced chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache. On the same date, the patient underwent body temperature test and the result was 101.1 (unspecified units). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills ,101.1 temperature, severe shoulder wrist neck aches, chest pains, shortness of breath, anxiety, fatigue, jaw pain, teeth pain and headache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
A THUMB SIZE INDENTION NOTED ON LOWER RIGHT DELTOID. THE INDENTION SITE IS SLIGHTLY RED. EMPLOYEE DID NOT COMPLAIN OF ANY OTHER SYMPTOMS. THE SIZE OF THE INDENTION GREW IN SIZE, WIDENING WITHIN 2 HOURS. CDC WAS CALLED, HOWEVER WAS NOT ABLE TO SHED ANY LIGHT ON THIS SIDE EFFECT OF MODERNA VACCINE. THE EMPLOYEE CONSULTED WITH A PHYSICIAN AND WAS ADVISED TO TAKE BENEDRYL, CALLING IT AN ALLERGIC REACTION. EMPLOYEE PLANS TO TAKE BENEDRYL WHEN SHE RETURNS HOME. EMPLOYEE HEALTH REFERRED EMPLOYEE TO OBTAIN A CT SCAN OR MRI TO OBSERVE WHAT APPEARS TO BE UNDERLYING TISSUE NECROSIS.  EMPLOYEE HEALTH WILL FOLLOW UP WITH EMPLOYEE FOR ADDITIONAL INFORMATION.
numbness and tingling of tongue - 360 mg Allegra one time continues headache - no response to treatment (prednisone, nurtec, fioroset, motrin, tylenol, amovig, gabapentin, magnesium)
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 4:37 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.90 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  2 vials with temperature 29 degrees Fahrenheit at 09:00 AM which were moved to fridge on 29-Sept-2021. Batch number 035C21A underwent temperature excursion on 27-Oct-2021. Product moved to clinic on 27-Oct-2021. Beyond used date was 29-Oct-2021. 4 vials with temperature 32 degrees Fahrenheit at 10:00 AM which were moved to fridge on 05-Oct-2021 and beyond used date was 04-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
4 days after SECOND Shot, 3/2, my upper rt arm - where I had received the Covid shot began to itch.  When I  got ready for bed I realized it was quite red and might have been swollen a little, but it was hard to tell. It itched again the next day and a little the 3rd day, 3/4 and a little more on 3/5 but hasn't itched since.
Pain, redness at injection site Rt arm.  Denies fever. Father states child did not go to school today. Recommended child be given either Tylenol or Ibuprofen for pain.  Cool compresses to site; may use warm compresses for relief if cool not helpful.
For about an hour. After vaccination, had a terrible tobacco aftertaste in her mouth and she is not a smoker and nobody was smoking around her. Her shoulder was also sore at injection site, on this morning she had a headache and felt stuffy.
Hospitalized with COVID-19. Admit with cough and hemoptysis. Remdesivir started due to age and possible underlying malignancy of lung.
This spontaneous report as received refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored vaccine of MMR II (lot # H014649, expired date 03-AUG-2014). The original reporter is unknown. Additional information has been requested.
Nausea, vomiting,  inability to keep water down, fatigue, dizziness, fever
Child received shots Mon 5-7-07. She came back to clinic Wed 5-9-07 with Left arm swollen, red, and hot from shoulder to elbow. It was bad enough that I suggested she go to an instacare, which she did. (We have no Dr, on site to look at it)