chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 9 hours after receiving the vaccine, I began to have itching and pain at the injection site. When I woke up the next morning, those symptoms continued but I also found myself shivering and tired. Within the 2 hours following that I had a fever of 99.3. (Rather high for me since a normal body temperature for me is 97.4. When I get to 98.0 I don't feel well.) An hour after that my stomach started hurting. I took Extra-strength EXCEDRIN before the fever started to help with the pain at the injection site, so I was surprised when I started running a fever. (After my first dose of SHINGRIX I had also experienced pain and swelling at the injection site and basically feeling like I had been hit by a truck, but no fever or stomach ache.)
A spontaneous report was received from a consumer concerning a 62-year-old, female patient who felt like a needle in her kidney/renal pain, feve/pyrexiar, fatigue, tiredness/fatigue, chest pain, upset heart/cardiac disorder, headache and inflammation of heart muscle/myocarditis.   The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, metformin, glimepiride, simvastatin, losartan.  On 16 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 001B21A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Mar 2021, 5 minutes later she experienced felt like a needle in her kidney. On 17 Mar 2021, she had fever. On an unknown date in Mar 2021, she had fatigue and tiredness. On 20 Dec 2021, she had chest pain and upset heart. On 21 Mar 2021, she had a headache and fever. On 22 Mar 2021 she had chest pain and went to the doctor and was diagnosed inflammation of the heart muscle. The event inflammation of the heart muscle was assessed medically significant.  Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.  The events felt like a needle in her kidney was resolved on 16 Mar 2021.  The events fever and headache were resolved on 21 Mar 2021.  The outcome of the evens fatigue, tiredness, chest pain, upset heart and inflammation of heart muscle were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "food allergies" (unspecified if ongoing); "pecan, pine nut, casein, milk, walnut," (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; TRAZODONE; CETIRIZINE; FLONASE ALLERGY RELIEF; IBUPROFEN; DAYQUIL; NYQUIL. Past drug history included: Erythromycin for known_allergies: erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative, notes: Recurrence of positive antigen test result after previous negative results since treatment; Positive, notes: Recurrence of positive antigen test result after previous negative results since treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.She received Paxlovid for the treatment of COVID-19 (start date: 24May2022, stop date: 28May2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
My daughter received the wrong vaccine. We were not notified at the time of the vaccination. We received a call hours later stating that she would be fine and that the health department had been notified. I contacted the health department and was informed that they were NOT notified. I am completely unsure how this is going to impact my daughter and I am livid that I was misled and lied to by my physician's office.
No additional adverse effects were reported in the patient; A patient received his first dose of GARDASIL 9 at 12, and recently received a second dose at age 23; This spontaneous report has been received from a pharmacist concerning a 23-year-old male patient. The patient's concurrent condition, concomitant medication, pertinent medical history and drugs or allergies were not reported.   In approximately 2009, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 1 dosage form, at 12 years old and on approximately 18-FEB-2020 (reported as about a week ago), the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at 23 years old(Inappropriate schedule of product administration) (strength, dose, anatomical site of injection, route of administration, lot number and expiration date were not reported) for prophylaxis. No additional adverse effects were reported in the patient.
While on duty and in uniform as an emergency paramedic I received my second  scheduled covid19 vaccination.  Approximately five minutes after receiving  C19 dose 2 vaccination (1335hrs). I experienced a syncopal episode while walking back to my work area and was lowered to the ground by another EMS provider. I was then placed in a wheelchair by the  EMS provider and an RN and taken to the emergency department at Medical Center. (1337hrs)  I  regained alertness and felt severe nausea and general weakness and was assisted into in ER bed.  Staff doctor attended along with RN . An assessment was completed, 12 lead EKG completed, IV established, 8mg Zofran administered, 1000ml of Normal Saline was bolused. Labs were drawn.  ED staff continued to monitor me for the next  2 plus hours I was monitored for anaphylaxis and other symptoms. My symptoms of nausea mostly resolved and my strength returned.  A Resident MD completed a final evaluation and determined it was safe for me to be discharged. (1607hrs)
Bilateral posterior neck pain and stiffness, started 17 hours after injection. DIfficulty moving head and turning neck side to side.
Last Tues 8/14 I felt pretty tired and had a sore throat. Wednesday I felt even worse, I got home and had a 100.8 temperature. I took a rapid covid test and it was negative. On Thursday my fever 101.6. I took Mucinex and Tylenol. I called Dr. and they told me I do not have covid or the flu, my lungs okay, but stated I was sick with something and my body was fighting it. I was told to come back by Monday if I didn't feel better. By Friday I was still coughing a lot but no fever. I started to feel better over the weekend. Now today, Wednesday 09/22, I am still coughing up some phlegm but I am still tired.
Pt reports she received the flu vaccine around 10:00am.  She returned to her desk and around 3:00 she started noticing her neck was stiff, and the left side was sore; at that time she took Tylenol.  At dinner between 6-7 pm, she reported taking 4 Ibuprofen.  She complained of ear pain, like her gland on the left side was swollen, it hurt to turn her neck to the left and the pain would shoot down her back, into her left shoulder and down her left arm.  She decribed the pain like an "icy feeling down her arm and it followed the vein over the top of her forearm. This is like what happens when I get stung by a wasp."  She applied a heating pad to her neck.  She reports she could move her arm in all directions but it was painful.  She applied the heating pad to her neck.  The meds and the heating pad helped some but did not relieve all her pain.  This morning at 4:40 am she took 2 Ibuprofen and had a hot shower hoping that would help loosened her stiffness with some relief.   Patient has doctor's appt today, 10/19/2018 at 10:00am. RN observed site of injection and found no redness, swelling, bruising and not warm to touch. Patient could move her left arm in all directions but did appear guarded and stiff when turning head.  Telephone call from PA-C at Clinic.  She reports there was no testing or labs needed, the dx was muscle spasm, was given recommendations of management and prescribed muscle relaxers.  She saw no ROM issues or concerns with the site of the vaccine.  PA felt the area of concern were the trapezius and stabilizing muscles.  Patient to give PA follow-up call Monday 10/21/2019 if no improvement.
Had the first Shingrix dose / contracted mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient stated that he/she received first dose of Shringrix and experienced Shingles before he/she could take second dose.
This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult female patient who received BOOSTRIX. Concurrent medical conditions included asthma (severe). In April 2016, the patient received BOOSTRIX. In January 2017, less than a year after receiving BOOSTRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the pertussis was recovered/resolved. It was unknown if the reporter considered the vaccination failure was unknown and the outcome of the pertussis was recovered/resolved. It was unknown if the reporter considered the vaccination failure and pertussis to be related to BOOSTRIX. Additional details were provided as follows: At the time of reporting, the patient was over 50 years of age. The age at vaccination was not reported. The sales representative was asked by the pharmacy if a patient who was given a TDaP vaccine in April 2016 could get a 2nd vaccination because the patient was hospitalized in January 2017 due to pertussis. The medical liaison was consulted due to the off label request. There was no clinical proof that the patient had pertussis as this was reported to the pharmacy by the patient's husband. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule with DTaP and lab test confirmation was not provided.
Information has been received from a Licensed Practical Nurse concerning a 25 year old female with hypertension, type 2 diabetes mellitus and no known drug allergies, who on 26-AUG-2008, was vaccinated with her first dose of GARDASIL (Lot # 660557/0072X) 0.5 ml IM right deltoid. Concomitant therapy included AVAPRO, metformin and prenatal vitamins (unspecified). On 02-SEP-2008, the patient experienced generalized pruritus without a rash a week after receiving her first dose. The pruritus was worse on her hands and face. The patient called the physician. The patient was instructed to take BENADRYL. The patient's generalized pruritus persisted. Additional information has been requested.
Pt is 24 yo female s/p full Moderna COVID vaccination: dose 1 on 1/27 and dose 2 on 2/24. Pt is an employee at this institution. On 8/6, she reports new onset fever, chills, fatigue, muscle/body aches, headache, and congestion/runny nose. Denies known exposure to a COVID positive person. COVID PCR test results positive on 8/6.
The pt developed 6x3cm area of erythema at DTaP site with pruritus, no lymphadenothy, no vesicles and no pustules. Treated with Benadryl.
When I went the first night, I had seven hearing losses in my left ear. I was given steroids to take in the ER with a prescription to take home. I woke up the next day with better hearing but a headache, I filled the prescription and took it, but it gave me a worse headache. I went back to the ER, and I was given IV fluids along with TYLENOL before I left. It took the edge off but not completely. The headache continued for a few days from about Monday to Friday. I started feeling better Saturday, not completely better but better than before.
temp began 14APR 101, cranky & clingy-teething;used APAP temp to 102 on 15APR used APAP;pt began shaking;dx pharyngitis given med;walking is unsteady today;
Dose left out at 2:36PM administered at 9:00AM the next day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose left out at 2:36PM administered at 9:00AM the next day) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose left out at 2:36PM administered at 9:00AM the next day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose left out at 2:36PM administered at 9:00AM the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
PT revd series of 3 Engerix-B vaxs (20mcg) on 7MAY90, 5JUN90, & 13NOV90; 30JAN91 test indicated PT was a low responder; recd 2 more doses on 8FEB91 & 11MAR91; 29MAY91 tested positive for Abs;
I got COVID; The is a spontaneous report received from contactable consumer.  A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 20Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Mar2021, patient was diagnosed with Covid19 and reported he was fine. Outcome of event was reported as recovered on an unspecified date 2021.  No Follow-up attempts are needed. No further information is expected.
Chills and shivering off and on for about 9 hours, accompanied by headache and fatigue. Arm became sore within a few hours, and lasted for about 48 hours.  ?Covid arm? was evident after a few hours - large red rash below the injection site- lasted 80 hours.
24MAR94 2AM fever, cough, fussy; c/o sore legs also pt to ER: blood drawn & CXR done; dx pneumonia & not related to immun; rx ATB 10 days;
pt had first dose in 7/2021, did not receive the 2nd dose in series,  admitted 10/14/21 for COVID
I had the shot and still had the shingles/ Suspected Vaccination Failure; I had the shot and still had the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The reported had the shot and still had the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
fever 29JAN97 ATB given;coughing 4FEB97 med given;vomiting 18FEB91 med given;
This spontaneous report was received from an unspecified source, concerning unknown female patients from unmentioned ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that on unspecifed dates, there had been about 213 (Vaccine Adverse Event Reporting System) VAERS reports involving amenorrhea and premature ovarian failure (premature menopause). The outcome of the events was not known.  The relatedness between events and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given.; Sender's Comments: US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: ZA-009507513-1507ZAF012830: US-009507513-1705USA003214:
This is a prospective pregnancy case. This 21-year-old female subject was enrolled in a study to detect and described any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 17th March 2015. The subject's last menstrual period was on 19th August 2014 and estimated date of delivery was 26th May 2015. The subject received BOOSTRIX at week 30 of the pregnancy and during the third trimester of pregnancy. On 17th March 2015, an unknown time after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to BOOSTRIX. Additional details were provided as follows: This was a normal conception. Follow-up information received on 28 April 2015 from nurse: Some of the patient's details were provided. The VAERS details were provided. Follow-up information received on 30 September 2015 form nurse: The subject had no previous pregnancies. 28 days after receiving BOOSTRIX and after 34 weeks of gestation, the subject gave premature birth to a female neonate via vaginal delivery with no apparent congenital anomaly. The neonate weighed 1831 grams (4lbs 1oz) at birth. APGAR scores were 8/9. It was unknown if the reporter considered the live birth to be related to BOOSTRIX>
Squeezy in the stomach"; Little nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea). On 09-Mar-2021, ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea) had resolved.            On  17 Mar 2021 again the patient felt squeezy in the stomach and on 22 Mar 2021 the event got resolved. Concomitant medications was not provided by the reporter. Treatment for the events included Mepromazin
Patient's wife came into the pharmacy and asked why we gave her husband a second flu shot. I checked and she was correct. The patient has a bit of dementia and he didn't remember the one given to him a month before.
Fever 101° Sore joints Recovered by 5/17/19 8AM
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "immune-compromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported:VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) negative, notes: positive covid with symptoms 7 days after completing Paxlovid, and after 2 negative tests; (23Jul2022) positive, notes: positive covid with symptoms 7 days after completing Paxlovid, and after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Adverse event: Rebound infection of positive covid with symptoms 7 days after completing Paxlovid, and after 2 negative tests  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.