chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on neck, chest, underarm and upper back; Violent body shakes; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 03Apr2021 at 11:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid (hypothyroidism). The patient had no known allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 04Apr2021 at 01:30, the patient experienced violent body shakes (not chills). On 05Apr2021 at 11:15, 48 hours after the vaccination, the patient experienced a rash on the neck, chest, underarm and upper back. The patient reported that the rash looked like a bad sunburn. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash on neck, chest, underarm and upper back and violent body shakes was resolved on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
high fever; aches and pains; Headache; muscle aches; extremely sick; soreness in the arm; feeling weak; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EB7533 and expiration date: not reported), via an unspecified route of administration, on 30Mar2021 (at the age of 59-year-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing hypertension, prediabetic, and High cholesterol. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 12Mar2021 (at the age of 59-year-old), as DOSE 1, SINGLE for covid-19 immunization.  On 31Mar2021, the patient was extremely sick, with high fever, aches and pains, headache, and muscle aches. On 30Mar2021 patient experienced soreness in the arm and started feeling weak. The patient underwent lab tests and procedures which included body temperature: 100.5 on 31Mar2021. The outcome of the events extremely sick and high fever was unknown, soreness in the arm, feeling weak, aches and pains, Headache and muscle aches was not recovered at time of report.  No follow-up attempts are possible. No further information is expected.
103 degree F fever, irritability.  No sleep.  Facial flushing immediately following vaccine (1 hour).
This spontaneous report was received from a nurse regarding patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored PEDVAXHIB (lot/batch# 1042835 with expiry date 19-AUG-2018 and dosing details not known). No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1042835 is an invalid lot number for PEDVAXHIB. This is one of the four reports received from the same reporter. Additional information has been requested.
ON 03/09/2010 MOM FIRST NOTICE RED SMALL KNOT IN THE AREA. ON 3/10/2010 MOM NOTICE AREA WAS LARGER AND HOT TO TOUCH
Moderna booster dose of 0.25ml was administered to pt out of a vial that was opened >12 hours. The vial was opened for approx 24 hours but remained in the stable temperature of 4-5 degrees Celsius. No adverse reactions noted
Pt showed no antibody to Engerix-B as of 5NOV90 (post series of 3 Engerix-B vaccinations); 3rd dose given 1May90;
pt recv vax 25AUG95&9MAR96 pt exp a mild chickenpox rash;the lesions scabbed over in 24hr;the pt mother was unsure of exposure,but the child had been in daycare;no further details were provided;
Jynneos was administered intramuscularly; Case reference number US-BN-2022-001862 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (third out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001863, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
female patient received expired IPOL vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician and other healthcare professional via call-center via Agency (Reference number- 00527288) and transmitted to Sanofi on 19-Mar-2021.  This case involves a 6-years-old female patient who received expired 0.5 mL IPV (VERO) [IPOL] vaccine  (strength: standard, frequency: once, batch number: R1B251M and expiry date: 13-Mar-2021 via an intramuscular in the route in right deltoid) (expired product administered) on 19-Mar-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter asks if the vaccine was valid and if the patient needs to be revaccinated.  At the time of reporting, no adverse event was reported.  No treatment was needed.  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.
Fever, muscular and all over body aches, worst symptoms I felt in the last 20 years.
Onset of Myalgia and extreme fatigue times 3 days, no fever Continued episodes of Myalgia and extreme fatigue with occasional low grade fever lasting several hours every 1-2 weeks with decreasing frequency to now happening every 2-3 weeks.
Patient called to report soreness and pressure along her entire arm. She stated that her deltoid was sore from the vaccine right after the shot, but about 2 hours later her entire arm was starting to feel like it was "falling asleep." She noted that she was still able to feel her fingers.
Headache, Sedation & Myalgia Narrative: Received 1st dose of vaccine on 1/5/21. Later that day developed a headache, achiness, and fatigue. Missed work x1 day.
There were many of us that has same complaint. Fever for 1-3 days post flu shot injection but the main complaint is the upper (in my case, left deltoid) where I had my intramuscular injection that is current until now. I can hardly lift my arm and I have to take 800 mg MOTRIN in order to work. Changing clothes was difficult.
Nausea, restless, unable to sleep, possible fever, warm, chills, and back pains
patient reported that today ( 10 th  day of  immunization) her arm is swelling ,inflamed and sore more than the first 3 days. no fever, no swelling in face or tongue , no breathing  problems , no hives.
got sick and had problems the rest of the winter; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (Patient) via social media.   This case involved a patient of unknown age and gender who got sick and had problems the rest of the winter (Illness), while received INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination details, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick and had problems the rest of the winter (Illness, non-serious event) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory tests reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on batch number for this case.
Mother of pt. called on the morning of 3/12/14 at approx 9 am, reporting "vomiting", decreased appetite, redness at inj site, swelling (whelp, where inj. was given) and inj site being "Feverish."
I received the second Pfizer booster for COVID-19 on 5/16/2022. On 7/19/2022, I started having a burning sensation in the sinuses. I somehow instinctively knew it was COVID-19, but I took a home test just to be sure, and it confirmed my suspicion. I then developed a sore throat, a headache, and a fever, which reached 102 at its peak. My doctor prescribed me a five-day course of Paxlovid, which I began taking on the night of 7/19/2022. After I began taking the Paxlovid, my symptoms decreased. I felt much better and back to normal on 7/23/2022. However, on 7/25/2022, the symptoms returned. Again, I had a burning sensation in the sinuses, a sore throat, and a fever, which again reached 102 at its peak. I also developed a cough, which was never severe and lasted only a few days. By 7/29/2022 or 7/30/2022, the symptoms were finally gone for good.
Syncopal episode for less than 60 seconds after receiving 3 vaccines. Patient remained on exam table, did not hit his head. Patient assisted to supine position, legs elevated. Vital signs monitored. Patient was given a pedialyte pop, remained supine for 10 minutes, then sat up and stool up gradually. He was discharged home when vital signs remained stable and symptoms resolved.
Shot administered at 2:30 pm. on April 12th. Chills started at 12:30 a.m. and lasted about 3 hours. Woke up with my whole body aching. Also had tightness in chest and rapid heartbeat and fever off and on for the next 36 hours. Fever was 100.9 at highest temperature. I took Advil to help with my symptoms. I returned to work on April 14th.
Right deltoid pain and swelling, likely hematoma. Treated on 11/17/04.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M024261, expiration date: 30-JUL-2018; and lot # N013695, expiration date: 21-MAR-19 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1708USA004836.
Irritability - Information has been received from a medical assistant concerning a 2 month old caucasian male, who on 28 Dec 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 631049/0105k intramuscularly.  Concomitant therapy included hepatits b vaccine recombinant MSD 637547/1373k diphtheria thoxoid (+) haemophilus b conjugate vaccine (+) pertussia vaccine (+) tetanus toxoid tetramune vaccine lot 472-251.  poliovirus vaccine ipol lot 70472 and hib conjugate vaccine hibtiter lot 570403A.  Subsequently the patient experienced temorary fussiness.  Unspecified medical attention was sought.  Additional information is not expected
Patient said she felt sick from date of administration until today (11/2/12). She was home in bed.
Patient said that after the vaccine was administered he felt a burning sensation as if his "blood vessels were peeling apart".   The patient said that this occured with the first dose as well.
Severe pain at injection site, shoulder, neck, and ear.  Swollen ear.  Hives on back.
fainted five minutes after the vaccination; pale; diaphoretic; vomited; she was extremely anxious about receiving the vaccine; This is a spontaneous report from a contactable nurse. A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: PAA165969, expiry date not reported), intramuscular, administered in left arm on 07Apr2021 10:30 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had known allergies or other medical history. It was unknown if patient had Covid prior vaccination. The patient was not pregnant at the time of the vaccination and report. It was unknown if patient received other vaccine in four weeks and other medications in two weeks. The patient received the vaccine at the doctor's office/urgent care. The patient fainted five minutes after the vaccination on 07Apr2021 10:30. She was pale and diaphoretic. She became responsive within one minute. She was given water and a cold compress, and reported she felt better, but then vomited a small amount of emesis 15 minutes later (07Apr2021). She was evaluated by the physician who determined it was an emotional response to the vaccine. The patient had reported she was extremely anxious about receiving the vaccine (07Apr2021), and had fainted when she tried to give blood, and hadn't eaten anything that day. After sitting for 45 minutes, the doctor felt comfortable letting her leave. A call was placed to the patient at 4:00 pm to check on her. She reported she felt fine. The patient received no treatment for the event vomited, while therapeutic measures were taken as a result of the other reported events. It was unknown if patient was tested for Covid post vaccination. The patient recovered on an unspecified date in 2021 from the events reported.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of syncope. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
History of present illness: Patient presents to urgent care center because of cough mild shortness of breath  Was diagnosed with COVID-19 and referred to ER and subsequently admitted.
Initial report was received from a health care professional on 01 February 2010. An eight-year-old  male patient who had a history of autism, received a second dose intramuscular left deltoid injection of H1N1, lot number UP040CA on 01 February 2010, and several hours after vaccination, he developed a nose bleed. The extent of bleeding was not reported, however, the patient recovered and subsequently played basketball afterwards with no problems. The event did not require a doctor's visit. The patient had no concurrent illness and he had not been taking any concomitant medications. On 24 December 2009, the patient had received a first dose of H1N1 (manufacturer and lot number not reported) with no adverse events experienced. Documents held by sender: None.
Extreme thirst started about a week or so after the first vaccine shot; It's an uncomfortale, annoying, desperate feeling from the back of your throat into mouth; I have to urinate about every two hours; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 17:00 (at the age of 50-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 14Apr2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy, hashimoto's disease, obesity, fibromyalgia and the patient was pre-diabetic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks prior to the vaccination. The patient previously received gadolinium (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, about a week or so after the first vaccine shot the patient experienced extreme thirst. The patient never experienced anything like this in life and it continued at the time of this reporting. It was an uncomfortable, annoying, desperate feeling from the back of throat into mouth. As soon as the patient had a drink of water, she was thirsty again within a few minutes. The patient drank only water and 2 cups of coffee a day. She was drinking so much water, that she had to urinate about every two hours. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The patient had a variety of labs done on 18Apr2021, the results of which were unknown. The patient was diabetic and they were all relatively consistent with labs done prior to vaccines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme thirst, uncomfortable, annoying, desperate feeling from the back of your throat into mouth, had to urinate about every two hours were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
16 year old was inadvertently given the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently given the Moderna COVID-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently given the Moderna COVID-19 vaccine). On 17-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was inadvertently given the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter Patient was not experiencing any symptoms
My left arm was dead for about 10-15 minutes/They could've cut my arm off & I wouldn't have felt it.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (My left arm was dead for about 10-15 minutes/They could've cut my arm off & I wouldn't have felt it.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 032L20A) for COVID-19 vaccination.     No medical history of patient was reported by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (My left arm was dead for about 10-15 minutes/They could've cut my arm off & I wouldn't have felt it.). At the time of the report, HYPOAESTHESIA (My left arm was dead for about 10-15 minutes/They could've cut my arm off & I wouldn't have felt it.) outcome was unknown.            No treatment drugs were reported.   This case was linked to MOD-2021-020830 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received contains significant information where the correct Lot number is updated for both doses.