chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA009022: US-009507513-1710USA009099: US-009507513-1710USA009101: US-009507513-1710USA009098:
A month and half after the vaccination, Couple of months,itchy and swells to big knot all over and it moves around. When it developed, it was on head and it itched then it showed up on arms legs between breast, not at the same time, it moved around.  Breaking out with rash or bumps and  Wen to the Dr. around 01/17/2022 , it told her to take Bendrayle and it not help with itching or the bumpsso,  put her on quartizone cream for itching and hydroxyzine  01/19/2022 picked up perscription.  Countion is improving but still has itching and bumps.
D1 severe headache, palpitations, achy joint/muscles, fatigue D2 Headache, achy joint/muscle fatigue D3 mild headache, brain fog, tingle/itching face (lips), fatigue, started menstural cycle 4 days early and heavy bleeding D4 - present: mild constant headaches, brain fog, tingling legs and  lips, fatigue
Information has been received from a pharmacist concerning a 19 year old female with a history of convulsions in childhood who on 19-NOV-2007 was vaccinated with a second dose of MMRII vaccine (Wistar RA 27/3) (Lot # 655415/0748U). Concomitant vaccine therapy that same day included DTAP-IPV vaccine.  The pharmacist reported that the patient developed chest pain and her hands turned black and blue after receiving her second vaccination with MMRII vaccine (Wistar RA 27/3) (date and or time of onsets not specified). The patient had received a first dose of MMRII vaccine (Wistar RA 27/3 on 4 JAN 1990. On 24-DEC-2007, the patient went to the emergency room (ER) and underwent several unspecified outpatient tests, and was subsequently released to home without a diagnosis. "Around the same time" the patient was seen by both a neurologist and cardiologist. The patient was also seen at a hospital for additional testing. On 08 APR 2008 the patient went to the ER again with chest pain and black hands. At the time of reporting there was no diagnosis and the patient had not yet recovered. There was no product quality complaint. Additional information has been requested.
Patient arrived to receive the Pfizer 12+ bivalent booster vaccine. Patient instead received the Pfizer monovalent vaccine. No noted adverse reactions. Outreach to the patient will take place soon.
Weeks after small pox vaccine pt had redden, swelling, pus and deep wound at site. Was put on Keflex improving and filling in with time. Today is approx 1 cm across x 1 cm deep lesion in skin with granulation tissue at base.
A report received from a health care professional on 06Nov02 concerning 2 adult vaccinees of unk demography who experienced headache and dizziness within 1 hour of receiving Fluvirin on 30Oct02. On 30Oct02 4 vaccinees experienced headache and dizziness within 1 hour of receiving Fluvirin. The vaccinees recovered the same day.  There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200200708 and PJP200200709.
CHOLERA; SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On MAR-2021, the patient experienced cholera, sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sore arm and cholera was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210355547-Covid-19 vaccine ad26.cov2.s-Cholera. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question.  Healthcare is working  on a compliance improvement plan and has been reinstated vaccination privileges.
Extremely fatigued; pain in sternum that traveled to right arm.; pain in sternum that traveled to right arm.; Chills; sweating after getting booster 2 weeks ago; Booster; This is a spontaneous report from a contactable Nurse. This 55-year-old female Nurse reported that: A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FF2588) intramuscular, administered in arm left on 29Sep2021 15:00 (at the age of 55-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included hypertension and food allergy (known allergies: Kiwi) from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was received other medications in two weeks HTCZ. The patient had covid prior vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL0142) intramuscular, administered in right arm on 06Jan2021 as dose 1, single and received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1284) intramuscular, administered in left arm on 27Jan2021 as dose 2, single both doses for covid-19 immunization (at the age of 54-years-old). On 29Sep2021 15:00, the patient had booster. On 11Oct2021, the patient experienced extremely fatigued, pain in sternum that traveled to right arm, chills and sweating after getting booster 2 weeks ago. Treatment was received in response to the adverse events Tylenol and Alka Seltzer cold and flu tablets. The patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. Covid test type Nasal Swab.  the patient underwent lab tests and procedures which included Nasal swab test: negative result. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Pt report feeling clammy and "vision going like about to faint about 2 to 3 minutes after the shot. Pharmacist went over to check and found that patient is sweating. Patient also complained about nausea, hot and thirsty. Pharmacist did not find any rash or swelling on the face. Patient drank some water and did some slow, deep breathing. He reported feeling better after about 10 to 15 minutes. Pharmacy staffs called 911 when pharmacist first checking on the patient. EMR arrived in about 10 to 15 minutes and got blood pressure 125/76 heart rate 60 to 64. Patient said that he feels okay and EMR that he does not need to go to hospital. Patient agreed to check with MD and let pharmacy follow up next day.
Rash, swelling over left deltoid area and fever of 100 F developed approximately 24 hrs after vaccine administration. No breathing or systemic symptoms. Treated with BENADRYL.
April 12, 2021 11:20am- dose #2 given and I was told to wait 35 minutes after to see if there was a reaction.  2:30pm- achy and chills started and I took a nap. 5:00pm- woke up with a fever 100.6, still achy with chills. 7:30pm- went to sleep fever 101.8, whole body achy, hurt to touch anything, headache, chills and exhausted.  April 13, 2021 6:30am- fever still, exhausted after only being up after 20 minutes, achy, headache and chills. Went back to sleep for the whole day. 5:30pm- woke up at but still same symptoms as before. Forced myself to stay away. 10:00pm- fever 99.6, exhausted, achy and headache. Went to bed April 14, 2021 6:30 am- woke up, fever 97.4, tired and midly achy, headache still around. April 16, 2021 Headache finally subsided on Thursday.
Warmth and redness at right deltoid. Pt seen in ER and treated with antibiotics.
Staff Administered Covid-19 Bivalent  injection for ages 12yo to adult to an 8 yo. pediatric patient  4/13/23.    Patient was given .2mL the usual pediatric dose before the information was entered into the electronic meter.  At this time the error was discovered as the media would not accept the order. Lot GL0447 Exp. 07/31/2023 .   At the time of providing the vaccine, pt was doing well.
POST-IMMUNIZATION SYNCOPAL EPISODE; CALLED - EMS; LOCAL EMT RESPONDED AND EVALUATED PT.; URGED FATHER TO SEEK DEFINITIVE MEDICAL EVALUATION; FATHER TOOK PATIENT HOME. PER MOTHER ANXIOUS, BUT RESTING.
Extreme fatigue day of vaccine. Headache, fever, body aches, nausea, dizziness two days post vaccine. One week post vaccine developed redness at injection site. Redness has been spreading and is warm to the touch. Pain at the injection site and radiating up and down left arm.
Complete loss of sense of smell from 3/16/21-7/11/21 Suffering from headaches in the front of the head (behind forehead) from 3/15/21 to present. Partial loss of sense of smell from 7/11/21 to present.
Vaccine 3/22/21, started with fatigue/generally feeling unwell 3/25/21, fever. Received Tdap vaccine 3/26/21. Persistent fever, pain around eye, ear and radiating into her head, nausea. Symptoms continued to worsen, developed chest pain and new onset seizure 3/31/21- Sent to ER for evaluation
Pt complained of itching all over his body with raised red blotchy areas beginning on 8/25/01 in the evening. Pt instructed to seek medical follow up.
The monovalent and pfizer bialent vacines  look alike vials. The monovalent was administered instead of the bivalent. Patient doesn't report any adverse events. They were told to come in after 2 months to get the bivalent vaccine
He had had COVID-19 in November 2020. His father was also ill with COVID at that time. He had fever, headache, fatigue, cough, and diarrhea then. His symptoms lasted one week and then resolved .He received his first Pfizer COVID vaccine on 7/21/21. He developed fever, dizziness and headache after the vaccine. Symptoms improved after one day. He recalled some slight chest pain then. On 8/11, he received his second dose. On 8/12, he developed fever, dizziness and chest pain. On 8/14, his chest pain worsened and became severe. He reports associated SOB and radiation to his neck. He was taken to an outside facility. He was transferred to ED for further management  He was admitted to the telemetry floor on the cardiology service. He was started on tylenol and motrin as needed for pain. The morning of 8/15 he developed chest pain. He denies any chest pain thereafter. He will not be cleared to return to football until a stress test is done in three months.
Patient described that throat got really dry and that was not relieved by drinking water.  As she left work that night and was driving home she said that her chest got really tight.  She then went to the emergency room.  While at the emergency room she reported that her eyes became blood-shot.  Her blood pressure was taken at the ER and was "slightly elevated".  Doctors at the ER performed a ECHO and found nothing significant with the heart.  Also performed a strep test--not significant.  Doctors reported that her throat did look red and irritated.  Patient reports that she kept drinking water and that her dry throat was beginning to be relieved while she was still at the ER.  Doctors at the ER believe she had an adverse event.  She left the ER with a prescription for some antibiotic drops for her eyes.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 27 year old male of unspecified race. Initial information was processed along with the additional information received on 21-JAN-2022. The patient's height, and weight were not reported. The patient's past medical history included: ankle surgery, and concurrent conditions included: alcoholic, and weed smoker, and other pre existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s(dose number in series:1) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, 1 total, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JAN-2022, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection( runny nose got a little heavier, a little bit of cough). Laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) rapid diagnostic test (NR: not provided) positive.(dose number in series:1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected clinical vaccination failure and suspected covid-19 infection. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000213496.  Additional information was received on 21-JAN-2022. The following information was updated and incorporated into the case narrative: product quality complaint number.; Sender's Comments: V0: 20220133740- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
This spontaneous report was received from a physician via company representative regarding a 48 year old female patient. Information regarding patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (dosing details were not provided) via intramuscular route. Physician reported that two days after vaccination, on 24-AUG-2016, the patient developed pain, swelling, and warmth in her arm (unspecified arm and also it was unknown if it was same arm where the vaccine was administered). It was unspecified if the patient required medication attention or not. The patient received unspecified treatment for the adverse events. Outcome of the events were unknown. Reporting physician did not provide the causality of the events with respect to PNEUMOVAX 23. Additional information has been requested.
17year old received Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received Moderna COVID-19 vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a three years old male patient who experienced swelling spread to the entire thigh and to the knee, he cannot bear any weight, limping and redness was seen at the injection site (pink here and there but no discrete area of redness), while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included In 2016 he got the FLUZONE QUAD 0.25 vaccine (LOT UT5663TA)and develop redness and swelling that extended to his upper FLUZONE QUADRIVALENT in OCT-2015, FLUZONE QUADRIVALENT in DEC-2015. The patient's past medical treatment(s) and family history were not provided. On 05-Dec-2018, the patient received a 0.5 ml dose of suspect FLUZONE QUADRIVALENT VACCINE lot UT6375MA via unknown route in the left thigh. On an unknown date, the patient developed a non-serious swelling spread to the entire thigh and to the knee (extensive swelling of vaccinated limb), he cannot bear any weight, limping (gait disturbance) and redness was seen at the injection site (pink here and there but no discrete area of redness) (extensive swelling of vaccinated limb) following the administration of FLUZONE QUADRIVALENT.Other relevant tests included test for egg allergies which was negative. Final diagnosis was extensive swelling of vaccinated limb, extensive swelling of vaccinated limb, gait disturbance and weight bearing difficulty. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for extensive swelling of vaccinated limb, extensive swelling of vaccinated limb, gait disturbance and weight bearing difficulty. List of documents held by sender: none.
2nd dose of Moderna on 3/9/2021 at 8:30am.  At 9:00pm started having upper respiratory distress leading to vomiting  and diarrhea (every 10 to 15 min) on 3/10 at 10:00 pm.  Went to ER on 3/11 at 1:00am. Admitted to ER with initial diagnosis (following lab work, x-rays,  etc.) of Anaphylactic Shock. Symptoms were allergic reaction,  chest pain, hypotension, acute kidney failure, diarrhea, DM2, hives/rash/itching. Multiple IVs of saline, antibiotics, steroids were administered.  Remained In critical care/ER for ~12 hours until stable and transferred to hospital room. Discharged on 3/12/2021 at 11:00 am.
Lethargic, no appetite, fever 12/25-12/28. 12/28 she woke up with a rash at het hairline that spread along her whole body by 1:00pm. Rash is itchy, red spots.
Varivax 8/20/03. 8/27/03 Presented with 3 papules on forehead and 2 on posterior right calf.
Patient was nervous about getting injection but said he wanted it and would be fine.  I gave the injection and stood by patient  (just in case) after 30 or 40 seconds he told me he felt funny, the next thing I see he slumped in chair, his head dropped back and his eyes rolled to back of his head, he had a mild seizure, body jerking for a few seconds then stopped, he started to come around but then passed back out and had mild seizure again. Patient came to again and stayed awake. He stated that he had a similar reaction when giving blood.  EM T came and took care of him, his heart rate was 30 as he was coming to.  He was advised to go to hospital but refused. Girlfriend came and picked him up.  I called him today and he said he was tired but felt better and even went to the gym.
Pain at injection site; fatigue; headache; overall did not feel well; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received bnt162b2 (Batch/Lot Number: EN6208, expiration date: Jun2021), dose 1 via an unspecified route of administration, administered in left arm on 12Mar2021 at 12:00 PM (at the age of 58 years old) as single dose for covid-19 immunization. Medical history included allergy to Sulfa. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient experienced pain at injection site, fatigue; headache and overall did not feel well on 13Mar2021. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. No treatment for events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Mother reports had severe abdominal pain and vomiting at 4am. Brought to ED had lab work, UA, and abd film- all were negative
I have not had excema flareups since I was about 9 years old. Roughly 2-3 months after receiving the second dose of the Pfizer covid vaccine (03/15/21) at 25 years old, I started to notice my skin becoming itchy and I was getting rough rashy patches on my hands, behind my knees, inside my elbows, and behind my neck. I began to see a dermatologist and was diagnosed with eczema. It has progressively gotten worse over the last year or so, and I am noticing an increase in people that I know whose skin-related immune disorders (shingles, vitiligo, psoriasis, eczema, etc) are suddenly resurfacing after being vaccinated.
All body hives lasting more than a month; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 24-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced all body hives lasting more than a month. The clinical outcome of the event all body hives lasting more than a month was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.