chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/09/00, the patient had a flu vaccine. On 12/27/00, the patient had tingling and prickly feeling in his hands and feet. On 12/28/00, the patient went to the doctors office with decreased feeling in his feet. He made an appt to see the neurologist on 01/02. On 12/29/00, the patient had difficulty waking, with decreased feeling in his legs and feet, and loosing balance. On 12/30/00, the patient called the doctor because loss of sensation was progressing up his legs, arms, and hands. He had difficulty sleeping because of discomfort. 12/31/00, the patient had numbness progressing in his thighs to his hips. The doctor sent him to the ER where he was seen by a neurologist. He was sent for an MRI and return was admission to ICU. On 01/05/01, the patient improved some and was discharged. He was able to use the walker with difficulty. He was evaluated by PT. He had therapy on 01/15,01/18, 01/22 and 01/25, condition declining, he was getting weaker. 01/16/01, More medication was ordered to be given at home for 3 days, an RN came to the house and stayed during treatment. 01/20/01, he felt a little improved. 01/22 & 01/25/00, the patient had PT. 01/26/01, his condition was worse, unable to go upstairs, or walk with a walker without falling. On 01/30/01, he saw a neurologist and was taken to the ER and was admitted and evaluated by referring doctor. The patient was given plasma phoresis prescription on 02/01, 02/02, 02/03, 02/04, 02/05, and 02/07. He had a nerve testing on 02/11 no improvement. On 02/12/00, he was transferred to another hospital via w/ch van for rehab. He had 1 hour of PT in the AM and 1 hour of OT in the PM. The patient's condition continued to decline. His appetite was poor, he had difficulty swallowing, weight decreased, because he became weaker each day, not eating. 02/20/01, The doctor was notified and the patient was transferred back to the ICU at the original hospital. On 02/21/01, more meds and had a nasogastric tube inserted for feeding.  His weight declined from 175 - 137. Still no movement in his legs, moving fingers; continued to improve. On 02/28/01, the patient was transferred out of ICU to a floor unit. He was moving his hands and his arms; able to hold a newspaper. On 03/01/01, doing better, getting OT & PT. Still NPO. Test showed inversion of epiglottis. On 03/02/01, moving arms, able to make a fist, NG tube out and stomach tube inserted via abdomen, sleeping poorly, breathing test improving. On 03/06/01, very lethargic, slept most of the day. 03/08/01, depressed,  complains of weakness of arms and legs. Had a sonogram of his leg. 03/09 and 03/10/01 more meds, moving his fingers a little, voice seems stronger.03/11/01, felt like increased strength in his right arm. 03/12/01, he was moving his arms and legs, and able to reach nose. Breathing test 2.6 + 60, chest clear. 03/13/01, weight down to 122, more meds, able to move arm back and forth on tray table (PT).  03/14/01, good spirits, able to move arms and legs but no real control. 03/23/01, patient went home, improving but still unsteady, moving arms and hands, legs still very flaccid. Diagnosed with GBS.
Same day onset of sluggishness and feeling sick. 3 days after receiving vaccination: debilitating back pain, low grade fever, headache, fatigue.
Per patient on Monday had fever with vaccine and blurry vision. On Tuesday patient experienced sore throat and blisters on upper lip. She called her provider Dr and he refer her to gargle with salt and water. per patient also experienced blurry vision and fever with first dose.
Has contracted varicella 2 weeks after her older brother (who was also vaccinated) contracted varicella from an outbreak at school.
Body aches, unable to raise arm where vaccine was administered, fever between 102 to 104, extreme fatigue, lose of appetite, and anxiety.
Information has been received from a licensed practical nurse concerning a 17 year old female patient with no medical history and an allergy to dust and animal dander, who on 30-APR-2008 was vaccinated intramuscularly in her left deltoid with the first dose of GARDASIL (Lot # 659657/1487U).  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently, the patient developed swelling at the injection site.  The swelling then changed to a 3 centimeter knot.  The patient sought unspecified medical attention by the physician.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/8/2008.  Initial and follow up information has been received from a licensed practical nurse concerning a 17 year old female patient with no medical history and an allergy to dust and animal dander, who on 30-APR-2008 was vaccinated intramuscularly in her left deltoid with the first dose of GARDASIL (Lot # 659657/1487U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 01-MAY-2008, the patient called the office with complaints of developing swelling at the injection site.  The nurse reported that the swelling then went away.  On 29-MAY-2008, the patient came into the office and was evaluated by the physician for swelling at the initial injection site, almost a month after the initial injection.  The physician treated the patient with an unspecified antibiotic.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
This is an initial spontaneous report by a contractible nurse. This female nurse reported on behalf of a 12 months old male patient who was administered PREVNAR12, lot number H45393, expiration date: 31MAY2015, 0.5ml injection on right upper leg on 30SEP2013. Relevant medical history included increasing head circumference and slow weight gain and it was unknown if these conditions were ongoing at the time of events onset. Relevant concomitant medications were unknown. Vaccines given on the day included VIVAX, MMR. Between 30SEP2013 and 08AUG2014 the patient was given three doses of pneumococcal 12-val conjugated vaccine (diptheria crm197 protein) as per the dosage regimen. The nurse mentioned that on 08AUG2014 pneumococcal 13-val conjugated vaccine (diphtheria crm197 protein) had sedimentation and was administered to the patient. The patient had fever of 102 degrees Celsius after administration of vaccine. Relevant lad date included unspecified blood work on 11AUG2014 and the results were unknown. At the time of report clinical outcome of the above mentioned events was unknown. The nurse suspected a causal relation between the drug and the adverse events. Follow-up (19SEP2014): Follow-up attempts completed. No further information expected.
PATIENT RECIEVED VACCINE AT 0815 ON 01/27/2021. SHE WAS OBSERVED FOR 15 MINUTES WITHOUT REACTION TO IMMUNIZATION. AROUND 2030 PATIENT REPORTS NOTICING SWELLING, HEAT, AND REDNESS TO INJECTION SITE. SHE THEN EXPERIENCED ONSET OF LOSS OF CONSCIOUNESS (APPROXIMATELY 1 MINUTE), WARM SWEATY FEELING, SHORTNESS OF BREATH, VOMITING, AND RINGING IN EARS. EMS CALLED BY FAMILY. PARAMEDIC EVAULATION. PATIENT VITAL SIGNS WITHIN NORMAL LIMITS WITH THE EXCEPTION OF HEART RATE, WHICH WAS TACHYCARDIC. PATIENT REFUSED CARE AND TRANSPORT. PATIENT REPORTED SYMPTOMS RESOLVED ON THEIR OWN AFTER APPROXIMATELY 20 MINUTES. PATIENT REPORTS EMS WAS ALSO CALLED ON 01/28/2021 FOR SAME SYMPTOMS. PATIENT AGAIN REFUSED CARE AND TRANSPORT.
ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included significant seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced aches. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches on 07-APR-2021, and chills, and fever on APR-2021. This report was non-serious.
febrile-pale-listless several hr p/vax;dec appetite;adm to hosp overnoc for observation-no other problems;
Patient was administered Kinrix, combo vaccine of Dtap, and IPV. Until 1630 same day, MA realized that Kinrix is to only be administered to children ages 4-6 years old.
This spontaneous report as received from a registered pharmacist refers to a currently 67 year old male patient with no drug reactions or allergies. On 10-APR-2014, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J001694, expiration date 08-MAY-2014) subcutaneously. Concomitant therapy included unspecified blood pressure medications. The pharmacist reported that in approximately MAY-2014, "s month and a half' after receiving ZOSTAVAX, the patient was diagnosed with shingles. The patient reported to the pharmacist that he came down with some rash on his back on an unspecified date and went to see a physician and patient was diagnosed with shingles. The patient received unspecified treatment for the adverse event. The outcome of shingles was reported as recovering/resolving. Additional information has been requested.
Developed ulcers around my genitalia 48 hours after being vaccinated and experiencing severe muscle pain/ weakness, nerve sensitivity, migraine, fever/chills and dizziness.  The ulcers were located on my labia; caused extreme pain around labia, intense pain while urinating, inability to use bathroom, dehydration. Ulcers lasted for 5 days, then the pain and sensitivity stopped.
Patient presented to the clinic on 14 Dec 2012 with redness, swelling, and heat in the upper right arm from the shoulder extending all the way down to the elbow.
Patient told check-in staff that she had pre-medicated for anxiety prior to coming for first COVID-19 vaccine.  Prior to vaccine, patient told vaccinator she was anxious.  She shared that she had a history of laryngospasm triggered by some smells.  Vaccinator approached writer asking if arm could be cleansed with soap and water prior to vaccination instead of alcohol wipe although patient stated she felt she would be ok with alcohol wipe being used.  Writer advised that vaccine site was not equipped with supplies to cleanse arm in that fashion.  Advised vaccinator to offer additional mask to patient to cover hers to prevent odors and to turn head while arm being cleansed.  (continued on next page)
15 days after receiving the 2nd moderna shot I had some midcycle bleeding (similar to a period) and severe cramping. All symptoms subsided within a few days, but my next cycle was 3 days early. I have no history of any type of cycle irregularity or bleeding and no familial history of uterine/ovarian cysts or anything else that could explain the bleeding and cramping.
Fainting after HPV #2 was administered 10 am - helped to floor - altered level of consciousness 30 sec to 1 min. Jerky movements associated with fainting (body stiff) - regained full alertness within 1 min. layed on floor for 10 min - sat for 20 more min - felt fine to go home B/P 130/70.
On several occasions, severe dizzy spells, extreme vomiting, rapid increase in blood pressure. I have been to the emergency room for this on about 5 occasions. No apparent cause has been found.
Information has been received from a certificated medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L038534, expiration date 19-AUG-2017, lot # reported as L0349638, expiration date 23-AUG-2017, lot # L046318, expiration date 28-SEP-2017, lot # M004542, expiration date 18-OCT-2017, lot # M007124, expiration date 05-OCT-2017; dose unknown), orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on back, arms, thighs, neck, face, stomach, chest Went to urgent care. Prescribed prednisone, pepcid, Benadryl
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 16-MAR-2017,  the patient was vaccinated with an improperly stored doses of M-M-R II lot # M028130, expiration date on 03-JUN-2018 (strength, dose number, route and anatomical location was not provided) for prophylaxis. It was reported that the vaccine M-M-R II was reconstituted with properly stored sterile diluent (manufacturer unknown). The dose of M-M-R II was in temperature of 48 °F (Fahrenheit ) degree for 52 hours. There was previous temperature excursion as 32°F (Fahrenheit ) for 15.5 hours. No adverse effect was reported and digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001059: US-009507513-1704USA001060: US-009507513-1704USA000553:
Date and time the adverse event (health problem) started. Chills started 12/31/20 in afternoon, more constant
Patient got a shingrix vaccine on 12/13/21 and reports today that he has tingling and weakness in his right hand. I expressed concern that he was going through side effects and asked if he had any soreness.   He got the shot in his right deltoid and had soreness the next day but did not have any symptoms for 2 to 3 days. On day 4 he experienced tingling and weakness in his hand and believes it is due to the vaccine. I asked him to consult with his doctor.  He reports he is fine otherwise.
Patient state that on 6/7/21 He became dizzy in the shower. On 6/8/21 he was very fatigue. 6/9/10 he started having burring in his leg and noticed red spots. called DR  6/10/21 and was told that if he was still have problems to come in. 6/12 - 6/14 patient stated that he slept for 15 hours of the day. 6/18/21 Patient stated that on this day he was in the shower he felt the water but could not feel temperature. He ran all Hot and then all cold and could not tell the difference.
Muscle aches in legs; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular from 18Dec2020 07:45 to 18Dec2020 07:45 at a single dose for COVID-19 immunisation. Medical history included sinusitis, HLD, and penicillin (PCN) allergy. Concomitant medication included vitamin c [ascorbic acid], tocopheryl acetate (VITAMIN-E), ergocalciferol (VIT D), magnesium and calcium. The patient experienced muscle aches in legs from 2 to 12 hours post vaccine administration (18Dec2020 10:00). Outcome of event was reported as recovered. No treatment was received due to the event.
Per mom - none - given too early - HEP A given at 2 months of age.
body ache; running nose; rough throat; cough; little chest pain; fever; This is a spontaneous report from a pathway via medical information team. A contactable patient (reporter) of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (age at the time of vaccination was not provided) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included sugar issue before the test from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Upon a forwarded document as an Adverse Event and Medical Inquiry by the team on 10May2021, the patient commented on the health condition that she had now after the first dose of Covid 19, the patient had sugar issue before the test (unknown). Now, the patient had symptoms of fever, body ache, running nose, rough throat, cough, and little chest pain when cough all on an unspecified date. The patient underwent lab tests and procedures which included body temperature: fever on an unspecified date. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
*Client received dose under minimum interval. 1st dose Pfizer received on 07/13/2021
weakness; Fatigue; lethargy; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: Unknown) via an unspecified route of administration on unknown date as 2nd dose, single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. On unspecified date, the patient experienced fatigue, lethargy, weakness. The outcome of the events was resolved on 3 days after 2nd dose of vaccination.  Information on the lot/batch number; Additional information has been requested.
The evenin of receiving vaccination I felt "normal" discomfort; pain, tender to touch and movement.  The following morning I felt pain/discomfort radiating from should downward but also felt a tingling/numbing sensation radiating down left arm.  Arm tingling subsided by end of day of 1/20/21, however, two fingers continue to have a tingling/numbing sensation - ring and middle finger of left hand
Patient receives an expired dose of ActHib described as the ActHIB portion was still within date but the diluent had expired/No AE; Initial information was received on 31-Mar-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case involves a 12 months old male patient who on 24-Mar-2020  was vaccinated with 0.5 ml dose of  HIB (PRP/T) VACCINE [ACT-HIB] (lot UI959AA  and expiry date of diluent was 07-MAR-2020  and ActHIB 19-Jun-2020) intramuscular route in the left thigh for prophylactic vaccination but the portion of vaccine was still within date but the diluent had expired (expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL VACCINE CONJ) [PCV-HAV] for immunisation.  Reporter stated that the box states the medication was expired not the bottle as the expiration date of bottle was 19-Jun-2020 and box had expired on 07-Mar-2020.  No laboratory data was reported.  It was an actual medication error case due to expired vaccine used.   At a time of reporting no adverse event 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 and Module VI of the 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.
Patient's arm swelled and became red within an hour of vaccine administration. She called today (next day) to see if she needed to go to the doctor. I explained that bruising, redness and swelling were all normal parts of a shot but she said that she never had a reaction before and was concerned. I told her to ice it, take anti-inflammatories, take benadryl or another antihistamine if the reaction continued and see a doctor if problems with breathing developed. Wanted to report it just in case the reaction escalated.
Headache, Myalgia, Fever, fever, body, aches, headache, fatigue Narrative: Day 1 - inj site sore; Day 2 -inj site sore, fever, headache, myalgia, fatigue; Day 3 - fatigue;
Cold Antibody Autoimmune Hemolytic Anemia; This is a literature report for the following literature source(s): (WITHHELD).   An 87-year-old female patient received BNT162b2 (BNT162B2), as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYANOCOBALAMIN; CALCIUM CITRATE; LATANOPROST ophthalmic. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 Immunisation. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (hospitalization, medically significant, life threatening), outcome "unknown", described as "Cold Antibody Autoimmune Hemolytic Anemia". The patient underwent the following laboratory tests and procedures: Blood bilirubin: 7.2; Blood lactate dehydrogenase: 567; Coombs direct test: Positive; Haematocrit: 13.4; Haemoglobin: 5.4; Haptoglobin: less than 30; Physical Exam: Within normal limit; Smear test: agglutinated erythrocytes; Vital signs measurement: Within normal limit. Therapeutic measures were taken as a result of autoimmune haemolytic anaemia. She received 5 units of Packed RBCs and was started on Rituximab and discharged home. Rituximab was later replaced by cyclophosphamide due to failure in therapy. Patient was then readmitted for worsening anemia and was discharged to home hospice.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the event is related to the vaccine administration cannot be excluded. 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.
fever and chills onset at 12:30am (13 hours post-vaccine). Fever and chills remained for approximately 17 hours. Symptoms resolved in 24 hours.
Patient experienced tingling on left side of ace and left side numbness from hip to foot.  Patient visited ER on 8/19/2021 and a stroke was ruled out
Fatigue; Ear pain; This is a spontaneous report received from a contactable consumer, the parent. A 23-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: P6955) in the left arm via an unspecified route on 20Mar2021 at 11:30 as a single dose (at the age of 84-years-old) for COVID-19 immunisation. The patient had no known allergies. Medical history included ADHD. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 12:00, the patient had fatigue and ear pain. The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue and ear pain was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.