chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with M-M-R II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 08-SE_-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes, no known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter linked). Additional information has been requested.
Right away I went back to bed, dizzy, no appitite, feeling really bad. Weak headache. 102 fever.
subconjunctival hemorrhage in left eye.  Had similar in right eye after first booster on 9/10/21.   I have never had a subconjunctival hemorrhage prior to my first booster.
Fever, rash following ADACEL and PNEUMOVAX vaccine administered on 04/27/2010.
24 hours later, 1.5 degrees of fever. 36 hours after, COVID arm with swelling and 2? diameter redness and tenderness. Swollen lymph node underarm and two small swollen nodes in same side of neck. Nodes still slightly swollen after two weeks.
During these holds the inflammation and stiffness came back; During these holds the inflammation and stiffness came back; This is a spontaneous report from a contactable other health professional and a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced  the inflammation and stiffness came back during these holds on an unspecified date.  The outcome of the events was unknown. Clinical course: patient reported after start of therapy she missed 7 days of medication for her first covid-19 vaccine at the end of April 2021and another 7 days for her second covid-19 vaccine two weeks ago. patient reported during these holds the inflammation and stiffness came back.  Information about batch/lot number has been requested.
Within 24 hours, left arm was red, swollen, hot and itchy. Measurements of left shoulder 24.5 cm diameter. Right shoulder: 22cm L mid arm 22.5 cm. Right mid-arm 18.5cm Left above elbow 15cm Right above elbow 16.5cm. Treatment: Keflex and Atarax with follow up in 10 days.
expired dose of flulaval; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number DM4FM, expiry date 18-JUN-2023) for prophylaxis.   On 20-JUN-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 20-JUN-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: expired dose of flulaval). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Jun-2023 The reporter consented to follow-up. The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.
I was having a cough on Sunday and it developed into congestion and runny nose. By the third day I was having flu like symptoms, a headache that was more like a migraine, and was tired and weak. I took a COVID-19 home test which was positive. I did lose my smell and taste on the fourth day. I tracked my blood oxygen levels and my heart rate and really did not have too bad of shortness of breath so I used cold medicine to cope with the symptoms.
pt recv vax 31MAR95 & 3APR95 devel pruritis; 4APR95 devel hives on abd, lower back & legs; joints in toes on lt foot swelled; seen by MD given Pred;
Patient states she became totally weak. She could barely stand or walk. Her daughter had to call the paramedics. Her pulse was 140 and BP was extremely low. She did not go to the hospital for treatment. By the following day she was still ill but feeling a little better. By the 3rd day she was getting some of her strength back, feeling about 40% better. It took her over a week to get back to normal. She was much sicker than she was ever when she was taking chemotherapy. She states she was so sick that she will never take another booster or Covid vaccine. She had an appt. already scheduled w/ her Cardiologist, so she let her know what happened after her vaccine.
Information has been received from a physician concerning a female patient who on 18-MAY-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The patient received zoster vaccine live (Oka/Merck) from a provider other than her treating physician because she had been exposed to shingles (time frame unspecified). On 19-MAY-2008 the patient experienced injection site soreness and swelling. The patient was seen in the physician's office and prescribed an unspecified steroid as treatment. No product quality complaint was involved. Additional information has been requested.
first shot of GARDASIL in March 2016/second and third dose she received GARDASIL 9; the first dose was "painful"; arm was sore; This spontaneous report was received from a consumer who refers to herself, a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in March 2016, the patient was vaccinated with 1 dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided). The first dose was painful. The patient explained that her arm was sore with the first dose.   The patient reported that for the second and third dose she received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot number and expiration date were not provided) vaccine in May 2016 and October 2016. The patient stated that she cannot remember if the second or third dose was painful.  The outcome of the event was unknown. The causality assessment was not provided.
approx 23hr p/vax presented w/non tender swelling & redness of upper arm just below shot area of darker redness 9cm x 6cm, total redness 9cm x 10cm;swelling <9x6cm;no fever;no systemic sx;
Received flu shot injection, on 10/28/14 in left arm, went directly to work afterwards but did notice some left arm tenderness that persisted throughout work day. Went home that evening showered then went to bed as usual but woke up this a.m; 10/29/14, and noticed injection site redness and swelling as well as sharp same w/left arm and left leg. Redness where bandaid applied as well as 2 inches swollen on (L) upper outer arm. Directed clinic supervisor to report. Denied further medical follow up. Did not seek medical attention for the other arm.
Patient experienced sudden onset of projectile vomiting, chills, weakness, and appeared pale approximately 2 hours after receiving her second dose of Pfizer/BioNTech COVID19 vaccine on 2/10/2021. She was sent to the hospital for evaluation per the recommendation of her physician.  She was discharged from NCH at 9:15pm back to Assisted Living.
Admin HIB to left upper arm. Dev urticaria type rash arm and torso approx 10-15 minutes after admin of shot.  Admin ITSP Benadryl LIQ after 20 min, rash fading. No resp distress.
HEAVY AND LONG MENSTRUAL BLEEDING; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 or 10-APR-2021 the patient had Heavy and long menstrual bleeding with large blood clots. Patient went to emergency room on 17-APR-2021 and was given Medroxyprogesterone (Provera) which minimized the bleeding but didn't stop it. On 02-MAY-2021 the bleeding started back heavier with the blood clots once again. Patient again visited ER and injection was given to stop the bleeding (lupron) and Megestrol was prescribed. On 04-MAY-2021, Laboratory data included: Biopsy (NR: not provided) patient did not note diagnosis. On an unspecified date, patient experienced headache. Treatment medications (dates unspecified) included: leuprorelin acetate, medroxyprogesterone acetate, and megestrol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heavy and long menstrual bleeding and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509200-covid-19 vaccine ad26.cov2.s-heavy and long menstrual bleeding . This event(s) is considered unassessable. The event(s) 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(s).
High fever to 104 F. @ 5pm precipitating a simple febrile seizure of about 2 minutes.
My son was given the first shot (of the 4 that needs to be given) on the 23rd March 07 at 2030 Hrs in the evening - he had a seizure the very next day on the 24th at 1120 Hrs and was rushed to the ER. CT Scan - LP Test and EEG was conducted on him and all were normal. He was hospitalized for a period of 5 days (2 Days of ICU Care) now he seems fine but i would like to know the possibilities of the Seizure to relapse in the future - the medication prescribed for him is EPTOIN a syrup and i was also told that it has some serious side effects to the Brain.
Monday around lunch I began to notice an inching feeling in my midsection. When I got home that afternoon I was reasonably certain it was shingles. The rash looked and felt consistent with a previous course of shingles about 18 years ago.  I set up an appointment the next morning. Course was short due to starting antivirals within about 30 hours of first symptoms.
After 2nd dose: red spot rash over stomach, arms and legs; After 2nd dose: red spot rash over stomach, arms and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH MACULAR (non-serious) all with onset Mar2021, outcome "recovered with sequelae" and all described as "After 2nd dose: red spot rash over stomach, arms and legs". The event "after 2nd dose: red spot rash over stomach, arms and legs" and "after 2nd dose: red spot rash over stomach, arms and legs" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash erythematous, rash macular.  Additional information: Patient received third dose in Oct2021, Lo no: fh8020 in left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. There were no known allergies. Events faded after dermatoligist drugs. Treatment included Oral and topical steroids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospital Course and Significant Findings: 65 year old woman with renovascular HTN, prediabetes, tested positive for COVID 1/18/23, admitted 1/29/23 with hypoxia.  Receiving remdesivir, dexamethasone, ceftriaxone, doxycycline. Initially required 3L O2.    Able to wean off of oxygen and felt ready to discharge home on 2/2/23. We discussed option to stay for final remdesivir, but given that she was feeling better and on room air she opted to go home which I agree is reasonable. She will complete additional 3 days of antibiotics. No dexamethasone at discharge as no longer hypoxic.  Rechecked A1C and it is slightly elevated 6.1 . She will work on diet/exercise. She did require insulin while admitted but this was likely steroid-induced hyperglycemia.    At the time of hospital discharge Patient is feeling well and she is eager to go home. Return precautions given for hypoxia (given pulse ox prior to discharge), chest pain, shortness of breath. She is in agreement with the discharge plan.
L arm swollen, red and with mild tenderness.  Swelling increased to elbow. No fever, no hand swelling.
Information has been received from a medical assistant concerning a 12 month old female who was vaccinated with a dose of MMR II, a dose of VARIVAX (Merck, a dose of VAQTA and a dose of PNEUMOVAX 23 (manufacturer unknown). Patient had developed blisters near the injection site. No further information provided. The medical assistant also reported that other patients that had similar reaction, said she had heard about them but did not see them. She thought there was 2 more patients. She did not know what vaccines had been given (if they were Merck drugs) or any other details, other than they had blisters near the injection sites also. Additional information has been requested. This is one of several reports from the same source.
During vaccine administration patient had an episode of syncope. Patient remained conscious but was out of if for a few seconds, was pale but vital signs stable throughout. Patient recovered after 5-10 minutes of resting, drinking water and ice being applied to head.
Moderate to severe full body muscle aches. Continue to worsen, especially following mild to heavy exertion.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Aug2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing), notes: Other medical history: CLL. Concomitant medication(s) included: VENCLEXTA, start date: 05Jun2022, stop date: 09Jun2022; BENICAR, start date: 05Jun2022, stop date: 09Jun2022; CRESTOR, start date: 05Jun2022, stop date: 09Jun2022; AMBIEN, start date: 05Jun2022, stop date: 09Jun2022; XANAX, start date: 05Jun2022, stop date: 09Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 immunization. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient did not have any Known allergies. Antiviral details-Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 05Jun2022, Treatment stop date: 09Jun2022, Indication: Treatment of COVID-19. Adverse event: I have had a rebound of Covid 19 after completing a 5-day course of Paxlovid. Symptoms include cough, low fever, headache. Adverse events start date: 13Jun2022, Adverse event start time: 04:45 PM, If patient recovered: Recovering, If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient receive first vaccine around 0930 on 8/30/19.  States she felt fine all day and went about her business.  In the evening she started feeling weak and went to bed.  Woke up, got out of bed around midnight and had difficulty moving arms.  Sat down and fell off of chair.  She was unable to get up after several attempts.  Daughter brought her to the ER. She stayed in the hospital 2 nights with PT/OT and was discharged home.  Below is a synopsis from her medical record:   " Patient is 82-year-old woman presents to the emergency room complaining of fall at home and weakness. Past history significant for hypertension, post-polio syndrome. Is normally fairly independent, ambulatory, drives herself. First shingles vaccine given the day PTA.    She was brought into our local ER, where on arrival she was hemodynamically stable. Blood pressure 150/80, heart rate of 90, temp of 97.8. She was SATing well on room air. CBC reveals no anemia or leukocytosis. Her metabolic panel is mostly unimpressive. Troponin is within normal limits. TSH is unimpressive. Lactic acid within normal limits. Her UA is negative. Chest x-ray is obtained revealing no acute infiltrates. Internal Medicine was asked to admit her as she is unable to ambulate in the ER."
Next morning woke up with numbness in hands and legs; Severe body chills; Shakes; Whole body hurt and body aches all over; Fever the night of vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 23:30, the night of vaccine, the patient experienced fever. On 17Apr2021, next morning, the patient woke up with numbness in hands and legs, severe body chills, shakes and whole body hurt and body aches all over. All side effects lasted until the next morning and were all gone at the same time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, numbness in hands and legs, chills, shakes and whole body hurt and body aches all over were resolved on 18Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd 3 doses of Engerix-B 7JAN91, 7FEB91 & 11JUL91 & reporter indicated due to neg HBSAB titer result; 4th dose of Engerix-B required 20SEP91;
This case was reported by a pharmacist and described the occurrence of vocal cord paralysis in an adult female subject who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. On an unspecified date the subject received 2nd dose of Engerix B at 20 mcg. At an unspecified time after vaccination with Engerix B, the subject experienced vocal cord paralysis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
I got sick to my stomach an hour after getting the shot and it lasted all night. I didn?t have much appetited. I had vomiting and diarrhea for seven hours. I had hives about an hour and a half after the shot all over especially and my feet. The hives were extremely itchy, and my skin felt like it was on fire. The next morning, I went to urgent care and gave me an anti-itch medicine/antihistamine Hydroxyzine. The prescribed medicine knocked me out, but it only helped a little with the itching. The hives stayed for another four days. I have also had severe joint pain that is still lingering in my feet and hands. I don?t normally have joint pain, but it started the day after the shot.
This spontaneous report was received from a physician refers to a 5 month old female patient. The patient's medical history included reflux and unspecified gastrointestinal symptoms. On 09-OCT-2013, the patient was administered a third dose of ROTATEQ (lot#, expiry not reported), 2 ml, orally earlier than recommended. The first dose of ROTATEQ (lot#, expiry not reported) was administered on 16-AUG-2013, and the second dose of ROTATEQ (lot#, expiry not reported) was administered on 18-SEP-2013. Concomitant therapies included PRILOSEC. The physician reported that the physician usually has unspecified gastrointestinal symptoms. However, the patient had extra gastrointestinal gas during the weekend of 11-OCT-2013 to 13-OCT-2013. Patient sought medical attention. The physician also reported that the patient was seen in her office on 17-OCT-2013, and the patient had developed a cold on an unspecified date in October 2013. No treatment was given. No laboratory tests were performed. The physician reported that the patient's gastrointestinal gas has completely improved on an unknown date in 13-OCT-2013. However, the physician was unaware if the patient had recovered from the cold. Additional information has been requested.
She got the vaccine, she started getting itching in the arm the following day around 6:00 PM.  She then started getting welts that were feverish and hot, and took Benadryl.  Last night she started itching really bad all over, and woke up feeling as if she could not breath, tightening in her chest, possible panic attack.  The welts went away, which was a big huge mosquito bite and also spots on her leg.  Today she has blotchy rash spots on her body in various places.   Also having nausea, slight headache today, did not sleep well due to the itching.  She continues to take the Benadryl.   She called the paramedics this morning around 6:00 AM, and they checked her out due to the tightness in her chest, and they checked her out, told her the oxygen was normal, and her VS were fine.  She declined to go to the hospital with the option if it got worse she would come to the hospital.
started with soreness to the right armpit after few hours. had some fever that night. woke up feeling  very tired and rested most morning. pain had moved to right upper chest that morning and then to the right neck. she also felt a tender lymph node in the right supraclavicular area. took tylenol to help on saturday.  symptoms are getting better now
Pt received PPSV23 vaccine in (R) deltoid at 1000. Pt developed worsening pain from (R) shoulder down (R) arm. Pt presented to ED, found to have intact strength, pulses, sensation, limited ROM S/T pain, this was on 9/22. Pt calling clinic C/O continued pain, no improvement, Pt to be evaluated in clinic.