chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Days after I got the first shot I got a bruise on my right foot. Went away.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Jun2021 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: food intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONTUSION (non-serious) with onset 2021, outcome "recovered" (2021), described as "Days after I got the first shot I got a bruise on my right foot. Went away.". The event "days after i got the first shot i got a bruise on my right foot. went away." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of contusion. Additional information: The patient was not pregnant at vaccination. Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Adverse event: Days after I got the first shot, I got a bruise on my right foot. Went away. Within like 2 days after I got my second shot I got the same bruise in the same spot. Since then, I started getting them on my arms as well, back on my foot, feeling of restlessness and a lump first on one leg that went away in about 4 days and then another around pelvic area also took about 4 days. One Dr said I do have something vascular going on. Blood and urine test came out ok. Doctors did not rule out that it could a reaction. I got several opinions, and nothing explains why.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101186410 same reporter/patient/product, different dose/event.
This spontaneous report refers to an 81 year old male patient. On an unknown date in 2013, the patient was vaccinated with ZOSTAVAX for shingles vaccination (dose, lot and expiry date were unknown). On an unknown date in approximately October 2013 (reported as a month ago) the patient experienced developed the shingles after receiving ZOSTAVAX. The outcome of event was reported as resolving. The patient was given VALTREX of unspecified dosage as treatment for the event. Lab diagnostics studies performed were done. The patient had seen his physician to seek medical attention. Additional information is not expected.
Pt felt ill later in the day on 10/21/2020 and vomited. Pt was described as lethargic on 10/22 and 10/23 and lack of appetite also observed those days. Pt was brought to local ER where he was admitted to the ICU. He had bloodwork done when admitted to ICU but was not specified to me. Pt died 10/24 around 3AM
Wrong Vaccine given. Zoster given instead of varicella vaccine. No reaction as of this time.
My symptoms started the second day after the shot. I started getting tingly in my hands and then my toes, which then the next day I had horrible pain in my legs. Every single day it would get worse, and also added fatigue, brain fog, and lightheadedness. We are now at day 8 and I am still having horrible pain in my legs, head pain, lightheadedness, brain fog, rapid heart beat etc. I went to the hospital on day 6 because I woke up with a racing heart, and feeling like I was going to pass out. They ran tests for blood clots and did not find any. However, we are still going now on day 8 with horrid side effects. My legs constantly feel like they are inflamed and on fire.
Patient presented to hospital clinic with c/o redness warmth tenderness measuring 8cm. Instructions to ice, Motrin, Preparation H applied to site and monitor
Initial report was retrieved via the scientific literature on 30 January 2012. From the published article: Objective: The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), in pregnant women who received H1N1 to assess for potential vaccine safety problems. Study Design: The authors reviewed reports of adverse events (AEs) in pregnant women who received H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010." Results: The results found 422 reports which involved pregnant women. Of the 422 reports, 128 were reports in which there were no AEs were reported. Of the remaining 294 reports, 288 had received inactivated vaccines and 6 had received lived vaccines. Medical records were obtained for 240 reports (81.6%). Sixty reports (20.4%) were coded as serious, including 2 maternal deaths. Serious reports corresponded to 59 pregnant women who were hospitalized for any reason and one to an infant born with a congenital anomaly. Of the reported cases 121 women had spontaneous abortions (at less than 20 weeks gestation) with onset interval from the day of vaccination to onset of AE reported as 0-3 days (61 reports with onset of 0-6 days). Stillbirths were reported in 19 women with the onset interval from the day of vaccination to onset of AE was 0-6 days. It was noted that there was no observed clustering of spontaneous abortions or stillbirth cases by geographic location or lot number. There were two maternal deaths which included one patient who experienced hemorrhagic shock because of uterine atony following a cesarean section and one patient who experienced a ruptured aortic aneurysm, which resulted in cardiac tamponade and subsequent death. Other pregnancy-specific outcomes reported included: preterm delivery, threatened abortion, preterm labor, preeclampsia, intrauterine growth restriction, fetal hydronephrosis (which was later determined not to be present), fetal tachycardia, neonatal intraparenchymal hemorrhage and intrauterine fetal death. The most common nonpregnancy specific AEs were nonanaphylactic allergic reactions, constitutional symptoms, and local reactions. Other non-pregnancy-specific outcomes reported included: paresthesias, Bell's palsy, syncope, dizziness, hypoesthesia, headache and one case of anaphylaxis. There were no cases of Guillain-Barre syndrome identified. Conclusion: During October 2009 through February 2010, approximately 3% of reports to VAERS after H1N1 vaccine were of pregnant women who experienced at least 1 AE after vaccination. Among 294 VAERS reports of AEs in pregnant women after H1N1 vaccination with inactivated and live vaccines, the authors did not observe any unusual patterns of adverse maternal or fetal outcomes. The reporter for this case is also the reporter for case 2012-01250. Documents held by sender: none.
Patient reports that the morning following administration of the vaccine that he had chills and spots/bumps that began to appear in random places on the body. Specifically the right side of his body. They are very itchy but not painful. He states they last about 24 hours then disappear but new ones appear in other random places.  Patient stated that if the symptoms continued he would follow up with primary care physician on Monday 10/21/19.
has a cold; flu like symptoms; throat drainage; cough; Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (has a cold), INFLUENZA LIKE ILLNESS (flu like symptoms), DRAINAGE (throat drainage), COUGH (cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 058H21A, 021B21A and 024M20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021). On 26-Feb-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DRAINAGE (throat drainage) and COUGH (cough). On an unknown date, the patient experienced NASOPHARYNGITIS (has a cold). The patient was treated with CAFFEINE, CODEINE PHOSPHATE, DOXYLAMINE SUCCINATE, PARACETAMOL (SYNDOL [CAFFEINE;CODEINE PHOSPHATE;DOXYLAMINE SUCCINATE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (has a cold), INFLUENZA LIKE ILLNESS (flu like symptoms), DRAINAGE (throat drainage), COUGH (cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 03-Mar-2021 and dose 2 on 21-Mar-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had cold and had symptoms of throat drainage, cough, and flu like symptoms.
Kinrix administered to a 1 year and 8 months old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 19th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 07-SEP-2022 Reporter's Comments: The health care professional reported that a 1 years and 8 months old patient received a Kinrix dose. The reporter consent to follow up. Additional Supportive Information: The 1 years and 8 months old patient received a Kinrix dose, which led to inappropriate age at vaccine administration.
T 103, in evening of 2/10/11, date of immunizations, next day T 101, Pt did not appear ill to parents, on 2/12/11, afebrile.
Symptoms began during night on 4/28/11. Bad headache, fever 103. 5 degrees, dizziness, vomiting and nausea. Fever responded to MOTRIN. Slept well. On 4/29/11 symptoms returned. Spiked fever of 104 degrees in AM. Took TYLENOL. Fever responded by suppertime 4/29/11 symptoms all resolved except a slight backache. Still experiencing backache on 5/2/11. Was relieved by TYLENOL.
Taken to the hospital and admitted due to low blood sugar (40's) and felt ill. He was released the next morning.
WEEPING EYE; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced weeping eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weeping eye was not reported. This report was non-serious. This case is a duplicate of 20221241285.
Headache, Lots of joint pain, muscle pain, fever. Pain in arm where vaccination was injected.
04/06/2021 -5pm redness that looked like a sunburn on both arms,  04/14or 04/15/2021  7pm worst leg cramp I've had since I was pregnant over ten years ago in right leg,  4/18/2021 about 3pm, all of a sudden there was a blood clot next to my eye (between my eye and my nose). No pain, just appeared.
Localized erythema, swelling and itching-Left arm. ( full length of humerus )
Swollen/red bicep and arm not at inject site. Patient stated arm is much larger than other arm and bleed a lot at time of injection.
Continuous migraine; Fatigue; Neck pain; Remittent chest pain; Burning back; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm left on 16Apr2021 at 13:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included interstitial cystitis, endometriosis, penicillin allergy, meat allergy (beef, pork, poultry), egg allergy and milk allergy (diary). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), amitriptyline (MANUFACTURER UNKNOWN) and hyoscyamine sulfate, methenamine, methylthioninium chloride, phenyl salicylate, phosphoric acid sodium (URIBEL) all were taken for unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 14:45, the patient experienced continuous migraine, fatigue and neck pain since the vaccine date every day for two weeks, still going strong. Remittent chest pain since then as well. Burning back, chest pain, migraine, neck pain, and fatigue began about an hour after receiving the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events continuous migraine, fatigue, neck pain, remittent chest pain and burning back were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Paxlovid was great but 3 days after I tested negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient had no known allergies. Patients did not receive other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was given the shot and almost immediately felt woozy, light headed.  The practitioner left the room to get a cold compress and upon returning found the patient had passed out in the chair and fell forward and hit her head on the countertop.  She proceeded to have a seizure per her mother.  She then vomited and then was beginning to feel better.  About 10 minutes later she complained of blurred vision and ringing in the ears.  Upon talking to the pediatrician's office the mom then proceeded to call for emergency services.  She was then transported to the hospital via ambulance.
This case was reported by a physician and described the occurrence of increased liver function tests in a 60 year old male pt with hep C who received hep A inactivated and hep B recombinant vaccine (Twinrix). The pt's past medical history included hepatitis C and "liver function tests" (NOS) that were "twice the upper limit of normal" at baseline. Concurrent medications included pirbuterol and methylcellulose. On 11/19/03, the pt received the first dose of Twinrix. Approximately 10 days later, on 11/29/03, the pt developed increased liver function tests, a fever of 102 deg F, chills, sweating, fatigue, tingling in his toes, weight loss and chronic neck pain. On an unspecified date, the pt also developed an elevated erythrocyte sedimentation rate. On 12/18/2003, the pt received the second dose of Twinrix. Approximately two hours after the second administration, the pt's fever "went up." At the time of reporting, the pt's liver function tests were "four times upper limit of normal," and he had experienced a weight loss of thirty pounds over an unspecified time interval. The events were unresolved at the time of reporting. The physician considered the events to possibly be related to vaccination with Twinrix. A weight loss of thirty pounds was considered to be medically serious (OMIC) by manufacturer.
rash on lower part of upper arm. not near injection site. started on 7/16. pt advised to use Benadryl or hydrocortisone for itching if needed. see doctor if worsening or no improvement
Rash: pink in color, oval around injection site, itched intermittently. According to column in paper, dermatologists are tentatively calling it "delayed cutaneous hypersensitivity." Treatment: None needed Outcome: itching gradually subsided; rash had entirely disappeared by 2/4/2021 (one week after it had appeared) I consider it more of an after-effect than an adverse event
w/in an hr, arm became swollen, red @ site, & very painful;inc in intensity for 36hrs; arm became difficult to use;bruising approx 3" x 4" @ site;
Patient verbalizes that the influenza vaccine (FLUARIX) administered on august 23, 2022 approximately on September 5, 2022 she began to present swelling in the face , cramps in both legs and left arm and pain in the lower back.
After injection, patient passed out, stiffened and had very short period of "shaking" of extremities falling to floor, responsive in few (5-7) came to. Was aware of surroundings.
I received a flu vaccine at Dr office. About an hour later my (L) arm began to burn and itch. I took a look at the site and my arm had a very large red area that was inflamed and itching. Lasted for 4 days. Cortisone cream applied.
When given the second shot, I had immediate tingling up neck into ear.  A day or two later I noticed I had tinnitus a rushing/fullness in ear - mostly left ear (side which I received shot).   Still have it once and a while, although not daily which I had in the beginning.
One to 1 1/2 hours post vax, saw small red spots on face, no hives, spots disappeared in the afternoon.
A report has been received from a Physician concerning , who had been receiving FLUMIST QUADRIVALENT (INTRANASAL), 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT (INTRANASAL) started on an unknown date. The patient experienced RUNNY NOSE. The outcome of the event of RUNNY NOSE is unknown. The report was considered to be non-serious.
Patient presented to outside ED with left-sided chest pain since the previous day. Troponin level was 0.9 so she was admitted to ICU on 7/30/2021. ECHO and CXR were within normal limits. Cardiac MRI was ordered but cancelled due to resolution of symptoms and discharge. Patient was discharged on 8/2/2021. Second COVID vaccine was given 6 weeks prior to onset of symptoms. Patient received the Pfizer vaccine.
about two minutes after standing up to go to the waiting room, I became incredibly dizzy. I sat down and closed my eyes. I had an instant sensation in my forehead, right side -- not pain, more like a tightness, like the beginning of the headache.  I couldn't move my eyes left and right without dizziness. It felt like I was on a pain pill. That kind of lightheadedness.  and the tightness moved around my forehead about every 10 minutes to different spots. Was also present in back of my head at bottom left pressure point. At one point my forehead was very tender and within the next few minutes it had gone numb. a doctor and EMS checked my vitals. All were normal. I've recently lost 25 pounds and the doctor thought maybe my thyroid function had improved and that potentially my medication dosage now makes me hyperthyrodic. I'm not dizzy on a regular basis, but am still going to check with my personal doctor.   They checked my vitals every 15 minutes and it was about an hour and 15 min before I felt comfortable standing and walking.  I went home and went to sleep (it was 3 pm), which is not normal for me.  I was wrecked. The next day, all was normal, except for the pain in the injection site, arm, which I expected.
This spontaneous report has been received from a pharmacist refers to a patient of unknown age. On 09-AUG-2010, patient was vaccinated with first dose of GARDASIL (lot # and expiry date unknown) injection 0.5 ml, intramuscularly. No concomitant medication was reported. The second dose of GARDASIL was given on 09-AUG-2011, and the third dose of GARDASIL given on 07-JUN-2012. No adverse effects reported. There was no product quality complaint. No further information provided. Outcome of the reported events were unknown. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. On unknown dates, since 02-OCT-2014 patients were vaccinated with GARDASIL (lot#, route and dose unknown) which had been exposed to temperatures outside of the recommended range. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received below shots, and 5 min later had syncopal event, passed out, hit head on floor. Hemoglobin, glucose, BP all normal. Patient had large lump on head, observed in ED, CT scan negative and had headache days later. Dx concussion.
Systemic: Allergic: Rash Generalized-Medium, Systemic: "blistering all over the body"-Medium
pt recv vax 20SEP96 on 23SEP96 pt exp gen malaise, fever;gen aches;cough & nausea;presented to MD;pt tx w/pred for 3 days which helped sx;
Chills started at 4:00 PM on 3/26/2021, I woke up at 1:30 AM, chills were gone but had a headache which lasted 2 days.  Nausea started that morning and increased in intensity associated with dry mouth.  The nausea was constant.  I couldn't stand the smell of food.  I drank lots of water, forced myself to eat some crackers, lay on the sofa all day for several days.  On 3/29 I started taking Omeprazole.  On 4/3 my nausea started improving and by 4/5 was gone.
Moderna vaccine  (NDC  80777-0273-98) lot#  039D21A + GTiN  00380777273983  was administered  after the beyond date of 10/23/2021. Contacted Manufacturer Monderna = no need to repeat the dose  .
Uncontrollable shaking x approximately 30 seconds. Color good, A and O, no resp difficulty, VS stable D/Ced home from ER.