chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with CDiff; rectal bleeding; she was experiencing recurring GI bleeding; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in arm left, administration date 06Jun2021 (Lot number: EW0187) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: sensitivity to milk" (unspecified if ongoing). No covid prior vaccination. It was unknown if covid tested post vaccination. Concomitant medications included: PROBIOTICS NOS (possibly); VITAMINS NOS. The patient did not receive other vaccine in four weeks of vaccination. Vaccination history included: Bnt162b2 (Lot number: EW0170, Administration route: Intramuscular, Vaccine location: Left arm), administration date: 16May2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant) with onset 2021, outcome "unknown", described as "diagnosed with CDiff"; RECTAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "rectal bleeding"; GASTROINTESTINAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "she was experiencing recurring GI bleeding". The events "diagnosed with cdiff", "rectal bleeding" and "she was experiencing recurring gi bleeding" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: GI inflammatory markers: high. Therapeutic measures were taken as a result of clostridium difficile infection, rectal haemorrhage, gastrointestinal haemorrhage and included treatment with vancomycin antibiotic. Clinical course: Reporter's daughter started experiencing rectal bleeding over the summer. Her GI inflammatory markers were high and she was diagnosed with CDiff despite not being on recent antibiotics or being in a hospital or nursing home. Because this happened over 2 months after the vaccine administration, it did not occur to reporter that this was a potential adverse event. However, given that she was experiencing recurring GI bleeding and a friend just texted about her mom dying with heart and lung inflammation (separate record report), reporter was wondering if she was having a long term inflammatory reaction due to the vaccine.; Sender's Comments: As there is limited information in the case provided, the causal association between the event clostridium difficile infection, rectal haemorrhage, gastrointestinal haemorrhage and the suspect vaccine COMIRNATY 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.
Patient reported developing sore arms, redness and swelling halfway down to the wrist, vomiting, nausea, and fever on 9-23-2021. Fever has resolved as of 9-27-2021. Other symptoms persist. Patient took acetaminophen for fever and promethazine for nausea/vomiting.
muscle aches; Chills; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, immediately after receiving Shingrix, the patient experienced muscle pain and chills. On an unknown date, the outcome of the muscle pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle aches & chills. The reporter asked could I take some acetaminophen to help with those reactions.
Patient was given .5ml instead of .25ML, denies any problems since vaccine administration, patien called and informed of dosage and letter also sent to patient
Patient developed coughing after 1 hr being vaccinated patient said he has a history of chronic tonsillitis and the cough may exacerbate c/o difficulty in breathing. He did not think that this was serious so he did not seek for medical advice. It resolved on the next hour by itself. He also developed dizziness and itchy eye, also mild rash all these symptoms disappeared the next morning.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Report received on 21-05-2021 updated event onset .Event onset date added.
48 hours after receiving the vaccine, I began experiencing nausea and abdominal pain/acid reflux, night sweats and chills, headaches, sinus inflammation and pressure. These symptoms continued for 5 days. 8 days after the vaccine, I had a wheal and flare reaction in my right arm in the injection site. This has been lasting for about 3 days.
Patient with redness and swollen left arm, low grade fever. After 4 days started with swollen gland under.
Mother called with concerns about side-effects from vaccines (nausea, dizziness).  She stated that she told her child to "sleep it off" and is checking on her periodically throughout the day.  I asked if child had high fever or unusual behavior, which mom denied. I told her that while it is not uncommon to have side effects to vaccines, that she should seek medical attention if they persist or become worse.  I asked her whether the child had a family doctor to seek attention.  Mom stated "she is fine.  Have a nice day."  That was the end of the call.  I will F/U with VAERS report.
15 hours after - fatigue, joint pain,  muscle ache. Lasted 10 hours.  Day 4 - Enlarged lymph nodes, sore lumps on both breasts, still present on day 11. Large golf ball size lump in right armpit sore to touch, developed 3 days after and still present on day 11.
Started with headache then top of my head went numb. All around the crown. Then had freezing chills
About six hours after the shot, I had a fever, headache, exhaustion, nausea, and muscle soreness. These symptoms lasted about 32 hours.
Severe Ringing in Ears,  Tinnitus, Particularly pronounced in right ear
Delayed local immune reaction. Two red patches, itchy, red, and swollen. One at site of innoculation and the other a few inches below both on left arm. Resolved within 72 hours
The patient became light headed and vomited. The patient ate crackers and juice and left on their own accord.
vomiting; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN5318, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 06Feb2021 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure (as reported) from an unknown date. Concomitant medications included amlodipine taken for blood pressure; colecalciferol (VITAMIN D 3) taken for vitamin supplementation; zinc for an unspecified indication; minerals nos, quercetin, thioctic acid, vitamins nos (EMERGEN-C) taken for an unspecified indication and cyanocobalamin (VIT B12) taken for an unspecified indication - all taken from 2019 and ongoing. On 13Feb2021 at 02:00, the patient experienced chills and was vomiting a half an hour later at 02:30. The patient did not knowhow long the chills lasted but probably lasted maybe an hour and a half. She went back to sleep and her husband gave her another blanket. The patient was vomiting for maybe 5 minutes. The patient recovered from chills on 13Feb2021 at 03:30 and from vomiting on 13Feb2021 at 02:35.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse refers to a 5 year old patient. On 30-SEP-2013, the patient was vaccinated with a first dose of an expired dose of PNEUMOVAX 23 (lot # 0491AE, expired date 15-SEP-2013). No adverse event was reported. Additional information is not expected.
Janssen COVID-19 Vaccine EUA  Major body aching, chills, fever. Still at 24+ hours after vaccine.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Developed severe bone and joint pain following vaccination. In addition, she was diagnosed with auto-immune optic neuritis which is a condition seen in Multiple Sclerosis (MS).  (OMIC)
Patient reports receiving vaccine on 11/10/14 without complication and on 11/17/14 reports a pinkish/red 4" long reaction. States on 11/18/14 may be itchy.
Pt. states she developed fever approx 10-12 days post MMR vaccination. On Thurs. 6/23/11 - pt developed all over body rash starting at head and spreading down trunk & extremities. Pt. was evaluated & treated at her primary care office for suspected measles.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 18-FEB-2016 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # K000737, expiration date 16-JAN-2016; dose, dose number and route not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a fever of 100.9 degrees F. when I brought her home from school around 5:30. I gave her 5 mL of children's Tylenol. She was acting lethargic and barely ate any dinner. We took her temperature at 6:45 pm and it had not changed. We gave her a quick bath. Her heart was racing and she was upset so we took her out of the bath. When we took her out she had a short convulsion. We were advised to call an ambulance. When they arrived her temperature had gone up to 102. The doctors at the ER later said it was likely a febrile seizure or something similar related to the COVID-19 vaccine she had received 2 days earlier.
No adverse effect was noted during the visit. The intake personnel at the covid vaccination clinic report that the family led them to believe that they were here for their daughters 2nd dose in the series. After the vaccine administration the nurse verbally asked "this was the 2nd dose, correct?" and at that time was told by the family that this was a booster dose. The family went on to say that they were instructed by their pediatrician (Dr) that they needed to get their daughters a booster due to traveling frequently.
Within 18 hours of injection: Severe chills(couldn't get warm no matter what I did) fatigue headache muscle/joint pain-hurt to walk Severe arm pain at injection site lump under arm(still here 5 days after injection) Two days after injection: Arm swollen from upper down to wrist Swollen, itchy,  painful....still red/rash/itchy five days later
This case was reported by a pharmacist via sales rep and described the occurrence of shoulder pain in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain and phantom pain. On an unknown date, the outcome of the shoulder pain and phantom pain were unknown. It was unknown if the reporter considered the shoulder pain and phantom pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient complained of pain in the both shoulders. The pharmacist stated that, the patient worked for the pharmacy and she complained often. The pharmacist felt that, the issue was not related to the vaccine but a phantom pain. The pharmacist did not want to report however the sales representative submitted the report in line with GlaxoSmithKline protocols. The pharmacist did not agree to follow up.
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patient's electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves a patient (age and gender not reported), who was vaccinated with a dose of DTAP-IPV (manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) and a dose of MMRV (manufacturer: other, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced cellulitis. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Upon internal review case was considered as serious due to important medical event: cellulitis. Documents held by sender: none.
On 1/5/2021 I started having pain on the vaccine site, It was red & swollen & it kept getting more swollen throughout the day. It was hot to the touch & it was slightly itchy. It lasted about 4 days. I seen my doctor on 1/5/2021 & he proscribed me antibiotics.
approx 9 hrs p/vax devel red rash on face, chest, back shoulders, neck & ears; 3AUG94 had rash some itching; 4AUG93 devel dizziness, eyes swollen, still had rash only became redder & had scaulded appearance; seen by MD;
Saturday morning after vaccine was administered: Tennis ball size oblong lump noted between eyebrows at middle of forehead. Felt "funny", cheeks flushed, no apparent fever (not hot to touch). Lump itself was not red, painful or itchy.  it was definitely "noticeable". Headache on the day he received vaccine, but no other reports of headache following. Tends to be anxious and has a history of "passing out" when leaving a dentist's office in the past.
The first few days the adverse reaction was just a red slightly swollen area around injection sight and achy body. Then I noticed a rash on my stomach.  Next there was a small rash on my buttocks.  The rash sights which were for the most part just pimple sized bumps began to pop up at various sights mostly on my torso.  They are very itchy.  Some sights are constantly red and irritated.  Others come and go, moving around from site to site..  Recently I started noticing bumps and itchiness on my scalp. I tried various types of creams (hydrocortisone, Benadryl, creams for eczema and psoriasis).  None gave more than temporary relief.  Oatmeal baths sometimes helped.  Witch hazel on spots helped temporarily.  Doctor subscribed hydroxyzine which made rashes worse.  I am trying to get in to see a dermatologist as my family doctor doesn't seem to know what to do to help relieve my symptoms.
Fever of 102; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102), CHILLS (Chills) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PYREXIA (Fever of 102), CHILLS (Chills) and HEADACHE (Headache). On 08-Mar-2021, PYREXIA (Fever of 102), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   No treatment details were provided.
Shortly after receiving influenza vaccine the patient reported that his leg had become numb. He left the store via ambulance after calling 9-1-1.
diarrhoea; lightheadedness; heavy feeling in stomach; Nausea; This is a spontaneous report from a contactable consumer(patient) or other non hcp. A 72-year-old male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 29Jan2021 as DOSE 1 and dose 2 on 19Feb2021(at the age of 72-year-old) for COVID-19 immunization. Medical history included type 2 diabetes mellitus and hypertension from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination the patient was not tested for COVID-19. Concomitant medications included metformin, furosemide, potassium chloride (LASIK), amlodipine, insulin glargine (BASAGLAR) and gabapentin (GABAPENTIN). The patient previously took tamsulosin and testosterone transdermal patch and was allergic to these medications. On 19Feb2021 the patient experienced nausea (heavy feeling in stomach, creeping up to meet the same thing in the back of my throat). On an unspecified date patient experienced diarrhea and intermittent light headedness. The patient did not receive any treatment for the adverse events. The events outcome was reported as recovering for nausea and resolved for diarrhea and intermittent light headedness. Outcome for the event heavy feeling in stomach was unknown.
20SEP91 late evening couldn't get up out of chair; rt leg gave way when tried to stand; shooting pain rt leg lower back; taken to ER 22SEP91; back xray neg; Seen by MD 23SEP91; rx Pred; 30SEP91 sx improving;
Case number PHEH2013US024953 is an initial spontaneous report received from a pharmacist on 26 NOV 2013 and a follow up report from the pharmacist received on 11 FEB 2014. This report refers to a 59-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with two doses of 0.5 ml FLUVIRIN 2013/2014 (batch number: 1307601, expiry date: MAR 2014) intramuscularly in the left arm on the same day (20 NOV 2013, at 7:00 PM). No adverse event was reported following this administration error.  Follow up report from the pharmacist received on 11 FEB 2014: Age of patient amended. Updated FLUVIRIN batch number, expiry date, vaccination site and dose.
Sudden loss of consciousness for about 2 minutes, collapse, 2"gash in head.  There were no symptoms prior to collapse. Transported to ER at local hospital by local Fire Dept. EM, then later to regional Hospital because local hospital did not have a room.  After tests noted below, Dr. (cardiologist) could find not immediate cause. She blamed it on the 95 degree heat that day and dehydration.
Chills at about 8pm on 3/6/2021. The woke with a rapid pounding heart rate just after midnight 3/7/2021. I went to the  Hospital emergency room. They ran tests; ekg, blood tests, chest X-ray.  They gave me fluids and Tylenol. My heart rate and blood pressure were fluctuating when I first went to the ER but then they went back to normal and I was released around 6:00pm 3/7/2021.
Severe headache, last 3 hours or more, 600 mg of Motrin taken
Pfizer COVID-19 EUA:  Fully vaccinated patient presented on 072921 with severe fatigue and "just feeling sick". He reported a COVID-19 exposure on 071621. Also reported having a dry cough.
HCP called to report VARIVAX was inadvertently administered with PROQUAD. No signs/symptoms of adverse effects have been reported; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-AUG-2023, the patient was inadvertently vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # w021743, expiry date: 10-JUL-2024 for prophylaxis (dose and route of administration were not provided) and with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # w026316, expiry date: 18-FEB-2024, albumin status: recombinant Human albumin (rHA) for prophylaxis ((dose and route of administration were not provided) (accidental overdose). No signs/symptoms of adverse effects have been reported.
At approximately 0900 on 10/18/07 fine pinpoint rash over body. Rash more red body not itchy no itchy no drainage no trouble breathing or swallowing has appointment at 4:15 with doctor on 1019.
27aug90 pt inadvertently vax hepta B. pt was supposed to recv purified protein derivative.
Nausea and body ache several days. Saw her own PCP (est 4/7/16). Rec'd anti nausea medication. Pt reports all symptoms resolved after est 10 days .
Patient experienced swelling in legs. She states that she developed blood clots and was forced onto blood thinners to treat condition.