chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Sept 24th at approximately  2:15 pm Staff patient received Flulaval flu vaccine with Lot # 60442 Manufactured by GSK with Expiration date 6-30-20 Pre-filled vaccine was given IM via Left Arm. At approximately 2:20 pm she complained  to the stahat she is hot and itching.  Staff was assesses by 2 RN's After few minutes mild rashes was noted to neck region and scattered mild rash on the posterior trunk and mild redness to left arm noted.  NO Shortness of breath during the assessment . Staff was alert and oriented and ambulatory. Staff Was referred to urgent care. Per RN of Urgent care patient was noted with nausea and vomiting.  Was given oxygen therapy and was referred to hospital for further treatment
Chills with shivering for several hours, mild fever, slight nausea. All adverse events gone after 48 hours.
Side-effects after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side-effects after vaccination) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side-effects after vaccination). At the time of the report, VACCINATION COMPLICATION (Side-effects after vaccination) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-APR-2021 included: Event outcome changed from unknown to resolving.
tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine; flu like symptoms; achy body; high temperature; there was throat involvement; very, very ill/sick; This is a spontaneous report via Pfizer-sponsored program and medical information team from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 25Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included thyroid disorder, ongoing incontinence. Concomitant medications included mirabegron (MYRBETRIQ) for Incontinence. Patient previously years ago took flu vaccine and she had feel sick with flu, she did have flu symptoms. No Prior Vaccinations (within 4 weeks). On Sunday (28Feb2021), she became very, very ill with flu like symptoms, she had an achy body, she had high temperature, there was throat involvement. She had those symptoms until Monday (01Mar2021) and was feeling better on Tuesday (02Mar2021). On Wednesday (03Mar2021), she had a COVID-19 test and it tested positive for COVID-19/ tested positive for covid 19 virus. She thought she was having a reaction to the shot when she got sick. Yesterday was her last day of self-isolation. She has not had another test, she was senior. She was scheduled for her second dose of the vaccine a week from now from tomorrow (19Mar2021) and she wanted to know if she should have the second shot or she has to undergo an antibody test since she got COVID after the first dose. The outcome of tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine was unknown; for illness recovered on 28Feb2021, flu like symptoms recovered on 02Mar2021, while for others was recovering.   No follow-up attempts are possible. No further information is expected.
No adverse event. Pt received second dose of Moderna off-label after inadvertently receiving her first dose prior to the 18th birthday.
Red, hot to the touch, swollen, hard around site and whole arm is sore. Recommended Tylenol, and icing area.
experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced INTESTINAL OBSTRUCTION (experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction) (seriousness criterion medically significant). At the time of the report, INTESTINAL OBSTRUCTION (experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.  No treatment medications provided by the reporter.  Company Comment: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Intestinal Obstruction. The event occurred approximately 1-2 days after receiving an unknown dose number of mRNA-1273 Vaccine with unknown outcome. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Intestinal Obstruction. The event occurred approximately 1-2 days after receiving an unknown dose number of mRNA-1273 Vaccine with unknown outcome. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
4/13/21 Patient presented to ED with LGI bleed. She had a positive screening test on admission. Daughter requested repeat testing which was also positive Hematochezia Likely diverticular bleed in the setting of Eliquis -Approximately 3 episodes of BRBPR with possible episodes of melena -Remains hemodynamically stable, Hgb 13.5-- > 9.0 -Held Eliquis on arrival -GI consulted -EGD done 4/14 with mild gastritis but no etiology of bleeding or old blood, suspect likely self-limited diverticular bleed; patient has had no further bloody bowel movements -Hemoglobin 10.9 on day of discharge, we are stopping Eliquis as below, patient and patient's daughter to follow-up with cardiology prior to resuming   COVID-19 positive -Patient asymptomatic, incidentally tested positive, previously received 2 doses of Pfizer vaccine > 1 month ago  -Positive COVID-19 on 4/13/2021, daughter requesting recheck, remains +
Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its mostly on her upper torso and they are sporadically placed.; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported), intramuscularly on the right deltoid, on 27Dec2020 (10:00) at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension; hypothyroidism; was allergic to shellfish probably over the last 20 or 30 years; and was allergic to penicillin and sulfa "many, many years ago". Concomitant medications included HCTZ for hypertension; losartan potassium (COZAAR) for hypertension; levothyroxine sodium (SYNTHROID) for hypothyroidism; amlodipine for hypertension; omeprazole for hypertension; and ongoing lansoprazole (PREVACID). The patient previously took Fluzone Quadrivalent influenza vaccine on 17Oct2020 for vaccination, and had itchiness. On 28Dec2020, the patient had headache; itchiness; phlebitis; and had what looked like flea bites on her skin which were not that many, and was mostly on the upper torso and sporadically placed. The patient had received diphenhydramine (BENADRYL) as treatment for the events. The patient was told that since itchiness was not a part of the normal side effects, the itchiness was considered an adverse reaction and that she could not get her second shot which was scheduled for 16Jan2021. The outcome of the events was recovering for 'headache', 'pruritus' and 'phlebitis'; and was recovered on an unspecified date for 'looked like flea bites on her skin'.
No adverse effects; An adult patient received a pediatric dose of VAQTA; This spontaneous report has been received from a registered nurse referring to an adult patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 14-JUN-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) lot # R034339 with expiration date of  23-NOV-2019 (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis.
pt recv vax 29FEB96 & pt was adm to hosp for dehydration & cellulitis of pox lesions;No further details were provided;
I ran a fever the night following the vaccine. Between the times of 11 pm and 10 am, I would run a fever and it would break and repeat. It always broke on its own and eventually stopped all together.
Client states she sat in the chair a minute, then left and about 3-4 hours after receiving the injection, the client says she fainted.  Her boyfriend reported she vomited.  Advised by clinic RN to call Dr. or go to the ER.  Dr's nurse advised her to go to the ER but she didn't.  Called her pharmacist friend who advised her to go to the ER if anything else developed as she was OK now.  Also advised to talk to her doctor about possible allergy and if she should complete the series.
This spontaneous report as received from a physician refers to three patients of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX23 0.5 ml, lot # K009809, expiration date 16-MAY-2015 (strength and route were not reported), that were improperly stored. No adverse experienced were reported. No product quality complain was reported. Additional information has been requested.
Mild fever (101.4F) at 26 hours after injection. Chills started at 8:00 a.m., 16 hours after injection of vaccine.
Patient experienced migraines (migraine meds did not work), chills, hot flashes, congestions, aches and pains, loss of taste/smell, shortness of breath, fatigue, and hair loss. PA tested her for Covid and Flu - both results were negative. Patient also tested today 12/30, and results were negative.
Patient described extreme achiness in his muscles & joints.  Most prominent in hips and both biceps, beginning a few days after his flu shot.  No respiratory symptoms or fever.  Pain still present nearly 1 week later.
Patient received the first Pfizer immunization on 4-22-2021. She passed away on 4-30-2021. Her husband notified the pharmacy. Patient had been hospitalized for a period of time before the vaccination for 'bleeding internally' due to an unknown cause.
Vaccine 2 Sore arm quickly Headache  Done at 3:11 (could go home) Ear pain then gone Neck pain then gone Right breast hurts outside side  then gone  Headache again then gone  Headache again 449 97.9 temp  Eyes sore 5:25  98 temp 7pm two Tylenol  Feeling heavy head and arm and shoulder sore.  Little congestion  Ears popped  Dizzy Went to sleep at 8pm  Swollen tongue and throat 10pm  Left arm sore forearm Broken toe kinda burns a little Sat was miserable ?kept falling alseep  Sunday was a little better but still all the same issues  Digestive issues as well? Did not go away until around noon Tuesday the 30th  Finally worked and went to gym on Wed but still sore eyes and throat slight soreness. Like having mono.  Super crusty eyes each morning and using saline solution since we started distance learning  Worked in person TH and F and went to gym Th and Sat. Woke up with super pain in sinuses Sunday  Bleb in right eye  Sinus pressure that usually indicates an infection? Went to Dr Monday for pressure and eye Bleb and got prednisone and an an allergy eye drop.  Sinus pressure is a little less as I started prednisone this morning.
1st dose of Engerix B onset of flushing same day, itching, rash, respiratory heaviness.  Event resolved.
Events: fever, chills,, achy all over, headache, tired, loss of appetite Treatment: rested and drank liquids Time: lasted from 11:00 pm Saturday (06/29/2021)  until 1:00 pm Tuesday (06/01/2021)
Patient complains of left arm pain post influenza vaccine. Seen in UC on 11/15/22
Intense redness,  hotness, spreading redness, knot all around injection site, itching, pain to touch
pt developed a red rash on her chest. she states she gets like this with every flu shot. she normally takes benadryl beforehand but had forgotten to take some prior. I had her sit for 45 minutes to 1 hour and had given her benadryl. she felt much better after 10-15minutes after taking the benadryl and the rash/redness went away. followed up with pt the next day and she felt fine not concerns.
Pt. developed a h/a and vomiting about 12hr. after receiving HBV.  Also received Flagyl at same visit as receiving HBV. Pt. had eaten lunch, waited 30 min., then took Flagyl as inst'd; had rec'd vaccine at clinic before lunch.  That evening, developed a "bad" h/a and the vomiting.  Vomiting lasted about 12-14hr. H/a lasted about 48hr. It was resolved with medicine for migraine h/a's that pt's mother gave him.  Pt. did not c/o of any hives, itching, dyspnea.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Lip numbness
Patient received as dose of IPOl on 22nd December that expired on 30th November 2020, no AE; Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 months old male patient who was administered expired 0.5 ml dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot number: PIF49 and expiry date: 30-Dec-2020) via intramuscular route in left thigh for prophylactic vaccination on 22nd December 2020 (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
THOUSANDS OF BLOOD CLOTS ALL OVER HIS HEART; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate) concerned a male of unspecified age. 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced thousands of blood clots all over his heart. It was reported that, "A friend of mine has thousands of blood clots all over his heart after getting the shot that he never had before. He didn't want the shot and was forced to get it. His doctor finally admitted it was from the shot. Thank god I never got it and never will". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thousands of blood clots all over his heart was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221154630-thousands of blood clots all over his heart . The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Moderna covid 19 vaccine EUA. 0.5ml given instead of 0.25ml
THE PATIENT STOPPED IN THE PHARMACY ON 4.5.18 TO REPORT THE INCIDENT. SHE SAID THE NIGHT FOLLOWING HER VACCINATION ON 4.4.18, HER RIGHT ARM WAS SORE. THE NEXT MORNING WHEN SHE WOKE UP, HER RIGHT ARM, BEGINNING RIGHT BELOW THE INJECTION SITE AND EXTENDING TO ABOVE THE ELBOW WAS RED, SWOLLEN, AND SORE. THE PATIENT SAID INITIALLY IN THE MORNING THERE WAS SOME BRUISING, BUT BY THE TIME THE PATIENT ARRIVED AT THE PHARMACY IT WENT AWAY.
onset paresthesia, 7 days p/vax;pt became weak, uncoordinated & exp diff swallowing;14OCT adm to hosp-CSF studies confirmed acute inflammatory demyelinating peripheral neuropathy;dx GBS- resp failure, hyponatremia, hypokalemia, paralysis
Information has been received from a mother she told the school nurse concerning her child who on an unspecified date was vaccinated with the dose of VARIVAX (Merck) (LOT# not reported). The mother was noted that her child developed chicken pox, in spite of being immunized with VARIVAX (Merck). No further information is available at this time of reporting. This is the second of three reports concerning the siblings. No further information is available.
I had a fever for 36 hours, headache and exhaustion after receiving the vaccine. I started not feeling with a fever and cough on 01/28/2023. I tested positive for COVID-19 on 01/29/2023.  I contacted my doctor, and she did not recommend taking Paxlovid, so I took over the counter medication. As of today, I have not retested but I continue to have symptoms.
Full body rash, hard to swallow, high fever 104F, peeling skin days later. Went to ER for assistance.
Chest pain onset 8 hours prior to presenting to hospital.  Myocarditis confirmed by abnormal troponin and cardiac MRI demonstrating myocardial edema, late gadolinium enhancement, systolic dysfunction.
I have had a runny nose since the first injection and powerful sneezing. The second injection caused painful swelling the size of half a golfball for a day  and general I?ll feeling, fatigue, tiredness.   The sinus  issue has morphed into what I believe is a sinuses infection. Face pain, sore throat, ear ache.
Technician was drawing up  the dosage for an immunization and we realized that it was a vial that had been first punctured the previous afternoon. Dosage was approximately 14 hours past BUD. Patient was alerted and at this time has no side effects and Pfizer was contacted and did not recommend a repeat dosage.
Redness, soreness, chills. Patient took BENADRYL. Pharmacy contacted MD 2/9/15.
on 1/30/2021 pt reported that the previous day she awoke with arm and eye swelling- pt self medicated with Benadryl (dose unknown to reporter) - with effect. Fellow Pharmacist reached out to pt on afternoon of 1/30/2021 at approximately 2pm and pt reported being fine with no additional symptoms being noted.
Chills, fever of 101.4. Fever was back to normal the following morning.
1 week after vaccine redness, swelling, itching, pain, and heat in left arm where injection was done. Redness spread outside of borders drawn and then proceeded to spread down the left arm each day up to day 12 after injection.
feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting position on couch i feel fine. too much movement gets me nausea and feeling light headed
No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (lot # T040418 was confirmed to be valid, expiration date: 01-DEC-2022 00:00; route of administration, anatomical location were not reported); both for prophylaxis. The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.4 degrees Celsius (C) for 15 minutes. There were no previous excursions reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II). Previous excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was -11.36 C for 6 hours. No additional adverse effect was reported.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA003333: US-009507513-2108USA003248: US-009507513-2108USA003331: US-009507513-2108USA003332: US-009507513-2108USA003335:
Report A0359940A describes joint pain in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received as part of litigation proceedings, with forwarding of limited medical records. This report has not been verified by a physician or other health care professional. The medical history included snoring, elongated uvula, partial upper airway obstruction, obstructive sleep apnea, and chronic fatigue. In the winter of 1994, the vaccinee injured his right shoulder while sledding.  He experienced numbness and tingling radiating from the right shoulder to the right thumb and first finger soon after the accident. The numbness and tingling persisted as of 17 May 1994, when he was evaluated by a neurologist. the neurologist made a diagnosis of mild thoracic outlet syndrome. Concurrent conditions and medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a Statement of Injuries, his attorney alleged thast the vaccinee suffers from joint pain, in particular in his shoulders and neck. He also experiences numbness in his hands and arms. In addition, he experiences fatigue. Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The adverse events joint pain and numbness do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.