chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of eyes and mouth; high fever; aches; chills; elevated blood sugars
RASH, HIVES, ITICHING, REDNESS. PATIENT WAS GIVEN A DOSE OF BENADRYL AND CHILD WAS ABLE TO RECOVER.
Site: Pain at Injection Site-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Medium
This spontaneous report was received from a medical assistant and refers to a 6 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a Registered Nurse, referring to a 25 year old female patient with drug reactions to Amoxicillin. The patient had not relevant medical history to report. The patient's concurrent conditions was not provided. Concomitant therapies included unspecified vitamins and birth control pills. On 25-JUL-2018, the patient was vaccinated with the third dose of GARDASIL 9 (strength, dose and administration route were not reported) lot number R008165, expiration dose on 12-NOV-2020, for prophylaxis (indication reported as "vaccine"). On 15-AUG-2018, the patient was seen in the office and was diagnosed with bursitis. The patient was being treated with prednisone 20 mg, then, tapering dose schedule, and with acetaminophen (+) hydrocodone bitartrate (VICODIN). Lab diagnostics or studies were not performed. The outcome of bursitis was reported as not resolved. The causality assessment between GARDASIL 9 and the aforementioned event was not provided.
patient received one dose of MMR II before she had found out she was pregnant; No adverse effects reported; This spontaneous prospective pregnancy report was received from a medical assistant referring to a 31 years old female patient. The patient's concurrent condition was not reported. Her medical history included migraine. Concomitant therapies included over the counter pre-natal vitamins (unspecified). There was no drug reactions/allergies.     The patient became pregnant with the last menstruation period (LMP) of 18-APR-2019 and estimated date of delivery (EDD) of 23-JAN-2020.   On 14-MAY-2019, before she had found out she was pregnant, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II) (lot # was R028004, expiration date was 01-OCT-2020) subcutaneous for immigration purpose (drug exposure during pregnancy, first trimester). It was reconstituted with a diluent. The initial exposure to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA(M-M-R II) was at 3 weeks. The patient sought medical attention and contacted a prenatal coordinator on 24-MAY-2019. There was no lab diagnostics/studies performed. No adverse effects were reported.
Dizzy; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced dizzy. The patient inquired about the vaccine information including manufacturing and Authorization product information. The patient participated in the Pfizer-BioNTech COVID-19 clinical trial and inquired about if patient could receive placebo. The outcome of the event dizzy was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1.5 hours after getting flu vaccine eyes began to itch and then eyes swelled almost shut.
no adverse effects; may have been stored improperly; This spontaneous report was received from a licensed practical nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 01-AUG-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R012638 with expiration date on 20-JUN-2020 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rha) lot number N024693 with expiration date on 08-SEP-2019. Dosage schedule, route and anatomical location were not reported for non of the vaccines, all of them were reconstituted with a properly stored sterile diluent and administered for prophylaxis.  Administered doses of vaccine had previously experienced no temperature excursion. The temperature of excursion was unknown as the vaccines were for 18 hours in a freezer that did not have a data logger. No adverse effects were reported.
Chills; Fever; This spontaneous case was reported by another health care professional and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
At March 9, 2022 had COVID-19 and was given an IV infusion, after testing negative from COVID-19, had a long lasting chronic cough until 5/9/22. Went to urgent care and had a Chest X-ray that showed Right Plural Effusion. Had a chest tube placed to drain the effusion, and that's when they discovered it was Empyema, at that point time I was placed on antibiotics for 30 days. I received medication through the test tube to clean out the infection in my lung. Was released from the hospital after 7 days of getting IV antibiotics. Sent home with oral antibiotics for 30 days. Currently back to normal.
Patient felt sick to her stomach, sweaty/hot and faint like. Patient had not eat any breakfast and was exercising just prior to her visits th the doctor. After drinking water and eating a snack, she felt rapidly better. She was nervous about receiving the vaccines.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer via other manufacturer concerned a 46 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose once total, start therapy date were not reported for prophylactic vaccination. 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 16-APR-2021, the patient had antibodies test done which came back negative for antibodies (coded as suspected immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210649679-covid-19 vaccine ad26.cov2.s-Suspected immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Started with tingling of the tongue and itchiness of the arms. I took 50mg of Benadryl immediately, but then progressed to hives all over on my, arms, trunk, eyes, ears, and scalp, and legs. Went to the emergency room in case it got worse or obstructed my breathing. In the ER continued to have itching and extreme redness of my arms, with some swelling of my arms as well. About an hour later the Benadryl began working and received prednisone and Pepcid. Stayed in the ER for another hour and my symptoms mostly resolved. Was prescribed 3 days of 40mg prednisone and given an epipen. Have not had issues since then.
Patient stated a worsening raised red rash developed over 3 days after receiving the shot. When I saw it on 12/12, it looked like a fried egg with a dark red round spot surrounded by a lighter pink spot with a white border. I advised her to take loratadine 10mg every day, I drew an ink line around the rash's current borders, and advised her to call her MD if it worsens. I spoke with her today and she said her MD said she didn't need to be seen and the rash is slowly going away.
Very intense sneezing; Stuffy nose; Eyes watering; Runny nose allergy attack at midnight; Trouble sleeping all night; Arm soreness; This is a spontaneous report from a contactable other health care professional, the patient. A 33-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in left arm, on 26Mar2021 at 13:15 (at the age of 33 years) as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously received codeine (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. Concomitant medications included ambien (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), vyvanse (MANUFACTURER UNKNOWN), doxylamine (MANUFACTURER UNKNOWN) and armour thyroid (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates and unknown if ongoing. On unknown date in Mar2021, the patient experienced arm soreness, very intense sneezing, stuffy nose, eyes watering, runny nose allergy attack at midnight and trouble sleeping all night. The patient received albuterol breathing treatment, ibuprofen, zyrtec, afrin treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events arm soreness, very intense sneezing, stuffy nose, eyes watering, runny nose allergy attack at midnight and trouble sleeping all night were not recovered at the time of report.    No follow-up attempts are needed. No further information is expected.
Fatigue; Pain in left armpit; swollen lymph node; Pain at injection site; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 09May2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (ADVIL) which might be one week prior for an unknown indication and unknown if ongoing and nighttime tea. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 18Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 01:00, the patient experienced pain in the left armpit (swollen lymph node), pain at the injection site (left arm), headache, fatigue and dizziness. 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 pain in the left armpit, swollen lymph node, pain at the injection site (left arm), headache, fatigue and dizziness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
mild itching; This is a spontaneous report from a contactable Other HCP (patient) via Medical Information Team. A patient of an unspecified gender and age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 29Dec2020 as a dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received the Pfizer COVID-19 vaccine initially on 29Dec2020 and the final dose on 19Jan2021. After initial dose, patient had some mild itching a week after on an unspecified date in Jan2021. Suspected it was from the vaccine. Nevertheless, completed the second dose and a week after that the itching got worse with rashes then maculae and papulae. Went to see an allergist and he ruled possible allergy to the vaccine. After initial dose, patient experienced mild itching on an unspecified date in Jan2021 (reported as a week after). The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure high, METOPROLOL for Instability cardiovascular.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced CHILLS (Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered.). The patient was treated with IBUPROFEN for Chills, at a dose of UNK dosage form; tea [SAMBUCUS NIGRA] for Chills, at a dose of 1 dosage form and CHLORPHENAMINE MALEATE, PARACETAMOL (CORICIDIN HBP COLD AND FLU) for Chills, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills one day last week and today 3 weeks after moderna Covid-19 injection was administered.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included tea.
Fluzone HD was administered to a 63 year old patient,no AE; Fluzone HD was administered to a 63 year old patient,no AE; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 63 year old male patient who was vaccinated with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number UJ253AA, expiration date:06-MAY-2020) via intramuscular route on the right deltoid on 25-Nov-2019.   The patient' medical history and concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for unknown indication.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.
Symptoms: Redness, warmth and pain, swelling to injection site. Initial treatment: Prednisone, OTC TYLENOL for discomfort. Subsequent treatment from doctor's visit: steroid, antibiotics, pain medication.
Patient feeling light headed and not quite right.  Needed to lie down.  Blood pressure was 98/60 initially and heart rate was stable.  Her blood pressure was running 110/70 and patient was continuously monitored by EMT from 9:39-10:11 Am.  Patient still sitting on ground felling unwell.
Gave injection in deltoid muscle of left arm and patient had bleeding and swelling (hard knot) immediately at the injection site. Had to use a cold compress right away for swelling. Swelling seemed to subside after cold application. Watched patient for additional reaction for 20 minutes to be sure she did not have any other symptoms.
On July 10Th the patient had  small rash on her abdomen thigh and down her leg. On July 13th the patient woke up and was covered from head tp toe in the rash. under her arms, behind her ears and neck and private area as well.
flue like symptoms; muscle ache on their eyes; Fever; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), EYE PAIN (muscle ache on their eyes), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flue like symptoms), EYE PAIN (muscle ache on their eyes), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (chills). On 27-Feb-2021, INFLUENZA LIKE ILLNESS (flue like symptoms), PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, EYE PAIN (muscle ache on their eyes) and FATIGUE (Fatigue) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported
Pt recv vax on 4/2/99; on same day pt exp diarrhea x 5 day
Patient experienced vomiting, diarrhea, chills, body aches the night of her vaccination. She is still experiencing symptoms, fever, loss of appetite, body aches.
Dizziness; Nauseous; head hurts really bad; Chills; The spontaneous report was received from a health technician (reporting on self), concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, head hurts really bad (headache), dizziness and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020 morning the patient received their first of two planned doses of mRNA-1273 (batch number: 039K20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On the night of 30 Dec 2020 or 31 Dec 2020 in the morning, she felt nauseas, her head hurt really bad, feels dizzy and she had chills, but she did not have fever. The patient was treated with ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, nausea, head hurts really bad, dizziness and chills was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I woke up with significant right-sided facial and eye swelling currently still present although improved in severity.   Other symptoms included pain/heat at injection site, myalgias, fatigue.
Lack of energy- Attempted to sleep off with limited success Major pain in joints- Took Ibuprofen, mostly ?treated? Still need to take it, or pain returns Stiffness- No actions can be taken to alleviate that I am aware of. Still present, but improved from yesterday and the night before Headaches- Took Ibuprofen, surprisingly ineffective . Relatively new symptom, just started today. Coughing- Did not treat, mostly disappeared by the next day. Only a very minor and sporadic cough still remains. Minor feeling of congestion- Did not treat, not serious enough to warrant action. Still present today.
Pt recvd 3 doses of Engerix-B 1NOV90, 27NOV90 & 9MAY91 & 23SEP91 it was determined that pt titer was neg p/3 doses of Engerix-B;
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild
About three weeks after the last vaccination which was done on March 4, 2021, I started noticing some numbness in my fingers that has progressively gotten worse and was intermittent for a week and now constant in varying degrees all the time.
Information has been received from a physician concerning a 14 year old male who on 07-AUG-1996 was vaccinated with first dose of MMR II (route, site, dose and lot number not reported).  On 15-JUN-1999, the patient was vaccinated with second dose of MMR II (route, site, dose and lot number not reported).  On 17-NOV-2009, the patient experienced mumps (the date of diagnosis was reported as 13-DEC-2009).  The patient was afebrile and had left parotitis.  The patient's fever count was 36 and his parotitis count was 43.  On 14-Dec-2009, the patient's serum immunoglobulin G test was 5.02 and serum amylase was 111.  The outcome for mumps was not reported.  Follow up information was received which reported that on 02-JAN-2010, the patient experienced mumps (the date of diagnosis was reported as 04-JAN-2010).  The patient was afebrile and had left parotitis.  The patient had other symptom reported as cough for 3 days.  On 04-JAN-2010, the patient's serum immunoglobulin G test was 3.81, serum immunoglobulin M test 0.55 and serum amylase was 68.  The outcome for mumps was not reported.  No further information is available.
2-6-2021 Woke up with muscle aches, headache and low grade fever (100.5), sore arm. 2-7-2021 Fever resolved. Fatigued. Sore arm.  2-8-2021 Able to go to work. 3-6-2021 Woke up with intense headache, muscle aches, fever over 101.0, shaking chills and 7 mouth ulcers. This lasted until 3-16-2021. Fever resolved 3-17-2021. Mouth ulcers resolved over time.  3-7-2021 Went to healthcare facility - viral illness 3-8-2021 Went to healthcare facility for fluids due to dehydration. Dx Viral illness 3-13-2021 Went to HCGH for fluids. Dx Viral illness. 3-15-2021 Healthcare facility Follow up and Blood work.
Vaccine administered 1/11 at Bushwick vaccine hub. Nurse administering vaccine noted injection was "difficult to push." Five hours post vaccine began to feel severe pain in left arm. Pain worsened overnight. 36 hours later unable to use arm due to pain and numbness noted in fingertips of left hand.  Went to emergency room, both nurse and doctor assessed area and could see injection site and noted it was inappropriate - not into the deltoid rather into my shoulder joint. Discharged with pain medication. This AM (1/14) left shoulder pain still significant.