chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 1st dose of Engerix-B & a few hrs p/1st dose exp diarrhea which lasted for 24 hrs;
Pale, whole body weakness, light headed, difficulty breathing, shakey, nauseous, migraine, vomited once, fast breathing all lasting 30 mins. Dr. called, all vitals taken, all normal. Given Tylenol and Pepto Bismol. Now 10:45 PM and still has migraine and weakness and very pale. Pulse 72, b/p 107/68, Resp. 22. Monitoring at home for now.
Pt was pregnant (@ the time or p/1st dose of Engerix-B a month ago); reporting MD was not able to provide specific ino or addtl detials @ the time; this was pts first visit & he had not seen pt yet;
Left ear ache, night sweats, headaches, bumps on my hands, swollen eyes, cough, shortness of breath, congestion, brain fog. The congestion, swollen eyes, coughs, and ear ache are ongoing and I am 1 week and 5 days past the shot.
Papule pustule lesions on skin. Fever 101 for less than 24 hours. Duration at time of report.
Itchy, red painful and solid mass at injection site (arm).  Showed up 7 days after the vaccine.  I just started itching and noticed it was painful and a raised lump under the skin at that point. Also felt warm to the touch.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On 08-APR-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot # 0886AA, exp: 23-NOV-2012), 2 ml orally (third dose in series). Medical assistant reported that the first 2 ml dose of ROTATEQ was given orally on 11-OCT-2012 and second 2 ml doe of ROTATEQ was given orally on 08-JAN-2013. No adverse effect reported. Additional information has been requested.
Within 12hr developed feeling of being "not well", progressed to 24hr of fever and then what patient describes as severe myalgias and neck stiffness. Reporting to VAERS because required doctor visit. Also had Hep B on the same day, but do not suspect symptoms are from Hep B. Hep B GlaxoSmithKlein, intramuscular.
hot red and swollen arm after receiving vaccine in the same arm, patient was seen in a walk in and received an antibiotic scipt
Approximately 9 hours after injection, and in mid sleep, intense body heat and severe chills woke up me up every hour for 5 hours(midnight to 5am). My body felt incredibly hot but I did sweat at all. If I would move the bed covers and any part of my skin below my neck felt the air I would get chills the would shake my entire body for a few seconds.  Later that morning; body aches all over, a fever reaching 101.3, fatigue. Over the counter medicines, napping, and a shower helped reduce symptoms.  All was gone by the next morning.
Fainted approximately 10 minutes after getting the shot .    ?Janssen COVID-19 Vaccine EUA
Extreme dizziness (unable to walk to restroom without assistance from restaurant server and wife) & nausea.  Lasted for about 30 minutes.  Left restaurant after about 30 minutes of heaves with some saliva and a little bile in bathroom, went home and went to bed.  One instance of heaves with some saliva on the way home.
No additional AE reported; Patient was inadvertently, concomitantly administered VARIVAX, PROQUAD on 02/06/2023.; The patient is a 14-year old; This spontaneous report has been received from a nurse and refers to a 14-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 06-FEB-2023, the 14-year-old patient was inadvertently, concomitantly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number W023865 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and established as 29-OCT-2023) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot number W008711 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and established as 14-MAR-2024), subcutaneous injections, both administered for prophylaxis (strength not provided) (product administered to patient of inappropriate age) (product administration error).
red; soreness; Some swelling; itching; rash on the vaccination site; A spontaneous report was received from a medical assistant concerning a ninety-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed rash on the vaccination site, some swelling, itching, soreness and red.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (BATCH # 041L20A) on 13 Jan 2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Reporter called regarding Moderna vaccine. Her patient received the vaccine on 13 Jan 2021, and today (22 Jan 2021), she had developed a rash on the vaccination site, and some swelling and itching and soreness. Reporter is patient's provider and also a CMA (Certified Medical Assistant). Vaccine was given on right arm as intramuscular injection. Second dose was due 11 Feb 2021. Patient continued to have the rash, red and itchiness. Swelling had gone down some. Consent was given for safety to contact the reporter for the patient and her HCP (healthcare provider). No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events rash on the vaccination site, itching and red was not resolving. The outcome of some swelling was resolving. The outcome of soreness was unknown.  The reporter did not provide an assessment for the events, rash on the vaccination site, some swelling, itching, soreness and red.
Swollen lymphs under the left arm. painful when raising arm, stated that started shortly after receiving vaccine on 10/16/21 and reported to pharmacy  10/19/21
Moderna COVID 19 VaccineEUA   About 10 days after the first dose of the vaccine my arm hurt. I noticed a circular red rash on my arm  surrounding the vaccination site. It was painful to the touch but not swollen or hot. It was the  approximate size of a baseball. It lasted about three or four days, fading and becoming less painful each  day.
Vaccine administered 9-9-16. On that evening, the patient experienced vomiting, headache, and low grade fever (100 F). On 9-10-16, the patient awoke with redness, swelling and heat in left arm from injection site down to her elbow. On 9-12-16 reaction was sublining.
Had a sore arm; Was more tired than usual after the second dose of Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021, as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history and allergies. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown whether the patient receive any other vaccines within two weeks prior to the vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. The reporter was talking to a friend and he told the reporter that on an unknown date in Mar2021, the patient (his wife) had a sore arm and was more tired than usual after the second dose of Pfizer COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient had tested for COVID-19, since the vaccination. It was unknown whether the patient received any therapeutic measures as a result of events. The clinical outcome of the events sore arm and was more tired than usual after the second dose of Pfizer COVID-19 vaccine was resolved on an unspecified date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous prospective pregnancy report has been received from a physician referring to a 23 year old female patient. The patient's medical history and concurrent condition were not reported. The patient was 32 weeks and 4 days pregnant with LMP of 11-AUG-2014 and EDD of 18-MAY-2015. On 27-MAR-2015, the pregnant patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency and route were unknown) in error. The physician did not have access to the lot number and expiration date of the dose of VARIVAX (Merck), since it was not administered in her practice. No adverse effects had been observed or reported. Additional information has been requested.
PATIENT RECEIVED PFIZER ON Dose 1 date: 01/26/2021,  Dose 2 date: 02/16/2021 AND TESTED POSITIVE TO COVID ON 9/1/21.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:30 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of the patient was reported as 66.80. Concomitant medication of the patient was not reported. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. The vaccines moved to clinic on 31-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures. No treatment information was provided by the reporter. This case was linked to MOD-2022-566976 (Patient Link).
Per nurse triage note patient received full covid vaccine. Pt hospitalized. Unknown dates or manufacturer provided by documentation. Patient came in with chest pain.
Pt already received 2 baby pfizer, third dose supposed to be giving, but instead received baby moderna bivalent third dose instead.  There was no side affect noted during the 15 minutes waiting period. Lead staff made aware. Patient's mother made aware.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt who recvd flu vax; above sx occurred 12hrs p/flu vax & resolved w/in 48 hrs;
July 6, 2023 annual physical revealed possibly trigeminy. EKG on same date confirmed this diagnosis. Scheduled for echocardiogram for additional information. No prior symptons or signs of this condition.
Patient experienced raised blood pressure some time after administration of SHINGRIX. Patient started on blood pressure medications and had blood pressure controlled on the medications. Patient called us in the afternoon stating blood pressure rose to around 240. Later around 5:30pm came to pharmacy and I had rechecked his blood pressure at the pharmacy and it was still 223/93. Spoke with his interal medicine doctor's office and arranged for him to go see the doctor immediately.
Initial misuse report received from a healthcare professional on 08 August 2013. It was reported that a child received only DTaP/IPV component of PENTACEL. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Headache Injection Site Pain and Swelling, Fatigue, Malaise Narrative:  Other Relevant History:
mom reported pt had a severe case of diarrhea the day p/vax;no elevation of temp reported;able to tolerate solid foods & liquids;inj site red, puffy & hot, size of silver dollar;
Patient received dose 1 from Pfizer and dose 2 from Moderna; Patient received dose 1 from Pfizer and dose 2 from Moderna; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna), COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1. the maroon cap Pfizer COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna), COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna), COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Patient received dose 1 from Pfizer and dose 2 from Moderna) and COVID-19 IMMUNISATION (Patient received dose 1 from Pfizer and dose 2 from Moderna).    No concomitant medication information was provided. No treatment medication were provided.
fever 101 & nausea & vomiting starting approx 12 hrs post vax; cont for 48 hrs total max fever of 103;
Dad called our office around Noon in 7/2/04. He stated that pt's eye and mouth are swelling. He was concerned that pt may be having an adverse reaction to an immunization. I advised dad to take the child to the ER. The pt was seen in the ER at 1:45PM 7/2/04. Dx allergic reaction; improving.
PATIENT HAS A HISTORY OF GBS AND A FEW HOURS AFTER ADMINISTRATION SHE STARTED HAVING NUMBNESS IN THE LOWER PART OF HER FACE AND HER HANDS.  OVER THE COURSE OF A FEW DAYS IT SPREAD TO HER EXTREMETIES AND HAS NOT RESOLVED AS OF 9/2/21.
discretion about mark on the breast; This spontaneous case was reported by a consumer and describes the occurrence of MAMMOGRAM ABNORMAL (discretion about mark on the breast) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 029L20A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient reports she had breast cancer 20 years ago.) and Surgery. Concurrent medical conditions included Immunocompromised.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MAMMOGRAM ABNORMAL (discretion about mark on the breast). At the time of the report, MAMMOGRAM ABNORMAL (discretion about mark on the breast) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) A discretion about a mark on the breast..         No concomitant medication was reported. No treatment was reported. Patient recently went for a mammogram, there was a discretion about a mark on the breast. Biopsy of breast was performed, results not provided.   This case was linked to MOD-2021-022507.
Treatment of Paxlovid from 17Nov2022 to 22Nov2022 for COVID-19; Treatment of Paxlovid from 17Nov2022 to 22Nov2022 for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. Dose 2 was also reported to be given on "11May2020" (possible discrepant). The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of Paxlovid from 17Nov2022 to 22Nov2022 for COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Shortness of breath; Massive headache; Hot flashes; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), CHILLS (Chills) and HEADACHE (Massive headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021021A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HOT FLUSH (Hot flashes) and CHILLS (Chills). On 09-Apr-2021, the patient experienced HEADACHE (Massive headache). On 10-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), CHILLS (Chills) and HEADACHE (Massive headache) outcome was unknown.            The concomitant medications were not provided. The treatment information was provided as ibuprofen for headache.  The action taken for mRNA 1273 with the events was considered as not applicable.
No additional AE.; administered Improperly Stored M-M-R II lot; This spontaneous report has been received from a registered nurse referring a patient of unknown age and gender patient. The pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date on October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 11-OCT-2022, 13-OCT-2022, 14-OCT-2022, 18-OCT-2022, 20-OCT-2022, 24-OCT-2022) the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot number W009107 with expiration date 04-DEC-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error).   The administered vaccine experienced a temperature excursion of 47.5 degree fahrenheit (F) for 5 minutes. There was no previous temperature excursion. No additional adverse event reported.   This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278: US-009507513-2210USA010278:
09/14/18 @ 2:30 pm, patient called and complained about redness and itching at site of IMZ injection (left arm). We advised patient to see her PCP and we will follow up with Dr. She received two vaccines FLUZONE QUAD and PNEUMOVAX 23. Rx 6795664,  Rx 6795673-09/11/2018.
Is leg tingling a side effect?; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Is leg tingling a side effect?) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Is leg tingling a side effect?). At the time of the report, PARAESTHESIA (Is leg tingling a side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
2nd shot: high fever within a few hours of shot, muscle pains, vomiting, head pain, back pain, followed by continuing chills that have not gone away and severe congestion that I still have almost a week later and is not improving.
nausea, RUQ pain, orange urine. Resolved spontaneously after two days. No hx of RUQ pain, cholecystitis previously or since.