chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at the injection site; Shevering; fever of 101; severe body ache (pain levelof 8); This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), CHILLS (Shevering), PYREXIA (fever of 101) and MYALGIA (severe body ache (pain levelof 8)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), CHILLS (Shevering), PYREXIA (fever of 101) and MYALGIA (severe body ache (pain levelof 8)). On 01-Feb-2021, VACCINATION SITE PAIN (pain at the injection site), CHILLS (Shevering), PYREXIA (fever of 101) and MYALGIA (severe body ache (pain levelof 8)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.  Patient stated, event resolved after 28 hours and nothing was lingering after that.   This case was linked to MOD-2021-380951, MOD-2021-380980 (Patient Link).
itchy, upper arms & back & chest, no visiable rash, hives resolved same day took Zyrtec.
states very painful that day, next day developed a blotchy rash that spread 2 d after vaccine. Seen 3 days after vaccine and very tender, red, swollen.
pt recv vax 29APR96 545PM & 15-20min later swelling of eyes, lips, tongue & diff breathing (stridor);brought to ER & given epi, hydrocortisol & 3 days course of pred;
Moderna vaccine.  Localized swelling, erythema, pruritus at injection site with pain and tenderness.
want to do the pregnancy registry thin; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (want to do the pregnancy registry thin) 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (want to do the pregnancy registry thin). At the time of the report, EXPOSURE DURING PREGNANCY (want to do the pregnancy registry thin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Patient admitted to the hospital with shortness of breath.  She received IV Lasix and admission.  She was also found to have anemia with a hemoglobin several points below the level last checked. She is feeling quite a bit better after diuresis. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
This case was reported by a pharmacist and described the occurrence of Haemophilus influenzae type B infection in a 3 month old female patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. On 2/7/05, the patient received a dose of Pediarix (dose number not provided). On the same day, the patient also received injections of Haemophilus influenzae type B conjugate vaccine and 7-valent pneumococcal conjugate vaccine. The pharmacist reported that the patient slept well that night. Approximately one day following the administration of the immunizations, on 2/8/05, the patient seemed to be generally ill, and experienced a seizure and fever. She was taken to the local emergency room. Her trachea was subsequently intubated, and she was admitted to the intensive care unit. A blood culture grew Haemophilus influenzae type B, and treatment with ceftriaxone was begun. Another blood test was reportedly positive for influenza A. The events resolved and the patient was discharged on an unspecified date on or before 3/21/05. The discharge (final) diagnosis was Haemophilus influenzae infection. The pharmacist considered the events to be probably unrelated to the vaccination with Pediarix.
Nineteen year old male with history of onset of slight fever evening of 3/20/09. On 3/22/09 began with cough and fever returned. Began vomiting early 3/23/09 and had difficulty breathing. Presented to local ED, diagnosed with pneumonia, blood cultures drawn, patient admitted.
Information has been received from a physician concerning a male consumer who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). In March 2008, the patient experienced urticaria. It was unspecified if medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved.
Blurred vision started within 30 minutes after vaccine, lasted for 30 to 60 minutes, then vision normal again. pt reported dizziness and "didn't feel right" within 15 minutes after vaccine to staff was told this was a listed side effect and is why persons are asked to stay 15 minutes after vaccine injection. She reported 04/10/2021 adverse reaction on 04/23/2021.
FEELING UNWELL (A LITTLE BIT UNDER THE WEATHER); This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling unwell (a little bit under the weather). The action taken with covid-19 vaccine  was not applicable. The patient recovered from feeling unwell (a little bit under the weather). This report was non-serious.
approximately 24 hours after vacicnation patient developed expected chills, fatigue, and headache.  He took a nap and woke up with swollen lips.  Took benadryl and swelling began to decrease the following day.  Continues with expected fatigue, but headache and chills have resolved.  Of note-has been on lisinopril for several years without reaction.
Initially it was sore and had a knot which persisted for days. After about a week the area became black and blue and went toward the inside of the arm. He put heating pad when hurting. Latest status, today, Feb 13 is that it is finally getting better per patient.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 041B21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN and LEVOTHYROXINE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with HYDROCHLOROTHIAZIDE at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) outcome was unknown. Not Provided
swelling up under the left armpit; booster; little lump; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for himself.  A 65-years-old male received third dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number was FC3527) via an unspecified route of administration, administered in Arm Left on 10Nov2021, between 11:00 and 12:00 (age at the time of vaccination was 65-years-old) as DOSE 3 (BOOSTER), 0.3ml SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had no adverse events following prior vaccinations. The patient had other conditions but nothing to do with the vaccine. The patient had no family medical history relevant to adverse events. Previously, the patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number was ER8734) via an unspecified route of administration on 31Mar2021 (age at the time of vaccination was 64-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number was EN6208) via an unspecified route of administration on 10Mar2021 (age at the time of vaccination was 64-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 10Nov2021, the patient experienced booster. On 15Nov2021, the patient experienced swelling up under the left armpit. On an unspecified date in Nov2021, the patient experienced little lump and swollen lymph nodes No relevant tests were done. The clinical outcome of swelling up under the left armpit was recovering, while the clinical outcome of booster, little lump and swollen lymph nodes was unknown.
Sudden onset of Uticaria on chest, back, breasts, palms of hands, scalp and feet.   This is now a daily occurrence. The only days I do not suddenly break out in hives are days I take Zyrtec. If I forget, I will have hives at some point throughout the day.
Resident received COVID-19 booster on 7/26 with no reactions noted. On 7/27 at breakfast, noticed resident with difficulty swallowing, mumbled speech, tremors and leaning to right side and altered mental status. Resident was sent to ER for evaluation on 7/27 and was admitted. Resident remained in hospital 5 days and is expected to return today to facility. Admitting diagnoses were: acute metabolic encephalopathy. Other dx were: benign HTN, senile dementia, elevated troponin and bradycardia and hyponatremia. Resident also had UTI and was treated on ABT in hospital for that. Mention of palliative care while in hospital, but no mention of hospice/palliative on discharge paperwork.
I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)
Rash; racing heart rate; hot flash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 at 12:00 as dose 1, single (Lot number: Ew0172) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 27Apr2021 at 12:00, outcome "recovered" (2022); HOT FLUSH (non-serious) with onset 27Apr2021 at 12:00, outcome "recovered" (2022), described as "hot flash"; PALPITATIONS (non-serious) with onset 27Apr2021 at 12:00, outcome "recovered" (2022), described as "racing heart rate". The events "rash", "racing heart rate" and "hot flash" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: covid prior vaccination No, known allergies Yes.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from healthcare workers refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL, lot # K023432, expiration date: 18-JUN-2016 and lot # reported as L000610, expiration date: 31-JAN-2017, (dose, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Parotid submandibular lymph node, started 07/31/2006 swelling and tenderness started 07/28/2006.
The vial exposed to room temperature for >24 hours/ approximately 30 hours; Patient receive a vaccine outside of the 12 hours from first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient receive a vaccine outside of the 12 hours from first puncture) and PRODUCT STORAGE ERROR (The vial exposed to room temperature for >24 hours/ approximately 30 hours) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022 at 7:45 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-May-2022 at 7:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient receive a vaccine outside of the 12 hours from first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial exposed to room temperature for >24 hours/ approximately 30 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient receive a vaccine outside of the 12 hours from first puncture) and PRODUCT STORAGE ERROR (The vial exposed to room temperature for >24 hours/ approximately 30 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Date vial was initially stored in refrigerator on 29April2022. Date and time vial was first punctured was on 01MAY2022 at 11:25 AM. Vial stored post puncture was on room temperature. The vial did not undergone any temperature excursions. HCP reported that  this was the patient's first dose and has not called to report any side effects. No treatment medications were reported.
Migraine; arm pain; light sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PAIN IN EXTREMITY (arm pain) and PHOTOPHOBIA (light sensitivity) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MIGRAINE (Migraine), PAIN IN EXTREMITY (arm pain) and PHOTOPHOBIA (light sensitivity). On 31-Mar-2021, MIGRAINE (Migraine) and PHOTOPHOBIA (light sensitivity) had resolved. In April 2021, PAIN IN EXTREMITY (arm pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD-2021-095763 (Patient Link).
Pain, redness, swelling, rash within 24-48 hrs of vaccination. Slight fever. Involved both thighs. The follow up stater per MD's notes-equal amt. of swelling and redness in both thighs-impossible to determine which vaccines caused reaction in right thigh.
pt c/o CP radiating to left arm x 1 day. Headache since Sunday. reports she had COVID-19 vaccine on Saturday. denies n/v. denies fever.
Information has been received from a certified medical assistant, concerning a 20 year old female patient with no pertinent medical history and no known allergies, who on 11-OCT-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5 mL of Gardasil (lot #659435/1265U). Concomitant Therapy included Ovcon-35. About 2 minutes after the vaccination, the patient passed out. She was lifted up and laid in a room, and a cold cloth was placed on her head. The patient recovered on the same day. Additional information has been requested.
pt recv vax & in AM neck hurt, arthritis, black & blue-lt arm hurting; muscles in body neck still hurt;
Fever, chills, muscle aches, extreme headache, flu-like symptoms. Also soreness in arm at site of shot.
shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEADACHE; This spontaneous report received from a patient 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 not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Initial information received on 01-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves 05 patients (gender unknown) who received vaccines ADACEL and TENIVAC and while treated with TUBERSOL after an extreme temperature of (-4.2) Celsius. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient started taking TUBERSOL dosage unknown (with an unknown batch number) for Tuberculin test. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported. It was a case of actual medication error due to product storage error. Vaccines were improperly stored and they reached an extreme temperature of (-4.2) Celsius. It was unknown whether patients had any adverse events. 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.
Above vaccine given at 9AM on 9/1/21 and vaccine expired on 8/31/21. Reported to Moderna awaiting further instruction.
Information has been received from a pharmacist, concerning a female patient (age not specified), with a sulfonamide allergy, who on 13-AUG-2007 was vaccinated with a dose of Gardasil (Lot # not provided).  Concomitant therapy included ORTHO TRI-CYCLEN.  On approximately 17-AUG-2007 (possibly 18-AUG-2007) the patient developed a rash on her abdomen and lower legs, and had a swollen eye.  The patient was given BENADRYL, and instructed to go to the emergency room.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Breakthrough case admission after 4 vaccines Moderna 1/29/21 Lot# 031L20A;  Moderna 2/26/21  Lot# 023M20A;  Moderna 10/25/21 Lot# 012F;  Moderna 5/12/22 Lot# 049L21A
Lays down or woke up in the morning gets really dizzy and takes several hours for the head to Come down; Stuffy; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Lays down or woke up in the morning gets really dizzy and takes several hours for the head to Come down) and DYSPNOEA (Stuffy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Lays down or woke up in the morning gets really dizzy and takes several hours for the head to Come down) and DYSPNOEA (Stuffy). At the time of the report, DIZZINESS (Lays down or woke up in the morning gets really dizzy and takes several hours for the head to Come down) and DYSPNOEA (Stuffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
on 12/06/08 Mom called provider office an spoke with nurse complaining of left leg swelling. 4/6/09-records received for DOS 12/18-12/21/08-DC DX: Right thigh abscess. Incision and drainage of right thigh abscess with penrose drain placement. Presented to ED with 2 weeks of swelling to right anterior thigh, febrile up to 102, completed 10 day course of amoxicillin. PE: large asymmetric  mass tender to palpation and fluctuant. Copious pus within abscess. Drain removed 12/29/08.
pt recv vax & exp an inj site rxn characterized by severe swelling & inflammation;This is 1 of 3 patients from this site who exp the above sx
5 hours after the vaccine, I started having a sore arm at the injection sight and a low grade fever of 100.0 with chills and I was uncontrollably shaking. I took ibuprofen at 8:00pm. That night at about 9:00 my fever was 100.8 and I felt extreme fatigue.  I woke up at 3:30am feeling both extremely hot and cold with a bad headache and my temperature was 101.5. I took ibuprofen again at 3:30am. I then woke up at 5:15 am with a horrible headache and was very hot and sweating. I put cold compresses on my forehead and back of my neck which helped. The entire night, my arm with the injection site was very painful and stiff to move.
Fever over 100 starting about 14 hours after vaccination. Chills, body aches, fatigue, headache, fever off and on treated with Tylenol over the next 30 hours.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. . Treatment medication was not provided by the reporter.