chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymphadenopathy of the left shoulder with pain, Lymphadenopathy of right shoulder.; Lymphadenopathy of the left shoulder with pain, Lymphadenopathy of right shoulder.; This is a spontaneous report from a non-contactable consumer. This 51-year-old male consumer (patient) reported. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FA7484), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 51-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, glucose tolerance impaired and pre-diabetic. Concomitant medication(s) included amlodipine besilate, hydrochlorothiazide, valsartan (AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE); losartan; simvastatin. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: PA6780), dose 1 via an unspecified route of administration, administered in Arm Left on 09Jul2021 (at the age of 51-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jul2021, the patient experienced lymphadenopathy of the left shoulder with pain, lymphadenopathy of right shoulder. The patient was hospitalization for the event. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report.   No follow-up attempts are possible. No further information is expected.
Approx 2-3 minutes p/vax administration pt c/o of feeling dizzy, stomachache, h/a, numbness/tingling of hands;  had pt sit w/head down for approx 10-15min; pt dx anaphylactic-hospitalized;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 02-OCT-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L017997, expiration date 19-MAY-2017, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
11.13.2020 - I had a terrible headache that started at around 1030. By noon, I was so cold, my fingernails were blue and I couldn't get warm.  I'm NEVER cold.  It was around 1400 that I contemplated leaving work due to exhaustion; I don't get tired during the day. This morning, in hindsight, I noticed I was a bit winded while talking on the phone, while sitting.  Around 1400 today, I noticed I was hot and feeling pain around my chest, neck and throat. I found that it's red and swollen with hives- like reaction from breasts to ears.
Developed pityriasis lichenoides after Moderna booster. Biopsy was performed, resulting in the diagnosis.
Vaccine administerred to a 16-year-old; Sore arm; Slight dizziness; A spontaneous report was received from a pharmacist concerning a 16-year-old, female patient, who received Moderna COVID-19 vaccine (mRNA-1273) and vaccine was administered to a 16-year-old, who experienced a sore arm and slight dizziness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the pharmacist called to report that they administered the Moderna COVID-19 vaccine to a 16-year-old patient. On 10 Jan 2021, upon following up, the patient reported that she experienced a sore arm and slight dizziness beginning 09 Jan 2021 and that these events had resolved on 10 Jan 2021.  No treatment information was provided.  The event vaccine administered to a 16-year-old was resolved on 09 Jan 2021.  The events sore arm and slight dizziness were resolved on 10 Jan 2021.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 16-year old, female patient.  The patient's medical history is not provided.  The event occurred on 09 Jan 2021, during administration of the first dose of the mRNA-1273. This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.  The patient experienced a sore arm and slight dizziness after the injection for a day. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
fatigue; bad headache; chills; muscle pain; joint pain; nausea; fever - 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Joint pain on 15-Jan-2021, Nausea on 15-Jan-2021 and Fever on 15-Jan-2021. Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees). On 17-Jan-2021, FATIGUE (fatigue), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever - 101 degrees) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Treatment included Excedrin
Initial unsolicited case received from a pharmacist on 02-Aug-2017. This case involves a 46-year-old female patient who was vaccinated with a dose ADACEL (Batch number, expiry date, dose, dose in series, were not reported) subcutaneously instead of intramuscular route in the arm on an unknown date. Patient's medical history, pre-existing allergies, medical condition and illness at the time of vaccination was not reported. Any other vaccine within four weeks of vaccination was not reported. On an unknown date, following vaccination patient experienced shoulder soreness. It was also a case of actual medication error due to inappropriate route of vaccination. Laboratory investigations were not reported. Patient used warm compresses to treat soreness. On an unknown date, patient got recovered from the event shoulder pain. It was reported that event got resolved by second day after vaccination. 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 and Module 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. List of documents held by sender: none.
Patient was admitted to Hospital  on 12/27/2021 for COVID pneumonia. This is considered a breakthrough case.
Regular reactions included sore arm, body aches and fatigue. However it also triggered dizziness that lasted several weeks.
This spontaneous report as received from a licensed practical nurse refers to a 23 year old female patient with "birth control". No medical history and drug reactions/allergies were reported. On 21-MAR-2013, the patient was vaccinated with a dose of GARDASIL 0.5ml, intramuscular (lot # J002641, Exp date 10-DEC-2015). On 10-OCT-2013, the patient was vaccinated with the third dose of GARDASIL, (anatomical location, dose, route and lot # not reported). Concomitant therapy included unspecified birth control medication. The nurse reported that "about 30 seconds" after the injection on 10-OCT-2013 the patient fainted and began seizing. She stated that the patient's body was shaking for about 15 seconds. She stabilized the patient, and the patient did not sustain any injuries. The patient did not receive any treatment. No lab diagnostics studies were performed. The patient completely recovered after the incident on 10-OCT-2013. The patient sought medical attention. Upon internal review, the event seizing was considered to be medically significant. Additional information has been requested.
On June 7, 2021 at around 1700 hrs. experienced crushing chest pain and extreme SOB  after climbing stairs in my home.  I asked my son to take me to hospital - less than  1 mi. distant. I was diagnosed as having a NSTEMI, placed on heparin drip and transported to Medical Center.  I was placed on a The following day Dr., Chief of Cardiology and Professor of Medicine, performed a coronary angiogram  A 90% mid-LAD stenosis was observed and PCI performed.  A drug eluding metal stent was placed with good result.  I was discharged the following day.
Respiratory distress, Atrial fibrillation, Acute Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics
I was doing ok the first couple days then a couple days later I started to have swelling in my lymph nodes under my chin. I had really bad body aches, fatigue and headache. I got a Covid test that was negative. then a couple days later did another Covid test that was negative. I was off two days from work, I felt every part of my body was really bad body aches. They got better over 3-4 weeks.
11cm x 9cm erythema and induration at left arm injection site. No complaints of pain. No functional impairment.
Information has been received from a pharmacist concerning his 68 year old wife who unspecified date was vaccinated SQ with ZOSTAVAX (Merck) (dose and lot not reported). Subsequently the patient experienced injection site redness and swelling. The outcome of the patient was unknown. It was not specified if the patient sought medical attention. Follow up information has been received from a pharmacist. It was reported the patient experienced injection site redness, pain, swelling. The patient's injection site redness and swelling after administered the vaccine persisted. The pain had decreased so that the area was "tender to touch". Additional information has been requested.
This spontaneous report as received from a physician refers to a multiple unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, since the "end of March 2016" the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027076, expiry date: 26-MAY-2017, (dose, route, site of administration and dose # were not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at a temperature range of 52F to 55F for a time frame of 40 days. There was no previous temperature excursion involved. The call was the result of a data logger. The physician stated that Merck cannot file a report because the "temperatures recorded are still under investigation." No adverse effects were reported. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the four reports received from the same reporter.
Positive COVID test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID test) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011520A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced COVID-19 (Positive COVID test). At the time of the report, COVID-19 (Positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Initial misuse report received from a healthcare professional on 11 April 2013. ADACEL was administered to a 3-year-old patient. No adverse event was reported. List of documents held by sender: none.
Pt experienced redness at injection site (3 - 4 inches) with itching, swelling and warmth.
Patient was admitted to the hospital with abdominal distension and jaundice.  Tested positive while in the ED.  Patient subsequently transferred to alternate hospital for potential mass in the abdomen.
Right after administration pt. had 5 second seizure. Normal neuro exam after. Vitals stable. Day after pt. was seen complaint of twitching in arms, stuttered vocabulary, sometimes unable to get words out.
IMMEDIATELY I started to get a headache which turned into a migraine that night. Migraine lasted 2 days. within 24 hours i did get a low grade fever that only lasted less than 11 hours. 24 hours after I had a sore arm and my lymph nodes were swollen under my arm and near my collar bone. I was very sore in the lymph nodes area.
swelling and numbness in lip and chin area of face.   fingers on right hand numb, tingling sensation, and swelling.   symptoms have lessened since this morning but still prevalent.
Woke up with mild symptoms - a runny nose, intermittent mild chills, cough and sore throat.  Lasted 24 hours.  I mention this, though 6 days after the vaccine because of my immunocompromised state.
Following receiving the vaccine I began to experience thoughts of "what if I were to commit suicide."  No thoughts to act, just "what ifs."  This has been occurring randomly since in varying frequencies.
Within 10 minutes of vaccine left arm (injection arm) began twitching involuntarily.   Evening of vaccine and the following day heart had frequent flutters, and was fast-beating.  The day after the vaccine, in addition to heart-flutters, patient had fever, fatigue and sore left arm (injection arm).
This case was reported by a pharmacist via call center representative and described the occurrence of oral pain in a 61-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. On 26th April 2018, the patient received the 1st dose of SHRINGIX. On 26th April 2018, less than a day after receiving SHINGRIX, the patient experienced oral pain and blistering of mouth. On an unknown date, the outcome of the oral pain and blistering of mouth were recovered/resolved. It was unknown if the reporter considered the oral pain and blistering of mouth to be related to SHINGRIX. Additional details were provided as follows: At 15:00 hours, the patient received SHINGRIX on left arm. The patient reported that she experienced pain and blisters in her mouth on the same day following the vaccination.
No menstrual cycle since vaccine 12/28/20. It has been 224 days with no period. I have never gone this long with no period and typically have a cycle between 30-40 days.
A day after the second dose, vision in my right eye was impacted. It progressively got worse. I saw an eye doctor for an emergency visit on Saturday, 3/13. He did a full exam with dilation, and suspects it is an optic neuritis. Today, I had a visual field test, but I am unaware of the results yet. There has been no improvement in my vision since Saturday when I saw the doctor.
Fatigue not fixed with rest 20 days Emotional spikes 5 days  Chills 5 days
No additional AE details or PQC; had not yet received their second dose; This spontaneous report as received from a pharmacist refers to a 14-year-old patient of unknown gender.      The patient's concurrent conditions, medical history, and concomitant therapies were not provided.  In January 2020 (reported as 2 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot#, and expiration date were not reported).         The second dose should had been administered in January 2021. However, at the reporting time, the patient had not yet received it (inappropriate schedule of product administration). No additional adverse event (AE) details or product quality complaint (PQC) were reported.
Flushing, redness-erythema on entire face, neck, upper back, L arm. Denies nausea, pruritus, dyspnea-BP 110/78. After 20 minutes, erythema decreased, no complaints. Referred to student health services.
11:43 am Patient received first vaccine of COVID-19. 11:53 am Patient had initial syncope and pharmacist went to do a quick check of systems and patient was alert and responsive. Patient claimed of having upset stomach. Patient was left at chair. Patient then left to go to the restroom with father. Pharmacist went to find patient and went to the restroom as well. 11:58 am Pharmacist found patient and patient was being supported and held up by father. Pharmacist had patient lay down and elevated feet. Pharmacist called EMS to make sure patient was cleared and okay.  12:05 EMS arrived and did a initial work up and found that the patient's heart rate, blood pressure and vitals appeared normal. Patient claimed that he felt fine and normal. EMS asked if father, who was with patient, would be able to keep him home and down and relaxing for the day.
Serum Sickness developed one week after given Hepatitis A vaccine.  She initially had severe hives, followed by extreme swelling of extremities, blue extremities.  Urgent care was sought and patient was treated with steroids and antihistamines.  Patient was unable to walk for two days due to pain and swelling of joints. She began sitting 2 days after the event and walking three days after the event. Patient had significantly decreased appetite for 2 days.
Patient fell back in chair, the chair fell and patient hit his head on the floor, slight swelling noted on right forehead. BP 93/41. HR 58. He was transferred to the ED via gurney. Lost consciousness for 1 minute. Recovered and was discharged home.
Extremely fever ranges from101.3- 103.9 on 8/30- 8/31 Extreme nausea Diarrhea  Pain in lower extremities  Swelling in arm  Extreme headache
I experienced some of the typical side effects, including muscle pain, joint pain and chills. The one unusual side effect I experienced about 18 hours after the shot was a coughing episode that lasted for two hours and then suddenly disappeared as quickly as the onset. As I write this I am 27 hours post receiving the shot and now I am just dealing with the lingering muscle and joint pain.
On 1/26/01, approx 10:00, throat started hurting, coughing and head hurting. On 1/27/01, states she had a fever but does not know how much. On 1/28/01, states she had a fever, chest and back was hurting she went to ER but she was not told how much fever. In ER, she had blood work x-rays done. ER doctor told her results were all ok. Told her probably virus and to go home and to recheck with her doctor in the morning. On 1/29/01, she went to MD and he told her it could be attributed to flu shot. Gave A/B for 3 weeks and gave shot and told her more like sinus infection. Please note that she has had the flu shot in previous years with no reaction.
Widespread flu like symptons.  Extreme tireness the day of second doe of COVID vaccination. Second and third day no appetitie.  Second day extremely achy kees.  Around fourth day back muscle requiring 1/2 tablet of vicodin in order to sleep.  Also, slight headach after about 5 days.
1st dose of vaccine given at noon on a Friday. General malaise by 7pm that evening. Over next 12 hours skin reaction at injection site, 3" in diameter, very red, warm to touch, hard and very sore . Area was marked and grew approximately another inch over the next 24 hrs.  Within 12hrs of shot developed a fever that peaked at 102.5 and lasted approximately 24hrs from start to finish, developed severe joint pain within 12 hours and was not able to stand or walk unaided. Overwhelming tiredness with a headache, loss of appetite. I slept on and off most of the weekend. Within 72 hours all but arm swelling and pain resolved.
Fever, body aches, Arm red and hard. Tx'd with Claritin, Tylenol, Celestone
Patient tested positive for COVID 19 on 5/21/2021, then admitted to Medical Center on 5/30/2021 with worsening dyspnea, cough and fevers.  Remains admitted as of 6/8/2021.  Had received Pfizer vaccination at the Vaccination Center Dose #1 in February 2021 Dose #2 on 3/17/2021
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 02-JUN-2014, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (lot number not provided). It was reported that the dose and route were administered according to the prescribing information for ZOSTAVAX. No co-suspect or concomitant therapies were reported. The pharmacist reported that on 02-JUN-2014, a patient was administered a dose of ZOSTAVAX that was improperly stored. No adverse effects were reported. Additional information has been reported.
right arm aches all the time; My right arm aches all the time, have limited Tom in Right arm.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 21May2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included insulin lispro (HUMALOG), insulin detemir (LEVEMIR), metformin (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN) and insulin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously took bupropion hydrochloride (WELLBUTRIN) from an unknown date for an unspecified indication and experienced drug allergy. On 21May2021, the patient experienced "my right arm aches all the time, have limited Rom in Right arm". The events did not result in doctor or other healthcare professional office/clinic visit, and 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 "my right arm aches all the time, have limited Rom in Right arm" was not recovered.    The lot number for BNT162b2 was not provided and will be requested during follow up.