chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was sore, a little more than normal/ when she tried to move her arm, it would hurt a little more than it should have probably/ soreness in the arm; Stayed on bed pretty much all day; Just generally feeling bad, not horrible, just bad; Body aches; Fever/ she thinks it was just a low grade fever; Achy joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore, a little more than normal/ when she tried to move her arm, it would hurt a little more than it should have probably/ soreness in the arm), VACCINATION COMPLICATION (Stayed on bed pretty much all day), FEELING ABNORMAL (Just generally feeling bad, not horrible, just bad), PAIN (Body aches) and PYREXIA (Fever/ she thinks it was just a low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 020B21A and 001CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore, a little more than normal/ when she tried to move her arm, it would hurt a little more than it should have probably/ soreness in the arm), VACCINATION COMPLICATION (Stayed on bed pretty much all day), FEELING ABNORMAL (Just generally feeling bad, not horrible, just bad), PAIN (Body aches), PYREXIA (Fever/ she thinks it was just a low grade fever) and ARTHRALGIA (Achy joints). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm and Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was sore, a little more than normal/ when she tried to move her arm, it would hurt a little more than it should have probably/ soreness in the arm), VACCINATION COMPLICATION (Stayed on bed pretty much all day) and FEELING ABNORMAL (Just generally feeling bad, not horrible, just bad) outcome was unknown and PAIN (Body aches), PYREXIA (Fever/ she thinks it was just a low grade fever) and ARTHRALGIA (Achy joints) had resolved.            No concomitant medications were provided.   This case was linked to MOD-2021-406211, MOD-2021-406224 (Patient Link).
Information has been received from a licensed visiting nurse through the Merck pregnancy registry concerning a 17 year old female patient with no history or allergies to medication, who on 09-APR-2007 was vaccinated intramuscularly into the right deltoid, with a dose of GARDASIL (Lot# 654885/1424F). Concomitant therapy administered into the left deltoid on included a dose of MENACTRA and a dose of VAQTA (MSD). It was noted the patient was not taking other medications. On 13-MAY-2007, a home pregnancy test was performed. On 14-MAY-2007, the patient was determined to be two months pregnant via information from the patient's mother. In June 2007, the patient had a miscarriage and was reported to be approximately 2 months pregnant at the time of the miscarriage. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Injection was very painful when received on 2/3. Arm was sore at and around injection site for 48 hours. Redness and minimal swelling developed on 2/5. Redness and swelling from injection site (right deltoid) to wrist. As of 2/6, arm is still red and warm to the touch.
Case number PHEH2014US020145, is an initial spontaneous report received from a nurse on 03 Oct 2014, with a follow up report received from the nurse on 16 Dec 2014. This report refers to a 26 year old female patient. Past vaccinations (unspecified) were well tolerated. The patient was vaccinated with the initial application of FLUVIRIN (batch number: 14512P) intramuscularly at a dose of 0.5 ml on 01 Oct 2014. On an unknown date (on the same date of vaccination or on the next day after vaccination), the patient's injection site was very hot to the touch and had redness and soreness at the injection site. Further on an unknown date, the patient experienced red hot raised rash which lasted for 3 to 4 days. The patient was hospitalized. The outcome of the events was complete recovery. Causality of the events was not reported. Follow up report received from the nurse on 16 Dec 2014: Updated patient demographics (26 year old female), vaccination history, added events (rash erythematous and skin warm), changed outcome (complete recovery) and seriousness (hospitalization).
Narrative:  Multiple ER visits (both to his local community ER and other ER) over a series of days - due to continued facial swelling, difficulty breathing. Provided both a steroid shot at local ER on 6/11/22 and then Medrol Dose pack on 6/13/22. This orginated with the other ER. It was suggested that patient take oral Benadryl.
Patient given immunization on right deltoid with immediate reaction, with a wheal with redness and splotchy rash. Patient was told to wait 15 minutes after being inspected by a provider and given an ice pack. Measurement of spot was 1.5 inches. Provider told to patient to wait 15 minutes and I re measured area and it went down significantly.
This spontaneous report was received from a certified medical assistant, and refers to 3 patients of unknown age and gender. The medical history, concurrent conditions and drug reactions/allergies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 digital data logger reported as yes, lot # reported as L00610 with expiration date of 31-JAN-2017 (dose, frequency and route were not reported). No concomitant medications and no adverse symptoms were reported for any patient. No product quality complaint was involved. Additional information about the temperature excursion described that it was not less than 0 degrees C for 80 hours. Even though, no previous temperature excursion was reported. Additional information has been requested.
Had C7-C8 right shingles starting 2-3 days after vaccine injection. Vesicular rash start soon after pain starting.
Patient experienced a syncopal episode. Passed-out and hit his head on the floor. He has a hematoma on his head due to the fall. Patient sweating and stated he felt very tired. 911 called and was taken to the emergency room by ambulance. Several tests were completed at the ER. Patient was sent home with instructions for rest and fluids. He has been in bed all day since returning home from ER. Patient very tired, difficulty standing-up, walking and not eating much.
Approximately 5 min after vaccines c/o dizzy, fatigued, Encouraged to lie down x 10 min. Episode resolved when walking to car. C/o numbness at left side of body and SOB. Denies HA or CP, diminished reflexes noted. EMS notified and detained pt. transferred to local hospital for evaluation, VSS.
Chills, and high fiver about 102F  to 104F.    After the fiver reducer the fiver went down to 99.9 but not bellow of that value.
Vaccine exp. on 09/19/2021.  Vaccine given on 09/21/2021.
Since receiving vaccination patient experienced pain that radiates to back upper arm. Unable to move arm fully back or fully extend over head since vaccination. Recommended use to NSAIDs and ice or heat on arm to see if any relief.
is she going to die/half dead; her whole body is falling apart; She is tired and venting; aches; She is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (non-serious), outcome "unknown", described as "is she going to die/half dead"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "her whole body is falling apart"; FATIGUE (non-serious), outcome "unknown", described as "She is tired and venting"; PAIN (non-serious), outcome "unknown", described as "aches"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "She is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts". The events "is she going to die/half dead", "her whole body is falling apart", "she is tired and venting", "aches" and "she is sitting here feeling like she is has a 1500 watt electricity running through from her feet to her breasts" required emergency room visit. The patient underwent the following laboratory tests and procedures: Mammogram: Unknown results, notes: Her breasts, are unbelievable, she had to get a mammograms. Therapeutic measures were taken as a result of pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received her 1st dose of Pfizer on 3/6/21 and got sick with COVID several days later. She received monoclonal antibodies (Bamlanivimab) on March 13, 2021. She was mistakenly given her second dose of Pfizer today within the 90 day window. Medication error was realized after the vaccination was given. Pt was informed to follow up with her PCP for further instructions.
GARDASIL, MANACTRA, TDAP GIVEN. PATIENT C/O GETTING DIZZY AND THEN FAINTED.  USED AMMONIA INHALENT AND SHE RECOVERED WITHIN 1-2 MINUTES
Temperature 103.7 Shakes  Chills and sweats  Headache Fatigue
CBC test that shows high platelets and high white blood cells; CBC test that shows high platelets and high white blood cells; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 2nd dose, single for COVID-19 immunization. The patient's medical history included Hashimoto's disease. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. The patient had received both doses of the COVID 19 vaccine. The patient recently had a CBC test that showed high platelets and high white blood cells. It was drawn two weeks after she got her second shot, and she wondered if the shot would have caused those things to increase temporarily. She said this test was done two weeks after her second shot. She had Hashimoto's disease, and did not have a bad reaction to the shots. The outcome of the events was unknown.  Follow-up (17Jun2021): New information received from a contactable consumer (patient) included: Updated the patient's demographics and details regarding Follow-up attempts.  Follow-up attempts are needed; information about lot/batch number can be obtained.
The  same evening I got my vaccine I felt very weak and had very body aches. The next day I lost my sense of taste and I felt very tired. I wasn't able to hold my grandbaby because I just felt very weak. As time went on I had a very bad cough that I couldn't get rid of. I went to the hospital and I also experienced a sharp pain in my body. I was prescribed some medication to prevent the coughing, this helped some. A couple days later, I couldn't keep up anything I ate. My coughing was very painful , and was told I probably caught a cold. I was diagnosed with acute hypoglycemia. The hospital also did call to check up on me after. I am just now getting rid of the cough which was around June 9, 2021. The fatigueness has not gone away.
This spontaneous report was received from an administrator refers to 8-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On an unknown date in 2012, the patient was vaccinated with first dose in the three dose of RECOMBIVAX HB (dose, units and frequency were unknown) (lot# and expiration date unknown) via intramuscular route. It was reported that on 11-APR-2018 the patient was in the physician's office to receive the second dose in the three-dose RECOMBIVAX HB vaccination series, but the vaccine was not available to administer to the patient, so the patient still has not received the second dose. No adverse effects reported. The outcome of the event the vaccine was not available to administer to the patient was unknown. The casual relationship between event the vaccine was not available to administer to the patient and RECOMBIVAX HB was not provided. There was no product quality compliant reported.
Sharp recurring chest/heart pains that would last 10 seconds to 3 minutes. Occasionally would occur for 10+ minutes, and one time occurred for 2 hours. Went away after 10 days.
"brain fog", difficulty thinking/concentrating, memory issues, confusion, dull headache, tinnitus, dizzy, vertigo, fatigue, elevated blood pressure, light sensitivity, nausea, feeling like going to faint, sweats/chills, sudden sweats when eating, felt feverish and flushed but temp never went above 98.6,
1/31 - received 2nd dose of Moderna vaccine at MD (where I work as M.D.) Approximately 8 hours later, experienced severe chills, fever 102,  chest pain, and shortness of breath. Fever lasted two days,  however ,still not feeling well then experienced palpitations, irregular heartbeat. Went to cardiologist on 2/8. Tests revealed pericardial effusion and pleural effusion.
Patient received smallpox vaccine on 3 Sept 2009. She did not return for her take check 1 week later. She return on 14 Sept 09 due to hives and red rash on inner lower arms. Provider gave BENADRYL, patient returned again on 16 Sept with HIVES/red rash completely covering entire body including bottom of feet.  12/02/09 Vax records received. No changes to VAERS.  12/28/09 Medical records of 12/8/09 received.  Unable to contact patient.  Derm phone consult done & dx w/immune mediated exanthem.
He is like a totally different baby... cries for hours at a time.. doesnt eat the same. Doesnt sleep the same. Can cry from 1:00 in the afternoon until 10:00 at night. Was sleeping through the night now wakes every two hours... tried Tylenol, and gripe water. Theres just no calming him down. Will sleep for 20 minute intervals during day then will wake up crying and can cry for 2-3 hours at a time.
there was no adverse reaction, the vaccine ordered, and vaccine given has the same generic name Bexsero and different age group, education was given.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Suffered unexplained seizures and gray-outs, ringing in the ears, dizziness, bone and joint pain following vaccination. (OMIC)
ILD (interstitial lung disease) - He was treated for acute on chronic hypoxic respiratory failure secondary to interstitial lung disease also for pneumonia.  He was evaluated by pulmonary specialist also was treated with oxygen and antibiotics. Patient was treated adequately and to stay discharged home with follow-up with the primary care physician as well as cardiology.  Patient needs to continue oxygen at home this was explained to the patient. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
t99-100 13JUN & 14JUN91; On 15JUN91 t104.4F; seen @ ER no infect identified; Temp normal 17JUN91; Lump @ inject site, some soreness;
Fever; Chills; breathing poorly; vomiting every 30 min for hours and can't hold any food or liquid down; She can't eat or hold anything down.; This is a spontaneous report from a contactable consumer (mother). A 24-year-old female patient received first dose of BNT162B2 (COVID Vaccine, solution for injection, Batch/lot number: EL3246, NDC number and expiry date: Unknown) via an unspecified route of administration on 05Jan2021 (in the beginning of Jan2021) in left upper arm as single dose for COVID-19 immunization. Patient was allergic to penicillin when she was little. Patient's medical history (including any illness at time of vaccination) and relevant family medical history was none. There was no administration of other products. No previous immunization with the Pfizer vaccine was done. Patient did not receive any prior vaccinations (within 4 weeks). None of the vaccines were administered on same date of Pfizer suspect. No relevant tests were done. Caller explained that with the first vaccine, patient had a reaction, but it was not as bad as this one. She had a fever, was breathing poorly, vomiting every 30 min for hours and could not hold any food or liquid down, so she was just vomiting bile. She had chills and fever, but the breathing had been a big issue ever since the first vaccine. Events did not require a visit to Emergency Room or Physician Office. Outcome of the events chills, fever, was breathing poorly, vomiting every 30 min for hours and could not hold any food or liquid down was not recovered. Investigation Assessment: No.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-AUG-2014 the patient was inadvertently vaccinated with expired (on 22-AUG-2014) PNEUMOVAX23, intramuscularly, dose and lot # were not reported. No adverse effects reported.  Additional information has been requested.
Fatigue/ tiredness, dizzy/ light-headed, foggy-headed, chronic allergies, inflammation, dark eyes and swollen eyelids.
Nausea, tiredness, chills, muscle aches, dizziness, frequent shooting pains, mild diarrhea, headaches, injection site pain, and my skin would hurt intensely if someone touched it. The latter, and the shooting pains were a shock.  The symptoms were so severe that, if they were much worse, I really think I would need hospitalization. My heart hurt a little, I guess because it is a muscle, and I was experiencing muscle pain.
(R) arm swollen from deltoid to elbow for few days. Also felt flu-like symptoms lower back pain, headache, respiratory congestion.
Noticed discomfort that didn't resolve by bedtime of 10/8/08. Redness and swelling of upper arm, hot to touch. No self treatment as of today. Area is expanding and is uncomfortable. Referred to Dr today.
pt recvd flu vax & exp pain, redness, & warmth @ the inject site which lasted for 24 hrs;
EXPIRED VACCINE ADMINISTERED; VACCINE GIVEN TWICE AFTER THE 6 HOUR WINDOW; OFF LABEL USE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. 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, batch number: Unknown) 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 expired vaccine administered, medication error, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered, medication error and off label used was not reported. This report was non-serious.
Presented via EMS w/ weakness, AMS and rt. hip pain, RLQ pain, cough & fever. Hypoxic to 74% w/ strong odor to urine upon arriving. Covid+, symptomatic. Tx w/ O2, Vit C, zinc, abx, Remdesivir, steroids
Approximately two weeks after injection, onset of shingles.  One week after that, onset of Ramsay Hunt Syndrome.
The morning after vaccination, patient finished bush-hogging his farm and when he came inside he noticed he was itchy and had a rash. It started to turn into big hives so he took a Benadryl. He also soaked in a baking soda bath for over an hours. He called his PCP who told him to take another Benadryl. After 4 or so hours, the rash began to dissipate. By the evening, it had almost completely gone away.
tightness in throat, sweaty palms & feet itch; couldn't swallow, felt like throat closing; given DPH;
Severe chills, headache, fatigue, weakness, shivering, fever 100 too weak to move
Employee developed severe weakness, fatigue, nausea, and body aches 24 hours after second COVID-19 vaccination.  He required ED evaluation for symptom management and conservative treatment but did not require inpatient admission.  He was discharged in stable condition and advised to rest and hydrate at home.  Symptoms fully resolved effective 02/18/21.
Patient reports developing a headache early the next morning after the immunizations. She also had a change in blood pressure medicine (from lisinopril to Benicar). She still has an off and on headache today, 10/24/15. Patient reports acetaminophen lessens the pain.
Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Additional Details: Wife of patient had called the pharmacy hours after patient had recieved his J&J vaccine to inform us of this symptoms a few hours when arrving at home. He experienced fainting, chills, fever, and pain and took a tylenol and symptoms started to subside and has been currently been resting in bed. Wife says they will continue to take tylenol around the clock if needed and will seek medical attention is symptoms worsen.
PATIENT RECEIVED VACCINE AFTER 16 HOURS STORED IN REFRIGERATION; VACCINE  STORED OUTSIDE RECOMMENDED  CONDITIONS; This spontaneous report received from a pharmacist concerned a female of unspecified age. 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 was not reported, administered on 08-DEC-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced patient received vaccine after 16 hours stored in refrigeration. On 08-DEC-2021, the patient experienced vaccine stored outside recommended conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received vaccine after 16 hours stored in refrigeration and vaccine stored outside recommended conditions was not reported. This report was non-serious.
Nausea, abdominal pain for 4 weeks. Treating with famotidine. Pending outcome.