chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness at injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness at injection site after first dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness at injection site after first dose). At the time of the report, VACCINATION SITE PAIN (Arm soreness at injection site after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Child developed red and tender swelling in Lt upper arm, 05/14/07 exam child had approx 9x9 cm erythematous mildly tender swelling of Lt upper arm
Initial report received from a health care professional, office manager on 10 Mar 2010: This patient was vaccinated with expired dose of FLUVIRIN (Batch No. 1013265P), 0.5 ml, intramuscularly, sometime between 01 Mar 2010 and 09 Mar 2010 (on an unspecified date). The outcome of the events was not reported.
Flu like symtoms; chill; sligh headache; a little tired; This is a spontaneous report from a contactable other hcp (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9810), via an unspecified route of administration on 08Feb2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on an unknown date for covid-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient experienced flu like symtoms, chill, sligh headache, temp at 97.8 and a little tired on 12Feb2021 09:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was unknown. The events were reported as non-serious.
Rash (arms, legs, feet, hands). Was diagnosed with Pityriasis Rosea by healthcare professional.
Blue discoloration at injection site (approx. 1cm diameter), irregularly shaped) appearing "1-2 weeks after" administration. Residual hypopigmentation at injection site still visible today.
Evening of vaccine intense itching. Site swollen and red. 48 hrs later muscle 7 joint aches & pains lasted 3 days. Itching continued. Week after exam, head went silent as if under water for a few seconds and came back but with loud ringing in R ear and "woozy" feeling.  Did not go away after 2 weeks, notified and saw both neurologist and primary MD.  Ears examined, told to see a ENT MD if no improvement in a month. Saw Neuro & Ophthalmologist to make sure wasn't PTC. Both said it wasn't PTC causing the ringing. Dizzy subsided around end of Nov.  Beginning of December saw ENT/vestibular specialist who did several tests.
Patient has already received HPV dose 1 and 2 and was inadvertently given a third dose.
29 Jan 2021 9am - received first dose of Moderna 12:30pm - diarrhea  8pm - started to not feel well 9pm - feeling cold and shaky 10pm - Feeling very tired, ready to sleep 11pm - throws up about 10 times, more diarrhea  11:30pm - drinks some water and throws it up immediately. Continues throwing up but it turns into dry heaving.  11:45pm - starts to experience Acidosis or Metabolic Acidosis. Muscles cramp so much it?s hard to walk, talk or write. At this point I?m worried about dehydration. Breathing becomes short and heavy.  30 Jan 2021 Midnight - arrives at the ER 12:30am - my heart rate is 150. I have a low grade fever at around 100 degrees F.  1 am - 3am - 3 different nurses try to stick me with an IV but my veins are so small they were unsuccessful. They ended up giving me a pill for nausea and encourage me to take small sips of water and eat some crackers. During this time I calm down enough so my heart rate lowers back down into the 90s and muscle cramping subsides. My bloodwork came back normal so no infections. 3:30am - discharged from ER 4am - falls asleep 3pm - wakes up feeling much better but still feel exhausted from the rough night
AFTER 1ST DOSE EXP FEBRILE ILLNESS(FLU LIKE SYMPTOMS). OK 11-18-89. AFTER 2ND VAX, SHE HAD FEVER, JOINT PAIN, MALAISE(ONSET 12-21-89) FOR 5 DAYS. SUBSEQUENT DEV OF SORE THROAT AND FULL BLOWN FLU. NO TREATMENT GIVEN.NURSE DOESN'T BELIEVE VAX
Rubbed sore arm in evening and proceeded to have severe chills all over the body.  Heart racing - very cold and shaking.. Then again after warm shower, got in bed; around 1:30am rolled over onto site and again with the chills and shaking.  went to restroom, covered up and eventually subsided.  Then at 4am, severe chills, heart racing, body shaking really bad; could barely walk to restroom - didn't subside for about 10 minutes.  Thought of calling 911, but stuck it out, warmed up and got back in bed.  Woke up at 7:30am  with severe headache; took BP meds & Tylenol and rested in a recliner.  No more chills as today has progressed, just feeling "spacy."
This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received PREVNAR 13 via an unspecified route of administration on 16Aug2017 at single dose for immunization. Patient medical history included blood pressure high, diabetes and asthma. Concomitant medications included metformin for diabetes, VENTOLIN for asthma and lisinopril for blood pressure high. It was confirmed that the patient received a single shot of PREVNAR 13 on Wednesday, 16Aug2017 at approximately 2:30. The patient stated "everything was fine and the next day I woke up, I had a huge soft ball size hot red at the site and then the whole lymph node in my armpit is swollen". The patient went to work and then she got fever of 100.8 so she took ibuprofen and stated that normally she took ibuprofen every 6 hours otherwise she will get fever of 100 and site was still extremely painful, hot and red. The patient experienced flu like symptoms and just feeling terrible. It was further stated that if she do not take the Ibuprofen, she gets flu like symptoms and sweaty. All events occurred on 17Aug2017 at about 8:00 am, and stated that she woke up with that. The nurse stated that events: huge softball size hot red at the site, whole lymph node in my armpit is swollen, got fever of 100.8 and extremely painful hot and red were related to PREVNAR 13. She further stated it was 100% the vaccine; events were like specifically at the site and underneath her arm. Outcome of events were ongoing, not recovered. Nurse mentioned that it was more painful. If she do not take the Ibuprofen (treatment), it was just like, she get the flu and sweaty and fever.
pt recv vax 14MAY96 & 29JUL96 pt devel a h/a which pt felt was stress related;10AUG96 lt eyelid would not close & lt side of mouth was drooping;seen by MD 11AUG96;Bells palsy was dx 12AUG96;Pred as prescribed;pt stated nothing tastes;
Patient is a 66 y.o. male patient of PA-C with history of metastatic esophageal cancer currently on radiation treatment, systolic and diastolic heart failure, hypertension hyperlipidemia, presented with generalized weakness, fever to outside facility found to have pneumonia due to COVID and possible superimposed bacterial pneumonia.   Pneumonia due to COVID-19 With possible superimposed bacterial pneumonia Covid-19 Virus Infection Acute hypoxic respiratory failure Symptoms: 9/10, positive test: 9/12 Vaccination status: vaccinated Imaging: Chest x-ray shows pneumonia Oxygen requirements on admission: 2L Current oxygen requirements: RA Medical therapy: Steroids and remdesivir added by ID Consultants following: Consult infectious disease  anticipated special isolation end date: 9/22 (patient noted COVID infection back in July and asking about isolation, will defer to infectious disease) Finished a course of ceftriaxone and azithro, also stopped remdesivir and steroids Discharge home with hospice    Acute metabolic encephalopathy, significantly improved Likely due to infection CT head was completed and shows no acute abnormality Continue monitor mental status improving   Esophageal carcinoma status post chemoradiation Status post esophagectomy complicated by bronchoesophageal fistula requiring prolonged hospitalization in 2020. Currently on palliative radiation therapy Follows with Dr. V, apprciate oncology input Resume home OxyContin twice daily and Percocet as needed   Chronic right arm and shoulder pain Continue pain medications as needed   Severe malnutrition POA Due to cancer  Anorexia Failure to thrive Depression Patient has agreed to try Zoloft which has been started.   Nutrition consult   Chronic combined systolic and diastolic heart failure Prior echo in 2021 showed LVEF of 45% On midodrine and home due to hypotension, will continue No diuretics for now patient appears euvolemic Continue monitor   Hyponatremia Mild, continue monitor.  Was given IV fluids in outside ED   Diabetes Placed on sliding scale for now
Received HPV immunizations in right deltoid 11/14/2013.  (Pt was also given influenza vaccine in the left deltoid on the same day.) Since that time has complained of pain in the Right deltoid that has not improved since. It is quite tender to touch, painful with range of motion of arm especially with reaching with the arm. There has been no redness or swelling to the area. Some decrease in pain with Tylenol. Has done some heat to area this week. No fever or other illness symptoms, although did have a URI starting the day after she had the immunization. No numbness or tingling in her arm, no radiation of the pain.
Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator; 3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022 at 3:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 3:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 Moderna COVID-19 Booster Shots were given to patients greater than 12 hours post-puncture) and PRODUCT STORAGE ERROR (Refreezed- the vial stored post puncture (ambient room temperature or refrigerator) refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported Patient received Second Booster dose. Number of doses/vials: 3 booster doses / 1 vial (15.5 ml) Red Cap Date the vial was initially stored in the refrigerator: 22 APRIL 2022 Date and time vial was first punctured: 22 APRIL 2022 at 9:55AM vial was stored in the Refrigerator post puncture. The vial did not undergone any temperature excursions Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F on 22-APR-2022 for 2 hours, 25-APR-2022 for 1 hour and 26-APR-2022 for 1.5 hours at room temperature.  The rest of the time the vial was in the refrigerator No treatment medications were reported   This case was linked to MOD-2022-551983, MOD-2022-551984.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2022: Live Significant follow up-Event added (Product storage error) Dosage information received On 28-Apr-2022: Live follow up - reporter contact number was added.
Mother reports that approx. 1 hour, post vax, the pt began wheezing, breathing funny and coughing. Mother called PCP at approx. 21:45, that night and immediately referred to the closest ER. Infant dx'd with aspiration and treated with nebulizers and oral steroids. Mom also reports that she experienced an adverse reaction to her 5 year old booster of DTAP. Hospital discharge diagnosis was; gastroesophogealreflux with mocroaspiration and a bronchospasm episode.
I have had a cold that I cannot recover from for over a month. The symptoms of this cold are similar to Covid symptoms with a sore throat, tiredness, and mucus in the lungs.
Patient received flu vaccine (FLUAD) in her right arm and PNEUMOVAX 23 in her left arm on 10/30/2017. She returned to pharmacy on 11/1/2017 with complaints of rash and pain in her left arm (from injection site to left elbow). Pt was advised to take BENADRYL and put ice on it. The Pharmacist called the pt back at 1740 on 11/1/2017 and rash was the same but pain was less. Pt followed up with PCM and got Rx for MEDROL and.
A mother reported that her 8 month old son received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine) on 07/09/02.  Concomitant vaccine therapy included Engerix B, Infanrix, Act-Hib, and EIPZ.  Medical history included sepsis and apnea at one week of age.  On 07/11/02, the child developed a fever, and "broke out in a rash all over his body, including the "bottom of his feet."  The rash got "progressively worse for two days" before spontaneously resolving.  During that same time period, the child developed "spontaneous bruising over his entire body, bloody eyes, sun sensitivity, irritability , and all hair on his hair on his head fell out".  The reporter indicated that her son "had a dark complexion and dark eyes, and now has a pasty, white complexion" and light eyes which appear "glossed over".  In August 2002, the child experienced hair regrowth and spontaneous resolution of the bruising and "bloody eyes".  She stated his hair color "changed from brown to light blonde".  From 07/02 through 10/02, the child did not gain weight; he currently weighs 22lbs.  In October 2002, the child was tested for "platelet pool storage disorder"; the results were negative.  At that date of this report, the child continues to experience irritability.  Information regarding these events has been forwarded to manufacturers of the concomitantly administered vaccines.
OBSTRUCTIVE SLEEP APNEA ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME
Low grade fever, malaise onset 10-12 hours after dose, persisted 12 hours.
Patient received second dose of SHINGRIX and saw MD complaining of feeling off balance with some pressure in his forehead. Symptoms were improving when patient was seen on 08/30/2018.  MD believed symptoms were related to SHINGRIX vaccine.
after the first and second vaccine shot . I experienced breakthrough menstrual like bleeding. It was heavy and lasted 10 days for both times. Both shots occurred a week after a regular menstrual cycle.
Patient had this vaccine administered on 1/14/22 after its "use-by date" of 1/1/22. 1/1/22 is the 31 days of refrigeration. Expiration date is February 2022. No adverse reactions reported. Per manufacturer, administration not recommended past 31 days + an additional 14 days of temperature excursion. Per manufacturer, patient will not need re-vaccination.
Vomit x 3 days starting within 24 hrs, fussy, decreased quality of feedings for 2 weeks - approximately 2 weeks after vaccine, new spasms developed - refer to neuro for eval.
Itching started in right arm and front of chest, redness. No hives or SOB. Offered water but patient refused benadryl. Stabilized and felt better afterwards.
CLIENTS MOTHER STATES 5 MINUTES AFTER ADMINISTRATION OF PFIZER VACCINE CLIENT HAD A 4 MINUTE LONG SEIZURE - SEIZURE WAS NOT OBSERVED BY NURSES - MONITOR NOTIFIED NURSE ONCE THE 15 MINUTE OBSERVATION TIME WAS UP AND MOTHER HAD ASKED TO SPEAK WITH A NURSE BEFORE LEAVING - MOTHER STATES THIS IS NORMAL FOR HIM - HE HAS DAILY SEIZURES - BUT SHE DID NOT KNOW IF IT WAS DUE TO THE VACCINE OR NOT.
Dyspnea. Patient came to ED on 26 July 2012 and was admitted. Work-up disclosed large bilateral pulmonary emboli. There was also a Right thyroid lobe complex nodule of about 4 cm diameter.
3/9/21: fever/chills/body aches/headache.  lasted 30 hrs 3/10/21: little red bumps appeared on left arm at the bend of elbow(size of pin head-about 50 of them)  lasted for 3 days 3/10/21: swollen eyelid (right eye) that lasted 3 days 3/18/21: bloody nose (I've never gotten a bloody nose before).  Only happened that day.
Patient's left arm between injection site and elbow is swollen, red, and hot.  She said it started on same day as the shot  I advised her to be seen in the adjacent urgent care.
Initial non-serious report received from a healthcare professional on 21 September 2011 under the local reference number 11-0601. A 74-year-old female patient who had many medications for years and allergies to PLAVIX and Sulfa had received a "lasted" intramuscular dose of FLUZONE HIGH-DOSE (batch number UH458AC) in the left deltoid on 20 September 2011. The patient had no illness at time of vaccination. The patient had no other vaccination within 4 weeks prior to 20 September 2011. On 21 September 2011 in the afternoon, the patient was seen by the physician for local redness on left arm with injection site "larger than a half dollar" with a rash over entire body, BP increased 170/100, pulse increased 120, and pulse oximeter reading of 90%. The patient required a doctor visit. At the time of the report, the patient had not recovered. Follow-up information received on 17 January 2012. Due to the following information, the case was upgraded from non-serious to serious: Concomitant medications included Baby ASA, LANOXIN, DIOVAN, ATIVAN and LASIX. The reporter clarified that the rash was from head to toe with terrible itching. The duration site was approximately 4 x 6 inches of erythema (adverse event coding updated to reflect size of vaccination reaction). The patient had recovered after treatment with steroids (one week later, the rash improved). Seventeen days after vaccination (which was on 17 October 2011), the patient was hospitalized due to COPD exacerbation. The reporter was not sure if this was aggravated by her reaction to the FLUZONE vaccine. Diagnostic tests/laboratory data or treatments for the COPD were not reported. Hospital discharge date not reported. At the time of this report, the patient had recovered (date not reported).
Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K016152 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Pain at the injection site starting right away. The next day I awoke with a headache, some body aches, and my skin hurt a bit. By the afternoon the day after my shot, my symptoms got worse and  I was very achy all over my body.  By the middle of the night, I also had developed pain in my left armpit. The following day (4/22) I am feeling better, but am still sore, achy, and my arm (injection site) and armpit still hurt.  My headache is lying just under the surface but is much better.
The COVID-19 vaccine administered through vaccine administrator between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
pt recv vax 5/19/99 c/o sore arm 5/21/99;5/24/99 rash, bump & fever @ site;5/27/99 pain & redness gone;no tx necessary;
Day after site - painful; pt felt lethargic, HA (severe), cold/chills, dizzy, nausea 2nd day after pt felt HA using new to APAP.
Patient got his Shingrix vaccination at Pharmacy on June 6, 2022.  He reported to his wife on June 7th, that he felt very fatigued .  1 week later, he had his INR checked at our Cardiology office and his results were > 8.0.  This result was obtained on June 13, 2022.  For reference, his INR 3 day prior to receiving the Shingrix vaccine was 1.8 (tested on June 3, 2022).   He reported no bleeding or bruising symptoms.  There  were no changes in his diet, OTC meds, Rx meds, no other potential causes for greatly elevated INR.
Patient presented to the ED and was subsequently hospitalized for acute respiratory failure with hypoxia within 6 weeks of receiving 2nd covid vaccination. Patient did receive booster dose in 12/3/21.
Pulmonary embolism; Spitting out blood clots; Labored breathing; Diarrhea; Body aches; Joint aches; Fever; Exhausted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (No medical history reported.). Concomitant products included METOPROLOL and LOVASTATIN.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted). On 07-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing) and VITAL CAPACITY ABNORMAL (Vitals are waked out). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), HAEMOPTYSIS (Spitting out blood clots), DYSPNOEA (Labored breathing), OXYGEN SATURATION DECREASED (Oxygen levels have gone as low as 76 and several in the 80's), HEART RATE INCREASED (Heart rate is normally around 60, and has been in the 90's several times), VITAL CAPACITY ABNORMAL (Vitals are waked out), DIARRHOEA (Diarrhea), PAIN (Body aches), ARTHRALGIA (Joint aches), PYREXIA (Fever) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 103.7 (High) 103.7. In February 2021, Heart rate: 90s (abnormal) In the 90s several times. In February 2021, Oxygen saturation decreased: 76s (Low) has gone as low as 76 and in 80s. In February 2021, SARS-CoV-2 test negative: Negative and Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.