chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 53 y.o. female with COPD, DM2, morbid obesity, CAD and hydradenitis suppurativa on Humira who presented to the ED due to shortness of breath, fever, cough, nausea/vomiting and headache that began 11/29.  She was seen by her PCP and treated with Levaquin and prednisone but did not have any improvement.  In the ED on 12/5, she tested positive for COVID-19.  She is fully vaccinated (vaccinated prior to starting Humira) and is not aware of any definite COVID exposures although recently discovered that her grandson was exposed at school and his test has not resulted.  In the ED, she was found to be hypoxemic to 87% on room air.  Admission was requested for further management.
Cough. C/O airway/throat tightness. C/O headache. BP 12:55, 193/109; 80; 100%. Called to charge nurse 12:57, 162/108; 80; 97%. Reports improved airway. C/O epigastric pain. MD called up to unit. Patient transferred to ER.
Patient received vaccines beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown whether the patient was diagnosed or tested positive for covid-19.  Acute illness at the time of vaccination and up to one month before was not known.  Chronic and long-standing health conditions were unknown.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported has 49 years 8 months.  The patient got Moderna with vaccine Ndc code 80777027399.  The medical notified of an audit that was done which made aware that some vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Concomitant drugs were not reported.  Treatment details were not given.   This case was linked to MOD-2022-542869 (Patient Link).
Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering Fever Upset stomach
I felt like their was a frog in my throat and my throat was starting to close 20 minutes after the vaccine.  Fire Department checked me out and advised that I go home and take Benadryl.
Local reaction of redness and warmth surrounding vacination site approximatly size of a small orange.
Case number PHEH2014US016357 is an initial spontaneous report received from a pharmacist on 25 SEP 2014. This case refers to a 77 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with two doses of FLUVIRIN 2014/2015 (batch number: not reported), intramuscularly on the same day (24 SEP 2014). No adverse reaction was reported following this administration error.
Heart rate elevated, increased blood preasure, upset stomach, headache, sore arm, severe aches 1st night, insomnia, tiredness
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-APR-2016, the patient was treated by an internal medicine physician for a blistering vesicular outbreak and decreased immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Patient is a 58 y.o. female with reported PMH of  has a past medical history of Asthma w/ hospitalization in past year for asthma exacerbation, Bronchitis, Chronic laryngitis, reflux esophagitis, OSA,  Morbid obesity, herniated disc, chronic back pain (walks with cane) and HTN who presents for SARS-CoV-2 vaccination (Pfizer Dose #2).    15 minutes after receiving the vaccination, the patient began to experience itching of the forehead, scalp, bilateral thighs,and bilateral hands and "tingling" of the tongue. The patient was brought back to the monitoring area and vital signs were checked and significant for mild tachycardia (100's). Physical exam + for obese female in mild distress with mild anxiety and restlessness, conjunctival erythema, Mallampati III, large neck circumference with shortened neck length, increased RR (24 breaths/min). Exam (-) for acute severe distress, oral/pharyngeal swelling, angioedema, CP, palpitations, SOB, increased RR and effort, wheezing or stridor, light-headedness, dizziness, syncope, near-syncope, n/v/d/abd pain, fatigue, fever/chills.     Of note, the patient reports that she should have brought her Benadryl with her to the vaccine appointment because she experienced a similar reaction 35 minutes after rec'ing her 1st dose of Pfizer COVID-19 vaccination on 6/17/21; she reported this to her PCP and was instructed to take Benadryl (she took Benadryl for 2 weeks post vaccination). She states she did receive instructions from her PCP physician to pre-medicate or forego the Pfizer COVID-19 Booster dose. She states that she disclosed the sx hx to the vaccinator.    1134 Sx quickly progressing symptoms which now include full body urticaria, tongue and inner buccal itching.    Patient did not wish for support system to be contacted. She agreed to go to the ED for further monitoring. She drove herself to the vaccination appointment and is unaccompanied.    VS 1128 HR 104 BP 138/84 O2 sats 95 % RR 24  VS 1134 HR 96   BP 128/74 O2 sats 96 % RR 18  VS 1139 HR 98   BP 126/77 O2 sats 96 % RR 20     Assessment: Anaphylaxis   Plan:    VSS Q5 minutes Benadryl 50 mg oral stat x 1- given at 1128; tolerated with no difficulty swallowing Focused Reassessment  Epinephrine 0.3 mg IM stat every 5 minutes x 2 if 1st dose not effective- given at 1134 and 1139  NPO 9-1-1 contacted for transport to the ED for further management and monitoring Disposition-stable; improved
I felt some of the vaccine go on my arm and some was on the table /  I only got half the shot; apparently the syringe was defective; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (I felt some of the vaccine go on my arm and some was on the table /  I only got half the shot) and SYRINGE ISSUE (apparently the syringe was defective) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced UNDERDOSE (I felt some of the vaccine go on my arm and some was on the table /  I only got half the shot) and SYRINGE ISSUE (apparently the syringe was defective). On 03-May-2021, UNDERDOSE (I felt some of the vaccine go on my arm and some was on the table /  I only got half the shot) and SYRINGE ISSUE (apparently the syringe was defective) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported No treatment medications were reported
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 11-Jan-2021, PAIN IN EXTREMITY (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided.   This case was linked to MOD-2021-213349 (Patient Link).
PATIENT HAD SORE ARM WITH SWELLING.  CANNOT LAY ON HER SIDEW AND ARM IS SORE WHEN MOVING IT.  SHE HAS TAKE OTC ANAGLESICS, USED ICE PACKS, RESTED.  SHE HAS CALLED AND VISITED HER MD.  HE CANNOT DETERMINE THE CAUSE. DOES NOT SUSPECT IT IS FROM THE VACCINE.  HE HAS SENT HER FOR FURTHER TESTING, X-RAY, TO ASCERTAIN REASON OF PAIN.
GARDASIL vaccine dose # 2 given 4-21-10 (Had dose # 1 7/20/07) - pt. returned to office 4/26/10 with rash (red, itching) on both arms, elbow, legs, top of (R) foot, back. - Tx w/ BENADRYL.
39y/o male presents with syncope, head injury and body shaking within 5min of receiving Pfizer vaccine in left arm on 3/16/21. Patient lost consciousness, fell from a seated position and hit the left side of scalp on the floor. Patient then experienced uncontrolled body shaking for <5sec. He had drool from his mouth during episode. Patient regained consciousness after cessation of shaking. He reports associated sweating and head pain. He denies throat enclosing, difficulty speaking, lip/tongue swelling or itching, injection site pain or itching, blurring of vision, light headedness, chest pain, palpitations, or shortness of breath.   He reports history of syncope when getting his blood drawn and at site of blood. He denies allergies to medication or vaccinations. He denies any current medical conditions or h/o seizures.   On physical exam: Vitals: Heart rate 88, blood pressure 150/100  Skin: his skin is diaphoretic and ~4x2cm skin abrasion to his left scalp is noted.  Cardiovascular: Radial Pulse 2+ . Heart regular rate and rhythm.  Lungs: clear to auscultation bilaterally   Patient was examined by EMS and informed that he could be transported to hospital via ambulance for immediate consultation with provider or can decline services and seek care at a later time. Patient opted to drive on his own to seek care at a later time.  He was advised to contact his primary care provider regarding his adverse reaction, seizure and head injury.  Note: MA called for PA on site when patient fell and hit head. PA told site manager to call 911 while attending to patient. When PA arrived to patient's side, he had regained consciousness and PA proceeded to provide care and investigate incident.
12/23 started with sinus pain/pressure, ear aches, low grade fever.  COVid home test negative on 12/25.  PCR test negative on 12/29.  Went to PCP office for sick visit on 1/4.  Started on antibiotics twice a day for 7 days.
Asthma seems to be acting up.; fever; fatigue; chills; had a sore arm.; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch / lot number: unknown) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. On 16Feb2021, the patient had a sore arm. On 17Feb2021, experienced fatigue, chills, fever. On an unspecified date had asthma seems to be acting up. She was wondering if she will have worse symptoms with the second dose. Outcome of the events was unknown.  Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Pt c/o of vomiting & stomach ache x 1 day. Local redness and swelling x 60x70 mm at injection site, left deltoid.
69 patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.
felt like she was on fire; pretty bad; fever; pain even pain eyes; everything was hurting; burning sensation; aches; body was really hot like inflammation; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches) and FEELING HOT (body was really hot like inflammation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatic nerve injury and Arthritis.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches), FEELING HOT (body was really hot like inflammation), MOOD ALTERED (pretty bad) and PYREXIA (fever). On an unknown date, the patient experienced FEELING ABNORMAL (felt like she was on fire). At the time of the report, EYE PAIN (pain even pain eyes), PAIN (everything was hurting), BURNING SENSATION (burning sensation), PAIN (aches), FEELING HOT (body was really hot like inflammation), MOOD ALTERED (pretty bad) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines includes blood pressure medicine, stomach medicine, thyroids medicine, pain medicine,muscle relaxer for arthritis. Treatment medicines were not reported.
sore arm; Covid arm; itchiness; hard; a little pink about 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE REACTION (Covid arm), PRURITUS (itchiness), INDURATION (hard) and ERYTHEMA (a little pink about 3 inches in diameter) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (controlled by meds), High cholesterol (controlled by meds), Pre-diabetes (controlled by diet), Drug allergy (sulfa drugs) and Penicillin allergy. Concomitant products included LISINOPRIL for Blood pressure high, ESTRADIOL (VAGIFEM) for Estrogen deficiency, SIMVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE REACTION (Covid arm), PRURITUS (itchiness), INDURATION (hard) and ERYTHEMA (a little pink about 3 inches in diameter). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, VACCINATION SITE REACTION (Covid arm) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itchiness), INDURATION (hard) and ERYTHEMA (a little pink about 3 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant product includes NATURE'S BOUNTY VITAMINS for biotin/vitamins.   This case was linked to MOD-2021-024929 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Reporter Information, Patient demographics, Relevant medical history, Concomitant medication and event were updated
Dizziness, Syncope, Chills Narrative:  Employee states that the morning of 1/14/21, he felt very weak, experienced myalgia and brief episode of syncope. Employee contacted his PCP and is currently being monitored. When last spoke with employee at 3:15pm on 1/14/21, he stated that he still feels weak but is "doing a little better".
rash on my arm underneath the site of injection, big 5-6 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my arm underneath the site of injection, big 5-6 inches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on my arm underneath the site of injection, big 5-6 inches). At the time of the report, RASH (rash on my arm underneath the site of injection, big 5-6 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Topical cream.
Day one and two, splitting headache, fatigue, flu like symptoms. Day three, extreme fatigue, ongoing, headache gone.
Information has been received from a licensed practical nurse concerning her 15 year old daughter who was vaccinated with a first dose of Gardasil. Subsequently the patient developed a heavier than normal menstrual period. A urine pregnancy test was performed before the vaccination, and the patient was not pregnant. Unspecified medical attention was sought. At the time of the report the patient's second menstrual cycle returned to normal. Additional information has been requested.
Breakthrough case admission after 3 vaccines Moderna 3/15/21 Lot# 044A21A;  Moderna 3/15/21 Lot#030A21A;  MOderna 4/14/21 Lot# 043B21A
Information has been received from a female registered nurse with 72 drug allergies and a history of scoliosis when was child who on 21-MAY-2008 was vaccinated with one dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included vitamins and "something for pain".  On an unspecified date, the nurse developed general malaise for one week, injection site reaction with swelling and pain at the site, severe headache over the right eye, the nurse thought "she was having a brain tumor", right ear ache that then became "stuffy", severe jaw pain, the nurse thought "she was having a coronary", uncontrollable hypertension (190/100).  Her blood pressure use to run in the 130's.  She also developed a rash on the trunk that was resolved.  The nurse felt "like she was losing her mind".  The nurse has seen an ear, nose and throat specialist and it is questionable if she is suffering from temporomandibular joint.  The nurse also saw a cardiologist and has been placed on medication for the hypertension that has not been controlled at the time of the report.  The nurse was hospitalized due to hypertension and was discharged on 15-SEP-2008.  The nurse has undergone a "cardiac cath" that was negative, a cardiac stress test that was negative, a renal sonogram that was negative and a renal arteriogram that was pending.  The nurse also mentioned that she had developed a rash after receiving the influenza virus vaccine (unspecified).  She did not received influenza virus vaccine (unspecified) and ZOSTAVAX (Oka/Merck) at the same time.  The nurse's status at the time of the report was not recovered.  Additional information has been requested.
numbness and tingling in her arm; numbness and tingling in her arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 2021, outcome "unknown" and all described as "numbness and tingling in her arm".  Additional Information: The case was reported as non serious. The pharmacist reported for a patient that, the patient received the 2nd dose of the Pfizer COVID vaccine and a few days later experienced numbness and tingling in her arm for a week now. She was worried about it that will it go away. Any information on that. The reporter stated "I am a healthcare provider and would like to discuss how to treat an adverse event that occurred in one of my patients".  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Patient was in our outpatient infusion center receiving DACOGEN IV and received her FLUZONE (Sanofi) vaccine. Patient started having back pain, flushing and breathing problems. Patient received SOLU-MEDROL IV and MD called. Patient did recover, she finished her infusion, and no further problems were reported.
30 hours post vaccine: excessive crying for over 3 hours, refusal to nurse or be calmed in any way. In the months following the vaccine appointment, patient experienced constipation issues which had never occurred before. During nursing sessions, he would grunt and groan and pull his knees to his chest. He would not nurse well. There were times when he would not have a bowel movement for 5 days. He was clearly in pain. Before the vaccinations, he had multiple bowel movements each day.
Large red, itchy, painful, hot  area on bicep area of arm where the vaccine was give
Patient called complaining of a really sore arm in the arm she got the shot in, so sore she could not take her jacket off. She also felt really faint and "everything went black for a few seconds." Patient went to ER they told her to keep putting ICE on the arm and take ibuprofen. I called the patient the next day and she still felt a little fainty and sicky but over all fine.
Patient called about 3 hours after shot to say she had hives and itching that was spreading all over her body. She was told to take diphenhydramine and go to doctor's office.