chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 y.o. male who presents with chest pain, elevated troponins and diffuse ST elevations concerning for pericarditis vs myocarditis admitted for cardiac monitoring and evaluation. Pt states he has had 1 day of sudden onset L shoulder pain and chest pain. Endorses dyspnea due to pain with deep breaths, denies tachypnea, nausea/vomiting, diaphoresis. Endorses mild chills and aches after COVID vaccine 3 days prior to onset of symptoms, denies any fever, URI symptoms, diarrhea, rash, known COVID contacts. Pain continued to worsen and spread across his chest, causing presentation to ED this afternoon. No history of PE, DVT, long travel, recent surgery, malignancy, alcohol or cocaine use. Significant cardiac history in family: dad with CAD w/LAD blockage, both parents with hypertension.    At ED, labs notable for elevated troponin 0.456, repeat 0.67 and diffuse ST elevations on EKG concerning for pericarditis. COVID neg, CXR unremarkable, blood cx drawn, no abx started. Patient was given toradol for pain with minimal improvement. Peds cardiology was consulted and patient was transferred to different ED for further care.   At different ED, repeat EKG showed similar diffuse ST elevations in I, II, aVL. Repeat troponins uptrending (4.91), proBNP 562, ESR 43, CRP 18. Mildly tachycardic but otherwise hemodynamically stable. Given tylenol for pain. Cardiology recommended admission for trending troponins, echo and cardiac monitoring.  CV: Troponins were trended every 12 hours with a max of 4.91.  His last troponin checked on the morning of discharge was 0.41.  He had an echo that showed normal cardiac function, an MRI that indicated normal ventricular size and function, with minimal or healing and inflammation or mild myocarditis.  During his admission, he had continuous cardiorespiratory monitoring, that did not show any arrhythmias.   Resp: On 2L NC for comfort, no respiratory distress or hypoxia.   FENGI: Regular diet   Neuro: Ibuprofen scheduled and tylenol PRN for pain.  He was initially started on ibuprofen 800 mg every 8 hours, but was starting to have pain prior to being due for medicine every 8 hours so his regimen was changed to 600 mg every 6 hours which controlled his pain adequately.   ID: Myocarditis panel sent with some results still pending.  Thus far, he is CMV negative, EBV IgG was positive but not IgM.  RVP was negative.  This all occurred in the setting receiving the Covid vaccine 3 days prior to presentation, which has been reported as a rare reaction to the Covid vaccine.  At the time of discharge, labs pending results include mycoplasma pneumonia, coxsackie, parvovirus, enterovirus. Etiology of myocarditis remains unclear at this time, could be related to infectious etiology not yet clear to us, vs related to his COVID vaccine prior to admission.
This spontaneous report as received from a nurse refers to a 10 months 20 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Extreme fatigue, chills, headache--duration=intermittent for 2 days.  Fever on 3rd day.  Muscle soreness at injection site x 7+ days.
Pt developed anaphylaxis, swelling and hives. He improved with subcutaneous epinephrine.
got the flu shot on wednesday, got the flu on friday; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an adult patient of unknown gender who got the flu shot on wednesday, got the flu on friday after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of got the flu shot on wednesday, got the flu on friday (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot on wednesday, got the flu on friday).  Outcome was Unknown for the event got the flu shot on wednesday, got the flu on Friday.
Became unresponsive for a short period on the way to the ER after vomiting; Became so sick and weak within 2 hours needed to seek medical help at the ER; Became so sick and weak within 2 hours needed to seek medical help at the ER; Uncontrollable cough; low grade fever; muscle aches; nausea; violent projectile vomiting; This is a spontaneous report from a contactable consumer (patient)   A 75 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 12Feb2021 at 14:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included lung cancer on 2007, Covid 19 infection on an unspecified date prior vaccination. The patient received first dose of BNT162B2 on 21Jan2021 at 15:00 in left arm. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and pravastin. On 13Feb2021 at 13:00 the patient started experiencing  uncontrollable cough, low grade fever, muscle aches, nausea, violent projectile vomiting. He became so sick and weak within 2 hours needed to seek medical help at the ER. It was also informed that patient became unresponsive for a short period on the way to the ER after vomiting. Treatment received included Zofran, LR (IV fluids).  The patient recovered from became unresponsive on 13Feb2021. At the time of the reporting the patient was recovering from the events.    Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's medical history and other drug allergic reactions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose number, dose unit, lot number and expired date unknown) for shingles prevention by an unspecified healthcare provider. No concomitant medications were reported. On an unspecified date the patient had injection site reaction, injection site was itchy and red. The outcome of injection site reaction, injection site was itchy and red was unknown. No further information provided. Additional information has been requested.
HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose). On 17-Jan-2022, ACCIDENTAL UNDERDOSE (HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No further information regarding patient side effect was reported.
Had the expected headache and tiredness that continued intermittently from first shot. Just a couple of days prior to second shot, upper teeth pain and some reaction to local high pollen count. Three days post second shot PCP started a course of antibiotics and decongestants thinking it was sinus related.  Also had a couple of weeks of night sweats, headache and cheek pain strong enough to prevent sleep and cause difficulty eating. Pain became excessively strong about Mar 8. PCP ordered lab and sinus CT on Mar 11. Neither of which were significant. Night of Mar 12 had significant visual difficulties.  March 13 morning the left temporal artery was tender and nodular with pain above left eye and left temple. March 13 suspicion of Giant cell Arteritis and administration of high dose steroids begun in afternoon.
1 week after getting 2nd COVID vaccine, developed chest pain, and left arm heaviness.  Reports intermittent sharp chest pain and chest heaviness for 1 week prior to going to Emergency room.  Patient states he still developed intermittent chest pain, that has not resolved.    Reports left arm heaviness for 3 days and left lymph node swelling.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma (Patient reports he does have asthmatic attacks sometimes in the spring, but is not sure if his hives are related to the vaccine or not). On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (hives). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigue). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at a dose of 3 days; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 milligram and CORTISONE for Adverse event, at a dose of 1% cream. At the time of the report, URTICARIA (hives), ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Doctor did a blood test after he told her about his reactions. No concomitant drug details were reported. This case was linked to MOD-2022-476845 (Patient Link).
Phone call from mother stating child had a measles like rash beginning 3/18/06 in the evening. Occasional low grade temp of 99-100 degrees. Took to primary care physician, told rash was a reaction to the MMRV vaccine.
blood sugar was 25, The patient then asked for information about potential hypoglycemia; Patient felt tired after the dose; This is a spontaneous report from a contactable pharmacist. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Feb2021 at 13:00, at a single dose, for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 12Feb2021, the patient felt tired after the dose and laid down to take a nap.  Patients husband later checked on patient and tested her blood sugar.  Husband reported that the patient's blood sugar was 25. The patient then asked for information about potential hypoglycemia post vaccination and whether she is safe to get 2nd dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of blood sugar decrease, cannot be completely excluded. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Similar to my reaction after the 2nd dose - chills and extreme fatigue. However, the symptoms ldidnt last nearly as long. I felt better later in the morning rather than symptoms lasting all day
I got my first Moderna booster for COVID-19 on 7/5/2022. On 7/6/2022, my period started, and at the time of this writing, it still hasn't stopped. I went to the ER on 7/16/2022, because my menstrual bleeding hadn't let up, plus I had intense pain in my abdominal and vaginal areas. When I got to the ER, they performed blood and urine tests. They informed me that I was not pregnant and that I had a urinary tract infection, iron deficiency anemia, and abnormal urinary bleeding. They prescribed me sulfamethoxazole-trimethoprim, ferrous sulfate, and naproxen. Meanwhile, my menstrual bleeding continues, and the medication they gave me has helped with the discomfort. I think I should also mention the fact that I went for the entire month of June 2022 without getting my period.
C/O dizziness, nausea, BP 92/54, then more dizzy, pale (lying down) - C/o vibration in arms - tingling B/L arms & (R) side face tingling. Cold compress, orange juice given BP 100/62, 98/64. Seen by PA. Feels better 4:45 pm. Informed to go to ER verbalized understanding.
Severe back pain and headache, also pain in most other joints but nowhere as severe as the back pain. As of 1:20 PM on 10/20/2011 all pain and headache is almost gone.
Patients got doses after the 30-day beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients got doses after the 30-day beyond use date).    This case contains information for the 5th of 14 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was reported that there was no information about the previous COVID-19 vaccination doses.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The pharmacist received a Moderna order on 15 November 2022 but, accidentally put the expiration date as 10 weeks instead of 30 days. Some patients got doses after the 30-day beyond use date.   The vial size was reported as 2.5 ml.  The vial was initially stored in the refrigerator on 15 November 2022.  The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706920:Master Case
Unable to raise left arm, severely limited ROM initially. Employee health sent me to MD (11/27/2017) who ordered x-ray. Second opinion MD (12/13/2017) ordered steroids PO and physical therapy 3x/week. F/U 1/5/2018 Minimal improvement. MRI ordered. F/U (1/21/2018) Orthopedic MD seen 3/2/2018, F/U 3/23/2018. Diagnosed with left shoulder bone contusion and bursitis S/P flu shot with penetration of bone and rotator cuff. Received steroid injection 3/2/2018. Physical therapy put on hold, light duty at work, limited 5 lbs. No significant improvement noted at this time. Continues to ache, throb, limited ROM, pain level from 4-8 on daily basis.
02/23/2021, 11:00 pm, severe chills lasting about 2 hours, tried sip of water for thirst, dry heaves short period about 2 minutes, headache, joint pain lasting until about 5:00 pm the next day, 02/24/2021 took one tylenol
Dry cough, palpitation, diarrhea, tiredness, somnolence, and chill
A report has been received from a Health Professional concerning a 40 year old, Female subject, Height: 64.0 Inches; Weight: 160.0 Pounds, who had been receiving Nasal FLUMIST. The patient's concurrent disease(s) included thyroid disorder. Concomitant medications included levothyroxine sodium. FLUMIST started on 12-Oct-2012. The patient experienced bronchitis, double ear infections, ear pain, sinus infection, slight sore throat and muscle aches which started on 12-Oct-2012. Cough, severe congestion, slight fever and headaches. The outcome of the event of bronchitis, cough, double ear infections, ear pain, severe congestion, sinus infection, slight fever, slight sore throat, headaches and muscle aches is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 16-Nov-2012 from reporter: new nonserious events of sinus infection & bronchitis & double ear infections added, patient details updated, new reporters patient, administered by & responsible physician added, relevant medical history updated.
Patient and parents were instructed to wait 15 minutes after getting vaccinations. Patient experienced syncope for less than a minute at 4:00pm in waiting area at clinic after receiving HPV vaccine around 3:30p.m. He regained consciousness and sat up at table. Patient was given water and cool air. VS : BP 100/60, T 36C, HR 64, R 16. Patient was able to verbalize that he felt ok and stated his name and birthday. Patient?s parents present with patient.  Parents denied any allergies or current medications.  Parents educated to monitor patient for any adverse reactions at home and to have patient eat. VIS form given to parents. Via interpreter they verbalized understanding of instructions.
Icy cold sensations in arms and hands for 45 min, some in my back. 3 hours later, a heavy fatigue, pain in legs began in random places, throbbing, pain in fingers, down both arms, in bones in hands and ankles. Right kidney area. Mild rash on my face, low grade fever,  tightness in chest, swelling at base of neck -both sides. Next day severe fatigue, fever, full on body pain all over. This led to over 5 weeks of neuropathy like nerve pain in groin, legs, some in arms, a few days of severe tingling all over. Brain fog. Two ultrasounds, appts with doc and neurologist. Vertigo and dizziness for a few days. Now left with severe nerve pain that I did not have before and fatigue that is very abnormal.
Vaccine given on Tuesday 3/30 Wednesday 3/31 - headache, body aches, fatigue Thursday 4/1 - severe headache, body aches, low grade fever, fatigue, diarrhea Friday 4/2 - sinus congestion, headache, body aches, low grade fever, fatigue, diarrhea, dry cough Saturday 4/3 - sinus congestion, headache, body aches, low grade fever, fatigue, dry cough Sunday - 4/4 - sinus congestion, headache, body aches, low grade fever, fatigue, dry cough Monday 4/5 - sinus congestion, headache, body aches, low grade fever, fatigue, dry cough - Covid Test Tuesday 4/6 - headache, body aches, fever of 102, severe diarrhea, fatigue Wednesday 4/7 - headache, body aches, fever of 100, diarrhea, fatigue Thursday 4/8 - headache, body aches, intestinal discomfort, fever broke, fatigue Friday 4/9 - headache, body aches, intestinal discomfort
14 hours after the second dose I had chills, fever, body and head ache for 5-6 hours.  Got up to get something to eat and blacked out momentarily.  Probably low blood sugar.  Bumped head on floor.
Severe all over body rash; Elevated heart rate; Tiredness; Chills; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Feb2021 (at the age of 69-year-old) (Lot Number: EL9262) as dose 1, single for COVID-19 immunization. Medical history included heart, kidney, bladder cancer, psoriasis. The patient had known allergy to sulfer. The patient's concomitant medications were not reported. The patient did not receive any other vaccines prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe all over body rash, elevated heart rate, tiredness, and chills on 26Feb2021. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Information has been received from a physician concerning an 18 year old female who on approximately 05-Oct-2007 was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  Subsequently the patient experienced pain, redness, and swelling at the injection site.  The patient sought unspecified medical treatment.  No further information was available.  Additional information has been requested.
Headache and vomiting one day after 2nd dose on Men B vaccine. No side effects from 1st dose.   Family requested clinic report symptoms to VAERS, although these can be noted side effects of vaccine.
vaccine had been in fridge past the 30 days of stability and was administered by the pharmacist. pharmacist was not aware of this at the time of the administration. contacted pt when discovered. pt reported sore arm and fatigue following vaccination.
pt recvd vax & exp n,d & a fever; pt devel elevated liver enzymes;