chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), EPISTAXIS (nose bleeding), ASTHENIA (really weak), ILLNESS and DIARRHOEA in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (really weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), HEADACHE, and FATIGUE. On 15-Apr-2021, the patient experienced EPISTAXIS (nose bleedings). On 14-Apr-2021, PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), and FATIGUE outcome was unknown. At the time of the report, EPISTAXIS (nose bleedings), and HEADACHE outcome was unknown. Not Provided.          No medical history were provided and concomitant medications include birth control pills. No treatment information provided
Rash; Light headache; Achiness; shingles; This is a spontaneous report from a contactable consumer or other non-HCP. A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0186), intramuscular, administered in Left Arm on 21May2021 02:45 as DOSE 2, SINGLE, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0173) intramuscular, administered in Left Arm on 30Apr2021 02:45 as DOSE 1, SINGLE (at the age of: 34-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. The patient previously took percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergy. On an unspecified date the patient experienced rash, light headache, achiness. On 24May2021 17:00 the patient experienced shingles. Therapeutic measures were taken as a result of shingles as Antibiotic. The outcome of event shingles was recovering while outcome of rest all events was unknown.  Follow-up attempts completed. No further information expected.
Chills during the night and in the morning when got up from bed had symptoms of orthostatic hypotension' headache neckache and while using bathroom my head was spinning when got up to go to bed I fainted and fell down on the floor which I dont remember until I got up myself and found my son crying next to me i was sweating
Pt was given Heplisav-B in error instead of pediatric Hep B.  Dr. to call mom and discuss with her pt mom.  Dr. would like pt to have the pt get Hep B for her age group in 1 month. 10/17/2022, 6:19 PM
Information has been received from a consumer concerning her approximately 36 month old son with no pertinent medical history or drug reactions or allergies who on 09-APR-2007 was vaccinated with a dose of MMR II. There was no concomitant medication. It was reported that the patient experienced developmental delays after receiving MMR II and had been diagnosed with pervasive developmental disorder (PPD). At the time of this report, the patient's pervasive developmental disorder persisted. Unspecified blood test were done and the results were not provided. Unspecified medical attention was sought via office visits. Upon internal review, pervasive developmental disorder (PPD) was considered to be other important medical event. Additional information has been requested.
81 y.o. female patient of local MD with a history of COPD, Hypertension, Hyperlipidemia, Tobacco abuse, admitted with acute respiratory failure with hypoxia hypercapnia   Acute respiratory failure with hypoxia and hypercapnia Secondary to CAP, COVID-19, and COPD exacerbation CTPA negative for PE, revealed consolidation RLL with small right pleural effusion VBG pH 7.23/CO2 68.1 (12/22 at local ED) -- > 7.24/76.1 on arrival to HCF Started BiPAP on admission Pulmonology following Increase in O2 requirements 12/27, repeat chest x-ray unchanged; required HF NC Discontinued lasix in the setting of contraction alkalosis, continue to monitor off Weaned from oxymizer to 6L NC 1/2 Slowly weaned down, discharge with 3L 02  Not previously on home oxygen    Covid-19 Virus Pneumonia Date of onset of symptoms: Approximately 12/19 Symptoms present on admission: Cough, dyspnea, wheezing Date of covid positive test: 12/22 Vaccination status: vaccinated Imaging: CTPA consolidation RLL with mild right pleural effusion Oxygen requirements on admission: Nasal Oxymizer/BiPAP Current oxygen requirements: HHF/BiPAP -> NC  Medical therapy: remdesivir (completed) and steroids, IV lasix (holding in setting of contraction alkalosis)  Consultants following: Pulmonology, cardiology Special isolation end date: 1/2/2023   Community-acquired pneumonia - resolved CTPA revealed consolidation RLL with small right pleural effusion Blood cultures obtained at local ED urine pneumococcal antigen, and urine Legionella antigen negative Received Rocephin (completed 7 days)/Zithromax (completed 5 days)    Hyperkalemia - resolved Giving calcium gluconate, insulin and dextrose  Repeat EKG NSR without any T wave abnormalities Resolved with Lokelma Acute COPD exacerbation Continue Decadron started at local ED Schedule DuoNeb/PRN albuterol nebs   Chest pain Elevated troponin Flat troponins noted at HCF EKG NSR, no acute ST/T changes appreciated Started aspirin and heparin drip on admission, discontinued heparin drip per cardiology  Consulted cardiology, signed off 12/8 Echo EF 55% no WMA   Continue aspirin 81 mg, lipitor 80 mg  No further cardiac work up    Essential hypertension Hypotension  - resolved Holding home lisinopril in setting of hypotension  Currently normotensive   Hyperlipidemia Continue simvastatin   Cigarette nicotine dependence Patient resistant to smoking cessation Nicotine patch, PRN nicotine inhaler during hospitalization   Transaminitis, resolved AST 75/ALT 59 POC labs In the setting of covid infection Acute hepatitis panel negative Repeat labs show resolution
This case involves Adult and unknown gender patient who experienced got the flu and covid while 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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious covid (covid-19) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the events (got the flu, Covid). At time of reporting, the outcome was Unknown for the event got the flu and was Unknown for the event covid.
Pt stated that the right side of his tongue went numb and tingly.  On 8/15/2010 the right side of his jaw line went numb and momentarily his right eye had double vision.
Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female who on 06-MAR-2008 was vaccinated IM, 0.5mL with a 1st dose of GARDASIL (lot# 657737/0522U). Secondary suspect therapy included MMRII (lot# and dose not reported). Other concomitant therapy included MENACTRA (lot# not reported). On an unspecified date the patient took a home pregnancy test. On 08-FEB-2008 the patient had an ultrasound and was positive for pregnancy (LMP approximately 29-SEP-2007, EDD 07-JUL-2008). The patient sought unspecified medical attention in the physician office. Additional information has been received from the nurse who stated that the patient's baby was fine. The baby originally spent three weeks in the NICU (neonatal intensive care unit) under bililights due to hereditary spherocytosis. The nurse stated that "this was not all due to the GARDASIL because it was a hereditary condition." Additional information has been requested.
Chill and fever (102).  Extreme pain in arm of injection, unable to lift arm for 2 days.  Extreme nausea and lightheadedness for two days.  Migraraine headache, which is still continuing.  Passed out for the first day.  Onset of symptoms about 5 hours after injection.
First shot (administered on 5 Mar 21, Pfizer Lot# EN6198) only had injection site tenderness (appeared next day) and arm pain which lasted for 2 days.  Second shot reaction, in order of symptom appearance; Injection site pain - within minutes of the injection Arm pain when lifting above shoulder level - within approx. 2 hours Exhaustion - started approx. 3pm Headache - started approx. 5pm and varied in intensity throughout symptoms. Chills (to the degree that a warm bath was required to heat extremities) - started approx. 7:30pm, interfered with sleep before soaking in hot water at approx. midnight. Diminished after soaking although chills did alternate with being overheated throughout the night. Mild joint pain - started approx. 7:30pm. Was worse in fingers/wrist and ankles where there are pre-existing joint issues. Nausea - started approx. 11pm. Did not advance to vomiting. Fever - temperature was elevated, 99.5F, around 12:45am and increased to 101.9F at 0345, at which point Tylenol was taken.   Temperature bounced around between 99.0 and 100.5 until the morning of the 28th. Other symptoms decreased (except fatigue) and were pretty much gone by approx. 5pm on 27 Mar 21.
Received Fluzone ~0930.  Developed palpitations ~1000. Developed resp. distress ~ 1015. Used personal inhaler at that time w/o relief.  Repeated x1 w/o relief.  Contacted PMD, who directed her to ED.  Arrived at ED ~1200. Received Benadryl 50mg po.  Only other sx. was dizziness; no hives, nausea.  To continue onZyrtec x1 week.  D/D diagnosis Asthma exacerbation d/t flu vaccine.
administrating less than 0,5 ml of the Shingrix vaccine to a patient due to leaking; This case was reported by a pharmacist via and described the occurrence of accidental underdose in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th May 2021, the patient received Shingrix. On 5th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The Health care provider reported that the patient administered less than 0.5 ml of the Shingrix vaccine to a patient due to leaking, which led to accidental underdose.  No adverse events details could be informed and no further events were reported.
Pt. states that after receiving the 1st dose of Shingrix 11/02/2021, started experiencing symptoms 11/03/2021 of headache, sensitive skin (pain to the touch), chills (shaking), feverish, and muscle aches. No noted Primary visit/communications.
This case was reported by pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the attack experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown. It was unknown if the reporter considered the pain in arm and swelling arm to be related to BOOSTRIX. Additional details were provided as follows: The age at the vaccination was not reported. The healthcare professional reported the patient developed a painful, swollen arm after receiving a dose of Tdap years ago. The healthcare professional was unsure if the vaccine was BOOSTRIX or an alternate brand. No further information was available at the time of report.
Fatigue aggravated; Vaccination site pain; Headache recurrent; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue aggravated), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache recurrent) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Cyst ovary from April 2020 to September 2020, Appendicitis in January 2015, Elevated liver enzymes in 2017 and Shingles from November 2020 to December 2020. Concurrent medical conditions included General physical condition abnormal since 2012, Weight gain since 2012, Diabetes since 2016, Fatty liver and Psoriasis since 2016.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 27-Jan-2021, the patient experienced FATIGUE (Fatigue aggravated), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache recurrent). On 30-Jan-2021, VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache recurrent) had resolved. At the time of the report, FATIGUE (Fatigue aggravated) had resolved.            This case was linked to MOD-2021-047574 (Patient Link).   Reporter did not allow further contact
injection site pain; aches; fever; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain, pain and fever. On an unknown date, the outcome of the injection site pain, pain and fever were unknown.   It was unknown if the reporter considered the injection site pain, pain and fever to be related to Flu vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The common flu shots caused injection site pain, aches and fever. This case has been linked with the case US2020AMR248144, reported by same reporter.
Beginning the night following the shot, I experienced extreme fatigue and muscle soreness. I spiked a fever of 100.4 in the middle of the night. This morning I was incredibly nauseous and vomited 5-6 times throughout the day.
I experienced heart palpitations. I had some soreness under my left arm and left breast about a week after the vaccine. I also had pain at the sight of the shot. I had to start taking a beta blocker due to the palpitations.
Pt developed varicella clinically diagnosed 06/03/02, viral culture and titers sent.
expired vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
Date and time of vaccination: (list both if they received both shots):   2-2-21 10AM Moderna LOT # 038K20A 3-2-21 10AM moderna LOT # 025A21A left sided flank pain, went to ED. had Ultrasound done was told it was possibly a kidney stone, scheduled for a CT.informed them on 3-4-21 this was likely not related to the vaccine but sounds to be possibly issues with kidney stones and to continue with CT as scheduled. verbalized understanding.
Information has been received from a licensed practical nurse for the pregnancy registry for GARDASIL concerning an 18 year old female with asthma, peanut allergy and 1 previous pregnancies and 1 full term delivery (no birth defects or infant complications noted) who on 05-DEC-2007 was vaccinated with the first dose of GARDASIL IM 0.5 ml.  On 05-FEB-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5 ml.  Concomitant therapy included albuterol inhaler as needed.  Other medications used during pregnancy included ferrousSO4 and biotin (+) carbonyl iron (+) docusate sodium (+) folic acid (+) minerals (unspecified) (+) vitamins (unspecified) (PRENATE ELITE) and iron supplement for anemia (begin on 12-JUN-2008 until delivery).  The patient was pregnant with an estimated date of confinement of 30-SEP-2008.  Fetal ultrasounds and positive pregnancy test were performed.  On 09-SEP-2008 the ultrasound was performed with the result of "small gestational age".  On 23-APR-2008 serum alpha fetoprotein was performed with negative results.  The complete blood cell count was performed with the result of anemia.  On 22-SEP-2008 the patient delivered a normal male baby weighing 6 pounds 2 ounces at 38 weeks with apgar scores 9/9.  There were no congenital anomalies and no other complications or abnormalities.  There was no complication during labor/delivery.  The patient sought medical attention in the office visit.  Additional information is not expected.
Sealed injectable medication vial barely had a drop in it. This is the second vial that has been discovered.
p/3rd dose of Engerix-B, pt exp diarrhea, vomited digested food & devel shivers, rigor, temp 40.1C on 17MAY91; Hospitalized & treated w/Ancef; No rxn to 1st & 2nd vax;
Pain in left arm described as "deep, achey... muscle pain + tightness" intermittent.
22JUN92 parent called states pt lt leg swollen & red; no fever; instructed to take to MD for eval 22JUN92 5PM parent came by clinic w/note states infected hematoma rt thigh due to vax; not allergic to DTP-started on ATB;
Right deltoid region there is a 2-3 inch area of induration erythema with superior ecchymoses at the 1 o'clock position.  Function of the deltoid muscle was normal. Oral temp 35.5 Will treat this localized reaction with Benadryl, ice, and NSAIDs as needed for pain control.
Information has been received from a 76 year old female with allergies to egg whites, sulfonamide, codeine and penicillin who over 5 years ago (approximately in 2004) was vaccinated with two doses of PNEUMOVAX 23 (manufacturer unknown). The patient indicated that a couple of years ago (approximately in 2007) she developed pneumonia a couple of times. The patient reported that two years ago she was diagnosed with cancer and had her bladder removed. The patient stated that she was not on any medication at this time; however her immune system was compromised. The patient was hospitalized on an unspecified date. The patient outcome was unknown. This is one of two reports from the same patient. Additional information has been requested.
Developed localized redness to the injection site. Then developed reddened itchy bumps on trunk and left side of back. Rash gradually improved.
Pt received Fluzone (single dose preservative-free vial) flu shot, immediately felt itchy and hot afterward, was taken to exam room for observation, developed generalized flush & hives within next 2 minutes, tachycardic to over 160bpm, pt then reported difficulty breathing & start of wheezing, 911 called, dyspnea dissipated as epi injection was readied, O2 @2Lpm via face mask started, pt remained alert & responsive.  Mom denied known egg allergy, reported pt to have history of multiple hypersensitivities but no prior anaphylaxis.
The Pfizer Covid injection was mixed incorrectly. Instead of 1.8 ml of 0.9% sodium chloride is was diluted with 0.9 ml. Pharmacy was called and spoke to pharmacist was directed to call Pfizer. Pfizer was called. Pfizer's recommendation was to follow CDC recommendation which indicates no harm to patient. Also reported states no adverse reaction has been reported. Only report was very sore arm for three to four days at site of injection. Left voice message for patient to call clinic.
Patient had dizziness, nausea, diaphoresis, abdominal cramps, and diffuse fatigue. No vomiting, no dyspnea, throat tightness reported. Symptoms lasted 2 hours at maximum intensity. Antiemetics and IV fluids given. Patient made full recovery within 24 hours. No hospitalization.
Was given in outside clinic, pt sent to ED, do not have other details at this time.  Pt states approximately 10 min after receiving vaccine, she started to have throat tightening and started to become very anxious. Clinic gave patient one dose of epipen and benadryl 50mg IM and sent pt to ED. Upon ED arrival, throat is improved, pt still very anxious. Throat feels dry. Exam unremarkable
Pt experienced redness and swelling at injection site 2 days following administration. Treated with diphenhydramine and rash started resolving.
Had 2nd Pfizer shot in upper left arm.  Developed swollen lymph nodes under left arm pit.
This case was reported by a pharmacist and described the occurrence of allergic reaction in a female patient who received FLUARIX QUADRIVALENT (batch number 2KJ3T, expiry date 25th June 2015). Previously administered products included influenza vaccine with an associated reaction of no adverse event. Concurrent medical conditions included sulfonamide allergy and specific allergy (drug). On 26th September 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On 26th September 2014, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction (serious criteria clinically significant/intervention required), pruritic rash on neck and face (serious criteria clinically significant/intervention required), labored breathing (serious criteria clinically significant/intervention required) and possible allergy to vaccine (serious criteria clinically significant/intervention required). The patient was treated with prednisolone. On an unknown date, the outcome of the allergic reaction, pruritic rash on neck and face, labored breathing and possible allergy to vaccine were recovering/resolving. The reporter considered the allergic reaction, pruritic rash on neck and face, labored breathing and possible allergy to vaccine to be probably related to FLUARIX QUADRIVALENT.
VIS given to father. Verified with another. Kept to 10-15 mins, no a/r.
shot really hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot really hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles shot really hurt but thanked it was better to get shingles shot than worried about it later.  The reporter hoped and prayed that everything would get better for you and thanked for the comment. The follow up would not possible as no contact details were available.