chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness / at injection site on left arm; swelling at injection site on left arm; swelling for both lower arms; redness / for both lower arms; This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a male patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On an unknown date, the patient received Fluarix. On an unknown date, unknown after receiving Fluarix, the patient experienced injection site erythema, injection site swelling, swelling arm and erythema. On an unknown date, the outcome of the injection site erythema, injection site swelling, swelling arm and erythema were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, swelling arm and erythema to be related to Fluarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix in left deltoid and had redness and swelling at injection site on left arm as well as redness and swelling for both lower arms. The reporter stated that the office was bringing the patient in to be seen it was reported to GSK rep over the phone before the patient was seen.
Strong, dull pain at injection site 12 hours after injection. Enough pain to wake from sleep.
This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 09Apr2021 12:00 (Batch/Lot Number: ER8729) at 64-years-old as single dose for covid-19 immunization. The patient was not pregnant. Known allergies: penicillin; mold/seasonal allergies. No other medical history. Concomitant medications included trazodone hydrochloride (TRAZODON) and ascorbic acid, calcium carbonate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin sodium phosphate, thiamine hydrochloride (MULTIVITAMIN [ASCORBIC ACID;CALCIUM CARBONATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE]). The day after her first shot on 10Apr2021 her upper Lip felt like it was swelling. For the next Two weeks her lips continued to feel Swollen but then would sting. This had continued. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 administered in Arm Right on 30Apr2021 11:30 am (Batch/Lot Number: EW0167) at 64-years-old as single dose for COVID-19 immunization. Last Wednesday 26May2021 her cheeks were very red and hot. In the past two weeks the rest of her face especially her checks and beneath her nose also feel Like they were swelling. This week her eyes were very red and Irritated. Above her upper lip was itchy. The strange lip feeling was very constant Whereas the hot cheeks and eyes Come in waves. When she lay down, there was a sensation in the back of her Left cheek in front of her ear. Adverse event start date was 10Apr2021 12:00 pm, AE resulted in [doctor or other healthcare Professional office/clinic visit, Emergency room/department or Urgent care]. Treatment received. No COVID-19 prior vaccination, no covid tested post vaccination. The outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021730515 same patient/ reporter/ product, different dose
Patient returned to pharmacy within 20 minutes of receiving vaccine complaining of "throat tightness". Discussed potential for allergic reaction with patient along with risks. He decided to go home at that time and that afternoon he went to his physician's office. Spoke to nurse at Dr's office. She gave the patient MEDROL 40mg intramuscular. She stated that his symptoms still continued for the next couple days. I spoke to patient on 3/28/18 and he stated that he was feeling back to normal.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions of allergies, concurrent conditions and concomitant therapies were not reported. On 06-APR-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10PK 0.5 mcg/0.5 ml SDLLolCap Ped" and lot number K008986 with expiration date of 01-APR-2016 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as " in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
6"×6" localized induration surrounding injection site with redness, swelling, warm to touch, Tenderness to palpation, that has not reduced since friday 12 hrs after shot.
I have developed hyperthyriodism with very high numbers?. I read that are similar cases to mine.
slight chills in both arms; uncomfortable; A spontaneous report  was received from a healthcare professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events slight chills in both arms, uncomfortable.  The patient's medical history was not mentioned.  Concomitant medications reported were metoprolol tartrate 25mg 1 4 tablet daily, levothyroxine 25mcg daily, Propranolol 10mg ½ tablet daily, Vitamin C, Multivitamin for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 021M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date patient experienced events as slight chills in both arms and uncomfortable.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s), slight chills in both arms, uncomfortable was UNKNOWN.
Pt. developed joint pain, redness at injection site, fever and vomiting the day after immunization for 24 hrs. Pt treated with TYLENOL and BENADRYL.
02/15/23 presents to ED for "SOB". PMHx of " arthritis, basal cell carcinoma, hypertension, stroke, history of cardiac catheterization, PFO"
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 09-JAN-2019, the patient was vaccinated with PROQUAD and M-M-R II (exact doses, lot# numbers and expiration dates were not reported) both for prophylaxis. It was reported that sterile diluent was used to reconstitute the vaccines. No adverse effects reported.
aching in muscle of upper left arm.  Hurts when I move the arm.  Didn't sleep well last night due to the aching, and continue  hurting all day.
Huge itchy red spot - rash around site of vaccination &  smaller but darker red rash down the arm about 2" on the bicep
chills; excruciating dizziness; fever; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIZZINESS (excruciating dizziness), PYREXIA (fever) and CHILLS (chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No relevant medical history provided.     On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (fever) (seriousness criterion hospitalization). On 14-May-2021, the patient experienced DIZZINESS (excruciating dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion hospitalization). The patient was hospitalized on 16-May-2021 due to CHILLS, DIZZINESS and PYREXIA. The patient was treated with MECLIZINE [MECLOZINE] for Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (excruciating dizziness) had not resolved and PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient underwent two EKG, and a  CAT scan while in hospital; unknown results.  Company comment: 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.; 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.
pt recv vax 19MAY98 & pt was seen by MD 10OCT98 & was dx w/chickenpox;
Patient has had severe right sided stabbing pain that radiated from her shoulder to her pinky. No treatment other than heat.
Later that night after receiving the first dose of Dtap, he became a bit lethargic with extreme hard knot under skin where injection was giving with red blotch that was very large at injection site. By the next day lethargy continued on and he developed a fever, then developed a cough and congestion in lungs, stuffy/runny nose, trouble breathing from coughing so much in a whoop like sound on some coughing fits, high fevers, very lethargic, and nausea with some vomiting of some liquids. This lasted almost 2 weeks. Cough lasted for a longer time as well as the very hard welt and red blotch on skin. He also seemed to stop responding to his name after this incident and lagged behind in speech development after this. He received the second dose 6/23/2017, his age was 9 months old, he didn't develop a huge fever, but had a slight one with cough, as well as a more severe welt and red blotch rash at site of injection that last for a few weeks. Again some of the progress made into getting him to respond to his name left and verbally delayed further. He is now to this day, delayed in speech by 47%, and now sometimes responds to his name being called.
Systemic Lupus Erythematosus; This is a literature report for the following literature source(s):   A 27-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), 14 days after the suspect product(s) administration, outcome "unknown".  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the systemic lupus erythematosus  and suspect drug. This case will be reassessed upon receipt of full publication. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
experienced a side effect; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect). At the time of the report, VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
This patient was given a booster dose of Pfizer vaccine although booster doses and not approved for this patient's age group. Upon discovery of this error, the patient's mother was notified and at this time the patient is not experiencing any adverse reactions.
mom stated > 1-1 1/2 hrs p/vax scream, crying tighten legs up until around 4AM, APAP d6id not relieve the screaming; redness around inject site sl fever 101/would not eat would not sleep;
TRUMENBA administered 5/15/15 (will go to boarding school). Nephrotic syndrome diagnosed approximately 6/11/15-symptoms present for.
Lump under my left arm. On Dec 26 at 4am my right arm was heavy, couldn't turn on phone, weakness in fingers, ache in neck. Went to hospital about hour away, vitals were normal, normal temp, strength had returned, took aspirin. Long wait to see MD, went home. By late afternoon was normal. 2 day heart monitor was normal. 60 days later I went vascular neurologist, wore heart monitor for a month, did not show atrial fib, 2 minor SVT. Heart went to 123.
Soreness, erythema with moderate edema from vaccination site distally to mid forearm limited to lateral aspect.  No other signs or symptoms.
Patient received a first Moderna dose on 04/08/2021. Patient received a dose of Pfizer on 05/06/2021 in error.  Patient was counselled by supervising doctor. No reaction reported.
Had diarrhea a few hours after vaccine - that resolved. Later developed warmth, redness of left arm. Treated as cellulite vs vaccine reaction with antibiotic and antihistamine.
I?ve never felt so ill in my life I couldn?t keep anything down I had diarrhea all I wanted to do was sleep had no energy and was in a fetal position for three days not wanting to move
This spontaneous report as received from healthcare worker refers to a patient of unknown age and gender. On 15-JUN-2016, the patient was vaccinated with expired dose of M-M-R II (lot # K012472 and expiry date: 11-JUN-2016). No adverse effects were reported. No product quality complaint was reported for M-M-R II. Additional information has been requested.
Initial misuse report received from a healthcare professional on 12 April 2013. A dose of ACT-HIB that was reconstituted over 24 hours ago was administered to child. No adverse event was reported. List of documents held by sender: none.
severe muscular pain that developed into shingles.  Rash appeared 5 days after the injection.
slightly red, slightly raised, itching,  2 cm round area at deltoid left site.
From 1/14/15 NP resident urgent care note: Pt noticed what he believes to a rxn to yesterday's zoster vaccine the morning in the shower at the site of injection. This morning it was very red, whole arm was painful, and there was a large lump underlying the redness. The lesions were very pruritic and slightly TTP. Hasn't put anything on it or taken any medications for it. Now he thinks it has gotten substantially less red, the underlying lump has dissipated, but it is still pruritic and TTP. No trouble breathing, cough, dysphoria or dysphagia, wheeze, other rashes or lesions, or GI upset or vomiting. No known allergies to gelatin or neomycin. Skin rash, rash and urticaria.
Case number PHEH2014US014995 is an initial spontaneous report received from a Healthcare Professional on 24 Jul 2014. This report refers to an 18 year old female patient. She was vaccinated with an expired dose of MENVEO (batch number: M11075) via intramuscular route at a dose of 0.5 ml on 24 Mar 2014. No adverse event was reported following this administration error (expired vaccine used).
Client  received Moderna booster vaccine at 1400 was sitting in the observation area was accompanied by mother, At 1405 pt complain of being thirsty asking where the water fountain was located. Then immediately reported feeling dizzy with palpitations. Patient states he has history of arrhythmias, and cardiac ablations x3 last one in 2019, also hx of anxiety disorder and panic attacks .  Pt reported after having the 2nd dose of Moderna during the 15 minutes observation period , pt fainted and was taken to the hospital. Pt was taken to patient room and place on bed and VS taken pt was AAOx4, skin warm and dry, denies pain, and SOB,  with BP of 120/68, HR 89, SPO2 of 98% room air , temp 98.1, blood sugar was 95 after drinking a 200ml of apple juice. EMS was called at 1420, arrived at 1432. Report given to EMS. clinical manager notified. Patient was evaluated and taken by EMS crew at 1437 accompanied by his mother.
I was starting to get intense bouts of nausea, dizziness, and lightheadedness. I was diagnosed with vertigo and given Antivert. The Antivert helps the symptoms of the vertigo.
Diarrhea started Sunday evening, woke up Monday morning had body aches, chills, diarrhea,  headache, fatigue. I took a 2 hour nap and still went to bed at 8:30 that night and slept until 6:30am the next day.
He developed a severe red raised rash around his neck, mild fever (no known temperature, he didn't take his temp), confused, lack of coordination, tightness on face and throat, and weakness.
CHILD RETURNED WITH MOTHER ON 9-2-09 DUE TO C/O OF HEART BEATING FAST, DIFFICULTY BREATHING, TURNED GRAY IN THE FACE, AND FELT WEAK. THESE SYMPTOMS OCCURED APPROX. 3 HOURS AFTER RECEIVING THE 2ND GARDASIL INJECTION THE PREVIOUS DAY. WE OBTAINED A PFT, EKG, HGB, BS, AND EXAMINED HER. ALL TESTS WERE NEG AND CHILD LOOKED WELL.
Erythema and firmness at site of injection (R) thigh - (cellulitis) mildly.
acute calcific tendinopathy starting ~3 weeks after vaccine, not at all sure if vaccine triggered this
heart was fluttering/heart problems; heart was only pumping 29% of the blood/heart wasn't pumping enough blood; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart was fluttering/heart problems), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) and DYSPNOEA (short of breath) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013M20A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included AMLODIPINE and ATORVASTATIN for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (heart was fluttering/heart problems) (seriousness criteria medically significant and life threatening), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) (seriousness criteria medically significant and life threatening) and DYSPNOEA (short of breath) (seriousness criterion life threatening). At the time of the report, CARDIAC FLUTTER (heart was fluttering/heart problems), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) and DYSPNOEA (short of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Cardiac stress test: abnormal (abnormal) Heart was pumping only 29% of blood. Heart was beating erratically..         Treatment  information was not reported.    Patient was not aware whether she experienced the symptoms after first dose of vaccine or second dose of vaccine. Patient was on Life Vest to keep herself from sudden death.  Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.  Company comment: Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.; Sender's Comments: Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.
This spontaneous report as received from a other health professional (Healthcare worker) refers to a patient of unknown age. Current conditions and medical history was not reported. On 23-JUL-2014 the patient was vaccinated with VAQTA injection 25/0.5 (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 22-OCT-2014, the patient received second dose of VAQTA. No adverse symptoms reported. Product quality complaint was not reported. Additional information has been requested.
10 hours after vaccination - fever, chills,  body aches, severe headache,  exhaustion, metallic taste in mouth 36 hours after vaccination - fever, chills, and body aches are gone; mild headache and metallic taste remain; very easily worn out
Patient presented on 5/25//17 with arm redness at injection site. Administered on 5/24/17.
Narrative:  Pt did not require any treatment. This event was reported when pt received Zostavax, pt refused shingrix. Symptoms:  SkinRash & RASH Treatment:
pt recv vax 21OCT98 & w/in 48hr devel a fever ranging from 101.4 to 101.8 & redness @ pnu immune inj site;MD dx flu;
The patient experienced inconsolable crying beginning 2 hours after the immunization and lasting for approximately 1 hour. The patient was treated with Tylenol and Motrin.
This spontaneous report was received from a pharmacist refers to an 18 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with a pediatric dose of VAQTA, strength: 25/ 0.5 (units not provided), lot # M002268 with expiry: 20-SEP-2017, intramuscularly. Then, on 29-SEP-2016, the patient received in error an adult dose of VAQTA, strength: 50/ 1.0 U/ml, lot # M031695 with expiry: 26-MAY-2017, intramuscularly. The patient had not reported an adverse experienced. No further information provided. Additional information has been requested.
SUDDEN ONSET OF 3RD CRANIAL NERVE PALSY - NECESSITATING EMERGENCY ROOM EVALUATION
Left Leg movement is painful and limited. The pain is in the thigh area and upper calf. The pain started 4 days ago and has gradually gotten worse.
now wheelchair bound for life; This serious case was reported by a other health professional via interactive digital media and described the occurrence of wheelchair user in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced wheelchair user (Verbatim: now wheelchair bound for life) (serious criteria disability). The outcome of the wheelchair user was not resolved.   It was unknown if the reporter considered the wheelchair user to be related to Flu vaccine.     It was unknown if the company considered the wheelchair user to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 12-JUL-2023 The case was reported by patient's wife via interactive digital media. The reporter stated the patient was now wheelchair bound for life, compliments of a mere Flu vaccine in 2009.