chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a dose of PROQUAD (lot S017247 expired 12/01/2020) on 15Dec2020; No additional AEs reported; This spontaneous report was received from a nurse referring to a 4 years old patient. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not reported.     On 15-DEC-2020,  the patient was vaccinated with 1 dose of post-expiry measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, route of administration were not provided; lot# was S017247 and expiration date was 01-DEC-2020) (expired vaccine used) for prophylaxis. No addition adverse events reported.
Myalgia, Arthralgia, Tachycardia,  inj site sore, chills, fatigue, low energy, episodes increased HR, body aches, joint pain Narrative:
Facial swelling, fatigue...went to WILLOWBROOK METHODIST ER...treated with meds & released.
Received 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Developed Shortness Of Breath, tingling in arm and chest, heavy arm. VSS. Observed and symptoms resolved with 20 minutes. Released home
On 2/3/10 developed rash on face, spread to forearms, then to entire length of arms, legs and back. Was seen in ER on 2/3/10 and was Rx steroids and BENADRYL. Rash got worse and child went back to ER on 2/5/10. Referred to dermatologist 2/5/10, Rx topical cortisone.
First few days was groggy, legs were tender.  Then vomiting began 2-3 days later. Was up a lot at night and crying; lasted 10 days.  Poops were a weird, slimy green. No curds.  Did not feel hot. Sleepwise still recovering. Nursed more often to soothe and still wanting that. Eczema flares up with his vaccines.
Patient was being monitored for 30 minutes by EMS due to anaphylaxis to Shrimp.  About 15 minutes into monitoring, the patient reported to EMS that he was feeling sweaty and had some shortness of breath.  EMS reported BP to be 171/89 and pulse of 88.  Patient stated that he does take blood pressure medication and reported that BP was elevated for him.  EMS contacted ambulance for transport to Emergency room, patient in agreement to transport.
The day after vaccination EMS was called to the patients home EMS States: Pt had right sided gaze noted possibly for the past 2 days. upon EMS arrival pt had tonic clonic seizure activity x3, family denies history of seizures. 12 lead EKG showed afib RVR.  Pt was stoke activated and transported to the hospital.
Case number PHEH2013US007536, is an initial spontaneous report received from a medical assistant on 25 Mar 2013: This case refers to a 12-years-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine, (batch number: X11050), subcutaneously without being reconstituted with Men A component on 28 Mar 2013. No adverse reaction reported following this administration error.
ABOUT 2 DAYS AFTER DOSE 2 THE PATIENT REPORTS A RASH APPEARED ON BOTH HANDS AND LOWER LEGS. IT WAS A LITTLE ITCHY. RIGHT ELBOW BONE PAIN ALSO STARTED ABOUT 2 DAYS AFTER DOSE 2. THIS PAIN COMES AND GOES BUT SOMETIMES IS SO PAINFUL THAT IT WAKES HIM UP AT NIGHT. THE RASH HAS PROGRESSIVELY GOTTEN WORSE SINCE IT FIRST APPEARED. HE HAS TRIED DIFFERENT CREAMS AND OINTMENTS. THE SKIN ON HANDS STARTED PEELING IN MID JUNE 2021. HE CURRENTLY HAS AN APPOINTMENT TO SEE A DERMATOLOGIST.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were stored in the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.   This case was linked to MOD-2021-350918, MOD-2021-350921, MOD-2021-350925, MOD-2021-350929, MOD-2021-350930, MOD-2021-350935, MOD-2021-350936, MOD-2021-350939, MOD-2021-350941, MOD-2021-350944, MOD-2021-350947, MOD-2021-350959, MOD-2021-350972, MOD-2021-350996, MOD-2021-350998, MOD-2021-351000, MOD-2021-351002, MOD-2021-351003, MOD-2021-351018, MOD-2021-351020, MOD-2021-351021, MOD-2021-351025, MOD-2021-351030, MOD-2021-351035, MOD-2021-351038, MOD-2021-351040, MOD-2021-351042, MOD-2021-351048, MOD-2021-351049, MOD-2021-351050, MOD-2021-351053, MOD-2021-351062, MOD-2021-351071, MOD-2021-351076, MOD-2021-351094, MOD-2021-351111, MOD-2021-351123, MOD-2021-351144, MOD-2021-351146, MOD-2021-351153, MOD-2021-351155, MOD-2021-351180, MOD-2021-351190, MOD-2021-351194, MOD-2021-351198, MOD-2021-351201, MOD-2021-351209, MOD-2021-351213, MOD-2021-351214, MOD-2021-351220, MOD-2021-351222, MOD-2021-351224, MOD-2021-351544, MOD-2021-351623, MOD-2021-351627, MOD-2021-351642, MOD-2021-351643, MOD-2021-351646, MOD-2021-351651, MOD-2021-351652, MOD-2021-351653, MOD-2021-351658, MOD-2021-351663, MOD-2021-351665, MOD-2021-351696, MOD-2021-351699, MOD-2021-351713, MOD-2021-351718, MOD-2021-351724, MOD-2021-351732, MOD-2021-351733, MOD-2021-351747, MOD-2021-351753, MOD-2021-351761, MOD-2021-351768, MOD-2021-351774, MOD-2021-351776, MOD-2021-351790, MOD-2021-351794, MOD-2021-351797, MOD-2021-351828, MOD-2021-351833, MOD-2021-351838, MOD-2021-351848, MOD-2021-351861, MOD-2021-351867, MOD-2021-351877, MOD-2021-351890, MOD-2021-351905, MOD-2021-351914, MOD-2021-351936 (Patient Link).
Information has been received from a health professional concerning a 62 year old female with CODEINE allergy who on 07-OCT-2008 was vaccinated S.Q. in the arm with a first dose of ZOSTAVAX (Merck) (lot # 662971/1214).  On 11-OCT-2008 the patient developed a rash at the injection site.  It was also reported that the patient developed a zoster like breakout on her forehead.  Subsequently, the patient recovered on an unspecified date.  Additional information is not expected.
Mother called day after vaccine to report "palm sized" red, hot, firm reaction at vaccine site.
flu like symptoms; sick; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case is linked to case: 2020SA283027 and 2020SA282902 (same reporter).  This case involves a patient (age and gender unspecified) who had flu like symptoms (influenza like illness) and sickness (illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu like symptoms (influenza like illness) and sickness (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that every time patient have had the flu shot after than got sick with flu like symptoms that were as bad as the flu. Then when the flu came around, consumer got the flu anyway. Consumer stopped getting the vaccine and have only had the flu twice in the last 20 plus years.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the lot number for this case.
7 hours after vaccine, felt fatigued with muscle aches.  15 hours after vaccine, worsening muscle aches with nausea.  20 hours, peak of muscle pain, nerve pain, nausea, and pressure in eyes.  at 20 hours, Tylenol and Benadryl were taken.  At 40 hours post vaccine, reaction subsided with new symptom of left axillary lymph node enlargement and tenderness.  Axillary lymph nodes normal 72 hours post vaccine.
Expired vaccine given. Patient reports no adverse effects and states he will get re-vaccinated for flu on 2/16/2022
confirmed a patient may have received MMRII reconstituted with non-MERCK supplied DILUENT and HCP used sterile water in place of the Merck DILUENT; confirmed a patient may have received MMRII reconstituted with non-MERCK supplied DILUENT and HCP used sterile water in place of the Merck DILUENT; No additional AE; This spontaneous report was received from a pharmacist and refers to an adult (also reported as middle aged) patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. Vaccination history unknown by reporter were not provided  On 09-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which reconstituted with non-MERCK supplied diluent and HCP used sterile water in place of the Merck diluent (product preparation issue; product use issue)  There was no additional adverse event (AE) or product quality complaint (PQC).
Patient answered no on the screening form to  monoclonal infusion in the last 90 days. Moderna booster shot given. After patient's waiti time after injection, it was noted that patient received BAM on 9.25.21 and therefore should not been eligible for booster shot until 90 days after (12.25.21). Patient notified after he left. He verified that he did receive BAM and said he forgot about this when he marked NO on the screening form. Patient denied any adverse reaction symptoms.
Reported from Mom 3/22/01 RT raise bump size of 50 cent piece, warm to touch, not fussy, no fever, no treatment sought. Mom will call or come in if treatment is sought.
Case number PHEH2015US026959, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 57-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into right deltoid on 24 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
suspected post influenza vax encephalitis w/myelitis/ensuing motor neuron paresis; upon discharge, pt was able to ambulate/speech improved;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:02/04/21pfizer,Lot#EL9264 2nd dose: 02/25/21Pfizer,Lot# EN6203 Diagnosed covid positive:04/14/21 Exposure:Home Symptoms:HA,loss of taste
Severe swelling under left armpit since injection date with fever(100) and very fatigue.
Red arm / Injection site redness; Arm hot to touch; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the skin warm was unknown.   It was unknown if the reporter considered the erythema of extremities and skin warm to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced redness at the site and on her entire left arm which was hot to touch for three weeks after the injection. The patient stated the intensity of the redness and heat remained the same for the first two weeks, and then gradually improved until it was resolved by the end of the third week. The reporter consented to follow up. The pharmacist did not had lot number of product available at the time of this call, but he did consented to follow up.
Information has been received from a physician concerning a 68 yr old male who on 02/12/2002 was vaccinated IM in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot number 640577/0995L). On 02/13/2002 the pt experienced an injection site inflammation and redness,swelling, and pain. Subsequently, the pt recovered. No further information is expected.
Patient complained of dizziness and heat during the required 15 minute observation period.  Paramedics were called to address patient's symptoms. Paramedics examined patient and told patient their health is ok and acceptable to just go home.  Blood pressure was elevated  at 175/110 per patients caregiver.
Initial report received from a healthcare professional on 19 September 2013. A 66-year-old female patient had received an intramuscular dose of FLUZONE HD vaccine (lot number U4760AA) in left deltoid on 13 September 2013. The patient's illness at the time of vaccination includes urinary tract infection and acute cystitis and concomitant medications include CIPRO, PYRIDIUM and Acyclovir. The patient's physician diagnosed allergies, birth defects and medical conditions include asthma. On 14 September 2013, the patient felt fatigued, had aching joints and a "temperature". Laboratory data was not reported and no treatment was provided by the physician. At the time of this report, the outcome was unknown. Documents held by sender: none.
No Diluent used with vaccine. Patient was given full concentration of pfizer covid-19 vaccine, 0.2mls. No adverse reaction noted at time of vaccine. Notified parent about 45 min after vaccine was given, no adverse reaction was noted at that time. Encouraged parents to monitor for any adverse reactions.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetanus shot, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received anti-viral treatment Paxlovid for covid-19 from 30Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After 2nd dose, bilateral lower extremity lymphedema became significantly worse.  All measures were taken to control swelling and nothing worked. This included complete decongestive therapy 8 weeks, Manual Lymph drainage, mechanical lymph drainage, compression, exercise.
Initial case received from a consumer, who is also the patient, on 18 August 2010. A 30-year-old female patient received a first post-exposure intramuscular left deltoid dose of IMOVAX Rabies (lot number not known) on 13 August 2010. The patient had received 3 doses of rabies vaccine 9 years previously as part of a pre-exposure series. She had no known allergies, no medical history, and was not ill at the time of vaccination. She was exposed to a bat and scratched by a cat on 13 August 2010. Approximately 30 minutes post-vaccinations, the patient developed ringing in her right ear which lasted 1 hour. Within 24 hours of vaccination she developed dizziness, fatigue, and muscle aches; on 15 August 2010 she reported that she fainted. She presented to the emergency department on 16 August 2010 and underwent laboratory testing including a CBC and "electrolytes"; no treatment was provided at that time. She continued to experience dizziness, slept for 17 hours, and developed red splotches on her face which lasted 30 minutes. On 17 August 2010 she returned to the emergency department and was treated with fluids at the time. At the time of the report, the events had not recovered, and the patient refused her second post-exposure dose.
Received flu shot at a workplace clinic event on Wed, 9/25/18. Woke up 2am Thurs, 9/26 with hives on both inner thighs, took BENADRYL. Raised hives and itching got worse as day went on, took BENADRYL every 4 hours. Pain and itching continued as hives spread to both buttocks, all over thighs, back and stomach. Kept taking BENADRYL with no relief entire weekend. Went to emergency room on Mon 10/01. ER doctor gave me shot of steroid and sent me home with BENADRYL, PEPCID. Relief for 1.5 days. Hives flared up again Wed, 10/03 all over body, continued to take BENADRYL. Hives continued through Thurs, 10/04 and I had to return to Emergency Room Fri 10/05, where they gave me IV DECADRON, BENADRYL and other meds. Today is Monday, 10/08 and I continue to have horrible red raised hives on both legs, torso, back, chest and arms. Doctors at hospital agree adverse reaction to flu shot but no one can figure out how to clear it up. PLEASE HELP.
really bad side effects after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really bad side effects after the second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first 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. On an unknown date, the patient experienced VACCINATION COMPLICATION (really bad side effects after the second dose). In 2021, VACCINATION COMPLICATION (really bad side effects after the second dose) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-358977, MOD-2021-359049 (Patient Link).
Is pain in my arm after getting the shot normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal). At the time of the report, VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.
No additional adverse effects reported; incorrect product storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 23-JUN-2020, the patient was administered an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date on 31-MAR-2021, for prophylaxis. Vaccine was improperly stored at a temperature of 12.1°C during a time frame of 2 hours and 20 minutes. There was no previous temperature excursions neither additional adverse effects reported. The call was because of a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt recv vax on 7/28/94; in 1995 pt exp hair loss & weight gain.
NO IMMEDIATE RESPONSE Day 2, into day 3 my Right lid swelled shut (which I have had happen numerous times) and then on day 3 into day 4 my upper lip swelled and then I had fever blisters cover my top, swollen lips. I have a history of Asthma and it has also caused me to have mild flare up causing me to use my inhaler more than once a day.
nausea, vomiting, headache, fatigue, chills, low-grade fever, pain at the injection site and the whole arm, joint pain
06/09/2021 : 1205 Pt admitted with SOB, AFIB and tested poitive for Covid19. Pt being treated for Covid 19 and is being reported as breakthrough case. Pt. Vaccinated on  April 12th 2021 and  May 5th 2021 with Unknown Lot # and  Body Site
A red, itchy, sore rash with some bruising developed after zostavax vaccine administration. Size 3x9 cm. Patient started taking Benadryl for the rash and itching.