chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an exposure took place described as due to the vaccine leaking from the syringe the consumer had a lot of fluid to drip down the arm with no adverse event; expired vaccine used with no adverse event; Initial information received on 07-Nov-2022 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 61 year old female patient who had an exposure to the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] leaking from the syringe the consumer had a lot of fluid to drip down the arm with no adverse event and expired vaccine used with no adverse event.     The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE  at a dose of 0.5 ml once (lot UJ888AA, expiry date: 09-Jun-2022) via intramuscular route in left arm for Immunization.  On 20-Oct-2022, an exposure took place described as due to the vaccine leaking from the syringe the consumer had a lot of fluid to drip down the arm with no adverse event (accidental exposure to product) and expired vaccine used with no adverse event (expired product administered) (same day latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported When she administered the flu vaccine to the patient and she started to inject, the medicine started to come out of the back of the syringe. Nurse would like to know if she needs to revaccinate because she is not sure how much the patient received. A Nurse reporting a partial dose due to having 1-FLUBLOK syringe to leak from the back of the syringe; that it is unknown to the caller the exact location of the leak; that the syringe has been disposed of in the SHARPS container; that there was no known defect to the syringe or the carton; and that an exposure took place described as due to the vaccine leaking from the syringe the consumer had a lot of fluid to drip down the arm.  Action taken: not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient became unconscious roughly 10 seconds after vaccine was administered.  Was shaking and eyes rolled to back of head.  Unresponsive for about 20 seconds.  911 was called immediately and paramedics arrived and transported patient to hospital.
Pt went to both separate flu sites in same building & received a Senior flu shot at each location on different arms.  Staff was not aware this had happened until consents were at the office going to be billed.  Family notified.  No adverse reactions known.
Infection of the left breast nipple which by sight showed breakage of skin on the right side and flesh protruding.  The area was very red with a discharge.  Mammogram was perform which was normal. Also a sonogram was performed and showed a large mass at the breast nipple and abnormal area under the arm pit.  Also saw a breast surgeon as a follow up.  The breast surgeon came to no conclusion as to the cause, but thought maybe a polyp  in the nipple.  The nipple was very painful and eventually healed but the nipple is now flat and dis-formed.
Client alerted onsite EMS concerning weakness. VS: B/P 130/60, Heart rate 72. Client stated she felt better and asked her husband to drive. Client released home at 8:28 am.
This spontaneous report refers to a 10 year old patient. On 08-APR-2013 patient received MMR II. On 20-APR-2013 the patient was vaccinated with VARIVAX (Merck) (Inappropriate schedule of vaccine). No adverse effects were reported. Additional information has been requested.
whole arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 08Jan2021, for COVID-19 Immunisation, reaction(s): "muscle soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "whole arm was sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Accidentally gave pt 3 pneumovax injections over the course of 3 years. Pt was supposed to receive Prevnar 13.
Red Bumps; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of erythropapular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 20th July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced erythropapular rash and pruritus. On an unknown date, the outcome of the erythropapular rash and pruritus were unknown.   It was unknown if the reporter considered the erythropapular rash and pruritus to be related to Shingrix.  Additional details were reported 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 patient developed red bumps and itching after dose 2 of Shingrix. The reporter consented to follow up.
redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Two days after the vaccination, I had a severe headache.  The headache has persisted every day.  It seems to be centered behind either one of my eyes.  It's not excruciating, but it hurts enough to be bothersome.  I'm not sure if it is related to the vaccination, but I can't rule it out either.
About 24 hours after shot I was overcome with headache, body ache, tiredness and brain fog. Most symptoms lasted two weeks but the tiredness has persisted leading to a need to significantly increase my average sleep each night.
Pt recv vax on 10/9/97; 3 days post vax pt exp tricep muscle sore, weakness w/ arm abduction, tender LA
This is cluster case of four patients (same reporter, same product and same batch number) and is linked to case numbers 2012-11083, 2012-11080, 2012-11094. Initial report received from a healthcare professional on 19 November 2012. A 65-year-old male patient, whose medical history, concomitant medications and illness at the time of vaccination were not reported, bad received a dose of FLUZONE vaccine (batch number: UH728AA, dose number and site of administration were not reported) intramuscular on 12 October 2012. It was reported that, the patient was unable to raise his arm for several days after the injection. On 19 November 2012, the patient was unable to raise his arm for several days after the injection. On 19 November 2012, the patient was unable to life his arm over his head because of site soreness, but otherwise he was able to use the arm without incident. As per the reporter, the patient would be seeing the physician on 19 November 2012. Corrective medications were not reported and lab investigations were unknown. At the time of this report, the outcome of the event was unknown. At the time of this report, the outcome of the event was unknown. Follow up information received from a healthcare professional on 09 April 2013: The patient's medical history included clinical depression, MI (Myocardial Infarction), TURP (Transurethral resection of the prostate), CABG (Coronary artery bypass graft) and femoral hernia. The patient's concomitant medications (experimental medications) included Fluoxetine Hydrochloride, Aspirin, Omeprazole and Clonazepam. The patient had received FLUZONE vaccine on the right deltoid on 12 October 2012 at 07:15 hours. The patient had not mentioned about Influenza injection to the physician. The patient had recovered from the events on an unspecified date. Documents held by sender: none.
got the shot and got it anyway/suspected vaccination failure; got the shot and got it anyway; Hope she is getting better with it now.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles and feeling unwell were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the Shingles shot and got it Shingles anyways. The reporter hoped that she was getting better with it till the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
On 11/5/99, mom called & said pt. had a fever of 104, the night before. No other symptoms. Instructed mom to bring child in to office this morning for evaluation, which mom did.
Mother was pregnant, during first trimester (10-11 weeks) and received vaccination. Born with birth defects.
Seizures (never had before), high fever 102+, dizziness, severe back pain, convulsions and confusion
Red rash extending vertically from injection site Pain in arm Swollen eyes Headache and body aches
Complained of sudden onset headache, sweating. Offered water and peanut butter crackers. Stated not better.  Moved to stretcher.  BP 122/80.  25 mg Benadryl PO given at 0820.  0827 BP 200/120 and c/o chest pain.  RRT called and patient taken to emergency department for further evaluation and treatment.
First gritty eyes and swollen throat, followed by hoarseness, occasional cough, then vomiting and diarrhea. Went to walk in clinic. Given sodium chloride (NS) 0.9% injection, SOLU-MEDROL 125 mg injection and BENADRYL 50 mg/ml injection solution intravenously .
This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot# M027879, expiration date 24-JAN-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Terrible chills,  up to 103 degree fever, body aches, inability to sleep.   Fever subsided to about 100 after 2 tylenol.  Total duration of chills about 5-6 hours, fever about 15-16 hours.
Breakthrough COVID 19 case tested positive on Sat. 05/14/2022.
Dose administered to patients from  vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patients from  vials stored in the fridge for more than 30 days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Dapsone,), Drug allergy (Pentamidine), Drug allergy (Sulfas), Drug allergy (Trimethoprim), Drug allergy (Atorvastatin), Drug allergy (Metformin), Drug allergy (Nelfinavir), Drug allergy (Statins), Allergy to antibiotic (Doxycycline) and HIV infection. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE), EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (ATRIPLA), LORATADINE, ISOSORBIDE MONONITRATE, APIXABAN and CARVEDILOL for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patients from  vials stored in the fridge for more than 30 days). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to patients from  vials stored in the fridge for more than 30 days) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vials were moved to the fridge on 28 Dec 2021 for 30 day expiration of 27 Jan 2022 and the dose was given from the expired vials. The patient was under treatment for HIV illness.  Reporter did not know if any treatment was given to the patient, as she did not know if patient experienced any symptoms after vaccination.   This case was linked to MOD-2022-475781 (Patient Link).
Both shots were administered in the deltoid region. Within 15 min facial swelling, itchiness of eyes and redness. Pt reports shortness of breath, chest tightness. Epinephrine 0.3ml sub q and Prednisone 60mg PO; With in an hour symptoms were starting to dissipate. Pt left with a RX for Prednisone 12 day taper. 09.23.21 Feelinh much better and decrease facial swelling.
On Feb. 24, 2015 at 12:15 P.M. received shot, 3 days later unable to see out of left eye, torn. Contacted office all adverse reactions occurred shoulder swelled up, fever, head and eye pain, temples, weak muscle pain shoulder still has pain. Shoulder pain left and returned. Future eye(s) surgery. (Ongoing rash). Hot-cold sweats.
This consumer report (initial receipt 25-Nov-2013) concerns a 66 year old male patient who had a medical history of vertigo. Concomitant medications included a multivitamin. On the 05-Nov-2013, the patient received an unspecified influenza virus vaccine injection (manufacturer and batch number not reported) one dose because it was recommended. The patient also received an unspecified pneumococcal virus vaccine (manufacturer and batch number not reported). On the 09-Nov-2013, the patient developed inflammation of the eyes, poor vision, double vision and his immune system was stirred up. The patient sought medical attention from a doctor. Treatment included acyclovir, PRED FORTE and cyclopentolate hydrochloride. Outcome was reported as recovering.
Redness and itchy around shot site (left arm)  7 days after vaccine.  I believe it?s called ?Covid arm?
About 2 hours after I received the vaccine I started to feel sharp random pains throughout my legs below the knees. The pain continued in my legs for about a week or so before I started to feel the same random pains in my arms. Sometimes the pain is worst around my joints and I?ve also felt it in my feet a few times. Although I feel the random sharp pains on all extremities, my left side feels effected greater.
Starting in July I was very tired.  Called my PCP and set up appointment for August.  While there and checking my pulse she was concerned about it being irregular.  Did an EKG and discovered I was in AFIB.  Set up a monitor for my heart in early September which showed I was in AFIB 98% of the time.  Also did a sleep study for apnea which was negative.  Met with cardiologist in late October set up a Cardioversion for the 23 of November.  The cardio version returned my heart rate to a normal rythm.  The AFIB returned in early December.  Another cardio version is scheduled for 16 January.  I have continued fatigue and shortness of breath.
Rash on chest and back starting 2 hours after 1st covid vaccine. Not itchy, no hives.  Seen in telehealth visit 11/9/21.  Per Dad: He took 25 mg Benadryl which did not affect him or the rash at all. He feels otherwise well. No other reaction to the vaccine. Dad says the rash is palpable (raised) but not dry or scaly feeling.  It came on all at once, did not start in one area and spread. No rash was present prior to the vaccine.   Exam: papular rash on chest and back, mildly erythematous. Diffuse patchy distribution. Photos in our chart were from 3 days ago when rash first appeared. On Zoom, rash appears slightly more dense and more red but same distribution and character of lesions.  11/15/2021: Called dad to follow up. He is doing fine but the rash is still kind of there. Has dried out on his chest, dry and bumpy to the touch. It looks about the same, same distribution on chest and back, not bothering him and he is not much interested in getting moisturizing cream on it.  11/27/2021: Had second dose of Covid vaccine; no reaction reported to us.  12/15/2021: Office visit for follow up of ADHD; no concerns raised regarding rash or vaccine.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Patient called on day following receiving Tdap and MMR stating that she had onset of tightness in throat & chest beginning approx. 2 hrs. after injections. Also experienced muscle spasms and twitching all over her body and a fine red rash on both lower extremities. No fever or other sx. Pt. self-treated with her child's albuterol inhaler and benadryl.                          Pt. has hx. of celiac disease. No prior hx. of childhood vaccines because "brother was paralyzed after vaccines" and pediatrician withheld vaccines from pt. because of this. No vaccines as adult until now when going to college. No known allergies to medications.                      Pt. was seen in ER on 3/13/07, diagnosed with "angioedema", & treated with albuterol inhaler & benadryl p.o. Advised to return to family physician in 1 wk. for followup. On 3/14/07 pt. continues to have slight tightness in chest, extreme fatigue, and low grade fever. No further muscle cramps.
Developed nausea and vomiting after leaving clinic.  Resolved day following injection.  Reported soreness at injection site.  Red skin discoloration 4 x 4 inch in size with multiple interrruptions in distribution.
Clients mother verbalized that the client c/o feeling anxious prior to vaccination today. Client verbalized to his mother that he felt nauseated and writer visually noted client vomit. Writer immediately assisted client to walk to MD and EMS on site called by nurse. Client visualized to vomit again x's 2. Clients initial set of vitals, 137/75 with O2 99% on RA and HR 128. MD on site assessed client and recommended client wait an additional 15 minutes. At the end of the 15 minutes, client noted with no further complaint of nausea and vitals noted as 122/68, O2 99% on RA and HR 94. Client discharged by MD.
Patient presented to emergency department on 11/16/2021 with left-sided weakness and facial droop and was admitted for acute CVA. He was found to be COVID-19 positive and did report congestion, cough, and shortness of breath for 2 days prior to presentation. He did not require treatment for his COVID-19 infection during stay and only had mild symptoms. He was discharged home on 11/22/2021.
Severe muscle soreness across full body that is still ongoing 24 hours later Extreme tiredness that lasted the full day Headache/feelings of dehydration Low grade fever Site of injection is still (two days later) red, raised, warm, and slightly firm to the touch   I treated with tylonel and took my medication for surgical recovery  (cyclobenzaprine and hydrocodone two hours after shot, Valium overnight, and cyclobenzaprine once the day after my shot)
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Pt vaccinated with Pneumococcal developed prolonged erythema, swelling & pain at inject site.
Hives developed a few hours after the vaccine was given.  No breathing difficulties or other signs of allergic reaction.  Hives spread over entire body by the next morning and  patient was b rought to the ED for evaluation.
t98 ax; parent c/o "2" x 1" bruise on posterior of lt thigh; unconsolable crying; rx cold compress to lt leg & APAP; local inject site warm & tender to touch;