chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect reported; were inadvertently administered doses of MMR II, that had been improperly stored; Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.      On 01-JUL-2019 the patient were inadvertently administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin(rHA); lot # R028224, expiration date reported as 04-OCT-2020, but upon internal validation established as 02-OCT-2020; strength, dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 15.9 degree Celsius for 5 hour and 15 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA002125: US-009507513-1907USA003025: US-009507513-1907USA003023: US-009507513-1907USA002218:
Vaccine administered on 06FEB2023 while improperly stored during temperature excursion.; LPN calling for stability evaluation of vaccines with multiple TEs dating back to 03FEB2023. Caller reports that vaccines were administered. No additional AEs. no PQCs reported.; This spontaneous report was received from a nurse and refers to a 71-year-old male patient.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-FEB-2023, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml/once, lot # U034712, expiration date 30-JUL-2023, strength was not provided) for prophylaxis (Product storage error). There were multiple temperature excursions dating back to 03-FEB-2023. No additional adverse event was reported.  This is one of multiple reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004511: US-009507513-2302USA004361: US-009507513-2302USA004369: US-009507513-2302USA004552:
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of ROTATEQ (lot # K016279, exp. 24-APR-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
no adverse effect; expired dose administered; This spontaneous report was received from a licensed practical nurse and refers to a 15-year-old female patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 13-SEP-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) one dose via intramuscular route, lot # R027431, expiration date 08-SEP-2019 (injection site was not reported) for prophylaxis. There was no adverse effects reported.
About 5pm, my son received the seasonal shot and the H1N1 vaccine (nasal spray). About an hour later, half-way through his homework, he stated, "Mommy, I can't see anything on the paper".  Then, I had given him his sight word list and he could not identify any of the words on the list.  An hour before the vaccine, he zipped right through his sight word list.  Now, he can't read any of the words on the list. He stated that he sees lines in the words.  I immediately took him to the urgent care center and the pediatrician was concerned and told us to go to the ER.  The doctor examined his eyes and had blood work done, which came back normal.  He referred us to an ophthalmologist, and his appointment is tomorrow.  Prior to the vaccines, he did math homework and read through the sight word list with no problems.  About an hour after he was vaccinated, he could not read the same exact word list that was given to him before the vaccine injection and nasal spray.  The next morning, I asked him to read something on my computer and he stated that he could not see the words.  About 20 minutes later, I asked him to read a book, he could not read the book for the first two pages and then was able to read the book with ease.  That night, I gave him a book that he was not familiar with and he read it with no problems. This morning, he was not able to read any sight words.  He seems like his vision comes and goes and he instead of seeing "lines" he said that he can't see the words. He had the seasonal vaccine (nasal spray) last year with no problem.  I truly believe that the H1N1 vaccine caused my son adverse events and his symptoms have not improved. He has never complained about his vision in the past and has never had any side effects to prior vaccinations.  11/9/09:  Emergency Department Records received for dates of service 11/2/09 to 11/3/09.  Dx:  Blurred Vision.  Assessment:  Presents to ED with difficulty reading.  States, "  I see lines."  Vision Left eye 20/40, Right eye 20/40, Both eyes 20/40. Follow up arranged with opthomologist for the am.      11/9/09:  ICD Codes received:  368.8
On 10/3/17 rec'd "Senior" flu-vaccine about 12 hrs later my blood pressure spiked to over 180/95. B.P. went UP and down following 3-4 days. M.D. prescribed add'l meds took 6/7 days to return to normal. Never had problem, never had side effects with reg. vaccine.
developed flu like symptoms and tested positive for COVID; the patient developed flu like symptoms and tested positive for COVID. He also reported nasal congestion, sore throat and tiredness.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Batch/Lot number: unknown), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Jun2022, outcome "unknown", described as "developed flu like symptoms and tested positive for COVID"; COVID-19 (medically significant) with onset 21Jun2022, outcome "recovering", described as "the patient developed flu like symptoms and tested positive for COVID. He also reported nasal congestion, sore throat and tiredness.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course -Description of Event: I am reporting on my brother. This 50-year-old male received the COVID vaccine on 22Feb2021, 15Mar2021 and 08Dec2021. On 21Jun2022 the patient developed flu like symptoms and tested positive for COVID. He also reported nasal congestion, sore throat, and tiredness. On 22Jun2022 he started Paxlovid and his symptoms are improving. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction from Moderna Booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.  Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for Prophylactic vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction from Moderna Booster). At the time of the report, VACCINATION COMPLICATION (Reaction from Moderna Booster) outcome was unknown. No concomitant medications were provided by the reporter. No treatment was provided by the reporter. Patient stated that they gave Moderna booster and on the paperwork, it said JNJ COVID booster.  The suspect product quality complaint has been confirmed to be voided (and did not meet Product Quality Complaint criteria) based on the RA evaluations.
Info has been received from a registered nurse concerning a 72-year-old male who on 03/11/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M). The reporter indicated that the pt developed swelling and redness. The pt is due to be seen. Unspecified medical attention was sought. The reporter indicated that 2 other pts developed reactions after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644219/1079M) (WAES #0303USA01236 and 0303USA01441). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Erythema, swollen area around injection site- seen in ER. 01/16/2003 and treated with Augmentin- heat at area.
HAD RASH OVER ENTIRE BODY-HAD FEVER 103-105; NO SZ- HAD COLD LIKE SX STARTING 1 DAY BEFORE RASH STARTED; APPETITE DEC.; PLAYED ALRIGHT; SEEN BY MD 26jan91; MD STATED UNUSUALLY SEVERE RXN TO THE MMR.
Patient developed dark bruising and redness near injection site. Patient expressed no pain, itching, or aggravation other than discoloration. Patient is taking Xarelto and endorsed frequent/easy bruising while on blood thinner. Advised patient that his bruising is likely a result of his chronic anticoagulation, but assured him that we would submit a adverse event report.
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 09-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-215; exact dose and route of administration were not reported. There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 816 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Extensive DVT from common femoral , superficial femoral , tibio peroneal vein
Patient states feelings of lethargy since receiving the vaccination. Also states that he sometimes experiences dizziness. He is concerned about the length of time these symptoms have lasted.
My chest got really tight, I couldn't breathe or talk. I went to the ER, they told me I had fluid in my lungs. I went to my dr, who confirmed I did have fluid in lungs and it was not a blood clot. but my lung capacity is lower. I keep losing my breath, it's hard for me to catch my breath, it started months after my vaccine. This started in December. Not entirely sure if it is related or not to the vaccine. I keep coughing all the time and I am severely less mobile now.
Jynneos vaccine was administered beyond expiration date; Jynneos vaccines went beyond the 8 weeks in the refrigerator; Jynneos vaccine was administered beyond expiration date; Case reference number US-BN-2022-004198 is a spontaneous case report initially received on 12-Oct-2022 from other health care professional via Communication (reference number: USBAV22-1694) and concerns one patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 26-Sep-2022, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) was administered beyond the expiration date and the eight weeks for refrigerating (explicitly coded as 'expired vaccine used', 'product storage error' and 'product administration error').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-004197 and US-BN-2022-004196.  Non-significant case correction performed for information received on 28-Oct-2022 to include local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.
Mother reports 2AM 8/19/08 fever 100.7.  8/20/08 child "staring not responsive stiffen arms & legs twitch left side of body x2.  8/21/08 2AM lethargic not responsive stiffen arms & legs.
Redness; Soreness; Inappropriate route of vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On 27th July 2019, the patient received Shingrix (intramuscular) .5 ml. On 27th July 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 28th July 2019, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm on Saturday before reporting date. 1 day after vaccination, the patient experienced redness around the elbow and the tricep and soreness. On 30th July 2019, Tuesday, the patient came into the pharmacy asking if the vaccine could have been given too low, which led to vaccine administration at inappropriate site. As of 30th July 2019, the redness and soreness had greatly improved and they were minimal. The reporter consented to follow up.
Chills; Fevers; Headaches; A spontaneous report was received from a 63-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fevers/pyrexia and headaches.  The patient's medical history included Rheumatoid arthritis. Concomitant product use was not provided.  On unknown date, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M20A) Intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the first dose, the patient experienced chills, fevers and headaches.Symptoms improved after about 36 hours. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, chills, fevers and headaches was resolving at the time of this report.; 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.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 17-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (dose, lot # and expiration date were not reported). On 17-DEC-2012, the patient received the second dose of GARDASIL (dose, lot # and expiration date were not reported). On 13-MAR-2014, was in the office 03/13/2014 to receive the 3rd dose of GARDASIL (dose, lot # and expiration date were not reported). No adverse effects reported. Additional information is not expected.
Patient was given an entire diluted bottle 1.8 ml (6 doses) of a Pfizer purple cap vaccine for adults. She experienced arm soreness, headache, tiredness, and nausea for at least the next 3 days. Patient also experienced anxiety due most likely to the situation and not the vaccine itself.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient reports dizziness, muscle weakness, and headache immediately after administration of vaccine. Patient was given benadryl once. Patient refused epinephrine injection. 911/paramedics were called and assisted patient.
Localized redness/swelling (10.5 cm x 13.5), hot/red at site, localized pain all started this morning. Recommended to alternate heat/ice to site.  Recommended to Tylenol or Advil as needed.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 64-year-old patient who received SHINGRIX for prophylaxis. Concomitant products included beclometasone dipropionate (Qnasl). In February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, headache, fever and discomfort. On an unknown date, the outcome of the muscle pain, headache and discomfort were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the muscle pain, headache, fever and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and had some bad reactions. The patient takes QNasal which was a steroid. The patient asked should I not had gotten the vaccine since the patient was on QNasal. The patient asked if QNasal was considered to be an immunosuppressant. The patient was worried about the 2nd dose being just as bad. The patient had 2 days of fever. And, stated that, the patient was on day 4 at the time of reporting and missed work due to muscle pain, headache and overall discomfort.
Patient had large, swollen, firey red and hot localized reaction around injection site.  Patient was reffered to urgent care where cellulitis was ruled out.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: sweating
pt was limp w/shallow breathing & not responsive for 2-3minutes;possible ALT;parents stimulated until woke up;
04:01: pt received Moderna vaccine injection.  04:21 pm left  eye slightly swollen.  Pt did not report until  04:31pm.  pt was told to wait so we can treat it but he refused.  Pt states that he will take Benadryl at home.  pt states that he gets this kind of allergic reaction constantly and he takes Benadryl.  pt states that this allergy is mild.  he has experienced worse swollen eye than this.  pt advised to go to E.R if symptoms continues or worse.  he was also told to follow up with pcp asap.  pt signed a waiver and left.   pt left at  about 04:45 pm.  no change in eye condition.
At onset had extreme back and arm pain.  Eventually pain in arm went into breast and armpit.  Pt became flu-like and had a red, hard eduration on arm.  Over next few days, redness and hardness spread down arm.  Pt went to ER 12/12 and was sent home.  Was told to come back if pain/redness spread, which it has.  now it is believed pt may have cellulitis.
27 y/o M presents to clinic c/o swelling and redness on L arm on the shoulder extending to area proximal of elbow joint. SM received an Anthrax vaccine on 1/29/20 and over last 2 days swelling and redness increased. SM became concerned today when swelling increased more and became painful.SM reports taking 1000mg ibuprofen last PM around 2030 with minimal effect.  Provider assessed as allergic reaction and angioedema and treated with prednisone burst, diphenhydramine and ibuprofen.  Provider documented exemption to anthrax immunization, and documented in allergy list.
Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20/2A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LOSARTAN, MELOXICAM and MONTELUKAST for an unknown indication.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 101 (High) fever- 101.         Treatment was not specified   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 contain no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Booster shot received 12/4/21 2pm. 24 hours - severe bilateral back pain; unrelieved by medications; 2 hours - gradually went away. 48 hours - sore back; swelling under armpit - painful to touch. Swelling increased - began to swell over left side of chest. Experienced shortness of breath, chest pain. All areas painful to the touch. Appeared to be at injection-side lymph nodes. No systemic illness. 60 hours - difficulty breathing and chest pain became severe/concerning. Went to Emergency Room for treatment - EKG, blood labs, vitals taken. Found out for the first time while waiting at the ER that swollen lymph nodes were a common and benign side effect of the COVID vaccine and booster. I was not warned of this, and would not have treated it as a possible cardiac emergency if I had been informed.
Patient received second dose of Moderna earlier than recommended interval of 28 days, and 4-day grace period.
4/5 9 pm vomited  4/6  2 fever and chills  body aches 4/8 noticed a bumpy rash on my upper back with no breathing issues