chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient called on phone saying she had a golf ball size swelling at injection site after going on a walk this morning
she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; lump at site of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at the age of 77-year-old) as single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208; Expiration Date: Jun2021)via an unspecified route of administration on 19Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had already completed her 2 dose series of the vaccine. After her first dose, she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm. After her second dose, the lump on her left arm had develop some rash, swelling and itching and just went away after a week. On 08Apr2021, the lump looks like a teenager skin blemish that looks close to a large pimple. She also noticed that on the exterior of the skin, there was still minute reddish purplish discoloration and that the little lump was still there. She mentioned that she did not feel alerted and concerned because initially when she asked a nurse in the vaccination center, they mentioned that they have already seen side effects that looks like this. Now, she was just wondering if there was any reported events about this. Reporter stated that she got her first vaccine on 26Feb2021, that it left her with a kind of like a little lump at the site, tomorrow will be six weeks. Stated at the time it was surrounded by black and blue and that finally went away, exact date not provided. Left with the blemish, although it is a reddish mark lump. Got it over at the hospital. Seriousness of the events was not specified and was considered non-serious. The outcome of vaccination site lump and injection site mass was not recovered and vaccination site discoloration was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 6/13/2011 received Hep A shot, had tummy ache and loose stool after the shot.  Low grade fever next morning 06/14/11 and when woke up Left eye was swollen shut.  Rash on tummy, legs, hands, feet, arms.  Taken to ER, admitted, CAT scan done with diagnosis of Periorbital Cellulitis.  IV antibiotics started, transferred to another Hospital on 6/15/11.  Discharges on 6/18/11, followed up with Dr. on 6/19/11 for further medication.  Had minor facial swelling but running around and playing as usual on 6/20/11.
felt achy after the second dose; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient felt achy after the second dose. The patient took Aleve and wanted to know if that was okay. The case was assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received a second dose of PCV-13 on 12/11/2020 in error.   She was due to receive her PPSV23 vaccine instead.  Patient had already received first dose of PCV-13 on 4/18/2018.
Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date; Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 038C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 09-May-2022/ Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 09-May-2022, patient received first booster dose.  It was reported by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  No treatment medication was reported.
Patient was administered Fluvirin. Sat down in waiting room. After approximately 5 min, was pale, loss of vision, sweating, cold, slurred speech, low blood pressure. Called 911 and evaluated by paramedics. Came to but went to hospital for further evaluation as advised by paramedics.
Rash and itching on neck and chest in V-shape  Looks like sunburn from V-neck tee-shirt Itchy and rough little bumps some neck swelling taking Benadryl April 6    April 7 taking Hydroxyzine 25mg      applying cold pack to reduce swelling
Injection given on arm's underside. 24 hr. later rash had developed & spread down to the elbow. Lump could be felt under the skin at injection site. That area of arm very painful, rash lasted for one week. Today (3-20) there is still a "blotch" at injection site.
Moderna COVID-19 Vaccine EUA  Hardness of 2 lymph nodes, on the left side of neck near collarbone
Headache, Chills, nausea, vomited x one, lethargic.
Notes from Doctor: Patient is a 32 year old male with no past medical history who presents for evaluation of chest pain   The patient has been apparently well without symptoms. He has no past medical history. He received his 2nd does of his covid vaccine (Pfizer) 21 days ago. He then developed sharp chest pain, stabbing, worse with inspiration, and lying down, relief with sitting up.
No adverse effects; dose of M-M-R II was administered the intramuscular route; Information has been received from a healthcare worker who was also pharmacy intern referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown.       On 19-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R001658 with expiration date of 17-JAN-2020, intramuscular; strength, dose and frequency unspecified) for prophylaxis (incorrect route of product administration). No adverse effects were reported.     This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA010012:
Received vaccine at 0830 on 2-1-21, felt well, took ibuprofen prophylactically at 0900.  Started feeling tired and mildly achy later in afternoon same day.  Increased fatigue and achiness when went to bed at 930 pm that night.  Woke up suddenly at 11:30 pm with severe shaking bone/body chills, severe weakness, tachycardia, shooting abdominal cramps/pains, nausea, heart pounding.  Crawled to bathroom, dry heaves, shooting burning pains through left arm into chest and left breast.  Loose stools, near-syncope.  Crawled to shower and laid in shower for 1/2 hour, chills improved.  crawled to living room couch, could not walk.  Tried to rest, could not.  Crawled back to bed at 0500 and fell asleep x 1 1/2 hours, son got up for school, he had to help me walk to kitchen.  Severe vertigo, headache, and tachycardia and nausea continued.  Laid back down to rest for several hours, but tachycardia 120's - 130's heart rate and pounding chest continued.  Finally at about 1:30 pm, heart rate came slowly down to 110's and not so bounding.  Symptoms slowly improved over next 4-5 hours where I could walk and drink.  Shooting pains through left chest and breast continued for several months, still have left breast tenderness.  Mammogram and US's on 1-20-21 an d1-21-21 were abnormal after 1st vaccine. Had to repeat.  Had screening cancer labs/24 hour urine on 2-4-21 due to SDH-B mutation in blood and were all abnormal, 3 days after second vaccine.  WBC was 2.5, neutrophils decreased. urine metanephrines and catecholamines were all very elevated due to stress reaction of vaccine per endocrinologist, had to repeat all tests one month later and were normal.  Vertigo and fatigue took several months to slowly improve.  Tachycardia and exertional dyspnea took months to improve.
INFLAMMATION OF THE BALL OF RIGHT FOOT; BRUISING OF THE RIGHT FOOT AND TOE; TINGLING IN THE BALL OF FOOT; SWOLLEN BALL OF FOOT; THE BALL OF FOOT WAS DISCOLORED/ DISCOLORATION (DEEP RED AND PURPLE) HAD SPREAD TO THE WHOLE BOTTOM OF FOOT AND BIG TOE; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included fractured vertebra, and concurrent conditions included no alcohol use, non-smoker, mast cell activation syndrome, seasonal allergies, and drug allergy, and other pre-existing medical conditions included the patient had seasonal and atypical (gastric and dermatologic) sensitivities to medications. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced inflammation of the ball of right foot. On 25-MAY-2021, the subject experienced bruising of the right foot and toe. On 25-MAY-2021, the subject experienced tingling in the ball of foot. On 25-MAY-2021, the subject experienced swollen ball of foot. On 25-MAY-2021, the subject experienced the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inflammation of the ball of right foot, had not recovered from bruising of the right foot and toe, and the outcome of tingling in the ball of foot, swollen ball of foot and the ball of foot was discolored/ discoloration (deep red and purple) had spread to the whole bottom of foot and big toe was not reported. This report was non-serious.
Patient adversely received Moderna as dose #2 in COVID-19 vaccination series.  Remained asymptomatic while in observation area. Spoke with patient's mother on 8/26/21, 1 day post vaccination, patient c/o mild soreness at injection site.
pt recvd vax; cellulitis rxn w/in 24 hrs of vax w/ ecchymosis in ctr; raised, tender & heat; 3x4cm; rx dicloxacillin;
Tested covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested covid positive) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested covid positive). At the time of the report, COVID-19 (Tested covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient was part of Moderna clinical study for the booster dose. No concomitant medication reported. No treatment medication details reported. Company comment: This is a spontaneous case concerning a unknown age, female patient with no medical history reported, who experienced the non- serious unexpected, according RA, AESI of COVID-19. The event occurred after the unknown dose of mRNA-1273 vaccine. The rechallenge was not applicable.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a unknown age, female patient with no medical history reported, who experienced the non- serious unexpected, according RA, AESI of COVID-19. The event occurred after the unknown dose of mRNA-1273 vaccine. The rechallenge was not applicable.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 27-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
tongue swelling that started 15-30 minutes after injections patient was taken to ED and given IV Benadryl 50mg and symptoms resolved
First menstrual cycle post vaccine seemed normal on 6/28. The following week on 7/12, I experienced spotting up and light cramps on my right side every day until my next menstrual cycle.   The second menstrual cycle post vaccine onset 7/27 and seemed normal the first day but has been much, much heavier than normal as of 7/28 and is accompanied with light cramps.
On 3rd capsule devel stomache cramps & that same day & the following day had diarrhea; No fever; No vomiting; No skin react;
knocked him out; shingles; administered 2 doses of Shingrix 6 months apart; This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in 2019, experienced Injection site pain(refer case US2020011363)).   On 16th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th December 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 17th December 2019, the patient experienced shingles. On an unknown date, the patient experienced loss of consciousness (serious criteria GSK medically significant). The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the loss of consciousness, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the loss of consciousness and shingles to be related to Shingrix.  Additional details were reported as follows: On 16th December 2019 ,patient received 2nd dose of shingrix vaccine and had shingles on next day. The patient went back to the pharmacy where the Shingles vaccine was administered and was prescribed antihistamines which knocked him out. The reporter did not consent to follow up. The case was considered as medication error without harm. This case has been linked with US2020011363, reported by same reporter.
Raised area Lt arm - swollen, feels warm to touch. Size of swollen is approx 2" long and 1" wide - hard to touch. Lt hand feels slight tingling.
Site of injection red, swollen warm to touch, starting day after injection neck stiff starting Friday after injection, still uncomfortable.  Received Fluzone 10/25/06.
I received my 2nd vaccine shot on Tues. 03-02-2021 and it has my right side from my neck down going into my fingers in severe pain, 6 days after receiving my 2nd dose. I have been taking Tylenol 500mg for pain and its not helping at all.
Facial numbness, tingling at first. later beefy red oropharynx. Severe cough. Angioedema, mostly sub-lingual but some tongue involvement. Red, weeping eyes.
It started as just a minor headache ( nothing i couldn't handle), and then I woke up in the middle of the night with a full blown migraine. I have taken 3 alive and 2 Tylenol.  I still have the migraine at 7 am.
Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where the shot was given. Day after vaccine: lower than normal energy, but otherwise fine. Two days after vaccine: low energy, body aching, occasional cough.  Three days after vaccine: similar symptoms of the previous day. Four days after vaccine: lower energy, body aches, coughing, persistent headache, eyes feeling tired and burning, and congestion starting in my chest, all worsened in the evening. Five days after vaccine: congestion in chest, regular cough, sore throat, runny nose, eyes feeling dry and burning, shortness of breath. Was tested for Covid on the fifth day after the vaccine. Six days after vaccine, chest congestion, coughing, sore throat, runny nose, shortness of breath, and still low energy. Covid test result came back as negative.
IPV given in LD on 4/24/07, pt tense and arm bled after injection.  Two days later, mom reports that she took child in to doctor on 4/25 for reddness and swelling at injection site.  Mild cellulitis reaction with affected area approximately 6" x 4" of erythema.  NO treatment at this time unless the area increases.
Initial unsolicited misuse report received from a non-healthcare professional on 23-SEP-2016. This case involves a four-year-old male patient who was vaccinated with a first dose of ADACEL (batch number: U5476AA) (expiry date, dose, dose in series, route of administration were not reported) in right thigh, a dose of FLUZONE QIV (batch number, expiry date, dose, dose in series, route of administration were not reported) in thigh, a dose of PROQUAD (manufacturer: MSD, batch number, expiry date, dose, dose in series, route and site of administration were not reported) both on 19-SEP-2016 and a dose of POLIOMYELITIS VACCINE (INACTIVATED) (batch number, expiry date, dose, dose in series, route of administration were not reported) in arm on 20-SEP-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 20-SEP-2016, one day following the vaccination of Adacel, Fluzone QIV, Proquad and same day following vaccination of Polio, the patient began to complain of right leg discomfort, patient stated it "hurt to walk", patient's temperature was noted to be 99 (unit not reported). On 21-SEP-2016, two days following the vaccination of Adacel, Fluzone QIV, Proquad and one day following vaccination of polio, the patient temperature was 99 (unit not reported) and complained of leg pain but did not complain of pain when walking. On 23-SEP-2016, four days following the vaccination of Adacel, Fluzone QIV, Proquad and three days following vaccination of Polio, the patient temperature was 100.6 (unit not reported). It was a case of drug administered at inappropriate site. Other lab data was reported as none and corrective treatment was reported as Ibuprofen. The outcome of the events was reported as unknown. List of documents held by sender: none.