chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My husband, is retired, after 31 years of public service. He walked 7 miles every day, up and down the steps, and in every kind of weather, plus dogs. Most days he would come home soaked to the skin and cold, and for years he never got so much as the sniffles. My husband was a saint to his many patrons on his daily route, and a teddy bear that talked to me. Later after he retired, he sailed right thru his heart by-pass and prostate cancer, and he remained very active since he tends to be practical and upbeat in all circumstances. He has always credited  his flu shots with the reason my husband remained untouched by the illnesses most people would talk about, making the rounds thru the years. I noticed when the next day after the flu shot he said he somehow did not feel good. The next morning he said he felt lousy and dizzy, and he had a temperature, and a stomach ache. He is not a complainer, and I was baffled, so I called the clinic. To my surprise they wanted patient to come in that very afternoon. I'm reading the newspaper when an ambulance pulls up and five big neck attendants walked to the back with a stretcher. I thought someone back there is in trouble. MD came to the waiting area and told me not to be alarmed, but she was sending patient to the hospital. She did not want me to drive him to the hospital since she wanted him to be monitored on oxygen, and a IV started, during the trip. Patient got out of the hospital nine days later. I expected him to be on the mend and be his old cheerful self, but weeks went by then months went by, and he was never the same person. The main result was an unfathomable and unrelenting decline in strength and stamina, not recovered, faster than general aging could account for. He put himself into physical therapy but even that finally proved to be too much for him, even using a cane. My husband turned quiet and now can barely move or lift his feet, without fatigue. My husband never took another flu shot. Some previous flu shots dates: 10-24-2011, 9-29-2010, 10-30-2009, 11-3-2008, 11-19-01, 11-9-1999.
Patient received seasonal flu vaccine and Pneumovax 11/8/12 with subsequent soft tissue swelling of the arm 11/12/12; followed by hospital admission due to sickle cell crisis 11/13/12.
FEELS BODY HURTS; DIZZINESS; WEAKNESS; HURTS HANDS ESPECIALLY; CHILLS; HEADACHE; FEVER 102 C; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021, 10:30 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102 C. On 23-MAR-2021 17:30, the subject experienced chills. On 23-MAR-2021 17:30, the subject experienced dizziness. On 23-MAR-2021 17:30, the subject experienced weakness. On 23-MAR-2021 17:30, the subject experienced headache. On 23-MAR-2021 17:30, the subject experienced fever 102c. On 23-MAR-2021 17:30, the subject experienced feels body hurts. On 23-MAR-2021 17:30, the subject experienced hurts hands especially. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, dizziness, weakness, headache, fever 102c, feels body hurts, and hurts hands especially. This report was non-serious.
- day after vaccine developed cough productive of white mucus, dyspnea on exertion. Finally sought care 3/17 due to progression of symptoms and was found to have bilateral pulmonary emboli. No DVTs. No risk factors for PE. No prolonged immobilization, travel, surgeries, obesity, active cancer.   - COVID negative rapid and PCR test on admission. No known prior COVID infection.
I woke up this morning and my arm near the injection site felt a bit sore again. When I looked in the mirror I have a large red round blotch on my arm. It's a bit bigger than a silver dollar. It is not perfectly round, but very close. It is not uniform in color but the round spot has a pink base color and red blotchy dots over it, but if you squint it is all one color so pretty close to being uniform. The blotch is warm to the touch and slightly itchy.  I have pretty sensitive skin so I was searching my bed for for any time of irritant but found nothing. I thought that it might be a spider bite, (I had one years ago that left a big round purple and yellow circle on my lower leg) but after some thought I realized that it is the injection site and found a few reports on the internet of something similar happening that people are calling "COVID arm." I'm not particularly concerned about it and am looking forward to my second shot. I do get hives now and again so I'm used to weird skin things!
Received FLUVIRIN vaccination in left deltoid. Pain with movement in left arm. Symptoms have persisted for over 8 weeks.
Initial information has been received from a consumer concerning her husband who on 10-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). The patient was also given TETANUS TOXOID at the same time. On 10-JUN-2008 post vaccination the patient experienced pain at the injection site with no other symptoms. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
w/in 24 hrs p/receiving the 1st DTP vax pt began w/URI sx along w/choking episodes & cough; pt was hospitalized;
heart arrhythmia; It has been more than 36 days and the patient has not received the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (heart arrhythmia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ARRHYTHMIA (heart arrhythmia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient has not received the second dose). The patient was hospitalized on 12-Mar-2021 due to ARRHYTHMIA. At the time of the report, ARRHYTHMIA (heart arrhythmia) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient has not received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided. Treatment medication was not reported.  This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 031M120A) with associated SAE reported as arrhythmia after the first dose of the vaccine.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 031M120A) with associated SAE reported as arrhythmia after the first dose of the vaccine.
Lethargic 12 hour periods of sleeping reduced appetite and reduced activity level extreme difficulties being woke up
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 15Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "metabolic syndrome" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "known allergies: all penicillin based meds" (unspecified if ongoing), notes: known allergies: all penicillin based meds. Concomitant medication(s) included: FLUOXETINE; PHENTERMINE; VITAMIN D3; EXCEDRIN MIGRAINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". It was reported that patient has taken Multivitamin as other medications within 2 weeks of vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid start date of the treatment as 16Jun2022 and stop date of the treatment as 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives on left face cheek for 20 minutes between 6 and 7pm same day of first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 15:15 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hereditary Elliptocytosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 09Nov2021 18:30, outcome "recovered" (09Nov2021 18:50), described as "Hives on left face cheek for 20 minutes between 6 and 7pm same day of first dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria.  Additional information: Patient was tested for covid by Nasal Swab on 12Nov2021 result of which was negative. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected. .
Received Flu vaccine aroung 11:15 am, noted started to itch over most of body but was mild at this time.  Continued through work, around 1:00 pm noted that was starting to feel short of breath with mild cough (tight feeling) and noted that tongue and throat starting to coated waxy feeling, cough started about this time.  By 2:45 couldn't speak more than a word, constant coughing and severe shortness of breath with flushing, sweating and feeling of fear.  Was taken into ER and received treatment. Received 2 doses of Epi and other emergency meds to relieve symptoms and was effective.
Patient was with her mother and she fainted while walking down the aisle. We got her water and a chair to sit in. She stared feeling nauseous and seeing "dark". 911 was called and she was assessed. was found to have low blood pressure (patient reported not having food or drink yet). Ambulance advised she go to the ER , She did with her mom.
next day woke up with fever 104 headache diaherra tickle or cough  arm site red and sore no apperite and wanted to just sleep temp all day run between 101 to 104
Red rash with whelts - arms bilateral, itching. Began 22 hours after injection - began resolving 72 hours. Tx topical Benadryl cream during day, Benadryl 25 mg po - evening at home.
Arm swelled and had a fever of 100.6. She was in bed all day. Patient feels better now. Swelling/pain started day of vaccine and sxs lasting until 9/28/14.
9 weeks since receiving 1st dose, has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (9 weeks since receiving 1st dose, has not received 2nd dose) in a male 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 PRODUCT DOSE OMISSION ISSUE (9 weeks since receiving 1st dose, has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (9 weeks since receiving 1st dose, has not received 2nd dose) had resolved.            No concomitant medications were reported.
At our COVID-19 vaccine clinic 10/20/21 this individual put on their consent form that they were 18 but their birthday that they also put on the form would put them at age 17. They requested J&J and were given it because their consent form said they were 18. The clinic was busy and the DOB age was not caught until the dose was being put into the database. We are unsure at this point if they deliberately ?posed? as 18 just to get J&J. Parent was informed after the fact. There was no adverse reaction for this individual that we know of due to this administered dose.
Redness and swelling on left thigh Omnicef 250 mg 15cc, 5cc PO q AM x 10 days.
Information has been received from a physician concerning a 4 wk old female who on 12Jul06 was vaccinated, by mouth, with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The pt had no symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Swelling and Rash at injection site.  Swelling the size of a small pear.  Some muscle soreness (probably due to swelling)
Syncope lasting about 20secs. Patient stated the he was feeling better after the episode. We observed him for an extra 15minutes.
Pt. c/o initially dizziness & unsteady gait with progressed to giving out of knees. Pt. then started having staring spells & tremors of neck muscles. Pt. cannot walk without knees buckling & falling at times.
43 yr old F received flu shot 11/4/2011 at 1315 hrs, appeared red faced at 1320 & when questioned said she had generalized itching all over without SOB. EPIPEN injected at 1325 & 911 called. Progressed to SOB, EMTs intervened with IV BENADRYL, IV Epi & O2 & improved & taken to ED. Last flu shot 2009. Reports 3 day itching episode 6 mos ago after house hunting, cause unknown. Pruritus resolved. EPIPEN prescribed. PMH asthma 2009. Taking ADVAIR & controlled.
This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL (strength, route of administration, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Pain and redness at injection right arm to elbow, redness progressive. Pain receding as of 10/22/2005. Pt tried ice, Benadryl, and Aleve
C/o redness, tenderness, inflammation at site of injection (right deltoid) hours after vaccination which worsen and spread to almost the whole right arm in 2 days. Also c/o pain the the muscle, which is getting better. Went to her MD and was told either reaction or infection from vaccine. Was prescribed Cephalexin, Benadryl, and ice. Pt reported looking swelling and redness went down substantially after 3 days on the antibiotic.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 12th December 2021 12:00, the patient received Shingrix. In December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix at noon, 24 hours ago of reporting and had experienced sore arm. The patient asked that he/she would have any additional side effects or was a lucky one who did not had bad side effects. The patient not asking for medical advice. The patient simply want to know how long after getting Shingrix did he/she get unpleasant side effects and realized that the answer would be general, just as the listing of possible side effects was a general statement. The follow-up could not be possible as no contact details were available.
Presented with SOB, productive cough, fever; dx Covid  ; treated with steroids, remdesivir, antibiotics, supplemental O2; discharged home with O2
chills; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age (reported as age:70; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for covid-19 immunisation. Medical history included cancer in liver, and chemo, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was supposed to get 2nd dose of Pfizer covid vaccination but woke up this morning (date unspecified in 2021) and had some chills, no other real symptoms. Patient wanted to find out if patient should keep my appointment. Patient had to do an internal radiology done last Thursday for cancer in liver (2021), that was fine which patient mentioned as wasn't from first dose. On Thursday and Saturday, patient was feeling great, this morning patient woke up with the chills. The chills were gone, not sure if they were going to come back.  Patient wanted to know if there wass anything about chills and getting the vaccine. The chills were following the procedure with the chemo. The first Pfizer covid vaccine was on 09Feb2021, last Thursday (2021), patient had the chemo done. And didn't have any side effects from the vaccination shot. Patient didn't feel bad, they were 2.5 to 3 hours away from getting, this was not easily scheduled. Patient felt good and didn't have any chills. Patient already spoke to doctor who he said he didn't think there will be any problem, and said he didn't know. The outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 6/25/21, MA administered two vaccines, Men B and MCV4 to Left arm. Men B and   MCV4.   24 hours after injection, child c/o pain and pruritic rash to back side of left arm.  Child was evaluated per Dr.  Per Dr.'s discussion with MA, injection of Men B was in deltoid area of arm, while MCV4 was administered lower and toward the back of the arm, thus giving per SQ route instead of IM.   Child was treated with OTC hydrocortisone cream.  Pt. instructed to return for further worsening or no improvement.  RN Clinical lead( myself)  and office manager were notified of event.  RN discussed with MA proper route for MCV4.  Vaccine adminstration reeducation and annual skills checkoff to be completed later this week with MA.
Pt called to report swelling under arms extending to anterior chest, right to left. Onset 5 days after yellow fever/polio vaccine received. 3 days after Td/Hep A received. Pt refused to come into clinic for evaluation. 9/19 seen for typhoid injection, reports swelling resolved. Would not allow nurse to examine or see areas involved.
No additional AE information provided; HCP states that she would like information on what to do if a patient received a series of three GARDASIL 4 as a teen, and then were accidentally administered one dose of GARDASIL 9 at age 22. HCP states that; HCP states that she would like information on what to do if a patient received a series of three GARDASIL 4 as a teen, and then were accidentally administered one dose of GARDASIL 9 at age 22. HCP states that; This spontaneous report was received from a nurse and refers to a 22-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2009, the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (also reported as "GARDASIL 4")  (strength, dose, lot #, expiration date, and route of administration were not provided) for prophylaxis. The third dose was received in 2010.   On an unknown date in March 2022, the patient (at age 22) was accidentally administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (single dose), lot number 1637442 (was not valid) (strength, expiration date, and route of administration were not provided) for prophylaxis. No additional adverse event provided (interchange of vaccine products, wrong product administered). Lot number 1637442 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number 1637442  does not match any Company product as confirmed by Lot Verification team.
10-12 cm of erythema, mildly swollen and warm at site of Varicella injection
muscle pain; joint pain; headache; metallic taste in mouth; nausea; This is a spontaneous report from a contactable consumer (patient herself). A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6203; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 09Mar2021 15:00 (at the age of 50-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ceclor, augmentine [amoxicillin;clavulanic acid], demerol and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 15:00 the patient experienced muscle pain, joint pain, headache, metallic taste in mouth and nausea. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a 13 year old female who on unspecified dates was vaccinated with her first and second dose of Gardasil (lot# unspecified).  Subsequently the patient experienced hand and foot joint pain.  The patient's hand joint pain and foot joint pain persisted.  No other information was available.  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-MAR-2016 (also reported as yesterday), the patient was vaccinated with the dose of expired ZOSTAVAX injection, 0.65 ml, subcutaneously in the left arm, lot # L000449, expiration date 08-MAR-2016. No adverse effects were reported. Additional information has been requested.