chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNABLE TO LIFT HANDS UP; CHRONIC PAIN; PAIN ON THE ARM OF VACCINE/DURING INJECTION; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination.  No concomitant medications were reported. On an unspecified date, the subject experienced unable to lift hands up, chronic pain, and pain on the arm of vaccine/during injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chronic pain, and the outcome of pain on the arm of vaccine/during injection and unable to lift hands up was not reported. This report was non-serious.
Pt began to have a severe nosebleed. Pt also began to vomit clots of blood. Provider applied Neosynephrine to a cotton ball and packed pt nose.
The day of injection I was getting Chills all afternoon with some feeling of anxiety. When I woke up the next morning My upper body (arms, hands, face) were swollen. At around 10 am I saw my Dr. and she felt my upper body was hot to touch but no fever. Swelling and torso had hives starting to form. Dr. gave me an injection of Solumedrol and sent me home to rest ansd to take benadryl.
Started with severe headache, muscle/joint aches then nausea.  Progressed with low grade fever.  As of this morning, most symptoms have subsided greatly.  Had a scratchy throat for several hours after injection but that went away by around midnight of the day of the injection.
Three seizures within a ten hour period. On 11/15/2010 at College suffered a seizure falling hitting head on walkway.
Information has been received from a licensed vocational nurse concerning a 4 year old white female with no medical history and no allergies who on 4/10/00 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 632717/1727J). There was no illness at the time of vaccination. Neither the patient nor her sibling developed adverse events following prior vaccinations. On 4/15/03 the patient came into the office with itching and a chicken pox rash with over 100 lesions with at least 50 lesions on one thigh. Some of the lesions were circled with a red ring about 1/4 inch from the center making the lesions about the size of a nickel to a quarter. It was reported on 4/16/03 that this was only day 2 and the patient is currently getting more. It was noted that this was an office visit confirmation and that there were no diagnostic or laboratory tests performed. Subsequently, the patient recovered. No further information is expected.
Given an expired vaccine to a patient, No AE; Initial  and additional information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 months old male patient who was vaccinated with a dose of expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot UT5897JA, Expiration Date: 30-Jun-2018) (formulation: prefilled syringe) via intramuscular route in the left thigh On 15-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), Varicella and MMR.  It was a potential medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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..
Headache, Fever chills times four days, mouth sores, swollen lymph nodes, joint pain, fatigue.
MMR given on 10/30/08.  On 11/6/08, child developed fever and then on 11/7/08, fever elevated and child suffered from generalized convulsion.  Seen in ER, dx with febrile seizure.  Labwork unremarkable, pt with no signs of other illness (no URI sxs).
It started out with a feeling of phlegm in my throat, the following day sore throat, fatigue, some coughing. I had 102 temperature and aches, so I went in for a test the following day. The urgent care tested me, and I was positive, they put me on albuterol, prednisone, and a cough suppressant benzonatate. I was so fatigued. I went to ER in morning on August 29th, I had felt heaviness in my chest, and they checked my heart, and they gave me monoclonal antibodies that afternoon. I started to improve with my symptoms. I still am fatigued.
suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months; suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months; This is a spontaneous report from a contactable consumer. A 82-year-old female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration on 12Mar2021 at the age of 82-years-old as single dose for COVID-19 immunisation. The patient took the shot at the regional vaccination center and she had an appointment of course set up by her doctor, but they don't have any specific name. The patient's medical history included blood pressure and atrial fibrillation. Concomitant medication included metoprolol taken for an unspecified indication, start and stop date were not reported. The reporter stated that his/her mother experienced a reaction after having the shot. She took the shot on 12Mar2021 and suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months and once she took the shot on the very next day (13Mar2021) she had atrial fibrillation which lasted about two and a half day. They went to her heart doctor and they checked her out and they said that other people that had taken the vaccine had experience the same thing so, the reporter was calling to see if that was something Pfizer has heard before or not. It was reported that the patient was scheduled to take the second shot this coming Friday and after speaking with her doctor they indicated to go ahead and take the second shot but again the reporter wanted to report this because the reporter knew the company was keeping a record of this information. It was reported that the patient was about 5 feet 7 inches and probably 140 pounds. The outcome of the event was recovered on 15Mar2021.
Chills in the morning followed by fever (ranging from 99.9-100.6). Muscle ache (full body). Headache. Stomach pain. Weakness.  So far it has been 24 hours and symptoms are continuing.
Temp 103 within 6 hours, vomiting next day, ataxia on second day after vaccines.  12/5/08 Reviewed hospital medical records of 11/2-11/5/2008. FINAL DX: fever & acute cerebellar ataxia on admit.  No d/c summary available Records reveal patient experienced fever, diarrhea & abnormal gait on day of vaccination after nap.  Seen in urgent care center & released.  Seen in ER same day & released.  Fever continued & began vomiting, lethargic, tiredness.  Returned to ER, tx w/IVF & meds & released.  Irritable & weak.  Then developed difficulty standing & falling w/walking, crawling  & sitting w/intermittent screaming & inconsolable crying, diarrhea.  Multiple people in family sick w/URI symptoms.
high fevers all noc, brought down w/APAP, Advil came down 100.7;also taking Phenergan w/codeine for cough (has had 4mon);pt on amoxil @ time of vax;amb called d/t sx 430AM or 445AM pt hosp;pt irritable;dx feb sz vs rxn to vax;
Patient suddenly developed numbness in one hand and his fingers became white below the knuckles then while on the phone with the pharmacy asking advise about the event his other hand became numb and began to turn white.  Patient was advised to seek prompt medical attention.
Symtoms: Chills, bruising and heavy swelling at and around injection site, dizziness, fatigue, severe diarrhea, headache treatment: lots of water, tylenol Duration: approx 12:30 am 2/19 to 11:00 am 2/19. Slept for several hours, symptoms dissipated almost immediately upon waking at 5pm 2/19.
My right eye will not adjust to light can't see. Can't think clearly after shot. Feel foggy thinking disorganized
Information has been received from a physician concerning a female who was vaccinated with Gardasil (date and dose not provided). Subsequently at an unspecified time, the patient had a Pap smear that tested positive for HPV 6 and HPV 11. It was also reported that the patient experienced a break out of genital warts not long after vaccination with HPV. It was reported that the patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a physician concerning a 22 year old female, with no known drug allergies, who on 07-NOV-2006 was vaccinated with IM with a dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included VALTREX. Subsequently on an unspecified date, the patient had a PAP smear that tested positive for HPV 6 and HPV 11. On 16-NOV-2006 the patient developed break out of genital warts. It was reported that the patient sought unspecified medical attention. The patient's break out of genital warts persisted. Additional information is not expected.
Information has been received from a physician concerning a 15 month old male with otitis media and no known allergies who on approximately 30-APR-2008 was vaccinated with PROQUAD. Concomitant therapy included amoxicillin for the treatment of otitis media. On 06-MAY-2008 the patient developed a febrile seizure and was hospitalized, and given ceftriaxone sodium (ROCEPHIN). It was noted that the patients two uncles had a history of febrile seizures. The patient subsequently recovered and was discharged on 7 May 2007. There was no product quality complaint. Additional information has been requested.
After administering vaccine, pharmacist realized she did not mix the 1.3mL of diluent first. Patient given 0.2mL of the pediatric vaccine, but undiluted.
Sensation of tongue swelling after 10 minutes thinks it may have been anxiety about the vaccine  14:34:  BP 120/78 HR at 60 RR 16  Tongue midline, not enlarged no lymphadenopathy color normal - not pale sitting upright S1 S2 at apical
Pt check out itchiness of bilateral arms. Abdomen and back area. Pt also noticed small red rash on above areas. Pt took Benadryl 25 mg. by mouth.
My period was delayed by 2 days the 2 months following my 2nd dose.
113 Bivalent doses administered after the BUD to patients 12 and up; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications details were not reported by the reporter.  Patient ID was reported as 8850855.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, In this report the patient was not Eligible for VFC. Breakdown of doses were reported as 51 doses from batch number AS7140C and 60 doses from Batch number AS7148B.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689946 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689946:Master case
The same night after vaccine I felt completely sick. I had fever, chills I was sweating and I couldn?t sleep completely. Next day it was the same. I felt very sick all day. After few days I got red spots on my skin and spontaneously headache till today. Also I used to go to the gym often but after vaccine I am much weaker and my muscles are shaking while I am exercising. Sometimes my legs feel heavy and not completely normal like before the vaccine. I lost lot of my hair. I got anxiety because of that.
patient got moderna vaccine and an hour after stated he throat started swelling, but resolved itself before anything serious
Patient initially developed leg pain and severe neck pain, followed by weakness in arms and  the legs worse on the left side. She at times was very uncoordinated and couldn't walk well, headaches, extreme fatigue, "brain fog" with trouble focusing
no additional AE; vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided.  On 24-JAN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliter, lot # U020239 established to be valid, with expiration date 28-JUN-2023 (route of administration was not reported) for prophylaxis (Product storage error). Administered dose of suspect vaccine experienced temperature excursion of -14.1 Celsius degrees (C) for 12 minutes. There was no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse event was reported (No adverse event).
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt with a history of varicella was exposed to her daughter who was vaccinated with varicella virus vaccine live. The pt experienced herpes zoster. The lesions are clustered and located in the lumbar area.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 15-Apr-2021 at 2:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 20.11.  Concomitant product use was not provided by the reporter.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 06-Apr-2021, beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
1st Vaccine:   I was in Menopause for over 2 years.   The vaccine included a period. 1st Vaccine:   I began having uncontrollable  neck and head tremors after the vaccine which have not subsided and continue every day.  It appears to have caused permeant nerve damage and cervical dystonia which did not exist before the shot. 1st Vaccine:   Covid Arm to the extreme and flu like symptoms, exhaustion and pain for several days. 2nd Vaccine:  Extreme, Intense and excruciating pain as if my body was being torn apart from the inside out (the most pain I've ever felt in my life)  Lasted the entire night of the vaccine 6-10 hours and then subsided.   The nerve damage and tremors continue.
Patient is a fraternal twin of a 36.4 week gestation with a birth weight of 6 lbs 8 oz. His development was normal, reaching all developmental milestones as anticipated, all of which occurred within 1-2 weeks of his twin. On 2/27/07 he was diagnosed with an ear infection and given a 10 day course of amoxicillan. On 3/22/04 he had a well-visit with the pediatrician. Before consenting, I asked the pediatrician about the possible connection between MMR and autism. He dismissed my concern, stating that there was no proof to support such a claim. MMR and HIB vaccinations were given. He was screaming and crying inconsolably and had a fever of 103F within an hour after the vaccinations. Within 14 days, he lost eye contact, lost speech, became sullen and withdrawn, no longer responded to his name, began arm flapping with mouth open and rigid, became tactile defensive, and he began head banging and hitting himself stopped trying new food textures. On 5/12/04 he had an appointment with the pediatrician re: above symptoms. I asked if this could be PDD. The doctor said "to give it more time" and that "teething likely source of expressive language delay." Pediatrician finally consented to PDD testing on 10/5/04 and referrals made. Diagnosed with autism spectrum disorder by pediatric psychologist on 11/2/04.  04/10/2007 MR received from pediatric psychologist for initial consultation on 11/2/2004 with F/Us 8/2, 8/10,& 8/24 2005 for c/o developmental delays primarily in receptive and expressive language skills and head banging. DX:  Meets the DSM-IV criteria for autism.  04/12/2007 MR received from PCP with OVs beginning 1/23/2003 through 4/4/2007.  2 month check "doing well",  "dev good", NL exam.  Normal development reported at 6, and 9 month check.  On 3/22/2004 at 15 mon. check reports child eats baby food due to disliking many textured foods. Dev. reported to be slightly behind his twin sibling. NL exam. Vax given.  Next visit 5/12/2004 with reported head banging, hitting self with frustration, and ear pulling.  Reported h/o waking screaming.  Assessment: Teething likely, Expressive Language Delay. Still problems with textures. Various behavioral issues noted over next several visits; PDD DXd on 11/30/2004. Two behavioral/educational consults included for DX of Austism.  Pediatric GI consult 5/24/06 for pseudomonas and yeast overgrowth in the gut, and eosinophillic inflammation of the esophagus. Most recent 4 yr. check of 4/4/07 with A?P of Autistic Spectrum Disorder, doing well.
Rash developed 10 days after vaccine, erythematous papules starting on face and spread to neck, trunk, arms, and legs; present on dorsal surfaces of hands and feet; no oral lesions. Pt also had other viral symptoms at the time of the rash - cough, runny nose, low grade fever of 100.2 for 1 day, sick contacts with similar URI symptoms.
Patient received flu vaccine around 12 PM, reported increase in heart rate and tingling of upper legs 25-30 min following administration. Following this, developed a headache, nausea, and upset stomach. Around 8 PM, developed a muscle spasm in right shoulder, then left. Additionally facial flushing and leg cramps again, metallic taste in mouth. All symptoms resolved around 11:30 PM.
Got COVID; Got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Got COVID". Clinical course: The patient received his booster shot and had "a bit of a reaction to it, more significant than the previous boosters". The patient got COVID during a cruise in Sep, but did not notice any changes in heart rhythm while sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My husband and I were on vacation, he started feel unwell the evening of February 4, 2023, I used a home COVID-19 test, it came back negative. The next morning, I had a burning in my chest, I retested myself and this time the COVID-19 test came back positive. I called my primary care physician. I discussed my symptoms with the on-call physician who sent a prescription of PAXLOVID that I was able to start that evening. I started feeling better the next day, I had a hard time moving without feeling like my heart was pounding out of my chest. I tried taking a shower, I could not lift my hands over my head without feeling like I want to pass out. I slept off and on the rest of the day. I tested negative on February 10, 2023, I tested positive again on February 14, 2023. I called my doctor, he did not recommend any additional medication, rest, plenty of fluid. My taste still hasn't returned to back to where it was before, I still have tachycardia upon standing and need to sit to let my heart rate get stable.