chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm soreness in arm of vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 13:00 (Lot number: 5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Nov2021 07:00, outcome "recovering", described as "arm soreness in arm of vaccination". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.  Additional Information: The patient did not have any known allergies. The patient did not have any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination.
pt states arms started itching @ school, got home 4PM & mom checked it;it cont to itch & arms began to swell & hurt;pt also began to c/o feeling weak;mom took child to hosp ER;dx allerg rxn to hep  B vax;
LTC patent was given a second booster dose of 0.25 ml 11/4/21. The facility director gave us a list of patients who needed a booster. It was later discovered that this patient had already received his booster vaccination. To this point no adverse events to report.
30 sec episode of syncope. Taken to ER. Evaluation (-) but for suggestion of UTI.
I did not go back for my second shot.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I did not go back for my second shot.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, 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 (I did not go back for my second shot.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I did not go back for my second shot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Initial adverse effects after vaccine #2 included expected side effects of chills, severe body ache, fatigue starting within 8 hours of dose and lasted about 24 hours. Fatigue persisted. GI upset, diarrhea developed 2 days after vaccine through 3 days after vaccine. Fatigue persisted, as did anorexia, mild nausea through present day. 4 days post vaccine, itching on R abdomen noted. 5 days following vaccine zoster lesions noted on R abdomen and R mid back. Diagnosed by visual exam and stared Valtrex on Day 6.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative citis" (unspecified if ongoing), notes: Other medical History:Ulcerative citis. Concomitant medication(s) included: IMURAN [AZATHIOPRINE SODIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive, notes: Positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain at injection site; Chills; Extreme leg weakness; Lethargy; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 27Sep2021 11:00 (Lot Number: FC3184) as dose 3 (booster), single for COVID-19 immunization (at the age of 78-year-old). Medical history included ongoing back pain from 2014 (Pertinent details: regenerative therapy 21Sep2021). Concomitant medication included paracetamol (TYLENOL). The patient previously received 1st dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 10Feb2021 (Lot Number: EL9269) as dose 1, single for COVID-19 immunization (at the age of 78-year-old) and experienced pain. She also received 2nd dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in left arm on 14Mar2021 (Lot Number was not reported) as dose 2, single for COVID-19 immunization (at the age of 78-year-old) and experienced pain. On 27Sep2021 15:00, the patient experienced pain at injection site, chills, extreme leg weakness and lethargy. Seriousness of the events reported as disability. No treatment received for adverse events. As of 29Sep2021, the clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
I'm 32 weeks pregnant. Due date june 17, 2021. Received first dose at 1015am and within two hours had a swollen tongue with white patches and bumps similar to thrush. Tongue was fine prior to vaccine. When trying to look up if it's common I saw pictures of what some call COVID tongue and it's does look similar to that.
Patient was given an IM injection in the left arm, however the immunization was administered too low and toward the back of the arm. There was bruising and soreness, and concern about the efficacy of the vaccine if it was administered subcutaneously
Generally health and robust, active.  Baseline body temp all life (inc records from birth-age 21) is "96.8" NOT like most people; 98.6F.  Soon after injection, got expected/prewarned sore arm. Unable to move arm 24 hours; fine now.  Problem was feeling sicker than I can ever remember that eve, full day today up until now (11pm).   Fever only stayed under 100.4 WITH back to back fever reducer (asked Pharmacist  today; she said "keep fever under 100."..back to back Tylenol, alternate w/motrin. Motrin didn't reduce fever. Body aches so bad I couldn't sleep last night. Fatigue all day I could do nothing but lie down, fell asleep, very unusual for me to be knocked down by anything. Chills, felt burning up, skin hot to (another's) touch. Every single molecule in my body hurt. Felt hit by truck. No mental confusion, no vomit (also took Pepto Bismal-helped immensely), no dirrahea, just fever that made me unable to  be functional, at all.
This spontaneous report was received from a Registered Nurse. On 07-JUL-2014, the reporter requested stability for doses of ROTATEQ which were evaluated and supported. On 22-JUL-2014, the reporter was requesting stability data for an additional temperature excursion, and she reports that the doses of ROTATEQ (dose, frequency and route unknown) that were supported on 07-JUL-2014, have been administered to unspecified number of patients on unspecified dates since 07-JUL-2014. Concurrent conditions and relevant medical history of the patients was unknown. Concomitant medications were not reported. No adverse effect was observed or reported. Product quality issue was not involved. This case is linked to #1407USA012378 and #1407USA012379 via same reporter link. Additional information has been requested.
could not walk; Severe pain in the belly; Pain in legs; really bad spasms in the legs; could not sleep for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (could not walk), PAIN (Severe pain in the belly), PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (really bad spasms in the legs) and INSOMNIA (could not sleep for 24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder (Intestinal problems), Bladder disorder and Neuropathy peripheral.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk), PAIN (Severe pain in the belly), PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (really bad spasms in the legs) and INSOMNIA (could not sleep for 24 hours). At the time of the report, GAIT DISTURBANCE (could not walk), PAIN (Severe pain in the belly), PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (really bad spasms in the legs) and INSOMNIA (could not sleep for 24 hours) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.    This case was linked to MOD-2021-048175 (Patient Link).
The evening of my shot (11/17/20) I had chills when I went to bed (around 10:00pm). When I got up to go to the bathroom, I became very lightheaded and dizzy in the bathroom and fainted, hitting my head against the toilet (sustained a small bump on my head). When I came to, and attempting to go back to bed, I fainted a second time.
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 19-DEC-2012. The reporter reported that patient was administered expired FLUMIST on 19-DEC-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious.
Fever 104.4 axillary (repeated for accuracy) after TYLENOL given (5 hours prior to recorded fever, 15 mg/kg) and ibuprofen given (1.5 hours prior to recorded fever, 10 mg/kg).
Reaction started Sunday, August 22, 2021 morning.  I woke up with Tachocardia,my heart rate was 125bpm.  I went ahead a took my Diltazem and hour later I was up to 165bpm so I took my Propanolol and still could not get it to lower so I had to repeat DIltazem but only lowered to 130.  This continued for the rest of the day. For the next three days it was still more elevated than normal anywhere from 120-150 bpm.  During this time I also experienced intense burning all through my body like it was on fire. This lasted only on Sunday and Monday.  I had severe body aches  and headaches, fever, and diarrehea from Sunday thru Thursday.  On Friday both my left and right arm elbow down from 12:00 pm to 6:00 p.m.  I did contact my family doctor but she told me that these were normal symptoms after receiving the vaccine but no one else I spoke with that had received the vaccine had my reaction.  I feel that this is not normal for me.
Patient received first dose of the Moderna Covid vaccination at a different facility on March 4th.  The patient then tested positive for COVID on March 14th and received antibody therapy on the 15th.  After speaking with a Moderna representative it was recommended that the patient still receive the second dose at least 90 days after receiving the antibody therapy.  She is scheduled to receive the second dose on 6/16/21.
Bilateral large pulmonary emboli with right ventricular strain requiring immediate hospitalization and anticoagulation
Prolonged seizure over 60 minutes in duration (staring, jerky body movements) received 6 ml of Valium, phenobarbitol, and other anticonvulsants in ER. Received breathing tube, stomach tube, catheter, antibiotics, and anticonvulsants in pediatric ICU. Also diagnosed with sinussitis and aspiration pneumonia.
This case was reported by a nurse via call center representative and described the occurrence of numbness in fingers in a 72-year-old male patient who received FLUARIX QUADRIVALENT (batch number CS979, expiry date 14th June 2017). In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced numbness in fingers and reduced dexterity. On an unknown date, the outcome of the numbness in fingers and reduced dexterity were recovering/resolving. It was unknown if the reporter considered the numbness in fingers and reduced dexterity to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine 2 weeks before reporting date and had experienced numbness in his left fingers. It was described as a dexterity issue. The nurse practitioner reported minimal details for 3 different patients. All had the shot administered somewhere else within the hospital system but mentioned the events to this healthcare provider. She did not administer the vaccine. It is not known if CS979 is the exact lot number of the administered vaccine but she assumed it might be since it was the lot she had. She was also in a hurry to speak with Medical Information (MI) and was quickly providing information and not allowing all questions to be asked. This case was 1 of the 3 cases reported by the same reporter.
burn-like lesion on top of right foot/started as a welt/looks like a blistered burn; sensation of low-grade current flowing through hands and sporadically throughout limbs; This is a spontaneous report from a contactable consumer reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1283/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 at 14:45 (at the age of 33 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included latex allergy and allergy to some white cheeses. Concomitant medication was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021, the patient experienced sensation of low-grade current flowing through hands and sporadically throughout limbs, mostly for 2hrs following the shot, then occasionally afterward. On 21Jan2021 at 22:45 the patient experienced a burn like lesion on top of right foot, which started as a welt approximately 8 hours after the shot. By morning of second day after shot (23Jan2021), it looks like a blistered burn the size of a dime. The patient did not receive any treatment for these events. The outcome of the events sensation of low-grade current flowing and burn-like lesion on top of right foot/started as a welt/looks like a blistered burn was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
experienced a reaction; hives/not truly noticeable; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (experienced a reaction) and URTICARIA (hives/not truly noticeable) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient was on no medications prior to getting the vaccines and has no past medical history other than seasonal allergies.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (experienced a reaction) and URTICARIA (hives/not truly noticeable). At the time of the report, IMMUNISATION REACTION (experienced a reaction) and URTICARIA (hives/not truly noticeable) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-682537 (Patient Link).
10:00 pm - Severe chills 1 am - Temp of 101.1 2 am - take tylenol 3 am - fever 100.4 and excessive sweat 6:30 am - 100.0 temp 8 am - 100.4 temp 9 am - excessive sweat All this time - muscle aches, joint pain
Information has been received from a husband and his 23 year old wife who on 6/27/01, the wife was vaccinated with varicella virus vaccine live and MMR. The pt stated that after she had the vaccinations, she found out that she had become pregnant on 6/17/01. Subsequently, on 9/10/01, the pt had a "natural miscarriage". Her physician told her that the miscarriage was not because of the vaccines, but because of "some chromosome problem". The pt further stated that after the miscarriage, her health was good although she was "still suffering from back pain but reducing day by day". Back pain was considered to be an incidental finding. Additional information is not expected.
pt recv vax 1NOV95 & 26APR(7 pt devel between 25 & 50 lesions & a low grade fever;pt tx @ home w/DPH & calamine lotion;11MAY97 pt recovered;
Fever, 99-101, body aches, chills, nausea x 3-4 days (12/20/07 - 12/23/07). Rash, fatigue, pallor started 12/23/07 and lasted 2 days.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 injection, lot # reported as K010215, expiration date: 05-MAY-2017 (exact dose, dose number and route of administration were not reported) and lot # L036245, expiration date: 09-SEP-2018 (exact dose, dose number and route of administration were not reported). There were no concomitant medications provided. There were  no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 120 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Lot number K010215 is an invalid number for GARDASIL 9. Additional information is not expected as reporter refused additional contact.
J96.00 ACUTE RESPIRATORY FAILURE 12/29/2021 ATRIAL FIBRILLATION, UNSPECIFIED
She developed fever for 3 days, severe muscle and body aches for 10 days. Low back pain started 3/28 accompanied by bilateral tingling, weakness, numbness in legs. Uveitis symptoms started 4/11. Tingling in hands started 5/3. Symptoms worsened. Did not respond to course of Prednisone. Steroid injectionused to treat uveitis. Rheumatologist thinks inflammatory issue. Neurologist thinks aggravated by covid vaccine.
24JAN97 c/o whiny, low grade fever about 4-5hr p/vax;later fever 103 w/swelling in leg;screamed, cried all noc, did not sleep;could not be consoled by family members;hosp for observation;given APAP #3;
Patient received dose of Janssen Covid vaccine in right deltoid. He chose the right arm because his left upper arm is fully tattoed. Patient sat for about 5 minutes and then he got up and fell forward on our counter in the waiting room. After about a minute he got up and sat on the bench for a few minutes. We discovered him after about 10 minutes lying sideways on the bench. First BP reading was 86/63mmHg and patient was clammy and sweating. His major complaint was fatigue. He took a sip of soda and ate a peanut butter cup. EMS arrived his BP had gone up to 120/68 mmHg. Oxygen levels were normal but patient refused to allow EMS to check his blood glucose.
felt really cold and chilly; Sneezing; felt really cold and chilly; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt really cold and chilly), SNEEZING (Sneezing) and CHILLS (felt really cold and chilly) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 025821A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included VITAMIN D NOS for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced FEELING COLD (felt really cold and chilly), SNEEZING (Sneezing) and CHILLS (felt really cold and chilly). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, bid. At the time of the report, FEELING COLD (felt really cold and chilly), SNEEZING (Sneezing) and CHILLS (felt really cold and chilly) had resolved.            Other concomitant medications included depression medications.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Outcome of the events were provided.
missed second dose; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). At the time of the report, NAUSEA (Nausea) and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient reported that no treatment medication was taken for the event.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
Vaccine (H1N1) administered 10-29-09. Approx 2 weeks later red bumps on chest then generalized. Sometimes the rash would be bumps, sometimes hives, some chest tightness. Took BENADRYL at night, ZYRTEC in the morning. Was seen by doctor. Lips, eyes started swelling, put on steroids with no relief than an anti-fungal with no relief. Was seen by a dermatologist, put on XYZAL, PREVACID and BENADRYL. No further lip, eye swelling for appox 1-2 weeks. Still wake up with hives.
Diagnosed lichen sclerosus had been quiescent for several years. On exam of Dec 1 it was fully flared up and has had to be locally treated which is ongoing. Uncertain if it is related to the vaccine, can't confirm from discussion with providers.