chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized w vertigo, vomiting and deafness in right ear on 8/38/2031.  Diagnosis of  acute labyrinthitis.  After 3 weeks am still deaf in right ear.  Being referred for assessment for a cochlear implant
Patient fell down 15 minutes after getting her second covid shot. She reported feeling dizziness. Her Dad and I took her to a chair to rest.  She said she felt better after 10 minutes resting and was able to walk normally. I offered to called ambulance then we decided that her parents will take her to urgent care for further check up . patient's parents stated that she was fine with the first covid shot
After eating supper on 4/29/02, redness and swelling began in left upper arm which worsened on 4/30/02. Came into clinic.
Acute ITP (idiopathic thrombocytopenic purpura). Presented to clinic with diffuse purpura and petechiae. Platelets critical at 33,000.
After two varicella vaccines, the pt failed to seroconvert. Unspecified medical attention was sought. Additional information has been requested.
Information has been received from a registered nurse concerning an unspecified number of female pediatric patients of various ages who were vaccinated with a second subcutaneous 0.5mL dose of varicella virus vaccine live (Oka/Merck). The patients developed an injection site reaction the following day and the area was red and hot to touch. All patients have recovered. Unspecified medical attention was sought. No other details were available. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
A nurse reported the occurrence of an injection site reaction in a 15-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The vaccinee had no relevant medical history and received no concurrent medications.  On 05/01/2002, the vaccinee received his fourth injection of Infanrix.  On the same date, in the opposite leg, the vaccinee received an injection of 7-valent pneumococcal conjugate vaccine (Prevnar) or varicella virus vaccine (Varivax).  That day, and unspecified time post-immunization, the vaccinee experienced an injection site reaction characterized by a "long, oval shaped, hard, red area toward the groin."  The vaccinee also experienced the "same reaction" in the opposite leg.  The child was seen by the physician on 05/02/2002.  The physician prescribed paracetamol (Tylenol) and cold compresses.  The reporter stated that the injection site reaction was probably related to Infanrix administration.  The injection site reaction resolved on 05/03/2002.
Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities; This is a literature report for the following literature source(s):  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 (manufacturer: unknown)), for Covid-19 vaccination. The following information was reported: TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities". The event "electrocardiography (ecg) showed sinus tachycardia with no st or t-wave abnormalities" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood bicarbonate (23-32): 22 mmol/L; blood calcium (8.6-10.3): 8.6 mg/dl; blood chloride (98-108): 107 mmol/L; blood creatinine (0.6-1.1): 1 mg/dl; blood glucose (70-99): 106 mg/dl; blood potassium (3.5-5.3): 4.3 mmol/L; blood pressure measurement: 152/99 mmHg; blood sodium (135-145): 138 mmol/L; blood thyroid stimulating hormone (0.27-4.20): normal limits; 0.24 IU/l; blood urea (6-20): 10 mg/dl; body temperature: 37.4 Centigrade; computerised tomogram: chest showed no evidence of pulmonary embolism or, notes: any identifiable pathology; drug screen: unknown results; electrocardiogram: showed sinus negative; fibrin d dimer (normal high range 0.5): normal limits; 0.41 ug/ml; full blood count: normal limits; haematocrit (36-47): 36.5 %; haemoglobin (12-16): 12.1 g/dl; heart rate: 135; metabolic function test: normal limits; oxygen saturation: 100 %; platelet count (140-440): 252 x10 9/l; pregnancy test: unknown results; thyroxine free (0.8-1.7): normal limits; 1.5 ng/dL; troponin (normal high range 14): normal limits; less than 6; less than 14; urine analysis: no rbc, wbc or bacteria; vital signs measurement: unknown result; white blood cell count (4-11): 7.9 x10 9/l. Therapeutic measures were taken as a result of tachycardia.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",; no energy; severe headache for 24 hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",), ASTHENIA (no energy), HEADACHE (severe headache for 24 hours) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION COMPLICATION (feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",). 12-Mar-2021, the patient experienced ASTHENIA (no energy), HEADACHE (severe headache for 24 hours) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 13-Mar-2021, HEADACHE (severe headache for 24 hours) had resolved. On 14-Mar-2021, VACCINATION COMPLICATION (feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",), ASTHENIA (no energy) and FATIGUE (Fatigue) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Had a patient who got vaccinated and was tested with # SARS COVID 2 Semi quantitative Total antibody test and come out negative; This is a spontaneous report from a contactable Physician. A patient of unspecified gender and age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unknown date, single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient got vaccinated and was tested with # SARS COVID 2 Semi quantitative Total antibody test and come out negative. The outcome of the event was unknown.  Information about lot/batch number has been requested.
4PM crying-gasping for air type of cry-arms & legs cyanotic face very red taken outside & color came back; taken to ER;
Swelling of Rt thigh area after vaccine. Swelling started morning after vaccine. Area also has some erythema.
Information has been received from a pharmacist concerning an adult female who was vaccinated with MMRII. The pharmacist reported that the patient broke out in a rash 14 days post vaccination. The patient had sought medical attention for her experience. Additional information has been requested.
pt recv vax 11JUL97 & a home pregnancy test was positive 21JUL97 (LMP 26MAY97) estimated date of delivery 3MAR98;f/u info from MD indicated that pt elected to terminate pregnancy 9wk from last menstrual period;
Since having COVID in October I have had shortness of breath and brought back my childhood asthma. I woke up feeling sick, I thought it was just a cold. I felt run down and had a runny nose. I also had a fever and extreme fatigue. I tested everyday due to work policy, and I tested negative. I tested that Sunday and then tested positive. I called my doctor and did a teledoc appointment. The NP did not prescribe PAXLOVID due to me already taking it two times before. I have only really started to feel better in the last week to 10 days.
First noticed itchiness around injection site. Later it became hot, red, sore and hard. For two days, I didn't feel well - chilling, fatigued. Symptoms disappeared after about four days.
Almost immediately patient states she began experiencing tingling in her arm and hand.  She remained at the pharmacy for approximately 30 minutes at which point she says her whole hand was numb.  She was advised to seek medical help at that point. She went to the ER, was evaluated, and given ibuprofen.  She was instructed to follow up with PCP.
Patient described as lump at injection site, approx 2 inches in diameter.  Patient also described it as red and sore, but not itchy.  Patient was recommended to apply cold compress and to monitor for any worsening of condition.  Patient was told to take Benadryl if it became itchy.  Patient was also instructed to seek medical attention if it continued to worsen severely.
Vasovagal Syncope: Intense nausea, light-headedness, anxiety, and chest pain 5 minutes after the injection. Blood pressure dropped, I went pale, and I fainted. No injuries were sustained. I lay on my back with my knees bent while being monitored by EMTs. My BP was around 110/70 and my HR was 55. I was monitored for another half hour and then released when symptoms subsided.
Patient accidentally received 0.3 cc of air before the mistake was recognized right away. Due to the lack of resistance encountered during injection, the vaccinator immediately realized that patient received air instead of the vaccine. After verifying it with the vaccine drawer, it was indeed the case. Patient was immediately informed and o.3 cc of the pfizer vaccine was given right away on the same arm. Patient was told of the mistake and was apologized too. A few hours after the event, she reported no discomfort during accidental encounter with our clinic staff.
3/20-3/21 : 12- 24 hrs after dose - fever, body aches 3/22:  strong headache, sore arm at injection site, body aches 3/23:  strong headache, joint pain, body aches 3/24:  strong headache, joint pain, body ache
On March 25, 2021, 2 weeks after the second shot of Moderna, I woke up with numbness, tingling, pain  on my left side from the middle of my back and stomach to my foot.   Was taken to the ER and was evaluated for a stroke.  No evidence shown.  Diagnosed with a pinched nerve.  Given 1 muscle relaxer and shot of morphine.  Neither did anything.  Have been seeing a chiropractor 2-3 times a week since being released from the ER.  Have followed up with my PCP and Endocronologist.  PCP has sent me for additional bloodwork - checked for Lupus, Lymes, RA, Vitamin D, B12, Folate, and Inflammation (Sed Rate and CRP).  I have a low Vitamin D and now taking a supplement and Sed Rate and CRP are both higher than the day I was in the ER.  I have tried Spinal decompression also (actually made the numbness worse)  I have been referred to a Neurosurgeon and he has negated everything from the ER.  I do not have a pinched nerve or bulging discs.  In fact, I was told my spine is in great shape for my age group and is straight with a perfect curvature.  Waiting to be scheduled for an EMG.  Also told to go to physical therapy and to try accupuncture.  I am over 6 weeks since my trip to the ER and 8 weeks since the second shot.  I still have no relief and am still numb.  My foot is on and off with the numbness.
It was stated by recipient that he developed redness, warmth and welling at the injection site.
BlurredVision, Dizziness, Myalgia, Arthralgia,  Fever, Angioedema,  INJECTION SITE PAIN, SWOLLEN GLANDS  Narrative:   Other Relevant History:
Patient received vaccine, then proceeded to the monitoring station in the clinic. Upon arrival to the Monitoring station, client stated she felt light-headed and appeared dazed. Client escorted to recliner chair to recover. BP 120/78 while seated with legs reclined. Gatorade was given, which the client drank with good effect. After 20 minutes, the client sat up (no longer reclining) and tolerated the position change well. After an additional 5 minutes, the client stood up  and felt she had recovered.
This spontaneous report as received from a healthcare worker refers to a 10 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (Lot# L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided). Concomitant medications was not reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Shingles took  oral medicine  went away but rash was in the bra line on left side of body
No adverse event; Vaccines were administered after temperature excursion; This spontaneous report has been received from an office manager regarding a patient of an unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported.  On 25-OCT-2021, the following vaccine had undergone temperature excursion at temperature of 6 up to 14 Fahrenheit degree for 4 hours and 14 up to 46 Fahrenheit degree for 4 hours and 45 minutes: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (valid lot # U017140, valid expiration date: 28-NOV-2022) 0.5 mL (strength, route, and anatomical location were not provided) as prophylaxis. Additionally, 0.5 ml of diluent MRK was administered. The vaccine was administered after the excursion (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported.; Sender's Comments:  US-009507513-2203USA001850:
A physician prescribe Shingrix  to a 44 years old female patient; A physician prescribe Shingrix  to a 44 years old female patient; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (chronic).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were provided as follows: The pharmacist reported that the physician prescribed Shingrix to the 44 years old patient because she had chronic shingles, which led to inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
arm pain; injection site pain which was worse than the 1st vaccine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (injection site pain which was worse than the 1st vaccine) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (injection site pain which was worse than the 1st vaccine) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (injection site pain which was worse than the 1st vaccine) and HEADACHE (Headache) had resolved.            Concomitant medications was not provided Treatment medications was not provided   This case was linked to MOD-2021-021347 (Patient Link).
Pt exp large local rxn involving swelling of affected rt arm-elbow to ax area, redness & induration @ shot site; tx Medrol dose pak;
pt recv vax 1JAN97 & 9MAR98 an enzyme immuno assay revealed that pt did not seroconvert;it was reported that pt is 17 wk pregnant;
After receiving the vaccine, the patient experienced tickling in the throat. Benadryl was given and patient soon felt fine
High fever for 4 days 102.8, 103.4, 103.1,  103.4 Extreme fatigue and nausea.  No appetite
pt recvd vax;exp soreness at inject site, leg discomfort & could not bear weight on leg;
a 4 year old patient was accidentally given the Adacel vaccination instead of Daptacel/no AE; a 4 year old patient was accidentally given the Adacel vaccination instead of Daptacel/no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 4 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Prefilled Syringe) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 20-Aug-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number U5748AA via intramuscular route in the left thigh.  It was of actual medication error due to Product administered to patient of inappropriate age and wrong product administered..  It was reported that no adverse event was observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Spotting (vaginal bleeding) and mild cramps for a few hours. I have had IUDs for 6+ years and no periods during that time until this. It was very mild and didn't last more than a day.
About a week after the vaccine, I noticed a swollen lymph node in my neck on the right side by my collar bone. I spoke with my doctor shortly after noticing the swelling and she told me it was probably a vaccine reaction and just to keep an eye on it. It did not go away until sometime in June. I started out very big and slowly got smaller over time.
Multiple Sclerosis flared up; Burning sensation in bilateral upper and lower extremities; Numbness in upper and lower extremities; tingling sensations in upper and lower extremities; Feel extremely weak; Fatigued; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced  events multiple Sclerosis flared up (multiple sclerosis relapse), fatigued (fatigue), feel extremely weak (asthenia), burning sensation in bilateral upper and lower extremities (burning sensation), numbness in upper and lower extremities (hypoaesthesia), and tingling sensations in upper and lower extremities (paraesthesia).  The patient's current conditions included multiple sclerosis. Concomitant medication includes gabapentin and albumin human, glucose, interferon beta injection.  On 05Mar2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch/Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06Mar2021, the patient started feeling extremely weak and fatigued. The patient's multiple sclerosis flared up after receiving vaccine. The same day, patient experienced burning sensations in bilateral upper and lower extremities along with numbness and tingling sensations. The patient paid a visit to her neurologist. Treatment medications included; multiple sclerosis medications as prescribed with no significant improvements. The event multiple Sclerosis flared up was considered as medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, multiple Sclerosis flared up was not recovered at the time of this report. The outcome for the events, fatigued, feel extremely weak, burning sensation in bilateral upper and lower extremities, numbness in upper and lower extremities, and tingling sensations in upper and lower extremities was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
my blood pressure was high; Was told that I have Congestive Heart Failure , which I did not have before the Vaccines .; watering my lungs; watering my lungs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (not pregnant) received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in left arm on 18Feb2021 13:00 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, diabetes, penicillin allergy, sinus rhythm (had been in sinus rhythm for a long time), atrial fibrillation. No Covid prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). The patient previously took first dose bnt162b2 in left arm on 29Jan2021 at the age of 70-year-old for COVID-19 immunization and after the first vaccine, patient went to the ER with shortness of breath and in A fib (atrial fibrillation). Had water in patient's lungs, stayed for 5 days. After the second vaccine in Feb2021, patient's blood pressure was high. Back to the ER, watering patient's lungs, Stayed for another 5 days. It was told that patient had Congestive Heart Failure, which patient did not have before the Vaccines. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. The patient was hospitalized for the events for 5 days.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Feb2021, blood pressure measurement: high in Feb2021, blood pressure measurement: high on unknown date. Therapeutic measures were taken as a result of events (unspecified medications). The outcome of the events was reported as recovering.  Information on the lot/batch number has been requested.
1st day sore arm, 4th day-stroke like reaction, had to go to er
pt had fever off & on for 24hr, as high as 101;had vomiting & diarrhea;saw by MD 11MAR97;had dx of ear infect;