chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. experienced severe stomach pain on January 12 , 2022 which led to a trip to the Emergency Room. A cat scan was performed and acute appendicitis was diagnosed.  His appendix was then removed by Doctor.  It was his second trip to the emergency room as pt. had a cat scan in August 2021 for stomach pain. His first two Covid 19 pfizer BioNtech vaccinations occurred on April 3, 2021 and April 24, 2021, respectively.  It must be noted his older brother who had the same Pfizer vaccinations on the same dates and schedule, had severe stomach issues (also August 2021) and after a cat scan was performed, had emergency surgery to remove his appendix for acute appendicitis.
nausea, vomiting, diarrhea. Symptoms began 3AM on 04/20/2021
THEY TOOK OUT MY GALLBLADDER. LATER FOUND  OUT I HAD GUILLIAN BARRE SYMPTOMS. STOMACH PAINS. DIARRHEA SYMSTONS EVERYDAY. LEFT  SIDE OF MY BODY WAS NUMB DURING SURGERY FOR GALLBLADDER . LEFT PART OF BODY WAS NUMB. DR. GAVE ME A SHOT FOR NUMBNESS. MY LEFT HAND IS NUMB. SHOT DIDN'T BRING LEFT HAND USAGE BACK.
Experienced a rash; Red spot at injection site; Drowsiness; Experienced a Headache; Injection site was painful; I could not stand up; Felt like a walking zombie; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie), SOMNOLENCE (Drowsiness), RASH (Experienced a rash) and HEADACHE (Experienced a Headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN and LEVOTHYROXINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie) and VACCINATION SITE PAIN (Injection site was painful). On 08-Feb-2021, the patient experienced SOMNOLENCE (Drowsiness) and HEADACHE (Experienced a Headache). On an unknown date, the patient experienced RASH (Experienced a rash) and VACCINATION SITE ERYTHEMA (Red spot at injection site). At the time of the report, DYSSTASIA (I could not stand up), GAIT DISTURBANCE (Felt like a walking zombie), SOMNOLENCE (Drowsiness), RASH (Experienced a rash), HEADACHE (Experienced a Headache), VACCINATION SITE PAIN (Injection site was painful) and VACCINATION SITE ERYTHEMA (Red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  The patient had visited the Emergency Room and was told at the Emergency Room that everything was normal.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Patient does not want further follow up.
I had very severe fatigue, I could not wake up for more than 10 minutes every couple of hours, could not sit up.  I felt like I was under anesthesia and could not wake up, I had a headache, nausea and very sore injection site.  That lasted 24 hours, then the next 24 hours were better still fatigue, headache and  nausea got better but still very off for next 24 hours.  Then for a week after cold like systems and still fatigue.  This is the worst reaction I have ever had to a vaccine. I did have covid in Nov 2020 and I am A positive blood type.  Husband had covid Nov 2020 is O positive and had chills, some fatigue the following day but was better in 24 hours.  Not nearly as severe as me. , same info as me
3 patients received their Moderna Covid-19 vaccine and later caught Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19). At the time of the report, COVID-19 (3 patients received their Moderna Covid-19 vaccine and later caught Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications details were provided. No Treatment Medications details were provided. Case summary: The patient reports that her son and daughter in law takes care of 2 people who are residents of their "home". The 2 residents received the Moderna covid-19 vaccine and recently tested Positive for Covid-19. None had received their Moderna Covid-19 booster doses.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced the unexpected event of COVID-19 (AESI) after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. It was reported that the patient had not received they booster dose. No further information is available. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no pertinent medical history or drug reactions/allergies, who on 14-Aug-2008 was vaccinated with the first dose of GARDASIL (lot # 659655/1486U) I.M. into the right arm. Concomitant therapy included the first dose of MENACTRA (lot# 02560AA) IM into the left arm, the first dose of BOOSTRIX (lot# AC52B015AA) IM into the left arm, and the second dose of HAVRIX (lot# AHAVB245AA) IM into the right arm. After the patient was receiving HPV vaccine she waited in reception area for 10-15 minutes and with departure in hall and she vomited. No further information is available. It was reported that the patient's experience was considered non-serious. The original reporter was not provider. No further information is available.
Information has been received from a Licensed Practical Nurse concerning a 24 year old female patient who on 10-SEP-2010 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot# 666121/1778Y). The nurse reported that on 10-SEP-2010, the patient fainted, her muscles got tight and the patient was hard to arouse. The patient developed a headache that lasted until 14-SEP-2010. At the time of the report, the patient was recovering from fainted, muscles got tight and hard to arouse. The patient did not seek medical attention. No further information is available.
This spontaneous report as received from a medical assistant via company representative concerning a 2 month old patient of unknown gender who on an unknown date was might have been vaccinated with a dose of MMR II lot # H017433, exp date 20-SEP-2014 (dose not provided). No adverse effects were reported. Additional information has been requested.
Child presented with cough and rash day of vaccines, no fever 11/13/2013. 11/14/13 first time event, child began to vomit at 10:00 AM consistently throughout the day 11/14/13 ran a low grade fever (100.9) mother stated child arms and legs began shaking uncontrollably approx, 02:30 PM. This happened almost 24 hrs after vaccinations. Child transported via ambulance to ER.
per patient's daughter, he did not feel well after the flu vaccine.  he had fever (highest @ 100.5F), chills, body aches, cough and chest pain due to excessive coughing.  Symptoms persisted for 3-4 days and the cough lasted longer (up to 9 days) so patient was brought to emergency room where he was given benzonatate 100mg tid, albuterol inhaler (2 pfs q 4 to 6 hours), pulse oximeter and an aerochamber.
Pain in shoulders, back and hips which has increased starting  3/28/21.  This is a disruption of my ablility to conduct normal life functions including my ability to walk.  My treatment includes lab work which shows I may now have inflammatory arthritis which I have never been  diagnosed with before.  I have had physical therapy for this which was not successful.
Pt. received the flu shot on Friday around 2:30.  While eating lunch Saturday his vision became blurred, face felt numb and and was twitching.  No difficulty breathing.  Parents took him to the ER.  Blood and urine tests all WNL.  CAT scan neg.  Advised to f/u with neurologist on Monday.  Sunday he was fine.  Monday went to school but didn't feel quite right.  Saw the neurologist - MRI was done and it was normal.  Has occassional HA, but nothing like at first.
fever 100-105 Fahrenheit; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 13:30 (Lot number: FL0007) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. No other vaccine in four weeks. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (medically significant) with onset 21Nov2021 01:00, outcome "recovered", described as "fever 100-105 Fahrenheit"; VOMITING (non-serious) with onset 21Nov2021 01:00, outcome "recovered", described as "Vomiting". The events happened also reported as beginning 60 hours after receiving vaccine. Fever lasted 24 hours. No covid prior vaccination. Covid tested post vaccination included Nasal Swab on 23Nov2021 with result of pending. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 100-105 Fahrenheit; sars-cov-2 test: (23Nov2021) unknown results. Therapeutic measures were not taken as a result of pyrexia, vomiting.   Follow-up attempts are completed. No further information is expected.
Started with ringing in the left ear, got up Sunday and could not hear out of my left  ear.
Headache, Myalgia, Rigors, fevers, and frontal headaches Narrative: 12 hours after vaccine given, experienced severe, extreme rigors, along with fevers to 103.2, unresponsive to acetaminophen and ibuprofen. Also reported as normal. Of note, reports history of mild COVID before (positive PCR  11/2020 with symptoms but never severe).
Syncopal episode immediately following injection with a few seconds of convulsive seizure-like clonic movements.  No postictal Sx after event.  Vital signs stable.
History of Present Illness       8 yo who received his COVID vaccine yesterday, last night developed a few hives on trunk/extremities. Today mom noticed hives much worse and quite pruritic, mom brought to ED for further evaluation.  There has been no fever, no URI symptoms, no cough, no shortness of breath or trouble breathing, no throat tightness or chest pain.  Denies tongue swelling.    Past MedHx: ADHD, asthma, o/w reviewed and not relevant to current encounter  SurgHx: reviewed and not relevant to current encounter  SocialHx: Lives with family  FamHx: reviewed and not relevant to current encounter  Meds: Concerta, melatonin  Immunizations: Up to date Medical Decision Making       Patient with hives as above, may be related to COVID vaccine. Benadryl given. No evid of anaphylaxis or severe reaction. Serial exams done.   Reexamination/Reevaluation       Temperature Temporal Artery: 37.2 DegC (11/17/21 20:34:00)  Systolic Blood Pressure: 114 mmHg (11/17/21 20:34:00)  Diastolic Blood Pressure: 55 mmHg (11/17/21 20:34:00)  Heart Rate: 89 bpm (11/17/21 20:34:00)  Respiratory Rate: 20 br/min (11/17/21 20:34:00)  Oxygen Saturation (SPO2): 99 % (11/17/21 20:34:00)  Remained well appearing. Repeat vitals normal, well perfused. Safe for discharge home. Instructions given Discussed reasons for return. Advised f/u with PCP within 48 hours.      Final Diagnosis   1. Hives L50.9  2. Allergic reaction T78.40XA
This is a spontaneous report from a contactable physician via a Pfizer vaccine sales representative. The physician reported a female patient in her 50s received PREVNAR-13 single dose on an unknown date. The patient's relevant medical history included ongoing atrial fibrillation since an unknown date. Relevant concomitant medications were unknown. On an unknown date, two days after receiving the vaccination, the patient developed cellulitis in her arms and her atrial fibrillation worsened for which she was taken to the emergency room and had seen a cardiologist. Relevant lab tests were unknown. Therapeutic measures taken for the reported events, cellulitis and worsened atrial fibrillation, were unknown. The clinical outcome of the reported events, cellulitis and worsened atrial fibrillation was reported as unknown.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 04-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Pfizer 4/7/21, 4/28/21, 11/17/21. Positive on 1/23/22
Day after injection the site became red, swollen, hot and very tender to the touch. Received DLA (dexamethasone) and antihistamines.
I had vaccination on 10/21/2022. On 04/19/2023 I started to have pain between my shoulder blades like a squeezing sensation. That is a sign to me that it has to do with my lungs. On 04/20/2023 I had sneezing migraine sore throat upset stomach and coughing. On 04/21/2023 I had pain shooting up my back. I tested COVID-19 Positive on 04/21/2023. I was prescribed Paxlovid. I did go to the emergency for pressure like feeling on my chest. I was diagnosed with Bronchitis and prescribed Toradol and Azithromycin. I am presently having a lot of pressure in my chest on 04/24/2023.
swelling, redness, warmness & pain of rt thigh, improving w/APAP according to the phone conversation w/mom on 14AUG95;
Administered ZOSTAVAX IM instead of subcutaneous. No information regarding correct route found on product vial nor in VIS sheet.
Fever chills and hip pain within 7 hours of the vaccine.  Hours 8-24 hours post vaccine extreme hip and knee joint pain (unable to stand for greater than 5 minutes) , exhaustion, loss of appetite, blurred vision, foggy memory/thoughts.  Hours 25-96 (current ongoing) joint pain in hips and knees, pain at base of skull radiating down neck and into back limiting movement, blurred vision, inflammation and swelling of right hand pointer finger joint (limited movement of joint), skin rash on legs, foggy memory.
A non-serious event of administration of expired product was received from a health care professional concerning a ten-year-old child. No medical or drug history was provided. FluMist was administered on 04-Jan-2008. The FluMist expired eight days earlier on 27-Dec-2007. Eighteen days after exposure to the expired product, the patient had not experienced ill effects. No additional dosing is indicated. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
hadn't walked too much; shot made me feel like was having another stroke; stiff; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff), GAIT DISTURBANCE (hadn't walked too much) and FEELING ABNORMAL (shot made me feel like was having another stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Stroke. Concomitant products included PREGABALIN for Nerve pain, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLENE) and DIAZEPAM for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff). On an unknown date, the patient experienced GAIT DISTURBANCE (hadn't walked too much) and FEELING ABNORMAL (shot made me feel like was having another stroke). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff), GAIT DISTURBANCE (hadn't walked too much) and FEELING ABNORMAL (shot made me feel like was having another stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Added medical history stroke.Event added
This spontaneous report as received from a Medical Assistant regarding herself as a female patient of unknown. Medical history, drug reactions/allergies and concomitant medications were not reported. In May 2007, the reporter was starting to inject a patient with GARDASIL, Lot # J006587 expiry date 04-DEC-2015, and she noticed the pre-filled syringe was leaking onto her hands. No adverse event symptoms were reported. A PQC was filed. The outcome of the events was not reported. This is one of two reports from the same source (MARRS case 1401USA001288). Additional information has been requested.
first 48 hours, light headedness, pain from shot area to elbow.  Light headedness continued off and on for nest 6 days.  5 days later woke up vomiting.  At first small amount.  Went back to sleep.  About 30 minutes later woke up with heavier vomiting.  Next evening I had chills.  By Sunday night all symptoms were gone.  I did not seek medical treatment because none of the symptoms were severe.
Red, slightly swollen, size of a tennis ball area occured approx. 24 hrs. of receiving influenza vaccine. No pain, but minor itch, within 36 hrs. - 40 hrs. 10/10/2008, swelling gone, slightly red, minor itch.
Weepy red rash to face, arms, legs, abdomen, and back. Patient reports intermittent mild to moderate itching. Rash is aggravated by heat and exposure to sunlight. Rash appears Intermittently but daily. Seems to improve in the evening but returns in the morning. Per moms report, rash appeared about 5 hours after vaccines were administered and rash has continued over the past 2 months.
Chronic vomiting for a few months with extreme weight loss. Inability to consume foods I once had. Psoriasis. Still have.
Pt devel fever, malaise, flu-like sx, nasal congestion, feels bad, weakness; Missed one day work;
Ringing in both ears (tinnitus): has been constant for 8 days now...not subsided at all tried Debrox for the possibility of ear wax build up
19AUG92 had red areas on inner aspect of lt upper arm, red areas under arms, scaly erythema opposite site;event cleared; devel 2 red areas 4-5cm, beginning to scale that was warm to touch, feeling of heaviness;
Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2022 18:00 (Lot number: KF9895) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "PNC" (unspecified if ongoing), notes: known allergies: PNC, Sulfa drugs; "Sulfa drugs" (unspecified if ongoing), notes: known allergies: PNC, Sulfa drugs; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: PROPRANOLOL; KLONOPIN; EFFEXOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: blood test: (19Mar2022) negative. Follow-up attempts are completed. No further information is expected.
Gave 3+ yr Fluzone instead of 6-35month Fluzone shot. No Adverse side-effects noted in office.
pt reported immediately feeling the injection travel to the fingertips in her left arm and  feeling swollen in her finger joints and at the injection site.  this morning she woke up and felt swelling in her joints throughout her body.
Tingling and numbness of tongue beginning 1 hr. after injection. No treatment required. Resolving at 240pm in 12-5-13.
Numbness of upper lip < lower lip as well a little swelling. Sinus area feel dry, rash developed on legs, arms, and face. Swelling of lower eye lids.
Caregiver complains of bilateral foot swelling beginning 11/6/22, more pronounced on left with bilateral foot pain;  caregiver treated condition with elevation of legs, tylenol, ibuprofen and allegra;  swelling was present for 24 hours and then resolved;
Information has been received from the CDC concerning a 15 month old male who at 10 months old, developed failure to thrive with his growth and development going from 90th percentile down to 10th percentile. A work-up at that time was unremarkable. On 2/23/01, the pt was vaccinated with 1 dose of Varicella virus vaccine live. It is unknown whether concomitant vaccinations were administered. On 4/13/01, the pt was hospitalized for a varicella-type rash. He received 3 days of acyclovir therapy and also 3 days of IV antibiotics because of possible infective lesions. He was discharged to home on erythromycin; however, on 5/2/01, he was readmitted to the hospital with approx. 1,000 varicella-type lesions throughout his body. It was reported that new crops were developing and there were bullous lesions on his hands and feet. A chest X-ray showed a defuse nodular pattern which the physician felt was compatible with varicella pneumonia. His heart rate and respirations were increased but he had not been placed on the respirator. A DFA staining of a skin lesion was positive for VZV virus. A CSF processed in an outside lab was positive for varicella zoster virus using PCR technology. The CDC has received a skin lesion crust but has not identified any varicella zoster virus. It was noted that the pt has a negative family history of immunocompromised disorders and he is HIV negative. Additional information has been requested.
Injection was placed on the tip of my shoulder, in the joint space. With a couple hours, severe pain, joint stiffness. Still trouble rotating my shoulder without pain today.
Patient received Pfizer vaccine at pharmacy. Per patient and his father, went out to car immediately after vaccine. Sitting in car during 15 minute waiting period. While sitting, became pale then per father passed out and became responsive. Preceding had abdominal pain and vomiting, but no rash, lip/tongue swelling, or difficulty breathing. On EMS arrival, patient with BP 80/30. Transported to ED, where vitals normal on arrival. Still felt shaky but symptoms had otherwise resolved. Did not receive treatment with EMS.