chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to the ED on 8/3/21 with shortness of breath and cough. She states that her symptoms started about 10 days prior to admission. Pt reports having a positive COVID test through pharmacy, but the exact date is unknown. Pt was tested in the ED which confirmed that patient was COVID positive. In the ED, pt was satting 88% on room air, so pt was placed on 3L O2 and admitted for COVID treatment (remdesivir and dexamethasone). Pt completed her Moderna vaccinations (4/29 and 5/27) PTA.  She is also on Gilenya for MS.
Immediate pain in the injection site and down the affected arm. Tingling in the left arm, face, tongue, nose, top of the head and upper left leg. Sensation difference between the left and right side of the body. Experienced a mild cough, sore throat and itchy eyes on day after the Flu shot through the weekend. Cough and sensation differences remain past the third day post injection.
redness,  hardness, swelling, warmth at site . body aches, fatigue.  ice pack to site x 15 min several x over 2 days. Site almost normal by 5 days after injection
patient regurgitated one dose of ROTATEQ; second dose of ROTATEQ due to the regurgitated dose being viewed as an incomplete dose; This spontaneous report was received from a registered nurse via company representative, referring to a 4 month old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, for routine vaccination (strength, dose, frequency, lot# and expiration date were not reported).   On an unknown date, the patient regurgitated one dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (infantile spitting up). It was reported that the patient did not seek medical attention and was unknown if diagnostic laboratories were performed.  On an unknown date (reported as "one week after initial dose"), the patient received a second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) due to the regurgitated dose (extra dos administered), which was viewed as an incomplete dose.   At the time of reporting, the outcome of infantile spitting up was reported as resolved on an unknown date. The causality assessment was not provided.
Information has been received from a pharmacist, licensed practical nurse and an office clerk concerning a 62 year old white female housewife with premature ventricular contractions and osteoporosis who on 03-AUG-2006, at 15:00, was vaccinated IM with a ninth dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 04-AUG-2006, at 08:00, the patient's arm was hot, swollen, painful and she had red streak running down her arm. The patient also complained of a headache and "ran a temp." The patient was treated with prednisone (DELTASONE) 20 mg daily and cephalexin (KEFLEX) 500 mg four times daily. On approximately 10-AUG-2006, the patient recovered. The reporting licensed practical nurse reported that the patient's hot, painful swollen arm with red streaks running down arm, fever and headache were considered to be other important medical events. Additional information is not expected.
Patient reported dizziness approximately 20 minutes after after 1st dose Pfizer COVID Vaccine. Vitals were assessed. Blood pressure 123/74, pulse 83, resp. rate 18, SpO2 99 %.  Patient reported no having breakfast. She was given water and a snack. Dr assessed the patient, instructed to wait until patient finishes snack and symptom resolves. Shortly after the symptoms resolved and patient was dismissed, with emergency room precautions.
Pt was given the varicella vaccine too close to the MMR.   No adverse side effects.      Pt timeline:  11/21- MMR #1  12/2- Varicella #1 (only 11 days from previous live virus vaccine MMR).
Information has been received from a registered nurse concerning a 12 month old male infant at 2 months of age was vaccinated with Comvax. At 8 months of age, approximately 10-SEP-2005, and on 26-JAN-2006 the patient was vaccinated intramuscularly with a 0.5 ml first and a second dose of Hib conj vaccine. There was no concomitant medication. A slight injection site reaction was noted. It was also reported that the patient had received 2 doses of Pediarix, dates unknown and some of the injections were given at another practice. Unspecified medical attention was sought. No product quality complaint was involved. Outcome unknown. Additional information has been requested.
About 10 hours after I received the vaccine  I developed chills and a slight fever (99.4). About 18 hours after I received it I developed shaking chills, fever of 100.6, and severe body aches. The fever responded to ibuprofen. It is now approx 28 hours after I was vaccinated and my fever and chills have returned along with the body aches. It is hard to tell if this is from the vaccine or if it from an unresolved pneumonia, as these are symptoms I had with the pneumonia and strep infection.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild
I tested positive in July . Many of the same symptoms.  Achy , headache,tiredness metallic taste low energy general malaise. No temperature but slight increase in heart rate. I seem slightly improve on the the second morning after but no appetite and no energy.
nausea, vomiting, sob; pnuemonia and COVID; cough and congestion x 2days. on non-rebreather and O2; Acute respiratory failure; encephalopathy
Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: leg pain-Mild, Additional Details: pt complained of fatigue, hives over upper half of body starting the day after vaccination and leg/thigh pain starting two days after vaccination
She reports on 15 February she reports she was in her usual state of health and received Anthrax (dose 6), Typhoid (ViCPs dose 1), and Japanese Encephalitis (dose 1). The following day she noted onset of fever/chills, malaise, myalgia's, nausea, and chest pain. She presented to the ER where she was noted to have fever (102.5 F) and treated with TYLENOL. Her symptoms lasted for two days and then resolved. She denies URI symptoms, cough, and sore throat. She denies rash and local swelling, redness, or pain at vaccination site. She denies sick contacts. She denies prior adverse vaccine reactions.
This spontaneous report as received from a certified medical assistant refers to a 2 month old patient of unspecified gender. On 04-SEP-2014, the patient was vaccinated with a pediatric dose of VAQTA, 0.5 ml, intramuscular (lot # and expiration date were not provided). On 04-SEP-2014, the 2 month old patient accidentally received pediatric VAQTA dose. No adverse effects were noted. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information is not expected.
0.7?F temp increase from my baseline. Nausea, lightheadedness for a few hours.
to ER c/o inc weakness both legs, unable to walk, difficulty w/coordination of arms & difficulties talking or swallowing; 2 days p/vax: URI, rx'd w/Trimox, Keflex, Antivert, & Humibid; dx: GBS w/C. Fisher variant; required therapy, d/c16OCT
Injection site of arm swelled to 2xs its size, intense hot flashes at least 3 times an hour for 24 hours,  headache for 24 hours, sore throat for 5 days,  extreme tiredness (ongoing),  and thyroid swelled up for 4 days.
This spontaneous report as received from a nurse and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (route, lot #, expiration date and dosage number were not reported), for prophylaxis. Nevertheless, no adverse effects were noted. (1)The vaccines experienced the following temperature excursions during 6 hours of more than 8 degree celsius (C) but less than 25 degree C. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009844: US-009507513-1703USA001137: US-009507513-1703USA001138: US-009507513-1703USA001135: US-009507513-1703USA001136:
Swollen and red at injection site the size of a baseball. Still continuing after 4 days. Now the pain is in her armpit and pain is worse.
Day after second vaccine, Had pretty bad nausea.  Couldn't eat, had no appetite and extremely fatigued.  I gave it time to see if it would go away and it has not.  It has been 10 days since my vaccine and the nausea has been moderate everyday.  I have to force myself to eat and I feel sick all the time.
The patient's son states his father had a fever of 102.6 for three days. The sickness began the day after the Flu injection. His blood sugar was 71, severe trembling, and very soar in the rib cage area.
Seizure--had tonic-clonic jerking lasting about 2 minutes about an hour and a half after flu vaccine
Massive inflammation,  Inc in wbc with multiple. Joint pain 2021 Neg for auto immune disease per lab work up Intermittent episodes/exacerbation  joint pain and inflammation 21-22 New onset left bundle branch block ( NO  history of heart disease) Dx routine ekg 4/26/22 SOB with exertion
Pfizer COVID-19 Pediatric Vaccine 0.2 mL dose (5-11 years old) was given to 14 year old patient.
Immediately upon receiving vaccine, pt became unconscious for about 5 seconds. Then responded verbally to nurse. Then student exhibited upper extremity tremors, lasting about 3 seconds. Then able to respond verbally to this nurse. Skin very warm and moist to touch. P 80 R 40 became more following tests. BP 50/40, P 37/9:05; BP 105/80 P 54/9:20; BP 110/84 P 70. Student picked up by mother who stated she would be taking him to doctor's office for evaluation. School nurse stated that student appeared to have recovered well from incident when sent home with mother.
Felt diaphoretic, looked pale and not feeling well after immunization.  Placed on a litter. Vital signs WNL.  After laying down and observed for 30 minutes total, felt better and okay to be released.
Source of report and patient demography: This spontaneous case was initially received on 11-May-2016. The case report was received from a Non Health Professional and concerns female patient. Linked case: US-BEH-2016062651 (same reporter). Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Influenza vaccine (brand and batch number unknown) on an unknown date. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, the patient experienced dizziness which comes and goes in the same week she had her vaccine. The outcome was not reported. Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the event Dizziness is a unlisted event of Influenza vaccine. Case Causality: Possible.
Dad reported today that at last vaccines pt had fever 103 x 24 hours, both legs swollen with red x 24 hours.
15 YEAR OLD FEMALE WAS ADMINISTERED THE PEDIACTRIC  DOSE OF PFIZER COVID. SHE SHOULD HAVE BEEN ADMINISTERED THE ADULT DOSE
Child is having sleep disturbances and now wakes up crying/screaming several times a night (approx every 2-3 hours). The first few days appeared to be teething pain and she was clingy/sensative during the day. She has now been her normal self during the day for about a week but continues to wake multiple times a night. Her sleep cycle is 1-3 hours longer than normal as a result of the nighttime disturbances.
Bloating, flatulence, stomach cramping, diarrhea - unresolved.
pt recvd vax & devel achiness, fever, vomiting, fatigue;
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concurrent medical conditions included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19). In 2021, COVID-19 (COVID-19) had resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The Humira was reported as HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB),  The treatment medication was not provided.  CC: This spontaneous case concerns a 69-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 28 days apart. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with unknown event's onset date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 69-year-old, female patient with a concurrent condition of rheumatoid arthritis treated with adalimumab, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine. Patient received a 2-dose primary series of mRNA-1273 vaccine at 28 days apart. Exact onset latency of the event COVID-19 relative to vaccination cannot be determined with unknown event's onset date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying rheumatoid arthritis and treatment with adalimumab could predispose the patient to various infectious diseases. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.
For 24 hours: extreme fatigue, nausea, moderate joint pain, overall flu-like aches, slight chest pain for a brief time, moderate headache. For 1st 12 hours: fever 103° For 2nd 12 hours: fever 101° All symptoms disappeared once fever went away.
-Right closed, same side as vaccine -Right side of neck distended and stiffness, same side as vaccine  Symptoms relieved within 12hours  Patients physician consulted, recommended if family felt uncomfortable receiving 2nd dose, avoid
Local reaction from injection site (redness, swelling and tenderness) for 5 days.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and fatigue (feeling tired) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. Concurrent medical conditions included type 2 diabetes mellitus and neuropathy. On May 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 7, 2021, patient experienced pain in extremity (sore arm) and fatigue (feeling tired). At the time of the report, pain in extremity (sore arm) and fatigue (feeling tired): resolving. Other concomitant medications included medication for type 2 diabetes and neuropathy. Treatment information not provided. Action taken with mRNA-1273 in response to the events not applicable. Reporter did not allow further contact.
The first dose gave me a lot of headache, nausea, tiredness, eye pain, body aches, pain in the injection area, a large, hard, itchy red welt, and vertigo. On the second day of the application they say that it has nothing to do but yes, because I did not bring any of that, 2nd dose that was on June 3, 2021 at the time I started with a headache, body, eyes, nausea, tiredness, sleepiness, temperature. On day 4 I was already there that I could not even breathe from the pain so strong that the 800 ibuprofen only calmed the pain for 3 hours and did not take it away completely, that same day I sent a message to my doc where they told me I had to go to the emergency room to help me, but I had no one to take me. By afternoon I could no longer bear the pain in my body, head, eyes, neck, armpits, and I had some bruises. Today the 6th I still have pain, head, body, neck.
had a mild case of myocarditis after her 2nd dose of PBCV; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Lot number: EW0150) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose:1, Lot: EN6207, Manufacturer Unknown), administration date: 24Mar2021, when the patient was 72 years old, for COVID-19 Immunization. The following information was reported: MYOCARDITIS (medically significant) with onset Apr2021, outcome "recovered" (2021), described as "had a mild case of myocarditis after her 2nd dose of PBCV".  Clinical course: She stated she had a mild case of myocarditis after her 2nd dose of PBCV and was asking how it will effect her eligibility for a booster dose. It was advice to go ahead and get the booster dose because they know how to treat the myocarditis.  No follow-up attempts are possible. No further information is expected.
At 9:59AM (9 minutes after vaccination) I suddenly felt dizzy and like I was going to pass out.  My body was tingling from head to toe.  My chest felt heavy but I think that may have been slight anxiety because it was a scary feeling and I did not want to be the person who needed EMS assistance.  I rolled down my window, took off my mask and took deep breaths of fresh air.  I slowly started to feel better.  At 30 minutes I felt much better and after an hour I was back to my normal self.
atrial fibrillation; First dose taken on 30Jan2021 and second dose taken on 22Feb2021; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007MC08) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoporosis.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 30Jan2021 and second dose taken on 22Feb2021). In March 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 30Jan2021 and second dose taken on 22Feb2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient was wearing a heart monitor.  Company comment- This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred a few weeks after vaccination of a second dose of mRNA-1273. The interval between the first and second dose is 23 days, hence Inappropriate schedule of product administration was also captured as an event. The patient reported that she is currently taking Eliquis (Apixaban) and has a heart monitor. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-647013.; Sender's Comments: This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) AESI Atrial fibrillation, which occurred a few weeks after vaccination of a second dose of mRNA-1273. The interval between the first and second dose is 23 days, hence Inappropriate schedule of product administration was also captured as an event. The patient reported that she is currently taking Eliquis (Apixaban) and has a heart monitor. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sore throat  Dizzy  Swollen AXILLARY Lymphnodes (W/ pain)  Pain with movement  Muscle soreness  Muscle cramps
Pt began having sharp, burning epigastric pain and RLQ pain the night of 10/21 and worsening on 10/22. Pt seen 10/22 at a health care facility for evaluation and referred to a second Hospital ER for further evaluation. CT abd/pelvis "most consistent with mild early acute appendicitis" and pt was admitted to hospital. Pt had laparoscopic appendectomy performed 10/23 by Dr.
Information has been received from a registered nurse concerning a 4 month old patient who on 17-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 along with a dose of PREVNAR due to an office error. Additional information had been requested.
Patient fully vaccinated. Diagnosed and hospitalized with COVID 19 from 8/17-8/24/2021
Pt states she began having fever, chills, sore throat, body aches and earaches on 6/10/14. Was seen by PCP and given antibiotic but s/s persist to present. States has been somewhat improved. But still feels fatigue. No longer has fever.
Patient experienced warmth/swelling at injection site (approx. 3 inches in diameter) and the area became hard and sore for about 5 days.
Within an hour, I was experiencing a very high-pitched ringing/buzzing in my head; and pressure behind my eyes and back of head. It's been over 2 weeks, and the noise still keeps me up at night, hard to sleep, anxiety and frustration.