chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen / hardened glands in left collarbone and lower neck area; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 16:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), turmeric (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 10:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 09:00, the patient experienced swollen / hardened glands in left collarbone and lower neck area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen / hardened glands in left collarbone and lower neck area was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Discharge Provider:  DO Primary Care Provider at Discharge:  MD  Admission Date: 4/27/2023 Discharge Date: 04/29/2023  PRESENTING PROBLEM: Hyponatremia   HOSPITAL COURSE: Patient is an 88-year-old female who presented to the emergency department at the direction of the urgent care due to elevated blood pressure.  She had been feeling fatigued with decreased appetite and was found to be positive for COVID-19.  In the emergency department, patient was hypertensive otherwise vital signs were stable.  Lab work was obtained and revealed sodium of 126. She was admitted to the Internal Medicine Service.  Urine study suggestive of SIADH.  Patient had recently had her Prozac increased so this was decreased back to original dose for potential cause of hyponatremia.  She was fluid restricted and started on salt tabs.  Her hyponatremia did resolve during her hospital stay.  Salt tabs were discontinued.  She was recommended to continue a fluid restriction at discharge.  She was recommended to have repeat BMP in 5-7 days.  Her blood pressure improved with taking her home medications.  She was recommended follow up to primary care physician.  She was discharged home in stable condition.
Patient experiencing tenderness in left armpit and left side of neck with slight swelling. No treatment sought at time of reporting.
I had continuous chills, unsteady legs , and general fatigue. I felt feverish on and off throughout the day, with much sweating  I spent the entire day and night of June 9th in bed, sleeping most of those hours.  I had no adverse effects with the first shot in this series
after 20 minutes of the tennis lesson in the afternoon, she felt fast heart beat, light headiness and can't catch her breath. she paused the lesson, sit aside and took few sips of water and rested for about 5 minutes, then resumed the tennis lesson.
this is all per family, 4 to 5 days after 2nd COVID vaccine he was acting unusual and was taken to the hospital. He had a clot in his brain and underwent brain surgery. He experienced seizures after the surgery, but it was ultimately reported the surgery went well. He remained intubated and on a ventilator after surgery. He developed complications of his lungs and kidneys while on the ventilator. Ventilator was removed 3/16/2021 and he passed away that day. The hospital providers thought the clot in the brain may have been from hitting his head over a month ago. From my understanding he was A&O, independent with ADLs, and lived in his private residence prior to these complications.
Soreness; Swelling; Redness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, swelling and erythema. On an unknown date, the outcome of the pain in arm, swelling and erythema were recovered/resolved.   It was unknown if the reporter considered the pain in arm, swelling and erythema to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. 2 months ago from the reporting date, the patient received Shingrix on left arm. The patient experienced sore arm, swelling and redness from monday until thursday. The reporter did not consent to follow-up. The caller did not want correspondence sent to her PCP above but only to herself, if necessary. Both doses received at by a nurse. For tolerance to 2nd dose, refer linked case US2019AMR154371.
Information has been received from a nurse concerning a "less than 10 year old" female patient who on an unspecified date was vaccinated with MMR (Oka/Merck). Subsequently, the patient developed autism and was diagnosed with PDD. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Upon internal review autism was considered an other important medical event. No further information was provided.
Patient developed nausea, vomiting, stomach ache, dizziness 1 or 2 hours after vaccinated. Patient reports vomiting 8 to 12 times daily for 3 days and lessening in dizziness. Patient was advised to contact her doctor or go to local health center and push fluids.
pt recv vax 6SEP95 & pt devel a mild case of chicken pox on 27JAN97;supportive care given;
This vaccine was provided to this patient as a second dose to a Moderna vaccine given at a different vaccination site and while he was still 17 years old.  Moderna COVID-19 vaccines are only authorized for use  in individuals 18 years and older.  I did speak with the patient today - almost 10 months after vaccination.  He states he is well and only felt mildly feverish the day after the vaccination.  He recovered fully and has not had any issues since.
I20.8 STABLE ANGINA 4/10/2023 STABLE ANGINA
The patient received her second Moderna inoculation January 20, 2021 at 8 a.m.  At around 7:30 p.m., she had a sudden onset of myalgias and chills.  Within 30 minutes, she had a fever at 99.9° F.  She went to bed without taking acetaminophen or NSAIDs based on new CDC recommendations of how to treat symptoms due to the COVID-19 vaccine.  The patient hydrated and went to bed around 9 p.m.  By 11 p.m., the patient?s fever was 100.4° F., accompanied by intense myalgias, chills and a migraine headache.  She woke again at 1 a.m. with a fever of 101° F.  At 2 a.m., she woke with right-sided pleuritic chest pain (severe pain with inspiration, some pain with expiration and no pain with holding of the breath), with her fever persisting at 101° F. And tachycardia to 109.   By 7:30 a.m., her fever dropped to 100.4° F. But still tachycardia at 101.   At this time, she took ubrogepant 50 mg, with resolution of her headache within about 30 minutes.  Because she had rhinorrhea at this time, she decided to get tested for COVID-19 that day.
Soreness in arm of injection, extremely swollen and sore lymph node under right arm, body aches, extreme fatigue
Right side of face numb from center of mouth to top of cheek near eye.  Pins and needles when touched.  No drooping or loss of function. Evaluated by PCP.   Advised most likely from vaccine.  Improveing by end of day.  Advised to contact PCP if full recovery is not achieved .
Patient felt pain immediately after injection radiating toward elbow.  He has developed a knot at the injection site.  He had soreness moving the arm and sleeping on that side for several months afterwards, but only has mild soreness now.
Myalgia, Diarrhea,  chills, Arm pain, could not raise it Narrative: Stayed home from work due to symptoms
From telephone correspondence received at manufacturer on 11/05/02, it was reported that a 42 year old female received Fluzone SV 2002-2003 USP (Lot # U0882AA) on 10/29/02.  The pt reported to employee health nurse on 10/31/02 that she developed sores in her mouth, which resolved in less than 24 hours after self-treatment with Listerine mouthwash. She was not evaluated by a physician when these sore erupted; therefore the cause is unknown per reporter. This case is closed.
Muscle twitching at injection site, "welt" at injection site, nausea, headache, dizziness.
Patient was given a flu shot meant for 3 years or older, patient is 2 years old. Patient is feeling fine, no adverse reaction noted.
Reports got Pneumonia vaccine and developed Lump and redness yesterday at site. Woke up in the AM with entire left upper arm to elbow with redness, warmth, and Swelling.
This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX lot # M024680 18-MAY-2018, M025870 24-MAY-2018. There was no previous temperature excursion. Temperature of 10F for 3 hours, 6F for 2 hours, 6.6F for 20 minutes. The vaccine was administered. Additional information has been requested.
Shoulder pain at time of administration of vacc. Pain persisted & now involves both shoulders & now hips.
History of Present Illness:  Patient is a 18 y.o. male with no pertinent past medical history who presents to the ED with complaints of chest pain.     The patient notes that he started noticing chest pain this AM after he woke up that is associated with nausea.  The pain is described to be in the center of his chest and is persistent.  EMS was called who administered 2 SL NTG and 1 dose of ASA 325 mg.     He notes that he received his 2nd Moderna vaccine on Thursday April 15th.  He is currently a senior in High school.  He had no adverse reactions to his 1st dose of the Moderna vaccine but after the 2nd dose he notes that he was having fever, malaise, body aches, and decreased appetite.  He also tells me that he has been so fatigued that he has not really gotten out of bed in the last 48 hours.  In regards to his oral intake he had (1) 16.9 oz bottle of water yesterday and nothing else but did have a glass of orange juice and some cereal this morning.   During my evaluation with the patient he notes that he is still having chest pain that he reports to be retrosternal any 5/10 in severity.  He denies any radiation into the left arm or jaw.  He feels the pain is worse with movement and better when he is resting.  He has had associated nausea and shortness of breath.  He has been having low-grade fevers at home but denies any coughing, abdominal pain, diarrhea, dysuria, burning or itching with urination, congestion, rhinorrhea.   He denies any tobacco use, drug use, alcohol use.   In the emergency department initial workup is notable for potassium 3.6, magnesium 1.7, phosphorus less than 1, troponin 7206 with repeat at 10,212.  CPK noted to be 380.  Initial EKG was nonischemic.  COVID swab was noted to be negative.     After I evaluated the patient around 1520 an RRT was called due to hypotension and bradycardia.  His blood pressure had dropped to 80/40 and heart rate was in the low 50s and he was symptomatic with diaphoresis and feeling as if he was going to pass out.  1L fluid was given running wide open.  Repeat EKG did show some diffuse ST segment elevations concerning for pericarditis.  Cardiology and ICU team were notified and evaluated the patient.  Response is likely that the be vasovagal from acute pain.     History obtained from:  ? patient                    ? outpatient clinicians  ? family                                  ? staff at facility  ? other                                   ? review of medical record as summarized below   Pt unable to provide reliable history because: ? Acute mental status change ? Acute illness/medical condition ? chronic dementia/mental challenges ? poor insight ? other  ____
Patient described site of injection formed a bump that moved down to the back of the elbow. The area became warm, red, and warm to the touch.
Patient received a flu vaccine on 10/13/16 and presented to the pharmacy on 10/31/16 complaining of not being able to raise her arm at the shoulder. Patient will visit her PCP.
Hallucinations beginning after first dose in February, patient did not report symptoms to doctor until some weeks after second dose when they became more severe and was.noticed by family members.  Doctor requested MRI test.  No treatment has been given yet.
Case developed uticaria and ? SOB.  Treated at Urgent Care and released after 2 hours.
The guy that injected me did it very high on my right shoulder I immediately felt a sharp intense pain that strangely went from my shoulder to the top of my hand.  I left went home did nothing then by 5pm or so I now cannot move my right arm it?s literally like it?s locked up I feel it in the right side of my neck!! I was sitting in a low chair and he was tall did he screw up my arm ? I?m feeling like I should go to the urgent care center if it gets worse I?m going to have to. My main concern is did  he did inject it in the wrong spot and what did he do to my arm?
pt presented to ED with c/o fever, headache, myalgias, SOB, cough x 3 days; O2 requirement of 3 L via NC; treated with Decadron, Remdesivir, toclizumab, Lovenox; pt's condition worsened and required intubation; despite maximum ventilator support, O2 sats were in the 70s; pt went into cardiac arrest and died in the hospital
This spontaneous report was received from a office manager (also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of MMR II, (lot number, expiry date was not reported which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient states he received a COVID vaccine injection December 27, 2022 and experienced left eye lid droop, with intermittent diplopia and axillary lymph node enlargement the following day. Patient went to an optometrist on Dec 29 and was instructed to go to the Emergency Department. Patient presented to the ED on Jan 1, 2023.  -Brain MRI and MRA negative for acute process -esr, crp, tsh, ana wnl -rapid meningitis panel neg -f/u musk ab and AchR ab/MG panel -LP today, showed increased protein, otherwise unremarkable -mri of orbits negative  Patient subsequently evaluated by Neurologist and Ophthalmologist and diagnosed with post Covid 19 vaccination vasculitic syndrome. Patient treated with IV methylprednisolone 1g IVPB  followed by oral methylprednisolone (Medrol Dosepak) as an outpatient. Patient discharged on Jan 3, 2023.
Generalized rash with palpable purira, no urticaria, pain, necrosis, oral mucosal involvement, or swelling. Rash progressing from arm to rest of body. TX: Prednisone 40 mg po, will recheck in clinic 08/11/2005. Rechecked 08/11 and 08/12 rash resolved.
Patients were given a possible counterfeit; A spontaneous report was received from a consumer concerning fifty or sixty people, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was noticied that the patients were given a possible counterfeit / counterfeit product administered.  The patient's medical history, were not provided. Concomitant medications were not reported.   On 29-Jan-2021, approximately fifty or sixty patients received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) for prophylaxis of COVID-19 infection. It was noticed that the patients were given a possible counterfeit and was considered as a medication error. The route of administration were unknown.   The reporter states that the patients have recieved the first of two planned doses of mRNA-1273 vaccine on 29-Jan-2021 and the second dose has been scheduled while the site suspiciously was not answering and deleted all information about the advertising and everything regarding the vaccination.  The repoter was concerned to get a list of approved places that have the moderna covid-19 vaccine. Upon follow up the reporter added additional information of two patients among the group. The patient details were hidden while the lot number was reported as 012M20A.  Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was considered not applicable.  The outcome of event, counterfeit product administration, were considered resolved.; Reporter's Comments: This report refers to a case of counterfeit production administered for mRNA-1273, lot #012M20A with no associated AEs.
This spontaneous report was received from a physician assistant, and refers to a 5 year old patient of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 07-AUG-2009, the patient was vaccinated with the first dose of GARDASIL, second dose on 15-AUG-2011 and third dose on 23-JUL-2012 for prophylaxis (route of administration, lot number and expiration date were not reported). No adverse effects were reported.
I had a headache with congestion and fatigue. It was treated with Tylenol. I was tested in the facility due to a COVID-19 Outbreak on December 05, 2022. I was told to continue taking Tylenol. I still have headache and fatigue currently. They are also giving me Lovenax Injections also. I have not recovered from the symptoms yet
HCP called to report t/e on VARIVAX, administered. T/E case: 02431749. No additional AE/No PQC.   Vaccine: VARIVAX Temperature:  -3.6c Time frame: 0hours 6minutes 0seconds Lot(s) & expiration date: w016746 exp 05/23/2024 No previous Excursion; No additional AE/No PQC.; This spontaneous report as received from a physician refers to a patient of unknown age and gender.     No information was provided regarding the patient´s medical history, concurrent condition, drug and allergy history or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W016746, expiration date 23-MAY-2024). It was reported that the vaccine was stored during 6 minutes under a temperature of  -3.6 °C (product storage error). Not adverse event was reported.
muscular soreness; deep soreness; no swelling-hard to lift arm-took APAP w/no relief; told to call MD try heat & APAP again;
Redness/erythema; fever blister; Pain in arm; Malaise; Injection site pain; chills; Fever; Blisters; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (fever blister), BLISTER (Blisters), ERYTHEMA (Redness/erythema), PAIN IN EXTREMITY (Pain in arm) and MALAISE (Malaise) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since March 2010, High cholesterol since 2015 and Shingles in 2017. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE), PRAVASTATIN and EZETIMIBE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-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 BLISTER (Blisters). 12-Mar-2021, the patient experienced PYREXIA (Fever). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). 02-Apr-2021, the patient experienced MALAISE (Malaise) and CHILLS (chills). 02-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 05-Apr-2021, the patient experienced ORAL HERPES (fever blister). On an unknown date, the patient experienced ERYTHEMA (Redness/erythema). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Fever blister, at a dose of 500 mg twice a day. On 04-Apr-2021, PAIN IN EXTREMITY (Pain in arm), MALAISE (Malaise), INJECTION SITE PAIN (Injection site pain), CHILLS (chills) and PYREXIA (Fever) had resolved. At the time of the report, ORAL HERPES (fever blister) had not resolved, BLISTER (Blisters) outcome was unknown and ERYTHEMA (Redness/erythema) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Fever blister on lip developed after each dose of the COVID vaccine, each lasting about 10 days.First fever blister treated with Valtrex 500mg X 2 tablets once. With second dose, treated with Valtrex 500mg X 2 daily for 7 days with little impact on resolving fever blister.   This case was linked to MOD-2021-073494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant Follow up appended for AE Event/Contact update
Rash on thigh, elbow, back, stomach; Dizziness,Feeling Lightheaded; Sweating; Mild Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild Soreness in arm), DIZZINESS (Dizziness,Feeling Lightheaded), HYPERHIDROSIS (Sweating) and RASH (Rash on thigh, elbow, back, stomach) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis (2 weeks prior to shot.), Ehlers-Danlos syndrome, Drug allergy (Allergy to Meperidine), Drug allergy (Allergy to Morphine), Latex allergy, Drug allergy (Allergy to qeutamycine) and Drug allergy (Allergy to Terbinifine).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Mild Soreness in arm). On 16-Jan-2021, the patient experienced DIZZINESS (Dizziness,Feeling Lightheaded) and HYPERHIDROSIS (Sweating). On 23-Jan-2021, the patient experienced RASH (Rash on thigh, elbow, back, stomach). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency; ACRIVASTINE (BENADRYL ALLERGY RELIEF) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at a dose of 0.1 percent. On 13-Jan-2021, PAIN IN EXTREMITY (Mild Soreness in arm) had resolved. On 19-Jan-2021, DIZZINESS (Dizziness,Feeling Lightheaded) and HYPERHIDROSIS (Sweating) had resolved. At the time of the report, RASH (Rash on thigh, elbow, back, stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient temperature was running low& got resolved on 19/Jan/2021.  Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-JUN-2021 and contains no new significant information On 28-Jun-2021: Patient heights and weight updated. Allergies and medical history updated.
Heart Palpitation on Day 2 in the morning, 153/94.  But slows down in the afternoon.  Some chills.  Day 3, completely recovered.
Red itchy swelling spot on day 8. I had a sore arm after the shot (the worst was at 30 hours).