chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented for second dose of the vaccine passed 42 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient presented for second dose of the vaccine passed 42 days.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient presented for second dose of the vaccine passed 42 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient presented for second dose of the vaccine passed 42 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
p/ pt recv vax, same day devel 1.5'' red, round, hot & swollen area at the inject site lasting 5 days
After 2 weeks the area where I got my shot is hot raised swollen red and 4 inches in diameter.  No pain. This wasn?t like this when I got my shot. I did have swelling and in pain for 4-5 days.  This is way different and getting bigger each day and itchy.
99.8 fever; Chills after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after booster dose) and PYREXIA (99.8 fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced CHILLS (Chills after booster dose). On 11-Nov-2021, the patient experienced PYREXIA (99.8 fever). At the time of the report, CHILLS (Chills after booster dose) and PYREXIA (99.8 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Body temperature: 99.8 (High) High.         no concomitants were reported. no treatment medications was provided   This case was linked to MOD-2021-384037 (Patient Link).
Patient calling to report that she noted in the shower this morning that her left breast was twice the size of the right breast. Her left arm pit is tender to the touch. Her left breast is not red or hot and is not painful to the touch.
On 04/10/21, 10 days after vaccination, was suddenly struck with extreme vertigo, never experienced before.  Lasted for two days. Reported to PCP.  They prescribed Meclizine.
Constipation; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) and FATIGUE (Fatigue) in a 24-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 Crohn's disease and Plaque psoriasis.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2021, received third 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) Citrate free (1 in 1 wk). In 2021, the patient experienced CONSTIPATION (Constipation) and FATIGUE (Fatigue). At the time of the report, CONSTIPATION (Constipation) had not resolved and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported No treatment medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Pt has a reaction to the vaccine. Pt had a welt that measured 1 in by 0.5 in.
vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator; No adverse event; Dose administered after manufacturer date of expiry to  patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient) and PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator).    No concomitant medication were reported.   Number of doses/vials: 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022. It was explained that vaccines were removed from the freezer on date of appointments to be used, and the unused portion was put back in refrigerator. The vial did not undergo any temperature excursions No treatment information was provided by the reporter.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse practitioner reported that, on unspecified dates, 25 patients were inadvertently administered ROTATEQ, orally (lot numbers and doses not provided), and another two vaccines, that had been improperly stored. No adverse effects were reported. This case is linked to cases MARRS # 1408USA001066 and MARRS # 1408USA001207 (same reporter link). Additional information is not expected because there was no consent to follow-up.
Dizziness, NauseaVomiting FATIGUE; SORE ARM Narrative:
Shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient got up and went to the bathroom and used to bathroom and when came back to lay down, patient had shortness of breath from the shot. Patient got shot on Thursday, maybe Wednesday(in Feb2021) something around it. Outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
cannot sleep since getting vaccine; can' walk straight; Feel so weak and pathetic; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep since getting vaccine), GAIT DISTURBANCE (can' walk straight) and FATIGUE (Feel so weak and pathetic) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INSOMNIA (cannot sleep since getting vaccine), GAIT DISTURBANCE (can' walk straight) and FATIGUE (Feel so weak and pathetic). At the time of the report, INSOMNIA (cannot sleep since getting vaccine), GAIT DISTURBANCE (can' walk straight) and FATIGUE (Feel so weak and pathetic) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetic medication.  No treatment medication was reported
Hypersensitivity; hives that spread to my legs and arms like welts; itching; horrible rash all overy my trunk; bit of soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY, URTICARIA, PRURITUS, RASH, and VACCINATION SITE PAIN in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Hypercholesterolemia since 2012, Meningioma since 2018, GERD, Migraine, and Drug allergy (Niacin (hives or rash all over)). Concomitant products included PANTOPRAZOLE for GERD, SIMVASTATIN for Hypercholesterolemia, TOPIRAMATE, and COQ10 for Migraine, VITAMINS, and RIZATRIPTAN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN. On 12-Apr-2021, the patient experienced RASH. On 13-Apr-2021, the patient experienced URTICARIA and PRURITUS. On an unknown date, the patient experienced HYPERSENSITIVITY. The patient was treated with BENADRYL for Hives and Rash, at a dose of 2 dosage form and CORTISONE (topical) for Hives and Rash, at a dose of UNK. At the time of the report, HYPERSENSITIVITY and VACCINATION SITE PAIN outcome was unknown and URTICARIA, PRURITUS, and RASH had resolved.            This case was linked to US-MODERNATX, INC MOD-2021-075061.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: ADR Form was received and medical history, patient demographics and concomitant product details were updated. Sender's Comments:  US-MODERNATX, INC-MOD-2021-075061: 1st dose.
Chest pain/burning for 14 hours following injection. Ongoing for a year and half now but usually just last a few hours or less but with my current episode it has now been 2 full days with chest pain and arrhythmia.
Information has been received from a consumer concerning her daughter, a 25 year old who in approximately March 2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  The consumer reported that her daughter developed paralysis on her right arm, has limited mobility and is in constant pain after getting the first dose of GARDASIL.  MRI and physical therapy were performed, however results were not provided.  The patient's paralysis on her right arm, limited mobility and constant pain persisted.  The patient sought medical attention.  Upon internal review, paralysis on her right arm was determined to be an other important medical event.  No further information is available.
Patient received her 3rd dose of TwinRix, just 1 month after her 2nd dose given 5-8-2023
Diarrhea, left shoulder sore, bodyaches, chills, malaise, nightsweats Narrative:
14OCT AM h/a, lethargy, muscle ache, chills, fever sx, arm warm, underneath armpit area, chest tightness;
It was reported that a 24-year-old female patient was administered a TD Adult vaccination on 2/12/02 in the left deltoid. ON 2/15/02 she returned to the office with a a warm swollen, red and tender left deltoid. Doctor put her on Keflex BID x 10 days, which resolved the reaction. RN, stated "it looked like cellulitis."
67 y.o. male with history of CLL (in remission, on observation), Type 2 DM, HLD, and OSA who presents with generalized weakness in setting of known COVID pneumonia.  Patient became symptomatic around the holiday time with mild upper respiratory symptoms and fatigue.  His symptoms were generally progressive, and when a family member tested positive for COVID, he decided to get tested as well.  This was positive on 1/4/22.  Received 5 day course of molnupiravir as outpatient shortly thereafter.  He subsequently went on to develop cough, fevers, chills, mild nausea without vomiting, nonbloody diarrhea.  Symptoms have generally waxed and waned, but weakness, fatigue, and low appetite have all significantly  worsened.  He has been seen in the ED multiple times.  Has never required oxygen or had any serious complications requiring hospitalization.  More recently, has seemed more short of breath with activity.  Today, he was barely able to move without assistance, and was therefore brought to the ED for evaluation.  There, he was mildly hypoxic requiring 1 liter/minute of O2 by nasal cannula, but vitals were otherwise stable.  Labs were significant for Na 131, creatinine 0.8, CRP 10.9, negative procalcitonin and D-dimer, lactate 1.2, WBC 1.3.  Chest x-ray revealed worsening bilateral opacities.  He received dexamethasone and has been admitted to the medicine team for further care.
nose bleeds; headache; dizziness; tingly; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine, Lot number: unknown) via an unspecified route of administration on 18Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and penicillin allergy. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), all from unknown dates and unknown indications. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021, the patient experienced nose bleeds, headache, dizziness and tingly. The adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the reported events. The clinical outcome of the events nose bleeds, headache, dizziness and tingly was unknown at the time of this report.   Information on lot/batch number has been requested.
Pt. expired 3 days after ck-up.  Parents reportedly found child dead in bed.  6/20/08 Autopsy states COD as SIDS.  Report states pathological diagnosis as patent foramen ovale; lungs w/congestion & atelectasis; small bowel IS; GERD.  Found unresponsive in bassinet after being placed prone approx 5 hrs earlier.  CPR initiated  1/4/08 Reviewed pcp medical records & vax records which confirms vax as reported.  Records indicate patient in good health on day of vax, only concern was constipation & formula changed.
pt states he has a sore arm, shakes, chills, fatigue, nausea, vomiting and general feeling of being unwell.  He said he has abdominal swelling and felt like his body has swollen up like a balloon but couldn't release the pressure.  Pt states these symptoms lasted about 12-18 hours.  He says he is still tired and still has some pressure in his belly but is feeling better.  He has to take dialysis today and will discuss these symptoms w/ them.
Received flu immunization on 09/25/2009. She claims she did not have any swelling, reddness or pain at injection site at time injection given. Describes a continuation of sharp, stabbing pain which radiates down left arm directly below initial injection site. Client did see her MD 2 weeks after receiving flu immunization.  She says her MD felt it might be possible inflammation of nerve near injection site.  Client has treated condition with occasional Extra Strength Tylenol a "few times" with no significant relief.  Heat and cold packs have not been effective. She has appt with MD again in 1 week and will follow up with writer regarding suggestions and treatment recommendations.
He was noted to have had a change in his mental status as per nursing home staff.  Over the night his saturation dropped to 61% on room air because the patient took off his oxygen bed saturation came back to 90s after oxygen was replaced.  He does have occasional cough.  He has developed worsening swelling in his legs and has gained 20 lb since February 14th. Was placed on dexamethasone, azithromycin, cefepime and vancomycin due to immunocompromised state and chest xray showing pneumonia. Also received remdesivir. Resolved and discharged on 3/26/21. Came back on 4/27/21  for 8 days due to acute hypoxic respiratory failure and found to have CHF exacerbation. Was put on Hospice. Died 6/3/2021
Mild but persistent fever alleviated by Advil.  Chest "soreness" started 2 days in, pounding heart and cold sweats and arm pangs went in and out over the next two days. Only comfortable with chest vertical. Symptoms abruptly vanished after 2 nights of this.
Yellow fever vaccine was reconstituted using the incorrect diluent (sterile water) and administered to patient. Sanofi Pasteur (manufacturer) was consulted and notified.
8/16/08 (Sat) - Mother called & spoke with on call manager & reported that child's R arm was swollen & hard, there is an area size of an egg that is swollen, it is warm to the touch & in the middle is an area that is black & blue & yellow (this is all per mother).  Mom reported these symptoms started on 8/15/08 (child received vaccines 8/14/08).  Referred child to family doctor or E.D.  8/16/08 mother reports child developed "blisters" on R arm.
diagnosed with ITP; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN1185), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient relays he had COVID vaccine in March, then subsequently was diagnosed with ITP on Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Fever-t-103, facial swelling, tongue tingling. Started 1/16/21- next day after vaccination, treated with Benadryl. Seen in ER- given prednisone.
sore arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unidentified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that patients get a sore arm following a dose of Shingrix. The reporter did not agree to follow up. The case has been linked to US2022AMR016132,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR016132:Same reporter
FEVER AND CRYING UNCONTROLLABLY AND WALKING WITH A LIMP. WITHIN AN HOUR (ABOUT 9PM) WOULD NOT WALK AT ALL AND OR MOVE HIS LEG.  HAS BEEN A FEW DAYS AND IS STILL NOT WALKING WITH A LIMP AND GETTING FEVERS. HAVING TO ALTERNATE WITH MOTRIN AND TYLENOL TO KEEP FEVER DOWN AND PAIN AWAY SO THAT HE CAN FEEL COMFORTABLE, BUT STILL CRIES AND COMPLAINS FOR LEG PAIN WITH A LIMP.
Nurse administering vaccine states that when reconciling the last flu shot received in the EMR she read it as 10/30/2021. The actual last flu vaccine administered was 11/21/2022. The nurse did not realize her error until after administration. The nurse contacted the manager at the inpatient facility to advise of the error. The manager advises he will communicate this to the patient and parent.
Patient describes having pain behind her right eye and blindness.  She says she had a stroke behind her eye and that it took a long time to get anyone to see her. She is receiving shots in her eye. She thinks it is related to the vaccine. Her doctor whom she sees for the shots says it was a coincidence.
I feel dizzy and confuse for few minutes but after I went home I was ok.  However  two weeks  after the first shot   I woke up  at 2:oo in the morning with the noise in my head. I thought I was going to get a struck and I was no able to sleep after that. I have to wait for the weekend to be over. I make an appointment with the doctor and I get referrals to a cardiologist and a ENT.  I got US of my carotid artery both sides with normal results. I had a hearing test and they said I has lost of hearing but in my daily life I have not experience problem with my hearing. The ENT sent me for an MRI of the brain and inner ear but came out normal. Since April 14, 2021 I can not sleep at night because of the ringing in my ear.  I spoke with others with this problem after the vaccine and I check on line and learn about others with similar effects and for that reason I am sending this report.
Per staff member, HCP, that attended to patient in observation area: " post covid vaccine note.  Pt received vaccine at 1120am, 1125 while in chairs pt felt dizzy with left arm and leg numbness.  Pt alert, skin warm and dry.  Placed on stretcher and brought to obs area.  120/77 99% on 2 liters 76 16.  Remains alert, dizziness and left extremity numbness persist along with facial numbness, bilat.  No facial droop, PERL midline grasps equal. 911 called.  124/71 76 16. EMS arrived, assessed pt and decided to trans to hospital.  Pt and  husband agree and understood plan.  Pt anxious at this time but remains alert but unable to raise left leg, speech slightly slurred.  Pt left clinic via ambulance about 1155am with belongings"
Pt recvd 1 dose of Engerix-B & exp inject site pain, tenderness, red blotching & itching; these have been resolved @ the time of this report;