chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left injection site was red and swollen, warm and painful to touch.  Difficult to lift arm.  Redness and swelling increased over the next 4 days and became the front half of the upper arm.  Also started with a temp 100-101 with chills, body aches, sore throat. This lasted 5 days.  Then on day 4 got petechiae like itchy rash on roof of mouth and discoid fluid filled pustules on upper back that were itchy.  Flu swab on 12/15/2012 was negative.  Had received flu shot in fall 2012.  Took Tylenol 1000 mg Q 6-8 hrs with naproxen in between Tylenol doses for fever and body aches.  After rash and itching started also took Benadryl 25 mg that night.
Tongue is tingly; Cheeks feel a little puffy; Arm is mildly sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue is tingly), SWELLING FACE (Cheeks feel a little puffy) and PAIN IN EXTREMITY (Arm is mildly sore) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tongue is tingly), SWELLING FACE (Cheeks feel a little puffy) and PAIN IN EXTREMITY (Arm is mildly sore). At the time of the report, PARAESTHESIA ORAL (Tongue is tingly), SWELLING FACE (Cheeks feel a little puffy) and PAIN IN EXTREMITY (Arm is mildly sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.
I experienced bad chills, whole body felt like I was rolling around in metals, I also had bit of fever and headaches on 02-12-2021. Also on 04-22-2021; my left carotid gland swelled up, went to have oral surgery and on 04-30-2021 went to see ENT specialist. Oral surgery was done as well as a panoram and 3D X-ray was performed. The problem resolved. On 08-02-2021; the metals on the right side of my body continued to increase in discomfort. Lab work was done and it was normal. This lasted about 21 days. As of today, that metal feeling on my right side is still present.
Patient presented to the ED and was subsequently hospitalized for Acute respiratory failure with hypoxia within 6 weeks of receiving COVID vaccination.
Mother reported that pt has 101.5 fevers over the course of the weekend following vaccine administration. Pt himself reported muscle aches and chills.
Myalgia, Fever, LEFT ARM PAIN Narrative:  Other Relevant History:
This case was reported by a nurse and described the occurrence of pain in the lumbar region in a 39 year old pt who received hep A vaccine inactivated (Havrix). The pt past medical history included diabetes type I. Concurrent medications included Insulin for type I diabetes and Inderal and HCTZ for unspecified medical conditions. On 04Feb2005, the pt received an injection of Tetanus and diphtheria toxoids adsorbed (adult formulation) in the left deltoid. On 07Feb05, the pt received the first dose of Havrix (lot VHA802B6) at 1440 EU in the right deltoid. Approx one day after receipt of Havrix, on 08Feb05, the pt experienced left leg pain and lower back pain. The pt resolved on 10Feb05. In the nurse's opinion, the events were unrelated to vaccination with Havrix.
Pain in 2nd toe (from big toe), swelling between 2nd and 3rd toe, all left foot. Took a Tylenol, applied ice-both on 1/17/00.
Patient experienced severe diarrhea, sore arm, achey joints, fatigue, depression, chest and lung pressure, injection site pain, leg pain.  2 to 3 weeks after the vaccine, patient experienced tinnitus and head pressure Patient noticed a blood pressure increase
Sore left arm, tingling in face, fever,, lymph node swelling within 24 hours of vaccine. Swollen tongue with tingling started 2 day after vaccine Benadryl improved but still have tongue swelling
Instead of a 5cc dose was given a 3 cc dose; A spontaneous report was received from a female nurse who received Moderna COVID-19 vaccine (mRNA-1273) and was administered an incomplete dose.    The patient's medical history includes bronchiolitis, asthma and high blood pressure. Concomitant medications included an unspecified inhaler and three different medications for high blood pressure.   On 15-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly in left arm (Lot# 011M209). On that day, instead of 5cc dose, she was given 3cc as the person administering the vaccine was giving Pfizer drug previously. She didn't experience any adverse event following the vaccine administration.    No treatment information was provided.   Action taken with 2nd dose of vaccine is not reported.  The outcome of the event, incomplete dose administered, was considered resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 011M209 with no associated AEs.
Increased confusion on 1/13/21 with delusions. Seen in ER. No fever. CT found mass in amdomen. Upon returnning to personal care home had a seizure. Patient on pain meds.
Information has been received from a licensed visiting nurse (L.V.N.) concerning a 2-month-old female (also reported as 4-months) who on 11-DEC-2007 was vaccinated with a dose of PROQUAD (lot# 657535/0541U) instead of HIB conj-hepatitis B vaccine.  No adverse reaction noted.  Medical attention was sought in the office.  The L.V.N. reported that "they did not administer the vaccine to the patient".  This error was discovered after reviewing the patient's chart.  The L.V.N. could not confirm if this was product confusion.  No product quality complaint was involved.  Additional information has been requested.
Vaccination adverse reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
Pt reported feeling hot and a little light headed, approximately 6 minutes after vaccination.  Pt reported not eating before vaccine, Pt vitals at 1:01 pm were BP : 110/78, HR : 88, Temp. : 98 and oxygen : 99% . Pt was given water and light snack. Last Vitals taken at 1:24 pm BP : 110/72, HR : 80, Temp : 97.7 and oxygen 99%.  All other set of vitals were within normal range> PT reported feeling better and was cleared by Clinical Staff
Facial edema, burning sensations in and feet and legs, feeling of throat closing, legs swelling, intermittent pruritis.
Information has been received from a 65 year old female consumer with MSD allergy and no other past medical history who in November 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. Subsequently, in approximately November 2001, the patient developed swelling in the arm she received the injection in along with a burning sensation that lasted for 3 weeks. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
2nd dose received after 50-52 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received after 50-52 days after 1st dose) 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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received after 50-52 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received after 50-52 days after 1st dose) had resolved. Not Provided          No concomitant medication provided. No treatment information mentioned.   This case was linked to MOD-2021-033525.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29 Jun 2021 included no new information (email address added).
pt recvd vax; devel redness, swelling, tenderness at inject site,lasted x 2 days;
Pregnant patient received expired FluLaval; Expired FluLaval administered; This prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number DB93X, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received FluLaval Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy and expired vaccine used. On an unknown date, the outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown. The pregnancy was ongoing.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2022 Reporter's comments:  The reporter reported that patient who was pregnant and administered an expired dose of FluLaval, not specifying the day.  They referred that the dose was given around November or December and did not provide other details. Vaccine information was disclosed.  The reporter agreed to received follow-up to provide further information on behalf of the safety team.  The reporter did not have any specific information about the patient or vaccine dose. The reporter was consented to follow up. Additional Supportive information: The patient was pregnant and received expired dose of Flulaval, which led to vaccine exposure during pregnancy and expired vaccine used.
4-7-16 mom called and spoke with interpreter. She reports (R) thigh swollen, red and tender to the touch. This began 4-6-16 in the am - unsure what time she noticed it. No fever. Advised TYLENOL or ADVIL per age/wt for discomfort. Cool cloth today to site follow with warm cloth tomorrow to site.
Body ached all over for 2 days after inject. Had 9 x 3.5 inch area of redness, swelling, tenderness, itching and warmth around site of injection x 5 days.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUN-2017 the patient was vaccinated with VARIVAX lot # N001530 with expiration date of 13-JAN-2019, 1 DF for prophylaxis. Concomitant therapies included sterile diluent. On 27-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013067.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # H021941, expiration date 11-JUL-2014 (route and strength not reported). No adverse effect reported. Additional information has been requested.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender started to receive TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stiff neck and felt ill on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
PMR (Polymyalgia Rheumatica) TIA (Transient Ischemic Attack) - mini strokes
36-48hr p/vax hives, itching, scalp, hands swelling, itching on DPH 3-4 days stopped it & sx reappeared;cont to have swollen fingers, also heavy feeling in deltoid when vax given;
resident expired; This is a spontaneous report from a contactable healthcare professional.  An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization.  Medical history included metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia.  Known allergies was none.  The patient took unspecified concomitant medication.  On 11Jan2021, the resident expired.  The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021.  There was no treatment given for the event. The patient died on 11Jan2021.  An autopsy was not performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient.  The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: resident expired
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: shortness of breath not allergy related-Medium
Patient received vaccine greater than 12 hours after being drawn up. No adverse event. MD contacted pt. Pt. chose to be revaccinated.
Given a 12 day expired booster dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given a 12 day expired booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given a 12 day expired booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given a 12 day expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.   Reporter did not allow further contact
muscle pain; severe joint pain in hands and fingers; This is a spontaneous report from a Pfizer-sponsored program Support contactable consumer or other non hcp. A male patient of an unspecified age received a dose of bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced muscle pain (myalgia), severe joint pain in hands and fingers (arthralgia). The clinical outcome of events was unknown.   It was unknown if the reporter was a health care professional. It was unknown if the reporter was the prescribing HCP.  Information about Lot/Batch number has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I felt almost instant pain and pressure in my arm arm as soon as vaccine was administered, which was instantly followed by  dizziness, nausea and lightheadedness that built and built until about two minutes after the vaccine when I passed out. My girlfriend who was next to me caught me before I fell and I was in a chair so was uninjured from passing out, however, I was told by m girlfriend that the store workers were extremely slow to react and do anything to help. When I woke about 30 seconds later I felt much better, however, was still extremely dizzy, lightheaded and nauseous for the rest of the day and it didn?t really go away for the next 3 days at which point I still didn?t feel fully right but we?ll enough to go out. The night after the vaccine I was in agony all over my body and was sweating abnormal amounts throughout the night, these aches and pains also lasted for about 3 days. In short, it was probably the most sick I had felt in as long as I can remember.
My son received the Tdap and Polio vaccine on 11/18/14. Friday 11/21/14 my son was at the babysitters as I was working day shift. Text came to me at 1:24 pm that the babysitter thought he wasn't feeling well, wasn't eating and very cuddly, and that she thought he had a low grade fever. Once I got my son home after work I checked his temperature tympanic and found it to be 102.5. This high temperatures and general malaise lasted from Nov 21st-24th. The highest we let the temp get was 103.7 in the night. We are positive it would have gone higher is not medicated. We gave him infant/child Advil. Eventually the symptoms resolved with no need to go back to the doctor but out son has had a cough and runny nose since it is 12/2/ 2014 today. We are thinking it was due to the Polio vaccine due to the info on the sheet given to us.
Pt received shot with no issues. He proceeded to stand against the wall while his family member took her seat in the vaccination chair.  Approximately 5 minutes passed, during which he was communicating verbally with staff and family member and using his cellphone.  Without warning , he tucked and rolled forward dropping his phone and proceeded to roll onto his back.  He regained consciousness right away. We kept him sitting on the floor asking if he had sustained any injuries (none visible).  He was pale and stated he was hot.  Declined nausea, dizziness, pain, or any other symptoms.  After a few minutes he wanted to move to the chair, which he did carefully under supervision.  We placed a small fan in front of him and provided a cup of water.  He remained verbal and coherent throughout.  He remained sitting for about 10-15 more minutes. Pt stated he was fine then and left with family member.
w/in a wk of vax pt slowly deteriorated & got bronchitis;lungs filled w/fluid & was adm to hosp p/collapsing;pt put in ICU on ventilator & then a respirator;dx pneumonia;pulmonary specialist felt problem not r/t vax;
Information has been received from a nurse practitioner concerning a 26 year old female who on 30-OCT-2007 was vaccinated intramuscularly with her 1st dose of Gardasil (lot # 659435/1265U).  Concomitant therapy included YAZ.  It was reported that the patient experienced pain at the injection site.  The patient's pain at the injection site persisted.  No further information was provided.  Additional information has been requested.
pt recv vax;felt achy & sore all over; no fever; arm TD given sore but not hot to touch; states MD at er gave pain pill & told pt was a vax rxn;
pt recv vax 5NOV98  c/o fever of 103 no relief from APAP diarrhea, emesis, achy muscles & joints & SOB;T103.7, large intestine was inflamed, swollen lymph nodes, sore throat;inc WBC only;
Mania lasting 2 days ( not sleeping or eating, constant talking, constant activity, hearing things that weren't there.
Headache; flush; diaphoretic; stiff neck; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: cl3249) intramuscularly at left arm on 22Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included hypothyroid, asthma, seasonal allergies and known allergies: bee stings. The patient was not pregnant. No other vaccine in four weeks. Other medications in two weeks included levothyroxine. The patient experienced adverse events included headache, flush, diaphoretic, stiff neck; with start date on 22Jan2021 at 12:00 PM. Treatment ibuprofen received for events. The outcome of events was resolving. No covid prior vaccination and no covid tested post vaccination.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, frequency and route of administration was not provided) lot # N011491, expiration date 04-NOV2018, and lot # N022703 with expiration date 27-FEB-2019, for prophylaxis. Other suspect therapies included improperly stored doses of RECOMBIVAX HB, lot# M036153, expiration date 31-MAY-2018. The doses of PNEUMOVAX 23 and RECOMBIVAX HB were exposed to a temperature excursion below 32°Fahrenheit (°F) (28°F) during a time frame of 13 days, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.