chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a pharmacist, describes the occurrence of pain in extremity (sore arm after 3rd full dose), anger and dyspnea (shortness of breath after 3rd full dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939904) for COVID-19 immunization. The patient's past medical history included cancer/chemotherapy/surgery (post cancer and chemotherapy, half her lungs removed due to cancer prior to vaccination). On Oct 27, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 27, 2021, patient experienced pain in extremity (sore arm after 3rd full dose) and dyspnea (shortness of breath after 3rd full dose). On Nov 15, 2021, patient experienced anger. At the time of the report, pain in extremity (sore arm after 3rd full dose): not resolved; anger and dyspnea (shortness of breath after 3rd full dose) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient visited the doctor and they are running tests.
Big Swelling and not going down since injection  for my second shot and is painful sometimes Has not sort treatment but sometimes take pain medication (Aleve)
I know a woman who has stage 4 colon cancer; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLON CANCER STAGE IV (medically significant), outcome "unknown", described as "I know a woman who has stage 4 colon cancer".  Clinical Course: The caller provided that he worked for the government in IT and he was very concerned because he had been researching products and the other day he saw PhD (Name withheld), professor with was an analytics professional in healthcare, provide a statement that said that was the worst roll out of a drug since the invention of drugs and should be stopped immediately. It was very dangerous. The caller stated that in 2016, the government took 200 thousand men and vaccinated them with mRNA, not containing a virus, in which the vaccine made their heart stop at least once. The caller stated that these drugs should not be allowed in the public. The drugs were making people infertile, causing myocarditis, pericarditis, blood clots and things like that. Those drugs carry the same load and those drugs had been seen before. The caller stated they stopped an entire flu over two dead German shepherds. The caller stated that Pfizer needed to fear for Private as they have made an article 1 that was published. Caller stated that he never saw a label for Comirnaty and the concoction did not pass legal ramifications in 49/50 stated as it had to pass two things. 1. It had to be made from the virus, and 2. it had to keep you from getting said virus, which it did not. Upon asking if caller had any MI questions, caller declined and then said yes. The caller know people who have had heart attacks, strokes, and died from it. The caller knew a woman who had stage 4 colon cancer. If they were a Christian person, you're going to burn in hell. MI agent asked caller for MI questions again, caller stated yes and continue to ramble on, with no MI questions. Caller was warned about disconnection, and caller proceeded to cuss at the agent. Disconnection was performed by MI agent. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
When pt came in received flu shot 11/2/11 said the shot was fairly painful thought it was a little high since then arms had tingling and numb that evening but had improved/when lifting arm still sore. Saw her doctor yesterday 11/30/11 during her moms appt. Doctor to come back in, in a few weeks if not better.
Fever (101.8), chills, night sweat, all over achy feeling for two days.  Did not go to a clinic.
Narrative:  65yo died at home on 10/2/2021 after non-agency hospital discharge for failing kidneys. Pt also had active liver cancer. See extensive problem list below. Problem list: CVA Hyperthyroidism CHF Hepatocellular carcinoma with mets to spine, bone, lung Arteriosclerosis aorta Insomnia Splenomegaly Left Ventricular Hypertrophy Tricuspid Valve Regurgitation Left Atrio Enlargement Mitral Valve Regurgitation Diabetic Retinopathy Dilatation of Aorta Hemorrhoid Aortoiliac atherosclerosis Diabetes, on insulin Panniculitis Heart Murmur Sleep Apnea GERD OA Constipation Hypertension Anemia Impairment Hyperlipidemia Cataracts Pt had received covid vaccinations from pharmacy store on 3/3/21 & 3/31/21. Likely this death is not related given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Vaccine received 6/21/2018 hurt STAT swelling began 1 HR later and continued to swell. Pain enough to take TYLENOL 5pm, bedtime, 3Am woke from sleep took more TYLENOL icing all along. Red, swollen warm to touch. TYLENOL continued today no fever. Alternate arm normal. Today CLARITIN at bedtime, ice. Woke fever will cont MD.
Within 10 mins of receiving vaccines pt. presented with hives on face, extremities and trunk. Dr was notified. Epinephrine 1:1000, 0.12 ml subq administered, steroids prescribed.
tinnitus; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (01Nov2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Feb2021 16:30 (Lot number: EN6200, Expiration Date: 20Jun2021) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colonscopy", start date: 10Nov2020 (unspecified if ongoing), notes: No issues; "psoriasis", start date: 1974 (ongoing), notes: Have been using biologic stelava for 8yrs.; "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for depression (ongoing); ZOCOR taken for blood pressure measurement (ongoing); PRILOSEC [OMEPRAZOLE] taken for gastrooesophageal reflux disease (ongoing); ZESTRIL taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Dose =1, Route of administration=Intramuscular, Anatomical site of location=Right Shoulder, Drug Lot Number and Expiration Date: Lot # EL9262, 20May2021, At: 10:30), administration date: 21Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Anatomical Site of injection for dose 2 was right shoulder. Vaccination Facility Type was Hospital. Prior Vaccinations within 4 weeks was none. As a result of the Pfizer vaccine. Patient now have continuous ringing in her ears. While it is extremely bothersome, it was something patient can deal with at its current level. Patient was eligible for a booster shots but was concerned that tinnitus will get worse and will become unbearable.   Follow-up attempts are completed. No further information is expected.
pt recv vax 12MAY97 & devel gastroenteritis 15MAY97 & fever up to 103.5;had 2-3 sz & was adm to hosp 17MAY97;
MMR given lt arm immed exhibition of (2) 3-4mm wheals, 2 cm medial of inj site w/red macular area surrounding site;red macular area near shoulder joint;no other sz-no treatment;
Patient behind on vaccines. Due for Tdap, Varivax. Was given DTaP instead of Tdap. Pt over the age of 7yrs. No side effects or adverse reaction to vaccine.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 09-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L009544, expiration date: 19-MAR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-JUL-2015 (also reported as 06-JUL-2015), the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Received Tdap, Hep A, IPV, Typhoid 6/11/08.  LA became very red & swollen & painful 6/12/08.  C/o achy joints, swollen glands; face rash 2 wks after vaccination.  Sxs somewhat relieved with MOTRIN.  Visited PCP.
localize reaction at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 20-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (localize reaction at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (localize reaction at the injection site). At the time of the report, INJECTION SITE REACTION (localize reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Date of Admission: 11/28/2022   Date of Discharge: 12/1/2022   Admission Diagnosis: COVID-19 [U07.1]     Hospital Principal Problem (Discharge Diagnoses): COVID-19   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis o Principal Problem: COVID-19 o AKI (acute kidney injury)  o SIRS (systemic inflammatory response syndrome)  o Type 2 diabetes mellitus  o Essential hypertension
I gave a blood for antibody test and results showed no antibody; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANTIBODY TEST NEGATIVE (I gave a blood for antibody test and results showed no antibody) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ANTIBODY TEST NEGATIVE (I gave a blood for antibody test and results showed no antibody). At the time of the report, ANTIBODY TEST NEGATIVE (I gave a blood for antibody test and results showed no antibody) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up received and action taken updated from Unknown to Not Applicable from initial version.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a male who was born to a 26 year old female patient with pain in shoulder and reflux, back pain and pain traveled to right leg a history of abnormal PAP in June 2008, and no previous pregnancy who received the first and the second (661952/1129X) dose of GARDASIL on 29-JAN-2009 and 26-MAR-2009 respectively.  After the patient was given the second dose, the patient was given a pregnancy test because she was reporting symptoms of "being tired and missed her monthly cycle".  It was reported that everything was normal and the mother had normal pregnancy testing at 6 months of pregnancy.  The patient delivered a normal male baby on 04-NOV-2009, 39 weeks from LMP.  The baby weighted 7 pounds 13 ounces, length 20 inch.  There was no congenital anomalies.  The baby experienced vomits, had diarrhea and buttocks were irritated.  The pediatrician thought it was normal.  Follow up information received from a physician via medical records indicated that the patient's mother medical history also included high blood pressure, stroke and kidney disease.  The patient's physical examination was within normal limits.  On 18-JAN-2010 the patient had a urine culture: 10,000 colonies/mL (insignificant quantity for further workup - mixed skin/genital flora, no further identification).  It was also reported that on 06-NOV-2009 the patient was vaccinated with a first dose of hepatitis B virus vaccine (manufacturer unknown).  On 12-JAN-2010 the patient received a second dose of hepatitis B virus vaccine (manufacturer unknown); and the first doses of PENTACEL and ROTATEQ.  The patient was treated with OMNICEF 125 mg/5 mL.  No further information is available.  The mother's experience has been captured in WAES 0903USA04915.
I had very fast irregular hear beat it felt very scrambled up it eventually slowed but felt very irregular so I went to the ER at a local hospital.
Initial case was received from a health care professional on 17 January 2014. This 33-year-old-male patient whose medical history and concomitant medication was not reported had received FLUZONE ID, batch number UT4721BA, expiry date and dose not reported) on 15 January 2014 in the left deltoid. On 16 January 2014, the patient developed redness, swelling and pain at injection, size of a dollar coin. He also complained of itching, raised area. The patient had no fever and otherwise was fine. No corrective treatment was given. The outcome of the event was not recovered.
Patient states tenderness and redness around injection site extending down arm to elbow. Patient also states headache and fever
Fever, chills, joint pain, headache, fatique, vomited one time -started 11 hrs after injection * pain in left jaw,ear, started 48 hours after vaccine. Difficult to chew, talk - pain almost constant but worse when lying down. ?TMJ pain? Treating with heat, ice,  celebrex, muscle relaxant@ nite.  Has continued for 9 days.  No facial drooping.
1st dose given 1/8/2021 dizziness, nausea vomiting, fatigue, body aches, congestion. Never got better now diagnosed with Virtigo 2nd dose 3/3/2021 dizziness got worse, fatigue worsened, high fever, cough, shortness of breath, list of appetite, horrible  body aches, congestion
This spontaneous report was received from a nurse and refers to an unknown number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (doses, route of administration, anatomical location, lot# and expiration date were not provided) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). Administered doses of vaccine underwent a temperature excursion between 9 degrees Celsius to 25 degrees Celsius for 48 hours. The digital data logger was not involved. No adverse effects were reported. Additional information has been requested.
Symptoms started within minutes after. I got extremely hot. The next day, at around 9:30am, the muscle aches started and I noticed a rash on my stomach. Around 3pm, I started to feel worse. I took a nap and woke up around 6pm soaked in sweat, with muscle aches, and a fever of 99. My fever never got above 100.8. The body aches were the worst part. It was extremely difficult to get comfortable. I did take Tylenol and Ibuprofen and it didn?t seem to help the body aches. It did however help keep the fever at bay.  I went to sleep that evening at 11:00pm. I woke up in the middle of the night around 2am, and all symptoms have resolved except for feeling extremely hot. The rash has gotten better but has not fully resolved.
I got shot and I have the flu; Initial information received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who stated i got shot and i have the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had a non-serious event of i got shot and i have the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported the shot does not keep u from getting the flu just not as bad I got shot and I have the flu many viruses out there with different types of strains I believe.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Allergy. Concomitant products included GUAIFENESIN (MUCINEX), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB), FLUTICASONE PROPIONATE (FLOVENT) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Outcome of the event Dyspnoea updated to recovered.
I had immediate onset of vertigo, I have been to a chiropractor and physical therapies. It is better but it is not gone.
Information has been received from a registered nurse concerning an 18 week old male patient who on 18-JUN-2007 was vaccinated with the first dose of Rotateq (Lot # not reported) and the second dose on 20-AUG-2007 (lot # not provided). Concomitant therapy included lactulose. On 25-AUG-2007, five days after receiving the second dose, the patient developed high fever (104.5 degrees/F), vomiting, diarrhea, and irritability. The patient was taken to a hospital emergency room in the night of 25-AUG-2007 to 26-AUG-2007. A stool culture was taken (outcome not specified) and an antibiotic injection administered (unspecified antibiotic). The patient's stool tested positive for blood. The patient was rehydrated in the hospital and was discharged to home. At the time of the report, the patient was at the physician's office for re-evaluation. The patient continued with a 100.4 degree/F fever. No other symptoms or treatment were reported. High fever (104.5), vomiting, diarrhea, irritability and stool tested positive for blood were considered to be immediately life-threatening. Additional information has been requested.  9/5/07 Received fax from pcp w/RO lot # handwritten.  No other medical records.  VAERS database updated w/same.  9/11/07  Reviewed ER records 8/26/07 which reveal patient experienced fever, projectile vomiting & diarrhea x 1 day.  Temp in ER was 104.7. FINAL DX: Febrile illness & viral infection. Patient did not improve & returned to ER later same day with continued fever & blood in stool.  Temp in ER 101.4  Given dose of IM antibiotic & d/c to home.  Stool c/s became (+) on 8/31 & parent & pediatrician notified of same & pcp to treat/follow. FINAL DX: febrile illness, diarrhea.
COVID arm, started feeling soreness, swollen, red rash on day 8 after getting 1st shot.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unknown dates, these multiple unspecified patients were possibly vaccinated with improperly stored ROTATEQ (strength and dose unknown, lot # M045545, expiration date 10-JUN-2018) orally for prophylaxis. The ROTATEQ was exposed 49.8 F for a time frame of 7 hours. There were no previous temperature excursions. A data logger was in use. No adverse effects reported.
May be a duplicate said he thought report filed in 2003 10/31/03, Flu vaccine (IM). Around 11/4/03, developed flu-like sx's. 11/8/03, felt winded. 11/10/03, progressed to SOB and mild chest pain. 11/14/03, awoke w/crushing CP ->ER-> admitted to Medical Center. April 2004, recurrence CP w/viral type sx's (no eval), self tx'd with NSAIDS with resolution. No recurrence since then.  12/3/09 Medical records received for date 11/18/09. DX: myocarditis, pericarditis. Medical records from VHC.  Pt states received flu vax 10/31/03, experienced chest pain, winded, SOB 11/10/03, crushing chest pain 11/14/03. Pt dx w/ myocarditis in <30days post vaccination. This form was from VHC for consult to have waiver for influenza and H1N1 vax due to h/o. VHC recommended a grant for waiver due to adverse event. Pt is military.
rash on chest, under arms, left side under ribs, above waist line.  Rash blistered.  Treated with hydration and Benadryl.  Rash was a week before starting to clear up.