chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left ankle and foot was swollen; left ankle and foot was swollen; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 53-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 09:00 as dose 4 (booster), single (Lot number: FK9894) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "chronic illness" (unspecified if ongoing), notes: 1x chronic illness; "known allergies pollen" (unspecified if ongoing), notes: Allergy: Mesquite, pollen; "known allergies Mesquite" (unspecified if ongoing), notes: Allergy: Mesquite, pollen. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization.  The following information was reported: JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 10May2022 at 12:00, outcome "recovered" and all described as "left ankle and foot was swollen". The events "left ankle and foot was swollen" required emergency room visit. Therapeutic measures were taken as a result of joint swelling, peripheral swelling.  Additional information: patient did not take any vaccine in four weeks and was not wish to answer regarding other medications in two weeks. Patient did not had covid prior vaccination nor tested covid post vaccination. Patient received Tylenol, Ibuprofen, Acewrap as therapy for the events.  No follow-up attempts are possible. No further information is expected.
Rash generalized, itchy red raised about 12 hrs after immunization. 9/24 woke with headache, nausea, numbness in hands, pain in both legs.
pt recv vax 31MAY96 & 7JUN96 pt exp low grade fever for several days & 3-4 red spots on lower back;
At around 26 minutes after the second vaccine was administered, patient started to have signs of an allergic reaction including dizziness, throat itchiness, and trouble breathing. Pharmacist and physician was notified immediately. Physician and MA took pulse Ox and looked into throat. Determined that patient needed Epinephrine. Patient was moved to a room where epi was administered within 3 minutes. EMS was called and patient was transported to hospital within 15 minutes of epinephrine administration.
Arm pain immediately at injection.  Whole arm to fingers.  Bad metallic taste in mouth.  Water also tastes different.  Arm pain is moderate to accute.  Not resolved 6 hrs post vaccine.
Heart rate increase, body weak, shortness of breathe, stomach pain, rib cage hurts, heart hurts
Have been very sick; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced have been very sick.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced have been very sick.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date the outcome of event have been very sick was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Five weeks after the second dose of the vaccine my left pinky finger stopped working and I was admitted to the hospital and I tested for Covid-19 and tested positive. I was diagnosed with a Transient Ischemic Attack. I have had a stroke in Embolic 2018 and a Stent placed in 2019. The TIA was identified as a clot in my Stent. I was diagnosed with Plavix and Aspirin 81mg.
Pt reported arm swelling and fever after vaccination. Spoke to her 2 days after the vaccine and she was still having adverse effects.
The patient reports having a sore arm which turned into general myalgias which included the quads, gluts and shoulders.  She also reports arthralgias of the wrists and ankles.  Her left wrist is still causing her pain when she lifts heavy objects.  The evening following her vaccination she reported a headache, temperature of 100.8, and a pulse of 100.  Her normal pulse is in the 50s range.  She woke up the next morning with severe ringing in her ears which has lasted for several days.  She reports feeling better at this time and has only residual left wrist pain that started on the day of vaccination.
This is a spontaneous report by a contactable nurse via a Pfizer Sales Representative. This nurse reported similar events for six patients. This is the fourth of six reports. A patient (age, sex and race unknown) received a dose of PREVNAR 13 as a schedule vaccination on an unknown date. Relevant medical history and concomitant medications were unknown. On an unknown date after being administered the PREVNAR 13, the patient experienced dark red, hard, and raising swelling at the site of injection. Relevant lab data was unknown. At the time of the report, the clinical outcome was unknown. Follow-Up (04Aug2011) Follow-up attempts completed. No further information expected.
15-20 minutes after vaccine, patient fell off bench, became rigid and slightly shook and was unconcious.  This lasted for about 15-30 seconds. He regained conciousness but was out of it.  Stated right before he did feel feverish/nauseous so tried to get up.  We called 911, EMS came and checked vitals and evaluated.  Everything they said was in normal limits and patient has a vasovagal reaction.  Patient felt better and was able to walk out of the store.
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant medication was reported.    Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment information was reported. This case was reported for 20th patient out of 20 patients.
Patient became acutely ill on 1/15/21 with recurrent pneumonia, treated with Augmentin. Pt became progressively worse on the next 48-72 hours, treatment goals changed to palliative-focused, and all treatments withdrawn. Patient died on 1/22/21.
Called call center. Pt stated she has left arm covid 19 vaccination injection site pain with tenderness since last Friday. Pt denies emergency s/sx. Pt said she is taking Tylenol 650mg 2T every 8 hours since last Friday and took ice pack on the site however it's not helping. Pt said she had pain on left arm covid injection site at 1st vaccination but symptoms it last couple of days. was seen by Urgent Care MD on 4/20//21 during which pt was advised to use PRN tyleno land ice area.   Can use ibuprofen PRN but sparingly since pt has DM.
The vaccine vial was diluted with 0.8ml of sodium chloride instead of 1.8ml. The 0.3ml dose was then drawn up and given. The patient was checked on the evening of 8/30/21 and felt fine.  A second follow up was done at 11:30 am on 8/31/21 and the patient reported feeling overall very fatigued.
weakness, shortness of breath with activity,disoriented, fever 100.7 Narrative:  symptoms resolved x 1 day with acetaminophen.
I have soreness at the injection site; I do feel mildly feverish; with a headache; slightly flushed; mildly nauseous; light-headed; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fever, headache, flushing, nausea and light headedness. On an unknown date, the outcome of the injection site pain, fever, headache, flushing, nausea and light headedness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, headache, flushing, nausea and light headedness to be related to Shingrix.  Additional details were provided as follows: The patient felt slightly flushed, mildly nauseous, light-headed, mildly feverish with a headache and had soreness at the injection site.  The patient was curious about the duration of the symptoms since the patient was supposed to travel on Wednesday.
On 9/15/18 (NIGHT of shot) I NOTICED his arm WAS RED, WARM, GOLF BALL SIZED AREA where shot was given. HE DID NOT COMPLAIN THAT IT HURT. I MARKED the outer diameter WITH A PEN to monitor any changes. I GAVE HIM SOME ZYRTEC AND APPLIED AN ICE PACK. THE NEXT MORNING, SUNDAY, the site was LARGER, ABOUT THE SIZE OF AN ORANGE. STILL NO COMPLAINT OF PAIN, JUST THAT IT ITHCED. I DID APPLY A TOPICAL STEROID. BY MONDAY MORNING IT WAS LOOKING LIKE IT WAS DISSIPATING, AND BY MONDAY EVENING IT WAS COMPLETLY GONE.
Coughing, swelling of eyelids, urticarial rash within 15-20 minutes of immunization. No wheezing, respiratory distress. Required epinephrine, Benadryl and steroids. Recovered very good.
7/31/00 Vax given, 8/1/00 left arm red, fevered, swollen, irriatable, 8/2/00 reported to WCHD, redness and swollen 90mm/75mm. Hurts to raise left arm advised Tylenol and warm compress.
This case was reported in a literature article and described the occurrence of uveitis in a 35-year-old female subject who was vaccinated with Hepatitis B (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B (unknown). At an unspecified time after vaccination with Hepatitis B, the subject experienced uveitis, influenza like symptoms, arthralgia and arthritis. This case was assessed as medically serious by GSK. This is one of 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis B vaccine between 1982 and 2009. It appeared that all subjects recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Very sore arm for three days, muscle aches for 2 days, stomach upset for one day.
c/o dizziness not feeling right very anxious scratchy throat taken to ER via wheel chair
This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a adult patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th October 2018, several hours after receiving SHINGRIX, the patient experienced injection site wheal, injection site warmth, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 11:00, the patient received SHINGRIX on left deltoid. Later in the evening, the patient experienced welt on her arm at the injection site that was 4 by 5 inches. The area was hot, swollen and itching.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-FEB-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 88 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported and nor product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
None. Pt requested flu vaccine, Dr ordered. Requested vaccine, when I went to document (after giving injection) I seen pt already received vaccine this flu seasons 13-14.
Within one year (as far as I noted) of vaccination I started having petit mal seizures. Was diagnosed with anxiety but still had the Deja Vu, fear/dread onset, and add smell or taste, lip smacking. Heart Rate (HR) when exercising went up by 15-20 BPM, plus extreme exhaustion during exercise (never happened prior in all my years). Kept going to doctor since petit mal seizures were increasing, then diagnosed with Epilepsy August 9, 2023 after a single event. Still have elevated Heart Rate.
no adverse event       Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Pfizer TRIS COVID-19 vaccine was administered to patient on 4/27/22. Vial was placed in refrigerator on 2/10/22 and NP entered expiration date 5/31/22 in medical data report. 10 week expiration date was 4/21/22. Lot # FK9895; vial exp date 9/2021; NDC: 59267-1025-04.
Unable to sleep on left side with both vaccines for one night.; Injection site pain vaccination #1; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2020 08:00 (Lot number: EH9889) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: SYNTHROID. The following information was reported: INSOMNIA (non-serious), outcome "recovering", described as "Unable to sleep on left side with both vaccines for one night."; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Injection site pain vaccination #1".  Additional Information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks was Synthroid. No covid prior vaccination. Not covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341429 same reporter/patient/product, different dose/event.
One day post vax, the pt experienced a fever. Otitis media was dx in the ER two days post vax. However a high fever to 105 and irritability developed prompting another ER visit. On 8/6/00, Otitis had completely resolved. Rocephin was given. By 8/7/00, symptoms have mostly resolved.
Pfizer-BioNTech COVID-19 Vaccine EUA  I received the first dose of the vaccine at the end of a vaccination clinic during which I had been administering the above vaccine. I completed screening, received the injection and waited under medical observation for about 20 minutes post-vaccination.  Approximately 10 minutes after leaving the clinic (30 minutes after receiving the injection), I experienced a sensation of facial  flushing, palpitations, a sense of anxiety, mild chest tightness, and lip numbness that spread into my face. I did not have any shortness of breath, tightness of the throat or any apparent swelling of the lips, tongue or face.  The above symptoms lasted about 10 minutes and gradually dissipated over the next hour.
After administering the IMZ, Dad and patient were standing and waiting in the IMZ area while I stepped back into the pharmacy to print off the patient's shot record. Dad got my attention by knocking on the window. I ran out of the pharmacy and Dad had patient seated on the chair. Dad said he caught her before she fell. She was completely pale and stated that she couldn't see. I had her lay down across both chairs and elevate her feet onto the IMZ panels, put a cold wet paper towel on her forehead and had the store manager get an orange juice for her to drink. After several minutes, she was able to sit up and said she could see fine again. Waited a little while longer and she was able to stand and walk around normally. Her complexion came back and she was smiling and laughing. Dad says she has never had any reaction to shots before, but she was not expecting to get a shot today so we think she was extra nervous/anxious.
Hardening , itching and radiating heat at injection site. Pain when trying to use arm, especially when lifting it 90 degrees of higher. This has been ongoing for three days, with very minimal improvement each day.
Respiratory events.  Multiple apneic events with desat.  Needed mild to vigorous stimulation
Breakthrough case admission after 3 vaccines Pfizer 1/21/21 lot# EL9261;  Pfizer 3/13/21 lot# EN6200;  Pfizer 8/26/21 lot# FC3182;
Discharge Provider: MD Primary Care Physician at Discharge: MD  Admission Date: 12/19/2022 COVID positive date 12/19/2022 PRESENTING PROBLEM: STEMI (ST elevation myocardial infarction) [I21.3] Shock [R57.9]   HOSPITAL COURSE: Patient is a 70 y.o. female with history of coronary artery disease, CHF, CKD 3, diabetes mellitus type 2, and peripheral artery disease with recent diagnosis COVID positive pneumonia and and antibiotic related rash who presented to an outside hospital with hypotension after dialysis with additional evidence of STEMI based ST-elevation in the inferior leads on EKG and elevated troponins over 2000. BNP was also elevated at over 59,000.  Patient was initiated on IV fluids and IV Levophed, but continued to remain hypotensive in the emergency department so she was subsequently transferred to the intensive care unit for septic shock treatment.  Per emergency department note and patient in the intensive care unit, patient reported no chest pain.  She did endorse dyspnea, nausea, multiple episodes of vomiting, chills, mild neck pain.  After questioning about vomiting, patient began developing coffee ground emesis on physical exam and was subsequently suction with NG tube place hooked to low intermittent suction.  During intensive care unit care, patient went into cardiac arrest with multiple rounds of ACLS attempted, however she could not be recessed stated and ultimately was pronounced at 1037. Further details of code can be found and intensive care unit note. Discussion of care and death was taken place with family
Within two hours spiked a fever too 102.00 degree became really sick pucking ever hours until 6am fever broke around 7am still feel really sick
PSYCHOLOGICAL EFFECTS; DEBILITATING 24/7 TINNITUS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced psychological effects, and debilitating 24/7 tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the debilitating 24/7 tinnitus and psychological effects was not reported. This report was non-serious.
Received the vaccine 1/5 at 8:09 am.  She was observed for 15 minutes and had no symptoms.  Next day, 1/6, she called work to say she had chills and headache and would not be reporting to work.  At 2:00 pm, she felt her heart racing, and noticed face and lip swelling and tightness in her throat.  She called her PMD who directed her to go to urgent care.  At urgent care, she got an EKG, IV fluids, IV steroids, and IV antihistamine.  Symptoms resolved within 2 hours.
L neck & upper L arm pain, tingling & numbness in L hand persisting till seen 4/12/21 (& beyond)
During observation phase after member received 2nd dose of Pfizer COVID-19 vaccine member c/o indigestion and abdominal discomfort. Member stated she was unsure if symptoms are related to her emotional status due to the loss of her grandmother yesterday. Adult emergency called and vitals obtained. BP 131/79, HR 80, O2 sat 99% RA. Member transported to the ACC via wheelchair.
Child experienced a seizure (eye's rolled back in head, tonic clonic movements, postictal period). Temperature of 102 F. No history of seizures. Fire department paramedics dispatched to home, child was transported by parents to Hospital ER. Diagnosed as febrile seizure, ibuprofen administered.
My period was was a few days late. The first four days, I had very bad cramps, which is very usual.  My period has been very watery, which is very unusual. I was bleeding through my clothes, even though I had a thick pad on and changing my pad hourly. I had to also use a thick washcloth and a pad, and I will still bleeding through my pants. When I would stand up after urinating, blood will just flow out of me like I was urinating, but it was definitely from my period. I was very concerned about the amount of blood I was shedding, but it was very watery.  I've had three babies, and I have never had a period I ever had before. It is day seven, and I am still on my period. Usually  my period lasts four days.
Day after vaccine, redness, heat, pain, itching. On 2nd day redness 17 x 9cm, tender, decreased with antihistamine.
8pm - chills 10pm - 103° fever Following 30 hours - lethargy, extreme body aches, clouded thoughts