chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large abcess in my mouth; subsequent mouth infection; subsequent mouth infection, likely thrush; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 22:30(at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included colecalciferol (VITAMIN D3), omeprazole (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, within 24 hours of the vaccine, at 12:00, the patient developed a large abscess in mouth and subsequent mouth infection, likely thrush. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of a large abscess in mouth and subsequent mouth infection, likely thrush and included antibiotics (unspecified). The clinical outcome of the event mouth abscess, infection and oral thrush was recovering at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PULMONARY EMBOLISM occurred just two weeks after the second dose of Pfizer Comerity. There were no other acute health conditions in this period that would account for the event.
very tired, sore arm, severe nausea and vomiting, feel very cold, shivering   within 6 hours within of vaccine until 10pm that night.   in the past 48 hours, still queasy.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient reports recurrent itching and hives since immunization. Previously received Moderna, but received bivalent Pfizer. Hives are relieved with diphenhydramine, but come back when dose wears off. Advised patient to seek treatment from primary care physician. Not severe or limiting activities, but irritating and unclear why they keep returning.
I have got COVID; I have got COVID; I have Heart disease; I can never work again because I have heart failure because of your vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: CARDIAC FAILURE (medically significant), outcome "unknown", described as "I have Heart disease; I can never work again because I have heart failure because of your vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have got COVID".  Clinical course: Consumer stated, "I have heart disease from Vaccine and in order to find anybody to help I have to speak somebody. Patient had heart failure because of vaccine that was supposed to save the world. Consumer was informed about the role of Pfizer Drug Safety. Consumer was informed about the Pfizer Legal Department and offered the fax number and the address of that department. Consumer further stated that they have got COVID. Then got heart disease and now getting a run around from somebody. When probed to clarify the suspect as Pfizer COVID 19 vaccine: Consume stated, "I am talking about your mRNA COVID-19 vaccine that came online in 2021. Consumer stated, "Drug safety is so bad. That worst or worst you all suffer, and all should be in prison. Consumer stated, "Yes here's the safety report. It's not safe. It was not inoculated. You all lied and now I am going to die in the prime of life and then what Just no more. Thank you, Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately two hours after immunization patient's blood glucose level dropped to 54. Patient self- treated with glucose tablets. Vaccine was given in arm with Sensor.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department with orthopnea and fatigue worsening over the previous two weeks. Hospitalized for acute heart failure exacerbation. Adjusted medications and symptoms resolved. Discharged to home medically stable.
Pt was giving a vaccine at 11:45. Patient started having itchy feeling on her back and neck at 12:16. No hives or redness on skin.. No complaints of difficulty breathing or shortness of breath. Itchy feeling went away 1226.  Vs 133/61  spo2 98%  reps 18.  Hr 73
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling Tiredness Muscle pain Chills Joint pain Nausea Feeling unwell Tender lymph nodes areas Felt feverish, but didn't take temperature
Immediately post vaccine with Covid -19 shot, noted severe pain to arm.  Vaccine administered to tricep area. Six days post vaccination, noted a lump to injection site. Skin was hot and itchy and sensitive. DX: Cellulitis. Treatment: Duricef 500mg po bid for 10 days. Supportive care.
Reports headache, sore throat, difficulty swallowing, feelings that can't catch his breath, smallpox site very red and raised. Prescribed azithromycin for systemic symptoms.
vertigo,  to the extent walking  was difficult.    ENT doctor diagnosed  vestibular neuritis.     Resolved in 10 days
Chills, muscle aches, fatigue and severe headaches. Continued for a full 48 hours and severe enough to keep me in bed the entire time.
When I wake up, my feet, ankles, and my knees where in pain. I felt like I am walking like I was walking on bare bones.  By Saturday my left knee was swollen. I try taking medicine and I iced it. It feels like my knee is twisted one way and my leg twisted another way. I went to my doctor. This is joint pain in my legs and foot. He put in a referral for a physical therapy and pain medicine. I as feel very fatigue.
Unexpectedly fainting while driving; Crashed my car; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 16:00 (at the age of 21-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient had no relevant medical history and no known allergies. Concomitant medication included birth control pill. On 18Apr2021 at 12:00, the patient experienced "unexpectedly fainting while driving, crashed my car." The reporter considered the events as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the events. The patient recovered with sequelae from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COAGULOPATHY, UNSPECIFIED TYPE 5/18/2022 DM 2 W PERIPHERAL VASCULAR DISEASE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/13/2022 DM 2 W PERIPHERAL VASCULAR DISEASE
This spontaneous report was received from the patient's wife and refers to a 79 year old male patient. The patient's pertinent medical history included rheumatoid arthritis, cardiovascular disease, ulcers and absence seizures (reported to be controlled). He was allergic to HUMIRA (also reported as HUMERA; the patient had also unspecified side effects from it) and valacyclovir hydrochloride. On 14-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (lot #, expiration date, site, dose and route of administration were not reported) for prevention of shingles. Concomitant therapies included ENBREL (also reported as EMBREL), VYTORIN, quinapril hydrochloride, phenytoin sodium, hydrochlorothiazide (also reported as HCTZ DIARTIC), metoprolol succinate, NEXIUM (also reported as NIXIUM), fexofenadine hydrochloride, potassium chloride, methotrexate (manufacturer unknown), vitamin D (unspecified) and sulfasalazine. On 20-NOV-2016, the patient started experiencing severe rheumatoid pain between blades, he broke into a cold sweat and became very pale. According to the reporter, the patient might have developed a reaction to ZOSTAVAX because he was on ENBREL. The effects were so severe that paramedics had to be called to take the patient to the emergency room. He was not admitted, but received an unspecified treatment for the events, had complete blood work and a full computerized tomography (CAT) scan performed (results were not reported). Subsequently, on the same day, the patient was released. The outcome of the events was reported as not recovered. The relatedness between rheumatoid pain, reaction to ZOSTAVAX, cold sweat, pallor and ZOSTAVAX was not reported. Upon internal review, the event of rheumatoid pain was determined to be medically significant. Additional information has been requested.
Spasm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Spasm at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCLE SPASMS (Spasm at injection site). On 13-Jan-2021, MUSCLE SPASMS (Spasm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt woke this AM w/sl rash to upper top of thigh & reddened are lt leg 3.5cm (non raised);5cm 3ich reddened irregular shaped non raised area;
3 days /p vaccine pt felt queazy, weak /w nausea, & vomited. 6 days post vaccine experianced lt buttock and LB pain, photophobia, headache, fever & chills. 15May90 hospitalized /w bilat. buttock pain,fever,rash,abdo & backpain. Recovered
Breakthrough Covid + a 69y.o. female presents to the EDwith worsening dyspnea and cough for the last 2-3 days. Admission CXR in the ED demonstrates chronic elevation of the left diaphragm but no obvious infiltrates.  ABG in the ED demonstrates both hypoxemia and hypercapnea.
While getting the vaccine I felt like an electric thing coming from back to head. Immediately felt dizzy. Got a benedril at pharmacy at 10:30. 10:45 I stand and still dizzy and lips were swelling, could not talk, and throat hurts.. pharmacy called rescue.  Rescue arrives At 11:10am, all vitals fine, couldn?t see throat, for it was Swollen. Took me to Hospital. 12pm I got epipen and other medicines. Start Getting better. 2:35 couldn?t talk again got benedril, then again at 7:15. Stay overnight under observation. Got a shot on the belly at 5:30am to avoid blood clothes. And benedril at 7:15am.  Got  medrol for 6 days. After that.
Patient called pharmacy the day after receiving vaccine stating she could not lift the arm the vaccine was administered in and she fell ill later that night and was unable to get out of bed
Pain at injection site 5/10 with limited ROM as donor reports that he is unable to lift his right arm above his head
At the Injection site, I have a 2?+  diameter red circle.  It is slightly larger than when I first noticed it.    It is slightly warm and slightly hard.  It does not hurt.  I have done nothing to treat it.
Case number PHEH2014US001235 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 17-year-old female adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, significant correction was done for the information received on 13 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Info has been received from an RN concerning a 12 month old Caucasian male who on 11/11/05 was vaccinated, SC, one time with 0.5 ml dose of varicella virus vaccine live (lot 646439/0551R). Concomitant vaccinations given on the same day included: a 4th dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj. vaccine (CRM197) (Prevnar lot 308636D) given, IM, in the left thigh; the 1st dose of MMRII (lot 649755/0380R) given, SC, in the right thigh. On 11/14/05, around 08:00, the pt developed his 1st varicella lesion. He was seen in the physician's office on 11/17/05 and he had 50-100 varicella lesions and a fever of 100.5F. It was reported that the pt had increased irritability and that his left eye was swollen from a lesion. The physician prescribed acyclovir 200 daily for 5 days and azithromycin (Zithromax) 200mg for 3 days. The pt was reported to be recovered at the time of this report. No product quality complaint was involved. Additional info is not expected.
COVID-19 Positive and hospitalization Narrative:  Patient completed Pfizer COVID-19 vaccine series 2/2/21 (first dose 1/12/21). Patient tested positive for COVID-19 on 4/18/21 and admitted to hospital with complications
Information has been received concerning a 59 year old female with a history of cold sores and no drug reactions/allergies who on approximately 08-JUN-2007 was vaccinated SC with Zostavax (Oka/Merck) (lot #657676/0619U). There was no concomitant medication. On 15-JUN-2007, about 1 week after receiving Zostavax (Oka/Merck), the patient developed a cold sore. Unspecified medical attention was sought. There were no labs performed. The patient's cold sores persisted. No further information is available.
Child had wheezing, paleness and pain down spine. Both arms hurt-no swelling, R arm warm where shot given, but no redness. Pt. dizzy. Not eating well. May have a fever.
Fever- day 1 and 2; coughing and runny nose- day 4 and currently (day 6 after shot)
infection control nurse notified this pharmacy ops manager that a resident received a COVID vaccine at Hospital on 6/23/2022. Nurse notified us that the patient passed away on 7/3/22.
1) Severe muscle cramping/pain in right shoulder/neck area 24 hours after injection.  Shot injected in right arm. 2) Severe gastrointestinal cramping and diarrhea 60 hours after injection. 3) Burning chest & dry cough 7 days from injection 4) 100 degree fever 9 days after injection w/muscle & joint aches and pains.
Patient Received the Shingrix vaccine in his left deltoid on 3/13/19. Two weeks later he developed a quarter-dollar sized blister on the top of his right thigh that had a burning sensation. ARNP saw the blister on 4/4/19. When I spoke to patient early May 2019, he said the blister had scabbed over but was still not healed. He saw another ARNP on 5/7/19 and it still had a painful burning sensation. ARNP recommends not receiving the second vaccine.
Pt reports that 2 days after 1st dose, she experienced right arm soreness (pt states she has a torn rotator cuff in her left arm). The day of her 2nd dose 5/11/2021 she as experiencing some itchiness, and 1 days post 2nd dose her left arm is sore and she broke out in hives on her left arm, torso and ankle areas and reports being itchy.  Pt reports she had applied Vaseline (did not help with itchiness); also applied moisturizing lotion and that seems to help a little but her torso areas are still a little itchy.
Swelling of lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included PARAFFIN (VASELINE [PARAFFIN]) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced LIP SWELLING (Swelling of lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling of lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment also included steroid injection and Vaseline.   Patient states she was told by her HCP the lip swelling was probably caused by the vaccine and not by chapped lips as she thought.
Initial information regarding this unsolicited case was received from a patient on 09-Nov-2016. This case involved a female patient of unspecified age, who complained of injection site reaction, unknown duration after starting therapy with influenza vaccine and alirocumab (Praluent). No relevant medical history, concurrent condition, past drugs and concomitant medications were reported. On an unknown date, the patient started treatment with influenza vaccine (other therapy details, lot/ batch number and expiry date: not reported). On 13-Oct-2016, the patient started therapy with subcutaneous alirocumab injection, at a dose of 75 mg every other week (strength: 75 mg/ml; other therapy details, lot/ batch number and expiry date: not reported) for hyperchylomicronemia, delivered via alirocumab prefilled pen (concomitant device). The patient reported that, she experienced an injection site reaction to a recent influenza vaccine (event onset and latency: unknown). Action Taken: unknown for influenza vaccine and no action taken for alirocumab Corrective treatment: not reported  Outcome: not reported.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022; No adverse event; Administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) 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 (Administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022).    No concomitant product use was reported.  Patient received full  dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Shot administered 6/25/14, local redness, tenderness > redness RUE > swelling RUE day 2-3 > seen PM 6/27 decreased redness decreased swell decreased tenderness > ice and ASA.
I experienced arm pain and swelling about 6 hours after the vaccine was administered. I also had body aches, pain, fever, and a migraine. My armpit began to swell on the right and both hands went numb. I was suffering from night sweats, insomnia and suicidal ideation. This went on for about a week. On day 5, my teeth started hurting and on day 10, I discovered a I had a cyst in my upper jaw in my maxillary sinus are. It swelled and grew to the point that the right side of my face was in excruciating pain. The pain was all the way to the midline of my teeth. My sinuses, right ear, cheeks, right temple, upper and lower palate and upper and lower right jaw were affected. I went to the ER. A Cat scan was completed and it was discovered that the cyst I had for 16 years had enlarged. I saw an oral surgeon, sinus specialist, dentist and had a telehealth visit with my neurologist. I was placed on  for a week that did not resolve the issue. The neurologist suggested that we start prednisone after my pain level reached 9. I also took Tylenol. The prednisone is working to resolve the issue. The cyst swelled enough to hit a nerve that affected my entire face.
Child presented to ER, lifeless and not breathing. Baby cool with rigor mortis. Mom had fed infant at 13:30 and he was fine. At 17:00, noted to be pale and lifeless. CPR began and brought to ER. Autopsy shows pulmonary vascular congestion, pulmonary edema, tracheobronchitis with bronchiolotis and peri-bronchiolar pulmonary inflammation, generalized visceral congestion, sudden infant death
Pt vaccinated with Haemophilus b conjugate developed temp up to 104.8 following day occassional episodes of vomiting.
This spontaneous report was received from a pharmacist referring to a 64 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2-16). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patients mother called the on-call physician on Saturday 03/28/2020 the day after getting the injection. Mother stated that patients eyelids are now swollen. Patient stated that she can't open eyes all the way, but can see fine. The eyelids are a little sore but not painful, and the eyes are not painful. She had a couple of little bumps on her skin that are itchy, but did not have any throat nor mouth symptoms.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.