chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One of my patient had a Pulmonary embolism after he got vaccinated with Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "One of my patient had a Pulmonary embolism after he got vaccinated with Pfizer vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Pulmonary embolism" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Myocardial Infarction; This is a spontaneous report from a contactable Nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No heart problems issues before, 4 days before 28Jun2021 (on 24Jun2021), patient went to the ER with Myocardial Infarction (MI). The outcome of the event was unknown.  information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect drug to the reported event "Myocardial Infarction" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
15 minutes of vacc nauseous, lightheaded sick to stomach, difficulty walking. 30 minutes throat  got tight and a metallic taste in mouth. Face and hands got flush. after an hour and a half felt better. Now achy.
This patient received a flu vaccine (flucelvax quad) on 10/17/21 by a pharmacist around 3 pm. She reported numbness of the lips shortly afterwards (within about 1 hour), but she attributed it to eating jalapeno chips right after being vaccinated. She asked a pharmacist and pharmacist advised to reach out to MD just in case if symptoms continue. The patient went home and waited until the next morning to call her MD when she felt like she could not walk right in the morning of 10/18/21 and had a significant area of numbness on the roof of her mouth. The doctor had her go right to the hospital and they confirmed she had a stroke. The patient admitted she was very high risk for stroke (hypertension, high cholesterol, diabetes, obese, numerous heart medications).  The patient is home and doing better. Her speech is a little slurred, but overall better. Her BP is very high and she is working with her doctor to bring it down. The patient states the doctor that treated her at the hospital does not believe the flu shot was a reason or contributing factor to the stroke.
I went for one year checkout for my Cardiologist and order an Echo (6/22) and then it was discovered that my Valve needed to be replace again, I had it replaced 5 years ago. I had CTA done. August 23, 2022, Cardiac catheterization.
they thought he may have an appendix burst; Severe stomach pain; Diarrhea; Outside of 42 days for second dose. First dose given 2 mar21; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS PERFORATED (they thought he may have an appendix burst) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M2049) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Caller is consider a "long hauler", person who had Covid for extended period of time, according to patient.  His symptoms lasted for an covid from December 18 through march.  Caller was put in the ICU.  Caller was on a ventilator for 23 days.  Caller had blood plasma transfusions.  Caller said he was on dialysis because kidney shut down.  Caller received first dose on 2march21.  Caller said stomach hurt to point that they thought he may have an appendix burst.  His appendix did not burst.), Kidney failure, Intensive care, Mechanical ventilation (23 Days), Plasma transfusion and Dialysis.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pain), DIARRHOEA (Diarrhea), PRODUCT DOSE OMISSION ISSUE (Outside of 42 days for second dose. First dose given 2 mar21) and APPENDICITIS PERFORATED (they thought he may have an appendix burst) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pain), DIARRHOEA (Diarrhea) and PRODUCT DOSE OMISSION ISSUE (Outside of 42 days for second dose. First dose given 2 mar21) outcome was unknown and APPENDICITIS PERFORATED (they thought he may have an appendix burst) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller  wanted to know if he needed a second dose and if so he wanted to knw when.  Caller wanted to know if he needed the second dose because of having Covid.
27MAR95 1 wk p/inj pt devel a low grade fever & measles like rash all over pt; 28MAR95; pt having some itching;
SWOLLEN LYMPH NODE/KNOT UNDER LEFT ARM.  IT APPEARED SEVERAL DAYS AFTER INJECTION.  SORE TO THE TOUCH.
Had chills all day of vaccine One week later chills on and off mot severe as first day Developed pain on rt side abdomen a week later which went from rt side abdomen now I. Hip the pain is constant and a week later nauseas in the morning
Swelling and whelp on left thigh. 20.5/40 mm mild itching at injection site.
kidney infection; This is a spontaneous report from a Pfizer-sponsored program,  Support. A contactable male consumer (patient) of unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on an unspecified date. Medical history and concomitant medications was not reported. On an unspecified date in Feb2021, after the second vaccination, the patient experienced kidney infection. His doctor prescribed antibiotics on 15Feb2021. The patient wanted to know if that will affect the efficacy of the vaccine. Event outcome was unknown.
had a really sore arm; a bad headache; upper back hurt; chills to where she kept being cold and shivery even when she had the heat on; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a really sore arm), HEADACHE (a bad headache), BACK PAIN (upper back hurt), CHILLS (chills to where she kept being cold and shivery even when she had the heat on) and FATIGUE (tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL SUCCINATE and ATORVASTATIN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (had a really sore arm), HEADACHE (a bad headache), BACK PAIN (upper back hurt), CHILLS (chills to where she kept being cold and shivery even when she had the heat on) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (had a really sore arm), HEADACHE (a bad headache), BACK PAIN (upper back hurt), CHILLS (chills to where she kept being cold and shivery even when she had the heat on) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
This spontaneous report was received from a physician via a office manager and refers to a 69 years old male patient. Patient's medical history included: shoulder pain and allergy to LEVAQUIN. On 06-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K004207, expiry date: 13-MAY-2015) intramuscularly. Concomitant therapies included acetaminophen, NORCO (indication unknown). On 08-MAY-2014 the patient seeked the medical attention, he came to the office and presented with soreness, redness, pain with extension to the armpit from the injection site. The physician diagnosed this finding as cellulitis, although it looked like "early shingles". Physician treated patient with a seven day regimen of KEFLEX. No laboratory test was performed. The outcome of the event was unknown. The relationship between the PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
Swollen, tender, red deltoid and tricep area.  No consttutroval symptoms.
Information was received from a pharmacist, who reported that a physician reported to him that an anonymous patient (demographics unknown) was vaccinated with PNEUMOVAX23 (date of vaccination, dosage and route of administration not provided). On an unknown date, the patient developed an unspecified adverse reaction after receiving PNEUMOVAX23. The outcome of unspecified adverse reaction is unknown. Additional information is not expected.
Gave 12-year-old pediatric dose (0.2 mL of 10mcg) instead of adult dose (0.3mL of 30mcg).
Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face was swollen/ cheeks were swollen; eyes started getting puffy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had side effects which was described as whole face was swollen and both of her eyes and cheeks were swollen in Apr2021. The right side was worse than the left. The patient stated that three days ago, it swelled up a little bit so she put some ice on it, but she woke up this morning and her face was literally swollen. Even yesterday it was swollen but it was not this bad. This morning like it's really really big and it's huge. Right now, her eyes were swollen. She could not really see from it. Few days ago in Apr2021, her eyes started getting puffy. She was kind of ignored it because she put ice on it. But each day it got worse and now this morning, her eyes were closed shut, both of her eyes were swollen. Right eye was more big than the left and her face, her cheeks were swollen. The outcome of events, both of her eyes were swollen/ could not really see from it/ her eyes were closed shut, whole face was swollen/ cheeks were swollen and eyes started getting puffy was not recovered.   No follow-up attempts are needed. No further information is expected.
I see all my heart up in my neck, definitely is speeding; higher blood pressure; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ETV6204), dose 1 via an unspecified route of administration on 16Mar2021 as DOSE 1 SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, probably a day or two days later, the patient experienced higher blood pressure and he took high blood pressure pill (Unspecified medication) and the patient do not necessarily had access to a blood pressure comforted measured, but the patient do reorganize the fact that the patient see all his heart up in neck, definitely was speeding and the patient had tried to, not called or have not seen a doctor yet, it was that want to manage itself. After reading the adverse reaction to the shot decided that should just call and see what was going on because now concerned about taking the second one. The event outcome was Unknown.  No follow-up attempts are possible. No further information is expected.
Patient received vaccine 10 days after the beyond  use date. Beyond use date was on 11/20/2021.
Information has been received from a nurse practitioner concerning a female, 24 years old at the time of this report, who was vaccinated as a child with a 0.5 ml dose (SC) of MMR virus vaccine live (lot # not reported). Subsequently the patient showed no immunity to rubeola. The patient received a "booster dose" in 1997 and in August 2001. A titer drawn in October 2003 was still negative for rubeola. The patient refused to receive another dose of MMR virus vaccine live and stated that she does no seroconvert. Unspecified medical attention was sought. Additional information is not expected.
covid PCR test 15Apr2021 after being fully vaccinated/Positive; covid PCR test 15Apr2021 after being fully vaccinated/Positive; is pregnant: Yes; This is a spontaneous report from a contactable physician. A 34-years-old pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 intramuscular on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history was none. No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. The patient was pregnant at the time of vaccination. Her last menstrual date was 03Jul2020 and delivered on (date). Gestational period was 33 (as reported). On 15Apr2021, after being fully vaccinated, the patient had post vaccination covid test which showed positive result. covid test type post vaccination was Nasal Swab, covid test name post vaccination was NAAT LumiraDX: This RT-PCR assay targets ORF1a. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of the events was recovered.  Information about the Lot/batch number has been requested.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure cannot be ruled out.
01/2003 SKIN DISCOLORATION 09/2007 - 3 PULMONARY EMBOLISM RIGHT LUNG THEN 9/2007 PLEURAL EFFUSION 7/2008 DVT IN RIGHT BICEP 2/2009 1 PULMONARY EMBOLISM. mY TREATMENT HAS BEEN COUMADIN AS OF RIGTH NOW I TAKE 10MG FRI-SUN 7.5MG MON-THU I HAVE HAS FACTOR V AND GENETIC MUTATION BLOOD WORK ALL CAME BACK NORMAL. I EXPERIENCE PAIN IN MY LUNGS FATIGUE HAD PULMONARY FUNCTIONS TEST FEV1 AT 70% OF PREDICTED LEVELS.
Patient stated she had generalized itching approx 5-6 hours after injection, self med with Benadryl 25mg PO. Itching progressed to severe generalized pain, beacme "unbearable" and patient went to ER approximately 13 hours after injection. Given IV morphine per pt, CT scan (result unknown) D/C to home 7 hours after admission with Rx Dilavid po, Xanax, Benardyl, Tylenol, Docusate and told to f/u with private MD.
About 48 hours after receiving vaccine client states site became red, swollen and itchy. Sore to the touch. Seen in HD office 12/5/13. RN notes skin red, swollen. Area of reaction covers back of arm around site. Recommended seeing MD. Antibiotics prescribed.
Patient received Positive Covid 19 test result on 02Jan2021; Patient received Positive Covid 19 test result on 02Jan2021; This is a spontaneous report from contactable consumers. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: IL0140), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received positive COVID 19 test result on 02Jan2021. The patient had unknown test with positive result on 31Dec2020. The case was identified as non-serious by reporter. Facility where the most recent COVID-19 vaccine was administered was in hospital. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the treatment received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The outcome of event was recovering.
Patient received vaccine and was waiting in the post vaccination area. About 10 minutes after getting the vaccine her husband come to the pharmacy window to inform the patient fainted. Ammonia inhalants were used and Liquid Benadryl was administered and 9-1-1 was called. She also started feeling nauseous and with urge to use the restroom. No hospitalization or further treatment required, per patient notification on 07/01/21.
pt states he came down with a 102 temp and was extremely week.  He had severe pain in ankles, knees and hips.  He ended up into the ER.  He had an US of legs, chest X-ray, and lab work.  They could not find anything wrong  with him and was told it was a reaction to the vax.  He had a negative Covid Test.  He has neuropathy in  his feet and the vax seemed to aggravate this condition.  This pain lasted at least 10 days.  He has started doing neuropathy therapy to help with his pain. He still has pain in his shoulders to this day.
Patient received Tdap 7/16/10. On Am of 7/19/10, patient was dropped off at camp, standing in driveway when he fell backwards, hitting head on drive way, had some tonic, clonic movements witnessed. Loss of consciousness for couple minutes. Awakened with headache. Transported to Hospital ER, admitted.
I. Body aches, headache, Fever, Chills, Leg swelling, rash on chest and legs, sores in mouth, and fatigue. II. IV steroids and oral steroids. III. Symptoms have resolved, but still taking steroids.
After 2 days pt experienced difficulty of breathing, dizziness, coughing, racing heart, palpitation, has a pacemaker, headache, was treated with Prednisone tablets
Dizziness started the next day and progressively got severe trying not to bump into things.  The dizziness lasted for a few weeks and progressed into weird feelings in her legs as if they were "jelly".  She was losing feeling in them and had trouble walking.   She was also progressively losing feeling in her hands and had numbness.  On 4/2 she had a bad fall due to her legs totally giving out.  She was taken to the hospital and released for bad sprain and bruising.  We went to her primary doctor to report her condition also.  I asked him to report about her condition and he had no idea what the VAERS database was.  A week after the fall she wasn't getting any better.  She was losing control of more of her body.  On 4/19 an ambulance took her to Hospital  and they did tests for a week and couldn't find what it was.  When she was transfered to another hospital she was diagnosed with Guillain-Barre Syndrome.  She was there for a week and is now in a nursing home and has no ability to walk or use her arms.
Patient was given an injection for the AFLURIA vaccine Lot R53107 exp 6-30-14 at 4:19pm on 9-1-13. On 9-5-13 I received a call from patient stating that after 3 hours from receiving the vaccine he felt sick and threw up. He had bad headache, body aches that lasted for 36 hours.
Existing light neuropathy in feet and hands increased about 4-5 days after first dose. Feet more pronounced than hands. Seems to be progressing vs receding. Have not had second dose yet. The neuropathy is not extremely painful or debilitating but is probably 25-50% more pronounced in my feet post vaccine and doesn't seem to be subsiding may be getting worse, but hard to tell.  Definitely some sort of reaction.
25Aug89 pt vax w/ hepta B; 29Aug89 exp vertigo + tingling in feet + hands. Disoriented in ER. MD attrib. exp to vax.
2/18/03 - fever 100.5 and took Tylenol and temp down to 99.5. Arm erythematous, edematous, very sore to palpation and unable to sleep on arm and did not sleep well since vax. 2/19/03 - continued fever, erythema and induration increasing in diameter, warm to palpation - call to PCP for c/o cellulitis. 2/20/03 Received antibiotics by PCP
This case was reported in a literature article and described the occurrence of systemic lupus erythematous in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced systemic lupus erythematous. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667867A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical TD controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical TD recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.