chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad headache; chills; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included sarcoidosis, asthma, morphea, migraines and obesity. The patient had no allergies to medications, food, or other products. Concomitant medications within two weeks of vaccination included vitamins (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE), chondroitin (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, 24 hours after the vaccination, the patient experienced chills and fatigue which lasted for 24 hours. On 22Mar2021, 72 hours after the vaccination, the patient experienced bad headache which lasted for 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills and fatigue was resolved on 21Mar2021, while that of bad headache was resolved on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
received shot at 9:26am on 2/5 and felt arm tender and took 2 tylenol later in afternoon - woke up around 2am Saturday  2/6 with body aches - headache -chills  - took 2 more tylenol  .  Got up at 7am - still with same issues but with fever instead of chills  and took 2 excedrin had symptoms on and off all day.   On Sunday 2/7 - symptoms very mild only real discomfort was left arm still sore but ARM Pit really is sore.  Took 2 excedrin and it made it mild discomfort.  Only to wake up today Monday 2/8- with again really tender left arm pit & top of arm still moderately tender..
patient called later in the day to complain his arm hurt and he thought he had been given the shot too high up in the arm.  He stated he felt pain with the shot.  Advised him he could take Tylenol or ice  the area.  I also told him he could return to the pharmacy if he wanted us to look at it and advised him to keep us updated if the pain persisted or got worse.
4 hours after receiving flu shot experienced heavy breathing, fatigue, nervous, tired and dizzy. 1 hive above knee, advised to go to ER. Did not go - said she felt better.
Over two months, my symptoms progressed from pain and numbness in the left side of my face, lip and tongue, to numbness in my left hand and fingers and toes, to numbness in my right hand, fingers and toes. I knew I was losing strength in my hands by mid March, and got in to see a Neurologist.  By this time, I couldn't lift my leg against slight pressure.  She started ordering outpatient tests, starting with an MRI.  Within a week or so, I was having trouble walking with weakness in both legs.  On April 2nd, I started getting dizzy and felt I would pass out, so my boss took me to the ER.  They admitted me that night.  After a few days of tests, I received 3 days of intravenous steroids.
Pt's mother reported that a "large baseball sized lump" appeared on left arm the day after vaccination was given. Patient was seen at hospital emergency and took Ibuprofen. Ice, Benadryl and Ibuprofen moderately alleviated redness and swelling. Patient does not complain of pain or itching.
Peripheral neuritis in left 4 and 4th digits vaccine administered in left deltoid.
Admitted to hospital for thrombocytopenia. Platelet count = 19,000. Hematology believes ITP secondary to MMR vaccine. Admit date was 9/5/02.  Nurse follow up on 07/08/04 states: "Bacteremia, otitis media."
Pfizer Dose 1 2/25/21 (EN6200) Pfizer Dose 2 3/19/21 (EN6208) Pfizer Dose 3 12/4/21 (FH8027) COVID Positive 1/5/22  1/12/22: A 75-year-old female with a past medical history of paroxysmal atrial fibrillation on anticoagulation with Eliquis, COPD, chronic hypoxic respiratory failure on home oxygen, hypertension, hyperthyroidism, thoracic aortic aneurysm and chronic HFpEF comes to ED complaining of chest pain.  Patient complains of left-sided chest pain radiating across to the right, started this morning, not associated with shortness of breath or palpitations or nausea or vomiting.  Denies cough or fever or chills.  States that she had some abdominal pain with nausea and vomiting and diarrhea a couple of days ago which is resolved.  Patient had recent upper respiratory infection, was tested positive for COVID-19 on 01/05/2022.   In the ED, she was afebrile, vital signs stable, pulse ox 98% on room air.  Troponin is positive 0.12.  EKG showed atrial fibrillation, rate controlled.  ED provider has discussed the case with on-call cardiologist, patient is started on nitro drip.  She is seen by me on the medical floor, states that she does not have any chest pain at this time.  1/15/22:  Patient is a 75-year-old female with a past medical history of paroxysmal atrial fibrillation on anticoagulation with Eliquis, COPD, chronic hypoxic respiratory failure on home oxygen, hypertension, hyperthyroidism, thoracic aortic aneurysm, chronic HFpEF adn recent diagnosis of COVID 19 came to ED complaining of chest pain.  Patient admitted for NSTEMI.  Patient was noted to have elevated troponin with no acute EKG changes. Patient was started on heparin drip.  Cardiology was consulted.  Patient had cardiac catheterization but did not require any intervention.  Continue medical management.  On discharge patient is chest pain-free.  Patient will follow-up with Cardiology as needed.
Severe hives, redness and swelling of the entire shoulder. And then temp elevation then it was causing me some respiratory compromise. Lots of wheezing and coughs. That resulted in me getting Benadryl injection and steroids', topicals and use of my inhaler. I probably added a couple of nebulizer treatments too. Dr. stated it's a localize reaction. It took about 3 weeks for me to be fine.
I had a headache, blurred vision, and nausea. My doctor prescribed diltiazem CR for hypertension.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concomitant products included valaciclovir (Valacyclovir). On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th November 2018, the patient received the 2nd dose of SHINGRIX. On 15th February 2019, 196 days after receiving SHINGRIX and 99 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient had a history of shingles and took valcyclovir.  The batch number and expiry date was not available. The patient reported that she developed another case of shingles and was very upset as the vaccine did not work.  The patient was requesting reimbursement as well. The reporter granted permission to contact her physician.
Tennis ball size swelling at injection sight (upper left arm); redness; skin hot to touch; extremely sore to the touch; shooting pains down arm.
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Pain in right arm, muscle pain through body, fever 102 degrees, chills, nightmares, lethargy, headache, profuse sweating
Extreme itching on neck & chest, arms & legs; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 23Feb2021 at 12:45 (at the age of 77-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Known allergies were not known. The patient did not receive any other vaccine in four weeks. Concomitant medications received in two weeks included lisinopril (LISINOPRIL) and metoprolol (METOPROLOL) both taken for an unspecified indication, start and stop date were not reported. The patient experienced extreme itching on neck, chest, arms, and legs on 23Feb2021. The patient did not receive any treatment. She was not sure whether to have second vaccination on 16Mar2021. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NauseaVomiting pain and stiffness at injection site; fatigue; nausea Narrative:
Headache, Myalgia, PAIN AT INJECTION SITE, FATIGUE Narrative:
Rash with itching and redness on right arm at injection site,Along with slight headache,Sore throat ,and fatigue
This spontaneous report as received from a physician via a company representative refers to an 18 years old female patient. On an unspecified date in February in 2014 the patient was vaccinated with the second dose of GARDASIL (lot# unspecified) (strength, dose, route and location unspecified). The patient developed Guillain-Barre syndrome "shortly after receiving the GARDASIL" on an unspecified date as reported (estimated on the same date of the vaccination). The patient was hospitalized on an unspecified date in 2014, the physician stated that the Guillain-Barre syndrome was life threatening and caused a significant disability in the patient. The patient was eventually transferred to an unspecified rehabilitation center on an unspecified date and it was unknown if the patient was still at the rehabilitation center. Patient was administered immunoglobulin on an unspecified date in 2014 as treatment for the Guillain-Barre syndrome. At the time of the report, the patient was not recovered from the event. Upon internal review, Guillain-Barre syndrome was considered as medically significant. The reporting physician considered the Guillain-Barre syndrome to be disability and life threatening. Additional information has been requested.
Patient came in after an ER visit for a reported intentional opioid overdose. She was doing ok at the visit, some minor wheezes on exam. She had requested refills on meds and reported having worsening asthma after her first shot but no ER visits.  We decided to give her the second moderna shot due to her high risk should she contract covid 19 and sent her home with a course of prednisone in case of exacerbation. RN administered injection and had her wait in the room after the visit per protocol, patient was  doing fine and was sent home. We found out several days later she passed away at home according to a coroners report of reported possible asthma exacerbation versus drug overdose, still being investigated. coroner reported finding drug paraphernalia at the scene and case is pending tox screen results.
DEATH Narrative: No information about patient's death in record, patient received most of his care outside the clinic with only 2 ambulatory care notes in clinic total. Had diagnosis of CLL and was no longer on chemo. No documentation of: prior COVID infection, immediate ADR to COVID vaccine, prior hospitalizations for covid or anything else, death note, autopsy Unlikely that covid vaccine resulted in this patient's death, but was due to advanced age and diagnosis of CLL.
4/9 IV vanc for MRSA pneumonia completed 4/18 1 PRBC 4/20 R thoracentesis 350 ml 4/21 Moderna COVAX booster administered 4/28 bronch: moderate mucoid secretions, all lobar bronchi patent. Pooled wash sent for GS/cx post-bronch CXR not done. Nephrology consult 5/2 Zoster R face. FEES "moderate pharyngeal dysphagia, silent macro aspiration of mixed consistencies and thin liquids. 5/4 ID consult 5/7 1 PRBC, AKI worsening 5/9 MRI new small strokes, likely embolic 5/10 HD initiated, RIJ vascath placed. Trach changed to 8 Bivona. Acyclovir resumed for POSSIBLE varicella encephalitis 5/11 LP, varicella in CSF, bradycardia worse. I spoke with Dr. - he reviewed the MRI - large old strokes but the new lesions are tiny and do not require intervention, recommends ongoing observation 5/25 1 PRBC, Pseudomonas and Serratia pneumonia, Staph epi bacteremia 5/30 comfort care 6/1/22 pt died
mom states pt cried all noc; no fever but had sl lump on rt thigh where DTP was given; cried from 10PM-2AM high shrill; MD contacted; deneid any other sx per mom; seen by MD following day;
Systemic: Body Aches Generalized-Medium, Systemic: pain in both arms radiating from arm pit to elbow-Medium
Was completely fine after injection (4/6) with just a little soreness for 24 hours at the injection site.  On 4/14, noticed swelling and redness at injection site on upper left arm.  There is about a 3" spot around the injection site that is swollen, warm and red.  Its not itchy, it doesn't hurt, and doesn't affect sleeping, any activity, etc., I can just feel the inflammation at the spot when I touch or raise my arm.  I have been using hydrocortisone cream and have taken ibuprofen to try to reduce swelling.  No other symptoms and I feel completely healthy otherwise.
woke up at 1am with chills and a headache; woke up at 1am with chills and a headache/felt rundown with a lingering headache; This is a spontaneous report from a non-contactable consumer (patient).  A 31-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 31-year-old via an unspecified route of administration on Left arm on 09Feb2021 09:00 (lot number=EN5318) at single dose for COVID-19 immunisation.  Medical history was none. There was no known allergies, no COVID prior vaccination or no COVID tested post vaccination. No other vaccine was received in four weeks. Concomitant medication included iron, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previous took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-year-old on Left arm on 16Jan2021 (lot number=EL3248) at single dose for COVID -19 immunisation. The patient felt fine all day, but woke up at 1am 10Feb2021 with chills and a headache (did not check temperature), took paracetamol (TYLENOL) and was able to get back to sleep. In the morning, felt rundown with a lingering headache, took ibuprofen. Around 1pm, symptoms were gone. The events did not result in emergency room or physician office visit. The outcome of the events was recovered on 10Feb2021 13:00.
Fever 104 F.; Chilling; dizziness; nausea; first dose of  BNT162B2 on 21Dec2020, administration date 07Jan2021, dose number=2; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date unknown), intramuscular in left arm on 07Jan2021 at 15:30 at a single dose for COVID-19 immunisation.  The patient had no medical history and no known allergies.  There were no concomitant medications. Historical vaccine included first dose of  BNT162B2 on 21Dec2020 for COVID-19 immunisation. Patient did not receive any other vaccines prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced fever 104 F, chilling, dizziness and nausea on 08Jan2021 at 13:15. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering at the time of report.   Information on the lot/batch number has been requested.
Fever + fussiness started the day after vaccination + continued x 4 days when seen due to increased fussiness
R eye swollen on Tuesday night after shot, resolved. Tongue swollen, which started Wednesday night, ongoing.
Started with redness on left side of chin on Thursday morning spread to right side and spread up to cheeks and down to chest. It became very itchy.; Started with redness on left side of chin on Thursday morning spread to right side and spread up to cheeks and down to chest. It became very itchy.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: En6208) via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included cancer of the mouth. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), nortriptyline (MANUFACTURER UNKNOWN) and lorazepam (MANUFACTURER UNKNOWN) all for unknown indication. The patient previously received levofloxacin hemihydrate and experienced allergy. The patient also previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EN9809) via an unspecified route of administration in the left arm on 22Feb2021 at 11:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 12:00, the patient experienced redness on the left side of the chin and on the same day morning it had spread to right side and spread up to cheeks and down to the chest. It was very itchy too. The adverse event resulted in an emergency room/ department visit or urgent care. The patient was treated with hydroxyzine hydrochloride tablet (MANUFACTURER UNKNOWN) and triamcinolone acetone (MANUFACTURER UNKNOWN) for the reported events. The clinical outcome of the events redness and itchy was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
What's known as "COVID Arm". After about two days I had a red circular lifted area at the site of the vaccination. Over the course of the next few days, I had a large (about 4 inches down and across) red rash area that was warm at the touch. It was a bit itchy.  This lasted for about a week and a half/2 weeks. Around week and a half/2 week mark it got less red and a bit flaky. The color now is pretty normal but still a bit flake.   *I'd also like to report that I was diagnosed with COVID-19 on January 4, 2022 , 6 days after I received the booster. I am not sure where or how I got it. It could have been before or after I got the booster.
Information has been received from a registered nurse concerning a 10-month-old male who on 13-NOV-2006, 12-JAN-2007, and 24-MAR-2007 was vaccinated with the first, second, and third doses of Rotateq. On 22-JUL-2007 the patient experienced intussusception and was hospitalized. The intussusception was corrected with a barium enema and the child was released from the hospital. The patient recovered. No other information was available. Intussusception was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested. 8/27/07-records received for DOS-7/22/07-DX: Intussusception. Reduced with Barium enema. C/O abdominal pain since toady 7/22/07-Cranky, crying, waking up. No fever. No vomiting. No diarrhea. No rash.
This spontaneous report as received from an medical assistant refers to a female patient of unknown age. On 04-MAR-2013 the patient was vaccinated with VARIVAX (merck) in error, instead of ZOSTAVAX. No product confusion discovered, just medication error. ZOSTAVAX (Merck). No adverse event reported. Additional information has been requested.
Slight headache (starting 15 hours post-shot); Fatigue (starting 15 hours post-shot); Chills (starting 24 hours post-shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 17:00 (Lot number: FF2590) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetic" (unspecified if ongoing). Concomitant medication(s) included: TRESIBA; HUMALOG; DIOVAN; OMEGA-3 FATTY ACIDS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731), administration date: 10Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534), administration date: 20Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Oct2021 08:00, outcome "recovering", described as "Slight headache (starting 15 hours post-shot)"; FATIGUE (non-serious) with onset 16Oct2021 08:00, outcome "recovering", described as "Fatigue (starting 15 hours post-shot)"; CHILLS (non-serious) with onset 16Oct2021 08:00, outcome "recovering", described as "Chills (starting 24 hours post-shot)". Therapeutic measures were not taken as a result of headache, fatigue, chills.  Additional information: Facility where the most recent COVID-19 vaccine administered was pharmacy or drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable pharmacist based on information received by Pfizer from Merck and Co., Inc. 00101802. A 1-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and the patient's concomitant medications were not reported. The vaccine was not effective. No additional information provided. Follow-up (12OCT2016): Follow-up attempts are completed. No further information is expected.
Shoulder pain in the injected shoulder radiating to the posterior scapula with paresthesias and numbness in median nerve distribution of the hand associated with axillary lymphadenopathy and tenderness for the 5 days so far since the injection. No signs or symptoms at the actual injection site.  No other systemic signs or symptoms after some malaise on the day following the injection. This shoulder was asymptomatic before the vaccination and is the shoulder for the non-dominant hand. The self-reporting patient is an orthopedic surgeon.