chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US025413, is an initial spontaneous report received from a healthcare professional on 03 Dec 2015. This report refers to a 36-year-old male patient. Past medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157603) subcutaneously at a dose of 0.5 ml, on 02 Dec 2015 at 18:15 pm. No adverse events were reported following the medication error. Follow up report received from a healthcare professional on 21 Jan 2016: Added suspect drug information (dose and vaccination time).
Patient waited 15 minutes after receiving the vaccine. He proceded to walk to our drop off area and  got dizzy and fell on the floor. It took him about 3 minutes to recuperate from the fall and I helped him to sit on a chair. Patient  started  being unresponsive so I decided to call the ambulance.  I put ice behind his neck and continue trying to communicate with him. Patient says he was just diagnosed with Afib and that his doctor has been swiching his medications . Patient says he has fallen twice at home .  Furthermore, this spell might not be caused by the vaccine but  by the patient  present condition and medications taken at the time.
diagnosed with Covid Virus; diagnosed with Covid Virus; This is a spontaneous report received from a contactable consumer.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid Virus".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Itchy rash starting on 12/22.  Rash moved all over body and varied in intensity gradually decreasing in intensity and duration over time.  Presently mild but still present on a daily basis.
Flu; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable female consumer reported that, a female patient of unspecified age received first dose of BNT162B2 (Pfizer COVD-19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via an unspecified route of administration on 13Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of vaccine and currently experiencing Flu. Outcome of the event was not recovered.  Information about lot/batch number has been requested.
Patient was administered HPV #1, right deltoid on 10/15/2014 3:50. Patient had local redness, swelling, pain at 6:00 pm. The reaction grew in size over 2 day to the size of a baseball. Mom iced area and ibuprofen for discomfort.
For two day, I did not feel good.  I had body aches.  I felt sick to my stomach. I felt like I was going to vomit.  I also had a slight fever.  I went to the doctor about it.  They gave me nausea pills.
Patient called the pharmacy and reported that after her vaccine she felt "bad". She had fever and itching and some SOB. It lasted about 24 hours then went away.  She did not report to the md but wanted to make sure that the pharmacy knew. She said a new guy had given her vaccine and she just wanted to make sure he knew what he was doing.  She was reassured that all staff administering  vaccines had been properly trained.
Tested positive for Covid on 17Sep2021; Tested positive for Covid on 17Sep2021; This is a spontaneous report received directly from a contactable pharmacist and also via the Program.  A 67-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 02Mar2021, as 2nd single dose, and via an unspecified route of administration on 03Feb2021 as 1st single dose, for COVID-19 immunisation. The patient's age at the time of both vaccinations with BNT162b2 was 66 years old. The patient's medical history and concomitant medications were not reported. There were no prior vaccinations within 4 weeks, while 8 weeks prior to vaccination (unspecified if 1st or 2nd). The patient had received pneumonia vaccine. The pharmacist stated that the patient tested positive for Covid on 17Sep2021. No hospitalization, ER visit or physician office visit was needed due to the event. At the time of the reporting the patient was at a rehab facility and where rehab tests were being done. The outcome of the event was not specified.   According to the reporting pharmacist the event was unrelated to BNT162b2.  This lot number for the vaccine, BNT162B2 was not provided and will be requested during follow-up. Based on information in the case, a possible causal association between the reported events COVID-19, vaccination failure and the suspect drug BNT162B2 cannot be excluded.
1 day after rec'd flu vaccine (and 5 d after starting Pen VK for strep pharyngitis) he developed urticaria and angioedema (face & feet), lasting 7 days (hives) (angioedema x 3 d). (I have referred for testing for Pen allergy)
Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for an unknown indication.     The patient's past medical history included Kidney cancer stage IV since an unknown date. Concomitant products included ATORVASTATIN, FINASTERIDE, METOPROLOL, CALCITRIOL and TAMSULOSIN for an unknown indication, FENOFIBRATE (FENOFIBRATE S).   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) outcome was unknown.            No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI
This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FC3184), at the age of 41, via an unspecified route of administration, left arm, on Sep 17, 2021, at 08:30, single dose, for COVID-19 immunisation. Medical history included allergy to hazelnut. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0172), at the age of 41, via an unspecified route of administration, left arm, on Aug 27, 2021, at 09:15, single dose, for COVID-19 immunisation. On Sep 17, 2021 at 09:15, patient felt flushed, had tingling in left arm and hand, also felt very dizzy and very tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of feeling flushed, tingling in left arm and hand, feeling very dizzy, and very tired were not resolved at the time of this report.
Allergic reaction/I started to get symptoms, I say about 20 minutes later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 04Feb2022 (Batch/Lot number: unknown) at the age of 24 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 04Feb2022, outcome "unknown", described as "Allergic reaction/I started to get symptoms, I say about 20 minutes later". Therapeutic measures were taken as a result of hypersensitivity.  Additional Information:The patient herself reported that her appointment was at 3 'O' Clock but she just running a little late so she would say more precise may be 03:15 (3.15 PM) 04Feb2022, she got the vaccine on her left and at about 03:30, she started to get symptoms as an allergic reaction, about 20 minutes later. She took some Antihistamine and some Tylenol as treatment medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT SHOWED PHARMACIST ON 10/11/2017 IN THE MORNING, SHE HAS ENTIRE RIGHT ARM SWELL AND RED. RECOMMEND HER TO GO SEE MD TO DETERMINE WHETHER SHE HAS INFECTION OR ADVERSE EFFECT FROM VACCINE. PATIENT HAD PNEUMOVAX 23 IN THE PAST WITHOUT ANY PROBLEM.
he has experienced Changes in his sense of taste, this being very similar to the taste of "medicine".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "he has experienced Changes in his sense of taste, this being very similar to the taste of "medicine"." Relevant laboratory tests and procedures are available in the appropriate section.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
ALL OVER ACHINESS, THROBBING IN ENTIRE HEAD, STIFF NECK
BURNING/ITCHING OF EARLOBE & LIPS (LFT SIDE), FOLLOWED BY SAME SYMPTOM -LFT EYE AND THEN TIP OF NOSE. (MY USUAL ALLERGIC REACTION TO MEDICATION).  TREATING W/BENADRYL - 25MG AS NEEDED. 2:55 PM, 3:55 PM, 7:05PM, 10:20PM, 11PM AND THEN 10 AM ON 06/20/2014.  WILL CONTINUE W/TREATMENT UNTIL ALL SYMPTOMS SUBSIDE.
Patient completed Pfizer COVID-19 vaccine series on 2/20/21. Patient presented to reporting hospital ER on 9/29/21 after complaint of weakness and was admitted for COVID and Troponinemia. He is currently not requiring oxygen. His symptoms were mild cough and weakness. Patient continues to be admitted at this time.
About three hours after injection i suffered a sudden severe joint pain in back of neck (cervical) where I had a previous neck surgery with disc replacement in the year 2019 and a terrible headache. Hours later I suffered from low back pain (old surgery site), fever, fatigue and more joint pain along with achey teeth.  Since 2/11 /21 , I have continued to have ongoing headaches with neck and low back pain, bilateral arm numbness and tingling  across shoulders.  Teeth still ache.  It's been over a month since second vaccination.
Extreme fatigue Dizziness Muscle aches Fever Pain at vaccination site Muscle soreness in right arm began within 39 minutes of shot administration. Pain worsened throughout the day, and by evening it was difficult to move it around because of the pain. This level lasted 30hrs and is reduced to initial soreness on day 3.  Dizziness began around 10pm, everything seemed disoriented. Extreme exhaustion occured about 11pm and patient slept for 18 hours. With brief episodes of coherence lasting no more than 5 minutes. Dizziness was still present when conscious. Fever occured in the middle of that night at 100.2. Fever was gone by 5pm. Dizziness had subsided also by 5pm. Muscle pain in full body persisted until 1am on may 4.
w/in 12hr of vax pt devel inj site rxn characterized by tenderness, redness, & swelling;tx w/DPh & Ibuprofen & recovered;
Left side of head fells like needles; Arm pain; Sleepiness and fatigue; Splitting headache on the left side of head/throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left side of head fells like needles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 001321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tuberculosis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARAESTHESIA (Left side of head fells like needles) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing). At the time of the report, PARAESTHESIA (Left side of head fells like needles), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing) had not resolved.     Concomitant medication was not reported. Treatment medication included paracetamol and oxycodone 5 mg.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Company comment:This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and non serious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on 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.; Sender's Comments: This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and nonserious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on 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.
Extreme pain in pad area at base of left thumb.  The injection was in the left upper arm.  I took Aleve every 6 hours for a day or more.  The pain subsided and left after 2 days.  On June 10th I was listless and without energy so sat most of the day and napped on and off.
Heaviness in arm after injection. Pain worsened and radiated to shoulder- no redness, bruising, swelling but decreased arm range of motion pain at deltoid but also into infraspinatous, tenes minor. NSAIDS, latab and use ice.
Patient was admitted due to acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Additionally was found to have bacterial pneumonia started on cefepime and Zithromax.  He was started on remsedivir along with Decadron.  CTA was negative for pulmonary embolism.  A few days into hospitalization the patient developed acute kidney injury nephrology was consulted felt it was likely secondary to thrombus.  The patient also developed bilateral foot ischemia surgery is consulted and recommended continuation of anticoagulation.  Surgery is consulted for line placement as the patient's renal failure progressed to needing dialysis with electrolyte abnormality and the patient's warfarin was reversed.  The following day the patient developed severe thrombocytopenia with platelet count and in the 30s thus further anticoagulation was held and hematology was consulted.  The patient's lower extremity ischemia progressed and his extremities were cold mottled from the knee down.  Multiple conversations were had with the patient and family and yesterday they decided given his overall poor prognosis and worsening condition the patient his family decided to cease aggressive care efforts and requested comfort measures.  The patient passed away today with family at bedside.
Substernal chest pain, with radiation to left arm which presented at rest, approx 10:00am. Notified physician at approx 12:00pm at which time vitals, physical done. Taken to local hospital where EKG findings consistent with pericarditis, elevated troponins indicated myocarditis. Admitted to hospital, discharged after 4 days.
pt recvd vax & devel redness, swelling & blisters formation of entire upper lt arm; pt was seen by MD & rx w/Pred for 12 days;
This spontaneous report was received from a pharmacist refers to approximately 65 year old female patient. The patient was allergic to penicillin. None concomitant medications reported. On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J008528 and expiry date 19-OCT-2014 (dosage regimen unspecified). On 12-DEC-2013 the patient developed an injection site reaction following vaccination. The injection site reaction was described as a raised, red, itchy area. The pharmacist reported that the patient had stated that the size of the injection site reaction had increased slightly reportedly since yesterday (approximately 12-DEC-2013) however exact size change was unspecified. The event was treated with cold packs. None lab diagnostics studies performed. The patient sought medical attention via contacting the pharmacist. The event was reported as not recovered. Reporter's causality was not provided. Additional information has been requested.
After 2 hours had severe shooting pain at site. Also had feelings of fatigue and lightheaded. Difficult to move left arm. Had short period of sharp chest pain which resolved. Still feels fatigued and achy.
Within 20 minutes from the time of this patient's shot, a rash broke out on her neck. The following day the rash is still on her face. No difficulty breathing or wheezing.
Almost immediately I experienced severe itching in both thumbs which spread rapidly over the hands and up the arms to the whole body, most severely in the scalp.  Self administered chewable children's Benadryl which I carry with me always. It needed 6 chewable while 4 is a standard adult dose. The itching reoccurs and remains severe in the scalp, it is most obvious at night. I self administered Tylenol for the itch and was seen by my dermatologist for my annual appt a week later and was given a topical steroid for the scalp. It is somewhat effective but it still reoccurs..
''I'' have had a chronic headache; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Aug2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 17Sep2021, the patient experienced chronic headache since the day after her last dose. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event chronic headache since the day after her last dose was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up (12Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts are completed. No further information is expected.
Developed itching, rash, facial redness, throat swelling, rhinorrhea, nasal congestion, chills and malaise starting approximately 10 minutes after intramuscular influenza vaccine--FluZone
Felt like a wasp sting at injection, very euphoric 8 minutes later and began the sweats, face is flushed and full feeling and medium headache
Chills, dizziness, fatigue, headache, and rapid heart rate were present from Tuesday 10/7-Wednesday 10/8. No fever, rash, or shortness of breath.
Patient reported being really drowsy a few hours after administration. Patient went to sleep and woke up around 4am with really bad stomach pain, body aches and chills. Patient went to the urgent care and stated that she had a fever when she arrived. The doctors told her it was a reaction to the flu shot.
Blood in the Stool, loss of appetite, and drowsiness for a week. Blood in the stool was for several days, one diaper had good amount, and later tinge.
Information has been received from a health professional concerning a 37 year old female pt who on 07Nov1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 07Apr04, the pt developed breakthrough chickenpox 50 to 500 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579,  WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
UrticariaPruritus Report by treating NP: "reported c/o itching s/p receipt of her COVIDdd-19 vaccination on yesterday, 11 January 2021 at 1440, was administered Benadryl 25mg po at 1242. Vitals BP-121/73; P-78; R 18; O2-99%. Discharged ambulatory without any use of any assistive devices. No reported SOB and/or other s/s, resolving of purititis upon discharge from COVID-19 Vaccine Clinic."
soreness of arm lasting more than 2 months. radiating pain but no tingling or numbness. soreness radiates to hand.
SWELLING OF THE VACCINE ADMINISTRATION SITE, FEVER, FUSSINESS, DROWSINESS, IRRITABILITY, INCONSOLABLE CRYING.
Flu like symptoms,  headache, body ache, no energy, nauseous.  She just started feeling better on 5/30/2021.
suffered permanent? hearing loss in rt ear w/in a few days of shot; dizziness & ringing in ears that is getting better;
This non-serious initial spontaneous case was received from Other Non-Health Professional on 02-Nov-2017, concerning a male patient of unspecified age. The patient's medical history and concomitant medications was not reported. On an unspecified date, the patient was administered with INN Flu Vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient had a bad reaction from the flu shot a few years ago - bad stomach pains. It was unknown if the patient took treatment for the event. At the time of this report, the outcome of the event was not reported.