chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of hepatitis B antigen positive in a 65-year-old male patient who received ENGERIX B adult (batch number 2FJ73, expiry date 8th July 2017). On 13th June 2015, the patient received the 1st dose of ENGERIX B adult (intramuscular) 40 ug. On 2nd July 2015, 19 days after receiving ENGERIX B adult, the patient experienced hepatitis B antigen positive. On an unknown date, the outcome of the hepatitis B antigen positive was unknown. It was unknown if the reporter considered the hepatitis B antigen positive to be related to ENGERIX B adult. Additional details were provided as follows: The patient was a dialysis patient who received 1st dose of ENGERIX B. The patient experienced prolonged antigenemia of hepatitis B surface antigen. On 2nd July 2015, the patient underwent laboratory test and was found to be positive for HBsAg (Hepatitis B surface antigen) and all other serologic markers were negative. The anti HBsAg was less than 3 mIU/ml, which was the lower limit of the test. On 6th October 2015, at the time of reporting, the patient underwent laboratory test and found to be positive for HBsAg (Hepatitis B surface antigen) and negative with regard to all other serological markers. The reported batch number (2SJ73) of ENGERIX B did not exist and was updated to 2FJ73 as per the sales database.
Not sure if it's due to vaccination. After getting a Colonoscopy, started going into Afib. Went to the ER and was given unknown medication to slow my heartrate back to normal. Was sent home after it stabilized. Was fine after this with no reoccurrences.
After about 15 minutes of having the shot administered in my left arm, my left hand starting tingling, then went numb.  I waited in the lobby for about 30-45 minutes to see if any more reaction was going to occur.  I left the medical facility to come back to work and my right hand also started going numb.  I called my husband to meet me for lunch to monitor any progress.  Both hands still being numb feeling, I started feeling my right leg starting to go numb after about 3 hours after taking the shot.  It subsided a little so I chose to drive home following my husband.  I was about .5 miles from home when felt a creepy, goose bump feeling going over the back of my head and my vision in my right eye got so blurry I could not see out of it.  I blinked numerous times to make sure it wasn't something in my contact lense and drove the remainder of the way home going.  My vision started to return by the time I made it home.  I was home about 30 minutes when my stomach had severe cramps for about 2-3 hours, then it subsided.  Then my left leg started going numb and I felt completely exhausted for 3 days and am still feeling "wiped out".  The numbness came and went all Friday night and into Saturday.  The numbness continued throughout the weekend off and on and into the next week and has forced me to rest. I am still experiencing numbness, swelling in my hands and feet, it is painful to type at a computer keyboard and the my energy level is very low.   My blood pressure was taken on Feb. 14, 2005 and it was somewhere around 170/90.  It has never been that high, but it was taken 40 minutes after a very light physical therapy session of which I couldn't do much because of my condition. I have made an appointment to have a complete physical done on Feb. 18, 2005, with my Internal Medicine doctor.  I talked to nurses at the Health Dept. and they all said they had never heard of a reaction like mine before.  Four days after the vaccination (Feb. 15, 2005), I received a flu shot with no adverse affects from that shot.
Got first covid vaccine on 1/29/21. no significant rash until 2/3/21 and 2/4/21. Patient stated it really did not seem to take off until 2/6/21 when the  rash came around on the right side of the chest and right breast. This had  a lot of associated pain. Patient went to the ER on 2/7/21 and followed up with PCP on 2/8/21.
had soreness at injection site (left arm) day of and 1.5 days after then nothing until Wed Jan 20 late afternoon. noticed itch in arm similar to bug bite then noticed large red patch  on side of arm and some swelling. more swelling and heat on arm Thurs 1/21 morning felt lightheaded and "off" around 0720AM but that went away by 0815AM and didn't occur again. redness and itch have persisted and continue to be present to this day though faded but with 2 darker red streaks about .25 to .5 inch. it has spread around arm toward medial. bruise at injection site. have not been able to get with primary care doctor at this point
stroke; severe urinary tract infection; cardiovascular issues; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 63-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) used: severe urinary tract infection, cardiovascular issues and stroke. The outcome of cerebrovascular accident, urinary tract infection and cardiovascular disorder were not reported. The reporter considered cerebrovascular accident, urinary tract infection and cardiovascular disorder to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was determined to be a medically significant event.
Flushing, palpitations, urticaria on chest, near syncope, chest tightness, BP 170/100 Pulse 130 Resp 18.  1:50 pm 50mg Benedryl po. Pt then felt worse. Transported to ER.
Swelling of lymph nodes in armpit same side of injection 2 days after; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Sep2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 03Sep2021, 2 days after the vaccination at same side of injection, the patient experienced swelling of lymph nodes in armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lymph nodes in armpit same side of injection 2 days after was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 20 March 2007 from a healthcare professional. A 54 year old female patient received on 13 March 2007 a dose of Decavac (lot# U1923GA) and three days post vaccination experienced headache, generalized myalgias - ankles, knees, hips, shoulder and wrist. Seven days post vaccination, the patient experienced redness at injection site. The patient was treated with Zyrtec 10 mg, Prednisone and Keflex. The patient had not recovered. The patient had laceration right meddle finger at vaccination time. Medical history included: gastric bypass (5 years ago), allergies to Cipro, Codein and Morphin. Other medications included: Ambien CR 6.25mg, Lexapro, Allegra, Zelnorm.
ended up with paralysis; got last flu shot in 1976 and was very sick for many days; Initial information was received on 01-Mar-2021 regarding an unsolicited valid serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210304000371).  This case involves an adult patient who experienced ended up with paralysis (paralysis) and got last flu shot in 1976 and was very sick for many days (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a paralysis unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date, the patient got last flu shot in 1976 and was very sick for many days (illness) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown for both the events.  Information on batch number is requested.; Sender's Comments: This case involves an adult patient who experienced paralysis and illness (unknown latency) after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
runny nose; slight chest tightness; wheezing; face flushed red; face flushed red; headache; chest skin got itchy; stomach cramps; bouts of diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 69 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205) via an unspecified route, administered in Left Arm on 02Mar2021 at 16:30 (69-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included stage 1 breast cancer IDC, diagnosed in Oct20219, seasonal allergy, dust allergy, avocado allergy, some food allergies, sensitive to many foods, known allergies to sulfa drugs. The patient's concomitant medication(s) included exemestane, docosahexaenoic acid, eicosapentaenoic acid (OMEGA 3), pravastatin, ergocalciferol (VIT D), ascorbic acid (VIT C), calcium carbonate (CALCI) within two weeks of vaccination. The patient previously took ciprofloxacin (CIPRO), MACRODANTIN and experienced allergy. The patient had not received any other vaccine in four weeks prior vaccination. On 02Mar2021 (after first dose of vaccination), the patient had experienced with headache at 16:45 after vaccination; chest skin got itchy, 55min; face flushed red, 120 min; runny nose and slight chest tightness and wheezing began. Most symptoms went away within 5-6 hrs. No injection site pain at all, but stomach cramps and bouts of diarrhea lasting a week.  She was advised by her allergist not to get dose 2 of vaccine. The outcome of the events was recovered on an Mar2021.  No follow-up attempts are possible. No further information is expected.
19AUG93 site of TD is red blotchy & painful; 20AUG site still very reddened & painful to touch involving most of upper deltoid area but better than 19AUG resolving;
3-4 days after shot i had tightness in chest and heart pain. after receiving care from ER i was informed i had developed Pericarditis. swelling of my heart. on 9/27/2021. i have never had any previous health conditions in the past.
Severe chills, fever, body aches, severe vomiting, severe dehydration from not being able to keep any fluids down, diarrhea, pain in chest during heavy breathing, and excruciating pain in neck and upper back (even with Advil and Naproxen).
04/11 (Day 4 after 2nd shot) - Scratchy throat starting, some cough 04/12 (Day 5) - sore throat, cough, fatigue, headache, fever overnight, Metallic taste in mouth.  Got worse throughout the day. 04/13 (Day 6) - heavy cough, sore throat, fever, chills, heavy fatigue, Metallic taste in mouth.  Unable to work the majority of the day.  04/14 (Day 7) - heavy cough, sore throat, fever, chills, flushed look in face, heavy fatigue, Metallic taste in mouth, loss of appetite.  Unable to work the majority of the day.  04/15 (Day 8) - cough, dizziness, headache, fatigue, teeth and left jaw hurt, metallic taste in mouth but not as strong.
felt like she had the flu; felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-354446 (Patient Link).
Initial information received on 03-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office staff). This case involves unknown demographic patient (age and gender not reported) who was vaccinated with a dose of PENTACEL lot number: C5463AA via unknown route in unknown administration site on an unspecified date (reported suspected incorrect dose dates as May 17-July 17th) without the diluent. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
"feeling lightheaded",   no chest pain, no sob. She has not eaten, symptoms resolved after crackers and ginger ale
Skin rash  on forearm- skin colored bumps, very faint. I had a bit of an itch there and noticed a few bumps however, the itch did not persist.  I inspected the rest of my body and I couldn't find any other signs of a rash. The rash is on both arms and is only on the outer part of my forearm covering about the entire area where hair grows on your forearm to give a general idea. The rash spans between my elbows and wrists.
Patient had a syncope episode shortly after sitting down in his seat for post vaccination. Patient fainted for less than 30 seconds and fell forward to the floor from sitting position. After regaining consciousness, I instructed patient to put his head down in between his knees and he said he felt a lot better, Patient waited in the post vaccination area for over 30 minutes and left fine.
VOMITING; NAUSEA; FEVER; CHILLS; DRY HEAVING; SHAKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced dry heaving. On MAR-2021, the subject experienced shaking. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, and had not recovered from chills, dry heaving, nausea, shaking, and vomiting. This report was non-serious.
I have lost 3 friends in Spain; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for twelve patients. This is one of twelve reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated "I have lost 7 friends in , 3 in , 1 in and a friend of my son 14 years." The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/product, different patient; Reported Cause(s) of Death: lost 3 friends
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-MAY-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (Batch # 671075, lot # and exp date 671075/1197AA, 25-OCT-2012), 0.65 ml (route and indication were not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Expired FLUZONE QUADRIVALENT was administered to three patients with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Regulatory authority (Reference number- 00801285) and transmitted to Sanofi on 06-Oct-2021.  This case involves three patients who were received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patients were not received any other vaccine.   On 06-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry: 30-Jun-2021, formulation: solution for injection) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller stated a temperature excursion on Fluzone (high dose) HD expired. Lot: UT7073LA Exp: 06/30/2021 Stated that the expired vaccine was given to 3 different patients. Pharmacist states that a box of FLUZONE QUADRIVALENT from last year's flu season was administered to 3 staff members (Nurses) today. At this time he does not have information on those individuals; identity, age, Et cetera (etc.) All 3 were given today and none of them received any other vaccines."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Low grade fever, fatigue and chest pain developed 1 day after meningitis vaccine. Seen at urgent care had ST elev on EKG -> sent to ER. Had high troponin levels, diagnosed w/ pericarditis and myocarditis observed for 4 days in cardiac step down unit d/c on colchicine 0.6mg BID, aspirin 325mg q day, naproxen 500mg BID, PROTONIX 40mg qd.
Dermographia  and chronic urticaria that lasted 4 months. Cetirizine helped taken in 5 mg tabs daily
I have a pea sized nodule  elbow my AC joint with swelling surrounding the strain the same side I received my injection on. I received both injections on the left side.
diabetic coma; blood sugar kept dropping; This is a spontaneous report from a contactable consumer (patient's neighbor). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes and coronary artery disease, and back surgery. The patient's concomitant medications were not reported. They think the patient went into a diabetic coma from low blood sugar dropping on 01Apr2021 and the patient passed away in his sleep. Reporter does not know if it had anything to do with the shot or anything but he thought they may want to know that. The patient started having problems with his blood sugar on Thursday 01Apr2021. The patient's blood sugar kept dropping and he went to bed that night and died. Patient was found deceased Friday morning 02Apr2021.  Information about batch/lot number has been requested.; Reported Cause(s) of Death: Blood glucose decreased; diabetic coma
right sided facial droop; blurred vision; head pressure; This is a spontaneous report from a contactable healthcare professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 21May2021 14:45 (02:45 PM) (Batch/Lot Number: EW0171) (at age of 48-years-old) as 1st dose, single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies. The patient did not have any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. On 21May2021 14:45 (02:45 PM), the patient experienced right sided facial droop, blurred vision, and head pressure. It was unknown if the patient has been tested for COVID-19 prior to vaccination. Therapeutic measures were taken as a result of the events which included vitals (as reported). The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event right sided facial paralysis, blurred vision, and head discomfort cannot be totally excluded.  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 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.