chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Booster 1/31/2005, 25 hours c/o swelling, redness and heat, ice and ibuprofen Tx reported and seen 2/3/05.
Information has been received from a physician concerning a male who was vaccinated with a single dose of ZOSTAVAX. After the patient received the dose of zoster vaccine, he developed a knot on his arm the size of a golf ball. No other information was reported. This is one of several reports from the same source. Additional information has been requested.
My entire right arm (including my fingers) went numb on Tuesday night (10/29/2013) when I sat down to relax after a long and active day. Wednesday night (10/30/2013) my arm went numb again after I laid down to sleep for the night, although my fingers were not affected. In addition to the numbness, I experienced a dull, throbbing pain which started shortly after recieving the vaccine, has been present all week, and flared up again on 11/02/2013 around 1745, keeping me from sleeping before my 2345 shift that night. I developed a cough on 11/01/2013 which may also be related to recieving the vaccine. Like I said, this wouldn't concern me after only a day but these problems have persisted for four days after recieving my shot. The pain is pretty bad, but not enough for me to want to use medications at this time.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant and treatment drugs were provided.   Reporter did not allow further contact
This study case was received from the investigator in a trial on 06 June 2011. A 29 year-old male subject with no significant medical history was found to have encephalitis following immunization procedures 9 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported) and Tdap (manufacturer, lot number, route and site of administration not reported) on 08 August 2010. He also received on 11 July 2010 an injection ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
making me so sick; elevated blood pressure; This is a spontaneous report from a contactable consumer or other non hcp (patient), based on information received by Pfizer (manufacturer control number: EC-2020-078599) license party for bnt162b2.  A female non-pregnant patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization, lenvatinib mesilate (LENVIMA), oral from 24Jul2020 (Batch/Lot Number: 156216) to an unspecified date, at 10 mg, once daily for Malignant neoplasm of endometrium. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced new elevated blood pressure and making her so sick on an unspecified date. Patient further stated she missed about 5 doses of Lenvima after 2nd COVID vaccine due to the vaccine making her so sick. The action taken in response to the event(s) for lenvatinib mesilate was unknown. The outcome of events was unknown.  Causality Assessment for Illness as Per reporter and Per Company was Not reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 29-years female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UI995AA, expiration date: 01-APR-2019, dose: 0.5, route: Intramuscular and site of administration was in right deltoid) on a 22-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was reported the FLUZONE HIGH DOSE was given to 29-year female employee. It was unknown if 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 holders 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.
Pt developed urticarial rash-noticed in am of 7/26/02; now new soaps/detergents or medications. Possible history of new food  on 7/25/02. No doubt rash is 2 to vaccines but report 2 to time interval.
PATIENT EXPERIENCED RASH ON BOTH SIDES OF HER FACE. NO OTHER SYMPTOMS REPORTED. RASH APPEARED 30 MINUTES AFTER ADMINISTRATION. ONE DOSE OF 10ML DIPHENHYDRAMINE 12.5MG/5ML WAS ADMINISTERED ORALLY.   RASH ON FACE MOSTLY DISAPPEARED 40 MINUTES AFTER DIPHENHYDRAMINE DOSE.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient was given an antibiotic by doctor to treat swelling/inflammation.
Prior to administration of the vaccine, 6 hours prior, patient warned pharmacist of needle phobia and panic attacks related to post injections. However, patient willingly chose to take the vaccine due to worker mandate. After administration, patient almost passed out three times. Pharmacy called 911. EMTs arrived, by the time, EMTs arrived, patient was back to normal. Vitals were checked and were normal also. Patient was monitored for thirty minutes. Patient was able to walk out on his own, with a family member.
24 hours after immunization a raised, itchy rash began on thighs, continued onto torso (front and back), then arms and finally to back of hands and top of feet within 24 hours. Given Benadryl Fri, Sat and Sun. Rx'd Zyrtec on Mon (8/18). Intensity of both itch and rash began to decrease on Tues (8/19) on arms and legs.
BP 138/78 L arm, heart rate 81, o2 98%, pt felt dizzy after sitting for 30 minutes felt better with water
Throat and chest tightening, heating up, swelling. Difficulty breathing. Occurred initially after 5-10 min of vaccine injection. Symptoms have been reoccurring in episodes since day of injection to present day.
Child given age-inappropriate Influenza vaccine incensed for age 4 + years.  No adverse event reported.
Initial report received from a patient on 24 July 2007. A 28 year old female patient (with a history of an adrenal tumour) had joint and muscle aches and low grade fever, 1 day after she Adacel (lot number C2769AA) subcutaneously in the left arm on 10 July 2007. She now had a "stiff neck" and black and blue" area and hard nodule at the injection site. The patient did not have any illness at the time of the vaccination, but had a needle stick at work. She was evaluated at the ER on 21 July 2007 and Motrin was given. At the time of the report, she had not recovered.
had a big red arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (had a big red arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE ERYTHEMA (had a big red arm). In 2021, VACCINATION SITE ERYTHEMA (had a big red arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking unspecified blood pressure medication and diabetic medication.  The patient reported taking first dose in Feb-2021 and a third dose on 20-Sep-2021.    This case was linked to MOD-2021-329087, MOD-2021-329306 (Patient Link).
Information has been received from a physician concerning a female who in "early" December 2007, was vaccinated with Zostavax (Oka/Merck).  Five to six days post vaccination the patient developed a rash on her face.  The rash remitted, and the patient developed another rash on the opposite side of the face (date unspecified).  The physician prescribed an antibiotic to treat the rash.  The rash resolved.  There were no other symptoms or treatment.  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
After a few hours starting feeling like I had the flu. Fever continued to rise and topped out at 100.7 around 9 pm. Had severe chills where  I was visibly  shaking.  Fever broke around 2 am and was severely sweating.  Chills had mostly stopped by this time. Still continued with a slight fever until it once again broke around 10:30 am. Continued to get better throughout the rest of the day and finally returned to work on Thursday morning.
Resident was weak, fatigued and had a fever of 101. F the following morning after receiving the 2nd dose of vaccine. Later in the day she was feeling better and vital signs were WNL. The next morning, she was found unresponsive and pronounced dead by paramedics.
Pt received small pox vax 04/03, 7-10 days later pt complained of body aches, headache and substernal chest pain. Chest pain described as mild, lasting for 2 days (etiology unknown). Pt did not report at that time of his symptoms. After return to states saw civilian MD for episode in April 2003 for pt's symptoms at that time. During outprocessing 07/23/03 pt informed MD.
A pharmacist reported that an adult male of unspecified age was a non-responder following completion of Hep B vaccine recombinant (Engerix-B) series. The subject's medical history, concurrent medical condition, and concurrent medication were not provided. Over a year ago, in 2001, the subject received three injections of Hep B vaccine recombinant (Engerix-B). Serological tests were performed and revealed that the subject was a non-responder. The subject was administered a booster injection of Hep Engerix-B (20 mcg.). Approximately 1 to 2 months later (date unspec'd), titers were performed again and revealed that the subject still was a non-responder.
Acute on chronic systolic (congestive) heart failure - Has appropriately diuresed on IV Lasix. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Pt received vaccine 11 days prior to due date. No adverse reaction noted at the time of observation after the administration.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minutes and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007705: US-009507513-1705USA007706: US-009507513-1705USA007707: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
ErythemaMultiform & UrticariaPruritus Narrative: URTICARIA, RASH HEAD TO TOE, PRURITUS after COVID Vaccine was given (evening)
4 days after 1st Pfizer vaccine, was on vacation. Had hiked earlier that day at national park and had seen the sunset on that evening. While sitting at the table playing cards, had an allergic reaction of unknown origin. Child reported that her lips started to feel funny, then she began to develop hives on her face. Gave a Benadryl tablet and took immediately to ER (hospital was thankfully about 2 minutes away from our vacation rental). Epinephrine administered and then monitored at ER and an additional dose of Epinephrine then given. Hives, swelling and redness were throughout her whole body. About 4 hours after first dose of Epinephrine, many hives went away however some were still present so given additional dose by ER doctor. Initially was told vaccine reactions will only occur within 24 hours of vaccine and the only possible trigger they could think of was a brown tailed moth hair which apparently is in the vacation location. Now we have to carry around an EpiPen for her. No allergic reaction after 2nd Pfizer vaccine. Since, has become allergic to neosporin and today allergy testing showed she is now allergic to Polymyxin.
CHILLS; FEVER; This spontaneous report received from a patient concerned an elderly female. 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: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 06-APR-2021. This report was non-serious.
The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; The patient received the 2nd dose of GARDASIL 9 and experienced redness tenderness and swelling of the face, a 4.5cm lump on buttocks where injection was given, and also edema in unspecified locations.; This spontaneous report was received from a 31 year old female patient reporting on herself via company representative. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.   On 19-JUL-2020 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, lot # and expiration date were unknown) for prophylaxis.   After vaccination on 20-JUL-2020, the patient experienced redness (erythema) tenderness and swelling of the face, a 4.5 cm lump (injection site mass) on buttocks where injection was given, and also edema in unspecified location. The patient seek for medical attention and was treated with diphenhydramine (BENADRYL). No laboratory diagnostics or studies were performed.   At the time of the report, the outcome of erythema, oedema, injection site mass, tenderness and swelling face was reported as resolving. The reporter did not mention the causality assessement between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
PT reported feeling dizziness, anxiety, and BP was 130/106 when reporting she did not he a hx of elevated blood pressure. Pt reported not eating anything all day except for two oranges. Pt reported feeling the room was "spinning". Pt given snack of granola bar, then rice crispies, and finished a juice box and a small water bottle. Pt was able to ambulate unassisted to bathroom at 1545. Pt called her husband to pick her up, and pt left with husband at 1555. Pt denied symptoms at that time.
14 year old male was seen at clinic for immunization administration. Child received the following vaccines: Tdap, Varicella and MCV4. Immediately after administration of vaccines child felt faint and got pale in color. Symptoms lasted a few seconds. Child monitored. Child voiced he felt better. Advised mother to stay a few more minutes before leaving. F/U with MD. Supervisor aware. Child ambulated out of clinic.
Got slightly dizzy as I stood up. Went to sit in observation room.  My heart was beating very fast for about 8 minutes.  Felt a tightness in my chest and had a slight bit of difficulty breathing.  Did not want to tell the monitors.  Afraid to go to a hospital with COVID.  My left hand turned blue and got cold and tingly.  That lasted for about 2-3 minutes.  So did the trouble breathing.  All subsided in 15 minutes.  Went home and took an antihistamine.  Had a light rash on my body.  Consulted with PCP and cardiologist.  They seem clueless.  We all agreed that i need the second dose but what is the antidote.  Cardiologist gave me a beta-blocker to take before the dose but these symptoms all appeared on the severe allergic reaction list.  The heart pounding was the most pronounced symptom.  What do I do?
Pt came around 3:30 For Flushot, around 3:40 I gave her shot, before giving her shot, I verified if she has any allergic reactions in the past to which she denied. After 10 min I Was called to Front of Store as she passed out. When I went there she was consious and drinking water. I was about to give EpiPen to which she & her mom denied. I was trying to convince them & meanwhile paramedic arrived. So I didn't gave EpiPen. Per Pt's Mom she passed out earlier this week & she don't think it is because of Flu-shot
Pt complained of dizziness, having difficulty breathing, and started vomiting. 911 called and notified supervisor.
Experienced random pains in heart area where I was unable to take deep breaths for 5+ minutes at a time. It would go away but then come back at random times. At worst this would happen 10+ times a day. The symptoms had subsided almost entirely by 4/15/2021, however, I still experience much shorter variations of this pain to this day that only last a few seconds and occur about once a week.
I have become dizzy, light headed about a week an half after shot, and still have those symptoms.  No one can figure out why.
This spontaneous report as received from Licensed Practical Nurse refers to a 50 year old female patient with drug allergy to DULERA (MARRS# 1308USA010544). The patient's medical history included asthma. On 15-AUG-2013 the patient was vaccinated with the first dose of PNEUMOVAX23(lot # was reported as H022280, exp. date 16-JUL-2014), 0.5 ml, intramuscular in the left arm. Concomitant therapies included desonide, montelukast sodium(manufacturer unknown), PROAIR, omeprazole(manufacturer unknown) and ESTRACE. Patient visited the physician's office today, on 16-AUG-2013, presenting with pain and itching at injection site as well as "extreme" swelling and redness from the patient's shoulder down to her elbow. Patient was administered the PNEUMOVAX23 in the left arm however both the patient's right and left hand are swollen. Nurse stated that the "patient's arm was quite swollen." Physician prescribed an unspecified dose of BENADRYL and ice to the affected area. The patient was not recovered from the events. The therapy did not discontinue. Additional information has been requested.
Still testing positive; Still testing positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Still testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Still testing positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Additional information: There was no other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
mild headache, dizziness,  nausea,  and lack of energy six days after shot... Let's hope this won't last long.