chrisvoncsefalvay/vaers-outcomes huggingface dataset:
KILLED; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use (dose number in series 3). No concomitant medications were reported.  On an unspecified date, the patient was killed and died from an unknown cause of death (dose number in series 3). It was unknown if an autopsy was performed. It was reported "Johnson & Johnson NON VAXED! Never got Covid or wore a mask unless I absolutely HAD to, used common sense and washed hands and used lots of hand sanitizers! Covid vaccine and boosters killed my friend". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was serious (Death).; Sender's Comments: V0-20230103418-Killed. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Red, swollen, area with hard limp to both legs at injection site. Patient's parent called and reported reaction 24 hours after vaccine injection.
11 days post Rubella vax (neg Rubella titer), c/o onset neck pain, dizziness, fatigue, fever, mild chills, unable to get out of bed; lightheaded x 1 day w/resolving sx;
According to patient's daughter, patient only complained of nausea the day of the immunization. Patient received 2nd dose of Moderna vaccine at 4:05pm and passed away around 8:30pm that same day per daughter's account. She had no pulse upon arrival to hospital. Autopsy was not performed.
Dose 2 administered 13 days after dose 1 (given 2/5/21 at another clinic)
Rash started to develop on the thighs, spread down to legs and feet and then to arms, hands and legs.  Rash began on September 21 and lasted until October 13.  During this time, client took OTC Benadryl, topical lotions and baths with little to no relief but did not seek medical care.    Client reports that the rash went away abruptly on October 13, 2022 while she was continuing at home measures.
poss sz activity requiring overnoc observation & EEG; DTP given 10JUL95; sz that PM, adm 11JUL95;
Greater than 35 days for second dose; Vaccine administered to teenager; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to teenager) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days for second dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to teenager). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days for second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to teenager) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days for second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
PNEUMOVAX injected IM into (L) deltoid on 6/13/2012. Site became  red, warm, swollen - confirmed on exam today, approximately 7 cm in diameter, mildly tender. No associated lymphangitic streaking / axillary adenopathy.
Lower back pain, stomach cramps (coincidence or caused by vaccine?!), fatigue, sore muscle on injection site
Pt received Pfizer x2.  Pt tested COVID + on 10/19/21 and admitted to hospital for COVID on 10/19/2021. Pt receiving remdesivir and dexamethasone.
Itching Injection Site; Swollen Injection Site; Red Injection Site; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching injection site, swollen injection site, red injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) itching injection site, swollen injection site, red injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itching injection site, swollen injection site, red injection site was unknown.
Swelling and redness at injection site, and around the upper arm, and into armpit.  Normal pain/redness after injection, but additional swelling noted next day.  Symptoms getting better when pt. reported on 7/5/16, but redness and swelling still present.  Pt. going to MD 7/6/16 for unrelated appt.  Will monitor and have MD examine tomorrow.
I received my first injection of the Pfizer vaccine on 2/12/2021. On 2/20/2021 at about 11 AM, I became nauseous and had to leave work early. When I got home, I felt even worse and began to vomit. I then went to bed to recuperate, but I had to get up about three times to go throw up. At my daughter's insistence, I went to the emergency room. I was given IV fluids and Toradol for the severe headache that I had at the time. I was told by the ER staff that I was dehydrated, and I stayed overnight at the hospital and was discharged on 2/21/2021 at about 6 AM. After being treated at the ER, the nausea, vomiting, and headache all subsided.  I received my second dose of Pfizer on 3/8/2021 at about 8 AM. At about 10 AM, I began to have pain and swelling in my left armpit. The pain and swelling lasted for about 48 hours and subsided on 3/10/2021. If I remember correctly, I believe I took Tylenol for the pain and that it helped.
pt couldn't cry, hard to get bottle down-didn't eat good, hard time swallowing;devel raspy high pitched voice;mom stated pt was much more complacence, n/responsive & stared @ area on certain walls;no fever;pt's behavior had changed compltly
Pt called 8/13/04 to report continued pain and limited movement in arm at site of injection. Advised pt to see medical provider.
About 2 hours after the vaccine, Patient reported feeling like her body caught fire. By 8pm she was in so much pain she couldn?t move. 12 hours later, she claims she has never felt this pain before and is worse than the worst pain she?s ever felt which was her abortion.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 11-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Chills; Shakes; Fever; Insomnia; Trouble breathing; Cough; Diarrhea; Fatigue; Sweats and body aches including a headache; Sweats and body aches including a headache; Sweats and body aches including a headache; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 52-year-old-female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and gastroesophageal reflux disease, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included valaciclovir hydrochloride (VALTREX), lansoprazole (PREVACID), bupropion hydrochloride (WELLBUTRIN), and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6202) on 19Mar2021 at 09:00 (at the age of 52-years-old) for COVID-19 immunisation. On 09Apr2021 at 21:15 the patient experienced chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache. The events were reported as non-serious, and no treatment was received for the events. The clinical outcomes of chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Pt had syncopal episode a few minutes after receiving vaccine. Episode occurred while getting blood work. Recovered quickly, no treatment needed.
Patient states lymph nodes were swollen and patient felt sluggish starting 2 days after the vaccination for about a whole month.
This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. Patient's medical history, concomitant therapies and concurrent conditions were not provided. On 08-NOV-2018, the patient inadvertently received a dose of PROQUAD recombinant Human albumin (rHA), lot# R017626, expiry date 18-DEC-2019 (dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with sterile diluent (lot # and expiry date were not provided). No adverse effects were reported.
Dull headache, body ache, low grade fever, malaise for 36 hours,  12 hours after vaccine administered
w/in 1 hr p/vax, fever 101 R, constant crying all day, high pitch to cry, also jerking motions;
Pt recv vax on 3/24/99; on same day pt exp red vax site
On 02/5/2021, within an hour of the second dose vaccination and observation and gave steroid cream based on prior reaction observation of Dose 1. I used the cream for a couple of days. It seemed to have worsened the effects of the pain, whelping and seepage of yellow fluids. I discontinued the steroid cream and the effects lasted 4-6 weeks. Although the pain and redness dissipated, the peeling was plastic skin peeling turned yellow and was thick and plastic like.
Increased left deltoid area swelling/edema x pain touch, size 9cmx9cm.
I was vaccinated at 36.5 weeks pregnant.  The following morning, I was nauseated, had muscle aches, and chills.  I went to the OB/GYN for a scheduled check up and my blood pressure was approximately 160/90.  It had been 118/76 the night before at the pharmacy and had been around 112/72 my entire pregnancy.  I got home and had a fever of 100.2F and took a nap due to pure exhaustion.  My BP remained elevated (130s/80s) for the following 3 days.  I then had to go back to the OB for a BP check 3 days later where it was then 175/95.  I was forced to be induced the following day due to my high blood pressures.  Baby was born 24 hours after the start of induction and weighed 6lbs 9oz (37 weeks, 2 days) and is healthy.  My blood pressure remained elevated (140s/80-90s) for weeks following vaccination.  It took approximately 4 weeks for blood pressure to return to my normal readings post vaccination.
pt call the pharamcy on 1/15 reported to us that she receive her moderna vaccine on 1/5/22.  on 1/14/22 the inject site started with a quarter size redness then on 1/15/22 it got bigger to a fist size it's red and a little hard.  Pt took benadryl and is taking aspirin for the pain.  RPH told the it was probably a allergic reaction to the injection and told the pt we will check up on her the next day or two.
15 day period beginning the morning after getting the vaccine. Typically my periods are a 2-5 days since getting my Mirena IUD on 9/9/2020, with a typical 28 day menstrual cycle.
I was told it was referred to as the seven day itch. A week after the shot I had a big red rash-like patch around the vaccination site
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Information has been received from a physician concerning a 14 year old female patient with no drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL "approximately three years ago" in approximately September 2006. Concomitant therapies included MENACTRA and another vaccine (manufacturer unknown). Right after getting the vaccine the patient experienced anxiety and temporary loss of vision. The patient was at the office when it happened. There were no lab diagnostic studies performed. The physician told the patient to remain seated for 10 to 15 minutes and the patient recovered. Upon internal review, temporary loss of vision was determined to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Suspected vaccination failure/I was told to get the vaccination for shingles, I did and got shingles; Got shingles on both sides of body, horrible; Pain; Constant itchiness, itch; Burned like you are on fire; Couldn't get comfortable enough to sleep at night; Couldn't get comfortable enough to sleep at night; Tingling; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus, burning sensation, discomfort, sleeplessness and tingling. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, discomfort and sleeplessness were unknown and the outcome of the pain, pruritus and tingling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus, burning sensation, discomfort, sleeplessness and tingling to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was told to get the vaccination for shingles, that did so he/she would never get shingles, well. The patient did and got shingles, horrible, the pain, constant itchiness and if you scratched, it burned like you were on fire. The patient got them on both sides of her body. The patient could not get comfortable enough to sleep night. The pain, tingling and itch came back, now and then. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I had a low grade fever of 99 degrees for 24hrs. I was fatigued for about a week. I had sinus pressure and sinus pain. I was offered antibiotics to ward off sinus infection by my doctor. Symptoms lasted about a week. Covid breakthrough.
Severe joint pain. Shoulders, elbows, wrists, knees. Weakness in arm given. No treatment, just Tylenol and Celebrex. Gradually getting better over 2 weeks. Still have weakness in arm although it is improving and still have right knee pain.
Donor given tetanus shot at 1116 at 1125 donor c/o light headedness, sweating and was pale. Donor completed donation without any adverse affects. She had not eaten since 7:00PM on 7/14/05.
Pt was seen in the office for a AWV on 6-20-16 and was fine. He was given a pneumonia vaccine that day. Wife called the office 6-24-16 stating he started getting sick on 6-22-16 with chills and a cough. Pt became sicker and went to ER on the 26th and died on the 27th. Patient is a 82 y.o. male who presents for a "Annual Wellness" exam. Current concerns included AWV. Pt still sees cardio once a year for HTN, HLD, aortic stenosis and hyperhomocystenemia. Sees neuro once a year for stroke. Chronic constipation - stable. Takes AMITIZA prn if needed.
Exacerbation of asthma. Required ER visit with steroids and magnesium sulfate.
Pleuritic chest pain, shortness of breath, subjective fever, and malaise within 24 hours. Symptoms and signs consistent with myopericarditis.
Patient presented to the ED on 3/7/22 for chest discomfort. Patient presented to the ED on 3/15/22 for Viral URI with cough. Patient presented to the ED on 3/17/22 for COPD exacerbation, Acute hypoxemic respiratory failure. These visits are within 6 weeks of receiving covid vaccination.
This spontaneous report as received from a physician refers to a patient of unknown age with no drug allergies, reaction and no concomitant medication reported. In 2010 ("4 years ago" as reported) the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular). On 21-MAY-2014 the patient was vaccinated with the second dose of GARDASIL (0.5 ml, intramuscular). No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
Rash from injection site to L elbow, warm to touch, light pink to red, no fever, patient visit to office 10/07/15 after watching for improvement, iced the site, presented 10/07/2015 after rash spread to above L elbow, physician confirmed allergic reaction and prescribed OTC Benadryl 3-4 times daily and to call office 10/09/15.  Patient reported no improvement, physician prescribed dicloxacillin 250 mg 1 capsule 1-2 hrs prior to meals for 7 days.
This spontaneous report as received from a physician via a company representative concerning a 70 years old female patient who is also the physician's wife was vaccinated with ZOSTAVAX on 19-JUL-2007 "5 years ago". No other co-suspects were reported. No concomitant medications were reported. The physician stated that on 05-JUL-2012, "two weeks ago" the patient developed ocular shingles had some sleepless nights and pain. No treatment information was reported. The outcome of patient developed ocular shingles, sleepless nights and pain was reported as "she is in the process of recovering". The relatedness for patient developed ocular shingles sleepless and pain was unknown for ZOSTAVAX. Additional information has been requested.
Flu mist administered 8/27/2009, On 9/7, developed calf pain, refusal to walk, and then rash.  Seen in clinic with typical rash of Henoch Schonlein Purpura, mildly tender calves without joint findings or abdominal pain. (9/8/09 clinic).
-Joint pain in wrists, knees and ankles began several weeks after injection and is continuing presently. This began several weeks after injection.  -tingling in hands frequently especially at night -dread-like feeling when falling asleep that comes over me like a wave right as I am falling asleep. Like a sinking feeling. This began the night after the vaccine injection -tendonitis in left ankle from no apparent cause began several weeks after injection
Patient stated 2 weeks after receiving the 2nd dose, left breast was tender (tissue-pressure).  Arm soreness and breast tenderness still continuing. Primary recommended mammogram and lymphoid exam.
After the patient received the immunization for Moderna, he sat in the waiting area for about 5  minutes and started to sweat profusely and have blurry vision. that eventually resolved after 15-20 minutes of rest, cold compress, and drinking water.
Patient reported severely swollen arm which had resolved by report date of 4/23. She also stated she experienced confusion for approximately 2 days after the vaccination. She described the confusion as feeling off and almost a depression.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M028798 for prophylaxis. Concomitant therapies included sterile diluent. On 21-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Information has been received from a physician concerning a 25 year old female with a history of cardiac murmur who in January 2008, was vaccinated with her first dose of GARDASIL (lot number unspecified).  Concomitant therapy included fexofenadine hydrochloride (ALLEGRA) and hormonal contraceptives (unspecified).  In January 2008, after receiving the vaccine, the patient experienced uncomfortable feeling on the injection site.  On 10-Mar-2008, the patient experienced scratchy throat and cold after a flight.  Patient still has the cold and scratchy throat. Additional information has been requested. Follow up information received from the physician indicated the patient never mentioned the adverse events. During the patient's visit in March 2008, the patient did not report any of those experiences with second injection.
Arm puffed up, got red and itched in a 2 x 3 inch area below injection site.