chrisvoncsefalvay/vaers-outcomes huggingface dataset:
health steadily declined; This case was reported by a consumer via interactive digital media and described the occurrence of general physical health deterioration in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced general physical health deterioration (serious criteria death). On an unknown date, the outcome of the general physical health deterioration was fatal. The reported cause of death was general physical health deterioration.   It was unknown if the reporter considered the general physical health deterioration to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's friend. The age at vaccination was not reported. The patient was fighting cancer and her physician felt she should get Shingles vaccine and she got Shingles vaccine.  The patient's health steadily declined after the vaccine and she passed away within 2 months of the vaccine.  The reporter requested not to complicate your body if you were already fighting a life-threatening illness.  The reporter was missing his/her friend. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: health steadily decline
their first dose was 11Aug2021 and their second dose was 12Oct2021; Just a little pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, They did very good with the first two doses. Just a little pain.), administration date: 11Aug2021, for COVID-19 Immunization, reaction(s): "They did very good with the first two doses. Just a little pain.". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "their first dose was 11Aug2021 and their second dose was 12Oct2021"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just a little pain". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200317235 same reporter/different patient/same AE;US-PFIZER INC-202200323190 same reporter/different patient/same AE
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 at 16:00 as dose 1, single (Lot number: EN6206), in left arm, on 11Apr2021 at 16:30 as dose 2, single (Lot number: ER2613), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: WEGOVY; SPIRONOLACTONE, Multivitamin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative on an antigen test 8 days after showing symptoms; Positive, notes: My symptoms started to return and I was testing positive again; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: vaccine was received. There was other medication in 2 weeks. Patient had COVID rebound after taking paxlovid. She tested negative on an antigen test 8 days after showing symptoms, but then 2 days later, her symptoms started to return and she was testing positive again, with the symptoms actually worse than the original case. With the symptoms actually worse than the original case.
0854: Rec'd Covid vaccine 0859: About 5 min after rec'ing vaccine, pt c/o itchy throat; had previous reaction to Moderna vaccine & PNA vaccine 0903: BP 120/70 HR 62 RR 20 SpO2 98% 0904: Benadryl 25 mg po given 0908: Pt c/o sl more itchy throat & tongue swelling 0914: Itching resolved 0916: BP 122/72 HR 62 RR 20 SpO2 99% 0926: BP 121/74 HR 56 RR 18 Sp)2 100% Right arm tingling/itchy, tongue tingling/itchy again; breathing feels "ok" 0927: Benadryl 25 mg po repeated 0929: Feeling "a little bit more labored breathing"; clear lungs 0934: Feeling better 0939: Itchy throat resolving; breathing better
INJECTION SITE PAIN FOR 2 WEEKS; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 7 decade old, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and heart issues, and patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on left arm on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After receiving the vaccine on MAR-2021, on an unspecified date the patient experienced injection site pain for 2 weeks. Patient went to his physician and had routine blood work due to his history of diabetes and heart issues. On AUG-2021 physician called and told patient that he tested negative for COVID-19 antibody test (confirmed immunological vaccine failure) and needed to get the COVID vaccine. When patient told physician that he had in March, physician told it looked like patient had no vaccine and no protection. Patient was concerned as was going on a cruise soon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192884.; Sender's Comments: V0: 20210918278-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
REDNESS OCCURRED 4 DAYS LATER, 1/2 DOLLAR SIZE CIRCLE (3 INCH ROUND CIRCLE) WELCH, WENT TO MED & WAS PRESCRIBED CEPHALEXIN.
Patient started experiencing hives the night of immunizations. Febrile 101.4 R. Hives have continued to next day. Temp 100.2 R today.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 19-JUN-2014 the patient was vaccinated with expired PROQUAD (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
itchy all over his body; stomach upset for days; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: itchy all over his body), upset stomach (Verbatim: stomach upset for days) and chills (Verbatim: chills).  The outcome of the generalized pruritus, upset stomach and chills were not resolved.   It was unknown if the reporter considered the generalized pruritus, upset stomach and chills to be related to Shingrix.     It was unknown if the company considered the generalized pruritus, upset stomach and chills to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 The patient reported that he received 2 doses of Shingrix, last dose about 6 months ago (in left arm). The patient stated that he had been itchy all over his body, chills and stomach upset for days and had not resolved.  Referred to health care professional. Did not consent to follow-up
flushed face, headache, hives on right thigh approx. 1 hour or sooner after vaccine. Called 911 and when they came told me to take benadryl. Next morning the hives were gone.
I received the 2nd dose of the Covid 19 vaccine on March 11th.  The first dose, I only had a sore injection area, so there were no other side effects for the first dose.  The second dose, proved other.  I got the 2nd dose at approximately 10 am, and did not have any effects until that evening.  At 1230 am, I awoke with extreme chills, a low fever, 101, and severe body pain. I was able to crawl on the floor and sit next to a heater vent and get warmed up.  I made a cup of tea and took 2 ibuprofen and was unable to get back to sleep for about 4 hours. Palms of both my hands were extremely hot, every joint hurt and especially the arthritis within my right shoulder.  5 days later, my right side organs feel uncomfortable
Client reports that he had a rash after first dose that was on his chest, neck, arms, legs and had a tongue were swollen within 15 minutes and received 25 mg of Benadryl.  Client reports it took 2 days for the rash to dissipate.  Client reports felling out of it for 2 days.  Client states he has had an off and on temperature.  Client reports an acne or small hives on chest on arms and back and his face is splotchy still today.  Client reports a hypersensitivity sensation in last couple of years going thru diagnosis now.
She began to have a fever within a few hours. Her fever went up to 104. She then broke out in a rash head to toe. She refused to eat and could not sleep, she withdrew and just cried all the time. I called her Dr's office, they said to not bring her in because she could be contagious. She did not want to eat or sleep for the next few days. After about two weeks, when these symptoms subsided, we began to notice that she developed an aversion to most foods, especially foods with texture like mushy, soft, etc. She became sensitive to temperatures, her food, drink, bath water had to be very specific and she cried it if wasn't the right temperature. She started speaking too loud or too quiet and couldn't seem to regulate her volume, while other loud noises bothered her. She cried that clothes and socks hurt her body. We discussed these issues at her next doctors visit, but he did not seem to think they were serious. These issues got better over the 1st year, but have not completely gone away. She is still very sensitive to touch, temperature, noise, etc.
Patient complained of tightness in her throat 15+ minutes after receiving the vaccine. Treated with 25mg IV diphenhydramine. Transported to  ER by Fire Rescue,
expired dose of Adacel vaccine administered inadvertently; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA172505 (same reporter).  This case involves a female patient of unknown age who was vaccinated inadvertently with a 0.5ml expired dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Exp. Date 02-MAY-2019) lot number not reported via unknown route in the left deltoid on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Approximately one week after second injection my gums began to get puffy and sore, progressed to the point where I couldn't bite down or wear my night guard due to the swelling.  Bleeding began on the bottom, and then on the top with brushing.  Had to reduce the amount of force needed to clean my teeth.  Cannot floss because of swelling, pain and blood.  Using waterpik (which is normal for me) had to be reduced due to blood and pain.  My dentists can confirm that my dental health is excellent.  Prior to this i have NEVER had bleeding gums even with professional cleaning.  also saliva glands at my jaw on each side were painful and swollen.
Arm hurt; Tired; Rash all over both of her legs; This is a spontaneous report from a contactable consumer (patient's grandparent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 20May2021 16:30 (Batch/Lot number was not reported), at the age of 17-years-old as 2nd dose, single for COVID-19 immunization. Medical history included allergic reaction of Sulphur drugs. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient had her second Pfizer shot on Thursday 20May2021 at 4:30, the only side effect she seem to have, was her arm hurt and she was tired and the reporter don't know, her aunt was a pharmacist and said that circle that she developed at the site of the shot, and called it as a Covid bullseye. On Saturday 22May2021, the patient had rash about the size of a diameter of  a lemon on the inside of her leg, the reporter didn't think anything out she has been out in the sun so they just observed until Sunday, 23May2021 she got the rash all over both of her leg. Previously she was has an allergic reaction of Sulphur drugs so with this rash all over both of her legs what they did was they called her doctors office Sunday and they haven't answering. They have a service that you can call about medical things, person that answers, there was a woman and said she know nothing about a rash they thought it would may be side effect from Pfizer because the reporter looked on the website and in the website rash was listed, usually rare. The patient does not have anaphylactic shock any of that there was a rash they think it was 0.001 they tried to explain this to the woman and she insisted it was something called Petechiae rash, which is a serious rash. She insisted not take the patient to the urgent care, she said they should take her to the ER and not urgent care, they took her to the ER they said they didn't know, it was definitely not the Petechiae rash which was a released that's a serious problem. They said it was okay to just give her Benadryl which they could have decided to give at home, but they didn't know if Benadryl was okay to take if the patient took the COVID vaccine. They were advised to bring her back to the doctor in 2 days if it doesn't go away. ER said they had never seen anyone who had a rash, they don't know any rash. The reporter tried to tell  that it's on the website it's on a Pfizer website and thought she was thinking she should alert them about this because this was a lot of lot of gut ranching and anxiety that if this person calling from the doctor saying that the rash was a Petechiae rash which was a serious blood disease. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Redness of injection site, swelling; fever 102 degrees; Given Tylenol; applied cold compresses
Rash on arms legs and neck, itching, shortness of breath, headache. On 6/5/2021, on 6/6/2021 body aches, migraine, nausea. Given Benadryl, Pepcid, and prednisone through IV. at Hospital ED on 6/5/2021. Given a 7 day prescription for prednisone, and a 15 day prescription for Pepcid and Benadryl.
Around 8/30/2021, Ms. went to the ER for coughing, weakness, and asthma.  A rapid COVID test was conducted, which showed "negative" results.  A regular COVID was also conducted, but Ms.  had to wait several days for the results to come back from that test.  In the meantime, while at the ER for the 8/30/21 visit, the attending ER doctor asked Ms. if she wanted the COVID vaccine.  Allegedly, Ms said no and refused multiple times.  However, she ultimately allegedly consented to receiving the J&J vaccine to get the doctor to quit asking her about it. About 3+ weeks after receiving the J&J COVID vaccine, Ms suffered a blood clot in her heart.  She was taken back to the ER, and admitted to the ICU.  Medical professionals did not give her a positive prognosis at that time, and stated her survival chance was about 17% due to the 2-3 cm blood clot in her heart, which was deemed inoperable.  Doctors described the blood clot as a "ticking time-bomb." While in the ICU, medical professionals attempted to treat the blood clot via medications.  End-of-life discussions were initiated due to Ms.  poor survival prognosis.  Ms.  was ultimately discharged to her home under hospice care.
Fever, chills, local erythema and induration w/ pain, diffuse myalgia, decreased appetite, nausea, lightheadedness, headaches.  Symptoms developed 1 day after injection.
Fourth dose of Hepatitis B vaccine administered on 02/18/2013 at 1500Hrs. Rash started later that evening on face & back. First 3 vaccines received elsewhere. Sent to ER-rash worse on 2/19/13.
After giving Tdap, pt became pale, light headed, and vomiting.  Monitored pt x 1 hour until symptoms resolved.
On 5-7-07 noted redness, edema, warm to touch, pain RLL injection site.  On 5-9-07 pt. seen in office with worsing s/s (size 2" X 3").
ringing in his ears / tinnitus; redness and tenderness at injection site; tenderness at injection site; Lethargy; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of tinnitus (1st dose received on 28th September 2020 and the patient experienced lethargy and redness and tenderness at injection site, refer case US2020252578.).   On 15th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness and lethargy. On 20th December 2020, the patient experienced tinnitus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site tenderness and lethargy were recovered/resolved and the outcome of the tinnitus was not recovered/not resolved.   The reporter considered the injection site erythema, injection site tenderness and lethargy to be related to Shingrix. It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows:  The patient received 2nd dose of Shingrix in right deltoid. Lot and expiration date were not known. After receiving 2nd dose of Shingrix, the patient experienced began to experience ringing in his ears which was intermittent and comes and goes, lethargy and redness and tenderness at injection site. The reporter was asking if this was a known side effect.   Caller declined to provide contact information for his medical doctor. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252578:
High Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High Blood Pressure). At the time of the report, HYPERTENSION (High Blood Pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician's assistant concerning a female who was vaccinated with the first dose of GARDASIL vaccine (site and route not reported). Concomitant therapy included Drospirenone (+) YAZ, prescribed at the same time as vaccination. On an unknown date the patient experienced hives. the physician's assistant believed that hives were caused by the birth control pills. Additional information has been requested.
Developed right neck swelling/adenopathy which spread to the left.  Significant to impair neck mobility.  Developed high fevers roughly 12 hours later with rigors.  Was seen in the emergency department.  Found to be febrile, significantly tachycardic (sinus) .  Was given vancomycin, ceftriaxone empirically.  Felt ill for the next 48 hours afterwards with weakness, slow to resolve tachycardia and cough.  Neck swelling subsided however, right neck lymphadenopathy persisted for well over a month.  Was sent home from ED with Bactrim and keflex for coverage of possible neck cellulitis.  However, I do not believe it was a cellulitis.  Neck was not tender, not indurated nor erythematous.  I am a hospitalist and had colleagues take a look as well.
now feels like arthritic knee; Left knee swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 3 (booster), single (Lot number: el3249), in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing), notes: heart disease; "Known allergies: milk proteens" (unspecified if ongoing), notes: milk proteens. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: efj4989, Anatomical location: arm Left), administration date: 21Jan2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EL9265, Anatomical location: arm Left), administration date: 10Feb2021, when the patient was 66-year-old, for Covid-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 02Jun2022, outcome "recovered with sequelae", described as "Left knee swollen"; ARTHRITIS (non-serious) with onset 02Jun2022, outcome "recovered with sequelae", described as "now feels like arthritic knee". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthritis, joint swelling.
patient  stated he almost blacked out , was sweating ,  dizzy, and after  a little while he was fine.  he also stated he had a lot of stress and was fighting with family member. He also was talked into getting the shot
HYPEREMIC MACULAR RASH ON FACE, TORSO (FRONT AND BACK).
About a day after the vaccine I noticed my left hamstring was quite sore and cramping and a day or so after that I had intense twitching in my right bicep. Throughout the next week the pain had moved to both of my legs being achy and cramping and intense muscle spasms throughout all the muscles in my body. I have had no headache, vision issues, shortness of breath or swelling within my limbs.