chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I didn't feel anything all day after my vaccine except my arm was a little bit sore. That night around 9:00/10:00 PM I started having a rash and itchiness. It lasted for a couple days so I called my work and they sent me to urgent care and at the doctor they said it wasn't and it could be a rash from the vaccine. It did go away for a couple of weeks and I was fine but I started one medication and it ended up starting all again in May. I only took one pill in the morning and I started having the itchiness in my eye in the evening. It was itching so bad so I took my medication again. They also gave me some eye drops for my eyes because it was really bad and it didn't help me. I made appointment with my regular doctor and explained everything and he gave me another medication to take for four days and it would stop everything but it didn't help me either. I made an appt with my eye doctor to see what was going on because my eye was red and itchy and he told me it was allergies and he prescribed me some more eye drops. It does seem to help a little bit but the itching now is getting worse and it's like a rash. I called my regular doctor again and he sent me to get lab work to see if it was an allergy and I called yesterday and they said the labs were normal. He said he's going to send me to the dermatologist to check my skin so I'm waiting right now to see them. My head burns, around my neck and it itches and when I put alcohol on it it feels a little bit better. It feels like a pimple on my head. I am a care taker and they have a dog and a cat and I thought maybe I was allergic to that but I had been there for a few months with no problem and it only started after vaccine. This is still ongoing.
I developed a rash on my left and right forearms and neck around 1700 and I had extreme pain at the injection site. The pain has improved but rash is still present. I was advised to go to the ER and be evaluated. I went down around 2245 received Pepcid and Benadryl and was told to follow up with my primary care provider and an allergist prior to second dose.  The next day the rash spread to my stomach and chest"
Headache, body aches, fever, chills, fatigue lasting about 12 hours.
Patient fully vaccinated for COVID who admitted to hospital with COVID positive test.  Provider discharge note:  "74-year-old female who presented to the emergency department with decreased oral intake and generalized weakness.  Patient was recently hospitalized a week prior to admission and she developed sudden onset fatigue and weakness without focal symptoms.  Patient recently had COVID diagnosis however she is out of isolation window.  She was hydrated with IV fluids.  She did not have any respiratory signs or symptoms.  Physical therapy was ordered and after evaluation she was cleared for home discharge."
Case number PHEH2012US012083 is an initial spontaneous report received from a nurse on 15 Jun 2012. This report refers to a female patient whose age was not reported. Her medical history, past drugs, current conditions and concomitant medications were reported. It was reported that on 15 Jun 2012 she was vaccinated intramuscularly on to unspecified site with expired MENVEO (batch number: 022011, expiry date: Apr 2012). No adverse event was reported following the maladministration.
According to the manufacturer's product label, the recommended dose is 0.5 ml. Per label "The dose for any age is 0.5 ml administered subcutaneously, preferably into the outer aspect of the upper arm." Also in the label the "Each 0.5 ml dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of measles virus; 12,500 TCID50 of mumps virus; and 1,000 TCID50 of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), recombinant human albumin (?0.3 mg), fetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin." The diluent contains an overfill of up to 0.7 ml total volume, which later in the label the entire content of the vial should be administered. However, the label identifies the dose is 0.5 ml and there is remaining volume that is not being administered to patients. The manufacturer is considering if the entire content of the vial is NOT administered then it's considered partial dose. The label is misleading because it states the dose is 0.5 ml and 0.5 ml contains a specific amount of product. However, the entire content of the vial, which may be up to 0.7 ml is considered the actual dose.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 65-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), on Jan 30, 2021, single dose, for COVID-19 immunisation. Medical history included COPD (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced pain in extremity/arm a little sore, with outcome of unknown. Laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported she was exposed to someone with COVID-19 virus that weekend following the second dose. She also reported she should get the monoclonal infusion. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
redness, swelling, tenderness, itching around the site with concern for cellulitis +/- vaccine reaction
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) 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. No concomitant medications were reported. On an unspecified date, the patient experienced injured by the vax, and ruined my life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injured by the vax and ruined my life was not reported. This report was non-serious.
Diffuse myalgias, mild headache, sinus congestion.  I?m treating it by resting. Did not have any adverse effects from the first 3 Covid(Pfizer) vaccinations
Sore upper arm up into neck, tight lower back, tight prostate, high fever (102f) lasting 5 hours, fatigue
Day after vaccine, severe  headache reported along with large amounts of blood in urine. Urgent care visit on 3rd day, 2/14/21, confirmed gross hematuria in urinalysis with referral to Urologist.
Moderna COVID-19 Vaccine EUA Lump and redness on Sunday following  Friday vaccine. Went away a few days later. The following Saturday swelling, redness, and itchiness, reappeared. 3-days later still active.
Pt recv vax on 4/20/99; 15 min post vax pt exp large hives on back of neck, shoulders & chest; pt to E.R.;  tx=Benadryl
Breakthrough case admission after 4 vaccines Moderna 3/4/21 Lot# 029A21a;  Moderna 4/1/21 Lot# 028A21A;  Moderna 11/17/21 Lot# 939909;  Moderna 5/24/22 Lot# 056M21A
a six month old patient was inadvertently administered a dose of GARDASIL 9 on 1/24/2020; This spontaneous report was received from nurse regarding a 6-month-old patient of unknown gender. The patient's pertinent medical history concurrent conditions, drug allergies or reactions, and concomitant therapies were not reported.  On 24-JAN-2020, the patient was inadvertently vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) injection (route of administration, anatomical location, lot number, and expiration date were not reported), for prophylaxis (product administered to patient of inappropriate age). The reporter indicated that the injection site looks good and the patient was doing fine.
Itchy red rash from knee down on both legs like chicken pox light headed and dizzy after shot
took two Shingles shots to prevent shingles,not only got Shingles it was worst / suspected vaccination failure; took two Shingles shots to prevent shingles, not only got Shingles it was worst; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: took two Shingles shots to prevent shingles,not only got Shingles it was worst / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: took two Shingles shots to prevent shingles, not only got Shingles it was worst). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 28-JUL-2023 The case was received from the patient's cousin via interactive digital media. The patient took two Shingles shots to prevent shingles and she not only got shingles, it was one of the worst cases that could imagine. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with case US2022AMR141810, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR141810:SAME REPORTER
8/12 12:30pm sweating 8/12 6:00pm body aches  8/12 fever and chills start over night 8/13 fever and chills continue and moderate joint pain through lout day  8/13 3:30pm Swollen bottom lip starts 8/13 9:30pm swelling of bottom lip increases and fever and chills and moderate joint pain
Redness, swelling, fever of skin, diagnosed cellulitis at Dr office. Extended down from patient's immunization site (deltoid) to the elbow area.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Ear infection as a result of congestion from active COVID-19 infection (symptoms started 2/1/2022 - positive at-home test 2/5/2022)
Left deltoid red and a little swollen. Itches.  Patient will use benadryl and ice compress.
Complained of headache starting around 1:30 PM with blurred vision starting 3 hours later.  Around 9 PM went to the ED for a CT scan which was negative.  As of 11/11 still has slight headache, but no vision issues.
Vertigo symptoms, Fatigue, dizzy spells, tinnitus , balance and sinus pressure issues that lingered for 3 months. The symptoms appeared about 3 weeks after the vaccination.  I have never had issues with vertigo until 3 weeks after the 2nd dose of the Pfizer vaccine.
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 11Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced Bell's Palsy on 28Mar2021 and was diagnosed on 29Mar2021. Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered. The event resulted in emergency room/department or urgent care and disability or permanent damage.
The day after receiving my second Pfizer dose, I had a fever of approximately 100 degrees.  Three days later, I noticed a ringing in my ears.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date in June 2014 (also reported as "5 months ago"), the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, (dose, route, anatomical location, lot number and expiration date were not reported) and on 20-NOV-2014 was inadvertently administered another an unspecified dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. No adverse effects were reported. No further information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm was sore in the area of injection; Arm was very swollen in the area of injection; Very tired and slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired and slept all day), VACCINATION SITE PAIN (Arm was sore in the area of injection) and VACCINATION SITE SWELLING (Arm was very swollen in the area of injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Very tired and slept all day). On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore in the area of injection) and VACCINATION SITE SWELLING (Arm was very swollen in the area of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Very tired and slept all day) and VACCINATION SITE PAIN (Arm was sore in the area of injection) outcome was unknown and VACCINATION SITE SWELLING (Arm was very swollen in the area of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Received Heplisav-B 2 Weeks Prior to Finding Out Pregnant; Initial Report Received on 01-DEC-2022, 02-DEC-2022 , 05-DEC-2022  This is a spontaneous report received from a pharmacist in the regarding a female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 1 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   The patient received the dose about 2 weeks prior to finding out she was pregnant.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
This was for the second dose of the Shingrex vaccine. I felt week in the evening. Woke up the next day with a fever slightly over 100 degrees, took tylenol and stayed in bed about two days though my temperature was back to normal on the Wednesday, two days after the vaccine. On Thursday, I woke with a terrible headache which is unusual for me, but was able to stay up most of the day. Saturday and Sunday, I was okay again but on the following Monday, 7 days after the vaccine, I developed a rash on the back of my legs. Tuesday morning, I felt sick again and am going  back to bed but my temperature is normal.
post vaccine client started to vomit. history of anxiety. NP and EMT on site, evaluated client. Zofran sublingual given by EMT. Vomitted again imediately after. client in observation for 30 mins, felt better after and left with parent at her side
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 16Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 66 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "chronic cough" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "tinnitus" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL (Manufacturer: Aurobindo Pharma), start date: 31Aug2021; OMEPRAZOLE (Manufacturer: Aurobindo Pharma), start date: 31Jan2018. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Novocaine, reaction(s): "Known allergies: Novocaine". The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 19Apr2022, outcome "recovered" (06May2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (26Apr2022) Negative, notes: On 26Apr I tested for the first time, negative for Covid (home test), and all the symptoms diminished; (28Apr2022) Positive, notes: On 28Apr, most symptoms returned (no fever), running nose, headache, fatigue, congestion - home test turned positive; (02May2022) positive, notes: on 02May, my symptoms became worse, test still positive; (06May2022) negative, notes: 06May I tested first time negative. Therapeutic measures were taken as a result of covid-19. Clinical Course: The patient was tested positive for Covid on Tue 19Apr2022, with fever 100F, muscle pain, sore throat, running nose, fatigue. On 20Apr2022, a five-day treatment of Paxlovid was prescribed. During 5-day round of Paxlovid (Lot number: 300691085301) from 20Apr2022 to 24Apr2022, on 23Apr2022, the patient experienced severe migraine & high blood pressure (as 168/109), same on 24Apr2022. On 26Apr2022, the patient was tested for the first time, negative for Covid (home test), and all the symptoms diminished. On 28Apr2022, most symptoms returned (no fever), running nose, headache, fatigue, congestion - home test turned positive. The patient has been testing daily, her symptoms worsened - on 02May2022, the symptoms became worse, test still positive. On 03May2022, at 6am, the patient called local ER, they suggested to come to ER. She saw instead her Family doctor who examined and said that she had no pneumonia, prescribed Albuterol Sulfate. On 06May2022, the patient was tested first time negative. This was 17-day span of testing positive with some remnants of symptoms. A rebound after Paxlovid as reported.  No follow-up attempts are possible. No further information is expected.
PFIZER Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Pt recvd vax 2APR91 & w/in 4 hrs p/immun, pt exp screaming episode, fever & diarrhea; On exam 4APR91, herpetic lesions were noted in mouth, under the tongue & palate; Mom reported pt has been unable to sleep;
The pt developed a fever that evening followed by eyes rolling and shaking. In ER, fever was 104.8F.
This spontaneous report was received from a medical assistant concerning a 10 weeks old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673.
I received my first dose of Pfizer-BioNTech COVID-19 Vaccine EUA on July 21, 2021 at 2:15 PM. Between 6 and 7 PM that same day (July 29, 2021) I started experiencing chest pains. Then the following day (July 30, 2021) I continued having chest pains but now my heart was beating faster than normal. Both of this happened in the evening. On August 1, 2021 I decided to go to the hospital to be looked at. They gave me an EKG and took blood to do a test on my thyroid and electrolytes and all of them came back normal. Also when they listened in the stethoscope they said my heart sounded normal. But they monitored my heartbeat and it was often still pretty high. It is now August 3, 2021 and I am still having these feelings. I do think it has got a little better but it is still there.
I began with having tremors/chills a few hours after receiving the vaccine.  I then developed a fever and pain, redness, swelling and warmth at the injection site.  Second day fever was up to 103.6, worsening symptoms.  Today (day 3), continued fever, very severe headache (can hardly open eyes or stand up), aches all over, appetite loss, shaky, chills, nauseous, hard to get out of bed.
Complaining of left arm pain(soreness), headache,Fever-102-oral, redness and small bumps at injection site. Taken to ER between 5 and 6PM. Scheduled for follow-up with M.D.on Tuesday, June 24th 2014.
This non-serious initial spontaneous case, was received from Other Non-Health Professional on 07-Nov-2017, concerning a 3-year-10-month-old, child female patient. On 03-NOV-2017, the patient was administered with FLUCELVAX QIV (dose; 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 31-May-2018). It was reported that the patient below age of 4 years received vaccine that was indicated for persons 4 years of age and older. The patient had no event following administration of the vaccine. The reporter assessed the event as non-serious.
p/vax pt devel a few lesions approx 10, on the trunk & head;
he had fever when he was scheduled for 2nd dose; He couldn't get 2nd dose because his throat was messed up; Patient hasn't received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (he had fever when he was scheduled for 2nd dose), OROPHARYNGEAL PAIN (He couldn't get 2nd dose because his throat was messed up) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose). On an unknown date, the patient experienced PYREXIA (he had fever when he was scheduled for 2nd dose) and OROPHARYNGEAL PAIN (He couldn't get 2nd dose because his throat was messed up). At the time of the report, PYREXIA (he had fever when he was scheduled for 2nd dose), OROPHARYNGEAL PAIN (He couldn't get 2nd dose because his throat was messed up) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not provided , treatment drugs not provided and no medical history   Reporter did not allow further contact