chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an adult dialysis patient between the age of 60-80 years who was vaccinated with a three dose series of RECOMBIVAX HB.  It was reported that the patient had antibody titer that was less than 10 mIU/ml.  A product quality complaint was not involved.  Additional information has been requested.  This is one of the several reports received from the same source.
3RD DOSE PFIZER COVID VACCINE GIVEN 11/6/21, LOT #32030BD;  pt brought to hospital via EMS with cough, SOB, hoarse throat, nausea, tachycardia; found to be positive for COVID; O2 supplementation; admitted with AHRF secondary to COVID 19 infection; superimposed bacterial pneumonia; FTT; fed through NG tube; transitioned pt to comfort measures and she passed away in the hospital
This spontaneous report was received from a physician refers to a 14 month old female patient. The patient had no pertinent medical history or drug allergies. On 14-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck), (lot number reported as H015137, expiry date 09-AUG-2014, route was subcutaneous). Concomitant medications were not reported. On 24-APR-2013, the patient developed shingles after receiving a dose of VARIVAX (Merck). The patient developed dermatomal rash on the legs. The rash was not painful. The physician sent the lesions for the analysis and confirmed that the rash was shingles. The patient was treated with Acyclovir. The outcome of the reported events were unknown. The patient sought medical attention (saw physician). Additional information has been requested.
Immediately after vaccine c/o headache, then fatigue that evening. Following day fatigue, muscle weakness/tightness, nausea, body aches. 2nd day thru today c/o muscle weakness/tightness, fatigue, SOBOE, chest tightness.
feeling of impending doom like I was going to pass out and my chest became heavy.  I felt the vaccine injection all the way down my arm into my fingers and my arm felt as if it'd lost strength
30APR redness & swelling; feels stiff & record show last TT 1977; red on 5MAY, but remembers having it in 1984; does not remember having one;
died of complications with Covid including kidney and lung failure; died of complications with Covid including kidney and lung failure; COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A 55 year-old male patient received sirolimus (RAPAMUNE) (ongoing) (Lot number: 2000012386, Expiration Date: Sep2022) at 1 mg for prophylaxis against transplant rejection; bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot # unknown), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Dose: 2, Lot # unknown), administration date: May2021, for Covid-19 immunization. The following information was reported: RENAL FAILURE (death, medically significant), RESPIRATORY FAILURE (death, medically significant) all with onset 12Jan2022, outcome "fatal" and all described as "died of complications with Covid including kidney and lung failure"; DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant) all with onset 12Jan2022, outcome "fatal" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2021) positive. The action taken for sirolimus was dosage not changed. Therapeutic measures were taken as a result of covid-19. The patient date of death was 05Feb2022. The reported cause of death was renal failure, respiratory failure, covid-19. No autopsy was performed. Additional information: Caller states the patient had both Covid vaccinations and the booster (in Sep or Oct2021), confirms these were the Pfizer vaccines. The patient was diagnosed with Covid on 12Jan2021, and was given the monoclonal treatment, No one told patient to stop taking the antirejection medication sirolimus, which he had been taking for about a year. The patient got Covid in Jan2022, and died on 05Feb2022 of complications with Covid including kidney and lung failure.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died of complications with Covid including kidney and lung failure; died of complications with Covid including kidney and lung failure; COVID-19
Immediately after receiving the MMR SC in the left arm, patient developed a large hive with redness at injection site. No other hives were noted. No itching and no breathing problems. Benadryl was given to patient per physicians request and patient was allowed to leave.
This spontaneous report as received from a physician refers to a 13 month old female patient. There was no information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On 25-JUL-2017, the patient was vaccinated with a dose of PROQUAD (therapy type: rHA, lot # N010247, expiry date: 25-SEP-2018) via subcutaneous route, for routine vaccination. She also received a dose of hepatitis a virus vaccine on the same day. Physician reported that 24 hours later vaccination, the patient developed a rash on her trunk and face. He mentioned that the patient's mother treated her with BENADRYL and a pharmacist recommended the patient with an antihistamine, VANACLEAR PD and PEDIAPRED by mouth. Outcome of the event was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
04/19/2022 Vaccination  07/09/2022 We went to Island 07/11/2022 Started to experience sore throats.  07/12/2022 Symptoms have progressed to include loss of appetite, sore throat, body aches, chills and fever. She sleeps all the time. She sleeps longer and longer as we progressed.  07/28/2022 Have had to cancel upcoming appointments.
PATIENT WAS IMMUNIZED 5/13. PATIENT WAS FOUND DECEASED IN THEIR APARTMENT ON 5/18. FAMILY LAST SAW HIM ON 5/16 WHEN THEY DROPPED HIM OFF AT HIS APARTMENT.  MEDICAL EXAMINER HAS NOT YET DETERMINED CAUSE OF DEATH OR EXACT DATE OF DEATH.
I am itching really bad; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 60, unspecified unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunisation .  The patient's medical history included iodine allergy and thyroid cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient had an itching that was really bad. It was further mentioned that she had a really bad allergic reaction when they did some kind of test on her a long time ago. Patient stated she forgot to ask if there was iodine in the vaccine as she had thyroid cancer. The outcome of the event was unknown.   Information about the Lot/batch number has been requested.
The pt experienced erythema, arm tingling, numbness, right leg numbness and chills. The pt also experienced uncontrolled arrhythmia.
The patient vision started becoming blurry on the same side of the injection was taken. Vision blurry started an hour or two afterward. Following the vaccination, the next day, the vision was blurry up until Friday 02/26/2021. The patient vision cleared up later that night.
Within 15 minutes-Itching mouth, by 30 minutes-face and lip swelling, blood pressure 210/110 for several hours.
pt became lethargic w/in 1 hr of immun; 4 hrs later devel fever of 104.8 R lasted all evening; seen in ER for 2 hrs; no adverse effects by next morning;
Some hearing loss; Constant rining in the ears; Pressure in the ears; A little headache; Pain on the Injection Site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (Some hearing loss), TINNITUS (Constant rining in the ears) and EAR DISCOMFORT (Pressure in the ears) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HYPOACUSIS (Some hearing loss), TINNITUS (Constant rining in the ears) and EAR DISCOMFORT (Pressure in the ears). At the time of the report, HYPOACUSIS (Some hearing loss), TINNITUS (Constant rining in the ears) and EAR DISCOMFORT (Pressure in the ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    No treatment information was provided.
intense viginal bleeding, fainted two times while on the way to urgent care, and currently are trying to get pregnant and can not
Approximately a few minutes after immunization, patient started feeling really hot, dizziness, prickly pain from head to toe, then things went black (she could not see anything but remained conscious) and had trouble breathing due to throat swelling. EPI-PEN was administered and EMT arrived and advised patient to go to Emergency room for further care and observation. Patient was given prednisone in emergency room and was observed. Patient was discharged with additional doses of prednisone for the next few days. Provider treating patient in ER.
The injection site itched a little from the beginning. It went away in four days, but then returned with a lot of itching a few days later. it got redder and bigger and the site also was warm to touch and swollen. I put ice packs on it to help with the itch, along with benedryl gel. it was difficult to sleep because of the itch. It is still getting bigger as of today. I did not go to the doctor. I followed what it said to do on the internet. The itch may be calming down some. I don't know if I should get the 2nd vaccine. Please let me know.
Lump at injection site; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. On 12th April 2019, less than a day after receiving Shingrix, the patient experienced injection site lump and pain. On an unknown date, the outcome of the injection site lump and pain were unknown.   It was unknown if the reporter considered the injection site lump and pain to be related to Shingrix.  Additional details were provided as follows: The patient had a lump approximately golf ball size formed at the injection site.   No additional details were provided.
Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: GL92113), intramuscular on 22Jan2021 at 14:15 at a single dose on left arm for COVID-19 immunisation. Medical history included depression, mitral valve regurgitation and hypercholesterolaemia from an unknown date and unknown if ongoing. The patient previously took guaifenesin;phenylephrine hydrochloride (ENTEX) and NOVICAINE and experienced allergies. The patient experienced headache, muscle fatigue, lymph node pain and left armpit on 22Jan2021. Treatment received for the adverse event was reported as No. The outcome of the events was not recovered.
Client requested Moderna booster but received Janssen 0.25 ml dose in error.
After vaccine was administered it was reported that child was not of age to receive the vaccine.  Our member contacted the guardian to  inform child was not eligible to receive this vaccine.  No adverse effects reported.
Continued ringing in the ears following the initial two doses of the COVID 19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Continued ringing in the ears following the initial two doses of the COVID 19 vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039M21A, 030M20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic thrombocytopenic purpura (history of ITP) and Autoimmune hemolytic anemia (history of autoimmune hemolytic anemia). Concurrent medical conditions included Seasonal allergy, Long QT syndrome and Asthma (controlled asthma without medication).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Continued ringing in the ears following the initial two doses of the COVID 19 vaccine) (seriousness criterion medically significant). At the time of the report, TINNITUS (Continued ringing in the ears following the initial two doses of the COVID 19 vaccine) had not resolved.            No concomitant medications were reported.   It was reported that patient experienced continued ringing in the ears following the initial two doses of the COVID 19 vaccine.  Company comment: This spontaneous case concerns a 43-year-old, male patient with no relevant medical history who experienced the unexpected, serious(medically significant) event of Tinnitus which occurred on an unspecified date after receiving the third dose of mRNA-1273 vaccine. It was reported that patient experienced continued ringing in the ears following the initial two doses of the COVID 19 vaccine. Further details on the clinical course, diagnostic test done or any treatment regimen was not provided in the case.  The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. No treatment medication was provided.; Sender's Comments: This spontaneous case concerns a 43-year-old, male patient with no relevant medical history who experienced the unexpected, serious(medically significant) event of Tinnitus which occurred on an unspecified date after receiving the third dose of mRNA-1273 vaccine. It was reported that patient experienced continued ringing in the ears following the initial two doses of the COVID 19 vaccine. Further details on the clinical course, diagnostic test done or any treatment regimen was not provided in the case.  The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Staff member received influenza vaccine from employee health nurse.  Received flu vaccine in right deltoid on 9/11/20. Complained of sharp pain in right shoulder immediately after vaccine injected. Advised to massage the area, apply ice and use ibuprofen or acetaminophen if needed. Stated that when she returned to her department she felt lightheaded & like she was going to pass out. Sat down for a few minutes & lightheadedness subsided. Stated that pain in shoulder was "pretty bad" for a couple days and on 9/15 was slowly improving.
Searing pain at base of brain. Searing pain through shoulders and lungs. pains and chills throughout body. Pain and ringing in ears. Swelling and redness at site of injection. Migraine headache for 2 days after injection. Pain and deadness in arm. Feel like been hit with a sledgehammer. Fever, Severe congestion, Weakness, Loss of hearing.  Annual follow up on 12/16/03: "Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  I am still suffering with headaches and odd thrushing spasm in my head.  The ringing in the ears continues as does the loss of hearing.  Concentration is poor and I am plagued by fatigue.  On exposure to the sun and heat my face breaks out with red bumps.  It is grossly unfair that I have not received compensation for my pain, suffering, lethargy, weight gain etc.  Burning in lungs, unable to cool down after being exposed to heat.
Severe pelvic pain; Inability to move legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Jan2022 17:30 (Lot number: FD0809) at the age of 18 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing); "COVID-19" (not ongoing), notes: covid prior vaccination. Concomitant medication(s) included: ZOLOFT; WELLBUTRIN; PROPRANOLOL; AMANTADINE. Vaccination history included: Bnt162b2 (First dose received in the right arm, at 05:30 PM. Lot. FH8027), administration date: 10Dec2021, when the patient was 18 years old, for COVID-19 immunisation. The following information was reported: PELVIC PAIN (hospitalization, disability) with onset 12Jan2022 07:00, outcome "not recovered", described as "Severe pelvic pain"; PARALYSIS (hospitalization, disability) with onset 12Jan2022 07:00, outcome "not recovered", described as "Inability to move legs". The patient was hospitalized for pelvic pain, paralysis (hospitalization duration: 15 day(s)). The events "severe pelvic pain" and "inability to move legs" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Jan2022) negative. Therapeutic measures were taken as a result of pelvic pain, paralysis. Treatment: Gabapentin, magnesium, morphine, Toradol, Tylenol.  No follow-up attempts are possible. No further information is expected.
Saturday evening May 1 I met with nine friends (all vaccinated) and ate a lot of food, drank moderately, and then did not sleep well. Approximately noon the next afternoon (Sunday, May2) while driving I noticed a developing dry-cough, chest congestion, and general fatigue. While camping that night I had some chills, thought I might have a bit of a fever, and had little appetite. I arrived home Tuesday, May 4 coughing a lot and very fatigued. Wednesday morning I went in for a Covid test. My cough and fatigue continued to increase along with muscle pain and headache. Wednesday night my fever topped out near 104. It broke and I felt much better but for the next few days (until around May 11) it fluctuated between normal and around 100-102. The Covid test came back negative but I went back for another just in case. It too came back negative. My temperature has now stabilized, the cough and congestion are mostly gone. I'm still a bit tired but feeling much better. It seemed like a case of Covid without the Covid. I am glad I got vaccinated but that was rough.
Today the area on her left upper arm is swollen to the size of a 3x3 post it note. It is slightly raised, red, warm to the touch itchy, and her arm feels achy. Patients states she has never had a reaction like this before to any vaccination. Patient denies any trouble breathing, swallowing, headaches, rapid heart rate, or fever.
Fatigue, vertigo, dizziness, brain fog, light headiness,  pain and discomfort in ears and around,  tinnitus, depression, mood swings,  and sleep disorder
COVID-19; FELT LIKE HEAD WAS GOING TO BLOW UP; CHILLS; MYALGIA; FEVER/TEMPERATURE WAS 101.4 DEGREES FAHRENHEIT; HEADACHE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; LOT OF PAIN; SHAKES; NECK PAIN; BACK PAIN; TROUBLE SLEEPING; This spontaneous report received from a health care professional via another pharmaceutical company (Moderna) concerned a 68 year old elderly female of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date 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 first booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 7 decade old. Concomitant medications included atorvastatin and metoprolol.  On SEP-2022, the patient experienced covid-19 (dose number in series 2). The outcome of covid-19 was not reported. The patient additionally received second booster dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, administered on 29-NOV-2022 10:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On 29-NOV-2022 between 18:00 to 20:00, the patient experienced lot of pain and myalgia (dose number in series 3). On 29-NOV-2022, the patient then got chills, shakes, neck pain, back pain, headache, fever, had trouble sleeping because of the fever and chills (dose number in series 3).  On 30-NOV-2022, the patient felt like head was going to blow up and had temperature of 101.4 degrees fahrenheit and her fever had not came down. Laboratory data included: Body temperature (NR: not provided) 101.4 F (dose number in series 3). The patient felt like she had Covid-19 (dose number in series 3). She was treated with paracetamol (Tylenol) for fever. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from fever/temperature was 101.4 degrees fahrenheit, and the outcome of myalgia, lot of pain, chills, shakes, headache, neck pain, back pain, trouble sleeping, revaccination with different covid-19 vaccine and felt like head was going to blow up was not reported. This report was non-serious.