chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 9/28/21, the patient complained of ear ringing and fatigue. After taking a nap, she complained to her daughter about the loss of hearing. She also complained about dizziness and balance issues. The daughter had reached out to PCP regarding sudden hearing loss. On 10/5/21, the patient was taken back to the PCP for a check-up. They completed a hearing test and recommended seeing ENT as her hearing was completely gone for the left side. The daughter was able to get the patient to the ENT that day. ENT performed the hearing test twice and was not sure as to how she developed sudden hearing loss. ENT prescribed Prednisone regimen to reduce the inflammation that can cause the nerve to be blocked. After 2 weeks of steroids, still no improvement. The family pushed the ENT for an MRI and the MRI scan came to be clean. The daughter took the patient to another ENT for a second opinion. That ENT also says that the flu vaccine could have triggered an inflammatory response that has led to her hearing loss. The ENT will be performing a series of steroids injecting in the patient's ear in hopes to save the hearing. But the ENT did say that if the patient's hearing has no changes after the injections, then the patient will suffer from permanent hearing loss and will need hearing aids. For the loss of balance, the ENT has also recommended for Vestibular therapy which she will have to attend weekly.
I had not complications after receiving the vaccine. A couple of weeks later, I developed hives on my left calf. They started spreading all over my body. I noticed they come up more so when I have sugar. I can't eat much bread, potatoes or kind of sugar and the hives return. I use CORTIZONE 10 to relieve my symptoms. At this time, I know what to do to prevent the outbreak so I have to be careful.
received both covid vaccines and has fatigue; This is a spontaneous report from a sponsored program. A contactable Consumer reported. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose, dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received both COVID vaccines and had fatigue and wants to know if it was a side effect of vaccine. The outcome of event was unknown.  Follow up attempts needed. Further information is expected.
One week following vaccination the patient noted pain from the left axilla, in the left arm down to the elbow and in the left shoulder joint.
Joint and muscle aches as well as fatigue. Began the day after my first vaccination and have continued for over two weeks. Symptoms were mild at first but have increased somewhat over the past two weeks.
BELOW THE INJECTION SITE THERE IS A 3 INCH RED, WARM CIRCLE, THE AREA IS PAINFUL.
On 07/09/2022, she started getting a fever and being frustrated. By the third day, she still had the fever and we got concerned. Took her to the doctor and they  COVID-19and flu swab negative; checked her blood check and white blood count was low end of normal. So the doctor thinks it is unlikely that she has a urinary track infection. They are looking into other possibilities as to way she still has a fever. To help her with her symptoms, I gave her children's Motrin.
3.3.2021 At Approx 1:25 pm - Upon injecting the vaccine into the upper left deltoid,  approximately .5ml of Moderna vaccine discharged from the area where the needle and syringe connect. This was a pre packaged needle and syringe combination that was shipped with a loose connection.  Due to amount of leakage it was determined that it was safe to re administer a new dose  .5 ml dose of Moderna vaccine in the Right Upper Deltoid. Patient was observed for 15 minutes with no concerning s/sx of adverse reaction.
When I woke up 24 hours after the booster shot, I had NO feeling in feet, ankles, or lower legs. It took several months and doctors to diagnose Guillain-Barré syndrome (GBS). I am now getting IVIG infusions; however, NO improvement has been noticed. In the meantime I broke my foot trying to walk on numb feet.  On 12/21/22 I was seen by my primary care physician for extensive bloodwork. On 1/5/23 I fell in the night and broke my foot and was taken by ambulance to the emergency room. Although I have no true feeling in my feet I do now suffer from extreme pain and discomfort at night. I have had to resort to a wheelchair for mobility out of the house and a walker inside. Bone fracture was assessed as healed in early March. On 3/8/23 I saw neurologist Dr. and had a nerve conduction study. Dr. scheduled an MRI on 3/25/23. Dr. also ordered additional blood work, urine test, and follow-up on 4/11/23. IVIG infusions were approved following formal diagnosis.
As employee entered observation area noted slight headache then complained of SOB  VS BP 150/90 states took medication in am O2 Sat 99-100% HR-74 RR-24 lung sounds clear  reported lightheadedness, confusion sent to ED via wheelchair
10 days after vaccination injection site became red, swollen, tender, and warm. Treated with ice and Advil
Severe rash on arm, near injection site, and extending to elbow.  Very red, sore, and itchy.  Lasted 3 days.  No treatment.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In 2008, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (dose, route and lot # not reported) and on 16-APR-2015, the patient received the second dose of (Oka/Merck) VARIVAX (dose, route and lot# not reported). No adverse effects were reported. Additional information has been requested.
Patient presented to ED on 11/12/21 with fatigue, SOB , nausea and positve covid home test. Patient is fully vaccinated. chest x ray was unremarkable. patient was scheduled for monoclonal antibodies at other insitution. Patient was discharged on 11/17/21.
Received a booster dose beyond the use date (beyond 30 days at 2-8C); BUD: 12/28/21 Notified manufacturer Moderna & Immunize Manager.
Information has been received from a medical assistant referring a 2-year-old patient of unknown gender who on 05-JUN-2015, was vaccinated with improperly stored VAQTA lot # K018181, expiration date: 04-JUN-2017 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because all available information has been obtained.
Information has been received from a medical assistant concerning a 15 month old female with no pertinent medical history who on 12-NOV-2007 was vaccinated intramuscularly into the left leg with a 0.5 ml dose of PEDVAXHIB (OMPC) (Lot #656522/0437U).  Concomitant medication included PEDIARIX and PREVNAR. On the night of 13-NOV-2007, the patient developed a fever which later resolved.  On 13-NOV-2007, the next day, the child called out "owie" and stiffened her left leg, was walking with straight leg. and hadnot wanted to bend her left leg since. No redness, warmth or other known injury reported. On 17-NOV-2007 at the physician's office, the patient's pulse was 120 and her temperature was 16.1C. Her physical examination was reported as a well appearing, well nourished in no distress, normal mood and affect. Bilateral thighs symmetric and normal in appearnace. Left thigh not tender to palpation. She did not resist flexion at the knee, but this can be overcome by persistence. The leg bends easily without crying or apparent pain. She walked with slight antalgic gait, but is bending her left knee now. The physician's impression and plan was reported as leg pain, suspect muscular hematoma following immunizations and refusal to bend knee in response to pain. No evidence for other pathology at this time. Advised passive stretches by bending at the knee and holding, and heat (either warm baths or warm compresses). Patient's mother was instructed to call if fever or worsening. There was no laboratory or diagnostic tests performed.  At the time of the report the patient's outcome was reported as recovered.  Additional information is not expected.
Patient received pneumonia vaccine 10/11/05 on 10/12/05 area (L deltoid) was painful and red.  Patient noted "streaks"; reported to Health Department.  I referred him to his physician.  Upon follow-up with patient, I found his physician had him take "allergy medicine" and redness and pain subsided.
I thought I was going through menopause as my last period was in late Aug., 2020, well, I'd gotten my period about 3 - 4 weeks after my 2nd dose of Pfizer and now about 1 month after that, I'm getting my period again.
fever; chills; body ache; sweet and headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US279225_NS.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose number unknown, single for covid-19 immunisation; ofatumumab (KESIMPTA) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; varicella zoster vaccine (SHINGRIX) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body ache"; HEADACHE (non-serious), outcome "unknown", described as "sweet and headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 2PM & returned 5PM w/hx of becoming limp, pale w/perioral cyanosis;T101 R;exam 1 wk later nl;
After receiving the Moderna COVID-19 Vaccine EUA, my left arm from shoulder to wrist became very sore the next evening.  It was very sore for about one week.  The soreness gradually dissipated over the next week, but then began to get worse over several days.  Beginning the third week after this dose, the soreness is mainly in my shoulder.
Fever chills headache body ache just wanted to let you know I'm sure I'll live. Thought you might need this information
Fast heartbeat; Chest pain; Sore neck; Sore arm; Bad headaches; fever; Swollen glands; Achy joints; achy muscles; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), CHEST PAIN (Chest pain), NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Bad headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heartbeat), CHEST PAIN (Chest pain), NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm), HEADACHE (Bad headaches), PYREXIA (fever), LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Achy joints) and MYALGIA (achy muscles). At the time of the report, HEART RATE INCREASED (Fast heartbeat), CHEST PAIN (Chest pain), NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm), HEADACHE (Bad headaches), PYREXIA (fever), LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Achy joints) and MYALGIA (achy muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was Tylenol.
Patient stated felt difficulty breathing and that swallowing was becoming difficult. Nurse looked at throat and saw some edema. Proceeded to administer epinephrine and call emergency services. Patient was taken to local ER and physician stated signs/symptoms were not present upon examination and the epinephrine may have resolved reported symptoms. Patient was discharged home in stable condition.
No additional AE/PQC reported.; HCP reported that an expired dose of the GARDASIL 9 vaccine was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 01-NOV-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number reported as 4029623 with expiration date 26-OCT-2023 (expired product administered), (dose, route and anatomical location were not reported) for prophylaxis. No additional adverse events were reported.  Lot number 4029623 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Under both arms became red, itchy, under doctor suggestion I used ointment, the bumps come and go. It was suggested to use the same powder used by athletes.
Mild fever and chills lasting about 6 hours. Also moderate soreness at vaccination site for pneumococcal vaccine.
During the second day (6/3/2021) of the vaccine I felt tired and with pain all over my body and a lot of pain in my left arm. The third day (3/7/2021) I was feeling pretty good already, but at 4:00 PM I had a stomach ache and I went to the bathroom with a bit of diarrhea.
a major bleeding event; subchorionic hemorrhage; severe cramping pain; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is the mother report.  A 36-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 17:00 (Batch/Lot Number: EW0153) as dose 1, single for Covid-19 immunization. Medical history included anxiety and irritable bowel from an unknown date and unknown if ongoing. Patient is pregnant at the time of vaccination. Last menstrual period was 23Nov2020. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS) and cetirizine hydrochloride (ZYRTEC ALLERGY) both taken for an unspecified indication, start and stop date were not reported. On 13Apr2021 18:00, 25 hours after first dose vaccination, the patient had severe cramping pain that felt like labor. The patient went to the ER for a major bleeding event. The patient had a subchorionic hemorrhage during her pregnancy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was advised to bed rest as was given magnesium as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100987373 baby case
Oromandibular dystonia; twitching of left side of face; difficulty speaking; This is a spontaneous report from a contactable consumer (patient) received via regulatory agency.   A 21-year-old non-pregnant female patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 12:30 (Batch/Lot number was not reported) (at the age of 21-year-old) as single dose for COVID-19 immunisation.  Medical history was none. There were no concomitant medications. No known allergies.  The patient has not experienced COVID-19 prior vaccination, the patient has not tested positive since vaccination. On 09Apr2021 at 23:00, the patient experienced twitching of left side of face, difficulty speaking within 24-36 hours after initial injection, dx oromandibular dystonia. The events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unspecified date, the patient underwent lab tests and procedures which included computerized tomogram (CT): unknown result, magnetic resonance imaging (MRI): unknown result.  Therapeutic measures were taken as a result of the events and included CT, MRI, labs, neurology, speech, medication (as reported). The patient outcome of the events was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
A few years ago I was innoculated against measles, mups, rubella, hepatitis, DTaP, Varicella and  received the flu vaccine (required for medical program) I did not have any adverse reactions. No adverse reaction to the flu shot last year or in years past (can't recall the dates).  After receiving my first Pfizer COVID vaccine dose on 3/25 I started having palpitations & chest tightness / discomfort around 12pm (about 2 hours after the shot). I went to Urgent Care and they gave me steroids & antihistamines which helped calm my system down. I was prescribed those same meds to take this week. Still experiencing some heart racing but it seems less frequent & not as severe today.
Injection site pain Tiredness Slight headache Dizzy and "fuzzy feeling" in head, room spinning when lying down Muscle pain Swollen lymph nodes and mild sore throat Sudden, unexplained, severe, crushing bone pain in both feet began 04/14/2021. Went to ER 04/17/2021, could find no reason for pain. Appointment with PCP on 04/19/2021, Podiatrist on 04/20/2021 and Cardiologist on 4/21/2021. No explanation for pain was found. Pain meds did not work. Podiatrist prescribed Prednisone and pain completely stopped after a few days. Pain in feet returned 05/30/2021, Prednisone prescribed on 06/01/2021 and pain stopped again after a few days. Sudden, severe, sharp, stabbing bone pain began in lower right leg around 07/14/2021. Pain continued for a few weeks and then also began in lower left leg. Had leg scans done and Prednisone prescribed again on 09/01/2021. By today, 09/05/2021, pain has somewhat subsided. No explanation has been found for pain.
Headache; Arm soreness; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 08:30 (Lot number: En6203) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Arm soreness"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are possible. No further information is expected.
20-30 min after immunizations, pt with urticarial rash. No resp difficulty. Rash head to toe with pruritus. Admin 25 mg Benadryl IM, resolved most after Rx.
My UTI, which was going away, developed into a raging UTI and then later into a bladder infection. I tried taking supplements from my chiropractor but they were not adequate. Even the Pads I wore were insufficient to stem the flow.  There was bleeding as well.  Then went to an Urgent Care facility and they prescribed an antibiotic which worked. It was both painful and embarrassing ( I have to stand and greet people in my position). I suffered for about 6 weeks through this.
mom said broke out in whelps all over w/in 20 mins of immun; called clinic & was told to take pt to MD or ER immediately; MD gave DPH inject & drew blood;
Patients mother reports that at 2:00 AM on 8/19/2009, patient had what appeared to her to be a possible seizure. Mother called our office around 8:30AM and was advised to bring her daughter into the office to be seen by Dr.
This spontaneous report has been received from a female nurse practitioner of unknown age referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-OCT-2018, while preparing a dose of M-M-R II (batch/lot# and expiration date were unknown), the nurse got some of the vaccine into her eyes. The outcome of the events was unknown.
LOWER RIGHT QUADRANT PAIN WHEN BREATHING IN; DRY THROAT; FELT AS IF HE IS ABOUT TO BE SICK; FELT WARM; This spontaneous report received from a patient concerned a 29 year old male. The patient's weight was 240 pounds, and height was 69 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 10-JUL-2022) dose was not reported, administered on 02-APR-2022 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2022, the patient experienced lower right quadrant pain when breathing in, dry throat, felt as if he is about to be sick, and felt warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry throat on 02-APR-2022, and had not recovered from lower right quadrant pain when breathing in, felt as if he is about to be sick, and felt warm. This report was non-serious.
Severe muscle pain, chills, nausea starting about 12 hours after the vaccine and lasting 18hours.  So much pain, I couldn?t get out of bed.  I am also having joint pain several weeks out that doesn?t seem to be improving.
chills; fatigue/tired; body aches; joints hurt; right arm hurts; This is a spontaneous report from a Pfizer Sponsored Program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, fatigue/tired, body aches, joints hurt and right arm hurts in Mar2021. The patient wanted to know if she can take a pain reliever. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Janssen COVID-19 Vaccine EUA  Nasty chills and fever started 10 to 12 hours after vaccination and continued through the night.   By 24 hours after the shot, things improved.   24 to 48 hours better -- no chills/fever-- but still general fatigue.  "less than 100%".   48+ still not fully recovered.  Arm muscle still sore at injection site.  Suspect will be better largely by tomorrow.
Initial consumer (patient) report received on 07 Oct 2010: This patient with a medical history of allergy to Gentamicin and "all mycins" was receiving Influenza virus vaccine (seasonal vaccine from unknown manufacturer) intramuscularly, every year (unspecified date). The patient presented with chronic kidney disease from unspecified date. The patient recently found that she also had breast cancer (date unspecified). The outcome was not reported.
Chills; aches; lethargy; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL0142 ), intramuscular in the left arm on 07Jan2021 18:15 at a single dose for covid-19 immunization. The patient had no medical history included. Patient has no allergies to medications, food, or other products. There were no concomitant medications. On 08Jan2021, the patient experienced chills, aches and lethargy. The outcome of the events was recovering on 08Jan2021 at 11:00. The patient was vaccinated in a hospital. Patient has no other medications received within 2 weeks of vaccination. Patient has not been diagnosed with COVID-19 prior to vaccination and has not been been tested for COVID-19 since vaccination.