chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriasis flair up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Feb2021, she had a psoriasis flair up and was wondering about taking the 2nd dose of the vaccine on 05Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy all over immediately following injection, treated with 25mg Benadryl.  Itchiness decreased but has not fully gone at 3hours later.
patient feels dizziness, nausea, light-headed, everything blacked out, and sweats, chills...
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 29-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot# and route not reported). On 22-AUG-2012, the patient experienced Guillain Barre syndrome. The outcome of Guillain Barre syndrome was unknown. Base internal review, Guillain Barre syndrome was considered to be medically significant. Additional information has been requested.
Painful paresthesias in both feet and to a lesser extent in hands, about 4-6 weeks after the injection; and it has persisted since then.
8/8/22 pt had a positive COVID test; admitted to hospital from SNF; did not require supplemental O2 during admission; given ABX and was to complete them in rehab when dc'd to rehab facility; 9/8/22 - 9/18/22 another hospitalization; aspiration pneumonia; ARF; septic shock; acute decompensated diastolic heart failure; IV ABX; O2 supplementation via NC; poor prognosis; discussed hospice but pt  needed more time to think about it; 9/25/22 - 9/26/22 another hospitalization from SNF with respiratory distress; EMS called: O2 saturation in the 80s on RA; CXR showed moderate left pleural effusion and probable aspiration, pneumonia; DNR/DNI; ICU; given IV ABX and fluids; O2 supplementation; transitioned to comfort measures and dc'd to hospice facility where he passed away
Became symptomatic 15JUL91; awoke w/ache in rt index digit; By noon pain & swelling rt knee present; went to clinic had 7cc fluid removed from knee; c/o lt hip, ankle & shoulder pain;
stated her immune system must be torn down or low; yeast infection after the vaccine; feeling a bit of nervousness and has to move around a lot; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age (reported as 75, units unspecified) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 (at an unspecified age) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included flu shot for vaccination and stated that she still gets flu. The patient stated that she received the first dose on 04Feb2021, and second dose was scheduled on 25Feb2021. The patient stated that she doesn't know if she does not want to get the second dose but wanted to know what would happen if she doesn't get it. The patient also asked if there is a reverse reaction and why would you need two doses. She stated that she has been feeling a bit of nervousness and has to move around a lot. The patient reported that she has never had a yeast infection in her life, and she contracted a yeast infection after the vaccine. Further clarified that it was not right after, but she happened to get it a few days later. The patient was taking Monistat over the counter. The patient's doctor said that the yeast infection could be from sugar, menopause, or her immune system. The patient got tested for COVID-19 after the vaccine and was tested negative. Her daughter's mother in law tested positive after getting the first dose of the vaccine. One of the sons tested positive, so the daughter's mother in law got tested and was positive. Stated that the daughter's mother in law may have had an infection or her immune system was low. The patient heard that the first vaccine was 60% effective. The patient stated that she still gets flu after getting the flu shot. Also stated that her immune system must be torn down or low, she takes all of her vitamins. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FD7218) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in the arm".  Additional Information: Consumer stated that, about two weeks ago, I received COVID-19 vaccine. Well, the first dose, I had no problems, I just had soreness in the arm. When clarified the concern, consumer stated that first I would like to get some medical information. I do not know if it was an allergic reaction, or I do not know what to do.  QR Comment: Reporter type was not clarified over the call. Hence captured as consumer or other non-health professional by default.  No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Severe, Additional Details: patient has been unable to raise or lower her arm. it is difficult to use for every day use since the vaccine was given
severe lower back pain beginning 24 hours after dose #2. The pain was so bad for 48 hours that I was unable to get out of bed, even to use the bathroom, despite high doses of Tylenol and Motrin. I called off work the first day and worked from my bed the second. The pain gradually subsided over the next week but did not disappear for months. I have a history of mild lower back pain that had rarely flared up after very specific causes (known strains, long car rides) but there was no such precipitating event this time.
Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was determined to be enough for the staff to miss work to stay home and rest.
Information has been received from a physician concerning a 79 year old white female who on 29-MAY-2007 was vaccinated with Zostavax. On 30-JUN-2007 the patient developed shingles on her left ophthalmic branch of the trigimenal nerve. It was a fairly mild case but the patient went to the emergency room and was started on drops and pills. The physician explained to the patient that Zostavax did not bring on her shingles and may well have lessened the severity of her attack. Unspecified medical attention was sought. In follow-up, the physician indicated that one month after Zostavax, the patient developed a mild case of shingles. As of 27-SEP-2007, the patient was recovered. No additional information is expected.
Began yellow runny stools after dose #3 ROTATEQ 11/29/07 given Amoxicillin, 12/6/07 intussusception bowel reduced in ED.  4/8/08 Reviewed hospital medical records of 12/11/2007. FINAL DX: Intussusception, enema reduced Records reveal patient experienced intermittent screaming, inconsolable crying, restless, vomiting, bloody/mucousy stool, diet refusal, red blotchy rash over face & arms x 1 day.  Had recent watery diarrhea & had been on antibiotics recently for sinus infection.  Formula changed to soy recently.  Peds surgery consult done.  Admitted overnight s/p IS reduction.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3-4 glasses wine). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] and FISH OIL for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Jul-2021. On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 25-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
28 hours after receiving 2nd Varicella vaccine c/o of itching at vaccination site - 38 hours later injection site red edematous, tender, warm to touch itchy - size 2 x 2 inches discussed comfort measures - 10-15-07 - localized reaction site less swollen today - 1 1/2 long red raised welt still present today - ice, Motrin, Benadryl over weekend- using arm - not itching today 10-15-07.
5 hours after PNEUMOVAX developed pain & swelling left upper extremity the evening of 11-6 (day after) redness & warmth. Improving as of 11-8.
On 8/20/17 10am, patient reported localized swelling/slight warm on site of injection located on Left Arm Deltoid. Injection was given on 8/19/17 10.30am. Informed patient it would go away in a few days. Recommended to ice the local area and to take Benadryl.
Parent noticed his right arm Fri noc 9/16/05. Reports right arm was red, hard and warm. Fever and c/o pain. Was worse on Sat 9/17 and took to urgent care. Parent states got Rx for cephalexin, 250mg/5ml, 2x 1 day x 10 days. Got better late Sun and early Mon AM 9/19.
over half of dose came out due to defect with syringe with no AE; over half of dose came out due to defect with syringe with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via the regulatory authority (Reference number- 00750752) and transmitted to Sanofi on 01-Sep-2021.  This case involves a 16 year old male patient for whom it was reported over half of dose came out due to defect with syringe while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (under dose and syringe issue).  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Sep-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was case of actual medication error due to syringe issue and vaccine under dose (Latency: on the same day).   It was reported "nurse states that she went to administer a Menactra vaccine to a 16 year old, and after the needle went in some of the Menactra went in, but then the rest of vaccine came out around the hub of the syringe. The nurse did not notice any breaks or cracks in the syringe. She asked how much she should reinject".  Details of laboratory data not reported.  No adverse reactions were reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
34 year old female received PNEUMOVAX (L deltoid) and AFLURIA (R deltoid) influenza vaccine at PCP appointment on 10/11/16. Presented to ER on 10/13/16 complaining of left deltoid pain, swelling, and redness. Pt also c/o chills, nausea, and aching and joint pain. Pt states she cannot raise her left arm. WBC elevated at 17 (H). Diagnosed with allergic reaction to pneumonia vaccine and discharged home in stable condition with prescriptions for hydroxyzine pamoate 25 mg QID PRN itching, OTC ibuprofen 200 mg QID as need for pain, ondansetron 4 mg PO QID PRN nausea, and triamcinolone 0.1% ointment topically BID. Myalgia, Arthralgia and Erythema; left arm swelling; nausea; chills.
On 05/22/2002 1 day after immunized, developed fever of 100-101 deg F, took a nap and when awoke had a seizure. Mother contacted 911. Paramedics measured temp of 103 deg F. Taken to medical center ER, observed 4-5 hrs, then discharged home with follow-up the next day with pediatrician.
Hospitalized for 1 day became  mottling, hypotensive, collapse-like rxn 2 1/2 hr p/DTP;
11/13/09: Became feverish with burning on tip of tongue. 11/18/09: Sensation had spread; tongue felt numb, had trouble talking and increased salivation.
I contracted Covid after having 3 vaccines. Started out feeling like a cold. By day 11 I had my daughter take me to ER because I could not even walk across the room.  Hold not catch my breath. Spent the night in ER but was sent home the next day after getting fluids and a strong steroid. Started breathing better and O2 levels were better.
VOMITING WITHIN 24 HOURS AFTER INJECTION AND RASH 48 HOURS AFTER INJECTION.
Information has been received from a nurse in a physician's office concerning a 6 week old patient who was vaccinated PO with the first single dose of Rotateq (no lot# provided).  Concomitant vaccinations administered on that same day were unspecified.  Almost immediately following administration of Rotateq, the patient experienced posturing.  The patient sought unspecified medical attention.  It was noted that the "patient was fine."  There was no product quality complaint.  Additional information has been requested.
Pt described feeling palpitations about 5-7 minutes post vaccine administration. She also stated her hands started to feel sweaty and she felt dizzy. She also stated she felt like she could not breathe.
For 2 days my arm was sore at injection site. 2 days later, I felt pain in my shoulder area (more in my rotator cuff area) but the injection site was tender to palpation. The pain increased for about a week and now is steady. I still have  pain in the same area and my injection site is also still tender to the touch.
Could not lift arm, severe pain in shoulder down arm, collar bone, up left neck. Kept me from sleeping with the pain and if I slept, would wake me up. Taking aspirins and rubbing BIOFREEZE. After almost 3 plus weeks still pain when trying to lift arm.
diarrhea; stomach cramps; body aches; fever; felt like tongue was on fire; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), TONGUE DISCOMFORT (felt like tongue was on fire), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever) and TONGUE DISCOMFORT (felt like tongue was on fire). On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches). At the time of the report, PYREXIA (fever), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches) outcome was unknown and TONGUE DISCOMFORT (felt like tongue was on fire) had resolved.            No concomitant medications were reported. No treatment information was provided
Pt received routine 6-month vaccinations on 09 May 08. Mom states all associated redness, swelling had resolved before appearance of rash on 12 May 08. Rash was raised, red and localized around each injection site; has persisted x 3 days but has improved. No fever or other symptoms per mother, no s/s of infection. No previous symptoms with same vaccines, no known sensitivities to latex, aluminum or adhesives.
Had pic line installed for osteomyelitis and within a month on October 8, 2021 arm swelled up and doctor diagnosed  blood clothad formed in left arm and shoulder.  Sent home with prescription of Eliquois.  Next day, October 9, 2021 went back to  hospital and could not breath.  Was hospitalized for blood clots in lungs.  While in hospital had a celebral stroke.
7-23-18 Vaccination with no redness or swelling. 7-24-18 Patient reports severe headache and fatigue. 7-26 patient reports she woke up and could not hear. She thought her ears were plugged with wax. She went to the audiologist and there was no wax and her hearing test was very abnormal. She was directed to the ENT specialist. There she received a prescription for steroids.
Vaccine was incorrectly diluted. It was diluted with 0.8 vice 1.8 ml dilutent. One dose of 0.3ml was drawn up and given.
Severe lower back and kidney pains for a week. TYLENOL and Ibuprofen.
Patient report persistent joint pain in left elbow radiating to left shoulder, neck and back following Anthrax vaccine #2 on 7/21/2003.  Denies numbness, tingling, headache, myalgia.  Recieved Antrax vaccine #3 on 8/4/2003 in the right arm,lolerated well
The day following administration of Nasal Flumist, developed mild urticarial rash on nose and cheeks.
Fever, chills, headache, nausea, sore muscles for first 6 days, then numbness in right arm spreading to left shoulder and neck
Eye swelled 14 days after each dose. Eye appeared to have additional eyelid folds. Lasted 4 days. Treated with hot compresses and Benedryl. Eye reaction happened in daughter, so I know it is vaccine related.
Site: Itching at Injection Site-Mild, Systemic: hives at site of injection-Mild, Additional Details: also described what appeared to be ink ring around injection site, gone shortly after injection
ARM WAS RED, HOT,HURT WITHIN HOURS OF RECIEVING THE VACCINE,THE NEXT DAY I VOMITED FOR 3-4 HOURS,THEN FEVER,CHILLS,BODY ACHES,FLU LIKE SYMPTOMS FOR 10-12 HOURS, EVERYTHING WENT AWAY EXCEPT THE ARM PAIN IT JUST PROGRESSED OVER THE NEXT FEW MONTHS UNTIL I STARTED LOOSONG MY RANGE OF MOTION AND THE PAIN BECAME UNBEARABLE.I AM A RN AT A SMALL TOWN AND I WAS THE ONLY NURSE TO SEE MY PATIENTS I COULD NOT TAKE OFF AND LEAVE MY PATIENTS WITH NO ONE TO TAKE CARE OF THEM.
no AEs; administration of an expired vaccine; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not provided.   On 30-JUL-2021, 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) (1 time dose, lot# 1602281, expiration date 21-JUL-2021; strength and route were unknown) for prophylaxis (expired product administered). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
hearing loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than 2 months after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The patient received the first does of Shingrix and In December 2019 she noticed some hearing loss. The reporter consented to follow up. Emergency room visit required.
Redness, swelling 3 wks following injection. Possible local infection put on Bactrim DS, warm compresses-and told to keep f/u appt. next week.
felt like liquid running through to her head; lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 15Mar2023 at 10:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years, in right arm for immunisation. The patient's relevant medical history included: "Covid", start date: 2022 (unspecified if ongoing), notes: She had been in the hospital for 9 weeks for Covid in 2022 at the beginning of the year; "Covid", start date: 2022 (unspecified if ongoing), notes: had it again at the end of the year and didn't go to the hospital for that one.; "disabled" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: B12 shot. Vaccination history included: Pneumonia shot (pneumonia shot previously about 6 years ago in the hospital), administration date: 2017, when the patient was 79 years old, for Immunization. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 15Mar2023, outcome "recovering", described as "felt like liquid running through to her head"; DIZZINESS (non-serious) with onset 15Mar2023, outcome "not recovered", described as "lightheaded". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: All of a sudden, she felt like it was going through to her head and running like it was the most, she has never in all the years she has had injections never had an experience like this. She felt like liquid running through to her head. States it has passed. Still lightheaded but not anywhere near what she felt like something was just running into her head. Never experienced that in all her 84 and half years. She takes her usual medications. Event did not require a visit to emergency room or physician office.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
THE DAY AFTER THE FIRST DOSE OF VACCINE (3/13/2021) MY HEART RATE STARTING RACING EVERY TIME I WAS IN AN UPRIGHT STANDING POSITION. AFTER 15 MIN OF BEING UPRIGHT I WOULD HAVE TO LAY BACK DOWN UNTIL HEART RATE WAS BACK TO NORMAL. THE NEXT DAY (3/14/2021) I WAS EXPERIENCING CHEST PAINS ALONG WITH A GALLOPING HEART WHEN WALKING AROUND. THE CHEST PAINS WERE ONLY BEING EXPERIENCED ALONG WITH EXERCISE.
Sore arm 1st two days  Afterwards severe ache and could not lift arm for 3 days Reddish sore on my foot.  Very painful. Cannot put weight on it
With the 1st shot, I got a rash of little dots on my right forearm.  I had been working in some evergreen trees, so I just thought it was from them.  With the 2nd shot, however, the injection site swelled up to 2" in diameter, & I got the rash of dots on both sides of my stomach.  It took Benadryl & Benadryl cream to stop the itching.  It last about 1 1/2 weeks.  Now, as of 10/28/2021, I am in the hospital with an auto immune disorder that attacked my kidneys.