chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received call from CDC Epidemiologist regarding 19 y/o female with possible vaccinia contact transmission. Girlfriend with recent intimate contact with active duty service member vaccinated with SPV. 10/30/2009 MD records dated 10/22/2009. Patient presented with rash, lesions on face, hands and vulva. The vulvar lesions were "weeping with pus". Patient developed these lesions after intimate contact with a boyfriend who had recently received a smallpox vaccination. Patient went to ED on 10/21/2009, no tx was noted.  Lab test: PCR assay test noted no Non-variola orthopoxvirus detected.
Started with chills then led to a fever, gave me a headache, and body ache. Took 2 Advils for it and put some cold cloths around my body to bring down the fever. Fever was gone by 5am so it only lasted approximately 6-7 hours. All symptoms were gone by the next day.
I started losing sensation in my (R) hands and feet in 1999. I suffered a miscarriage 4/24/00 and 5/15/00 it was twins gestation.  The loss of sensation moved from (R) hands to both hands and arms and both legs and feet.  My regular doctors ran tests for years and are still running them as I type this to determine cause.  I have been diagnosed with neuropathy, fibromyagia, possible lupus and MS, severe anemia, among other things ...it wasn't until meeting with a naturalist recently and reading the effects of the anthrax vaccine today that I realized I may be undergoing all of this because of either taking the vaccine or not finishing the series. Prior to this I had been a very healthy person.  I not missed a day of high school and only 1.5 days from K-8 (1 day for my brother's graduation and .5 to appear on a show).
no additional AE; vaccine was administered after temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 06-NOV-201, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin (rHA)) (PROQUAD) 0,5 millilter, lot#U017140, expiration date: 28-NOV-2022 (route of administration  was not reported) for prophylaxis (Product storage error). The vaccine was reconstituted with properly strored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 6 up to 14 degrees Fahrenheit for 4 hours and 14 up to 46 degrees Fahrenheit for 4 hours and 45 minutes. There were no previous excursions reported. There was no adverse effect reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA001841:
1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER vaccination: headache, fatigue, cough, GI distress, fever (100) 48-72 hours AFTER vaccination: headache, elevated temperature (99.7)
1011: After receiving Covid vaccine, pt c/o lips tingling 1013: Benadryl 12.5 mg po given 1021: Benadryl 25 mg po given 1031: Feeling much improved
This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 35-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Complication of pregnancy since an unknown date and Pregnancy (She has 3 previous pregnancies and its outcome was spontaneous abortion). Concurrent medical conditions included Drug allergy (Clindamycin). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Mar-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 27-Jul-2020 and the estimated date of delivery was 03-Apr-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. Not Provided      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 treatment drugs are not provided by reporter. Patient had three previous pregnancies which were miscarriages spontaneous abortion in Jul 2018, Feb2019 and Nov 2019. Had unremarkable course of current pregnancy to date except for a short cervix.
HYPOTENSION 5/24/2021 AORTIC VALVE STENOSIS    ATRIAL FIBRILLATION, PAROXYSMAL
Shingles symptoms onset 4 days later, rash outbreak 5 days later.  Severe shingles pain continuing  now 3 weeks.
Received vaccination at 11:10. Waited 12 minutes in observation and left because felt fine. At 11:45 while driving home, experienced numbness and tingling in my whole face like receiving a novacaine injection at the dentist.  A few minutes later experienced tachycardia.  A few minutes later, experienced a walnut sized lump in my throat that was more evident with swallowing. Voice was also raspy, but did not experience any difficulty breathing. Got off the highway and went to a hotel lobby to call 911 as my cell phone battery was about to die. This was around 12 noon.  BP was 160/94 which is high for me; usually runs 90-95 systolic. Was transported to the ER. Next BP was 150/84. Upon arrival to the ER, the symptoms described had not worsened. Was discharged later that day around 5 PM. No treatment was administered. The next day, arm very sore, had joint aches and felt tired. By 1/23/2021 had mild arm soreness without other symptoms.
At 11:30PM I started having chills, my chest hurt, difficulty breathing, headache, body ache, like a flu, I went to the hospital, they told me I had fever, was dehydrated, earing ringing. At the hospital they took a chest x-ray, gave some fluids; when I finished the IV (2 bags) they sent me home, from that day symptoms got less and less every day. They also gave me TYLENOL.
COVID breakthrough first dose 5/23/2021 EW0202, second 6/13/2021 EW0196.  COVID test + 5/26/2022.  53y.o. male with no significant past medical history who was diagnosed with coronavirus about 5 days PTA after he developed fever, chills, myalgias.  He has been taking an COVID treatment kit since the diagnosis which includes the combination of azithromycin, prednisone, ivermectin and hydroxychloroquine.  The fever, chills and myalgias have resolved but last night when attempting to fall asleep, he acutely felt like he could not catch his breath so he presented to an outside ED where he was found to be in atrial fibrillation with RVR.  He was placed on a cardizem gtt which was titrated to 15mg/hr with improvement in his heart rate.  He was started on therapeutic anticoagulation and is admitted to our hospital.  Currently he feels fine.
This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 60-year-old female patient who received HAV (Havrix 720) (batch number ce74n, expiry date 19th June 2022) for prophylaxis.   On 21st December 2021, the patient received Havrix 720. On 21st December 2021, unknown after receiving Havrix 720, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The reporter reported that on 21st December 2021 an adult patient received a pediatric dose of Havrix, which led to underdose and adult use of child product.  The reporter consented to follow up.
dizziness and weakness started around 2000  severe chills that lasted from 2100 throughout the night.  insomnia could not sleep due to chills  headache, weakness, short of breath
Pfizer Dose 1 2/17/21 (EN6200) Pfizer Dose 2 3/11/21 (EN6208) PFizer Dose 3 11/1/21 (FE3592) COVID Positive 1/12/2021  1/7/22: 88-year-old male who presented to the Emergency Department with increasing epigastric and abdominal pain.  Pain did been going on for several days.  CT scan of the abdomen and pelvis revealed a a small-bowel obstruction with a demarcation line zone at the distal small-bowel of the area of the cecum.  Patient was transferred to hospital has no beds were available on the LUE side of the river.  Patient recently had a mitral valve procedure and he is doing much better as far as his breathing and heart.  Patient with multiple other medical problems including COPD coronary artery disease, Agent Orange, chronic diarrhea chronic back pain.  Has been many years since the patient has had a colonoscopy  1/13/22: Patient admitted with SBO that resolved spontaneously.  Patient became COVID+. Discharge to skilled care nursing
Patient came in on 9/20/16 to show me that her injection site was red, hot to the touch and hard. Only the left arm where the PREVNAR 13 was given, the right arm (FLUZONE HD) had no reaction.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-JUN-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, route of administration and indication were not reported, lot # L040181 with expiration date: 18-AUG-2017). Concomitant therapy was not reported. No adverse effects were reported. Administered vaccine experienced the temperature excursion of 61.5 degrees Fahrenheit for 5 hours 30 minutes. Data logger was involved. Administered vaccine also experienced previous temperature excursion of 52.5 degrees Fahrenheit for 1 hour 15 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
High fever of 102.3, severe headache and muscle pain. Dizziness and sweats. For 48 hours
Information has been received from a medical assistant concerning a 19-month-old male patient who on 08-MAY-2004 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Vaccine was administered as 2:10PM; while waiting for designated 15 minute period, began to feel increased heart rate, left arm tingling, and gradual facial warmth. Left facility around 2:37pm to parked car where noticed in mirror redness in face from jawline to cheeks. Began feeling lips and tongue tingling and puffiness. Returned to vaccine administration site to be seen by nursing staff on-site. Vitals were taken and in consultation with ER staff, was transferred to ER on site for additional evaluation and monitoring. Vitals were taken in ER which looked "good" and was given prednisone. Was discharged around 4-5pm with 5-day prescription of prednisone and epi-pens.
Patient became light headed, nauseated & one episode of emesis. He related that he became quite anxious leading  up to episode, BP was initially 92/50 but he became normotensive  126/82 prior to D/C to home  He  declined transport.
Fever, now resolved, nasal congestion now resolving. Axillary lymph nodes on left sides with pain and swelling. Patient is using Tiger Balm and warm compresses. Swelling pain at injection site. Additional info see attached... A 29 yr old female who presents for Reaction to TDAP, immunization given in left delt on 07/31/08, PT states she has had flu like symptoms and swelling and pain in left delt. AL/SMMA.
Redness, drying, flaky area around injection site with diameter of approximately 1 inch.
Shortness of breath, tightness in chest.  Patient treated himself with Benadryl and inhaled albuterol.
Patient received first dose of Pfizer COVID vaccine at one of our pharmacy off-site COVID clinics held at  University. He reported not having any previous vaccinations. However, when I went back to the hub/spoke store (the pharmacy that we run all the paperwork at from off-site clinic post-clinic), his insurance rejected the Pfizer vaccine stating "Per patient history, pt has received both doses." I did a central search for all pharmacies and found that he had gotten the Janssen vaccine 03/20/2021 that was entered at another hub/spoke pharmacy post-clinic. I immediately called the patient, the patient answered and stated that he "doesn't remember getting the J&J vaccine but maybe he actually did" and apologized. He reported no adverse effects at that time (this was around 6 hours post-vaccine administration that I made this discovery), and I plan to follow-up again to check in with him in case he has problems. I informed him that "although the CDC provides considerations for a mixed series in exceptional circumstances, this is still considered an administration error that required reporting and a mixed series is not authorized under the vaccine Emergency Use Authorization." I also informed him that it is not advised to give any additional doses.
13:26 COMPAINED OF EYES TINGLING (EYEBALLS) T 97.6, BP 120/74, HR 84.  13:43 BP 136-82 EYES STILL TINGLING, LIPS TINGLING, HANDS TINGLING, RESPIRATORY UNLABORED.  50 MG BENADRYL ELIXIR PO GIVEN, PARENTS CALLED TO PICK UP.  13:44 GRANDPARENT CALLED BACK TO CONFIRM PCN ALLREGY.  STUDENT RESTING.  13:46 STUDENT REPORTS HE FEELS BETTER 13:51 T 97.9, 13:58 MOM ARRIVED TO TRANSPORT HOME.  MOM WILL TAKE TO DOCTOR IF WORSENS.  STUDENT RETURNED TO NORMAL.
Systemic: Exhaustion-Mild, Systemic: Fever-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Headache-Mild, Systemic: patient experienced pain when taking deep breaths but was positive for covid in march2020 and out of work until june 2020. last covid swab was 12/22(negative)and 12/29. temperature was 99.6 and pulse
25 weeks pregnant patient was administered Fluzone Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via The Agency (Reference number- 00370249) and transmitted to Sanofi on 24-Nov-2020.  This case involves a 30 year old female patient who was received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was 25 weeks pregnant (exposure during pregnancy).   Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported.  The estimated due date was not reported.  Previous pregnancy (if any) not reported.  Medical history, medical treatment, vaccination and family history were not provided.  No other concomitant vaccines were used.    On 24-Nov-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7108MA and expiry date: 30-Jun-2021) (prefilled syringe) once via an unknown route in the right deltoid for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day).   At the time of report, no adverse event reported following vaccination.  Pregnancy outcome was unknown at the time of report  Reporter was informed that they will be receiving a follow-up questionnaire and all pregnancy cases were added to the registry as per FDA (Food and Drug Administration) requirement. It was reported as product, device was used and no potential product technical complaint involved in this case.
Patient received influenza vaccine on 7 October. Was seen in clinic on 17 October for generalized pain and weakness to the left shoulder that began 11 October. Following visit patient was encouraged to take over the counter pain medications as needed and utilize ice intermittently. Patient continued to have weakness and pain to the left shoulder with minimal to no relief with current pain regimen. Was seen again in clinic 05 December. NSAID (naproxen) and physical therapy ordered.
Had severe rash and itch.    With time it got worse.  Got blisters .  Used over the counter lotions for months.  Went to Urgent Care hoping for relief  June 17/21.  I did remember I had Darier's  disease.  Prior rash minor no blisters.  This flare up worse in 30yrs.  Covered both lower leg left side.  Then and now both lower legs blisters. Triamcinolone 0.1% made it worse.
shivering on and off; soreness on the shoulder; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 16Apr2021 on Friday at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness on the shoulder in Apr2021 where the vaccine was administered and it lasted for about two days, shivering on and off in the upper part of his arm, where the soreness was, occurred on 21Apr2021 at around 07:00 in the morning. Patient would like to talk to someone about these symptoms whether he should go to the hospital or not. The outcome of the event soreness on the shoulder was recovered while outcome of the event shivering on and off was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Needle malfunction. Greater than 1/2 dose not administered.  A second dose was administered in the contralateral arm per CDC Guidelines.
rash at site of vaccine (left deltoid) and severe pruritic rash on both ankles
slight cough; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (slight cough) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy and Leukemia since 2010.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced COUGH (slight cough) and HEADACHE (headache). On 03-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, COUGH (slight cough) outcome was unknown and HEADACHE (headache) had not resolved.            No concomitant and treatment drugs were reported.   This case was linked to MOD-2021-030579, MOD-2021-030579 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Added address of the reporter, second dose of the drug, patient demographics (height, weight, race, allergy, current condition). Added the events (cough, headache).
DTaP/DTP ; Polio; HIB; Hepatitis B; PneumoConju; Rotavirus. The Dr. did not give additional information to properly list item 17. Infant began running a low fever about 10-12 hours after vaccination, we administered a dose of acetaminophen and fever subsided. About 0030-0100 infant woke up crying and running a fever about 102. Other parent took them to ER in response.
Current unresolved symptoms include swollen lymph nodes and pressure, in and around head and throat, and tinnitus, and 1- I feel pressure in my head, behind my ears, and pressure, on and off, at different nodes / locations around my head and throat. The nodes are very tender. This increases and decreases with intensity and can make me feel sick and dizzy occasionally.  2- Bumps come and go around my head / skull and behind my ears. 3- Occasional sharp pain comes and goes in my head. 4- I hear a very high frequency sound that I can best describe as "old tv static", heard from both ears, and to me it sounds like it's coming from inside my head. I tend to believe that the sound I hear is due to the swollen lymph nodes. 5- I feel like I have a marble in my throat.  6- A taste that I best describe as metallic comes and goes.  7- The intensity can bring on severe headaches and brain fog.  Prior to this I was a healthy and physically active 50-year-old. I had never had any health concerns. Also, I was extremely careful about protecting against any covid-19 exposure since the beginning of 2020 and do not believe I have had any exposure.    The only unusual physical event I believe I have experienced was extremely harsh side effects from the Moderna vaccines. ( I am 100% pro vaccine. My husband who received the vaccines at the same location and day as me seems fine and had a milder reaction to both shots.)    After the 1st  Moderna vaccine (1/20/2021) I said "I've never felt so physically tired". My eyes were very sensitive to light. My body ached and felt physically extremely exhausted. This resolved after 24 hours.   After 2nd Moderna vaccine (2/16/2021) initial symptoms included light sensitivity, cold sweats, pounding and pulsating headache, feverish and extremely achy all night, barely slept, felt I could not lift arm. Most of this resolved over 48 hours. Initially I believed the pressure developing in my lymph nodes would resolve in time. The pressure however increased and by April I started hearing the high frequency "old tv static".    April 15th 2021 I visited my primary care doctor. He identified Tinnitus' and advised me to visit an ENT doctor.    April 19th 2021 I visited ENT doctor. (audiogram / tympanometry all normal). I was prescribed Methylprednisolone 4mg which helped a little on the first couple of days of the taper. I subsequently asked for a second prescription of same. In both cases the benefit wore off quickly.  ENT doctor ordered blood tests (collected same day).  I was told the blood test results were normal and ENT doctor prescribed a brain MRI.  However, later on, I noticed the blood test result for the Thyroid Peroxidase (TPO) Ab test was HIGH at 80 iU/mL . The earliest Brain MRI was scheduled for May 26th 2021. The result was reported normal for what was tested.    (On May 27th 2021 I requested by phone that my primary care doctor prescribe me Amoxycillin and I took Amoxicillin-pot clavul for the 10 days)
Both vaccines once given I had side effects within 2-3 hours.  Listed below: High fever (101-102 F) 2-3 days long Full body aches Nausea Headache Severely sore arm pain at location of shot Vomiting (first day/night) Ringing in ears Light headed
Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
3-4hr p/vax pt reported abd pain/nausea for couple days;stopped the series & sx abated w/o treatment;
When I arrived home I was very hot.  I didn't any way to take my temperature.  About three hours after the shot, I started itching all over my body.  The itching lasted all night and all the next day.  I took diphenhydramine (2 tablets 25 mg. each).  It helped for a while, but now that 4 hours have gone by, I am itching all over again (face, arms, buttocks, legs).
68 year old male reported to have received two vaccines (flu and "pneumonia"). Ambulance was called. Pt was purple from neck up. Medical examiner declined autopsy.