chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. Patients concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of ROTATEQ Lot # L013203, expiry date 28-JAN-2017, oral route (dose was not reported) that had been exposed a 34 degrees F for less than 30 minutes, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Red, swollen, warm-to-touch arm; Red, swollen, warm-to-touch arm; Red, swollen, warm-to-touch arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 17Feb2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received morphine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) and pantoprazole sodium sesquihydrate (PROTONIX) all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, 8 days after vaccination, the patient experienced red, swollen and warm-to-touch arm. It was reported that welcome to contact her doctor but she did not go to show her reaction on her arm. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events red, swollen, warm-to-touch arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
FIRST DAY: *HIGH GLUCOSE; *NAUSEAS; *LITTLE HEADACHE; *CHILLS; *TIREDNESS.  SECOND DAY: *HIGH GLUCOSE; *TIREDNESS; *HEADACHE; *SMALL BLEEDING.  THIRD DAY: *HIGH GLUCOSE; *MODERATE BLEEDING.  FOURTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING.  FIFTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING.  SIXTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING.  SEVENTH DAY: *GLUCOSE A LITTLE MORE CONTROLLED; *MODERATE BLEEDING.  EIGHTH DAY: *GLUCOSE A LITTLE MORE CONTROLLED; *ENOUGH BLEEDING; *WEAKNESS.
Systemic: Chills-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Severe
pt very combative,hitting & screaming @ mom; Pt given vax 15APR93 @ 225PM then turned pale & collapse to floor; pt limp & vomitted on floor; PB 60/40, pale, cool & clammy; unresponsiveness, vomitted x 2; weakness, not feeling well;
codeine in my urine analysis; I had my 3rd shot of the Pfizer covid vaccine; I had my 3rd shot of the Pfizer covid vaccine; This is a spontaneous report received from a contactable consumer or other non hcp via Product Quality Complaint Group. A 47-years-old male patient received bnt162b2 (Comirnaty, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0170, expiry date unknown) via an unspecified route of administration on 23Aug2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date unknown) via unspecified route on an unknown date (at the age of 47-Year-Old) as dose 1, single and BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date unknown) via unspecified route on an unknown date (at the age of 47-Year-Old) as dose 2, single for COVID-19 immunization. On 23Aug2021 patient stated 'I had my 3rd shot of the Pfizer covid vaccine' and codeine in my urine analysis'. Patient stated he needed information on the ingredients of the Pfizer covid vaccine. He had a urinary analysis done. Patient stated I had codeine in my system. On 23Aug2021 I had my 3rd shot of the Pfizer covid vaccine. On 24Aug2021 I had a urine analysis which presented codeine in my urine analysis'. Patient was asking if codeine was in the Pfizer covid vaccine. The patient underwent lab tests and procedures on 24Aug2021 which included Urine analysis: codeine in my urine analysis. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
On 9-5-11 patient's arm from shoulder to elbow red and swollen. Went to doctors office was given steroid. After a few days arm swelling subsided arm ok for about a week. Around the 20th, swelling returned to arm. Went to doctor again did MRI, took x-ray, shows nothing. Patient took BENADRYL and ALEVE which helped a little but as of 9-27-11 still a little swelling.
The next morning post vax, the pt passed out and developed a fever of 102.4, achiness, and fatigue. He was treated with rest, fluids, and Advil. He recovered.
This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. The patients' pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the unknown number of patients were vaccinated with improperly stored GARDASIL 9, for prophylaxis (dose, units, lot number and expiration date were not provided). Administered vaccine reached temperature excursion high of 15.9 Celsius degrees and lasting for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002132: US-009507513-1705USA007630.
Patient came to receive a updated Bivalent Pfizer booster but was accidentally given the original Pfizer vaccine
Client received immunizations commensurate with age: DTaP, IPV, MMR, and Varicella. Client ambulated approx 10 feet to the exist window with mother - then "passed out." Client aroused quickly and responded to commands without difficulty. Client did appear cyanotic, but not normal (slow came back quickly. Assessment performed per nurse.
Normal vaccine arm soreness and tiredness until 2 days later and i got a painful red, burning rash on my flank and abdomen that is getting worse by the hour. I don?t know what to do. I?m going to try to contact a doctor tomorrow because the pain is bad and it hirts to move.
States (L) deltoid started swelling and became painful after the vaccine was given 1/16/12. (L) deltoid tender and swollen.
MOC stated child c/o LA discomfort since the night of vaccination. She states that upper LA has two areas (one golf ball size, the other tennis ball size) that are red and warm to the touch. She states that this local reaction has progressively become more pronounced. Vaccines may have been given in opposite arms to what is noted below per MOC comment.
Severe nausea and vomiting; Severe nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration in the left arm on 05Sep2021 at 15:00 (at the age of 28-year-old), as a single dose for COVID-19 immunisation. Medical history included heart supraventricular tachycardia (Heart SVT) and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 06Sep2021 at 05:00, the patient experienced severe nausea and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vomiting and nausea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next day it spread partly down my arms and legs. On day 6 I had malaise and fatigue  and lessening of rash.
pt recvd vax 16NOV93 & exp pain @ inject site; 3-4 hrs later intense pain; tenderness @ biceps tendon & humeral groove; tx'd w/IV solu-Medrol; sx worse (pain radiating from arm to lt neck & chest wall); neuritis; melena; stool was guiac pos
Information has been received from a physician concerning a 12 year old female who on 26-JAN-1999 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported).  On 06-MAR-2002, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported).  On 06-DEC-2009 the patient experienced mumps (though the date diagnosed was reported as 26-NOV-2009).  The patient had body temperature of 102 degrees F.  The outcome for mumps was not reported.  Follow up information has been received from the physician who reported that the 12 year old patient (also reported as 9 year old at onset date) experienced mumps on 01-JAN-2010 (previously reported as on 06-DEC-2009).  The date diagnosed was reported as 03-JAN-2010 (previously reported as 26-NOV-2009).  It was reported that the patient was afebrile and experienced bilateral parotitis.  At the time of the report the patient's outcome was unknown.  This is one of several reports from the same source.  No further information is available.
Information has been received from a health professional concerning a 5 year old female who on 25-APR-2007 was vaccinated SC with a dose of Zostavax instead of Varivax. It was reported that this was due to a nursing error. The vaccines and been stored together in the freezer. The reporter stated that the vaccines are now stored in separate bins which are marked pediatric and adult. As of 04-MAY-2007 the patient was "still fine with no problems". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Caller's husband experienced foot pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the caller's husband experienced foot pain on an unknown date. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
left upper arm swelling; blister at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   On 25th May 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced swelling arm and injection site blisters. On an unknown date, the outcome of the swelling arm and injection site blisters were unknown.   It was unknown if the reporter considered the swelling arm and injection site blisters to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced left upper arm swelling and blister at injection site.
Red, swollen, tender injection site several hours following the injection.  Symptoms persisted for several hours.  Mild generalized malaise.
Sudden hearing loss in right ear.  Patient is a hearing aid user and had a hearing test most recently before vaccination on Oct. 14 2021.  Hearing in both ears was tested again on Nov. 30.  The audiogram showed decrease in the right ear of up to 25db, though it was less at most frequencies, and even zero change at others.  First attempt at treatment was oral prednisone on a 10-day taper, starting with 60mg/day for five days.  Hearing was tested again on Dec. 7 and there was no significant change.  At this point a steroid injection was done on the right ear.  As of this writing on Dec. 11, there does not seem to be any improvement.  Another hearing test is scheduled for Dec. 16.
Dizziness; Rash all over the body; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness), RASH (Rash all over the body ) and HEADACHE (Headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced DIZZINESS (Dizziness), RASH (Rash all over the body ) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), RASH (Rash all over the body ) and HEADACHE (Headache) had not resolved.        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.   Treatment medications were not reported. Concomitant medications were not reported.
Fatigue; Tightness in the left jawand  left neck; Chills; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in the left jawand  left neck), CHILLS (Chills), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in the left jawand  left neck), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at injection site). On 30-Jan-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, MUSCLE TIGHTNESS (Tightness in the left jawand  left neck), CHILLS (Chills), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received on 24-06-2021: No new information
Blistery rash on side and back painful, itchy, and burning patient diagnosed w/shingles 5/9/18.
Sparkling flashes in vision. Unfocused vision about 5 hours after shot. Mild muscular ache in site
On August 20, 2022, I went for a walk but didn't walk far because I had trouble breathing. The next day we began to leave the house for a walk, but I couldn't make it out of the driveway because I was unable to breathe. I went to the urgent care, and they sent me to the hospital for appropriate tests. I left the hospital and went home. The physician's assistant called to let me know my D Dimer levels were very high and I needed to return to the hospital immediately. I had a CT scan and blood clots were found in my lungs. I stayed in the hospital for one night for monitoring. I was given blood thinners. I went to a hematologist and I was told I had to be on the blood thinner for the rest of my life regardless if the clots disappear or not.
Information has been received from a consumer concerning her approximately 20 month old son with no pertinent medical history and no drug reactions or allergies, who on 25-JUL-2008 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included a dose PREVNAR. The child's mother reported that he received VARIVAX (Merck) and experienced high fever that would not do down with TYLENOL. The child also experienced moodiness after receiving the vaccine. At time of reporting, the patient had recovered. The patient sought medical attention as his mother called the office. There were no lab or diagnostic studies performed. Follow up information has been received from an office member of a physician's office who reported that the patient received the VARIVAX (Oka/Merck) on 25-JUL-2008 but was not  a patient at their office at that time. It was not given at their office. The consumer also reported that the patient experienced an adverse event with HPV-77 (WAES # 0902USA02199) and MMR II (WAES # 0902USA01781). Additional information has been requested.
Patient presented to the local Health Department to receive a Pfizer Bi-Valent booster vaccine. Patient was inadvertently administered a Pfizer Mono-Valent vaccine.
vaccinated with Pfizer in Feb-March 2021.  developed mild tiredness and came for the covid testing
Gave patient booster dose before six month due date. Patient received two Pfizer doses. First dose on May 13, 2021 and second dose on June 4, 2021. Moderna 0.25ml booster dose given on 11/18/2021 before six month mark had been med.
Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills.  Jan 12th- Fatigue, soreness at injection site, and chills.  Jan 13th- chills and fatigue.  Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue,  body aches and chills.  Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue,  body aches, chills,  sore throat, left ear pain and nausea.  Jan 20th- sore throat, body aches, fatigue, hives
tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 03Mar2021 12:00 (at the age of 52-year-old) (Batch/Lot Number: E13247) as DOSE 1, SINGLE and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 24Mar2021 12:00 (at the age of 52-year-old) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Known allergies to Penicillin and Celebrex from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken for an unspecified indication, start and stop date were not reported. After dose 2, the patient tested positive for covid 19 (vaccination failure) (medically significant) on 15Sep2021 12:00. The patient underwent lab tests and procedures which included covid-19 virus test (Nasal swab): positive on 15Sep2021. Patient did not receive any treatment for adverse events. Patient did not have pregnancy at time of vaccination. Patient did not receive any other vaccine in four weeks. It was reported that the patient had not been diagnosed with covid prior to vaccination. Outcome of events were not recovered.   Follow-up attempts are completed. No further information is expected.
Pt received DTaP and Polio in RT/IM on 12-10-08 at 4 yr WCC. Mom called answering service stating pt developed swelling and rash around the injection site. Mom is to use 150mg IBU Q6 hrs x 24 hrs for swelling and RTO if worse or concerned.
Client vaccinated with Moderna vaccine for Covid on 3/1 and 3/29/2021 at a CVS pharmacy.  Had contact with Covid+ person on 11/4 and client tested + on 11/9.  Symptoms started 11/10 - nasal congestion and low grade fever.
Headache immediately, spike in blood pressure, dizziness, swelling and pain at injection site after 10 minutes.
Redness on left arm increased over last 3-4 days with streaking.  1 cm blistered area surrounded by edma and warmth 5-6 cm in diameter with a lymphangitic streak extending 8 cm medially towards the axilla. Seen at civillian ED, diagnosed with bacterial cellulitis and treated with 3gm IV Unasyn and Augemntin 875mg 1 b.i.d x10 days.
COVID Breakthrough  Pfizer Dose 1 3/2/21 (EN6203) Pfizer Dose 2 3/23/21 (EN6207) COVID Positive 8/23/21  8/24/21: Patient is a 77-year-old female with history of Alzheimer's dementia, CKD stage IIIB, and recent prolonged admission for surgical intervention of rectal prolapse was admitted with increased confusion from baseline and recent diagnosis of COVID-19 and found to have hypoxemia.  History is obtained from chart review as well as discussion with the ED provider.  Patient is quite lethargic and does not provide a history.  Patient resides in a nursing home stay with her Alzheimer's dementia.  She is on multiple antipsychotics given frequent combative behavior.  She had a prolonged admission in May and June of this year after an admission for a repair of a rectal prolapse.  She did require multiple subsequent procedures secondary to complications.  Patient reportedly was COVID positive yesterday at her nursing home.  She was noted to be more altered today than her baseline which is combative most of the time.  She was brought to the ER.  Did found to be hypoxemic in the 80s and now on 2 L. CT showed concern for possible right lower lobe pneumonia.  She is currently afebrile.  She was given Haldol in the ER and currently quite sleepy.  8/28/21: 77-year-old female with PMH of Alzheimer's dementia, CKD stage IIIB, recent diagnosis of COVID-19, recent surgical intervention for rectal prolapse who presented from long-term care due to confusion and concern of hypoxemia.  Patient admitted for questionable COVID-19 pneumonia however she was not on oxygen and did not need treatment COVID-19 pneumonia.  Was started on Rocephin and Zithromax to cover for bacterial pneumonia, she is very agitated at times, and I think part of her confusion and encephalopathy is polypharmacy.  At this point I do not think she needs treatment for COVID-19 or any in-hospital treatment.  The plan was discussed with patient's daughter/POA yesterday over phone and she is in agreement. Patient will be discharged back to long-term care in a stable condition.
Severe lymph node swelling - tennis ball sized, 72 hours later still egg sized  102 degree fever for 24 hours, 72 hours later still at 100  High heart rate (130 bpm).
On admit to Medical Center on 3/10/21 patient was noted to have to have chronic urticaria which she reports that started after her Moderna vaccination for COVID-19. She developed hives after her first vaccine (2/6/21) which affects her upper arms chest back and axilla.  They are itchy, wax and wane. Patient had been using Benadryl at home and this was continued on an as-needed basis along with scheduled cetirizine and famotidine with good improvement of hives.
This case was reported by a pharmacist and described the occurrence of hepatitis B surface antigen positive in an adult female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  On 30 May 2007 the subject received 1st dose of Twinrix (unknown).  Two weeks after vaccination with Twinrix, the subject tested positive for hepatitis B surface antigen and was negative for immunoglobulin M.  At the time of reporting the outcome of the event was unspecified.
pt's mom states pt exp immed pain in arm followed by erythema & swelling of arm from inj site to wrist that evening;pt states several days later swelling & pain had subsided;refused to return to clinic for eval;