chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product storage error; This spontaneous report was received from a physician regarding to a patient of unknown age and gender.    Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 08-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot # T021302, expiration date 19-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not provided).  The improperly stored suspect vaccine experienced a temperature of -5 degree Celsius (°C) for 20 hours with no previous temperature excursion.   The call was made due to a digital data logger.
PATIENT CALLED US ON 12/20 TO REPORT THAT SHE HAD JUST BEEN DIAGNOSED WITH A DVT.  SHE STATED AFTER VACCINE ON 12/14/21 SHE FELT VERY ILL, RAN A HIGH TEMPERATURE AND HEADACHE FOR 48 HOURS.  SHE TRIED TO SLEEP IT OFF BUT CONTINUED TO FEEL ILL.  THE NEXT DAY SHE STARTED TO HAVE PAIN IN HER LEG SO SHE WENT TO THE DOCTOR.  THE DOCTORS OFFICE DIAGNOSED HER WITH A DVT.  I TOLD PATIENT TO FOLLOW UP WITH US AND LET US KNOW ANYTHING ELSE THAT WE CAN HELP WITH.  THE PATIENT WAS GOING TO REPORT ADVERSE EVENTS VIA THE VSAFE APP AS WELL.
the baby had 104 fever for 9 hours; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  A 7-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 3, single (Batch/Lot number: unknown) for immunisation; rotavirus vaccine (ROTAVIRUS VACCINE), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (medically significant), outcome "unknown", described as "the baby had 104 fever for 9 hours". The patient underwent the following laboratory tests and procedures: Pyrexia: 104 fever for 9 hours".  Clinical course: Caller mentioned that it was "a 7-month-old baby who was given 3rd dose of Prevnar 13 with rotavirus vaccine on the same day, and the baby had 104 fever for 9 hours". Caller wants to know if there is a contraindication giving the 4th dose of Prevnar 13 for the baby, given that the patient experienced a fever -which caller mentioned that most babies got post-vaccination- after the 3rd dose that was administered with rotavirus vaccine. Caller insisted for recommendation.  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.; Sender's Comments: Based on available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine PREVNAR 13 and the reported event "the baby had 104 fever for 9 hours". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
painful lymphadenopathy of the left armpit(deep in) with swelling. pain radiate to back and no erythema
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/5/2021 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE RESPIRATORY FAILURE 12/2/2021 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 12/5/2021 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE RESPIRATORY FAILURE 12/2/2021 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Opposite arm, not injection arm, was hurting for three to four hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 "Opposite arm, not injection arm, was hurting for three to four hours".  Additional information: Patient was asking in their community if anyone else had a problem. His arm hurt for 3-4 hours and then it was fine. Caller advised him to report his experience. When querying information for patient, caller wanted to ask the patient if caller can report on his behalf. Caller did not feel it is caller's place to proceed with report for the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills; fever (his temperature was 104-105°F); muscle weakness in legs and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever (his temperature was 104-105°F)) and MUSCULAR WEAKNESS (muscle weakness in legs and shoulders) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever (his temperature was 104-105°F)) and MUSCULAR WEAKNESS (muscle weakness in legs and shoulders). On 03-Feb-2021, CHILLS (chills) had resolved. At the time of the report, PYREXIA (fever (his temperature was 104-105°F)) and MUSCULAR WEAKNESS (muscle weakness in legs and shoulders) had not resolved.             Treatment information was not provided.    This case was linked to MOD-2021-033733 (Patient Link).
I found a lump in my right breast. I immediately made an appointment to see my doctor for a mammogram, he also ordered a biopsy and ultrasound. He then ordered a PET scan that I had done on November 25, 2022, that showed that the lump had metastasized. I will not have a lumpectomy it will not affect the outcome. I am taking oral cancer treatment, bone strengthening medication.
Extreme muscular pain, diagnosed with Polymyalgia Rheumatica (Originally misdiagnosed with Myositis)
patient had febrile seizure lasting approx. 2 minutes, patient was dyspneic, cyanotic, unresponsive during episode. patient recovered and was treated with acetaminophen
Had vaccine on Oct 21. On Oct 22 patient complained of pain and swelling. On Oct 23 there was a 3 inch area of redness, heat, swelling below the vaccine site.
RECEIVING 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 44 year old female. The patient's height, and weight were not reported. 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: 1822809 expiry: 07-MAR-2022) 2.5 ml, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-NOV-2021, the patient experienced receiving 2.5ml of the janssen covid-19 vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the receiving 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Vaginal spotting previously reported for this patient. Second instance reported yesterday. 20+ years post-menopausal.
(L) arm - pain at injection site, pain with movement of arm past 90 degrees in arc of motion and pain when reaching above my head with (L) arm.
Initial unsolicited report received from a consumer on 10-SEP-2016. This case involves a 76-year-old female patient who was vaccinated with a dose of FLUZONE HD batch number: UI636AA, expiration date: 27-MAR-2017, intramuscularly, in the right deltoid on 09-SEP-2016. Patient received a previous dose of FLUZONE HD on an unspecified date in 2015 any adverse event with the vaccination was not reported. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as denied to provide. Concomitant medications were not reported. On 10-SEP-2016, one day following the vaccination, the patient had a 2 inch area of redness 6 inches below the injection site. It was reported that there is nothing at the injection site itself. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
pt recv vax 3NOV97 & 5NOV97 pt exp fever 99.8, chills & achiness;pt also exp an inj site rxn described as 2x4 in size that was hard, warm & erythematous;poss cellulitis;
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Information regarding concurrent conditions, medical history and concomitant medications of the patient were not reported. The patient was vaccinated with a total of 4 doses of GARDASIL 9 injection (dosing details, lot# and expiry date not known) on 22-MAY-2015, 21-JUL-2015, 18-DEC-2015 and 21-OCT-2016(Extra dose administered). No adverse symptoms were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
No adverse effect; Received first dose at age 11 years old, received second dose at age 15 years old; This spontaneous report was received from a nurse prescriber and refers to a 15-year-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the 11-year-old patient, received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in June 2019, the 15-year-old patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effect was reported.
Extreme fatigue (4/8; 10:30 PM - 4/9: 10:30 PM) Headache (4/9; 1:30 AM - 7:30 AM) Fever/sweating (4/9; 2:30 AM - 3:00 AM) Chills (4/9; 3:00 AM - 7:30 AM) Body ache/myalgia (4/9; 3:30 AM - 4/10; present time); Note: symptoms are improving  One (1) naproxen sodium taken (220 mg) on 4/9 at 1:30 AM One (1) naproxen sodium taken (220 mg) on 4/9 at 5:30 AM One (1) naproxen sodium taken (220 mg) on 4/9 at 11:00 AM Two (2) Tylenol taken (650 mg each) on 4/9 at 3:00 PM Two (2) Tylenol taken (650 mg each) on 4/9 at 11:30 PM
About 5 hours after the shot I got a migraine that lasted 2 days. That night in bed, my muscles tensed up, especially around my lumbar spine, and I couldn't get comfortable sleeping in any position. That also lasted 2 days. I also had the shivers for a short time, and I was totally drained of energy and stayed in bed the next day, not eating and barely drinking anything. The second night I got really nauseous and had to thow up, but only water came up since there wasn't much in my stomach. Despite continuing to be dizzy and nausous after vomiting, I got up to go back to bed and passed out cold, smashing the left side of my face on the wood floor. This gave me a large black eye around my left eye. I continued to feel very weak and stayed in bed for five days. I'm much better but still don't feel normal. I have intermittent dizziness and headache. I had no reaction other than a sore arm after the first shingles shot in June.
Aggravation next day, anxiety, night sweats a couple days later, fatigue, tired, hard time concentrating, and less than a week later extreme lower back pain that continues especially walking or stand for short periods of time. She has never had nights sweats or pain in the back or anxiety like this till the shot.  She is a swimmer on the swim team at school, honor roll student and know she can't hardly make it through the mall with out back pain.  Our orthopedic is ordering a MRI next week and blood work.
2 hours after receiving 2nd COVID vaccination began to itch and broke out in hives all over body.
At 4:30 on 9/25/08 my daughter received the flu mist at her doctor's office. By 12:00 the next day she went home ill from school. Breathing became progressively worse. Around 2:00am we were admitted into the ER. At 9:00 am transferred and stayed there until after noon on Sunder 9/28/08. Then we had to go to our pediatrician office 3 days the next week on Monday for pneumonia the other times for monitoring.
While in monitoring area, patient stated she got nauseated, lightheaded, dizzy, sweaty, and was getting tunnel vision. This was at 16:07. She was wheelchaired to monitoring area, VS taken: BP 100/60,  HR 76 BPM. Pt returned to baseline, she felt better with rest, gatorade, and water PO. Wheeled to vehicle, mother driving home stable.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was being monitored after their immunization when started to feel dizzy. Patient fainted and fell out of chair to the floor where we responded to him and called EMS. Patient was still breathing and became coherent as he was rolled onto his back. EMS confirmed he was ok to not go to the hospital so patient opted out.
The patient received the vaccine and did not have a reaction until Tuesdays the 19th. He had fever and chills. His grandfather signed the consent and told  the nurse that he need to have the vaccine because he has asthma.  The pediatrician increased his breathing treatment and prescribed antibiotics due to an upper respiratory infect that he had previously.  He is now stable and remaining in the home.
lt deltoid erythema & mild edema & pain 24hr p/vax w/itch;
Immediately felt strange and somewhat dizzy. By evening, I felt fatigue and dizzy. The next morning, I had slight stomach pains and diarrhea. As the following day went on, I had the chills and aches. By that following evening, it was back to fatigue only and all other symptoms were gone. The second day following the shot, all symptoms were gone.
High fever, body aches, headache - presented roughly 8 hours after injection. General soreness around injection site.
Could not sleep for 6 days and  nights.  The first night I did not sleep at all, the next 5 days and nights I could sleep a few hours at a time but it was quite fitful sleep.
No other AE; Vaccines were administered following a temperature excursion; This spontaneous report has been received from a vaccine coordinator concerning a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 28-SEP-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number W004501 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 20-APR-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered had been suffered a temperature excursion of 8.6 Celsius (C) degrees for a time frame of 18 minutes, and had also suffered the following previous temperature excursions: 11.5C for 1 hour 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours 41 minutes (Product storage error).   No other information was available. No other adverse event (AE) or product quality complaint (PQC) were reported.  This is one of nine reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010872:
Hives; Blistering; Terrible rash; splitting headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (splitting headaches). On 17-Apr-2021, the patient experienced BLISTER (Blistering) and RASH (Terrible rash). On 18-Apr-2021, the patient experienced URTICARIA (Hives) (seriousness criterion hospitalization). On 17-Apr-2021, HEADACHE (splitting headaches) had resolved. At the time of the report, URTICARIA (Hives), BLISTER (Blistering) and RASH (Terrible rash) had not resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: abnormal (abnormal) abnormal.  The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were provided.  On 10-Apr-2021, the patient experienced a  splitting headache which had lasted for a week. On 18-Apr-2021, she broke out in hives and went into an urgent care. They told her to get to a hospital emergency room. The emergency room told her to take Benadryl (diphenhydramine hydrochloride).  At  the time of the report the rash was not completely resolved, it was still  on her face, the palms of her hands which were also blistering, and a terrible rash between her legs.  Treatment included diphenhydramine hydrochloride every  6 hours until the rash was gone.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient's HHA noted a red, hot, puffy spot just below her deltoid on the left arm.
Mother of patient reported that patient had fever 103, woke up screaming around 5.30 am the morning after the day she received flu shot. When she tried to stand up, her both knee were wobbly and collapsed. But she was full conscious for the whole time, mother knew that because she was crying all the time. She had fever for a couple day and now she is doing fine. But mother was worried about the second booster influenza vaccination that she would need to get by the end of the week if she might have the symptom again.
The Paxlovid cured symptoms by Day6; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The Paxlovid cured symptoms by Day6) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient's past drug allergy was reported as none.  Concurrent medical conditions included Asthma.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (The Paxlovid cured symptoms by Day6). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (The Paxlovid cured symptoms by Day6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.        The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment with Paxlovid. No concomitant medications were reported. company comment This spontaneous case reported by a 40 year old female patient, with relevant medical history of Asthma, who experienced the unexpected, non-serious AESI of covid 19 Infection on an unknown date, about 6 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Details of primary doses was not provided. On an unknown date SARS-CoV-2 test was positive. the patient was started on Paxlovid for Covid 19 Infection for 6 days. The outcome of the event was unknown. It was reported that the Patient again tested positive for SARS-CoV-2 test about 5 days after stopping Paxlovid with return of symptoms and having new symptoms including, upset stomach, head and chest congestion, sore throat and fatigue. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a 40 year old female patient, with relevant medical history of Asthma, who experienced the unexpected, non-serious AESI of covid 19 Infection on an unknown date, about 6 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Details of primary doses was not provided. On an unknown date SARS-CoV-2 test was positive. the patient was started on Paxlovid for Covid 19 Infection for 6 days. The outcome of the event was unknown. It was reported that the Patient again tested positive for SARS-CoV-2 test about 5 days after stopping Paxlovid with return of symptoms and having new symptoms including, upset stomach, head and chest congestion, sore throat and fatigue. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Moderate local reaction to Anthrax #5. Moderate edema/erythema (11 x 11cm) to posterior right humerous. Also fever (99.5 degrees F.) and malaise. Treated with Motrin 800 mg PO TID #20 and ice to local site.
Patient reported getting covid arm (red, itchy rash on whole upper arm) appearing 8 days post fist Moderna Covid Vaccination
Day after vaccination, felt itchy, by Sunday could see 4-5 red dots that "looked like fingerprints," today was ~1"x8" rash below injection site
i had a mild headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via intramuscular route of administration on 15Mar2021 at 13:00 (at the age of 65-year-old) as 2nd dose, single in upper left arm for COVID-19 immunisation at public health department. The patient's medical history and concomitant medications were not reported. The patient did not receive any other medications prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201) via intramuscular route of administration on 24Feb2021 at 01:00 PM, as single dose in upper left arm for COVID-19 immunisation. On 25mar2021, at 06:00 AM, the patient experienced mild headache. There was no treatment received for the adverse events. Patient did not experienced nausea and fainting. The clinical outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.