chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient exhibited swollen arm and redness at site of injection. Patient advised to ice affected area to take an antihistamine (claritin or benadryl) She was also advised to follow up with pcp if no relief by monday
Fever of 100.9 F; arm site soreness (moderate); moderate body aches; moderate headache; moderate chills; tiredness; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 24-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: unknown) via an unspecified route of administration, administered in right arm on 25Feb2021 at 13:45 pm (age at vaccination was 24 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included migraines. The patient did not have allergies to medications, food, or other products. Concomitant medications patient received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), birth control and multivitamin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, Expiration Date: unknown) via an unspecified route of administration, administered in right arm on 04Feb2021 at 13:45 pm (age at vaccination was 24 years) as 1ST DOSE, SINGLE for COVID-19 immunization. On 26Feb2021 at 01:00 am, the patient experienced fever of 100.9 F, arm site soreness (moderate), moderate body aches, moderate headache, moderate chills and tiredness. The patient underwent lab tests and procedures which included body temperature: 100.9 Fahrenheit on 26Feb2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The events were reported as non-serious. The outcome of events was recovering.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Had heartburn like she was going to have a heart attack; Intense GERD; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose BNT162B2 via an unspecified route of administration on 21Jan2021 12:50 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had first COVID shot today (21Jan2021) at 12:50. Was doing fine, arm wasn't even sore. While eating dinner started having intense GERD on 21Jan2021. Had heartburn like she was going to have a heart attack. Took a Famotidine, but it didn't do anything. Took one of a Pepto Bismol Ultra at about 5:30PM. Starting to get some relief, but just didn't know whether she is going to be relieved throughout the night. Wants to know whether she should go to an urgent care facility to give her something to quiet it down. Events outcome was recovering.  Information on the Lot/Batch number has been requested.
24hr p/vax erythema, pain & warmth @ inj site;n/v, diarrhea;temp to 102;
pt recvd 3 doses of Engerix-B 2 days p/1st dose devel stiffness in the shoulder which lasted 2 days; recvd dose w/o a reaction;
ACHES in spine, neck, top of head  Chills Fever PAIN EVERYWHERE
Received the First Dose of Heplisav-B that had Expired One Day Prior to Administration; Initial Report Received on 03-Oct-2023  A registered nurse reported that a female patient (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  The patient has no known drug allergies.    No relevant concomitant medications were reported.    On 26-Sep-2023, the patient received the first dose of HEPLISAV-B (Lot #937782, expiration date 25-Sep-2023, NDC # not reported) intramuscularly in the left deltoid from a nurse.  The dose was one day expired.  No side effects have been reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
24 hour post vaccine: soreness. Day 8 post vaccine: hives, welts at injection site. Day 13: cellulitis, swelling, tightness, heat, numbness at the center, and itchiness. The edges are raised creating a wall where the redness ends. Covers most of my upper arm, from shoulder to elbow and starting to work into the inner arm, armpit, and left breast. Just received a dose of Kenalog this morning.
Initial medication error report received on 07 September 2013 from a Nurse. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) on an unspecified date. Patient used ADACEL twice in a two month period. A woman administers a dose of Tdap vaccine to pregnant women during each pregnancy ideally at between 27 and 36 weeks. Patient did not have any adverse events. List of documents held by sender: none.
Vaccines given 11/26/07.  Patient reported nausea and vomiting on 12/26/07 which he stated had been going on for 2 weeks.  He was seen by an MD on 12/26/07 who diagnosed and started treatment.  Patient reported fever after vaccines.  Contacted school nurse.  Patient presented to school nurse on 12/10/2007 with fever.  She remembers the fever being 101.4.  Patient stated he stayed home 2 days with the fever.
HEADACHE; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 21-MAY-2021 was received on 21-MAY-2021 and concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included mercury allergy, nickel allergy, and sulfates allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
PATIENT SAID SHE STARTED FEELING DIZZINESS, HEADACHE,  EAR RINGING, RED BUMPS AT SITE OF SHOT, STOMACH PAIN, DIARRHEA RIGHT AFTER SHOT, CALLED TODAY 2/24/22 TO REPORT BUT SYMPTOMS BETTER, RESOLVED
Patient may have received vaccine subcutaneously rather than IM.; Experienced mild local reaction including itching; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  An elderly female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Patient may have received vaccine subcutaneously rather than IM."; PRURITUS (non-serious), outcome "unknown", described as "Experienced mild local reaction including itching".  Additional Information: Patient may have received vaccine subcutaneously rather than IM. Experienced mild local reaction including itching. Pharmacist had already reported this to VAERS.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and some increased warmth to left medial bicep area since am of 5/4/22.  Slightly tender to touch.
Injection Site Red rash was the size of a Baseball 9CM X 7CM; Super Hot Injection Site; Injection Site was a little brown in the middle where the needle went in; Itchy Injection Site; Swollen Injection Site; Tender Injection Site; Chest was irritated; Red rash on her lower back triangle shape; Throwing up mucus; Coughing could not stop; Red injection site the size of an egg; This spontaneous case was reported by an other health care professional and describes the occurrence of SECRETION DISCHARGE (Throwing up mucus), COUGH (Coughing could not stop), RASH ERYTHEMATOUS (Red rash on her lower back triangle shape), VACCINATION SITE WARMTH (Super Hot Injection Site) and VACCINATION SITE DISCOLOURATION (Injection Site was a little brown in the middle where the needle went in) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Red rash (reaction to PCN many years ago).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced SECRETION DISCHARGE (Throwing up mucus), COUGH (Coughing could not stop) and VACCINATION SITE ERYTHEMA (Red injection site the size of an egg). On 10-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on her lower back triangle shape) and CHEST DISCOMFORT (Chest was irritated). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Super Hot Injection Site), VACCINATION SITE DISCOLOURATION (Injection Site was a little brown in the middle where the needle went in), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender Injection Site). On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection Site Red rash was the size of a Baseball 9CM X 7CM). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Jan-2021, SECRETION DISCHARGE (Throwing up mucus), COUGH (Coughing could not stop) and VACCINATION SITE RASH (Injection Site Red rash was the size of a Baseball 9CM X 7CM) outcome was unknown and RASH ERYTHEMATOUS (Red rash on her lower back triangle shape), VACCINATION SITE WARMTH (Super Hot Injection Site), VACCINATION SITE DISCOLOURATION (Injection Site was a little brown in the middle where the needle went in), CHEST DISCOMFORT (Chest was irritated), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red injection site the size of an egg), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) had 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.   No Concomitant medications were provided
My 14 year old daughter had her first GARDASIL shot on May 24, 2013. She was taken by ambulance both times to the hospital where she was given meds and stabilized. Bloodwork and an MRI came back fine. There is no family history of seizures at all. We have been referred to a Neurologist and we will also be doing an EEG. Prognosis is that my daughter is going to have to be put on medication for seizures.
Below narrative includes initial report received from a consumer on 02 October 2013 plus subsequent follow up: A 56-year-old female patient who had PCN and egg allergy and no illness at the time of vaccination, had received an intradermal dose of FLUZONE ID (lot number: not reported) in the left shoulder on 01 October 2013 at 12:30 hours. On 01-Oct-2013 at 13:00 hours, the patient felt nausea then vomited. The patient was tingling and her body was "going numb". Corrective treatment included Laboratory investigations were not reported and patient had a "shot" for the nausea and fluids. Patient was discharged and sent home after a few hours. 01-Oct-2013 the patient had recovered from the event. Documents held by sender: None. Additional report received from a consumer on 07 November 2013: Administered by name added. Country and state where vaccine administered were added. Contact #  of patient was added. Any other medication received within 4 weeks was reported none. Corrective treatments were added.
Normal heart rate is around 70 bpm, around 8 hours after injection heart rate went up to 120bpm and remained that high for 12 hours.  Slight fever. Fatigue.  Blisters on toes that persisted for 2 weeks.
Tetanus-diphtheria vaccine given 5/01/09 to patient with poorly controlled Parkinson's disease. She called office 5/11/09 with twisting sensation in legs with rubber band sensation around chest. These symptoms have long resolved. Now she complains of right arm pain and weakness.
45 min after vaccination welt occurred, 2 days later pt saw her Dr who thought the pharmacist had only gone through a vein. It would turn black & blue, but her arm was hot & swollen. She came back on 2/13/13 with the swelling plus redness is better but now plus feels tight, pins & needles plus itchy plus pt had 2 cold sores since shot.
Generalized maculopapular rash both arms, chest, abdomen, back and legs.  Seems to be almost completely faded by this afternoon.  Patient is asymptomatic otherwise-no fever, chills, arthralgias or angioedema.
Patient reported having discomfort and pain when moving her arm since the vaccination (73 days ago).
PATIENT REPORTS HER ARM HAS BEEN SORE FOR OVER A MONTH TO THE POINT OF LOSING MOBILITY IN THE ARM. SHE HAS AN INJURY IN THE ARM THAT SHE OBTAINS STEROID INJECTIONS FOR BUT STATES THE VACCINE (SHINGRIX) MADE IT MUCH WORSE.
Severe morbilliform rash starting on D# 10 after MMR given, fever 103.  Has been seen on 1/13/ and 1/14 due to worsening of rash. Being followed due to decreased oral intake and irritably.
he caught covid-19 virus after his 1st dose and was done with his 14days quarantine yesterday; he caught covid-19 virus after his 1st dose and was done with his 14days quarantine yesterday; This is a spontaneous report from a contactable consumer, the patient. This male patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on 06Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that he already got his 1st dose 3 weeks ago (06Apr2021) and was scheduled to have his 2nd dose on 27Apr2021. The patient caught COVID-19 virus after his 1st dose (Apr2021) and was done with his 14 days quarantine yesterday (23Apr2021). The clinical outcome of caught COVID-19 virus after his 1st dose was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2011, the patient was inoculated at a clinic with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-MAY-2016, the patient was treated by a physician at a clinic for the onset of a severe vesicular rash which was diagnosed as acute zoster. The patient was prescribed FAMVIR and lidocaine patches for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Extreme headache after the 2021 flu shot. Extremely persistent even 24 hrs later.
Threw up after taking the vaccine. Severe mental decline. Dizziness and inside of mouth has thrash.
No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    Concomitant medication was not reported. Treatment medication was not reported.
Beginning 12/11/08 Pt reports bumps on the back of hands bilaterally approx 1cm in diameter that spread all over body.  Pt repots the bumps are very itchy.  Pt was seen by GYN due to irritation in vaginal area and used Monistat cream twice without success.  Patient's GYN prescribed prednisone and a vaginal cream, which will start today.
Patient noticed that vaccine in syringe was cloudy; This spontaneous case was reported by a consumer and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (Patient noticed that vaccine in syringe was cloudy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (Patient noticed that vaccine in syringe was cloudy). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (Patient noticed that vaccine in syringe was cloudy) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: TCR form received on 16-JUN-2021 contain no new information.
Female caller stated she received the Modernaa COVID vaccine on 1/20/2021 and then the next morning at work she began experiencing chills. The chills continued throughout the day and when she got home from work she had a temperature of 101.0 F.  Caller instructed to recieve in person care per guidelines for Severe of Temperature = or >100.0 F. Caller verbalized understanding of recommendations 1/22/2021 @ 1611
Child who is 8 yr got COVID after father got covid from offsite dinner event/covid test result: Positive; Child who is 8 yr got COVID after father got covid from offsite dinner event/covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 24Feb2022, outcome "unknown" and all described as "Child who is 8 yr got COVID after father got covid from offsite dinner event/covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Feb2022) positive, notes: covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown whether the patient tested positive for Covid-19 prior to vaccination and she was tested positive for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective, COVID-19 cannot be completely excluded.
Tingling in left arm about 30 minutes after administration, followed by numbnes in the pinky and ring fingers for approximately 12 hours. Moderate left arm pain for approximately 48 hours.
Alopecia relapse causing both eyebrows and a portion of the left eyelashes to fall out.  Treatment with Xeljanz 4 mg 2x per day continued and is currently still being administered. Also attempted to use triamcinolone cream,  bimatoprost,  and topical ruxolitinib.  No therapy has produced any regrow that of either eyebrow or the eyelashes.
pt recvd vax & started crying & was red; apap given; pt continue this behavior fr 16:30pm to 20:30pm;
pt recvd vax;fever of 100.4; not sleeping or eating;given apap when felt warm;30oct eve red rash starting on stomach, legs & forehead;mom called MD 1nov94;gave DPH; MD had seen sore throat; ATB given; MD thought rash due to sore throat;
Pt received her 1st dose of Moderna; waited 15 minutes in observation and left with hour spouse.  Pt reports feeling the left side of her face felt numb.  She was visibly shaking and had increased anxiety.  Pt denied any other symptoms.  She was taken outside for fresh air and educated on deep breathing exercises.  Staff used distraction techniques, such as, music to assist.  Pt VS BP. 212/116 P. 86 R.20 Temp. 98 Pt reports "I know Im working myself up".  At 1650, Benadryl 25mg capsule PO x's 1 was given without further incident.  Medication and distraction techniques effective.  Pt and spouse was educated on when to call 911/EMS and V-Safe information provided. VS: BP 176/101 P. 63 R. 18 Temp 97.8
Pt recvd 3 doses of Engerix-B vax 19JUN90, 9JUL90 & 19DEC90 & was found to be a non-responder;
Patient received vaccine around noon, and indicated she felt pain upon injection. She left a msg. on our voice mail around 5:45 pm that she felt she had a severe rxn - trouble breathing, sick to stomach. She then phoned her MD & was told to take BENADRYL & TYLENOL. She recovered.
Fine rash appeared over entire body 24 hrs (8/14/02/7pm) after Td-MMR-TB test. Bactrim discontinued; Benadryl given, Hydrocortisone cream applied. Nurse called at 5pm 8/15/02 to report incident. Child's rash and itching has decreased somewhat. MD notified at facility 5am of actions taken by nurse.