chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke up with chest pain, worsened by position changes and with inspiration. Saw pediatrician who suggested Tylenol for symptom relief. Pain subsided somewhat with 500mg Tylenol. Later changed to 400mg ibuprofen 400mg three times daily. No associated shortness of breath, palpitations, syncope.
Her arms were red and on fire and very sore below the injection site by 4 to 5 inches. She was nauseous and not feeling well. Did not remember anything the day after the injections. Cold chills.  I told her to put cold packs on injection sites and to go home to rest.
Information has been received from a certified medical assistant concerning an adult pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (IM). Subsequently, the pt experienced injection site reaction with injection site redness, warmth and soreness within a day of vaccination. Unspecified medical attention was sought. Additional information has been requested.
Patient called office after leaving and headed home with complaints of a terrible metallic taste. Metallic taste increased as patient returned home. Drank Sunny Delight and metallic taste was resolved. Patient was given FLUVIRIN Tdap vaccines. No treatment given to patient.
Swelling at the injection site. Looked like a bubble and swelling was slowly spreading. Pt did not report dizziness or trouble breathing. Blood pressure machine was not accurate so bp not reported.
Received Moderna on 1/12, 2/12, 10/25/21 Tested positive for COVID by PCR on 11/2/21. Has been hospitalized at Hospital since 9/29/21. Developed cough, congestion  after wife tested positive for COVID and visited him at hospital.
On 7/16, pt represented to Emergency Department with pain and swelling on her left tricep. Patient was diagnosed with an abscess on her tricep. An I&D was performed and patient left AMA. On a subsequent visit to the ED on 7/21, the patient was admitted and placed on IV and PO antibiotics for the abscess due to sepsis.
18JUL96 sm lump noticed per pt on 23JUL96 red-lump 2 inches length 1 inch width in size;itchy-warm to touch;very sensitive to area;27JUL96 saw MD given instructions to use ibuprofen;
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 15-OCT-2015 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue Employee reported fever 1/5/2021 and both 1/27/2021 and1/28/2021 fever was 100 degrees. Muscle pain 1/6/2021, and "severe pain" 1/27/2021 and 1/28/2021. "More fatigue and lasted longer from second dose then first dose." Nausea 1/26/2021. "For the second dose, my left neck hurt more than the injection site (injection was on the left hand). Could not move head without pain. Gradually pain faded, then noticed crackle sound when trying to turn head left and right. The crackle sound sounded when one cracks and knuckle. Also feel like air bubbles when move the heard". Did not seek medical attention for symptoms. Neck pain and crackle sounds when turn head persists. Resulted in unable to work 1/28/2021. Medical record for employee documents administration site was left deltoid.
Patient was given covid vaccine 1 at 1:10 PM and had face and neck urticaria within 5 min.  Denied throat tightness, or breathing difficulties.  Was taken to ED for observation.  PMHX includes anxiety, HTN; Meds: Amlodipine, acyclovir; Allergies to Betadine, Erythromycin, Fentanyl, Minocycline, PCN, Versed, and reactions include dyspnea and Hives
Tingling itchy feeling in feet & hands with redness of palms & soles noticed at 6AM today when waking up - (lasted 48 hrs) (9/17/10)
Information has been received from a registered nurse concerning an approximate 8-year-old patient who on 05-JUN-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. this is one of several reports received from the same source. Additional information has been requested.
Patient developed shingles (physician-diagnosed) six days after receiving shingles vaccine, ZOSTAVAX. Lesions are on her right side (chest and back). She has burning pain on her right side.
Patient received booster vaccine on 12/3/21 and states later that evening he experienced some swelling, nausea, and dizziness and also has a small blister at vaccine site.
Began Covid 19 symptoms on 6/14/21 and tested positive for covid 19 on 6/16/21
Experiencing kind of like vaginal bleeding and I had, my period ended two weeks ago; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was calling to ask like or to actually state like, patient had her Pfizer shot done yesterday and today, patient experiencing kind of like vaginal bleeding and patient had, her period ended two weeks ago. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
had a sore arm; since getting the vaccine/ has had no cold sores, but previously had them.; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (In the 3 years since getting the vaccine the patient has had no cold sores, but previously had them).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced pain in arm and unexpected therapeutic drug effect. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the pain in arm and unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced sore arm. In the 3 years since getting the vaccine the patient has had no cold sores, but previously had them. The reporter Consented to follow up. This case had been linked to the case US2021140781, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021140781:same reporter and same patient
I had pain at the site.  I was fatigued the next day.  I had headache and cough.  These symptoms lasted for about 2 days.
This spontaneous report as received from a registered nurse refers to a 12 years old patient of unknown gender. On 16-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # K003422, expiration date 06-MAR-2016 (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.
I have not developed any antibodies 6months after taking the Pfizer vaccine. Am I protected, should I try another vaccine?
Death SAH (subarachnoid hemorrhage)  Observed seizure-like activity  Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Thrombocytopenia, unspecified
Chief Complaint:  Fast heart rate for 8 days   History of Present Illness: Patient is a good historian.     Patient is a 60 Yo female with PMH of anxiety, left ankle fracture (20 yrs ago with chronic ankle edema) and recent left proximal tibial fracture (11/8/2021) who presented to the ED with above complaint.  Started noticing fast HR on 3/2/22 after Ob-gyn exam.  Since then she has been monitoring her HR at home and noticing it has been 110's - 130's.  Denies feeling it.  No palpitation, chest pain or SOB.  She emailed her PCP and got response today to go to a clinic for EKG.  She was in a PT session today for her left knee when receiving the response so went to a clinic, had EKG and was told to come to ED.  In ED, EKG done showing Afib with RVR at rate 165.  Pt reports since the tibial fx surgery Nov 8, 2021 she had been sedentary until 1/8/22.  She c/o some tightness of left calf.  Chronic left ankle swelling from past surgeries (revisions x4).  Rare cough w/o phlegm attributing to allergy.     Recent admisisons: 11/8/21  ED visit for left proximal tibial fx.  On-call orthopedist Dr. recommends knee immobilizer crutches nonweightbearing and CT scan E consult referral for follow-up with orthopedics.    Pt denies smoking, or drug use.  Occasional alcohol.  Last drink was 3 weeks ago with 3 glasses of vodka tonic.  No caffeine use.  Pt had covid vaccines and booster (Dec 2021) with J&J   Meds were reconciled with pt.  Wants full code.  3/13/22- Cardioverted, then returned to floor Rapid response, stroke alert, patient found to be seizing . Code blue remained in progress unable to verify progress.
This case was reported by a consumer via call center representative and described the occurrence of injection site redness in a elderly female patient who received Flu vaccine. Previously administered products included Flu vaccine with an associated reaction of injection site pruritus (received each year) and flu vaccine with an associated reaction of injection site erythema. Concurrent medical conditions included drug allergy (allergic to several drugs). On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced injection site redness, injection site itching and feeling unwell. On an unknown date, the outcome of the injection site redness and injection site itching were unknown and the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the injection site redness, injection site itching and feeling unwell to be related to Flu vaccine. Additional details were received as follows: The patient stated that, each year after receiving flu vaccine, she experienced redness and itching on and around injection site. Sometimes these reactions reached to her elbow. On an unknown date, last year, after receiving Flu vaccine the patient also felt very ill, which recovered after 12 hours. The patient was asking whether to continue with the vaccines. The patient's husband did not experienced any adverse events after receiving Flu vaccine. Also, he was having compromised immune system and decided not to receive further flu vaccine doses. The patient stated that she her husband were 73 and 75 years old.
Low grade fever (100.7, 99.9, etc.) for several days. After fever, rash on body first on front then on back. Then 2 chicken pox-like bumps on arm at vaccine injection site developed. (Also, went from sleeping through the night to waking every 1-2 hours for the past 2 nights.)
2 plus days of: Fever, extreme headache, nausea, diarrhea , (unusual tiredness on days 3 & 4 post booster)
Increased pain sensativity, nausea, malaise, fatigue, exasperation of other medical conditions both physical and mental,  severe muscle pain, bowl upset, loss of appetite
Patient states lost control on her muscles in the legs and fell X2 The first episode happened in the evening at 6p, the same episode happened the next morning as well. She is having difficulty swallowing as of today 8/23/21. Not sure if this is related to the vaccines or not.
Patient presented to hospital with headache 6/21/21. CT head with contrast showed 1. Sinus thrombosis suspected in the patient's sigmoid and transverse right sinus.  2. No venous infarction or other acute finding identified. MRA neck showed thrombosis of right jugular vein and right sigmoid sinus.  Patient started on heparin drip. Transitioned to Eliquis by neurologist and hospitalist. Remains hospitalized at this time.
This patient received rubella vaccine but all lab results were negative from any rubella titer or evidence of any antibodies.
15 seconds after administering both vaccines the patient had a mild seizure lasting 15-20 seconds. He was immediately taken to urgent care where he was diagnosed with over-stimulation of the vagus nerve causing vaso-vagal syncope.  He quickly recovered and was sent home.
11-18-08 5:30pm lower lip swollen, then both lips swollen, hives on (R) wrist and (L) fingers. On call Dr advised Benadryl and ER. At ER pt given Prednisone x6 days.
Employee received vaccine at work yesterday. This afternoon, her arm was painful and she noticed a red raised area at the insertion site measuring 1.5 inches in diameter. Warm to touch. Employee is currently afebrile. Recommended she take TYLENOL or ADVIL for discomfort and apply warm moist compresses. Instructed to go to walk-in clinic for evaluation if worsens.
Started with not wanting to eat, very crabby...7pm started with fever of 103 Motrin given. Saturday fever of 103 not eating, very crabby...Sunday fever continued, crying, interrupted sleep. Monday fever of 103 continued, not eating, crying, not sleeping well (very interrupted by crying spells) break out in chicken pox rash behind ear, on face, inbeteween thighs, on stomach and back. Took to pediatrician 1:20 PM she stated he's having a reaction to chicken pox vaccine. Reaction still ongoing.
Nonspecific acne-like rash on face at upper torso (w/o eye or CNS involvement) with onset 11 days after 10 Vallinia vax.
This spontaneous report as received from a physician via a company representative refers to a patient (child of reporter's friend) of unknown age or gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of either GARDASIL 9 or GARDASIL for vaccination. Dosing details, lot # and expiry date were not reported. On an unknown date, 2 weeks after onset of therapy, the patient experienced loss of concentration and focus at school. It was reported that the child was not a patient of the physician. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Product quality complaint (PQC) was not involved.
Vivid dreams and intermittent tinnitus began 1 day following the vaccine lasting approximately 3 months before gradually going away.  Excessive inflammation and pain began approximately 30 days after the vaccine, progressively worsening and becoming motion-limiting over the following  3 months.  Prednisone 10mg prescribed to help reduce inflammation and pain, with gradual improvement over 45 days.  Continuing to taper down Prednisone and began Turmeric supplement that appears to be providing additional relief.  Inflammation and pain almost returned to regular levels.
Expired Engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 25th December 2022) for prophylaxis.   On 5th January 2023, the patient received Engerix B. On 5th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The reporter did not want to provide any detail, so vaccine lot was not provided. The reporter did not consent to follow up. Additional Supportive Information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
dizziness; my arm hurt; headache; fever; chills; nausea; pain at  the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at  the injection site). At the time of the report, DIZZINESS (dizziness), PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at  the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: reporter email address was updated; 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 said she began to experience a breakout of shingles within the follow day of receiving the vaccine. Patient knew it was shingles because she had shingles before.  She eventually followed up with her doctor who advised her to not get the 2nd dose of shingrix and she agreed she would not get it either.
Cramping on  lower legs; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping on  lower legs) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O18B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Allergy to feathers, Allergy to animal (animal fur) and Dust allergy. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and SALBUTAMOL (ALBUTEROL HFA) for Asthma.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (Headache). On 12-Apr-2021, the patient experienced MUSCLE SPASMS (Cramping on  lower legs). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramping on  lower legs) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This female subject was enrolled in a study. On 01 July 2014, she received a 1st dose of INFANRIX HEXA, Pfizer's PREVENAR 13 and ROTARIX. On 01 July 2014, approximately 6 hours after the 1st dose of INFANRIX HEXA, approximately 6 hours after the 1st dose of PREVNAR 13, and approximately 6 hours after the 1st dose of ROTARIX, this two-month-old subject developed lethargy event. The subject was hospitalised. The event resolved on 01 July 2014. The investigator considered that there was a reasonable possibility that the lethargy event may have been caused by INFANRIX HEXA, PREVNAR 13 and ROTARIX. Investigator text: Baby was given vaccines at 10:20 this morning. At approximately 16:00. Baby was noted by mother to be blue around the lips baby was aroused, and then had 2 more episodes and at that time mother noted baby appeared to have some floppiness. Mother also noted some short breathing patterns and it appeared that the baby was having a hard time expelling air. Brought into the Clinic to be examined by the MD. Per exam it was normal at that time. Baby was admitted to the hospital for observation at this time. No treatment being done at this time. Per the Principal Investigator this event is possibly related as there is noted to be a possibility of an lethargic event after episodes that can be traumatic to infants under 3 months of age.
This serious spontaneous case, initially received on 08-Mar-2018, reported by other non-health professional, concerns a patient of unspecified age and gender. On an unspecified date, the patient was administered with FLUCELVAX QIV (batch number: 195124 (reported as 185124), expiry date: 30-Apr-2018, dose, route of administration, anatomical location: not reported). On an unspecified date, 2 months after the administration of vaccine, the patient developed brachial neuritis. It was reported that, no surgery or trauma was performed. At the time of this report, the outcome of the event was not reported.