chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 vaccine was administered to a 14 year old girl; A spontaneous report was received from a consumer concerning a 14-yeasr-old female patient who received Moderna's COVID-19 Vaccine and experienced the event, inappropriate age at vaccine administration.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number either 025J20-219 or 025J20-214) intramuscularly for prophylaxis of COVID-19 infection, and the vaccine was administered to a 14-years old patient.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, inappropriate age at vaccine administration, was resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 14-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-219/4), reporting Product administration to patient of inappropriate age without any associated adverse events.
I contracted COVID-19 on 07/07/2022 with symptoms of diarrhea, cough, fatigue, fever of 101.2, congestion, headache, runny nose, loss of smell, night sweats, brain fog, and chills. I was prescribed PAXLOVID on 07/09/2022. My symptoms have begun to improve, but I am not recovered yet.
herpes on her eye 8 hours; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced herpes on her eye 8 hours after getting the first dose of the vaccine. Patient stated that she had no medical information question and was calling in just to report the adverse event. The outcome of the event was unknown.  Information about lot/batch number has been requested.
The health care facility in which the recipient is a long term patient has had no obvious reactions or negative response to the 3 vaccination. The vaccination as administered 28 days after the second shot.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The healthcare worker reports that an improperly stored VAQTA (lot#, expiry not reported) that was exposed to a temperature of 27F for 1 hour may have been administered. The healthcare worker did not have patient or physician details available at the time of the call since it was unknown to her whether or not the vaccine had been administered. No adverse effect reported. The healthcare worker also reported that the vaccines were stored as low as 33 F for up to 225 hours. This excursion was supported so there was no adverse event. This is 1 of several reports received from the same reporter. Additional information has been requested.
PFizer vaccine was administered after being discovered that the vaccines were in the freezer for 11 days longer than the two-week standard time.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-01-22.
Fever started the evening of the shots.  The next day went limp, fell back, jaw clenched, not breathing.  Mom gave rescue breaths and EMS came.  After being cooled by EMR, the rectal temp at ER was 102.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 14:30 as dose 4 (booster), single (Lot number: GH9694) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obstructive Sleep Apnea" (unspecified if ongoing); "non-24 Sleep-Wake Circadian Rhythm Disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (18Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive, notes: Treatment of COVID-19; (18Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Jul2023 to 16Jul2023. Clinical course: The patient had no known allergies. Patient finished Paxlovid course on 16Jul2023. Felt better over 5-days while taking it. Throat and cough cleared up, sinuses were getting better. Symptoms mostly subsided Monday, 17Jul2023. Tested negative via at-home rapid test on Thurs 18Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257791 same patient, different drug/events;
Acute urticaria  Antihistamines  Still ongoing requiring  Cetirizine approximately every 3 days
Within 24-36 hours of my second dose on 4/19/21 I developed diarrhea, multiple times per day, which worsened to include abdominal cramping and blood after several days. These symptoms, along with weight loss, continued/worsened until my appointment with a GI specialist (Dr. info provided on first page) on 6/7/21. I was scheduled for a colonoscopy with biopsy on 6/8/21, and received a diagnosis of Ulcerative Colitis/Ulcerative Rectosigmoiditis. I began treatment with medication on 6/9/21 and to date have not experienced an improvement in symptoms. As of my second vaccine does on 4/19/21, I had no prior history of GI symptoms or disease.
Missed miscarriage at 11 weeks (baby dating at 7 weeks). This was the first ultrasound so difficult to confirm if dates were accurate, but dating showed baby may have passed prior to vaccine date so might not be directly related.
I had a fever of 102 , Chills , achey . This shot really it me good for about 24 hours.
Pt C/O face tightness and vomitted X2 after administration of the vaccine .  EMS on site interviened and vital signs as follows  B/P 108/70  P 150 O2 96% , repeated  5 min  P118 O2 100 %
Rash on arm.  Specific swelling, bitching, redness of previous BCG site
4APR inj site w/blister & redness;arm sore to touch;5APR seen in office warmth, swelling, redness started on ATB;
pt began scratching both sides of face;pt said throat was closing;Epi given SC;pt remained pale sx subsided in about 5-10mins;BP 140/60;P100-amb responded by 10AM pt transported to hosp
Body completely covered in hives.  Hives were layered on top of hives.  In her ears.  Fever of 100 degrees, water diarrhea, extreme fatigue, weird feeling in arm of vaccination spot.
On 19 DEC 10, patient had a low-grade fever at 1400.  Dad administered fever reducer and the fever went down.  At 1830 patient's fever spiked to 105 and he had a full body seizure: unconscious, eyes rolled back, tongue sticking out, and foaming.  Clinic on cruise ship, administered antibiotics and examined him.  His physical exam was fine, noted that he probably had a viral infection.  Upon entry to the port on 20 DEC 10 a pediatrician also examined patient and also stated that his exam was good and felt that he had a viral infection.  Patient was immediately cleared to fly out of the country where he was seen four days later in by our pediatrician.  Our pediatrician on 24 DEC 10 noticed that patient had developed an ear infection and prescribed antibiotics.  An EEG was scheduled for 3 MAR 11.  On 20 JAN 11, a PSA reported that some children receiving flu vaccines recently were having seizures (Sanofi Pasteur FluZone brand).  Upon examining patient's vaccine record, dad noticed that not only did patient receive the "suspect" Sanofi Pasteur vaccine (initial and booster) he was also dosed with .5ml instead of .25ml on 2 DEC 10.  Therefore, patient was overdosed.
redness, erythema, raised itchy, grew over the span of two days in the upper arm region, required ibuprofen to help with discomfort
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Lot number: el0142), at the age of 57 years, on 21Jan2021 as dose 2, single (Lot number: el3302) at the age of 57 years, and on 14Oct2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Post gastric bypass surgery", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; CELEXA [CELECOXIB]; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022 at 05:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 from 29Jun2022 to 03Jul2022. Clinical course: return of COVID symptoms, after taking Paxlovid. Mild cold symptoms after resolution. The patient did have a minor cough with sputum production, but on 10Jul22 significant nasal symptoms, sore throat again. No fever, but she never did have fever. Her antigen test remains positive as of reporting dat is the 14th day since original onset and 16 days from assumed exposure.; Sender's Comments: Based on data provided and temporal association, the reported events are assessed as possibly related to BNT162b2.
Chills, body sweats, sore muscles, joint pain, nausea, headache for 20 hours
SEVERE SHAKES AND CHILLS, BALANCE PROBLEMS FOR AND HOUR OR TWO. 101.1F FEVER. TIREDNESS THE NEXT DAY. LOSS OF APPETITE. LETHARGY.
Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Chest heaviness. Denies all other symptoms. Patient transported to ER via wheelchair for evaluation.   Upon re-evaluation in ER, patient felt back to her baseline and was discharged
Twenty-four hours after the second dose of the COVID vaccine, my teeth on the right side of my face, both upper and lower, began to hurt.  This continues on and of for a few months.  When it became progressively worse, I saw a dentist who examined me and took X-rays.  Her exam was normal except for the fact that she could reproduce the pain.  The pain persisted and started to go to my neck along with my teeth. At this point, I saw an acupuncturist who felt this was more from my neck and treated me there.  It improved somewhat and then returned.  I saw a physical therapist who gave me exercises for my neck.  The pain continued and at one point became almost unbearable almost necessitating an emergency room visit at night. The physical therapist recommended sleeping with a towel under my neck which really helped the night pain.  All through this, I kept my medical doctor informed and he recommended a neurologist.  The first appointment I have for the neurologist is this November.  In the meantime, I saw a chiropractor who recommended use an occu-pivot which I purchased and use every night prior to bed.  If the neurologist cannot help, I may have to see a dental surgeon. There is not a day where I do not have discomfort in my neck or teeth.
erythema, local edema, induration around inj site, pain, tenderness, low grade fever 9100), & itching @ inj site;
Pain at injection site a week after shot. Pink rash that is warm, hard, and itchy
developed rash and redness in the arm i recieved the shot; there was pain in the arm as well in the area i received the shot
Awoke around 9 hours post-1st vaccine with a gripping unnatural headache in back of brain.  This lasted for 3.5+ weeks, and moved to prefrontal lobe.  Headache still comes and goes 4 weeks post vaccine, with rainy weather.  Headaches were not an ailment prior to this vaccine.   Oxygen levels were normally at 99% as measured on oximeter, and were at 96% for 5 days.  Fatigue began morning after vaccine and lasted for 1.5-2 weeks.  Normal morning workout routine starting requiring a 5 min rest after each squat, when doing 30 squats or pushups was normal, now a rest was needed after each one.  Focus with glitch out.  Memory also would glitch out.  Almost like an electrical brown out or like the lines in the sand that connected a person to their memory, were no longer available, as if they'd been washed away.  Memory and focus returned after 2.5 weeks.
Pt was observed in observation appeared pale, nurse went over pt said he wasn't feeling well, paramedics assessed pt, he had low HR 40's,BP, 60/50 they put him on stretcher rechecked vs pt still had low HR 50's,BP 100/70 he refused transport. Had family member come to drive him home.
BLISTER LOOKING BUMPS ON FINGERS, RASH ON ELBOWS, SWELLING IN FINGERS, LESION ON BOTTOM OF FOOT Narrative: painful blister looking (although not fluid filled) bumps on fingers (both hands). Some are in clusters that form a path of sorts and right plantar foot. This started (was noticed) on February 21 on the knuckles, tenderness on tips on both fingers, also some rash on the elbows February 28. Swollen and difficult to bend his fingers. Received COVID vaccine February 15, symptoms happened 8 days after no fever, started to clear by March 2. Treated in urgent care with tramcinolone.
Patient presented to the ED and was subsequently hospitalized for acute embolic stroke within 6 weeks of receiving COVID vaccination.
Felt ill (malaise).  Vaccine exposure during pregnancy.  Non serious spontaneous case from a Pharmacist involving a woman who felt ill.  The reporter causality is possible to FluMist. A woman received FluMist vaccination intra-nasally for influenza immunization on 12 Nov 2005.  The woman was 31 weeks pregnant at time of vaccination. On an unspecified date she felt ill. It was not reported whether or not the symptoms continued.
Patient reports in the weeks following 2nd dose of Pfizer COVID-19 Vaccination he experienced of bilateral trigeminal neuralgia, itching/burning sensation in V2 Dermatome. Symptoms are constant per patient. Severity between 2-3/10. Patient has sensation he wants to dig fingers into his skin. He self-treats with rubbing alcohol then cocoa butter, patient advised to stop rubbing alcohol use. Patient notes this regimen has caused some relief.
Neck muscles & shoulder muscles in the back hurt, significant pain lasting 3 days Throat irritation and productive cough all thru the day & night
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Completed Paxlovid regimen at 10AM Friday 14Oct2022 but still testing positive for COVID-19 24 hours later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details was product COVID 19 Treatment, brand was Paxlovid, treatment start date was 09Oct2022 and stop date was14Oct2022,indication was treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
History of eye concern: Patient went to get vaccinated on Friday 4/30/21. He waited the 15minutes for observation, then once home he started feeling eye irritation and started seeing purple in his left eye all afternoon. The next day he had burning irritation feeling in his left eye and slightly blurred vision, both symptoms have remained to this day.    His eye hurts when he blinks or his eyes are open, but when they are closed they feel fine. He was given some eye drops (see below) that initially burned worse and made his vision green. He tried various other drops, but they did not improve or worsen his eyes. One of his latest examination said that his eyes had inflammation, but everything else looked good.
In the base of her spine where the tailbone is to the left she could hardly put any weight on it. She took prednisone and it started getting worse. She went to the dr a week later. She had to start using a walker. She is currently in the hospital.
Intense joint pain. Worst in my elbows and shoulders Aching/burning sensation. Most Lasted 2 days, but still have some elbow discomfort 5 days after vaccine.
This spontaneous report as received from a male patient of unknown age who ws also pharmacist refers to  himself. On an unspecified date in approximately August 2011 (reported as 3 years ago), the patient ws vaccinated with ZOSTAVAX 19400 PFU (route of administration, lot # and expiration date were not reported). On an unspecified date in approximately August 2011, when he received ZOSTAVAX, the patient experienced soreness in his arm, inflammation and a rash. The patient reported that symptoms went away a week later in approximately August 2011 (also reported as 3 weeks ago). The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Client stated on initial screening that she had some post vaccine shakiness after the first dose.  After second dose, 30 minute close observation initiated.  After several minutes, client complained of palpatations and asking to have her pulse checked.  Pulse palpated - assessed as irregular; VSS.  Client states she doesn't normally have an irreguar heartrate.  Call to EMS for evaluation.  Client transported to ED via EMS stable.
5cmX6cm area of erythema, warmth to left arm at site of DTaP injection.
Fever, fatigue, headache, diarrhea, body aches, difficulty walking, dizziness, confusion.
Information has been received from a physician concerning a 13 year old female who was vaccinated intramuscularly on an unspecified date with Gardasil (lot# not reported).  Subsequently the patient experienced anxiety after receiving the vaccine.  The patient sought unspecified medical attention and her outcome was not reported.  Additional information has been requested.
Pt received vaccine, advised parent before at check-in and after vaccination that pt needs to wait in immunizations clinic wait area 20 minutes post-vaccination. Patient/parent did not wait, proceeded to leave wait area and walk to clinic pharmacy. Several minutes later in pharmacy wait area, patient experienced a syncope episode, rapid response team was called and responded.
This spontaneous report was received from a pharmacist refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 (injection, lot # K009874, expiry date 19-MAR-2016)(dose, frequency and therapy route were not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Hives developed last night esp (L) thigh (same location as PEDIARIX). No fevers. N/V, or change in act level or appetite.
Pregnancy; Sore left arm; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Sore left arm) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Mar-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and PAIN IN EXTREMITY (Sore left arm). On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. On 24-Dec-2020, PAIN IN EXTREMITY (Sore left arm) 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.; Reporter's Comments: This is a case of product exposure during pregnancy with associated AE (sore left arm) for a 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the event of sore left arm, a causal relationship cannot be excluded.
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient described "paralysis" in immunization arm. Was very hesitant to receive vaccine. Administering pharmacist discussed risk/benefit of vaccination with patient. Patient stated her doctors wanted her to get it, but wasn't sure. Pharmacist stated she didn't have to get shot if she was concerned, but patient decided to proceed. Before the needle punctured skin, patient yelped in pain and pulled away, and did the same after administration. Did not notify pharmacy of issue until day of 2nd dose.
I woke up about 11 hours later, in the middle of the night.  I felt radiating heat going through my body.  I could not get warm.  I started shaking violently from being cold.   This probably lasted about 20 minutes.  I think I had a fever, but I didn't want to move once I got warm.  I cat napped for the rest of the night.  I had a headache the next day.  I took some Tylenol the next day alternating with ibuprofen.  I was unable to get out of bed for two days.  I stopped taking the medicines this morning.  I feel week today, but other than that, I feel fine.
12hrs post vax pt devel chills & myalgias, 24 hrs p/rx, c/o lower mid chest pain, deep & intermittent; no SOB, PE unremarkable; P88, R26, BP 138/86;
Between 6pm and 7pm the evening after the vaccination I could not get warm. I did not have a fever, I developed a headache and was very achy all over. I had several blankets on me trying to get the chill off. By Monday I was starting to feeling better.
12  hrs after injection: fever of 100. Flushed all over,  heat rash on legs and arms. Entire body ached, painful, in most joints. Brain fog. Fatigue. Sleepless. Symptoms abated in 24 hrs.