chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started scratching approximately 3 days after I received the first dose of the Pfizer vaccine.; I started scratching approximately 3 days after I received the first dose of the Pfizer vaccine/she was scratching throughout the day and night and would wake up very itchy in the morning; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E13246, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12Jan2021 at 12:00 pm (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any known allergies. The patient was in excellent health and was never sick. The patient did not receive any concomitant medications or other medications in two weeks. 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. On 15Jan2021, the patient started scratching approximately 3 days after she received the first dose of the Pfizer vaccine. She assumed that she must have gotten some mosquito bites. After the 4th day when she was still scratching, she started taking Benadryl every 4 hours or so. After several days of that, she contacted her doctor's office and advised of her reaction and that she had been taking Benadryl for several days. They prescribed a 6 day steroid pack for her but did not advise her to continue with the Benadryl which she stopped as soon as she started on the steroid pack. When the steroid tablets wore off, she started scratching again. She started back up on the Benadryl on the 4th day of the steroids. When she finished the 6 days of the steroids, she was scratching throughout the day and night and would wake up very itchy in the morning and continue to do so. She spoke with her doctor, plus the dermatologist that she saw that day, as well as the Director of Nursing and Pharmacist from the hospital's vaccination. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 12/1/21, LOT # 018F21A; pt to hospital with c/o weakness, nausea, vomiting, diarrhea, dyspnea; required intubation; CXR showed multifocal pneumonia; found to be positive for COVID; started Remdesivir, but had to dc due to rise in LFT; given ABX and dexamethasone; renal function worsened; pt extubated and still on O2 supplementation; made some improvements, then dyspnea worsened; taken to ICU; oxygenating well on 6 L O2 via NC; pt experienced hypoxemic respiratory failure and passed away in the hospital
Raised red site, hard & painful at site....next day I could barely move my arm & one month later still occasional nerve [?] pain.
Fever, chills, body aches & shaking, headache, leg cramping, lethargic
FAST HEARTBEAT; BLURRED VISION IN LEFT EYE; LIGHTHEADEDNESS; PRESSURE IN THE HEAD, HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced fast heartbeat. On 12-APR-2021, the subject experienced blurred vision in left eye. On 12-APR-2021, the subject experienced lightheadedness. On 12-APR-2021, the subject experienced pressure in the head, headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heartbeat, blurred vision in left eye, and lightheadedness on 12-APR-2021, and was recovering from pressure in the head, headache. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
pt states she already had some pain under her shoulder blade before her vax.  Pt stated about an hour and half after her vax that her left arm starting hurting really bad.  Her left arm is sore and swollen and has a knot on it at the injection site.  Pt went to an Urgent Care for shoulder/arm pain.  she was prescribed a muscle relaxer and anti inflammatory cream.  She was told to FU w/ PCP if she did not improve.
Pt called hospital reporting after pt got the Moderna vaccine, pt stated the rapid heart beat came back and becomes almost daily with increased frequency.Pt stated he was previously positive for covid19 in September of 2020 and started experiencing rapid heart beat at times. Advised pt to go to ED immediately to get evaluated.
2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.; Vaccine with 0.2 mL dose was administered to a 2 years child; Vaccine with 0.2 mL dose was administered to 1 child that was 2 years; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 2 years), PRODUCT PREPARATION ERROR (2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.) and ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to a 2 years child) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .2 milliliter. On 08-Jul-2022 at 8:00 AM, the patient experienced INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 2 years) and ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to a 2 years child). On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.). At the time of the report, INCORRECT DOSE ADMINISTERED (Vaccine with 0.2 mL dose was administered to 1 child that was 2 years), PRODUCT PREPARATION ERROR (2.2 mL of 0.9% sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.) and ACCIDENTAL UNDERDOSE (Vaccine with 0.2 mL dose was administered to a 2 years child) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient race was reported. Patient was not diagnosed or tested positive with Covid-19.  Concomitant medications details were not reported by the reporter.  The vaccine was administered after being diluted by the Pfizer COVID-19 vaccine diluent, 2.2 mL of 0.9 percent sodium chloride (normal saline, preservative free) of the diluent used for Pfizer COVID-19 vaccine into the bottle of magenta border Moderna.   No adverse reaction reported at the time of the report.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-610051 (Patient Link).
Chills periodically for two days after shot. Fatigue, muscle aches and headaches for three days after shot. Required rest and took Advil to help relieve pain. Redness on arm near injection site that started appearing two days after shot. Area is warm to the touch, but not bothersome. Starting to lessen.
it gave me an stomach ache; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was unknown.   The reporter considered the stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 61 year or 62 years. The patient took first shot of Shingrix in October need to take second shot but had been really afraid to go because of the coved virus how long could they wait to get second shot, because it was coming up to six month. 1st dose of Shingrix gave patient an stomach ache.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with BNT 162 (Pfizer) (Dose number in series:1) (form of admin, route of admin not reported, batch number: EN6208,expiry: unknown) dose was not reported, administered on 02-MAR-2021 for prophylactic vaccination, (form of admin, route of admin not reported, batch number: EM9810 ,expiry: unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No adverse event was reported with BNT 162 (Pfizer) (Dose number in series:1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series:2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total administered on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-FEB-2022, the patient experienced suspected covid-19 infection and patient tested with Binax Now test (suspected clinical vaccination failure) and Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive (Dose number in series:2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number was requested.; Sender's Comments: V0: 20220229470- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient developed fever to 101 deg F within 24 hours (of DTaP and IPV administration) and swelling of the upper right thigh with redness, warmth of 10 x 15 cm diameter
metallic taste; sensitive teeth; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 19Apr2021 14:15 (Lot number: EW0164) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "low thyroid" (unspecified if ongoing); "cataract" (unspecified if ongoing), notes: cataract surgery in a few months. Concomitant medications included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ESTRACE (ongoing). Vaccination history included: BNT162B2 (dose 1, Lot number: ER8733), administration date: 29Mar2021, for COVID-19 immunisation, reaction: "Sensitive teeth"; Zostavax (dose 1, Lot number: unknown, arm did not hurt), administration date: Oct2018, for immunisation; Shingrix (dose 2, Lot number: unknown), administration date: Oct2018, for immunisation, reaction: "arm hurt". The following information was reported: DYSGEUSIA (non-serious) with onset 19Apr2021 16:15, outcome "unknown", described as "metallic taste"; HYPERAESTHESIA TEETH (non-serious) with onset 19Apr2021, outcome "unknown", described as "sensitive teeth".  Additional information: The metallic taste started two hours after the second shot. It kind of went away. That could have been because she was eating and didn't notice it. It came back about 6 hours after she got the shot and then it went away and she went to sleep. Then it came back about 10:00 AM. She kept eating and it went away. She ate every few hours.  No follow-up attempts are possible. No further information is expected.
Started to have vertigo, vertigo has not stopped and has continued for one day so far; nausea; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El3246), via an unspecified route of administration at site of right arm on 11Jan2021 at single dose for COVID-19 immunization. The patient previously received first of dose BNT162B2 with lot number: Ek5730, on 22Dec2020 at site of left arm for COVID-19 immunization when he was 39-year-old. Other medical history reported as none. The patient's concomitant medications were not reported. The patient started to have vertigo and nausea on 15Jan2021, no history of vertigo in the past. Vertigo has not stopped and had continued for one day so far. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment received for adverse event. No COVID prior vaccination. No COVID tested post vaccination. No known allergies. The outcome of events was not recovered.
Patient experienced a bruise at the injection site and a few days later developed a blister on her wrist and started to develop a fever blister.
hives-splotchy color, paleness-crying-gave epi & DPH;
Cried & fretful from 7PM to MN, then slept off & on for 24hrs-then was normal self x/fever to 103 intermittently for 3 days; APAP drops was only tx;
The first day I had some heart palpitations in the afternoon about 3:00 -3:30 P.M.  I also was tired.  Five days later I was sick and vomiting and my blood pressure was elevated, but I was uncertain if that was caused by the vaccine.
Pt received FLULAVAL (influenza virus vaccine) 2009/2010 formula. No reaction or adverse reaction noted. (vaccine for ages 19 and over).
I was Covid positive back in August, so the day after getting vaccine i started having chills, fever, body aches, and broke out with small red flat bumps on my arms  and  left side.
Starting 07/06/2022, I woke up dizzy and nauseous. It went away in the middle of the day. I didn't think to much about it. I woke up the next day on 07/07/2022, I woke up dizzy and didn't think I could drive to my mammogram. So, after the appointment, my husband took me to the urgent care right next door. They said I likely had benign paroxysmal positional vertigo and I was prescribed meclizine. I was told to take them 3 times daily and rest. If I was not better by 7/11/2022 it was recommended I follow up with an ENT. As of today, 07/11/2022, I am fine and having no symptoms.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot number L004740, expiration date: 16-NOV-2017 and lot number L009649, expiration date: 29-NOV-2017, (dose, route of administration and injection site were not reported). Thee were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 54.9 degrees Fahrenheit for 2 hours and 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
swelling,redness at injection site, pain,hives,headache,itching,increased heart rate
fever t101.2, pulse 132, resp 20, BP 94/60 laying, BP 82/60 standing position pulse 158 standing;, n/v, diarrhea, acute gastroenteritis;light-headedness & weakness;nonspecific gas pattern;
My daughter started feeling achy and nauseous. She couldn?t see and had a terrible headache. She couldn?t sleep for two nights because of the pain. She was throwing up and moaning and crying.
Eight hours after receiving vaccine, the patient was in bed and was fine. The patient suddenly screamed. The parents went in and found the patient limp, pale and somewhat cyanotic. The patient was taken to the ER and seemed well.
Covid 19 infection; Covid 19 infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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 (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 infection".  Clinical course: Patient was a clinical infectious disease pharmacist. Patient was wondering if there were any formal recommendations for how long to wait after Covid 19 infection to receive a booster dose in someone who has already received their primary series. DSU- non-phone case; e-transmitting as potential AE since we unable to confirm if this is regarding an actual patient.  The lot number for bnt162b2 was not provided and will be requested during follow up.
20 y/o Male received Pfizer vaccine 1 dose at 1:45pm, while in the recovery area, @ 1:55 when standing to exit as his 15 minute wait period had completed, c/o dizziness, was assisted back to the chair by the recovery nurse, stated, "I don't feel right", noted to have a staring gaze, speech slow but responsive, diaphoretic, initial vitals 1:56: 109/87, 89,20, stat 99% on RA, skin color pale. Repeat vitals @ 1:58 : 122/80, 104, stats 94, awake, very slow responsively, continued w/staring gaze, 911 called.  Arrived at 14:03, Engine #2 arrived, patient evaluated, vitals stable @ 116/79, HR 75-78, Resp: 16-20, BG 136, EKG WNL, AAOX4, Patient declined transportation to ED, AMR cancelled, remained in recovery for add'l 15 minutes for ongoing monitoring, DC vitals @ 2:19pm: 11/78, 68, sats  97% on RA, exited from recovery w/Father, stable, ambulating freely, in no further acute distress.
Patient given Moderna Booster Instead of 2nd Dose of the primary Series of Moderna. No reaction to the vaccine. Booster given before primary 2nd dose.
RECEIVED FIRST DOSE OF TRUMENBA ON 09/09/20. WAS NOT DICYMENTED IN HIS EHR. THEN GIVEN FIRST DOSE OF BEXSERO ON 10/14/21 AS WAS UNKNOWN AT THAT TIME ABOUT THE TRUMENBA SO MENINGITIS B VACCINES WERE MIXED. THE PATIENT HAD NO SYMPTOMS. NO ADVERSE EFFECT
On 01/05/2001 the patient developed an infection, which was treated with Suprax. On 01/09/2001, the patient began to lose his appetite. The physician reported in follow up, the patient experienced "anorexia, mild-moderate for 4 days." On 01/09/2001 the patient began vomiting, 2 to 4 times a day for 4 days. On 01/09/2001 the patient was also running a fever of 101.5F. The patient also had diarrhea, which the physician described as "loose watery non-bloody, non-mucoid stools 3 to 4 times per day for 4 days. On 01/14/2001 the patient recovered from his experience. The patient's physician stated, "possible that the symptoms were antibiotic related". No further information is expected.
shortness of breath; sore left injection site arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Fever for 5 days Muscle cramps and pain Pain in feet when walking Severe anxiety, brain fog, memory loss Heaviness on chest, cough, hurt to breath Headaches, fatigue, no energy, bloodshot eyes
Child had rectal temp of 101.4 F and episode of going limp, eyes rolled back for < 1 minute. Child taken to hospital in post-ictal state, then transferred to another hospital. Evaluated by neurology; mother told possibly pertussis. Child discharged with symptoms.   8/20/09 Hospital records received DOS 7/16/09 to 7/17/09. Assessment: Recurrent febrile seizure. Fever, going limp with eye rolling back, "out of it". Afterwards lethargic, hard to arouse, sleeps, appetite is also declined. Disposition overnight was well. No further seizures.  9/3/09 ICD-9 Codes: 780.32 Complex febrile seizures, 530.81 Esophageal reflux, 780.39 Seizures other, E948.6 Adverse effects of bacterial vaccines Pertussis vaccine including combinations with pertussis component.
Sharp stabbing chest pains began for the first week on left side and progressively worsened to all  areas of upper chest and back. Shortness of breath and anxiety. I?m also having trouble sleeping
No additional AE's and no PQC's were reported.; The nurse stated that improperly stored vaccines were administered to patients.  ?; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 05-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported
Patient presented to the pharmacy 12/4/18 to pick up prescription for Valacyclovir and reported outbreak of shingles post SHINGRIX vaccination.
Initial report received from a non-healthcare professional (other) on 31 May 2013. This is an invalid case as individual patient identifiers are missing. A cluster of 4-5 patients of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of ADACEL vaccine (lot number-unknown, dose in series, route and anatomical site of vaccination were not reported) on an unspecified date. On an unspecified date after few days of vaccination, 4 to 5 patients had swollen, red, warm to touch reactions at the injection site. After 2 weeks of vaccination, 1 patient had persistent redness. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of events was not reported. List of documents held by sender: none.