chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a non-contactable consumer (patient). This 36-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 30Mar2021 10:00 (Batch/Lot number was not reported) as single dose at age of 35 years old for COVID-19 immunization. There was no concomitant medication. The patient did not receive other vaccine in four weeks, no other medications in two weeks. Medical history included asthma and migraine, from an unknown date and unknown if ongoing. The patient had known allergies but unspecified. The patient's concomitant medications were not reported. The patient experienced irregular menstrual cycle (12 days late), extremely heavy flow and blood clots on 01Jun2021. No treatment received for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Very slight, small area of tenderness yesterday morning at injection site; This is a spontaneous report from a contactable consumer (patient)  A 43-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm from lot# EL 3247, on 27Jan2021 (at 43 years old) 12:30 at SINGLE DOSE for covid-19 immunisation . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. Medical history included asthma, severe Osteoarthritis (OA) in right hip. The patient  didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) 100/50, fluticasone (FLUTICASONE) OTC, montelukast sodium (SINGULAIR) 10 mg.  The patient previously took theophylline and experienced drug hypersensitivity.  The patient experienced very slight, small area of tenderness yesterday morning at injection site on 28Jan2021 07:00 with outcome of recovered. No treatment received. No Prior to vaccination, was the patient diagnosed with COVID 19 .Since the vaccination,  the patient hadn't been tested for COVID-19
This spontaneous report was received from a registered nurse and refers to a 2 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N001528 with expiry date: 13-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
sore arm; Headache; Fatigued/ Tired; Fever of 100.4°-100.7°; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), FATIGUE (Fatigued/ Tired) and PYREXIA (Fever of 100.4°-100.7°) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021L20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), FATIGUE (Fatigued/ Tired) and PYREXIA (Fever of 100.4°-100.7°). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Feb-2021, PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), FATIGUE (Fatigued/ Tired) and PYREXIA (Fever of 100.4°-100.7°) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient concomitant medication included thyroid medication.
About 10 minutes after injections, client stated she did not feel well. This RN instructed the client to remain seated, however she stood up and walked to the kitchen to get a drink. On her way out of the kitchen, she again stated she did not feel well. This RN noticed that the client was pale and diaphoretic and proceeded to assist the client. The client lost consciousness, but was caught by the nurse during descent and eased onto the couch in a semi-fowler position. Loss of consciousness lasted about 5-10 seconds. Client awoke pale, diaphoretic, with loss of memory of syncope, but oriented to person, place and time. Client continued to display heavy diaphoresis and complaints of shortness of breath, but no complaints or physical evidence of itching/tingling/edema of oral mucosa or local rash/hives. Vital signs were obtained and ice packs were applied to brow and neck. Dr. was consulted via telephone at 1332. Client began to complain of abdominal cramping and EMS was called at 1338. Epinephrine 0.5 mg was drawn up by this RN while on the phone with EMS, but was instructed by EMS to hold medication unless patient's level of consciousness deteriorated. After EMS arrival, assessment, and education, client declined transfer to hospital. This RN remained with client after EMS departure. At time of RN departure, client's vital signs were within normal limits and client denied any further complaints other than "feeling tired."
On this day, Medical Assistant gave the wrong vaccine to a patient.  Medical Assistant gave the pediatric Pfizer covid vaccine which is intended for ages 5-11 years to a patient that was already 12.  When asked about the incident the Medical Assistant did not even know this error had happened. The Medical Assistant was coached to check the ages of every patient no matter what, especially for the covid vaccine that has such specific age guidelines.
42 y/o female with past medical history of HTN, Asthma and Hypercholesterolemia who presents with Dizziness pot vaccination. Patient states that this is her 1st vaccination in the two-dose series. Patient denies previous reaction to vaccinations in the past. Patient states that she received the vaccination to her left arm. NP and Paramedics at patient side. Patient given a bottle of water and vitals assessed. Patient initial BP 180/116, 84HR, 99% RA. Patient states that she took her BP medication this am. Patient monitored for a period and BP was taken manually, 140/90 Left arm, much improved. Patient discharged home with resolution of dizziness and elevated BP.
Approximately 48 hours after receiving my second COVID-19 Pfizer dose, I woke up with a very slightly swollen upper lip, and it was itchy and very dry. At first I thought it might have been a bug bite, but then I noticed I?d developed some small bumps on my lip. This morning, 72 hours post-shot, it had gotten a bit worse, and there were a few more bumps visible. There have been no signs of anaphylaxis and I feel fine other than slight discomfort and occasional itchiness. I did not consume anything abnormal, nor did I use something on my face or mouth that I normally don?t. Therefore I assume this is a slightly delayed reaction to the vaccine itself. It is localized to my upper lip only.
pt recv vax 6JUL98 & 21JUL98 pt found to have IGM positive;pt feels fine;pt was not treated for the event;
5 days after getting flu shot at public clinic experienced painful and inflamed gums which required medical visit. Condition is improving.
The patient had itchy hives appear on her right wrist after receiving her first Shingrix vaccine. They disappeared the following day.
Injection site bleeding at time of shot. Second bandaid applied.  Dizziness and nausea within 20 mins of shot Shortness of breath (when walking) within one hour Fogginess Extreme fatigue  Muscle weakness  Arm pain at and around injection site radiating up left side neck area Over 24+ hours later all side effects persists
chills; fever; feeling unwell generally; almost like the flu; her left arm felt "a little bit sore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 17Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced her left arm felt "a little bit sore, chills, fever, feeling unwell generally and almost like the flu. It was reported that after first injection in her left arm, her left arm felt "a little bit sore, for about 2 days, had chills, fever, feeling unwell generally almost like the flu then it went away, in 3 or 4 days it was gone. The patient wanted to know how long does the protection last or is it only good for 6 months and may require a booster dose (3rd) in the future. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had syncopal episode 5 mins after receiving vaccine pt hit head during episode; slow to recover Admitted to hospital for observation 12/29/08-records received for DOS 12/4-12/5/08-DC DX: Syncopal episode. C/O feeling warm and pale after receiving vaccine, felt dizzy, fell, losing consciousness. C/O headache and ears hurting, hit the right side of had on door frame. Remained drowsy and pale.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Sarcoidosis" (unspecified if ongoing); "Chronic UTI" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had no known allergies. The patient received Nexium medication in 2 weeks. On 12Aug2022, the patient received Paxlovid for treatment of COVID-19 and stop on 16Aug2022. The patient finished the medicine. 3 days later, the patient was sick again. First time while taking the med the patient was tired for 2 days with headache and nauseous then fine. Rebound, the patient was coughing a lot with a headache. The patient was on day 4. Adverse event start time: 10:00 PM, which resulted in none of the above and was recovering with no treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 22 year old female with a history of sulfonamide allergy, penicillin allergy and Levaquin allergy on 22-JUN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 657868/0523U). Concomitant therapy included hormonal contraceptives (unspecified). The patient received a second dose of GARDASIL (lot# 654539/0742U). Subsequently the patient experienced macrophagic myofascitis about two weeks after being vaccinated. The physician states that the patient has been treated with corticosteroids and has improved. The patient had a muscle biopsy and sought medical attention in the office. Therapy was discontinued. Additional information has been requested.
Parent called to report that patient had adverse reaction to fifth dose of DTaP administered in March.  She states for 2-2-1/2 days patient was complaining of leg pain not just at the site of the vaccine but also in his ankle and knee on the same leg.  There is no redness or swelling or palpable lump that mother could appreciate.  Additionally he was very clingy, requested mother to carry him around, seemed more emotional and agitated than his normal self.  This lasted for about 2 days as well.  He has since returned to his normal self with no behavioral or other changes beyond the 2 days after the vaccine.
Severe palpatations and chest pain. Medication was preventing any palpatations until vaccination. Heart began to work really hard every beat. Tired and fatigued
pt had 2 episodes of lightheadedness, nausea, diaphoresis & near syncope following inj;
pt recvd vax 3rd dose of OPV, 3rd dose DTP/HIB & 1st dose of MMR on 25jan95; pt died at home 27jan95;
Almost immediately (within 15 seconds) after administration, patient stated she did not feel well.  Soon after, stated she was going to vomit, requested water, stated "I'm going to die",  leaned head back once and full body forward 2 times in chair and almost(or did for a moment?) pass out seated, requested and tried to roll out of chair to floor.  Pharmacist was resting arm on patient shoulder to stop potential fall, changed position to front of patient, then assisted to the floor (~2:15-2:19pm).  Patient continued drinking and completed ~4oz of water while changing position from back to right side.  Rolled up smocks were under her head and neck for comfort.  Pharmacist and supervisor continued to ask questions which were answered correctly and she was able to grasp pharmacist's hand and squeeze with both of her hands.  Patient stated this is reason she does not donate blood and '?' and ginger have helped her in the past.  She stated she was feeling better and sat up against the wall.  When informed that paramedics were coming to assess. She stated no need and requested water and snack, stating possible that lack of food or water and being in the warehouse for awhile may have contributed.  Water and snack were denied to patient upon medical dispatch request.  Patient brought herself back to lying on right side until paramedics arrived.
pt recv vax & approx 1wk post vax pt exp sz;f/u was recv which indicated that no info was recv from the pt prev clinic;
Circular rash at the site of the vaccine injection, about the size of a golf ball.  Itchy  patch of raised bumps.
Client complained of dizziness from changing from a lying position to sitting position. Symptoms began after client had a pelvic ultrasound performed. Since initial symptoms c/o syncope and nausea no vomiting, denies ear pain, rhinitis, HA.
pt recv vax 15DEC95&4JAN96 pt father devel full blown case of chicken pox;
THE PATIENT WERE ASKED 4TIMES (FROM THE ENTRY SCREENER, GATE KEEPER, LOGISTICIAN, AND VACCINATOR) WHAT TYPE OF VACCINE SHE RECEIVED FROM HER  1ST DOSE SHE ANSWERED MODERNA INSTEAD OF PFIZER VACCINE. SHE FORGOT TO BRING HER IMMUNIZATION CARD. SHE RECEIVED HER 1ST DOSE OF VACCINE ON 3/15/2021 ON 4/05/2021 WITH LOT # EN6208 ON HER LEFT ARM  AND 2ND DOSE IS DUE ON 4/05/2021 . INADVERTENTLY, SHE WAS GIVEN THE WRONG VACCINE. AFTER FEW MINUTES AFTER RECEIVING  THE  VACCINE SHE COMPLAINED OF DIZZINESS, NAUSEA AND VOMITING. VITAL SIGNS WERE TAKEN ALL WITHIN NORMAL LIMITS. AFTER RESTING FOR 45 MINUTES SHE FELT BETTER AND WENT HOME WITH HER MOTHER AMBULATORY, AWAKE AND ALERT.
I had sore throat, dry throat, fatigue, and loss of appetite. These symptoms lasted for about a month. On Jan 14th, I tested positive for COVID-19.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a two-months old female patient who received and PENTACEL and PEDIARIX concomitantly. This was a case of actual medication error as the patient received extra dose of vaccine. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were reported. On an unknown date, the patient received a dose of suspect PENTACEL Vaccine lot number, exp date not reported via unknown route in the thigh NOS and a dose of suspect PEDIARIX not produced by Sanofi Pasteur lot number, exp date not reported via unknown route in the thigh nos. Medical inquiry: Physician called to ask if any interaction is known, short term and long term effects of administering PENTACEL and PEDIARIX concomitantly. Caller stated that a 2 month old female patient received both concomitantly in her thighs. No additional details reported. It was not reported if the patient experienced any adverse event. Lab data and corrective treatment: not applicable. The patient outcome: not applicable. Documents held by sender: none.
Appx 20 hours after the 3rd dose of Moderna Covid Vaccine, I woke up and my arms were slightly jerking up and down involuntarily. The right arm more than the left. The middle and ring finger on the right hand were the more pronounced. They were moving like the motion to tap keys on a keyboard.  It was intermittent for a  couple of hours.  Then sporadically the next day. Then nothing for a few days and then the fingers - index, middle, and ring finger on the right hand started the movements again but only lasted for 10- 15 minutes. Since then the symptoms have been increasingly more intermittent in the right arm/hand only. I did not seek medical evaluation. I emailed my doctor just for documentation sake. Since the 3rd dose is so new, I thought the symptoms were worth reporting. I am  a registered nurse which helped my assessment of the symptoms.
Information has been received from a health professional concerning 3 to 4 patients who were vaccinated with one dose of varicella virus vaccine life. It was reported on 01/15/2001 that the patients developed varicella in the past few months. The cases have been as long as 2 to 3 years after vaccination. The patients sought unspecified medical attention. Additional information has been requested.
Fever, pain and swelling at injection site. Red, and warm to touch. Intermittent nausea. Clinician ordered treatment of Keflex and prednisone course of medication and Zofran to manage symptoms of nausea.
I had a tumor growth on my salivary gland that had to be surgically removed in June.  The growth was noticed a few weeks after the shot
Patient received a full 0.5 ml dose of the 4th booster dose for an immunocompromised patient
Patient experienced profound thrombocytopenia causing epistaxis, melena, and painless oral lesions. This required an emergency room visit, and hospitalization on the general medical floor to receive steroids, IVIG, and 4 platelet transfusions.
Narrative:  Pt treated with Mehtylprednisolone 125mg IV, Diphenhydramine 50mg IV, Famotidine 20mg IV
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2021 LUNG MASS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/1/2021 LUNG MASS R09.02 HYPOXIA 11/14/2021 LUNG MASS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/12/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/1/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) R09.02 HYPOXIA 11/14/2021 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
HARD-QUARTER SIZED LUMP UNDER SKIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 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 hard-quarter sized lump under skin at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hard-quarter sized lump under skin at injection site. This report was non-serious.
may have been an underdose; vaccine leaked out onto the patient's arm; vaccine leaked out onto the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a adult female patient who received Herpes zoster (Shingrix) (batch number NZ5E5, expiry date 23rd November 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not ask about follow-up and pharmacy contact information in health care professional's details. Additional supportive information: While administering Shingrix, the syringe malfunctioned and some of the vaccine leaked out onto the patient's arm so the dose might had been an underdose, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
No additional AEs or PQC reported; Caller reports PROQUAD and VARIVAX were inadvertently administered at the same office visit to a 16 month old; This spontaneous report was received from a registered nurse and refers to a 16-month-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, historical drugs and concomitant therapies were not reported.  On 29-AUG-2023, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #X011980 rHA, expiration date: 19-JUL-2024, administered intramuscularly for prophylaxis (strength was not provided); and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #X006980, expiration date: 07-MAR-2025, administered intramuscularly for prophylaxis (strength was not provided) (accidental overdose.)  No additional adverse events were reported.
Shingles, both had the SHOT two to 3 weeks prior; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: Age at vaccination was not reported. The reporter knewa patient with Shingles, who had the shingles shot two to 3 weeks prior from the date of reporting. No contact details were reported. The case had been linked with US2021AMR178308.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178308:Same reporter.