chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have no side effects as of 0334 the next morning besides injection site discomfort.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Apr2021 16:00 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; CALCIUM. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, Administrator route=Intramuscular,, Vaccine location=Left arm,, Dose number=1), administration date: 30Mar2021, for Covid 19 immunisation. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 22Apr2021 02:00, outcome "unknown", described as "have no side effects as of 0334 the next morning besides injection site discomfort.". Therapeutic measures were not taken as a result of vaccination site discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446816 same reporter/drug, different patient and event.
T.C. from sister to communicate the hospitalization of her sister. She reported that on Friday patient collapsed and started foaming at the mouth and was rushed to hospital. She stated that  patient is on a ventilator and at 5PM today they are going to take her off. Sister was very upset and I was uncomfortable asking more questions. She will call me with more information at a later time. She did say that the hospital staff was not sure of what caused her collapse.
The itchy red dots started 1 day after the vaccine was administered. 1 itching dot on rib area and 1 itchy dot around navel. She tried BENADRYL to relieve the itch without success.
Pain in arms and legs; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arms and legs), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Heart disease, unspecified and Cholesterol. Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN) for Heart disease, unspecified.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arms and legs), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in arms and legs), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI- patient denied further follow-up
headache; fatigue; fever; muscle ache--for about 24 hours beggining at 10AM on 3/8/2021
4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was started on O2 at 2L NC and was admitted on IV Remdesivir and Decadron. By 4/8, she was able to be weaned off O2 and completed 4 days of Remdesivir and Decadron therapy. She refused rx to complete 10 day course of Decadron due to concerns regarding hyperglycemia and her diabetes.
horrible headache; fever of 101 Degrees Farenheight; horrible chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (horrible headache), PYREXIA (fever of 101 Degrees Farenheight) and CHILLS (horrible chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (horrible headache), PYREXIA (fever of 101 Degrees Farenheight) and CHILLS (horrible chills). At the time of the report, HEADACHE (horrible headache), PYREXIA (fever of 101 Degrees Farenheight) and CHILLS (horrible chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 101 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported.  No treatment information was provided.
Headache, body aches, and extreme fatigue for 8 days.  6 days after dose one developed canker sores in mouth.  Sought medical attention for headaches on day 8, however, fell and hit head on day 7 and likely suffered a mild concussion.  But this was a prolonged course of fatigue symptoms for vaccine, and I hadn't heard of canker sores as a side effect before.
R09.02 HYPOXIA 7/2/2021 ATRIAL FIBRILLATION, UNSPECIFIED R09.02 HYPOXIA 7/2/2021 HEART FAILURE W REDUCED LVEF 41-49%, UNSPECIFIED ACUITY
No issues after first dose of Pfizer. After second dose, patient reports abnormal taste (everything else is normal). Fried potatoes taste raw and bitter, chicken tastes stale/out of date, oatmeal has no flavor/no sweetness. Only thing that is normal is water.
I started off with itching on my back and then a red, raised rash and after a day, it became extremely painful. Did a video visit with doctor. He said it was shingles. He prescribed an anti-viral medication and I took that. That helped with the symptoms.
EPILEPSY, UNSPECIFIED  10/10/2022  -- RECURRENCE OF SAME SYMPTOMS
after administration patient showed immediate signs of dizziness and fainted. they came to almost immediately and seized for a moment, no longer than 30 seconds from the moment they fainted and revived.
Some hearing loss-ongoing treatment with Doxycycline Hyclate 100 mg and Prednisone 10 mg tabs for 13 days Left side facial weakness-ENT thinks it?s due to nerve damage possibly caused by vaccine-has seen others with similar symptoms-symptoms ongoing
right neck pain, fatigue, anorexia, then emesis, fever, red eyes, rash, diarrhea, tachycardia, hypotensive, cervical lymphadenopathy IVIG, pulse steroids, anakinra
Hospitalization / + SARS test on 08/04/2022. Headache and fever x 1 day.
Information has been received from the patient's mother concerning her son of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. The patient might have received GARDASIL (lot #, expiration date and dose were unknown; intramuscularly) that were not intended for him (Wrong drug administered). It was unclear if the patient received each dose within the series, and at what age the vaccine dose(s) were allegedly administered. The patient had not experienced any specific adverse systems as a result. It could not be confirmed if the patient received doses of GARDASIL at all or if the patient's records contained clerical error that listed him as receiving the vaccine, when in fact he did not. Additional information is not expected as the reporter did not want to be contacted.
Dizziness that lasted for 3-4 hours. Onset was within a couple minutes of injection. Was monitored for 15 minutes and allowed to drive home. Dizziness got worse after approx 1 hour. Dizziness resolved after sleeping a couple hours
The RSV vaccine lot HF5017 was administered on 10/3/2023. The patient returned for additional vaccinations and was administered a second RSV vaccine by mistake. It was a duplication of therapy for this single dose vaccine.
Soreness of the injection site: Started about 6 hours after injection and lasted for about 1.5 day. Chills and fatigue, feeling like starting a cold or flu: Started about one day after the injection. Lasted for one night.
Covid arm. Delayed itch at site of injection. Also sore at this location (was completely normal became sore at day 6 after shot)
Fever, chills, body aches, loss of appetite, fatigue, malaise, swollen lymph nodes, rash, tachycardia
Fever of 103 degree, severe body ache, headache and injection site pain. Sever fatigue.
This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (age at vaccination: 48 years old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EKS730; Expiration date was not reported), intramuscularly on the left deltoid on 06Jan2021 (17:00) at a single dose for COVID-19 immunization in the hospital (not a military facility). Medical history obesity, osteoarthritis and low vitamin D level. Concomitant medication included ibuprofen from 18Dec2021 to an unspecified date. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EKS730; Expiration date was not reported) on 18Dec2020 (when the patient was 47 years old) for COVID-19 immunization, and had numbness and tingling on the left arm to fingers. In Jan2021, the patient had muscle soreness and fatigue. The outcome of the events, muscle soreness and fatigue, was unknown.
<5 minutes after receiving the vaccine, the mother noted that patient's face was red-the area around her eyes. Patient was also crying excessively. The mother said after receiving the first set of vaccines, Patient did not cry. The mother notified the MA who came in and noted the redness and the MA then notified me. Entering the room, I noted a fussy baby with visible redness around both eyes, red maculopapular lesions on forehead and as I continued to observe Patient, erythematous edema beneath both eyes. Patient never displayed any other symptoms-including no vomiting, diarrhea, increase work of breathing or hives.  Diphenhydramine dose po x 1 given. Pulse ox and other vitals evaluated-all within normal limits. After ~15-20 minutes, redness started to fade, pt stopped crying and returned to gurgling. After 20 minutes, swelling beneath eye resolved
Received vaccine 6-8-10. Came to ER 6-9-10 at 1930 c/o resp. difficulty, fever, lethargy 6-8-10 PM coughing. BP 121/88, T 99.1, HR 160, R 40 lateral.
Pt received vaccines on 4/20/00. On 4/21/00 at 8:00 AM had seizure lasting <10 minutes. Had fever all night. Had a second brief seizure with combined fever at 11:00 on same day. Seen by MD on 4/21/00 with temp of 103.8.
pt devel a purpuric rash, confined to head, arms, trunk;legs not involved;no other sx;CBC,platelets, PT, PTT, UA negative;
Treatment of COVID-19; Treatment of COVID-19; Dose 5: Pfizer/BioNTech, Dose 4: Moderna; This is a spontaneous report received from a contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Apr2022 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: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Zoloft, reaction: "Known allergies: Zoloft". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Dose 5: Pfizer/BioNTech, Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Negative, notes: test day 5 and 7; Negative, notes: test day 5 and 7; positive, notes: positive day 10. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: Rebound positive COVID test and symptoms. Negative test day 5 and 7, positive day 10 with worse ache, body fatigue, headache, abdominal discomfort. The patient was treated with Paxlovid from 09Mar2023 to 14Mar2023. Product Quality Group provided investigation results on 21Mar2023 for BNT162b2. Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PRIVACY concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Follow-up (21Mar2023): This is a follow-up report from product quality group providing investigation results.; Sender's Comments: Based on the limited information reported, a causal relationship between the event "COVID-19" and the suspect product cannot be completely excluded.
Pt waited 5 min out of required 15 minutes. She stated she felt fine and decided to leave.  As she was leaving, she had dizziness and fainting spell.  Her brother caught her and prevented her from hitting head.  She was incoherent for 5 minutes not knowing where she was.  After she regain her senses, she stated she did not eat anything the whole day.  She had blood pressure of 114/84.  Paramedics came, evaluated and discharged her.
Not able to lift my right arm for four days, fever, chills, high heart rates 3 different times lasting ten minutes at a time 24 hrs after shot while sitting in a chair watching tv.
A huge itchy and red rash all over my tricep, starting from my shoulder all the way down to my elbow, as well as the spread  f pimples all over my body. I cannot have caught anything from anyone because I live alone and dont interact with people in person
shingles; This is a spontaneous report from a contactable consumer (pending clarification). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer COVID-19 vaccine on 08Feb2021. On 13Feb2021, the patient developed shingles and wanted to know if it was ok to take antivirals. The outcome of the event was unknown. The case was assessed as non-serious.  Information on the lot/batch number has been requested.
Three hours after injection, cough, tightness in chest. Administered Abuterol inhaler 2 puffs and resolved also Benadryl 25mg.
Started with slight dizziness within minutes of receiving vaccine and progressed to severe dizziness with quick turn of head by the afternoon. Progressed into that evening and night to "bed spins"and nausea. Persisted severe dizziness for the following day. Had to call off sick for work. By day three, dizziness had lessened and could return to work.
Pulsatile tinnitus. I hear my heartbeat on my right ear.  It is a vascular problem in the head.
During vaccine administration, a small volume of vaccine (estimated volume 0.05mL) leaked between the syringe and needle. Likely due to needle being loose. No adverse effects noted
This spontaneous report was received from a Medical Assistant  referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (strength, dose, frequency) lot # M038728 with expiration date of 25-APR-2018 and lot # M041184 with expiration date 31-MAY-2018, orally for prophylaxis. No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 16 and 32 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA008773: US-009507513-1707USA008774:
He became purple, swollen at injection sites. Would not eat for approximately 12 hours, screamed the entire time, blood pressure skyrocketed, breathing shallowed. Also was speech delayed, and has spd, which led to speech and occupational therapy.
Patient felt nervous, difficulty breathing and complained about swelling in the back of the throat within 15 minutes of administration.  Her face was red and heart rate was elevated to 120bpm with blood pressure of 140/90mmhg.
pt recv vax & pt exp a fever & rash;pt recovered;no further details were provided;
Information has been received from a medical assistant referring to a 2 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 13-FEB-2019, the patient was vaccinated with VARIVAX (strength, dose, frequency, batch/lot # and expiration date were not reported) subcutaneously for prophylaxis. No known adverse effects were reported.
CDC Reports: 2 mo infant received DTP/OPV on 14DEC89 and died 1JAN90.
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter
an hour or two after vaccine small rash lumps appeared on wrist and hand, as day went on they went all over my body, by 5pm they were becoming larger and red.  They are a moderately painful and itchy. 24 hours laters I still have red rash all over my body, they mildly painful and itchy.  Took two 1/2 Benadryls upon going to bed.
Information has been received from a health professional who was informed by a physician's office concerning a 5 year old patient who on an unknown date was vaccinated with a dose of PEDVAXHIB instead of hepatitis A injection (unknown manufacturer). No adverse reactions were reported. This is one of several reports received from the same source. No further information is available.
she had headache and was tired; she had headache and was tired; This is a spontaneous report from Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and was tired. The outcome of the events was unknown.  Information regarding the batch/lot number has been requested.  Follow-up attempts completed. No further information expected.
Red rash developed in the area of the shot 2 weeks after the shot.  The area is slightly raised and slightly hard.  Minor iching.
I was fine for a week then on April 22nd I woke up to redness on my left arm where the injection was given. It was hot and you could feel a bump. On April 24, the redness and bump were getting smaller and it was slightly warm. On April 26th, the redness has gotten bigger, about 5 inches in diameter. It's warm the area and sometimes itches.
I first experienced extreme fatigue. I've never been that fatigued. This was within the hour of the shot. 3-4 days of flu like symptoms, fever, cough, aches and pains, vomiting. Everything else cleared except the vomiting continued for at least 2 weeks. I called the doctor and spoke to his nurse and she told me to treat this as the flu, with bed rest and plenty of fluid. Lost 17 lbs.
Swollen lymph nodes; described as "pimple/pustules" on upper torso, arms and groin area. Approx 2 wks following last injection to present.
Fatigue; Sore throat; Pain around site of injection; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Mar2021 at 13:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 01Mar2021 at 14:45, the patient experienced fatigue, sore throat and pain around site of injection. All occurred within an hour of injection. Pain at site and sore throat persisted 18 hours past injection time. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat and pain around site of injection was resolved on 02Mar2021 at 08:45, after the duration for 18 hours and fatigue was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.