chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After an hour of receiving the vaccine I experienced mild pain at injection site, body aches, fever, nauseated, headache and diarrhea. This lasted for 24hrs except for the diarrhea which was only within the first 10hrs. Then at the injection site it is red and hot to the touch. The fever continued for another 24hrs but low grade (99.8-100.8)and feeling a little nauseous. 3 days after receiving the vaccine the injection site is still hot, red and sore. The whole experience felt like having the flu except for the injection site of course. I didn't have any reaction to the first 2 doses that I received of the same vaccine brand
pt recv vax 27FEB98 & 9MAR98 pt devel a mod varicella like rash;
Pt complaining of dizziness and SOB and had mild hives at injection site and posterior shoulder.  Pt was given Benadryl IM and transported to hospital by paramedic ambulance.
Fine, itchy rash on upper left arm surrounding injection site.  No bumps or blisters. Treated with Benadryl Gel topically applied 2-3 times daily.  This is third day since appearance of rash, still itchy, but not as red in appearance.
29OCT91 recvd 1 dose of Engerix-B in the middle of the noc on 29OCT91 pt noticed that was itchy; devel diffuse rash 5 to 7 cm in size;
Received seasonal flu shot 12/2. Noticed increased pain, swelling and redness at site. 12/3 in evening 47 cm area of Erythema with swelling surrounding and induration. Tender to palpation and any movement. Large swelling/induration.
Initial report received from a healthcare professional on 09-SEP-2013. A patient was given ADACEL inadvertently by subcutaneous route. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
pt recvd vax & exp tingling down lt arm along w/tingling in lt face in particular in lips;
pt recv vax 14NOV97 states itching to area on 21NOV97 noticed redness surrounding inj site on 22NOV97 cont until present time;ring of erythema approx 2 inches from center of in site;
not receiving 2nd dose of the Moderna COVID19 vaccine because of fear; Facial swelling/swelling that went down to her/swelled on the left side,; Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face; Left eye kept jumping/left side keeps jumping; Face is sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling/swelling that went down to her/swelled on the left side,), FACIAL NERVE DISORDER (Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face), OCULAR DISCOMFORT (Left eye kept jumping/left side keeps jumping), FACIAL PAIN (Face is sore) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine because of fear) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053e21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high and High cholesterol.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced SWELLING FACE (Facial swelling/swelling that went down to her/swelled on the left side,), FACIAL NERVE DISORDER (Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face), OCULAR DISCOMFORT (Left eye kept jumping/left side keeps jumping) and FACIAL PAIN (Face is sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine because of fear). At the time of the report, SWELLING FACE (Facial swelling/swelling that went down to her/swelled on the left side,), FACIAL NERVE DISORDER (Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face), OCULAR DISCOMFORT (Left eye kept jumping/left side keeps jumping) and FACIAL PAIN (Face is sore) had not resolved and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine because of fear) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include high blood pressure medication and high cholesterol medication. No treatment medication was reported.  Not too long after the first dose patient started having stroke like symptoms and they have not gone away.Patient wanted to get the second dose but she was afraid.
heart palpitations; left earache; slept; Felt tired; bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), SOMNOLENCE (slept), EAR PAIN (left earache), HEADACHE (bad headaches) and FATIGUE (Felt tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL, HCTZ, OXYBUTYNIN, PROGESTERONE, DOCUSATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FAMOTIDINE and PRAVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (bad headaches). On 05-Apr-2021, the patient experienced SOMNOLENCE (slept) and FATIGUE (Felt tired). On 07-Apr-2021, the patient experienced EAR PAIN (left earache). On 08-Apr-2021, the patient experienced PALPITATIONS (heart palpitations). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Apr-2021, EAR PAIN (left earache) had resolved. At the time of the report, PALPITATIONS (heart palpitations), SOMNOLENCE (slept), HEADACHE (bad headaches) and FATIGUE (Felt tired) outcome was unknown.        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.   This case was linked to MOD-2021-076726 (E2B Linked Report).; Sender's Comments:  MOD-2021-076726:Second dose of vaccine case.
This spontaneous report as received from a health care worker (office manager) refers to an unspecified amount of patients of unknown age. On unknown dates the patients were vaccinated with M-M-R II (lot # J004204, expire date 12-APR-2015) (dose and route not reported). The office manager stated this temperature excursion was supported and the vaccines were out of range for approximately 3 hours. This is one of several reports received from the same source. Additional information has been requested.
administration of expired DAPTACEL to a patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Healthcare professional).  This case is linked to case 2022SA391373.  This case involves a 2 years old male patient who experienced administration of expired daptacel to a patient with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation.  On 20-Sep-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5774BA) (dose, formulation, strength, and expiry date: unknown)via intramuscular route in the right deltoid for prophylaxis vaccination.  On 20-SEP-2022 the patient developed a non-serious administration of expired daptacel to a patient with no reported adverse event (expired product administered) (latency one day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt reported itchy, red rash and edema (hives) on upper left arm 5 days after vaccine administration. The rash was reported on 9/17/01. Pt saw MD for assessment on 9/19/01 without further treatment. Pt reported ingesting raspberries on morning rash appeared.
No initial reaction following IM injections. However, overnight, patient developed significant swelling, erythema, induration, and warmth to the left upper arm and shoulder around the area of injection. No weaping or drainage. No fevers. Denies shortness of breath, wheezing/coughing. No facial swelling. Denies mouth tingling. No vomiting/diarrhea.
Injection site swelling and moderate pain within 20 minutes of injection; within 30 minutes the left forearm, left metacarpal region (in particular, tissue surrounding base of left pinky finger) experienced swelling. Left calf (gastrocneuius) experienced mild, yet noticeable, swelling which diminished and was gone within 8 hours. Pronounced fatigue set in within 3 hours after injection and I was in bed the following 2 days. Mild, continuous ringing in the ears began on day 2. By day 4 was back 100% to a normal routine.  The only remaining symptoms as of the date of this report are the mild, continuous ringing in the ears and the small, yet noticeable swelling of tissue around the base of the left pinky finger.
This non-serious initial spontaneous case, was received from other health professional via Merck on 30-Oct-2017, concerning a 35-year-old adult female patient. On 27-Sep-2017, at 02:30 pm, the patient was administered with FLUCELVAX TIV (batch number: 195124, dose, anatomical location: left arm, route of administration, expiry date: not reported). It was reported that, patient had no illness at the time of vaccination. On 28-Sep-2017, after 21 hrs 30 min of vaccination, the patient experienced hurts and swelling around injection site. The patient used cold compress and received BENADRYL for the events. At the time of this report, the outcome of the events was not reported.
Headache; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced headache and pain in arm. On an unknown date, the outcome of the headache and pain in arm were unknown.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient just had a headache the day after getting the Shingles shot and a sore arm. The follow-up would not possible as no contact details were available. For tolerance of the 2nd dose, refer case US2021AMR202848 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202848:same reporter, same patient, same suspect, different dose
no adverse e; administered 1 dose of improperly stored PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.  On 09-OCT-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot No. S008569 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 16-SEP-2020, but upon internal validation established as 16-SEP-2021 , therapy type: rHA(strength, dose number, route, anatomical location was not reported) for prophylaxis (product storage error) which was reconstituted with properly stored sterile diluent. It was reported that the vaccine was exposed to a temperature of 17.6 degree Fahrenheit for a time frame of 1 hours 39 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse events were reported. No product quality complaint was involved.
01/29/2022 after a shower I notice blisters that looked like cold sores. I had a fever and aches the week before and work had me stay home and took a COVID test on 01/26 which turned out negative. I went to urgent care and identified the blisters that showed up as Shingles. Was given acyclovir, which took about a week and a half to recover by 2/10. Only the scarring from the blisters remain. No other issues occurred as of 3/10.
Information has been received from a nurse practitioner referring to a 78 year old female patient with rheumatoid arthritis and leukemia. No other relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX for rheumatoid arthritis (dose, route, lot#, expiration date were not reported) (drug maladministration). Concomitant therapies included methotrexate (manufacturer unknown). On an unknown date the patient experienced an outbreak of shingles all through her body after receiving ZOSTAVAX. Her leukemia was also deteriorating and she had lost 15 pounds. The patient was experiencing oral lesions and it was unsure if the lesions were from the ZOSTAVAX vaccine or from a complication of the Leukemia. The patient was hospitalized due to the events on an unknown date. The patient sought unspecified medical attention on an unknown date and her present status was reported as not recovered. The reporter considered the events to be life threatening. Additional information has been requested.
Left anterior thigh where vaccine was administered is erythematous, warm and tender. Reaction site 17cm x 13cm. BENADRYL and MOTRIN.
Lost consciousness and hit the floor from a seated position. Most likely vasovagal syncope which I have experienced previously. Dizziness and vertigo passed in about 15 minute and I safely left. 6 hours later I am experiencing some lightheadedness.
On April 26, 2022, I experienced cold like symptoms following by muscle aches. I saw my primary care on May 29, 2022, who prescribed amoxicillin. My doctor recommended that I test for covid during the telehealth visit and I tested positive on May 29, 2022. I started the Paxloid on May 30, 2022. I continued the amoxicillin with the Paxloid since I had already started it.  On May 12, 2022, I went to the Emergency Room and was diagnosed with colitis. The hospital took stool sample and I tested positive for C Diff.
headache after the first vaccine; severe joint pain after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after the first vaccine) and ARTHRALGIA (severe joint pain after the first vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache after the first vaccine) and ARTHRALGIA (severe joint pain after the first vaccine). At the time of the report, HEADACHE (headache after the first vaccine) and ARTHRALGIA (severe joint pain after the first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-114551 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114551:dose 2
Client received Moderna as first dose on 07/29/21. Client was inadvertently given Pfizer as second dose on 09/23/21. Patient was made aware at the time of the incident. 1415 on 08/23/21.
This spontaneous report was received from an office manager via field representative and refers to a patient of unknown demographics. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (unknown route) (lot#, expiry date and dosing details were not reported) for prophylaxis. On an unknown date, the patient experienced an unspecified reaction to ZOSTAVAX. It was reported as unknown if the patient received treatment for adverse event. At the time of this report, the outcome of adverse event was unknown. The reporter did not provide the causality of adverse event with ZOSTAVAX. Additional information is not expected as no contact details were provided.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Reported to get the vaccine, and within a couple of hours or days, test positive for COVID; Reported to get the vaccine, and within a couple of hours or days, test positive for COVID; This is a spontaneous report from a contactable other HCP received from a Pfizer-sponsored program.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported to get the vaccine, and within a couple of hours or days, test positive for covid. The outcome of the event was unknown  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520145 different patients, same drug and event
Pt reported tongue feeling swollen 10 minutes after receiving vaccine. Physical exam normal, vital signs stable. Denies SOB, CP, NVD, difficulty swallowing. Monitored for 45 minutes, vital signs remained stable. Gave benadryl 50 mg, symptoms resolved.
First day it was very hot and could not touch site. On 2 day no mobility could not lift arm.  Still can not raise arm without pain, have to use other hand to move arm sometimes. No mobility can not use arm.
Allergic reaction; itching from head to toe; rash; broken vessels in cheeks, turned red; difficulty breathing; arm went numb; was not feeling good; blotchy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 25Mar2021 14:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were none. No prior vaccinations within 4 weeks. The patient experienced itching from head to toe on 25Mar2021 with outcome of not recovered, rash on 25Mar2021 with outcome of not recovered, broken vessels in cheeks, turned red on 25Mar2021 with outcome of not recovered, difficulty breathing on 25Mar2021 with outcome of recovering, allergic reaction, arm went numb, was not feeling good and blotchy on 25Mar2021 with outcome of unknown. The events itching from head to toe, rash, broken blood vessels in cheeks and difficulty breathing require a visit to Emergency Room. No relevant tests. Clincial course reported as follow: Patient received her first dose 25Mar2021 and within 3 hours she was in the Emergency Department. She had an allergic reaction. She has had itching and rash since receiving the shot. The allergic reaction wasn't even 5 minutes of getting the shot her arm went numb and she thought she's in trouble and was this normal. She asked people running the clinic and asked if this was normal and they said no never heard of that. After that itching started. Itching started at her head and moved to her face and then her entire body. She had a rash on her face, neck and chest. The blood vessels broke in her cheeks. She knew she should have some diphenhydramine hydrochloride (BENADRYL) and the emergency department didn't have any there. The staff made her wait for 30 minutes after her injection. She was not feeling good. It was hard for her to take a deep breath, and to catch her breath after 30 minutes of waiting there. Then she drove herself to store and got diphenhydramine hydrochloride, and drove herself home, she was not feeling any better and took the diphenhydramine hydrochloride. She called her doctor's office. It was like an hour after the shot and she told them at the doctor's office she was blotchy, itchy, and having trouble breathing. She talked to the nurse and was advised she must got to the Emergency Department. The nurse told her that the staff should not have let her leave the facility where had shot administered and should have called an ambulance and did not. The staff did not even have diphenhydramine hydrochloride. She went to the Emergency Department and she was still itchy. It had been since 25Mar2021. The rash was mainly on both sides of her neck and under her ears. It comes and goes. She confirmed outcome as persisting. The broken vessels, turned red, under her eyes were no better. She would get spells of difficulty breathing. She couldn't get a deep breath for about a week after the shot and it has gotten better.  No follow-up attempts are needed. No further information is expected.