chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mouth soreness and tender gums; Mouth soreness and tender gums; sore throat; fever up to 102.1 F; injection site soreness; This spontaneous case was reported by a non-health professional and describes the occurrence of ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness). At the time of the report, ORAL PAIN (Mouth soreness and tender gums), GINGIVAL PAIN (Mouth soreness and tender gums), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever up to 102.1 F) and INJECTION SITE PAIN (injection site soreness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: upto 102.1 F.         No concomitant medications were reported. It was reported that fever lifted after 48 hrs. Still have sore mouth, gums, throat. It was unknown if the patient experienced any additional symptoms/event. No treatment medications were reported.
Sore and red arm at injection site the day of that lasted for two days Day 3 after the shot I developed a fever of 102 and chills and nausea and diarrhea
Pt complained of blurry vision 20 mins post 2nd vaccine.  Taken to ED.  EKG normal.  Discharged home.  On 5/30 pt presented to the ED with severe fatigue, lightheadedness and  HR changes.  Tests performed were all negative (EKG).  Patient discharged home.
I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the  hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.
Pt.'s daughter reports 03/29/2021 pt. started experiencing symptoms of dizziness, nauseous, dry mouth, fatigue, severe headaches, and confusion. On and off symptoms daily until 05/10/2021 severe weakness ER (by ambulance) confirmed Stroke. Bed-riddened currently and still severe confusion.
After the first COVID vaccine, she just had pain in her arm, and she had to hold her arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: EW0153) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "After the first COVID vaccine, she just had pain in her arm, and she had to hold her arm".  No follow-up attempts are possible. No further information is expected.
Continuous, on-going menstrual cramping for 8-10 weeks nearly everyday once started, then tapered (at this age I typically cramp maybe once or twice a year) and vaginal bleeding including large blood clots (I had a uterine ablation so I haven't bled for 6 years). Chronic fatigue, intense, had to nap almost every day, and slept 9-12 hrs. a night whether I took a nap or not. Cognitive problems, foggy, couldn't focus or concentrate, often confused by simple tasks. Aches off and on. Cramping and bleeding dissipated completely after about 12 weeks. Fatigue and cognitive issues continued. At about 4 months after last Covid-19 vaccine, administered Fluvoxamine 50mg BID for 14 days. Mental acuity returned to prior state before vaccine, and fatigue dissipated.
COVID-19 PRIZER GRAY TOP WAS DILUTED WITH 1.8 ML OF DILUENT IN ERROE. PATIENT RECEIVED DILUTED DOSE
Patient was administered a FLUAD vaccine at the Pharmacy - after the wait she headed out after grabbin some milk at the cooler - felt dizzy and got into the car after the purchase, she passed out at the wheel while driving out of the Pharmacy and had to call 911 - after about 45 mins of observation left for home - her husband drove her.
Pt reports redness & warmth in area of lt arm where vaccinated & wheezing beginning 2 hrs p/inject lasting 3 hrs;
IPOL (opened) exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: Yes, with no reported adverse event; IPOL (opened) exposed to a temperature excursion was administered to the patient with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 months old female patient who was administered IPV (VERO) [IPOL] (opened), which was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Jul-2023, the patient received 0.5 ml dose of suspect IPV (VERO) (frequency: once; strength: standard) Suspension for injection of lot V1A021M and expiry: 27-Feb-2024 via intramuscular route in unknown administration site for immunization.  On an unknown date, it was reported that the suspect IPV (VERO) (opened) was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event (product storage error) (unknown latency).  On 11-Jul-2023, the patient was administered IPV (VERO) (opened) exposed to temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was provided.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events product storage error and poor quality product administered.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Chills fever and body aches. Started at 930PM the night of the shot lasted thru the next day and night. Second day after the shot I was fine.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-DEC-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "HTN" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid (anti viral) as COVID 19 Treatment from 26Nov2022 to 01Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.
Unable to speak, (stroke like symptoms),  was taken to ER and was treated for a stroke but was later determined to not have had a stroke. Was unable to function for two days. After two iv ingested antibiotics she started to talk and walk. There was never a diagnosis given for the 3 days spent in ER.
Swelling of the tongue, shortness of breath 2mg oral BENADRYL given to pt. Transported to hospital via EMS.
5/4/21 Pt had first covid vaccine to right arm and aprox 5-6 hours later pt c/o sharp left upper back pain the proceeded to radiate to right arm and chest, causing some sob due to pain with breathing. Pain cont. throughout night. Seen in office 5/6/21 for symptoms that persisted, but improving. Denied swelling, n/v/d, palpitations. Pulse ox 97% on RA, RR 20, HR 88. No acute distress. EKG and CXR done, no abnormal findings. Advised motrin for pain, f/u if worsening of symptoms occur.
child behind on vaccines, came in for vaccine catch up, DTaP was given instead of Tdap.
Patient has large red circle on (L) upper arm around injection site. Upper arm doesn't hurt but is hot to touch. Pt stated had fever-night of injection.
a temperature excursion on RECOMBIVAX HB. This product was administered today.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's current condition, historical condition and concomitant medication were not provided.  On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# R028528 with expiration date: 04-JUN-2021; formulation vial, 1 time dose, strength and route were unknown) for prophylaxis (product storage error).     The vaccine was stored above 47 Fahrenheit (F) for 1 hour. The previous temperature excursion was 50F for 45 minutes. The digital data logger was involved.
Day of inj-headache slight, soreness at site. Day 2 - erythema, hive at location. Itching.
Fever for around 24 hours without use of fever-reducing medication; Chills; Headache; slight nausea
Adult dose was administered to child in error. Child demonstrated some anxiety before injection. Immediately following injection child exhibited seizure-like activity for approximately 5 seconds and seemed disoriented afterwards. He was pale with clammy skin. Minutes later he was oriented to place and self and was able to ambulate, although he was still pale. Vitals were stable and WNL. He was transported to hospital via ambulance.
PT STATES FLU SHOT HURT WHEN HE REC'D IT (10/12) AND GOT PROGRESSIVELY WORSE. TODAY (10/17) HE STATES HIS LEFT SHOULDER JOINT HURTS AND CAN'T LIFT HIS ARM. FLU WAS GIVEN UPPER L DELTOID AND TDAP JUST BELOW THE FLU VAX. APPT SCHEDULED WITH THE DR FOR TOMORROW (10/18) FOR EVAL.
Broke out in eczema all over his body. Recurring eczema, especially on his face. At its worst, his face was raw and oozing and there were similar patches on his arm, leg and stomach.
Information has been received from a certified family nurse practitioner (CFNP) concerning a 25 year old female clinic employee who in August 2006 was vaccinated with first dose of Gardasil (lot # not reported). In October 2006, the patient was vaccinated with second dose of Gardasil (lot # not reported. In February 2007, the patient was vaccinated with third dose of Gardasil (lot # not reported). In October 2006, the patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CFNP via telephone. The sore arm lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been received.
Confusion; FREEZING; Fever 101 F; Chills; Extreme Fatigue; Confusion after Second Shot; Sleepy after Second Shot; Less Severe Reaction after Second Shot; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), FEELING COLD (FREEZING), PYREXIA (Fever 101 F), CHILLS (Chills) and FATIGUE (Extreme Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. # 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Blood pressure high, Cholesterosis and Seizure. Concomitant products included SIMVASTATIN for Cholesterosis, METOPROLOL TARTRATE for Hypertension, VALPROATE SEMISODIUM (DEPAKOTE) for Seizures, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (Fever). On 29-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion after Second Shot), SOMNOLENCE (Sleepy after Second Shot) and VACCINATION COMPLICATION (Less Severe Reaction after Second Shot). On 14-Jun-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), FEELING COLD (FREEZING) (seriousness criterion hospitalization), PYREXIA (Fever 101 F) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and FATIGUE (Extreme Fatigue) (seriousness criterion hospitalization). The patient was hospitalized from 15-Jun-2021 to 17-Jun-2021 due to CHILLS, CONFUSIONAL STATE, FATIGUE, FEELING COLD and PYREXIA. On 31-Mar-2021, CONFUSIONAL STATE (Confusion after Second Shot), SOMNOLENCE (Sleepy after Second Shot) and VACCINATION COMPLICATION (Less Severe Reaction after Second Shot) had resolved. At the time of the report, CONFUSIONAL STATE (Confusion), FEELING COLD (FREEZING), PYREXIA (Fever 101 F), CHILLS (Chills) and FATIGUE (Extreme Fatigue) had not resolved and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 29-Mar-2021, Pyrexia: 103 f Fever 103 Fahrenheit. On 15-Jun-2021, Blood glucose: normal normal.         No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226361 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
28JAN93 devel rash onlegs states has felt SOB; referred to MD;
Tiredness, headache, chills, vomiting, diarrhea, night sweats, temperature
fever (t100.9),chills,h/a,malaise,apap,IV NaCl;
16 hours post vaccine - severe chills, fever up to 100.4, mild nausea, muscle aches 24 hours post vaccine - fever up 100, moderate fatigue, mild chills, poor appetite, mild redness just below injection site, unable to report to work, mild congestion 48 hours post vaccine - fever resolved, moderate fatigue, improved appetite, resolved chills, increased swelling and redness just below injection site,  improved congestion, mild sore throat, unable to report to work
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. The patient's past medical history included open heart surgery. Concomitant products included Aspirin, Vitamin C, vitamin D, Flax Seed and SYNTHROID. On 24th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 18th June 2018, 25 days after receiving SHINGRIX, the patient experienced skin lesion, skin swelling and peeling. On an unknown date, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were recovered/resolved and the outcome of the skin lesion was recovering/resolving and the outcome of the skin swelling and peeling were unknown. The reporter considered the pain in arm and skin lesion to be related to SHINGRIX. It was unknown if the reporter considered the pain, skin swelling and peeling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 72 or 73 years old. The patient received SHINGRIX vaccine on the left arm. The patient received multivitamin as concomitant drug. The patient experienced arm pain and soreness after the injection which lasted for about 7 days and resolved.  25 days after vaccination, the patient experienced 2 skin lesions on her head, one on her forehead and one on her cheek. The lesion on her forehead was about the size of a dime, was raised and almost swollen and was peeling. The lesion on her check was about the size of a pea and was clearing up.
Did not think vaccination was given in her deltoid muscle in upper left arm; A report was received from a consumer, who is also a nurse and a 29-year-old, female patient participating in the mRNA-1273 Emergency Use Program and who did not think vaccination was given in her deltoid muscle in upper left arm.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, at the same time as the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.    The patient, a nurse practitioner working on the front line, stated that she did not think the health care provider injected the vaccine in her actual deltoid muscle because she is skinny.  To her, the injection seemed further back. She was not having any side effects from the injection.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, does not think vaccination was given in her deltoid muscle in upper left arm, was considered unknown.   The reporter did not provide an assessment for the event, does not think vaccination was given in her deltoid muscle in upper left arm.; Reporter's Comments: This case concerns a 29-year-old, female patient who experienced the unlisted event of product administration error- did not think vaccination was given in her deltoid muscle in upper left arm. The event occurred the same day after the first dose of Moderna COVID-19 Vaccine administration. The reporter causality assessment for the event was not provided. The reported event is more of a human error and noting the subject's thin built, the event was unlikely related to Moderna COVID-19 Vaccine.
Before patient visit, called patient to verify which vaccine and what dose he would be receiving. As well as our patient list stated Pfizer with 2 people receiving at the same location. Patient stated Pfizer third dose. Upon arrival at the residence, clinician asked questions from the questionnaire about medical history. Once the Pfizer 3rd dose was administered, clinician checked immunization card which stated 1st and 2nd dose of Moderna. Notified clinician managers and office of medical error as well as patient at 1117am on 9/28/21. Stayed at the patient's home for 15 min observation. No Adverse effects. Patient teaching on possible side effects after the vaccine.
Got major sinus congestion a few days after and went completely deaf in right ear by Oct 27th. Treated with prednisone 10mg tablets and IC Acyclovir 400mg 5 times a day for 8 days.
Irritablilty and abnormal staring for about 6 weeks following the 4th DtaP immunization. Staring with no response to voice or touch. Long-term consequences to be determined.
vertigo; dizziness; nausea; soreness in injection arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness), MYALGIA (soreness in injection arm), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05CD214) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced MYALGIA (soreness in injection arm) and HEADACHE (headache). On 16-Jul-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness), MYALGIA (soreness in injection arm), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: other (Positive) other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Urticaria at site of injection that appeared the morning  after vaccine was administered.  Shortly after injection: Fatigue, Nausea, Pain