chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 5 minutes my eyes were blurry.  That seemed to be somewhat better in 15 minutes.  I got a taste in my mouth immediately upon receiving vaccine.  That lasted about 24 hours.  I got a terrible headache within 30 minutes.  That has persisted everyday since.  Nothing takes it away.  My resting heart rate was increased for approximately 10 days, often times around 105 bpm.  I was tired the first day receiving the vaccine and wanted to sleep all day for about 5 days.  I am still struggling with extreme sleepiness throughout the day.  Although better than the first 5 days, it still persists and makes my daily function challenging.  Lastly, my eyesight continues to be blurry, at times, and feels as thought it has gotten much worse overall.  I just got a prescription for reading glasses in the spring but feel that prescription is no longer working.
sleepy; felt a little bit tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (sleepy) and FATIGUE (felt a little bit tired) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No allergies reported.  Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Blood pressure high, Heartburn and Arrhythmia (Irregular heartbeat). Concomitant products included CLONIDINE for Blood pressure high, PROPAFENONE for Heartbeats irregular.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (felt a little bit tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy) and FATIGUE (felt a little bit tired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient received OTC medication as concomitant for heartburn.  It was reported that one time, either with the 1st or 2nd dose of the Moderna COVID-19 vaccine, felt a little bit tired and sleepy.   This case was linked to MOD-2022-678666.
Patient called the pharmacy stating of severe bone aches. She has never experienced these side effects after a covid shot previously.
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: 6H9705) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm 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: "Osteopenia" (unspecified if ongoing); "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" (Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: home test; Negative, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19 from 22Aug2023 to 26Aug2023; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291000 same patient/drug, different dose/events.;
Start as inflammation at injection site with pain, unable to raise arm, developed into infection which had to go to hospital for, now in treatment with doxycycline.
As I was driving away (after waiting 15 minutes ok). My throat felt like it was closing. The next day I had almost unbearable pain in my legs. I think the shot interacted with my fibromyalgia. The pain processing is already confused with Fibromyalgia and it was magnified to the intensity of 26 years ago when I got fibromyalgia without any medical intervention.
Patient tested positive for COVID and presented to the ED for monoclonal antibody infusion roughly 6 months after receiving both doses of Pfizer vaccine.
Information has been received from a medical assistant concerning a 12 months old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 24-OCT-2018, the patient was vaccinated with a dose of VAQTA for prophylaxis, lot # N020689 with expiration date of 22-OCT-2018 (dose, route of administration and anatomical location were not reported). No adverse effects were reported.
Swelling, redness and pain of right thigh 24 hours after giving Pediarix to right thigh. Pt seen at 48 hours and treated with Keflex with which swelling decreased.
Very dizzy; Blood pressure inreased to 190; Felt like she was dying; Heartbeat goes down, and goes up; Heartbeat dropped to 44; Suddenly her blood pressure goes down and up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of BRADYCARDIA (Heartbeat dropped to 44) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Hypertension, HYDROCHLOROTHIAZIDE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up). On 21-Mar-2021, the patient experienced BRADYCARDIA (Heartbeat dropped to 44) (seriousness criterion medically significant), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up). The patient was treated with ATENOLOL (ATENOL) ongoing since an unknown date for Heart disorder, at a dose of 50 milligram. At the time of the report, BRADYCARDIA (Heartbeat dropped to 44), BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: high (High) Reported as 190. On 21-Feb-2021, Heart rate: low (Low) 44. On 24-Mar-2021, Blood pressure measurement: high (High) 173/92. On 24-Mar-2021, Heart rate: normal (normal) 72.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  suffers from high blood pressure, takes medicines. Since the first dose of vaccine she felt a abrupt changes in her blood pressure and heartbeat. She doesn't know if this could be a side effect, she even thought she made a mistake and took 2 doses of her medication.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Pt reports 3 episodes of vomiting throughout day of 2/6. Reports body aches, general weakness, fatigue, nausea. States sx were almost resolved on 2/8. Denies fever, HA. Reports arm pain and local reaction on arm starting on 2/6 - deltoid where shot was administered is itchy, hot, red. Examined pt arm on 2/8 - pt states area has gotten more itchy and red over time. Pt states she took Tylenol for pain and fever sx.
Excessive sleepiness. She slept for 11 hours which is very usual for her.
Narrative: Symptoms:  & LOCALIZED EDEMA; ERYTHEMA; INJECTION SITE PAIN Treatment:
At injection site, at 1202, redness, rash, itchiness, and warmth. Then at 1206 head itchiness. Cold Compress applied to injection site. Later patient reported whole body itchiness and rash that was not raised. Patient is an NP and took prednisone.
(R) Deltoid @ site of PNEUMOVAX c/o swelling and pain and decreased ROM on set eve of vaccine. gradually decreased over 5 days. Also sweats @ HS and fatigue and headaches. Chest itching rash (? ulcer bases on 5 days post vac) and fatigue and sweats and headaches.
pt had swelling below where the injection was given , arm turned red, along with pain as well - this extended from the injection to the elbow
Allergic reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction to the first dose). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
disoriented; chest pain; after the second dose he felt very ill for a few days/felt uneasy/felt severely unwell; his blood pressure was dropping down to 90s/60s when it usually runs around 120/80; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 34-year-old male patient received bnt162b2 (BNT162B2), administration date 23Jul2021 (Lot number: EY0584) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 02Jul2021, when the patient was 34 years old, for COVID-19 Immunization, reaction(s): "Chest pain". The following information was reported: CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "after the second dose he felt very ill for a few days/felt uneasy/felt severely unwell"; BLOOD PRESSURE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his blood pressure was dropping down to 90s/60s when it usually runs around 120/80"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "disoriented". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician of 53 year old concerning herself. On an unknown date patient developed hives after administering penicillin. Patient had no other previous medical history. On 07-FEB-2014 the patient was vaccinated with ZOSTAVAX, (dose number unknown) 0.65ml with lot # J011882 and expiry date 04-JAN-2015, 0.65 ml, subcutaneously. No concomitant medications were administered to the patient. On 07-FEB-2014, within 24 hours patient developed erythema and a little itching at injection site after receiving ZOSTAVAX. Patient hasn't sought medical attention and no treatment was given for the events. No laboratory tests were performed. On an unknown date of February 2014 (3 to 4 days later), patient recovered from erythema and a little itching at injection site. The outcome of she developed erythema and a little itching at injection site was reported as recovered/resolved. This case # 1402USA007605 is linked to case # 1402USA007610 via same reporter link. Additional information is not expected.
After injection, the patient notified staff w/ c/o a serial migraine and palpitations . The On-Site Paramedics were notified and took over care for the patient. At transfer the patient's vitals were as follows: BP: 160/90, Sinus Rhythm, but the EMTs did not specify a heart rate. The patient was then transported via ambulance to the hospital for further evaluation.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 20-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # H022152 and expiry date 18-MAR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Chills; fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient).  A 22-year-old female patient, who is also 22-year-old at the time of vaccination, received bnt162b2 (BNT162B2), lot number: EL9265, via an unspecified route of administration on Left arm on 02Feb2021 10:00 as single dose for COVID-19 immunization.  Medical history included Peanuts, tree nuts, cat allergy. The patient received first dose of BNT162B2, lot number not reported, on 12Jan2021, 11:00 AM on left arm. Concomitant medication included fluoxetine hydrochloride (PROZAC).  On 02Feb2021, the patient experienced Chills, fever, headache, body aches. The outcome of the events was recovering. No treatment was received for the events.
This Spontaneous case, initially received on 13-Apr-2017 was reported by other healthcare professional and concerns a female patient of unknown age. On 28-Sep-16, the patient was administered FLUCELVAX QIV (dosage: 0.5 ml, route of administration: intramuscular, batch number: 185327 and expiry date: 30-Apr-2017). On 05-Apr-17 after administration of FLUCELVAX QIV, the patient experienced type B influenza and vaccination failure. On 10-Apr-17 the event type B influenza has stopped. Batch review report 1021283 was received from quality assurance department on 08-Jun-2017. Based on the document review, it was stated that the concerned FLUCELVAX QIV batch number 185327 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. The outcome of the event type B influenza was recovered/resolved and vaccination failure was unknown. The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This was a serious case (medically significant). Non-significant case correction received on 03-May-2017: The case comment and typo errors in narrative were corrected. Follow-up report was received from quality assurance department on 08-Jun-2017: Batch review report and expiry date were updated.
t102F for 24hrs only - rash starting on face & extremities & then entire body; pimples & red; Pt fatigued & out of school; Exp some joint pain now gone;
Information has been received from a Nurse Practitioner (N.P) concerning a 26 year old female patient with allergic reaction to bee sting who on 09-APR-2009 was vaccinated with the first dose of GARDASIL. On 12-JUN-2009 the patient received the second dose of GARDASIL. It was reported that the patient developed a low grade of fever, and swelling and itching at the injection site after her second vaccination with GARDASIL. The patient was seen in the office. It was reported that the patient recovered on an unspecified date. Follow up information has been received from a facility indicating that the patient received "the shot" at another facility. No other information was available or provided. No further information is available.
COVID-19 Treatment; sars cov2 infection; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), on 01Apr2021 as dose 2, single (Lot number: ER8732), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ8762) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; CETIRIZINE; ADVAIR; FLONASE [FLUTICASONE PROPIONATE]; ALBUTEROL [SALBUTAMOL]. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: VACCINATION FAILURE (medically significant), outcome "recovered" (18Jun2022), described as "COVID-19 Treatment"; COVID-19 (medically significant), outcome "recovered" (18Jun2022), described as "sars cov2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: rebound 8 days after completing course of Paxlovid with concurrent strong positivity, COVID-19 antigen rapid test; (unspecified date) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had stopped rosuvastatin and Advair from 1 day before through 2 days after treatment.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.
C/o "Hot flashes" "warm all over neck and chin" denies breathing difficulties, no acute distress.
Difficulty sleeping; I am having major chest congestion; Coughing up lots of mucus; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 13:00 (Lot number: Fr3182) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 25Aug2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Difficulty sleeping"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 26Nov2021, outcome "not recovered", described as "I am having major chest congestion"; PRODUCTIVE COUGH (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Coughing up lots of mucus"; DYSPNOEA (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Shortness of breath". Therapeutic measures were taken as a result of insomnia, respiratory tract congestion, productive cough, dyspnoea.  Additional information: Patient received treatment OTC medicine. Prior to vaccination, was the patient does not diagnose with COVID-19. Since the vaccination, has the patient does not test for COVID-19.  Follow-up attempts are completed. No further information is expected.
flu symptoms that occurred after my first shot (2 days of flu-like symptoms); This case was reported by a consumer and described the occurrence of flu-like symptoms in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced flu-like symptoms. On an unknown date, the outcome of the flu-like symptoms was recovered/resolved.   It was unknown if the reporter considered the flu-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 52 year or 53 year.  The patient stated flu symptoms that occurred after first shot (2 days of flu-like symptoms).
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT, UNSPECIFIED VEIN  6/7/2022 --  RECURRENCE OF SAME SYMPTOMS
Reporting to VAERS due to patient under 18 years of age.  Patient had fever the night of administration, felt weak ("similar to flu-like symptoms") the next day and all symptoms resolved within 24 hours.
pt recvd flu vax on 23NOV92 & exp severe pain in the deltoid for the next 1-3 days which limited ability to lift arm; pain went away then recurred on 8DEC92;
Patient sat on the examination table, and received 3 vaccinations -2 on left arrm, and the last one on right arm. Immediately after the 3rd injection, patient said that she felt dizzy, and slouched forwards. She was placed flat on the examination table immediately. Dr. was summoned from the next examination room, and attended to the patient immediately. The patient was then noticed to have jerking movements of both upper extremities, lasting 15 to 20 seconds. No color changes, no bradycardia, no tachycardia. Soon after the jerking movements stopped, the patient opened her eyes. Dr. asked the patient --- > "Who am I ? ". The patient responded --- > "Dr.". Patient was observed for 45 minutes, then sent home