chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fatigue; Slight chills within 24 hours.; Minimal soreness at injection sight; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 ( Formulation: Solution for injection, Lot number: EL3249, Expiry date: 28Jan2021), dose 1 via an unspecified route of administration in right arm on 28Jan2021 at 07:30 as 1ST DOSE, single for covid-19 immunisation. Patient's History of all pervious immunization with the Pfizer vaccine considered as suspect included, Hepatitis A vaccine, (Lot/Expiry date: 06Sep2015) administered via R deltoid, Influenza Quad NPT vaccine (Lot/Expiry date: 15Oct2015; 02Oct2020) administered via R deltoid, Influenza Fluzone high dose Tri PF (Lot/Expiry date: 14Oct2019 administered via R deltoid, Pneumovax 23 (Lot/Expiry date: 02Nov2016). Patient' had Environmental Allergies since, Long Term 40years + and no other known allergies. Patient did not receive any other vaccine in four weeks. The patients concomitant medications in two weeks included Good sence acetaminophen for headache as a dose of 100 mg 2x/day on 28Jan2021 (Lot/Batch number: 0FE2766C) which is ongoing. Meloxicam (MOBIC) 15 mg daily since, 29Jan2021 which is ongoing. Ergocalciferol (VIT D) and Trazodone 100 mg daily since, 28Jan2021 which is ongoing. On 29Jan2021, patient experienced Slight chills within 24 hours at 6:00AM and fatigue at 9:30. Patient also experienced, Minimal soreness at injection sight on 28Jan2021 and headache on an unspecified date at 10:30. primary infection site was Right Deltoid. There were no any predisposing factors. Culture was not performed. Patient did not receive treatment for the events. Events did not require hospitalization or visit to Emergency room or Physician Office. Since, vaccination patient has not been tested for covid. Treatment received for the event headache. The outcome of the event headache was unknown and other events were resolved.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Patient complains of pain in her right shoulder. Pain starts at elbow and radiates to her neck. Says it started sooner after receiving vaccine. Had no trouble with the two previous vaccines. Denies any other symptoms.
does endorse some rhinorrhea and cough for the past 3 days.  Of note, he was seen in the Emergency Department on 01/02 for nausea and vomiting with unremarkable labs.  It was this day that he tested positive for COVID    Pfizer vaccine given at outside facility. unsure of lot number
This spontaneous report was received from a consumer's mother refers to a female patient of unknown age. Medical history was not reported. Approximately in July 2014 (also reported as last week) the patient was vaccinated with the fourth dose of GARDASIL lot number, expiration date, route and dosage were not reported). Concomitant therapy was not reported. The reporter informed that the patient received all 3 shots of GARDASIL on unspecified date in the year 2009. But her doctor accidentally gave her a fourth shot of GARDASIL. No adverse events were reported. Additional information is not expected, because no reporter details were provided.
Headache, Myalgia,  a couple quarter size welts below the injection site reported employee developed  Narrative:
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Information has been received from a nurse concerning her 26 year old daughter who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL several months ago. Subsequently the patient developed flu-like symptoms after administration of the first and second dose  of GARDASIL. She also experienced vomiting and muscle aches both times. She missed work because of the severity of her symptoms. Her symptoms were worse after the second dose of GARDASIL as compared to the first dose. She would not be administered a third dose of GARDASIL. The patient recovered on unspecified dates. Flu-like symptoms, vomiting and muscle aches (both occurrences) were considered to be disabling because the patient "was very, very ill". The patient sought unspecified medical attention. No further information is available.
Severe dizziness, headache, heart racing, pale, weakness, nauseated, Headache and nausea remained through 12/10/2009. All symptoms appear to be gone morning of 12/11/2009.
torn rotator cuff; can't raise her arm or hold it straight out/she can't raise on own; it really hurts; mild fever; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Apr2021 08:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. There were no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 (batch/lot: ER8733 also reported as "EN6204") in the left arm for COVID-19 immunisation and experienced arm soreness. The patient received second dose of the Pfizer BioNTech Covid 19 vaccine yesterday (05Apr2021) at 8AM. At 10:30 PM, torn rotator cuff in the arm, and no problems with it since the diagnosis. She only received an injection and some exercises for it. This morning, she can't raise her arm or hold it straight out, she has a mild fever on 05Apr2021. The patient wanted to know if there has been reports of having flare ups of a rotator cuff with receiving the vaccine. She can't move arm up to raise it above her head, has to have other arm help her raise it up, she can't raise on own; it really hurts - the left arm which was reported as worsened. She is not concerned about her temperature; she figures a lot of people run a temperature. She has a torn rotator cuff on her left arm that it was given in and she didn't think about it. Now she can't move her arm up to raise it above her head, she has to have the other arm help her raise it up. The patient stated that she is sure it is from the shot. She is concerned and wanted to know if this is going to subside. She tore the rotator cuff, had an MRI, got a shot and had physical therapy and she never had anymore trouble with it, so she didn't do anything about it. Her arm is killing her, and she can't raise her arm. The patient stated that it is hard to get up and it is hard working with one arm.  The patient clarified that this is after her second vaccine. Her arm was sore after the shot but the pain and couldn't raise it really kicked in around 10:30 P.M. She has a call into her primary care to see if anything needs to be done. They are thinking this will subside over a couple of days, but it is a little scary to not be able to raise her arm, that is why she is wanting to find out everything she could. She took Tylenol because the doctor's office said she could and wanted to know if that is correct that she could have Tylenol. The outcome of the event pain in arm was not recovered while the other events was unknown.    Information on the lot/batch number has been requested.
Tested positive for COVID-19 on 7/28/21, admitted to the hospital on 8/3/21 with a date of death of 8/8/2021 via cardiac arrest.
Six weeks post vaccination I developed severe nausea and a pressure headache. The pressure headache has still not resolved to this date, seven months after receiving the vaccine. I also developed other vestibular and neurologic issues such as dizziness, internal tremors, brain fog, impaired short term memory and fatigue. I have also developed eye floaters which I never had previous to receiving the vaccine. I received an MRI of the brain, thoracic cavity CT scan, spinal tap and numerous blood labs. The only significant finding is that I developed autoimmune antibodies. The only treatment given was antidepressants for the headache which has had little effect.
FEELS WARM; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 046AZIA, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feels warm. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and feels warm. This report was non-serious.
Moderna COVID19 Vaccine EUA I received the first injection on Feb. 13, 11:00. Because I am very thin, I wasn't too worried when my arm was sore for a couple of days, but on the 6th day, I was awakened at night with an intense itch at the injection site, and in the morning I saw an egg-shaped and egg-sized bright red area and it was swollen. I contacted my doctor on line, and she recommended hydrocortisone cream and Benadryl, which I have been doing for three days. The red patch has calmed down to light pink, but it's still sore and a bit swollen. It's been two weeks since the injection and I'm scheduled for the second injection on March 13. I'm concerned that the reaction will be worse next time.
left swollen axillary lymph node; INFLUENZA VACCINE was given to the patient on the same day as BNT162B2, BNT162B2 OMI BA.4-5; INFLUENZA VACCINE was given to the patient on the same day as BNT162B2, BNT162B2 OMI BA.4-5; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 18:45 as dose 4 (booster), single (Lot number: GJ6665) at the age of 54 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 21Oct2022 as dose number unknown, single (Lot number: 942415), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COLACE; FAMOTIDINE; UMCKA A; VITAMIN D [COLECALCIFEROL]; PROBIOTICS. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "INFLUENZA VACCINE was given to the patient on the same day as BNT162B2, BNT162B2 OMI BA.4-5"; LYMPHADENOPATHY (non-serious) with onset 23Oct2022, outcome "recovering", described as "left swollen axillary lymph node". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: The patient had no known allergies. The patient did not receive any other vaccine within the four weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Patient was given adult dose of Vaqta instead of pediatric dose.  No signs, symptoms or adverse effects noted.
PT HAD VASOVAGAL RESPONSE AFTER VACCINE ADMIN. PT BECAME NAUSEOUS, AND DIZZY. HAD PT LAY DOWN ...PTS EYES BEGAN ROLLING BACK AND BECAME VERY PALE...TRIED TO TAKE BLOOD PRESSURE (ONLY HAD ADULT CUFF) BP WAS VERY LOW 59/42 PULSE 63, CALLED 911 TO BE SAFE. PT WAS TALKING AND RESPOSIVE, BUT EYES CONTINUED TO ROLL BACK. MOM IS A PHYSICIAN AND SHE DID NOT FEEL IT WAS AN ANAPYLACTIC RXN. SQUAD SAID HIS BP WAS LOW, BUT HE WAS UP AND STANDING, FEELING BETTER BY THE TIME THEY ARRIVED
A dent first appeared at injection site then round red scaly spot appeared left arm. Also was drainage from middle of injection site - now 5 days. Still has spot about a quarter size.
I developed a dry cough 3 days after getting the 2nd dose of Pfizer vaccine; This is a spontaneous report from a contactable consumer(patient).  A 59-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, in left arm on 08Jan2021 (at 59 years) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had previous known allergy to flurbuprophen. Previously on 18Dec2020 at 14:45 (at 59 years) the patient took the first dose of the vaccine in left arm for covid-19 immunization. On 11Jan2021, 3 days after getting the 2nd dose of the vaccine, the patient developed a dry cough.The event required doctor or other healthcare professional office/clinic visit. Patient was tested negative for Covid (via Nasal Swab) on 05Feb2021; X-ray in Feb2021 was negative for pneumonia. Patient had a course of antibiotics, a corticosteroid and cough medicines. As of 23Feb2021 patient still had the cough. The final outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
Rash, 2/2 reaction, redness, swelling, warmth to left upper arm. PREVNAR 13 given on 10/12/15-came to clinic on 10/15/15. TX cool compress. BENADRYL PRN, TYLENOL PRN. Instructed pt to go to ER for chest pain, SOB, anaphylaxis, tongue swelling, wheezing.
medical assistance gave out Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; 37-year-old patient was given Fluzone-HD quadrivalent, no AE; 37-year-old patient was given Fluzone-HD quadrivalent instead of the Fluzone Quad, no AE; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a 37-year-old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ453AB, expiry date 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. Patient did not have any other vaccines.   It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Arthritic pain in one hand occurring intermittently over two weeks, sufficient at night to affect sleep. No other symptoms. Resolved completely after two weeks.
Two hours post injection, experienced excessive, productive clearing of throat with a feeling of congestion in chest which is still present. One week post injection could not sleep due to onset of frequent and bothersome cardiac palpitations with chest tightness which is still present at two weeks post vaccination.
Patients mother reported that the patient woke up the day after being vaccinated and her mouth was full of a large amount of small blisters.
ear infection; hypertension 168/98; Branch Retinal Vein Occlusion; blurry vision in my left eye; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:00 as 1st dose, single for COVID-19 immunization. There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No known allergies. No COVID-19 prior to vaccination and not tested post vaccination. On 25Mar2021 08:00, the patient had blurry vision in my left eye and was referred to a Retina Specialist. The patient was diagnosed with Branch Retinal Vein Occlusion and is receiving AVASTIN shots in the eye monthly in the hopes of getting the vision back to normal. On 02May2021, the patient visited a walk-in clinic for an ear infection and was diagnosed with hypertension. BP 168/98. Patient had several reading in this range after the visit. The patient visited his general practitioner (GP) and was started a regimen of Lisinopril 2.5 mg to help bring down the BP. The outcome of the events was reported as not recovered.
Redness and swelling at injection site extending from upper thigh to knee; no knots.
Patient received vaccine,  1-2 minutes later stated she was feeling dizzy and passed out and began to seize. 911 was called. patient was monitored and given water and an icepack upon regaining consciousness. Paramedics did a physical assessment, including checking blood pressure and blood sure. Patient's guardian refused going to hospital. After 30 minutes patient and guardian went home as patient stated she felt fine. Pharmacy planning to follow up with patient the next day.
Very bad Dermatographia. Drastically effecting day to day activities. took two months to stop,  visited dermatologist and allergist. No one could help and due to breast feeding I could not take medication for it.
Dizzy spell; Episodes of high blood pressure; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizzy spell) and HYPERTENSION (Episodes of high blood pressure) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Blood pressure high.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Apr-2021, the patient experienced DIZZINESS (Dizzy spell) and HYPERTENSION (Episodes of high blood pressure). On 13-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 20-Apr-2021, DIZZINESS (Dizzy spell) had resolved. At the time of the report, HYPERTENSION (Episodes of high blood pressure) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood pressure measurement: 134/82 (High) Elevated. On 27-Apr-2021, Blood pressure measurement: 144/80 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided.  The patient stated that she quit smoking in 2020. Her average BP between 28-Mar-2021 and 10-Apr-2021 was 108/62. Her highest systolic reading was 155/80 and her highest diastolic reading was 142/91.
Developed hives all over her body and itching on Nov 21. Took BENADRYL 50 mg BID, on Nov 22-24. It helped. No other symptoms. Mom did not seek medical care. Mom told me today (Nov 27).
Loss of tastebuds; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of tastebuds) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced AGEUSIA (Loss of tastebuds). At the time of the report, AGEUSIA (Loss of tastebuds) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Received Flu shot 10/19/11 - left deltoid - Thurs. & Fri the 20th & 21st felt groggy. Fri. night - fever 102 degrees F shortness of breath and left side of body felt numb, fever resolved over the weekend, numbness & SOB resolved over night - saw MD 10/24/11 and put on antibiotics.
Slightly scratchy throat and heart started racing for a few seconds.  Recorded heart rate was noted at 83 bpm.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years 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: "SLE" (unspecified if ongoing), notes: SLE , endometriosis, migraine HA; "endometriosis" (unspecified if ongoing); "migraine HA" (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 07Jun2022, outcome "recovered" (15Jun2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Oral Anti viral as Paxlovid for Covid-19 Treatment. The treatment started on 28May2022 and stop on 01Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective and COVID-19 cannot be completely excluded.
Arm was quite sore for about 24 hours at injection site. Had a Body aches and slight chills for about 7 hours the next day.