chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to pharmacy to receive hepatitis A vaccine and after receiving the vaccine, patient stated his arm was sore within seconds and asked if he could get an ice pack. I asked patient to sit in the post vaccination waiting area while I get him some ice. As I was getting a bag, customers flagged me to let me know that the patient has fallen out of his chair. When I came out of the pharmacy, the patient was holding his head. I asked the technician to call code as I stayed with the patient. I asked if the patient was okay to which he stated he felt dizzy and did not know he even fell until now. I followed up with the patient after the incident. He stated that he is fine now and felt the vaccine go in his arm but a factor may be that he has not eaten today so he felt light headed.
Felt soreness on entire right arm, tingling, numbness and dryness in mouth.  Took Advil for discomfort.  Worked the next day, at about 6pm (24 hr mark), really felt muscle aches everywhere, overnight, chills, elevated temp (100F).   Seems to be subsiding but residual exhaustion, still taking advil for pain (reporting at 34 hrs)
This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 08-APR-2015 was vaccinated with an expired dose of VARIVAX (Merck) subcutaneous, 0.5ml dose, lot # J002618 which expired on 01-MAR-2015. No adverse events were reported. Additional information has been requested.
Pain at injection site; base of neck hurt; felt a lump near my collarbone, lump was floating and moving, hurt/tender to the touch; collar bone area swollen; This is a spontaneous report from a contactable consumer reported for herself. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Lot number: EN6205) via an unspecified route in the right arm on 06Mar2021 at 10:00, as a single dose for covid-19 immunization. Medical history included covid-19, allergic to Lipitor, statins, high blood pressure and slightly overweight. Concomitant medications included naproxen sodium (ALEVE), minocycline, VITAMIN C (ascorbic acid), VITAMIN D (colecalciferol) and quinapril hydrochloride (ACCUPRIL). Prior to vaccination, patient was diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 07Mar2021 (Sunday) at 15:45, patient experienced pain at injection site, base of neck hurt, felt a lump near collarbone, lump was floating and moving, hurt/tender to the touch and collar bone area swollen. Adverse events resulted in doctor or other health care professional clinic visit. Patient went to dermatologist today felt that it may be nothing and was prescribed to minocycline a day for a week. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
About 24 hours after the vaccination I had severe dryness of mouth. Then I had acute burning, redness, and inflammation. My dentist did notice it is well. I am a physician so I am tested regularly for COVID. I didn't have a fever, I was fatigued, and I couldn't eat. If I was not a physician, I would have went to the ER. I self-treated with salt-water rinses and some OTL pain medication. I could see it was not tonsil or any infection of sinuses. Soft and hard palate was redness and it was ok within two weeks.
A non-serious spontaneous report of handle broke off of five FLUMIST syringes cutting the nurses hands has been received from a health professional concerning an adult. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient did not receive FLUMIST. On an unknown date, during the preparation of FLUMIST for administration, the handle broke off of five FLUMIST syringes and the nurses sustained a cut to their hands. Ninety percent of the handle broke off from one syringe and about 25% of the handles broke off from four other syringes. The product was not administered. There were no observed damages to the boxes or the plastic moldings and the were no product leakage. It was reported that the nurses are fine. The outcome of the reported adverse event was not reported.
This case was reported by a physician via sales rep and described the occurrence of chest pain in a 16-year-old female patient who received MENVEO (batch number X17098, expiry date unknown) for prophylaxis. Co-suspect products included BEXSERO (batch number ABX752BA, expiry date unknown) for prophylaxis. On 11th March 2019, the patient received MENVEO and BEXSERO. On 18th March 2019, 7 days after receiving MENVEO and BEXSERO, the patient experienced eye muscle paralysis (serious criteria GSK medically significant), swelling of eyelid and eyelid ptosis. On 19th March 2019, the patient experienced headache and myalgia. On 25th March 2019, the patient experienced chest pain (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chest pain, eye muscle paralysis, swelling of eyelid, eyelid ptosis, headache and myalgia were unknown. It was unknown if the reporter considered the chest pain, eye muscle paralysis, swelling of eyelid, eyelid ptosis, headache and myalgia to be related to MENVEO and BEXSERO. Additional details were reported as follows: The patient's mother brought the patient to physician due to having headache and muscle ache. The day prior to that the patient's eyelid looked swollen and droppy. No fever and redness presented. The physician thought it might be a palsy type illness and administered steroids. The patient again visited emergency room complaining of chest pain On 25th March 2019, the patient had computerised tomogram (CT scan) but results were unknown then transfer to another facility for eye concern.
experiencing a lot of itching; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Jan2022 (Lot number: FL3197) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; LOSARTAN; SIMVASTATIN; METHIMAZOLE taken for thyroid disorder. The following information was reported: PRURITUS (non-serious) with onset Jan2022, outcome "not recovered", described as "experiencing a lot of itching"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "Rash". Therapeutic measures were taken as a result of pruritus, rash.  Additional information: Today, patient took an allergy pill (Further clarification unknown, hence suspect captured conservatively as unspecified medication). Patient put a little Cortisone (Suspect captured as per verbatim; further not clarified hence Pfizer not checked) cream on it but the itching is still there and now the rashes.  Follow-up attempts are completed. No further information is expected.
A report has been received from a Physician via medical representative and the follow-up report from a physician via Health Professional concerning a 40 year old, male subject. The medical representative stated that the physician reported that he had received FLUMIST (intranasal) during 2003 and later had fever and Chills. In the follow-up report the admin checked with the physician if he had reported the adverse event of fever and chills for himself, but he had denied that he reported anything or had any adverse events. The report was considered to be non-serious by the company physician.
itchy arm; red arm; (arm) bumpy near injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy arm), ERYTHEMA (red arm) and INJECTION SITE SWELLING ((arm) bumpy near injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (itchy arm), ERYTHEMA (red arm) and INJECTION SITE SWELLING ((arm) bumpy near injection site). At the time of the report, PRURITUS (itchy arm), ERYTHEMA (red arm) and INJECTION SITE SWELLING ((arm) bumpy near injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Site: Pain at Injection Site-Medium, Additional Details: PAtient has been complaining of signigicant pain in her left arm. Unable to lift over her head. Has been on going since vaccination. Recommended to patient to see MD. She states that is feels like there is "another muscle" on her arm as well
Marked local reaction, induration (6x6cm) and erythema (15x10cm) of left thigh. Prescribed Motrin and Benadryl.
Her rash was on her shoulder, hand, belly, and back; She stopped being itchy and it is painful.; This is a spontaneous report from a contactable consumer (Patient) reported for herself:  A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 22May2021 (at the age of 60 years old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date (at the age of 60-years-old) as dose 1, single for covid-19 immunization. On 23May2021, the patient experienced rash. Reporter was asking if Prednisone was the correct treatment for her rash. Patient started to develop a rash on Sunday 23May2021. She was on her second day of taking prednisone and it was still there. It was a little bit of a lighter color but it was still there. How long will she have this rash?She just wanted to only speak with them because she was a little panicked right now because this rash is killing her. She stopped being itchy and it was painful. She was prescribed prednisone for 7 days and went to her doctor on Monday. Her rash was on her shoulder, hand, belly and back. The outcome of the event rash was unknown and outcome of itchy rash was recovered on an unspecified date.  Information on the lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
All day dizzy, head wouldn't stop spinning; head wouldn't stop spinning; This case was reported by a consumer and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced dizziness and head spinning. On an unknown date, the outcome of the dizziness and head spinning were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and head spinning to be related to Shingles vaccine.  Additional details provided were as follows: The reporter was the patient's brother/sister. The age at vaccination was not reported. The reporter stated that, his/her sister just got a shot and she said she would never in her life want to get another vaccine. The patient was at the doctors all day felt dizzy her head would not stop spinning immediately after the second shot. The reporter hope that it was just a rare occasion. Follow-up would not be possible as no contact details available.
I had fatigue, congestion from mucus, achiness in my knees and hip joint on one side, a fever. I did a home COVID-19 test on both May 18, 2023, and May 20, 2023, that came back positive. I called my doctor to let them know I had tested positive for COVID-19, I really needed something to help with the coughing. I was prescribed azithromycin and methylprednisolone dose pack. I was only able to take the methylprednisolone dose pack for a day as it raised my sugar levels. I went to have a chest x-ray as the chest congestion was worrying me and I was afraid I may be getting pneumonia; it came back negative. I will be going back to see my doctor tomorrow, 05/26/2023.
Rash at injection site and erythema; arm pain (R) at and around injection site; rash on (R) side of trunk.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    The beyond use date (BUD) of the vaccine was 21-May-2021. Patient received the vaccine at a pharmacy.   No concomitant medication reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up document received on 30-Jan-2023 with no new significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Pt recvd vax 10NOV92 @ 10PM pt had t102 & cried cont until 6AM the next AM; no swelling/redness @ inject site;
received FLUZONE QIV NP vaccinations from single-dose vials that had expired with no adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under the reference 00798634).  This case involves ten patients (unknown age and gender) who had received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from single-dose vials that had expired (expired product administered).  The patients' past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patients received a dose of suspect INFLUENZA QUADRIVAL (0.5 ml, single dose vial, lot U7045DA and expiration date: 30-Jun-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine administered (same day latency).  It was reported "Caller states that ten employees at her facility received FLUZONE QIV NP vaccinations on 01OCT2021 from single-dose vials that had expired on 30JUN2021. Caller asked whether or not those doses counted or if the employees should be revaccinated."  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 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.
Patient fainted and fell outside of pharmacy but within warehouse (in front of pharmacy). Patient became conscious upon falling and taken care of by paramedics. Patient taken to nearby urgent care.
Started as hives developed into large red welps  on buttocks, neckine and in hair.  On shoulder and stomach aera.
bad reaction to my first dose of the vaccine; didn't take her second dose; lost the feeling in her hand and feet; heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (lost the feeling in her hand and feet), PALPITATIONS (heart palpitations), VACCINATION COMPLICATION (bad reaction to my first dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (didn't take her second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PALPITATIONS (heart palpitations). On 08-Apr-2021, the patient experienced HYPOAESTHESIA (lost the feeling in her hand and feet). On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction to my first dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (didn't take her second dose). The patient was treated with VITAMIN B12 [VITAMIN B12 NOS] ongoing since an unknown date for Hypoaesthesia, at a dose of 1 dosage form. On 20-Apr-2021, PALPITATIONS (heart palpitations) had resolved. At the time of the report, HYPOAESTHESIA (lost the feeling in her hand and feet), VACCINATION COMPLICATION (bad reaction to my first dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (didn't take her second dose) outcome was unknown.        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.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Significant follow-up received on 06 Sep 2021: Added new event
Received vaccination 3-27-08; on 3-28-08 left arm sore and fevered; patient woke on 3-29-08 and states tongue swollen and sore, by day of report swelling had reduced, but continued to be sore.
First vaccine: When I took the vaccine at pharmacy , they followed protocal. When I went home, there was slight soreness in my right shoulder, I took a tylenol advised by my mom. I took it an hour after, I was fine. And then the next morning when I was suppose to go to work, I could not come out of bed. My muscles ached all over my body, head to toe. I told my job I could not come to work cause of the shot, I stayed home that day. I made that call at 5 am, so then because of the pain from my neck on down, I could not get out of bed until 2:30pm on the 25th. I could not eat all day. My body ache so much, I said to myself OMG I cant believe what I am experiencing right now. I was holding on to the walls walking, I was able to make me some lunch. That evening I warmed up my dinner, and with that I was able to sit at my table and eat, and then after I was done with that. Approximately a quarter to 4, I had to fight to get in the shower. I said to myself, that If this is what covid is, I dont want to ever have the real thing. Back pain, elbow, shoulder. When I was done taking the shower, it took me like 30 mins to get dress. Second Vaccine (COVID PFIZER LOT# EW0177): June 14, 2021 I went back to the same pharmacy, I was able to go to work, I went to work at 7am. At 11am, I made it back to my office at work, It made me very drowsy. I couldnt work, I was so drowsy, I couldnt hardly keep my eyes open. I took a light nap, sitting in the chair, I was able to clock out and come home. I went to bed after dinner and shower.  THIRD VACCINE (COVIDPFIZER LOT# FK9829): February 1st, 2022, It was this one when I arrived home, that night I went to bed and that entire night, I tossed and turned, my epidermis was itching me, from head to toe, and I tossed and turned,  I couldnt scratch cause it was internal. Itching underneath my skin. It was my body trying to push it out. I developed a little rash, which is very itchy. I went back to her approximately in October of 2021, and I didnt know what was causing it then, then I went to her on Sept of 2022 reporting this itching I was having, and it went to my scalp. She said it's like a fungus and gave me meds, and it didnt work, so I was hospitalized throughout this process.
On 10/14/03 father child "gray and not breathing". Was taken to hospital ER.
A different mRNA vaccine product was inadvertently used for patients 2nd dose.  Patient received Moderna for 1st dose and was given Pfizer for 2nd dose by mistake.  No action was taken and patient, provider consulted, and patient given information from CDC website stating that she was still considered fully vaccinated 2 weeks after 2nd dose and that no further doses were recommended
Pt was also given T-DAP- MENACTRA, HEP A Pt was given GARASIL (LA), within 30 sec. Pt became pale. unresponsive arms & legs became rigid, lasted for aprox 2 min. After that Pt was pale for aprox 10 min. pulse cx 81 HR 113 pulse cx 91 H.R. 114, pulse cx 73, HR 81, pulse cx 71, HR. 46. B.P. 118/70 4:35 pt. States feeling better - 4:30 ambulance called, pulse cx in 70's H.R. in 40's - B.P. 106/72. Pt no longer pale & able to stand Pt was alert, conscious, coherent GCS (15) when sent to ER. Pt. received total total of 4 shots, #1 T-DAP (LA) #2 GARDASIL #3 HEP A, #4 MENACTRA. Pt states she doesn't remember the 4th shot. When she woke up, she didn't know where she was on the shots. After 10 min she did remember getting shots except for the 4th shot.