chrisvoncsefalvay/vaers-outcomes huggingface dataset:
don't think the patient got much of it, no AE; vaccine squirted out underneath the skin, no AE; vaccine squirted out underneath where the needle was attached to the shot, no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number UJ251AD expiry date:01-May-2020 via unknown route in unknown administration site, patient didn't got much of it, and vaccine squirted out underneath where the needle was attached to the shot on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to vaccine underdose and also a case of syringe leak. It was reported that,  the vaccine squirted out underneath where the needle was attached to the shot, don't think the patient got much of it. The vaccine was leaking where the needle was attached.   At the time of the report, 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 holder's 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.
an improperly stored dose of GARDASIL9 was administered to lhe patient on an unknown date; no adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N022952 with an expiration date in 14-JUN-2020), for prophylaxis (strength, dose and route were not provided), that underwent a temperature excursion from 36 degrees Fahrenheit to 32.1 degrees Fahrenheit, during a time frame of 8 hours. Digital data logger was involved, however no previous temperature excursion was reported. No adverse effects.
Pain, swelling, warmth and redness at injection site started within an hour after shot. Abdominal pain and severe diarrhea started after two days .
I had shortness of breath, body aches, fever, and flu-like symptoms, had a very high fever for the first few days. This lasted for two to three weeks. I was prescribed promethazine, which I took for 10 days.
scratching; itching; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (scratching) and PRURITUS (itching) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and FENOFIBRATE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SCRATCH (scratching) and PRURITUS (itching). At the time of the report, SCRATCH (scratching) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided by the reporter.
Runny nose; Throat is white from back; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and PHARYNGITIS (Throat is white from back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042A21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, EZETIMIBE (ZETIA), POTASSIUM CHLORIDE (KLOR-CON), HYDROCHLOROTHIAZIDE, OMEPRAZOLE (OMEPRAZOLE ABBOTT), LABETALOL and GABAPENTIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Apr-2021, the patient experienced RHINORRHOEA (Runny nose) and PHARYNGITIS (Throat is white from back). At the time of the report, RHINORRHOEA (Runny nose) and PHARYNGITIS (Throat is white from back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient passed out about 7 min after getting both COVID and flu shot. He stated after passing out that he was anxious/nervous about getting the COVID vaccine/side effects. He was checked out by paramedics. He called his roommate to pick him up. He was feeling normal, apologetic, and appreciative of the time and care I provided to him.
Fever or chills for about 6 hours Fatigue for about 30 hours Muscle or body aches for about 9 hours Headache for about 30 hours Nausea for vomiting for about 12 hours Diarrhea for about 2 days
Patient described a racing heart/chest pain immediately following administration. She then reported dizziness and weakness that lasted at least 30 minutes. Blood pressure was elevated. She requested 911 to be called. She requested paramedics to transport her to the ER.
Next day following vaccine (07/19/2017) child showing  swelling and redness to about two thirds of the leg with most of the swelling on the lateral side where vaccine injected. Per parent information child started to scratch the area and swelling worsened. when parent brought in child to clinic, parent stated swelling was decreasing compared to how it looked the previous day.
flu-like symptoms; headaches; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (headaches) and CHILLS (chills) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (headaches) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.            Action taken with mRNA -1273 in response to the event was not applicable. No concomitant product information was provided. No treatment product information was provided.
Patient had completed 15 minute post vaccine wait time, felt light headed, unable to stand, patient laid on floor, BP checked and elevated, patient became very drowsy and lethargic, difficulty staying awake, HCP had to sternal rub patient to arouse, EMS called
blood shot right eye; Allergic reaction; Chills; Her lips are a pinkish color as if she is still having some type of reaction; She did have nausea this morning; This is a spontaneous report from a contactable consumer reporting for herself.  A 68-years-old female patient received bnt162b2 (BNT162B2; Lot # EL1283) , via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunisation .  Medical history included cataract operation on 10Nov2020, oedema , swelling  , brain operation on 2016 , aneurysm (aneurysm that did not rupture and there are 8 coils protecting that) , implantable cardiac monitor insertion , hypertension.  Concomitant medication included lisinopril dihydrate (LISINOPRI)Lacetylsalicylic acid (ASPIRIN BAYER), amlodipine besilate (AMLODIPIN)  pravastatin sodium (PRAVASTATIN) The patient experienced chills  on 21Jan2021 with outcome of not recovered , her lips are a pinkish color as if she is still having some type of reaction  on 21Jan2021 with outcome of not recovered , she did have nausea this morning on Jan2021 with outcome of unknown , blood shot right eye  on 22Jan2021 with outcome of not recovered , she thinks she had an allergic reaction  on 21Jan2021 with outcome of not recovered.   The patient received Benadryl, Prednisolone and Ketorolac as treatment.  Follow up information has ben requested.
Narrative:  Patient received Pfizer COVID 19 Vaccine Feb 2021. The patient tested positive for COVID 19 on 15 September 2021 and was hospitalized with COVID pneumonia on 16 Sep 21. The patient was discharged in stable condition on 21 Sep 21.
Hospitalization 8/6/21 for Covid19 and death 8/10/21
Tinnitus and profound hearing loss in left ear. Adverse effects continue to occur at time of reporting.
The usual for the first 36 hours (fever, nausea, chills, weakness, sore arm).  Then the day after, around 44 hours later, I noticed my hands had a significant rash, which my doctor diagnosed as DYSHIDROTIC ECZEMA.  I'd never had it before.  There were no other changes in my routine that could have accounted for it.
Voice is changing due to runny nose; Feels lousy; Runny nose; Legs are rubbery; Has flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice is changing due to runny nose), FEELING ABNORMAL (Feels lousy), RHINORRHOEA (Runny nose), SENSORY DISTURBANCE (Legs are rubbery) and INFLUENZA LIKE ILLNESS (Has flu like symptoms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No relevant concomitant medications reported.  Concurrent medical conditions included HIV disease (HIV patient with a weakened immune system).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPHONIA (Voice is changing due to runny nose), FEELING ABNORMAL (Feels lousy), RHINORRHOEA (Runny nose), SENSORY DISTURBANCE (Legs are rubbery) and INFLUENZA LIKE ILLNESS (Has flu like symptoms). On 01-Mar-2021, DYSPHONIA (Voice is changing due to runny nose), FEELING ABNORMAL (Feels lousy), RHINORRHOEA (Runny nose), SENSORY DISTURBANCE (Legs are rubbery) and INFLUENZA LIKE ILLNESS (Has flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.
Approx 10 min. after giving immunizations pt produced a rash over (B) arms (B) legs and abdomen. No wheezing noted. Pt was given oral BENADRYL, and rash faded after 25 to 30 min.
had close contact* with a person who has a LABORATORY CONFIRMED case of COVID-19 in the past 14 days?: Yes    Patient never had symptoms
Dermatographia, chronic urticaria, and full body discoid rash after 10 days of receiving Moderna bivalent booster. Symptoms have not resolved. Same symptoms appeared after each Moderna dose (2-5).
Acute Myocardial Infarction on 2/16/2021 Patient had a CABG performed on 2/17/2021  Patient is post-surgery - remains hospitalized
Pain, hot, swollen, red, doctor visit cellulitis, bacterial infection, prednisone, cephalexin, ciprofloxin, Vicodin.
Fairly loud tinnitus all the time.  Descdribed by constant tinny sound, not whooshing, high pitched
Swollen arm, large inflamed red area covering most of the left deltoid, upper arm. Hot to touch, very sore and very hot to the touch. Have pictures of area.
February 10, associate goes to the clinic with her appointment for 7:06 AM. She completely bypassed the registration door where they could?ve verified her immunization card and her time frame on when to get the vaccine and went straight to the conference room.   Individual, who oversaw documenting the vaccination, was currently helping a person before her since they were anxious regarding the second shot. After she was assisted, they went on with patient. They verified her birthday, allergies, side effects from the first dose and verified that she answered all the questionnaire but missed the part where it said Moderna on the first dose and was sited down to get vaccinated. Her immunization card it didn?t say Moderna either and only had the lot number with the date administered written down. The student that oversaw her vaccination was the College ADN. (She was new to our clinic and was usually in the Moderna Clinic) and was under the supervision of RN for that room. She did go through her 7 rights and in the end, she told associate that she is giving her the Pfizer vaccine 0.3 ml and then administered it. After administration, associate then told them that she had Moderna first dose and thus this situation was sent back to EH Manager.   The associate was placed in observation for 30 minutes and no reactions were seen and the associate was able to go home but her contact info was taken. Upon investigation, patient told us that she knew it was a Pfizer Clinic since it said Pfizer on the registration and the EUA form is also for Pfizer but since she placed Moderna for her first dose she still came and thought that we would know that she is Moderna. Patient information was taken down and then reported to the Director.
Started as just red circle size of half dollar, four days later at night I felt my arm and blood felt so hot like almost boiling, than day after day it spread further and further til it was my whole arm.  Now, two weeks later starting to subside only while I am taking Benadryl and cream, and as the histamine runs out after a day, rash still comes back.
1st dose 23-Oct2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd October 2021 batch number 9435L and expiry date 8th April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's comments:  The pharmacist was asking information about the validity of the first dose as the patient wished to receive the second dose. Information about the vaccine and patient given. The Vaccine Administration Facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The details were reported corresponding to the 1st dose as the 2nd dose was not administered yet.
Pain in whole body, dizziness, lose of appetite and allergies (bumps on my nose).
No other issues or concerns noted; received expired MMR II and diluent; 19 years old patient vaccinated with M-M-R II; This spontaneous report was received from a pharmacist referring to a 19 years old patient of unknown gender.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 12-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S022753 with an expiration date on 22-JUL-2021), and sterile diluent(MERCK STERILE DILUENT) (lot# R032162 with an expiration date on 22-JUL-2021) for prophylaxis (expired product administered).  Strength, dose, frequency, and route of administration were not reported).   No other issues or concerns were noted.
Diarrhea - A report was received from Wyeth (8-99130-003A) regarding events in Ohio.  A territory representative reported that an infant received the first dose of Rota Shield and, later that evening, developed mild diarrhea which resolved the same evening.  Follow-up information received from the infant's mother indicated that her 4 month old son received Roth Shield, DTaP (Wyeth-Lederle), Hib (Wyeth-Lederle) and IPV (PMC France) vaccines in January 1999.  Within 24 hours, the infant developed diarrhea.  He recovered.  No additional information was provided with correspondence returned to Aventis Pasteur US on 19 Jan 2000. From follow up #2 correspondene received on 12/10/01 it was reported that the pt received the vaccinations on 1/29/99. No treatment was required. The pt recovered from this experience and is healthy. The lot numbers and the route/site info for the products were also provided. No further info is expected, this case is closed.
Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: CT3175) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 29Mar2021 as dose 2, single (Lot number: EN6201), in left arm, on 17Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 29Jun2022 as dose 4 (booster), single (Lot number: FP7139), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient received Paxlovid as Treatment of COVID-19 from 21Feb2023 to 27Feb2023. Patient took no other medication in 2 weeks. Patient had no known allergies and had other medical histories.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300098568 Same reporter and patient, different product and event;
experienced uncontrollably shivering for 2 hours after receiving Shingrix; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. The patient received shingrix and experienced uncontrollably shivering for 2 hours. The reporter refused to provide any other details. The reporter did not consent to follow up. This is 1 of the 6 linked cases, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099469:Same reporter
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. In 2023, COVID-19 (Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, SARS-CoV-2 test: Positive and Negative.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported.  Patient tested negative for Covid after 3rd dose. Said tested positive for Covid morning and didn't start till evening. Also mentioned did have new vaccine/latest vaccine Moderna on 28-Sep-2023.   No treatment medications were provided.
Pt. had syncopal episode after receiving vaccines. Pt fainted after receiving immunization when getting into car to leave clinic. Suffered small bump. No visual disturbance. Vitals stable. After observation released home.
developed PHN symptoms / Suspected vaccination failure; developed PHN symptoms; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: developed PHN symptoms / Suspected vaccination failure) (serious criteria GSK medically significant) and post herpetic neuralgia (Verbatim: developed PHN symptoms). The outcome of the vaccination failure was unknown and the outcome of the post herpetic neuralgia was not reported.   It was unknown if the reporter considered the vaccination failure and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the vaccination failure and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt date: 10-AUG-2023 A reporter reported that patient developed PHN (post herpetic neuralgia) symptoms even after having been vaccinated. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of post herpetic neuralgia were unknown at the time of reporting. The reporter did not agree to follow up from GSK.
The vaccine vial was only diluted with 0.8ml of sodium chloride. The 0.3ml dose was then drawn up and administered. The patient was checked on the evening the dose was given and the following day around 11:30 am and no side effects were experienced at that time.
Rash appear all over right arm and arm is swollen  in the cleaves of arm. rash is also on stomach and right hip.
Body aches for 16 hours, headache lasted 2 days. Feeling miserable. Light headed for 10 hours took Tylenol but couldn't tell it helped any.