chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves a patient (age and gender not reported) who was vaccinated with FLUZONE HIGH DOSE (batch number, expiration date, dose, route and site of administration was not reported for vaccine) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as product which was too long in transit was given to a patient. It was unknown whether the patient had any adverse event. 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. List of documents held by sender- none.
pt threw self around & scramed & babbled for about 45 mins; pt also had a temp;
T104 w/APAP being given every 4 hrs; had sz @ home; taken to ER put on ATB for ear infect; MD in ER according to mom, was unsure if fever & sx were from immun or ear infect;
Patient had a large reddish green blood clot. It was growing in size and itching. The blood clot was under the skin and was 2 inches X 1/2 inch size. The emergency room physician said it is a haematoma. He asked her to take some TYLENOL and BENADRYL.
Child had a fever of 101 and was lethargic for 24 hours.  He did not eat for most of the day.
suspected Vaccination failure; I have had the 2 shots required 2 to 3 months apart and still get them; They are miserable; Lasting nerve pain can last for quite awhile; This case was reported by a consumer via media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling miserable and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles, feeling miserable and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling miserable and nerve pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient was the reporter itself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2 doses of Shingles vaccine and experienced shingles, nerve damage and felt miserable. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
A rash developed on patient's back. Rash was red and itchy and spread to patient's face and trunk area. Mom did bring baby in for an appointment on June 21, 2019. 1 yr vaccinations were given on June 13m 2019 in our office.
HORRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 05-APR-2021, the subject experienced horrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible headache on 05-APR-2021. This report was non-serious.
Patient called on July 17th stating that she had developed facial swelling, increased heart rate, dizziness, fever of 102 F for full 24 hrs after receiving TRUMENBA and MENACTRA on 7/13/17. Symptoms normalised after 24 hours.
Symptoms: Body aches, chills, fever of 101 degrees, nausea.
pt recv vax 4OCT96 & pt came into contact with another child over the christmas holidays;6JAN97 pt exp chicken pox over 100 lesions & a sl fever;pt recovered;pt sibling vaccinated same day but did not break out;
Headache, Myalgia & Arthralgia  Narrative: reports persistent symptoms of ha; fatigue; night sweats for 6 to 7 months post vaccine
Got positive,  testing for CoVid 19 on,12/30/2020.  Symptoms started gradually on 12/19/20 w/ sore arms, fatigue  then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms.   I knew then I needed to get swab.  Symptoms is still current.
Unk pt was given Fluarix in error should have been preservative free Fluzone.
FLAT, RED RASH ON INSIDE OF ARM COVERING 1/2 OF LENGTH OF ARM. AT BOTTOM OF RASH 2IN DIAMETER LUMP OR POCKET OF FLUID. NO ITCH, PAIN OR HEAT. NOTHING AROUND INJECTION SITE.
A patient receievd an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00327404) and transmitted to Sanofi on 25-Mar-2021.  This case involves a patient (unknown demographics) who received an expired 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA and expiry date: ) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (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 guidelines. 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.
Erythema 7 x 4 cm with mild induration over left thigh.
30 wk premature doing well; 15hrs post vax had sudden onset of hypotonia/apnea x 2 recvd mouth to mouth resus by father; Other cause ruled out;
14 year-old experienced an adverse reaction after receiving her 2nd Pfizer vaccination. She had complaints of dizziness and was observed to vomit.
Narrative: Patient reported injection site pain following administration of 1st dose of Pfizer covid vaccine. Patient was released with no additional intervention.
Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 152.2.  No concomitant medications were reported.  It was reported that, the pharmacy had sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator. The vaccine was administered to the patient after the 30 days use by date. The vials did not undergo any temperature excursions. No adverse reactions were reported for the patient.  No treatment medications were reported.
Skin flushing and racing heartbeat within a few minutes of receiving first vaccination. After sitting for a minute, symptoms ceased. Came back after ten more minutes of sitting for another minute of symptoms then ceased. Pain at injection site as expected.
After receiving the vaccine in April 2 I had nothing more than a mild headache and slight fatigue for a day. Then on April 10 after being in menopause for 2 years I started bleeding again. I typically never got cramps and have been experiencing mild cramps throughout the day.  I have not been ill in any other way. I do feel that the vaccine caused this and the reason I am reporting this information.
7/6/17 Patient's mother called and stated patient has a below 100 degree temp x 3 days following vaccines given on 6/21/17. After that, for the last 10 days has had body rash, it started itching on 7/5/17.
A serious, spontaneous report of seizure, influenza, wheezing and fever was received from a physician concerning a 27-month-old female subsequent to FLUMIST. The CDC isolated a virus from the child that was confirmed as FLUMIST vaccine type B strain. The patient's past medical history includes abnormal development with a developmental level of a six-month-old and seizure disorder with history of febrile seizures. Concomitant medications included ranitidine. The patient received FLUMIST on 30-Oct-2008 for influenza vaccination. Family members received trivalent influenza vaccination. On 2-Nov-2008 the patient experienced fever, wheezing and seizure and was hospitalized. The patient was diagnosed with influenza. A head CT scan was normal and the white blood cell count was 11.2. It is unknown if the seizure event was febrile in nature. On 7-Nov-2008 the patient was discharged and the events were considered resolved. Additional information was received on 19-Mar-2009 and incorporated into the narrative: changed event term from sick to seizure. Added terms of influenza, wheezing and fever. Added medical history and con meds. Required follow-ups have been performed. Physician did not wish to divulge any additional information.
extreme fatigue for 3 days with doses 1, 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-535874 (moderna).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733) at the age of 59 years, in arm and on 23Apr2021 as dose 2, single (Lot number: EW0172), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered" (2021), described as "extreme fatigue for 3 days with doses 1, 2".  Additional information: Patient received Dose 3 (Moderna, Lot/Batch #: Moderna 052E21A) on 29Oct2021, Route and body site: Arm. Patient received Dose 4 (Moderna, Lot/Batch #: Moderna 025L218) on 30Mar2022, Route and body site: Arm, Dose/volume: 25ml. Patient had not been diagnosed with/tested positive for Covid-19. Patient did not had acute illness at the time of vaccination and up to one month before. Patient did not had chronic or long-standing health conditions. With previous Covid-19 vaccines, never felt Sick-Patient just had extreme fatigue for 3 days with doses 1, 2 and 3.
1 wk after vaccine administration (7/18) patient developed shingles. Seen in clinic 8/5, treated with acyclovir.
ON THE ABOVE DATE AND TIME, THE ABOVE NAMED GUEST (MINOR) HAD A REACTION TO A PFIZER-PEDI 2ND DOSE 0.2ML I/M LEFT ARM AT 15:10PM.  WITHIN MINUTES, GUEST COMPLAINED OF A MILD HEADACHE RADIATING TO HIS JAW.  GUEST'S VITALS WERE TAKEN, ALL NORMAL RANGE.  AN AMBULANCE ARRIVED ON-SCENE FROM A PREVIOUS CALL.  GUEST WAS PLACED ON THE STRETCHER AND BROUGHT OUT TO AN AWAITING AMBULANCE.  PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL.  NO FURTHER ACTION WAS TAKEN.
Felt like she couldn't walk/get out of bed on evening of 9-28-18, spiked a 102 F fever the next day with chills.
MOC reported on 22SEP97 that on 4SEP97 approx 2-3PM pt had a t105.2 R;pt given motrin & MD called;pt seen by MD pt to recv DT next vax;
A week or two after I got the first vaccine, I developed an itch that turned into a rash with big reddish bumps on my arms and legs.  When I went back for the second shot I was told that could happen and I could still get the second shot.  I could sometimes control the rash during the day, but it would come back overnight.  I tried Benadryl cream, Benadryl pills and cortisone cream with limited results.  Ibuprofen sometimes helps.  It's been a month and a half and while the rash is much better, it's not gone yet and and tends to flare up sometimes.  Sometimes the rash is more like goosebumps and it tingles when in contact with warm water.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE STABLE ANGINA ACUTE NON ST ELEVATION MI
pt recvd vax & 4 hrs later the pt exp inc BP, h/a, swollen tongue, dry mouth, sl unsteady on feet, pale, clammy, nauseous, felt as if could pass out; treated in ER;
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, fever and feeling bad were recovered/resolved. The reporter considered the influenza-like symptoms, fever and feeling bad to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The vaccine was administered at a pharmacy. The physician stated that, the patient received SHINGRIX and experienced flu like symptoms, fever, and felt pretty lousy for 3 to 4 days. Events started the night of vaccination to next day, unsure of exact timing on onset of adverse event. The patient called the physician to discuss the issue.
Next day fever and swollen red hot bump 4" diameter at shoot location. Lasted 3 days. One week later the start of the following, fever and fatigue constant throughout: Fever and Fatigue Rapid pulse Low oxygen Brain fog Low appetite Weight loss 8 pounds Hives  Shaky Sweats, sweat induced excema in left ear Dry cough Intermittant sore throat Intermittant Diarrhea Intermittent Nausea Headache, one day Muscle ache, neck shoulders wrists for a short period NO runny nose, NO sneezing,  NO shortness of breath, NO chills
Information has been received from the husband of a 33 year old female who on 08-FEB-2008 was inadvertently vaccinated with GARDASIL instead of the influenza virus vaccine (unspecified).  The reporter stated that the patient was in her second trimester of pregnancy.  The patient sought unspecified medical attention.  No additional information was provided.
I got shingles.  I got a Toradol shot for the pain and was given an antiviral medication, Ibuprofen, and Tylenol 3 with Codeine.
After giving the patient her Boostrix and Shingrix she got a little dizzy.  I sat her down outside the IMZ room and gave her some water. She started to sweat a little and was feeling a little hot. I gave her a cup of water and started to fan her while sitting with her for 15 mins.  She felt better and I told her to call if anything changes.  I checked in with her later in the evening and the next day and she was fine.  She just said her arm was a little sore.
PT RECEIVED BOTH IMMUNIZATION IN SAME ARM ON 11/16/18 PT RETURNED TO PHARMACY ON 11/19/18 AND EXPLAINED ADVERSE REACTION. PT VISITED URGENT CARE AND REPORTED MUSCLE REACTION ON ARM ON WHICH IMMUNIZATION ADMINISTERED. PHARMACIST NOTED REDNESS ON ARM ADMIN SITE.
Raised area of redness to left thigh, at initial visit for reaction, redness localized, no vesicles. On second visit lesions had spread somewhat, no fevers, erythematous papules with crust formation . Dx varicella infection
Cough, runny nose, sore throat, congestion, chills, HA- positive swab for Covid 12/28/20
Vaccine triggered ITP platelet drop: purpura observed in right armpit. This is common for me when platelets drop below 75k. Since the purpura began on a Sunday, I decided to wait until Monday to see my doctor; however, by Monday morning the purpura were gone and no other symptoms presented.
Pt received Moderna Booster at 0948 and went to sit to be observed for 15 mins. While being observed vaccinator noticed patient was rubbing his eyes and shaking his head. When asked how patient was feeling, he stated ?he felt a little light headed.? Vaccinator had patient sit on the ground with back against wall and offered water.  Clinic lead was notified. Patient stated that he worked at night and just got off work and didn?t have a chance to eat dinner or breakfast. When asked what happened, patient said he felt lightheaded, a little dizzy, and hot. Offered chips and took BP at 10:05am; 139/81. Continued to keep patient on ground to be observed. Patient?s affect was polite and pleasant, patient was very talkative. At 10:10am patient stated he wanted to sit on chair, helped patient move to chair and monitored signs of syncope and dizziness. Retook vitals at 10:20am; BP 138/83, HR 80, Temp 97.1F, RR 18. Patient stated that he didn?t feel lightheaded anymore and wanted to leave. Patient appeared stable and was walked to his vehicle by accompanied by a volunteer.
I got the vaccine in the morning and late that evening I started getting hives again on my abdomen, fever of 102.0, body aches, extreme right arm pain (to the point where I could not raise it), localized swelling and heat. The next day body aches and nausea.
L sided H/A, nausea, L arm numbness and tingling, myalgia, injection site discomfort.
Patient presented to the pharmacy 5 days after the immunization was administered. She states that on day post immunization, she noticed redness and swelling  in the arm. When this didn't improve, she went to Convenient Care where she was given topical OTC lidocaine and told the swelling should improve. Two days later, she still hadn't noticed any improvement, so she went to the ER where she was given famotidine and benadryl and was told to contacted her allergist if there was still no improvement
Vomiting yellowish mucus material w/foul odor, t96 ax; leg warm to touch; reports pamper looked red streak this AM; MD felt probable virus;
mouth/tongue numbness; metallic taste; This is a spontaneous report from a contactable consumer (friend). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. On an unspecified date, the patient experienced mouth/tongue numbness, and metallic taste. The outcome of events was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse concerning a 15 year old white female who on 25-APR-2007 was vaccinated IM into the right deltoid with a 0.5 ml first dose of Gardasil (lot# 657621/0387U). On 25-APR-2007 the patient experienced pain at the injection site for three to four weeks after her injection. The patient obtained relief with MOTRIN. The patient has occasional discomfort at the injection site with movement currently. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an adult male patient (age was not reported) who was vaccinated with a 0.5 ml dose of DAPTACEL (lot: C5206AA; expiry date: 05-May-2019) via subcutaneous route in the left forearm instead of ADULT TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and Inappropriate route of vaccination. It was also a case of Inappropriate age at vaccine administration. It was unknown whether patient had adverse event related to vaccination. 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 and Module VI of the 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. List of documents held by sender: none.
Initial unsolicited report received from a Pharmacist on 21 October 2016. This case involves seven patients (gender not reported) who were vaccinated with a second dose of FLUZONE HD (batch number: UI685AB, expiration date: 23 April 2017, dose and site of administration were not reported) intramuscularly on 20 October 2016. Patient Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Any other vaccinations within 4 weeks of vaccinations were reported as unknown. On 21 October 2016, one day following the vaccination, the patients had a site reaction. It was reported that all the reactions were as golf to tennis ball size, red, itchy and non-painful. Relevant diagnostic tests or laboratory data was reported as none. The patients were advised to take OTC medications and apply compresses. Outcome of the events was reported as not recovered. List of documents held by sender: none.
redness & swelling @ site;site was warm & sore;limb was sore to elbow & into shoulder for about 3 days;had very mild flu sx for 1 day;site still shows redness;
Fever Chills Fatigue Headaches Hot flashes Nausea  Dizziness Upset stomach