chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Pentacel vaccine was to be administered, but the nurse did not reconstitute the HIB portion of the vaccine, The child received only the DTaP/ IPV portion of the vaccine with no adverse events; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who experienced pentacel vaccine was to be administered, but the nurse did not reconstitute the hib portion of the vaccine, the child received only the dtap/ ipv portion of the vaccine with no adverse events while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR),  HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 18-Oct-2022, the patient received 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6970BA and expiry 31-Jan-2023, strength- standard) (formulation: unknown) was to be administered, but the nurse did not reconstitute the hib portion of the vaccine (product preparation error), the child received only the dtap/ ipv portion of the vaccine (single component of a two-component product administered) with no adverse events (latency same day) via intramuscular route in vastus lateralis site for prophylaxis vaccination.  It was reported that "Treatment- separate ActHIB (lot-UJ659AA) will be administered".   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: unknown, for both events   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.
Herpes zoster symptoms began 14 days after receiving the first vaccine with Radiating pain from my back on the left side to the front of my left torso.   I could not lie comfortably on my left side.  On day 19, a rash developed under my left breast. On the night of day 20, the rash had gotten worse and shingles was speculated.  My dermatologist confirmed it was herpes zoster on the morning of day 21.  I had a rash from my left front torso along a wide line to my back.  I got on valacyclovir on day 21 and will be on it for 10 days.
Approximately 2 hours after shot, my tongue started ?tingling?.   Then my throat and tongue swelled up to where it was difficult to swallow.    Immediately took 50 mg of Benadryl and sought treatment.   Was prescribed 5 days of prednisone (50 mg
no adverse event; administration of an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 2 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUN-2021, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1684157, expiring on 26-JUN-2021, 2 milliliter, oral, for prophylaxis.  The administered dose of the vaccine experienced a temperature excursion of 8.6 degrees Celsius for 4hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Headache back of neck, twmples and eyebrows, really sore injection site. Fatigue, Malase, nausea off and on, decreased appetite. Feeling dehydrated, chills/ at times painful sensitive skin similar to the flu. Muscle aches throughout the body.
Two to three days post injection noticed 2 larger red, raised, itchy areas along with 2 smaller areas of the same description.
stomach upset about 4-5hr p/vax;next morning rash all over body that afternoon knees started hurting progress to ankles, elbow shoulder & wrists & wrists by next AM;back huring also;swelling in fingers, hands, feet & ankes 36-48hr p/vax;
A few hours after my vaccination, i began having a headache, pain at injection site and body aches/sinus issues/sore throat that evening. The next morning, I had left underarm pain/lymph area that was painful for 3 days. I continued with the flu symptoms for approximately 2 days along with night sweats. I had a telehealth visit with my pcp physicians assistants about my lymph area pain and they told me to just take aspirin and call them back if it got worse. I began feeling better after 7 days.
Case number PHEH2015US000668 is an initial spontaneous report from a pharmacist received o 05 Jan 2015. This report refers to a 50-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen instead thought it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Chills; sweating; headache; body aches; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3248; expiry date: unknown) via an unspecified route of administration, in the right arm, on 02Feb2021 at 06:45, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248) on an unspecified date at 13:30, in the right arm. for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 02Feb2021, at 22:00, the patient experienced chills, sweating, headache and body aches. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
At 9pm I took my dog for a walk and upon return home at 9:20 I had a mild anaphylactic episode with hives and some mouth/throat swelling. I took Benadryl and went to bed. I have not had any idiopathic anaphylactic episodes for 2 years.
Vaccine given with sterile technique. About 1 min post-injection, pt attempted to stand up from chair, pt not coherent. Ran to patient who made a jerking motion, then after a few sec - was able to respond, but not making sense. Very pale. Co-worker came into room. We assisted patient to the bed and placed in supine position. Pt stated "I can't see, are my eyes open." Within 30 sec, pt was answering appropriately, vision returned. Vitals taken and normal. Complete return to condition prior to incident. Total time of black-out, loss of vision about 1.5 min. Monitored for 45 min post-reaction. Notified mother. Notified FNP. Mother picked up patient. Made f/u care call 1.5 hrs later, patient doing well, just "tired".
The Moderna booster was administered more than 12 hours after the vial was first punctured. The vial was opened on 11/23 at approx. 1530. There has been no adverse reaction that the patient has reported.
Fever, heart pain or chest pain, shortness of breath, dizziness in hives on my arm in severe soreness in my arm for months all away until now and I had to go to the medical department for an EKG it showed abnormal on my results in damage to my heart.
pt recvd vax; prolonged crying w/ large area of erythema (palm sized); ice pack to size;given dph po;instructed to go to er if problems develop;
Progressive symptoms of URI, runny nose, cough, lethargy, irritability, mom called on day #12 of illness reporting acute worsening over past 2 days.
Janssen on 4/6. Positive on 9/9 admitted9/9 to current
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Oct2023 to 17Oct2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336307 Same patient, different product, different dose/event;
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-SEP-2020, 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) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
10 minutes or so after injection, I had a strange sensation, became extremely shaky, sweaty and had tachycardia (152). Never became dizzy. No respiratory issues. Self resolved in a matter of minutes.
Patient was given pediatric dose instead of adult dose. Waited in room 20 plus minutes with no reaction.
I have developed PMR. Polymyalgia Rheumatica. It took me over a year to realize that was what was actually developing. It took a long time to come on full. I can't exercise and it caused inflammation throughout my body. I even was losing my voice because of it.
This spontaneous report as received from a medical assistant (also an office manager) refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L048237, expiry date 15-MAY-2017; dose and route were not reported). These doses were exposed to 56 F for 798 hours and 33 F for 273 hours. There were no previous excursions. Data logger was not involved. No adverse effects were reported This is one of the two reports received from the same reporter. Additional information has been requested.
Parent called office on 3/2/00 to report child was ill with an elevated, red pruritic rash all over his body and had a fever beginning on 3/1/00. Treatment consisted of Tylenol, Benadryl and baking soda baths as needed.
Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot# unknown). On the same day as the vaccination the patient developed dizziness, shortly after her vaccination with GARDASIL vaccine (yeast). Medical attention was sought at the office. The symptoms resolved later on the same day. No other symptoms were noted. No other information was available. Additional information has been requested.
Information has been received from a health professional concerning a 23 year old female with no known drug allergies who on 09/08/1999 was vaccinated with a second dose of varicella virus vaccine live. The first dose was given on 08/02/1996. On 01/21/2002 the pt had a titer done and it did not show seroconversion. Unspecified medical attention was sought. Additional info has been requested.
Transient delirium and numbness of lower extremities, patient neg  CT of head, neg MRA and MRI and neg LP and neg drug screen.
complained of burning pain from side of face down to elbow on arm where shot recieved.  symptoms noted day after receiving shot
patient received flu shot and boostrix vaccines. He came back to office about 30 minutes after leaving. His lips were swelling up and his tongue was swelling up. He was having some difficulty breathing.
Cold symptoms started 3/30/11 and increased to difficulty breathing with diagnosis of croup. Hospitalized 1 day for medical treatment then released 3/31/11 improved.
Site of injection is swollen and presents abscess, no treatment necessary at this point. Patient will follow up if condition is not getting better.
Dec. 29: she developed arm soreness and joint pain.   Dec. 30: she developed pain in chest area radiating towards the back Jan. 01: she noticed a rash in the mid abdomen radiating towards the back.  She has been experiencing pain in the affected area.
Second dose: light headed; Second dose: tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 09:30 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "COPD", start date: 2007 (ongoing), notes: Verbatim: COPD. Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (dose 1 single, Lot: EN6203, Expiration: Jun2021, Route of administration: Left arm , Time the Vaccination Was Given: Noon), administration date: 26Feb2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: light headed"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Second dose: tired".  Additional information included: The report was related to a study or programme. Patient was diagnosed with high blood pressure 10 years ago and started taking Losartan 10 years ago. Investigation Assessment: No. When the caller received the second dose Pfizer Covid Vaccine the caller was light headed and tired for about one or two days. Time the Vaccination Was Given as second dose: in morning about 09:00 09:30. Family Medical History Relevant to AE(s): No. Relevant Tests: none.   No follow-up attempts are possible. No further information is expected.
2/14/22 pt had a positive COVID test; 2/17/22 pt found at home by wife deceased in recliner; EMS contacted; sudden cardiac death; acute COVID 19; brought to ED
Severe bilateral tinnitus, the patient has trouble hearing conversation over the tinnitus and it is impacting her ability to work. has not improved since onset.
From telephone contact received at manufacturer on 01/06/03, it was reported that a 9 month old male received Tripedia (Lot # U0581AA) on 09/16/02.  Within 72 hours after vaccination, the pt developed red spots and hard at the injection site. After 7 - 10 days it developed into a large red spot, size of half dollar (reported by parent, also states she reported to VAERS).  It is unknown if the pt recovered.
Assuming "adverse event" means when I had covid beginning on 1/23/23, my initial symptoms that first day were tiredness.  On Day 2-5, I had a fever that ranged from 101-102 F.  On Day 2, I took ibuprofen.  After Day 5, the fever subsided.  After that, I felt tired for about 3 weeks.  Also, I felt like something in my sinuses right behind my nose--I wasn't congested but my sinuses felt clogged or some sort of odd pressure.  That lasted for about 3 weeks.  Occasionally, during the four week period of recovery, I would feel feverish and achy  but I never had a fever except for the first few days.  I sporadically took Mucinex during the period I wasn't feeling well but I don't think it made a difference.  I did contact my doctor's office on 1/24/23 via their portal and they prescribed rest, fever reducers, cough medicine and mucinex, as needed.
Fever; Joint pain; I couldnt sleep/I cant sleep; Joint muscle pain; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 47-years-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 17:00 (age at the vaccination 47-years-old) (Batch/Lot Number: EW0186) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient had not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in leg Right (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation and patient could not sleep. On 21May2021, after few minutes of the vaccine she had some dizziness on the (Facility) Center. On 22May2021 at 01:00, patient experienced fever, joint pain, joint muscle pain and couldn't sleep. It was reported that patient took Tylenol. Adverse event result doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of fever, joint pain, joint muscle pain and dizziness. At the time of this report, the outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt. had MMR and chicken pox vaccine given on 5/24/2007. One week after administration of vaccine onset fever occurred and possible febrile seizure. Pt. was limp and motionless for almost 1/2 hour also      dazed. Took pt. to ER and was given tylenol supp. for fever which was at 102 degrees. Then blood work, chest xray and antibiotic (Rocephin Inj) was given. MD's conclusion was a possible febrile seizure and acute otitis media. Pt. had a follow up appt. with regular physician and still had continous fever for 24 hrs. MD could not detect anything wrong, urine sample was OK and pt. responding fine. Pt. had up and down fever until 6/5/07. Had another follow up with regular physician on 6/4/07 and still had no findings of why high fever occured until I brought up the fact that pt. had a vaccine given 1 week prior. So MD ruled a possibility of reaction to vaccine.  Pt. then broke out in upper chest rash to face and fever went away(POSSIBLE ROSEOLA).
WAS ADMINISTERED THE VACCINE ON 10/20/04, WAS A LIITLE SORE ON THE FIRST DAY, THE NEXT DAY ON THE 21ST WAS A LITTLE MORE SORE ON SITE(RIGHT FOREARM). THAT SAME EVENING LATE STARTED FEELING SICK WITH SYMPTOMS OF HEADACHE, TIREDNESS, NAUSEA.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: patient described what feels like heartburn but also chest tightness that started day of vaccination and has continued daily, suggested provider follow up and patient has not called back to report visit resuts.
3/20/2021 Right knee hurt, could not walk on it, could not straighten it.  Put a brace on it, went on crutches.  3/23/2021 went on 5 drops of CBD oil 250mg Full-spectrum.  3/31/3021 took 4 Prednisone 10mg, 4/1/21  took 3 Prednizone, 4/2/21 took 2 Prednizone, 4/3/21 took 2 Pred., 4/4/21 took 1 Prdnizone.  Right knee doing better, Left knee won't support me.
administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that 173 doses were administered on 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022 from batch 070H21A. No information was reported on date of the storage of vaccine in refrigerator.Vaccine was expired on 07-APR-2022. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Follow up received patient and reporter added and narrative updated. On 08-Jun-2022: Follow-up received contains non significant information.
A rash broke out all over my body and has been flaring up for the past 2 months. Have taken oral steroids and using topical steroid creams. Finally had a skin biopsy preformed and the results came back as Spongiotic Dermatitis.
Patient came into pharmacy Saturday morning of 10/08/16. She had received FLUZONE HD on 10/02/16 in the upper right deltoid area as per VAR. Patient stated her arm was swollen, red and painful after getting vaccination. Patient called pharmacy during weekday with concern that her arm was still hurting. Patient was advised to take ADVIL to help relieve the pain and contact her doctor. Patient did NOT take ADVIL or call her doctor. On 10/08/16 patient came into pharmacy complaining of pain in her right upper arm.