chrisvoncsefalvay/vaers-outcomes huggingface dataset:
by mistake gave Daptacel to an 11 yr old instead of Adacel, no AE; by mistake gave Daptacel to an 11 yr old instead of Adacel, no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old patient who received 0.5 ml dose of vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot U5798AB and expiry date: 15-Nov-2019) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] via intramuscular route in the arm NOS by mistake on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) for Immunisation.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse 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 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.
This spontaneous report as received from a female patient of unknown age refers to herself. No information regarding the patient's medical history was provided. In January 2013 (reported as about a month ago) the patient was vaccinated with ZOSTAVAX. No concomitant medication was provided. A day after the injection the patient experienced a hive at the injection site, accompanied by redness, itching and swelling. The patient reported that the reaction mostly went away after 10 days, however on date of this report she still had a faint red ring around the injection site. No causality assessment was provided. Additional information is not expected.
Swelling to upper throat and difficulty swallowing. Itching and rash with bumps to chest and back roughly a half hour to hour following FLUBLOK vaccine. Went to ED and was administered a total of 3 shots of Epi, albuterol nebs, Benadryl, solumedrol, Zofran and morphine,famotidine, meloxicam, tramadol, and ondansetron.
7 days after injection felt slight itch like mosquito at injection site, then it swelled and became hot and red but not itchy. 6" diameter. Sore and hot. I applied an anti-inflammatory Chinese herbal patch for 24 hours. Inflammation/heat slowly subsided, gone within 2 or 3 days
Body tingling itchy feeling throat clearing after several hours of administration of vaccine. Went to Sewickley ER 12/22. IV steroid then discharged on prednisone x 4 days
Sore throat; chest discomfort; This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported for a male patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 11Mar2021, as dose 1, single for COVID-19 immunisation at hospital. Medical history included fear of exposure to COVID-19 virus. Concomitant medications were not reported. On an unspecified date in Mar2021, since first dose, the patient experienced sore throat and chest discomfort for a week. Events took place after use of suspect vaccine product. The clinical outcome of both the events was resolved on unspecified dates in Mar2021.   No follow-up attempts were possible; information about lot/batch number cannot be obtained.
2/21/21 had  slight chest pressure radiating to shoulder blades. Rested for half hour. Didn?t go away. Went to Hospital. Normal ekg. Normal bp. E.R. Determined elevated Troponin level of  .10, admitted inpatient for observation, Troponin level went up to 6.3 within hours and 10.9 a day later.  Was given heparin iv drip. Cardiac cath  w dye done. No blockages found.  Several more normal ekg?s done. Normal echocardiogram.  Level of heart damage unknown because cardiac mri was not available for use (fully booked). Discharged home.
On 10/26/2009 developed malaise, body aches. On 10/27/09 developed fever.  On 10/28/09 developed bil hand weekness, which progressively worsened, as well as paresthesias in feet.  Developed a soft stool several times a day for the next 1.5 days.  Patient went to Hospital on 10/29/09 where he was treated with IVF.  Symptoms worsened for 1 day, then started improving spontaneously.  Patient was not treated with IVIG.  Patient was diagnosed with acute polyneuropathy, possible Guillian Barre syndrome.  12/8/2009 DC summary for date of discharge 11/2/2009. FINAL DX: malaise, fatigue, disorder of iron metabolism, musculoskeletal symptoms. Patiient with c/o's malaise/fatigue post vaccine, tx IVF, bedrest neuro consult.
rhabdomyolysis; Swollen face; high fever; vomit; This is a spontaneous report from a contactable consumer (patient's parent). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 24Oct2021 16:00 PM (Batch/Lot Number: FF2590) (at the age of 12-years-old) as dose 2, single for COVID-19 immunization. Facility type vaccine was pharmacy or drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. Medical history included allergy (relevant past drug history: Name of Drug as Reported: None, Reaction: Allergy). There were no concomitant medications. The patient had no other medications in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in the left arm on 03Oct2021 16:00 PM (Batch/Lot Number: FF8841) (at the age of 12-years-old) for COVID-19 immunization. The reporter stated that on 25Oct2021 at 08:00 AM, the patient experienced severe reaction: Swollen face, high fever, vomit, rhabdomyolysis. The events resulted in emergency room/department or urgent care. The events were reported as non-serious. The patient was tested for COVID post vaccination which was a nasal swab on 25Oct2021, and result is pending. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
Chills, extreme joint and muscle pain, fever of 101, dizziness, headache, listless, 6;x3: raised knot at injection site, severe itching at injection site.
I cleaned patient's left deltoid with alcohol wipe and administered 0.5 mL of monkey pox vaccine intramuscular. Patient tolerated vaccine with not reaction.
I woke up with vertigo- I was unable tp sit up or get out of bed due to extreme dizziness and disorientation for 90 minutes
Because I was traveling from another country, I had to prove that I was negative for COVID, I found out that I was positive and went to the hospital - saw a Dr. and I was quarantined. I went back to my home when I tested negative. Waiting to see my personal Dr right now .
Information has been received from a healthcare professional referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates since 30-MAR-2016, the patients were vaccinated with improperly stored doses of MMR II (lot # L027591, expiration date: 23-JUL-2017, dose and route were unknown (50 Fahrenheit (F) for 45 minutes and 32F for 72 hours). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter didn't like to be contacted.
Vaccine was mixed with 1.6 mL instead of 1.8 mL 0.9% sodium chloride. Vaccine was more concentrated because incorrect diluent amount was used.
Information has been received from a registered pharmacist concerning an adult patient (age and gender unknown) who was "recently" vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23.  Subsequently the patient developed injection site redness, swelling and local heat.  The patient sought unspecified medical attention.  At the time of this report, the patient was recovering.  Additional information has been requested.
11 year old was administered Flublok with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under the reference 00812454).  This case involves a 11 years old female patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.   On 13-Oct-2021, the patient received a dose of suspect FLUBLOK QIV (0.5 ml, total, injection, lot QFAA2108 and expiration date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration (same day latency).  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 received COVID vaccination with his employer in March 2021.  Patient was reported to be vaccine-hesitant and his vaccine records were inconsistent.  Nonetheless, his unit confirmed Janssen vaccine info provided on this report.  Patient became ill with respiratory symptoms on/about 20 Nov2021, tested positive for COVID on 26 Nov 2021, and was admitted to hospital on 30 Nov 2021 for COVID pneumonia.    ID consultant dxd 'severe COVID pneumonia' based on imaging and hypoxia.  Treated with dexamethasone, remdesivir, and baricitinib.  Required facemask O@ support but not intubated.  Remained stable in hospital as of the time of this report (06 Dec 2021).
rash on arm of baseball size; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm of baseball size) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (rash on arm of baseball size). At the time of the report, RASH (rash on arm of baseball size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication and treatment information was provided.
This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 16-year-old male patient who received BEXSERO (batch number 169701, expiry date unknown). On 13th September 2017, the patient received the 1st dose of BEXSERO (intramuscular). In September 2017, less than a week after receiving BEXSERO, the patient experienced cellulitis (serious criteria disability, GSK medically significant and other: as per reporter) and fever (serious criteria disability and other: as per reporter). The patient was treated with KEFLEX. On an unknown date, the outcome of the cellulitis and fever were recovered/resolved. The reporter considered the cellulitis and fever to be almost certainly related to BEXSERO. Additional details were reported as follows: The patient received 1st dose of BEXSERO on unknown deltoid and experienced a fever of 102 degree F and cellulitis. The cellulitis was in the arm that received the BEXSERO injection. It was unknown if he received any other vaccines in his other arm. On 15th September 2017, the patient returned to the office with these symptoms. The patient's parents were instructed to call the office if the symptoms did not resolve. The office had not heard back and assumed the symptoms had resolved. The reporter believed that was disabling and jeopardized the patient because he had to seek medical treatment and was prescribed KEFLEX. The patient visited emergency room. This case was 1 of the 3 cases, reporter by the same reporter.
ITCHY; FACE SWOLLEN; RASH ON ARMS, CHEST AND LEGS - LITTLE DOTS; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rash on arms, chest and legs - little dots. On 18-MAR-2021, the subject experienced face swollen. Treatment medications included: diphenhydramine hydrochloride. On 19-MAR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash on arms, chest and legs - little dots, and face swollen, and the outcome of itchy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Extreme fatique and  weakness, slight confusion, cough, severely decreased appetite, constipation lasting more than 2 weeks.
developed joint and body aches and pains, generalized complaints of not feeling well and weakness.  She fell as a result of weakness.  Physician ordered her to be sent to the ER
Pt came to office 3/28/03 w/ what looked like blisters (2) underneath vaccine site. Slight swelling no pain or fever. (Left arm) Dr prescribed Benadryl and Prelone cream Rtn 3/31/03.
hives all over body (mentioned back, under breasts and arms); Red itchy burning patches on her body; acid reflux; headache; breast pain; no appetite; Red itchy burning patches on her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, BREAST PAIN, DECREASED APPETITE, ERYTHEMA, and PRURITUS in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 03A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced BREAST PAIN, DECREASED APPETITE, ERYTHEMA, GASTROOESOPHAGEAL REFLUX DISEASE, and HEADACHE. On an unknown date, the patient experienced URTICARIA and PRURITUS. The patient was treated with TYLENOL at a dose of 1 dosage form BENADRYL at a dose of 1 dosage form. At the time of the report, URTICARIA, BREAST PAIN, DECREASED APPETITE, ERYTHEMA, PRURITUS, GASTROOESOPHAGEAL REFLUX DISEASE, and HEADACHE had resolved.            Treatment was taken along with concomitant medication by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: outcome of the event has been updated.
No adverse event; Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out; They repeated the bivalent booster on him; This spontaneous case was reported by a patient and describes the occurrence of DEVICE CONNECTION ISSUE (Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out), EXTRA DOSE ADMINISTERED (They repeated the bivalent booster on him) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced DEVICE CONNECTION ISSUE (Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out) and EXTRA DOSE ADMINISTERED (They repeated the bivalent booster on him). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine leaked out of the syringe where the needle was attached while being vaccinated.A lot of liquid came out), EXTRA DOSE ADMINISTERED (They repeated the bivalent booster on him) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication were reported.  It was reported that patient took first dose of Moderna on unknown date, Lot number and Expiry date were also unknown.Second shot was given on unknown date, Lot number and Expiry date were also unknown.First Original Booster dose was given on 27-NOV-2021 Lot number and Expiry date were unknown.  It was reported that the person administering the vaccine asked the Pharmacy manager. They repeated the bivalent booster on him.  No treatment medication were reported.   Reporter did not allow further contact
Plaque psoriasis; This case was reported by a pharmacist via call center representative and described the occurrence of psoriatic plaque in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced psoriatic plaque. The patient was treated with ixekizumab (Taltz). On an unknown date, the outcome of the psoriatic plaque was unknown.   It was unknown if the reporter considered the psoriatic plaque to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist reported that the patient received their first dose of Shingrix a few months ago and in the meantime, has started Taltz for plaque psoriasis. This patient was new to the caller, but she assumed the patient had plaque psoriasis prior to receiving the first dose of Shingrix. The reporter has no other information. No further information captured.
severe headache; dizziness; nausea; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration (left arm) on 16Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) on 26Dec2020 for Covid-19 immunization. The patient's medical history included sleep apnea and increased blood pressure (managed); no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, dizziness, nausea on 16Jan2021. There was no treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination
This spontaneous report as received from a registered nurse refers to an 8 week old patient. On 31-OCT-2013, the patient was inadvertently vaccinated wiht HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJ)) (dosages and routes of administration not provided) tha thad been improperly stored. No adverse effects were reported. Nurse informed incorrectly stored vaccine had been disposed of and she did not have lot numbers or expiration dates. She confirmed that no patient had been vaccinated with GARDASIL. This case is linked to 1311USA000343 and 1311USA011720 due to same reporter link. Additional information is not expected.
patient blood sugar read 44 at 2:oopm patient took 4 to 5 glucose tablets
Pt. was given Hep B (adult) for Hep B (ped/adol).
Initial report received from a health care professional on 12 Jan 2010: This patient was received FLUVIRIN (batch no. 104043P1, exp date: 30 Apr 2010) on 12 Jan 2010. He was received the FLUVIRIN under the age of 4. The patient did not have a adverse event. The outcome of the event off label use was not reported.
Narrative:  Patient reported mild nausea that started 24 hours after second dose of Moderna vaccine. Within 24 hours of the start, symptoms resolved.
Swelling at injection site - firm at the size of a baseball. Pain, welts, and low grade fever. Approximately 6-8 hours after injection. Prednisone 40 mg x 5d q 6 and Ranitidine 150mg BID, Benadryl 25-50 mg q 6, Hydromorphine 2mg PRN prescribed by ER doctor.
About 6hrs after receiving the vaccine, I had to leave work due to the side effects of having extreme chills & being hott at the same time buy mostly chills, headaches, body aches all over, no energy, became dehydrated, no fever,
Wheeze, soreness, some neck rash post flu vaccine today--took some Benadryl and feeling better.
pt recvd vax; subsequently, it was learned that a vial of vax was mixed w/ diluent & then mixed was added to another vial of HIBV vax,then injected to pt;at time of report no problems noted;
This spontaneous report was received from the Vaccine Coordinator referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Fever of 102 degrees, diarrhea, not eating, vomiting, rash all over body, fussy, crying, won't sleep, can't put the baby down or he cries. Fever gone after five days, eating better but still fussy, not sleeping good and rashy.
I started with sinus issues and a cough. I took a COVID-19 test which was negative. However, the symptoms worsened. I took a COVID-19 test on that Monday and it was positive. I came home and did water Tylenol and Gatorade. It took about 10 days to feel better. I did have a lot of joint pain but no fever.
Patient had chest pain; chest xray showed infiltrate. He was given Zithromax for URI.Two days later he presented to ER with complaint of chest pain and hemoptysis. He had an elevated Troponin level and EKG changes (ST elevation). He was transferred to another treatment facility. His echocardiogram showed normal ejection fraction and no wall abnormalities. A follow up report received 6/27/2003 adds: Pneumnoia, myocarditis, hemoptysis, cough.