chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three teenagers / received an adult dose / instead of a Pediatric dose; Three teenagers / received an adult dose / instead of a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2021, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an adult dose of Havrix instead of a Pediatric dose, which led to overdose and adult product administered to child. The reporter consented to follow up. This is 1 of the 3 cases reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021130436:Same reporter. Patient #1 of 3. US-GLAXOSMITHKLINE-US2021130437:Same reporter. Patient #2 of 3.
After receiving her COVID -19 vaccine, the patient became lightheaded and sweaty. We had her lie down, elevate her feet, and EMS that was onsite took her to the ambulance for vitals and monitoring.
Information has been received from a physician concerning a 60 yr old male who on 08Dec04 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647657/0947N). The pt reported that he had pneumococcal vaccine (unspecified) about ten years ago. On 09Dec04 the pt c/o swelling, redness, and pain at the injection site. The physician reported that the pt had a history of reacting to most vaccines or medicines he has tried. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
LOCALIZED SKIN ERYTHEMA, AND HIVES ON LEFT UPPER ARM OVER DELTOID EXTENDING TO ALMOST CLAVICULAR LINE AND AXILA AREA.  ONSET V+7 (ONE WEEK POST TYPHOID VACCINATION)
20APR98 fatigued, gen malaise;rash throughout entire body;rt knee sore;22PAR98 rt knee swollen (jeans did not fit);lt knee sl swollen;rt shoulder, wrist fingers, swollen to extent that diff to use;T100.6;23APR98 lt fingers swollen;
This spontaneous report was received from a physician concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of VARIVAX as prophylaxis (Strength, dose, route, lot # and expiration date were not reported) and a dose of sterile diluent (manufacturer unknown) (Strength, dose, indication, route, lot # and expiration date were not reported) instead of a dose of ZOSTAVAX. The physician stated that it was not in his office practice site. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA002147:
pt was fussy, big burp, then became very pale & quiet for 20 mins, falling asleep; looked gray & was cold;
it was rpt fr MD concerning a pt who was vax approx 2wks following pt devel a mild varicella-like rash w/10-12 lesions on trunk & neck
Fast heart rate of 117BPM; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate of 117BPM), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included Blood Pressure Medications, FISH OIL and MULTI VITAMINS & MINERALS for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heart rate of 117BPM), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Fast heart rate of 117BPM), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a medical assistant concerning a 6 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658004/0729U). Subsequently the patient experienced an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This is one of several from the same source. Additional information is not expected.
Severe muscle pain from rhabdomyolysis. The muscle pain began on 9/15/21, the evening of the vaccination. Presented to the ER on 9/18/21, treatment was initiated and he was transferred to an ICU bed at Hospital for ongoing management.
Lack of appetite; rash at injection site that was warm and burning; rash at injection site that was warm and burning; rash at injection site that was warm and burning; Joint pain; extremely fatigued; body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), VACCINATION SITE WARMTH (rash at injection site that was warm and burning), DECREASED APPETITE (Lack of appetite), FATIGUE (extremely fatigued) and VACCINATION SITE PAIN (rash at injection site that was warm and burning) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 01-Apr-2021, the patient experienced PAIN (body aches) and CHILLS (Chills). On 02-Apr-2021, the patient experienced FATIGUE (extremely fatigued) and ARTHRALGIA (Joint pain). On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (rash at injection site that was warm and burning), VACCINATION SITE PAIN (rash at injection site that was warm and burning) and VACCINATION SITE RASH (rash at injection site that was warm and burning). On an unknown date, the patient experienced DECREASED APPETITE (Lack of appetite). On 02-Apr-2021, CHILLS (Chills) had resolved. On 03-Apr-2021, PAIN (body aches) had resolved. On 04-Apr-2021, VACCINATION SITE RASH (rash at injection site that was warm and burning) had resolved. On 16-Apr-2021, FATIGUE (extremely fatigued) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (rash at injection site that was warm and burning) and VACCINATION SITE PAIN (rash at injection site that was warm and burning) outcome was unknown.            Concomitant medication was not provided  Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: ADR received, AE updates, additional AE.
Severe headache high fever internal aches and pains joints ache chills soreness to the touch lasted approximately three days
Burning in hands; Painful hands; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "unknown", described as "Burning in hands"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Painful hands". 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-2021563277 Same reporter/drug/event, different patient.
(2) episodes of racing heart beat 110 and 139 with High Blood Pressure; (2) episodes of racing heart beat 110 and 139 with High Blood Pressure; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration, administered in right arm on 10Apr2021 12:00 (Lot Number: EW0161) as SINGLE DOSE  (at the age of 57 years old) for covid-19 immunisation.  Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Prior to COVID Vaccine on 07Apr2021 he entered in AFib and needed to be Cardioverted. The patient did not have any known allergies. The patient's concomitant medications was none.  The patient did receive any other vaccine within 4 weeks prior to the vaccine. The patient received the BNT162B2 vaccine at Public Health Clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient called his primary care physician and asked should he take the shot scheduled for 10Apr2021 and she told him he was ok to take the shot. On 16Apr2021 22:00 and 18Apr2021 he had (2) episodes of racing heart beat 110 and 139 with high blood pressure. On unknown date, he was admitted to the hospital on the second and had a Cardiac CT Scan and Echocardiogram both came back negative for coronary heart disease or any heart issues. He was on a patch for 2 week electrical study. On beta blockers and antianxiety. He had no prior heart or anxiety issues ever in his life. The events resulted in Emergency room/department or urgent care, and Hospitalization. Number of days of hospitalization was 1. The patient underwent lab tests and procedures which included blood pressure: high on 16Apr2021, Cardiac CT Scan: negative on unknown date, echocardiogram: negative on unknown date, heart beat: 110 on 16Apr2021, heart beat: 139   on 18Apr2021 , Covid test: Negative on 01Feb2021. Outcome of the events was not recovered.
Received FluMist 10/27/2004. Developed fever 103F for two days and missed two days of school. No other signs or symptoms of respiratory infection. Medical Records received on 1/3/2005 states pt experienced headache, rhinitis, and viral syndrome. Headache, runny nose, chills. Dr states not disabled. Treated symptomaticly for viral illness.
administered 2nd booster dose to a 48 year old; non immunocompromised patient; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (administered 2nd booster dose to a 48 year old; non immunocompromised patient) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065A21A, 071F21A, 045B21A and 093A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXTRA DOSE ADMINISTERED (administered 2nd booster dose to a 48 year old; non immunocompromised patient). At the time of the report, EXTRA DOSE ADMINISTERED (administered 2nd booster dose to a 48 year old; non immunocompromised patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was not immunocompromised and received 1st booster dose on 10Nov2021and 2nd booster dose on 08Apr2022. No concomitant details were reported. No treatment information was provided.   This case was linked to MOD-2022-536386 (Patient Link).
4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6.  Slight headache and nausea.  No energy at all. Took doses of ibuprofen throughout day.  4/11 - Continued with alternating sweats/chills. Continued taking ibuprofen and generally able to function.  4/12 - Morning of 4/12 similar to 4/11.
This is a spontaneous report by a contactable Pfizer internal colleague. This female Pfizer internal colleague reported on behalf of her 12-year old niece of an unspecified ethnicity who received PREVNAR via an unspecified route of administration on an unknown date. The patient's medical history and concomitant medications were unknown. It was unknown if other vaccines were given on the same day. Vaccines taken within the last four weeks were unknown. On an unknown date the patient developed bacterial meningitis. It was unknown if the patient had any siblings. Relevant lab data was unknown. The clinical outcome of the bacterial meningitis was unknown. Follow-up (20Jun2013) Follow-up attempts completed. No further information expected.
TOOK FOUR DOSES OF EXPIRED VIVOTIF; This spontaneous case report (PVX2019-1676, PTC-000067) was received from a pharmacist on 27-Jun-2019. It describes a female consumer who "took four doses of expired Vivotif" (expired product administered), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took all the expired doses of Vivotif, two weeks ago. The doses were expired in April.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took four doses of expired Vivotif" was considered as not applicable.
pt recvd vax & immed p/dose 2 pt fainted; No treatment was given sx resolved; reporter indicated the event was probably unrelated to Engerix-B as the pat was emotionally upset about receiving inject;
I had a sore arm the first couple of days, on the 22nd I had  chills sore throat headache congestion sneezing sniffling and low grade fever 99.6. on the 23rd loose stools  nasal drainage, I called the hospital hotline and I had to be off for ten days and went to Urgent care and took a rapid test and the test was positive. I have been quarantined for 14 days . The 25th was probably the worst day the 26th was a little better. the 27th symptoms were more mild and I also had diarrhea The 28th I woke up with a headache and light sniffles and the 27th I had no symptoms
This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 22-OCT-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
"staff member experienced hives and rash over 50% of body 30 hours post second dose of Pfizer vaccine   Sought medical treatment and was prescribed dose of steroids."
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022).    No concomitant product use was reported. Patient received half dose. The number of doses/vials administered were 35 vials On 04-Jun-2022 the vials were initially stored in the refrigerator.The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022 Vial did not undergone any temperature excursions. No treatment information was provided.
5 hours after vaccine was vomiting the next day at 12 I started having  shortness of breath which lasted the rest of the day even using my inhaler it did not help
vaccine was administered to a patient post excursion with no reported adverse event; ADACEL was giving after experiencing several temperature (over 72 hours) excursions with 54° FAHRENHEIT with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Infant of unknown gender who was administered vaccine post excursion with no reported adverse event and  adacel was giving after experiencing several temperature (over 72 hours) excursions with 54° fahrenheit with no reported adverse event ,while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported  at  a dose of 0.5ml via intramuscular route at an unknown administration site for immunization.  On 04-Jul-2022, the reporter stated that adacel was giving after experiencing several temperature (over 72 hours) excursions with 54° fahrenheit with no reported adverse event (product temperature excursion issue).  On an unknown date, the patient developed a non-serious event of vaccine was administered post excursion with no reported adverse event  (poor quality product administered) ( latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   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.
pt recv vax 28JAN98 & was seen on 3FEB97 for onset of sz activity, that mom felt could have started on 1FEB98;EEG showed persistent/recurrent spike slow wave complexes;
Warm to touch skin around injection site; Hard around injection site; Red around injection site; Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), VACCINATION SITE WARMTH (Warm to touch skin around injection site), VACCINATION SITE INDURATION (Hard around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness). On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch skin around injection site), VACCINATION SITE INDURATION (Hard around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Left arm soreness), VACCINATION SITE WARMTH (Warm to touch skin around injection site), VACCINATION SITE INDURATION (Hard around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Saturday shot, on Tuesday my ears started feeling clogged, by late Tuesday they were clogged enough that I felt I had about a 50% loss of hearing and loud ringing in my ears. kept me up late Tuesday, by wednesday morning I my hearing was slowly getting better.  by midmorning it was feeling getting better as far as hearing. Ringing in ears is still very intense in both ears as of time of this report.
Child given "meningitis shot" and 2 hours later developed fever, 24 hours later fever between 100-103 continues, with no appetite, complaint of fatigue and headache. Some relief with Tylenol and Motrin - per mother.
Muscular pain on left arm and ribs muscles while having a deep breath. Very light fever. Took1g of paracetamol every day to help. (Doliprane) Fatigue. Left arm pain started 3/4 hours after injection the rest came the morning after.
Started out feeling faint & dizzy. Muscle pain started at 12:30 PM on the side the vaccine was given (left arm) and then all around my neck and left outer ear. Fatigue set in and I had to lay down and cancel the rest of my day. Advil and Tylenol did not help. Warm shower and heat pack did not help.
Grapefruit sized induration.  Splotchy, warm, red, and tender.
Sometime last evening (around 9.30pm on 12/30) I became aware of a constant ringing in my right ear. Orienting my head in different ways had no effect. Sometimes it's louder than other times. It still persists this morning as I write this.
4 days p/ immun while with grandmother cried & screamed with blank look on face.No eye contact but eyes open,whole back was twitching, legs were stiff,lasted 10-15 min. Recovered 14 days p/ immun.