chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of ADACEL was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Consumer/ Other Non Professional via Global Medical Information (Reference number- SANOFI) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 11 years old female patient who received expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 11-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6518AA, expiry date 05-Nov-21 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired product administered (latency same day).  It was reported "Caller is looking for information on possible adverse effects as well as if they need to revaccinate the patient."  At 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 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 fully vaccinated with moderna vaccine. Last dose administered on 3/15/2021. Patient tested positive for COVID 19 on 12/7/2021. Admitted to Hospital on 12/07/2021. Expired on 01/11/2022 while still admitted to hospital.
Chills; Fever; Body aches; Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer(patient). A 45-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single doe on 16Apr2021 15:00 via an unknown route in left arm for Covid-19 immunization. Medical history included obesity, allergies, eczema and allergy with penicillin.  Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 03:00 PM in left arm for Covid-19 immunization. No other vaccine received in four weeks prior to the COVID vaccine. It was unknown if other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Apr2021 01:00, patient experienced Chills, Fever, Body aches, Sore arm, and Diarrhea. No treatment received. The report was reported as not serious. Outcome of the events was resolved.       Serious: No         On 17Apr2021 : 01:00 AM, patient experienced adverse events of Chills, Fever, Body aches, sore arm, Diarrhea. No treatment received.    Outcome of the events was resolved.    No covid tested post vaccination.       No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistance refers to an unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On 22-SEP-2015, the patients were vaccinated with an expired dose of ZOSTAVAX lot # J014851, expiration date on 24-OCT-2014 (strength, dose, anatomical location and route of administration were not reported). There was not a product quality complaint (PQC) involved. No adverse effect was reported. Additional information has been requested.
No additional information available or provided; Product storage error; This spontaneous report as received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#T027789 with expiration date: 27-FEB-2023, dose: 0.5 ml, route and strength were unknown) underwent multiple temperature excursions and was then administered to a patient for prophylaxis on 30-SEP-2021 (product storage error). No additional information available or provided.  Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced the temperature excursion below 54.1 Fahrenheit degrees (F) for 1 hour and 43 minutes; 47. 8F for 1 hour and 0 minutes; 46. 4F for 1 hour and 54 minutes; 46. 6F for 6 hours and 0 minutes; 40. 0F for 1 hour and 18 minutes; 32. 1F for 1 hour and 6 minutes; 32. 9F for 13 hours and 18 minutes; 33. 8F for 60 hours and 12 minutes. All excursions prior to administration listed above.
10/30/14 at 1655-10/31 at 0600. Full psychotic break with self abuse and aggressive behavior. She was admitted after administration of multiple medications and did not return to baseline for 12 hours.
Pt received 1st dose at HyVee on 2/12/2021.  Pt scheduled herself for 2nd dose without knowing the 28 interval.
Initial report received from Healthcare professional on 24 October 2014. This case is linked to case 2014SA147665 and 2014SA150234. A two patient over 65 year, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Batch number, expiry date, route, site of vaccination and dose number was not reported) on an unspecified date. The diabetic patients with elevated glucose 3 hours post administration on an unspecified date. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects was not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
his heart in enlarged/two weeks later (after shot) hearts getting enlarged; Child was 16 years old; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (his heart in enlarged/two weeks later (after shot) hearts getting enlarged) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was 16 years old) in a 16-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIOMEGALY (his heart in enlarged/two weeks later (after shot) hearts getting enlarged). an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was 16 years old). At the time of the report, CARDIOMEGALY (his heart in enlarged/two weeks later (after shot) hearts getting enlarged) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was 16 years old) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient played football, basketball and baseball. It was reported that two weeks after shot, his heart got enlarged.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow up contains no new information.
It looked like I was about to lose my voice; voice and sound of voice was affected; Running nose; Throat swelling; Burning sensation on the left side of the Body; Left side of the body bigger than the right side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (It looked like I was about to lose my voice; voice and sound of voice was affected), FEELING ABNORMAL (Left side of the body bigger than the right side), BURNING SENSATION (Burning sensation on the left side of the Body), RHINORRHOEA (Running nose) and PHARYNGEAL SWELLING (Throat swelling) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (Left side of the body bigger than the right side). On 01-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation on the left side of the Body). On an unknown date, the patient experienced DYSPHONIA (It looked like I was about to lose my voice; voice and sound of voice was affected), RHINORRHOEA (Running nose) and PHARYNGEAL SWELLING (Throat swelling). At the time of the report, DYSPHONIA (It looked like I was about to lose my voice; voice and sound of voice was affected) and PHARYNGEAL SWELLING (Throat swelling) had not resolved and FEELING ABNORMAL (Left side of the body bigger than the right side), BURNING SENSATION (Burning sensation on the left side of the Body) and RHINORRHOEA (Running nose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported drinking warm tea with honey and lemon that makes the event feel better.  He had X-rays taken and scans done on an unknown date which showed that "lungs are clear." The patient reported the same reactions occurred after both doses of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR was received on 11-MAY-2021 included Anatomical Location of 1st dose and additional event details. On 31-May-2021: Follow-up was received on 21-MAY-2021. It contains no new information.
On January 20, 2022 I had a Cardiac Calcium Score (CT) done, and the results were forwarded to my physician. It showed a "Small Concentric Pericardial Effusion". I was referred to a cardiologist, and have had three echocardiograms done, and also a treadmill stress test. The second echo showed that the effusion had improved, but not resolved. The third echo showed the same amount of fluid as the second. I have had an echocardiogram in the past which did not show an effusion, and have not had any viral illnesses which could have caused this effusion. There has been no treatment done other than to monitor my cardiac function, and a probable echo in one year.
DEMENTIA; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced dementia and now permanently in a nursing home. It was reported that, "I nearly died from COVID. With all the occurrence of variations, I was TOLD to get the vaccines later. I don't EVER want to go through COVID again, so I got the shots. (I'm a vulnerable adult with NUMEROUS health issues and am allowed to live with my boyfriend if I am in safe living conditions and am compliant with doctor orders) I thankfully didn't suffer from side-effects. I was VERY skeptical because of the newness of the vaccine, but had no choice. All my siblings were ok, too. ONE brother-in-law got VERY sick and now is permanently in a nursing home with dementia. Every vaccine has dangers, even the 'tried and true' we trust. My brother-in-law was one of the unlucky 1 percent who have had a bad reaction. obviously, we are heart-broken for him, but in the bigger picture, MANY lives have been saved because of the vaccine making the COVID experience much less deathly." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dementia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220937541-covid-19 vaccine ad26.cov2.s-Dementia. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Hot and tingling face and hands, slight dizziness and weakness, pulse 130-140, high level of anxiety.  Symptoms came on suddenly, after about 30 minutes they began to subside slightly.  Returned to 90% of normal after approximately 2 hours.   Remained  jittery for another 6 hours after that.
Information has been received from a nurse (L.P.N) concerning her approximately 20 year old daughter with a history of bronchitis and without pregnant, concomitant medication or drug reactions/allergies, who in her 4, or 5, or 6 years old was vaccinated subcutaneously with a dose of 0.5 ml VARIVAX (Merck). It was reported that the patient developed chickenpox after receiving VARIVAX (Merck). The patient developed rash 2-3 years ago, in approximately 2009. The rash appeared on her back, chest, trunk, and face. BENADRYL was given for treatment. There was no lab diagnostics performed. The patient was recovered in 7 days after developing rash. The patient sought medical attention by seeing the physician. Follow up information has been received from a physician who indicated that this patient did not belong to the physician reported. Additional information is not expected.
Information has been received from a physician and a registered nurse RN concerning a 5 year old male with no medical history who on 04DEC2000, was vaccinated SC in the right arm with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The physician reported that on 05JUN2003, the patient had moderate outbreak. The RN clarified that the moderate outbreak was an itchy papular rash that started on the patient's neck, back and trunk. The patient was seen by the physician on that same day. In June 2003, a week and a half later, the patient's itchy papular rash resolved. The patient's brother also developed a pruritic rash after being vaccinated with the first dose of varicella virus vaccine live. Additional information is not expected.
afib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "afib". Therapeutic measures were taken as a result of atrial fibrillation which included apixaban (Eliquis).  The lot number for bnt162b2 was not provided and will be requested during follow up.
The caller refers having, since the primary series administration, an itchy rash all over her legs, arms and body. "It is like getting hives"; The caller refers having, since the primary series administration, an itchy rash all over her legs, arms and body. "It is like getting hives"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Lot number: EN6201) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies to Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN (ongoing); BYSTOLIC (ongoing); ZOCOR; CETIRIZINE taken for hypersensitivity (ongoing); FLUTICASONE nasal (ongoing); IPRATROPIUM BROMIDE nasal (ongoing); OMEPRAZOLE (ongoing); LORAZEPAM (ongoing); DILTIAZEM (ongoing). Past drug history included: Clonidine, reaction(s): "Allergies to Clonidine". Vaccination history included: BNT162b2 (First dose, Lot: EL9269, NDC/Expiry: Unknown, not on the CDC vaccine record card., Dose: Unknown strength/formulation/dose injection to left arm), administration date: 06Feb2021, when the patient was 82-year-old, for COVID-19 immunization, reaction(s): "Covid-19", "Itchy". The following information was reported: RASH PRURITIC (non-serious), URTICARIA (non-serious), outcome "not recovered" and all described as "The caller refers having, since the primary series administration, an itchy rash all over her legs, arms and body. "It is like getting hives"". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash pruritic, urticaria.  Additional information: The patient reported her doctor gave her antibiotic but it wouldn't go away.
PATIENT CAME TO PHARMACY TO PICK UP A RX ON 11/10/17 AND I ASKED HER HOW SHE WAS DOING TODAY SO SHE STARTED COMPLAINING ABOUT THE PREVNAR SHOT THAT WAS GIVEN TO HER ON 10/14/17. PATIENT CLAIMS THAT  SHE COULD NOT MOVE HER ARM SINCE THEN AND DR HAS BEEN TRYING TO TREAT HER SINCE THEN. SHE STATED THAT SHE IS BETTER NOW AND SHE IS MOVING HER ARM BETTER. SHE ALSO STATED THAT THE DR WROTE HER A RX FOR TOPAMAX TO TREAT THE PAIN. BY LOOKING IN HER PROFILE, PATIENT WAS PRESCRIBED TROKENDI (TOPIRAMATE ER) ON 9/28/17 WHICH IS MORE THAN 2 WEEKS BEFORE THE SHOT WAS GIVEN.
Patient has her one-year appointment on Tuesday May 12, 2020 at 12:30. She was healthy and had vaccines. Tuesday evening she started having a fever. It was around 101-102 tympanic most of the evening and through the night, with a high of 102.9 but it broke several times with Tylenol. She continued to have a fever yesterday, but with Tylenol also had some normal readings.    This morning (Thursday) she has a 104.1 tympanic fever at 7am and mom called into the triage line, and sent message to provider.   Tylenol and a cool bath given and it cam down to 100.9 by 7:30.  Pt recovered without  further fevers or need for OV>
12 hrs post DTaP, IPV, hep B, HIB, Prevnar child experienced fever to 102.7 without other cause. Child refused all caregivers expect mother. Refused to eat except breast feeding x 24 hrs.
Mom reports a high pitched unusual cry in the evening p/immun given (in AM). Had never cried like this before or since this date. MD called p/hrs. Was directed to give Tylenol which she did do.
Mild headache, mild sore throat,  99 degree temperature, mild aches, moderate intestinal pain but no vomiting and no diarrhea-lasting from about 1:00 am to 9:00 am. Mild stuffy nose, fatigue, mild  left arm pain and mild  pain between shoulder blades in back- starting around 1:00 am and not yet resolved. (current time 10:42 am 1/23/21)
(R) leg 1" red area posterior thigh bruise at site. (L) leg 1" red area site with bruise.
coughing a lot; losing her voice; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing a lot) and DYSPHONIA (losing her voice) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Allergic reaction to antibiotics, Drug allergy (Aspirin allergy) and Drug allergy (Lipitor allergy).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced COUGH (coughing a lot) and DYSPHONIA (losing her voice). At the time of the report, COUGH (coughing a lot) and DYSPHONIA (losing her voice) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant medication history included blood pressure medicine. No treatment information was provided.
Localized vesicular rash/eruption at vaccine injection site, calamine lotion topically, no further treatment warranted.
11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022; no adverse event; Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vial that experienced excursion in the refrigerator on 03OCT2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (11 Adult patients received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022).    Concomitant medications details were not reported by the reporter.  It was reported that excursion occurred in refrigerator on 03-Oct-2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes. It was the first time the excursion occurred. It was reported that some of the vials were used and some were discarded.Treatment details was not reported by the reporter. This case was reported for patient 2nd of 11 adult patients.
Patient was constipated which was out of norm.  On 2/12, patient went to dermatologist for annual check-up and had no skin issues. Patient went to doctor on 2/14 and given MiraLax; symptoms resolved.  Shingles symptoms started 2/13 or 2/14; patient noticed the shingles blisters on Saturday. Patient checked-in with pharmacist on 2/16 and was encouraged to follow-up with clinician.  Patient went to doctor on 2/17 and verified patient had full-blown case of shingles. Doctor prescribed Valacyclovir HCL 1 gram (3xday) and 800mg of Ibuprofen.  Patient has not used Ibuprofen yet..  Medicine is not working fast enough.Patient had shingles outbreak in 2004.  Patient received the Zostavax vaccine 2 years later with no problem It is not working fast enough.