chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given 2nd COVID-19 vaccine yesterday 7/12/2021 at age of 17.  This was at the direction of clinic to go ahead and give the second at 17 since he got the first at 17 as long as he had no s/s with the first one and if the parents gave permission.  Patient had no adverse reaction to the first vaccine and parents did give permission for the second vaccine.  Tolerated with no reaction during wait time.  No adverse reaction noted as of yet.
4 hours after injection I became very tired followed by severe abdominal pain, cramping. and chills. No Fever. Blood pressure elevation. Pain was slightly relieved by burping and passing wind. After 3 hours of these symptoms I Called EMS, who checked and could find no other cause other than reaction to the injection. I took pepcid, gas pills and additional blood pressure pill but had no relief. After EMS visit I took Tylenol and was up for hours before finally falling asleep. Awoke this morning with no cramping but still very tender in abdominal area. Additionally I had a muscle cramp in my upper thigh this morning
No additiona AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 13-NOV-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection as prophylaxis (dosage regimen, route of administration, and anatomical location were not reported; lot number S004548, which has been verified to be valid, expiration date reported and validated as 12-AUG-2020) (product storage error). No additional adverse event information provided.  The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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-009507513-2005USA000310: US-009507513-2005USA000317: US-009507513-2005USA000352: US-009507513-2005USA000356: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000415: US-009507513-2005USA000425: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000493: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000624:
sore left arm the next day;  chills the next day (Saturday Dec. 4) at approximately 8:00pm followed by increasing fever up to 100.5 degrees F and fatigue.  I went to bed.  Fever did not start coming down until around Monday morning, Dec. 6 and then it went away.  Basically the same thing happened after my second Moderna Covid shot although the fever did not last as long.  The arm soreness lasted a couple more days.
Moderna Covid 19 vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks; Received the Moderna Covid 19 vaccine after manufacturer date of expiry/Patient Administered Expired Doses; Dose 1 was administered on 22-Feb-2022 and dose 2 was administered on 17-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry/Patient Administered Expired Doses), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 22-Feb-2022 and dose 2 was administered on 17-May-2022) and PRODUCT STORAGE ERROR (Moderna Covid 19 vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies (NKDA).    On 22-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry/Patient Administered Expired Doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 22-Feb-2022 and dose 2 was administered on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid 19 vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine after manufacturer date of expiry/Patient Administered Expired Doses), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 22-Feb-2022 and dose 2 was administered on 17-May-2022) and PRODUCT STORAGE ERROR (Moderna Covid 19 vaccine was stored and administered on 17-May-2022 and found out that the vaccine had been expired for 2 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Number of doses/vials: 26 doses some were primary doses and some boosters  On 17-May-2022, the vial was stored in fridge. The vial did not undergo any temperature excursions. Reporter stated that none of them had reported side effects. No treatment information was reported.
Vaccine was given to the patient without being diluted. No known adverse symptoms reported from this at this time.
(1) Severe headache. (2) Motion (range of motion) decreased due to (L) deltoid and whole arm pain. (3) Extreme nausea, no ?. (4) Left neck "felt swollen". (5) Felt feverish - 99 temp at home.
It is driving her insane; Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb; Almost fell; First Dose 11Oct2021, Second dose 30Dec2021; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It is driving her insane), HYPOAESTHESIA (Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb), DIZZINESS (Almost fell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 11Oct2021, Second dose 30Dec2021) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced FEELING ABNORMAL (It is driving her insane), HYPOAESTHESIA (Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb), DIZZINESS (Almost fell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 11Oct2021, Second dose 30Dec2021). On 30-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose 11Oct2021, Second dose 30Dec2021) had resolved. At the time of the report, FEELING ABNORMAL (It is driving her insane), HYPOAESTHESIA (Eye numb, Whole left side numb/ more stuff's numb, Whole left side of face is numb, Whole left side of legs is numb/her leg, toes numb, Whole left side arm, chest numb, Whole left side neck numb) and DIZZINESS (Almost fell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.   Patient stated she just tried to kept moving everything, but it was not helped her.
This spontaneous report was received from a pharmacist refers to a 50 year old male patient. The patient's medical history included two shingles outbreaks in face without drug reaction and/or allergies. On 30-DEC-2014 the patient was vaccinated with ZOSTAVAX single dose, lot # K010967, expiration date 16-NOV-2015, subcutaneous (dose was not reported). There was no concomitant medication. On 31-DEC-2014 the patient experienced shingles on his face. He called his pharmacist but did not receive any treatment for the adverse event. There were no laboratory diagnostics studies performed. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Patient was given TDAP as part of her PE on 7/22/13. She visited our facility. Presented with fever and joint aches, nausea.
I had the right side of my face not moving correctly.  Afraid I was about to have a stroke, (similar symptoms), I was taken by EMS to the ER at Hospital.  They diagnosed it NOT to be a stroke, or TIA, but rather Bells Palsy.  I was given three medications :  1. valACYclovir 1,000 MG TAB. TAKE ONE TABLETBY MOUTH EVERY 8 HOURS (FOR SEVEN DAYS). 2. predniSONE (DELTASONE EQ) 50 MG TAB.  TAKE ONE TABLET BY MOUTH EVERY DAY FOR SEVEN DAYS. 3. ERYTHROMYCIN (ILOTYCIN) 5 MG/GM OPTH OINT.  APPLY TO RIGHT EYE AT BEDTIME.
Central retinal vein occlusion with macular edema of left; Central retinal vein occlusion with macular edema of left; ophthalmic and retinal artery occlusion left eye; nuclear sclerosis of both eyes; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EL9262) via an unspecified route of administration in the left arm on 29Jan2021 14:45 (at the age of 72-year-old) as a single dose for COVID-19 immunization. Medical history included acid reflux and allergies to mollusks. The patient did not receive other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN). On 08Feb2021 at 06:00, the patent experienced central retinal vein occlusion with macular edema of left eye; ophthalmic and retinal artery occlusion, left eye and nuclear sclerosis of both eyes. The seriousness criteria were considered as disability. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with intraocular injection of anti-VEGF. The outcome of the events was unknown.
Fever/chills /body aches  Fatigue /headache Feel like lightning goes throughout my body Muscles and bones extreme pain Extremely thirsty  Couldn?t walk properly because of fatigue
fever of 102F; nausea; dizziness; weakness in the arm where the vaccination was administered; rash that extended from the injection site "all the way down the patient's arm"; rash that extended from the injection site "all the way down the patient's arm"; Indication for PNEUMOVAX: the patient is diabetic and the patient just had pneumonia; This spontaneous report was received from a medical assistant referring to a 53 year old male patient. The patient concurrent conditions included diabetes mellitus, pneumonia and hypertension. Concomitant therapies included atorvastatin calcium (LIPITOR), pioglitazone hydrochloride (ACTOS) and metoprolol. The patient did not have any drug reactions or allergies.  On 01-OCT-2019, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot # S005857 with expiration date 03-DEC-2020, indication reported as "the patient was diabetic and the patient just had pneumonia" (product use in unapproved indication).  Subsequently on the same day, the patient developed a fever of 102 Fahrenheit (F) (pyrexia), nausa, dizziness, weakness in the arm where the vaccination was administered (muscular weakness), and a rash that extended from the injection site "all the way down the patient's arm (vaccination site rash, rash). The patient sought for medical attention and went to an office visit. It was unknown by the reporter if treatment was given for the adverse event. No laboratory diagnostics or studies were performed. At the reporting time, the status of the patient was reported as not recovered.  The causality assessment was not provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2022 at 14:00 as dose number unknown, single (Lot number: gh9720) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart - with stent" (unspecified if ongoing); "heart - with stent" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "known allergies cipro", notes: known allergies cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2022) Negative, notes: completed doses of paxlovid 23Oct, took antigen test - negative; (28Oct2022) Positive, notes: symptom free - symptom returned on 28Oct - antigent test positive; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
the patient received expired Dapacel vaccine, no adverse event; Initial information was received on 02-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to 2020SA058733 and 2020SA057112 (same reporter).  This case involves a 32-months-old female patient who received a fourth dose of 0.5 ml of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left arm for prophylactic vaccination, on 13-Feb-2020 (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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 vaccine at 1323. At 1343 said she did not feel good and then did not respond to verbal or normal pressure tactile stimuli. Patient did respond to sternal rub. Patient has a history of epilepsy and several allergies. Patient did not have audible wheezing, has trach to vent, and mark above lip that was potentially a hive.  APN was at bedside and instructed to administer epinephrine. EMS was called. Approximately 3 minutes after administration of epinephrine patient became verbally responsive. When EMS arrived, patient was oriented to person, place, and time. Patient was transported by EMS to the hospital.
pt recvd vax & was limp 3AM, hardly responsive, t104 gave APAP, warm bath 530AM, t103.3 seen by MD couldn't stand nor eat.  10JUN t102, vomiting;
On Friday, April 2nd, I took my son to pediatrics for a well child checkup at 3pm.  At the end of his visit, he received two vaccines.  The DTAP, in his left deltoid, and the IPOL in his right deltoid.  Approximately ten minutes later, as we were leaving and I was putting my son in the car, my son started to uncontrollably cough and drool at the mouth, repeatedly saying, "This cough just won't go away, my throat."  I immediately returned back to the office where Dr. examined him; he examined his throat and listened to his lungs.  The coughing and drooling persisted.  My son also said his head hurt.  His face was beat red and I noticed the whites of his eyes were also red.  At that time, Dr. said he was going to call 911 because he didn't like the way my son was retracting.  He then received two nebulizer treatments, and was given some supplemental oxygen via nasal cannula.  His oxygen saturation was 95% at the time.  I then noticed the beginning of a rash on my sons chest and back, so my son was given 7.5ml of BENADRYL.  The doctor also attempted to give my son oral PREDNISONE, which he spit out.  The ambulance arrived shortly thereafter.  In the ambulance I noticed that my son had welts on his left arm.  By the time we arrived to the ER, my son was completely red, from his head to his torso.  His face was swollen, he had hives on his legs and welts on his left arm.  I noted to Dr., the ER doctor that the injection site on his left arm was also red and swollen.  My son was placed on a cardiac monitor and was given a epinephrine injection in his right thigh.  He also received additional BENADRYL and PREDNISONE via IV.  Shortly thereafter, things started to slow down, and the body rash faded and went away.  My son was discharged from the hospital at aprox. 8pm.  I was told by the ER doctor that my sons condition was "very alarming" upon his arrival to the ER, and that she has never seen this kind of reaction to a vaccine in her 30 years of practice.  I noticed that Clostridium tetani is grown in modified cassamino acid medium without beef heart infusion.  Casamino Acid is an acid hydrolysate of casein, and casein is a milk protein.  My son has a level 4 MILK ALLERGY.  Awareness needs to be brought to this, if this is the cause of my sons severe reaction.  If there truly are milk by-products in some of these vaccines, then it needs to be brought to the attention of the medical professionals, so that appropriate precautionary measures can be taken when administering vaccinations to children with food allergies.  My son experienced a life threatening, systemic, allergic reaction.  No child should ever be subjected to what my son experienced, and hopefully we can prevent this from ever happening again.  Thank You for your time.  Follow-up - Vaccines lot #'s - DTAP - C3192BA - Polio IPV - D0513
she is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she is not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (she is not feeling well). At the time of the report, MALAISE (she is not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
PAIN AND REDNESS IN RIGHT ARM APPROX. ONE HOUR AFTER GETTING PNEUMOCOCCAL VACCINE. ON 12-4-07. SHE ALSO HAD A HEADACHE, NAUSEA AND CHILLS THE NEXT DAY. SHE SAID SHE FELT "SICK ALL OVER". FEELS AS THOUGH HER ARM IS "ASLEEP" TAKING TYLENLOL, SAW PCP FOR A PRESCHEDULED APPT.
3AUG92 according to mom pt was limp, trembling, chills, purple lips, vomited x 2; pt seen by MD; pt throat was red;
This spontaneous case was reported by a physician and describes the occurrence of MEDICATION ERROR (about 300 people received a vaccine after an excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No medical history was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEDICATION ERROR (about 300 people received a vaccine after an excursion). At the time of the report, MEDICATION ERROR (about 300 people received a vaccine after an excursion) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant  information was  provided. No Treatment information was  provided.
Janssen 3/18/21. Moderna 11/30/21. Positive on 7/28/22
pt recv vax 1995;31MAR95 pt to MD w/n,v & sx of UTI;UA revealed white cells w/some red blood cells;tx Sulfa then switched to sulfamethoxazole;12APR95 pt seen by MD-t102,lost 8#,elevated liver enzymes;dx subclinical hepatitis
Approximately after two weeks after the first dose of the vaccine, I developed Tinnitus in both ears. I saw my Primary Dr. who referred me to the EMT Dr. who did a number of test and then referred my to a neurologist and she also did a number of test and the result was that all test were negative, and the Dr. felt that my Tinnitus was caused by the vaccine.  She said that she had seen and evaluated a number of patients with the same experience.