chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blacked out/felt going down; feeling weak/could not stand and walk; bumped on floor; dizziness; nausea; headache; fatigue; chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 10:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (felt going down), seriousness criterion medically significant),  VACCINATION SITE PAIN, CHILLS,  DIZZINESS,ASTHENIA (she could not stand) (she could not walk)(feeling weak), FALL(bumped on floor), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (blacked out) (felt going down),  ASTHENIA(she could not stand),(she could not walk)(feeling weak), FALL  (bumped on floor), NAUSEA (nausea), HEADACHE (headache) ,VACCINATION SITE PAIN, CHILLS,  DIZZINESSand FATIGUE (fatigue) had resolved.            Concomitant medication: very low dose of cholesterol medication.   This case was linked to MOD-2021-060481 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
booster; received the booster he developed Omicron after a Christmas Party; received the booster he developed Omicron after a Christmas Party; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (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 (Manufacturer: unknown, Dose number: Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received the booster he developed Omicron after a Christmas Party". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive for omicron.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid19 cannot be totally excluded.
Elevated blood pressure revealed after immunization, while asking about patient-owned wrist blood pressure monitor. Concern expressed over the high readings. Patient's son took her to urgent care. No further information at this time.
Patient received dose #2 of Pfizer vaccine on 6/9/2021 in vaccination facility and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Clinic re-administered dose on 6/14/2021 as recommended. No adverse reactions identified on site.
Allergic reaction to (L) arm erythema, warmth, and approximately 2 cm by 2 cm.
This spontaneous report was received from a physician via a company representative, referring to a male patient of unknown age. The patient's concurrent conditions, concomitant medication, pertinent medical history, drug reactions or allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose #, route, lot number and expiration date were not informed) for prophylaxis. On an unknown date (reported as "later that night"), the patient had the "flu" and was hospitalized for an unspecified amount of time. The patient sought medical attention, and received treatment for the adverse. It was unknown if laboratory diagnostics or studies were performed. The outcome of ""flu" was reported as not recovered. The causality assessment between "flu" and therapy with PNEUMOVAX 23 was not provided.
NUMBNESS IN UPPER LIP AND NOSE, CHECKED OUT BY EMS AND VITALS TAKEN, MONITORED AND THE RELEASED
I took the second dose of the Pfizer Covid vaccine at pharmacy  on May 21, 2021.   My next menstrual cycle was a nightmare.  I have been bleeding for 3 weeks straight.  I have never had irregular periods.   I truly feel this irregular period/heavy bleeding was caused by the vaccine.
Information has been received from a physician concerning a 19 year old female who in early September 2008, was vaccinated with the first dose of GARDASIL (lot # not reported). The physician stated that the patient received the first dose of GARDASIL and then she started to have numbness all throughout her body. The physician does not know if the numbness started at the injection site or not, but the numbness started to get progressively worse. The patient had a test done for multiple sclerosis and lyme disease with negative results. The physician indicated that the patient still has the numbness throughout her body. The physician considered the event to be disabling. Additional information has been requested.
Pt recvd vax 1030AM & 1030PM the same day exp nausea, vomiting & diarrhea; self-treated w/compazine inject; resolved p/1 day;
My arm was immediately sore. It felt very thick and I told the nurse. She kept saying 'yes it's cold' but it wasn't cold. It was sore. Over the next two days the soreness continued. It's now been 2 weeks and it's very sore and is sharp pain when I lift or move my arm.
Lt leg reddened, swollen from knee to thigh area; hot to touch; incessant crying , leg tender to touch; fever;
Vaccine was delivered IM on the upper region of the medial deltoid, near the acromion process. Approximately 2 hours after injection, loss of mobility in the shoulder was noted accompanied with pain. Possibility of the vaccine being delivered to the bursa due to location of injection
Per administering nurse: "Gave benardryl 25mg PO x 1 dose. Feeling flushed, light headed, O2% 97%, HR 88, stayed for 1 hr felt back to baseline after 1 hr, left to go home safely"
I was broke out, all over my body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9267, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was trying to report the side effect, the patient was told to do so by emergency room, the Pfizer Covid Shot the patient had on friday and a hour and half later the patient had to go the emergency, the patient was broke out, all over her body and they told the patient to call the hotline and ask if the patient should get the second shot. The adverse event resulted in emergency room visit. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Upon initiation of the vaccine administration, the luer-lock needle become disengaged from the barrel causing the needle to remain in patients arm and vaccine leaking out of barrel onto patients arm and floor.
Information has been received from a consumer concerning her currently "42 years old" husband who was vaccinated with a single dose of MMR II injection when he was an infant. The consumer reported that her husband had a history of vaccine induced seizures. When the patient was due for his routine vaccines (as a child) and one of the vaccines that caused the seizures was MMR II. The other vaccines names and manufacturers were unspecified. The patient had recovered. Up on internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 031L20A and 028L208A) for COVID-19 prophylaxis.     No parental vaccine exposure was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-687666 (Patient Link).
it's getting a little itchy; a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (it's getting a little itchy) and RASH (a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history information was reported.  The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), DIGOXIN and METOPROLOL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH PRURITIC (it's getting a little itchy) and RASH (a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over). At the time of the report, RASH PRURITIC (it's getting a little itchy) and RASH (a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Patient developed intense itching 10 minutes following the administration of the COVID 19 vaccination while waiting in the post vaccination recovery area. Emergency personnel present, PO Benadryl and Epipen administered. Patient sent to ER via ambulance for observation.
HIVES OVER ENTIRE BODY, SWELLING OF NECK, FAST HEART RATE, SWELLING OF TONGUE, SWEATING. I RECIEVED THE INJECTION ON 2/26/21 AND THE SYMPTOMS STARTED 3/3/21 AND THIS LASTED FOR 3 DAYS. THE FIRST DAY I TOOK 2 BENADRYLS AND THAT DIDN'T WORK THEN I GOT A DECADRON SHOT IT GOT SOME RELIEF THE NEXT MORNING I BROKE OUT IN HIVES AGAIN AND TOOK 3 BENADRYLS AND WAS ABLE TO GET SOME RELIEF. THE NEXT DAY MY TONGUE SWELLED AND THEN I WAS FINE THEREAFTER.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000862: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
Case number PHEH2015US019274, is an initial spontaneous report from a pharmacist received on 28 Apr 2015. This report refers to a pregnant female patient of an unknown age. Medical history and concomitant medications were not reported. Last menstrual period (LMP) was not reported. On an unknown date, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly. No adverse event was reported.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Infant fatality Review Committee today made clinic aware of demise of pt on 27JAN95 autopsy findings: SIDS (natural causes);
Reported onset migraine type HA, nausea & vomiting, lethargy & fever x 48 hrs with onset 5 days after immunizations.  Recurred one week later with decreased HA, but diarrhea.  c/o being "totally incapacitated" and went to private Dr. who is naturopath.  Now 25 days after imms received & states that she is a "little bit better".
After receiving the Tdap vaccination, I had arm swelling, dizziness, nausea, fever after receiving the TDAP vaccination starting on the day I was injected (Thursday, September 13th, 2018). The side effects carried on September 13th 2018 through September 18th 2018. Today (September 19th 2018), I still have arm soreness from the injection but the nausea, dizziness and fever have gone away.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who experienced discomfort, redness, induration of 4 cm, fatigue and inappropriate route of vaccination, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy taken. On 13-Aug-2018, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5872AA via subcutaneous route in the left arm. On an unknown date, the patient developed a non-serious discomfort following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious redness (erythema) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date The patient developed a non-serious induration of 4 cm (vaccination site induration) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date The patient developed a non-serious fatigue following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that Adacel was administered too low on the arm and it did not get into the deltoid. It seems to them that it was given SC. It was also a case of Inappropriate route of vaccination and Vaccine administered at inappropriate site. Final diagnosis was fatigue, induration of 4 cm, redness and discomfort. It was not reported if the patient received a corrective treatment. The patient was not recovered from 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 Directive 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.
dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "allergic to ibuprofen" (unspecified if ongoing), notes: Verbatim: allergic to ibuprofen. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  Additional Information: Caller would like to know whether she can take Tylenol for her side effects from the covid vaccine. Caller said she just got the 2nd dose of the Pfizer covid vaccine today, 16Apr2021. She feels a little weak, has a headache, feels a little bit dizzy, but the 1st time it (dizziness) was worse. Caller also said she is allergic to ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site pain, followed by dizziness, disorientation, confusion, body aches, chills, severe headache, nausea, g.i. distress, and fatigue
15FEB97 nauseous, queasy, sore throat & fever;cramps upper abd;16FEB97 nauseous;17FEB97 nauseous;18FEB97 nauseous, queasy;no tx;
At the end of April, I was having pain in my hands because I had just been diagnosed with Carpal Tunnel and the doctor prescribed me some steroids. I took them one day and that night I checked my blood pressure, and it was very high. I thought it was the medication that increased my blood pressure, but my doctor said it was not. I had to go to the ER because my blood pressure kept getting higher and higher. They did a CT of my brain because I was feeling dizzy, but it came back normal. They told me to go to my primary care physician. They just told me to continue taking the medication and did a urine test which came back normal. Then I went to a cardiologist and they did blood work and it came back normal too.