chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My period early shortly after getting the shot. The following month I also started early.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 11:00 (Lot number: FC3180) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Usually have a consistently long cycle/ it was ever short" (unspecified if ongoing), notes: it was ever short like this was when I was on the pill over 15 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FA7485, Administration time: 08:00 AM, Vaccine location: Left arm, Dose number: 1), administration date: 02Aug2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 31Aug2021 08:00, outcome "recovered" (2021), described as "My period early shortly after getting the shot. The following month I also started early.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination and not tested for COVID post vaccination. I usually have a consistently long cycle. The only time it was ever short like this was when I was on the pill over 15 years ago.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and refers to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (dosing details and route of administration unknown) (lot # M010671 with expiry date 02-JUN-2018; lot # M035487 with expiry date 23-FEB-2019; lot # M041384 with expiry date 07-JUL-2019) for prophylaxis. Medical assistant did not know which of the vaccine lot numbers were administered. The administered doses of RECOMBIVAX HB experienced a temperature excursion of 47 degree Fahrenheit (F) to 77 degree Fahrenheit (F) for a time frame of 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. No additional information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001442: Original Case: 1706USA001442.
SLOWLY OVER A WEAK DEVELOPED EXTREME PAIN 7 BURNING ON RIGHT BACK OF HEAD FROM EAR TO THE MIDDLE 7 TOP TO BOTTOM. DEVELOPED LARGE LUMPS ON HEAD IN THAT AREA. RIGHT EAR EXTREMELY RED & PAINFUL TO TOUCH.   LASTED 2MO. GIVEN AN ANTI VIRAL DRUG. DR THOUGHT IT COULD BE SHINGLES ONLY BECAUSE OF PAIN  & THAT IT WAS ON ONE SIDE. NO SHINGLE LIKE LESIONS DEVELOPED.
Substantial flu-like symptoms.  Chills.  Mild ache near injetion site next morning for less than hour.  Cured with 1000mg Acetaminophen several hours later.
Pt was unknowingly given additional Pfizer BV. Upon review after pt was given the vaccine - pt shows Pfizer given on 03/2023. Vaccinator believed Pfizer given was a monovalent - but was unable to confirm. No adverse reactions.
Fussy, irritable for 3 weeks, decreased muscle tone and behind on milestones after 2nd shot. Follow up on 11/06/2003: "Vaccine recipient did not recover from the adverse event.  Child is receiving speech and occupation therapy walks with a walker.  Has physical delay in development."
No adverse event; HCP advised that her office administer 3 vaccinations with expired vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     On 12-Jul-2023, 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. On 12-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733038, US-MODERNATX, INC.-MOD-2023-733100 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733038:Same reporter US-MODERNATX, INC.-MOD-2023-733100:Same reporter
pt had temp 12MAY97 & devel a fever, lethargy 17DEC97 in the mid afternoon;pt was treated w/APAP but cont to have fever until 20MAY97;pt was fussy until 22MAY97;has completely recovered w/o med intervention;
On the evening of 4/6/01, left upper arm was noted to be red and swollen by mother. Taken to ER and physician documents large amount of redness and swelling and ecchymosis from left shoulder down to just above elbow. No adenopathy, lymphangitis or fever.
PATIENT WAS 62 YEARS OF AGE AND RECEIVED GARDASIL 9 ON JULY 18, 2017 WHICH ACCORDING TO ACIP GUIDELINES SHOULD ONLY BE ADMINISTERED UP TO AGE 26 FOR FEMALES. NO ADVERSE REACTION OCCUR. PATIENT CAME TO THE PHARMACY TO GET SECOND DOSE HOWEVER PHARMCIST STATED IT WAS NOT CLINICALLY CORRECT BASED ON PATIENT'S AGE.
Administration error. A 47-year-old female received a Td vaccine intradermally instead of a PPD, on 10/10/11. The day after the vaccination, the patient experienced discomfort, erythema (2.0 cm), induration and tenderness at the injection site. The patient returned to the doctor's office on 10/11/11. Follow up obtained on 10/18/11: The doctor's office had contacted the patient by phone. The patient reported that the erythema and tenderness had worsened on the 4th day after the injection, but had since started to improve. Follow up obtained on 11/1/11: The patient was contacted by the doctor's office and had stated that she still feels a little nodule under the skin at the injection site. Follow up obtained on 11/17/11: Patient went to the doctor's office for a visit on 11/10/11. The reaction on the patient's arm was still visible. The clinic staff contacted the patient on 11/17/11. Patient had stated that the reaction was 90% better, not tender, and the nodule was going down, but there is still some discoloration. Follow up obtained on 12/6/11: Patient went to the doctor's office for a visit on 12/6/11. The reaction was 95% better, but still detectable, and the reaction site was slightly raised.
Pt complained of dizziness within 15 minutes of receiving Moderna COVID vaccine. Vitals were taken, pulse was in the 40's, pt alert and oriented, soda given to see if blood sugar dropped. Continued to monitor, pulse remained low and pt continued to complain of feeling dizzy. 911 was notified and EMS arrived by 12:35pm. EKG strip performed, along with vials from the EMT in the health department. Positive orthostatic hypotension found by paramedic. EMS notified ER doctor on call for recommendations. ER doctor said vitals were consistent with dehydration and could be admitted for IV fluids or return home and encouraged to increase fluids. Wife and pt declined ambulance ride and request to return home.
pt recvd vax 17OCT95 & 2-3mins p/vax pt devel an inj site rxn characterized by pain radiating from site to elbow & across back), redness;sx also included nausea & flushing;pt given DPH;
Started with lite diarrhea within a couple of days after the first shot.  After the second shot the diarrhea was constant until Mid Nov.  I tried changing my diet and fiber supplements.  The only thing that changed in my life was the shot.  About 6-7 months later, my bowel movements are starting/almost back to normal.
near syncopal episode; This is a spontaneous report from a contactable physician (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient recieved the Pfizer Covid 19 Vaccine in early January. Caller stated that he had a "near syncopal episode, was seen by cardiologist and everything was fine. Patient asking if the Pfizer Covid 19 Vaccine has graphene oxide in it. He is a doctor, and one of the first people to get vaccinated in Jan2021, when his hospital got access to the vaccine. He got a bad reaction after the second dose. He had near syncope. He has been reading reports on certain websites that the vaccine could contain toxins, such as graphene oxide? has been hearing reports, that graphene oxide is poison. he has read this in many places on websites and on the internet, but wanted more information to make sure in wasn't anti vaccination hysteria. He does not know what to believe anymore. Event outcome was recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This very pleasant 52 year-old female from a nursing nursing home fell and sustained traumatic brain injury and was admitted;---more detailed history per attending physician, is verified and reproduced below .....  Tested positive on 9/6/2021 This very pleasant 52 year-old female from a nursing nursing home fell and sustained traumatic brain injury and was admitted;---more detailed history per attending physician, is verified and reproduced below   The patient presents following fall.  The onset was just prior to arrival.  The occurrence was single episode.  The fall was described as UNKNOWN.  The location where the incident occurred was REHAB FACILITY.  Location: Right head. The character of symptoms is pain.  The degree at present is minimal.  The exacerbating factor is none.  The relieving factor is none.  Risk factors consist of age and anticoagulated.  The patient's dominant hand is the right hand.  Therapy today: emergency medical services.  Preceding symptoms PATIENT UNCERTAIN.  Associated symptoms: none.  PATIENT RECENTLY DISCHARGED FROM THE HOSPITAL ON ELIQUIS.  STROKE..  PATIENT INITIALLY EVALUATED IN RAPID ASSESSMENT BY MIDLEVEL PROVIDER.  I ASSUMED ALL CARE POST ASSESSMENT..
Headache, body aches, chills.  Fluids and sleep.  Next day, better.
12 hours later after I had the shot my heart was pounding so hard it woke me up. Tried to look up information and couldn't find information about a speeding heart rate. The more I moved around the higher my heart beat got. I ended up calling 911 and they suggested I go to hospital, admitted into the ER. They did a chest x-ray, ran some EKGs and blood work and then was admitted into the cardiac unit.  They sent me home and told me to check up with my doctor. Did some more blood work later and a thyroid checkup and everything came back fine.
fever -103, fever/chills & diarrhea-24hrs;hallucination;seeing spiders on the wall & talking incoherently & was confused;evening 15OCT95 inj site swelled (15mm on 16OCT95);
Patient 2 to 3 hour after receiving Hep B vaccine got tonic seizure at home per mother lasted for 30 to 60 seconds & happened again next day in the morning.
Patient presented to emergency department on 2/2/2022 with dyspnea for 1-2 weeks. He had tested positive for COVID-19 at the medical center on 2/2/2022 prior to presenting. He was admitted for further management. He was treated with dexamethasone, remdesivir, and baricitinib. He was discharged home on 2/8/2022. Patient's symptoms worsened and he was readmitted from 2/9/2022 to 2/17/2022 for shortness of breath. He was discharged home after this admission.
Muscle pain; Lethargy; Headache; Temp of 100.9; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 27Sep2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer surgery in Nov2020 and high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. Concomitant medications included influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT) on 15Sep2021 for unknown indication; letrozole (MANUFACTURER UNKNOWN) and atorvastatin calcium (LIPITOR); both for unknown indications from an unknown date and unknown if ongoing. On 27Sep2021 at 20:30, the patient experienced muscle pain, lethargy, headache, temperature (temp) of 100.9, diarrhea and nausea. On the same day, the patient underwent body temperature test and the result was 100.9 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, lethargy, headache, temp of 100.9, diarrhea and nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
7 days post 1 dose, large red circular rash developed at the injection site.  Approximately 2? x 3? in size.  Upper arm is swollen. No pain or itching. Also no underarm swelling.
Pt with itching and burning of both ears.  Mild rash over ears and nape of neck at hair line.  Also with posterior lymphadenopathy as well as axillary lymphadenopathy.  Triamcinolone helped rash and itching.
itching and being irritating; itching and being irritating; Intentional administration of >2doses, Intentional dose administration < or > 1 month; Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives), PRURITUS (itching and being irritating), SKIN IRRITATION (itching and being irritating) and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 013M20A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS and Chronic kidney disease stage 3.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives) and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month). On 27-Aug-2021, the patient experienced PRURITUS (itching and being irritating) and SKIN IRRITATION (itching and being irritating). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Hives, at an unspecified dose and frequency. On 27-Aug-2021, URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives) had resolved. At the time of the report, PRURITUS (itching and being irritating) and SKIN IRRITATION (itching and being irritating) had not resolved and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Patient received Benadryl and cortisone cream as treatment.
Initial report received from a health care professional on 19 October 2007. A 28-year-old female patient with no significant past medical history received an intramuscular injection of Adacel, lot number C2824AA, in the left deltoid on 28 September 2007. At the time of vaccination the patient was diagnosed with a bacterial sinus infection and was treated with amoxicillin. The Adacel was administered at the same visit. The patient returned to the office on 08 October 2007 complaining of numbness and tingling in her feet. She was admitted to the hospital on 11 October 2007 with progressive symptoms and was diagnosed with Guillain-Barre syndrome. She was treated with IVIG in the hospital and was discharged on 14 October 2007. She was evaluated by a physician on 19 October 2007 and her symptoms had resolved. The patient recovered from the events.
VZV given 5/17/11. On 5/20/11 pt. developed pustules on face. Had 9 pox total - crusted over - resolved. Mild fever resolved .
Headache; Nausea; Heaviness in "my" chest; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medication was not reported. The patient previously received AMPICILLIN, on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UA7533) via an unspecified route of administration in the left arm on 19Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 07:00, the patient experienced headache, nausea, and heaviness in her chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, and heaviness in chest were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
received only the adjuvant; received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number F5TT2, expiry date 4th February 2023) for prophylaxis.   On 2nd November 2021, the patient received Shingrix. On 2nd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the adjuvant ASO1B of Shingrix without lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021237471, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237471:same reporter
I know four people who had a stroke; This is spontaneous report from a contactable consumer. A contactable consumer reported similar events for 4 patients. This is 1st of 4 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that "I know four people who had a stroke" on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Slight buzzing in ears (tinnitus) noticed since 2nd shot. Only notice when quiet and usually in bed. Found others complaining of significant ringing in ears on other websites.
This spontaneous report as received from a vaccine coordinator refers to a 3-year-old male patient. The patient's medical history was not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored PROQUAD therapy type RHA, lot # N023001, expiration date 19-FEB-2019 or lot # N019249, expiration date 20-DEC-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005177: US-009507513-1802USA005178: US-009507513-1802USA005179.
Mild fever (99.7); chills; fatigue; This is a spontaneous report from a contactable consumer (patient)   A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Mar2021 11:00 (Batch/Lot Number: unknown) as single dose (at the age of 59) for covid-19 immunisation. Medical history was none. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, omeprazole (PROTONIX) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced mild fever (99.7) on 17Mar2021 01:30, chills on 17Mar2021 01:30, fatigue on 17Mar2021 01:30. No treatment received for the adverse events. The patient recovered in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained