chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstruation after menopause; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 12:00 as dose 3 (booster), single (Lot number: EN4207) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN4207, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 20Mar2021, when the patient was 57-year-old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 30Apr2022 at 12:00, outcome "not recovered", described as "Menstruation after menopause". The event "menstruation after menopause" required physician office visit. Therapeutic measures were not taken as a result of menstruation irregular  Additional information: 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.  No follow-up attempts are needed. No further information is expected.
DTap given s/p puncture wound given IM in right deltoid. Approx 48 hours later pt now has red, raised lump approx 2x2 in painful to touch.
redness & pain around inj site;joint pain, chills lasted until 11/2 around 10PM;
Nauseated for 2 weeks, Vomiting for 10 days , Urine Retention / blockage for 3 days
Pfizer / BioNTech/ positive test result; Pfizer / BioNTech/ positive test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 15Jul2022, outcome "not recovered" and all described as "Pfizer / BioNTech/ positive test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: A rapid antigen kit showed a positive test result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
Varivax received on 5/31/96. On 12/28/00, exposed to varicella. Had a mild case of varicella with about 10-12 pox. Still continues with rash.
tingling in arm, sweating, got dizzy while driving on freeway p/leaving MD office; pt taken to ER & observed for 1-2 hrs & released; pt cont to have anxiety attacks;
Diagnosed with COVID 19 after being fully vaccinated. Tested positive 10/12/2021. Fever for a couple of days, sore throat, shortness of breath, sneezing, and coughing.  I received the Regeneron shots with mononuclear antibodies and it WORKED.
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported.
4 days after COVID 2nd booster, I went to the ER with chest sensation (not pain) and light headedness. The EKG was abnormal (ST depression) but the cardiologist on site said it was normal. All blood tests normal except Potassium slightly low. I headed home with the intention of following up with a Stress Test. My primary help schedule the Stress Test and prescribed Lexapro for anxiety. On day 3 after start of Lexapro, I went to ER. This time my Troponin was elevated (.05 and .1) and Stress Test EKG was markedly abnormal. Long story short, I believe the COVID booster may have caused the abnormal EKG?s.
Alerted by vaccination RN at 12:01 PM that the first 8 doses administered of the day had been given in insufficient amount. The RN stated she realized with the last patient of the morning (receiving dose #9) that the syringe was not the 3mL syringe she was used to using, and was in fact a 1mL insulin syringe. She noted that she had been drawing up the vaccine up to 5 (meaning 5 unit, equivalent to 0.05mL) rather than to 50u to give the full dose (0.5mL).  She stated she recognized her error with patient #9 and administered the correct amount (0.5mL) from a 3mL syringe she was used to using.  .
Ringing in ears/head.  Fullness or congested feeling in ears.  Pressure feeling like always need to pop ears.  Muffled sound.  Sensitivity to loud noise.  I?ve seen two internists and they say it sounds like inflammation in tube behind eardrum.  They didn?t want to put me on a steroid so they both advised Flonase.  I?m hoping there?s a recommendation coming soon for all the thousands of us who are having this problem with ears and an obvious allergic reaction to the vaccine..
Generalized seizure lasting approx. 20 minutes; began with arms convulsing and immed. spread to entire body; rectal diastat applied 2 minutes into episode; call 911, taken to hospital; blood taken, phenobarbital level at 48; phenobarbital dosage maintained at 45mg in a.m., 60mg in p.m.; keppra increased from 2ml twice daily to 3ml twice daily; 11th seizure episode since 3/5/05 (1st episode).
Half dollar sized rash on top of right hand with secondary quarter sized rash splotch on right wrist
Narrative:  This patient has received three doses of Pfizer COVID 19 vaccine in Mar/Apr/Dec 2021. The patient presented to the ED with cough, fever, and nasal congestion on 1 June 2022. The patient was admitted to the hospital with covid 19 and tachycardia. Patient was treated for symptoms and was discharged in stable condition on 4 June 2022. Reported per EUA.
No additional AEs or PQC reported; Caller reported vaccine administered after temperature excursions; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milligram, lot #X006983, expiration date: 07-MAR-2025, administered intramuscularly for prophylaxis (strength was not provided).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 18.3 degree fahrenheit for 1 hour and 5 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.
Client reported 1/29/21 to clinic phone call that had rash Returned client phone call and client reports rash/hives on left arm, (opposite of injection site) back and chest.  No airway closure noted. Client felt fine and was able to converse. 1:02 p.m.  Dr. was notified, recommends client take benadryl x7. If anything changes please call 911 or go to local healthcare facility and report to VAERS.1:04 p.m.  Client will not receive second dose. Client will check in periodically, or if anything changes.KM 1:23 p.m.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 6 year old male pt who received a dose on 12/03/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/03/03.  Dose regimen was 0.5mL 1 time per day (IN).  Concomitant medications were not reported.  It was reported by a pharmacist, that a 6 year old male, developed a fever of 101.3 deg F.  Symptoms occurred on 12/05, two days after receiving Flumist.  Reporter indicated there was no causal relationship between Flumist and fever.  No additional information was available at the time of this report. Follow-up information received from the physician's office on 05 Jan-2004 stated that, "This was not a reaction and no further work up was done."
PR RECVD 1ST INJECT(IM,DELT) 4-5-90 THAT NIGHT HAD ONSET OF PARESIS. LOSS OF MUSCULAR STRENGTH IN BOTH UPPER EXTREMITIES PROGRESSED,RESEMBLING RADICULOPATHY PATTERN. NO TREATMENT GIVEN. TO DATE NEUROPATHY IS PROGRESSING
Redness and swelling at vaccine site left thigh. 3cm raised red, warm welt, surrounded by 5-6 cm pink circle.
Patient got clammy and dizzy with paleness at 1:32PM. At 1:33PM patient fainted. Blood pressure dropped to 80/41, O2 saturation dropped to 89%, Heart rate dropped to 51. Patient recovered after O2. Patient left office with stable vitals with mother at 2:20PM
Patient shaking uncontrollably about 20 minutes after administration of the vaccine. Continuously warm-to-touch and but shaking involuntarily. She spoke to me but could not stop shaking. I recommended a 911 call. They took her to the hospital for observation.
This case was reported by a consumer via sales rep and described the occurrence of back pain in a 54-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included pain in cervical spine (about a week previous to the SHINGRIX vaccination). On 3rd March 2019, the patient received SHINGRIX. On 6th March 2019, 3 days after receiving SHINGRIX, the patient experienced back pain, inflammation, interscapular pain and hyperesthesia. On an unknown date, the outcome of the back pain, inflammation, interscapular pain and hyperesthesia were unknown. It was unknown if the reporter considered the back pain, inflammation, interscapular pain and hyperesthesia to be related to SHINGRIX. Additional details were reported as follows: The patient reported that about 3 days later receiving SHINGRIX, he experienced pain and soreness between his shoulder blades. The patient reported that he was in pain below his rib cage in his back and he was sensitive on the front side. The patient also had some inflammation on the same front side. The patient had an epidural with a steroid to alleviate pain in his cervical spine. The patient wanted to discuss his side effects as he was having concern about this.
Soreness felt at injection site in evening on 04/03/14. Then noticed redness at site injection site approximately size of a half dollar. No other symptoms as of yet.
patient was entered in for bivalent booster, but accidentally received the monovalent purple cap pediatric primary series dose
Patient presented with chest pain and found to have bilateral pulmonary emboli. He was 2 weeks post 2nd dose of Moderna vaccine. He has personal history of cerebral venous sinus thrombosis and also has positive family history of DVT's (mom had 2 DVT's during pregnancies)
Outside recommended dosing window; Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside recommended dosing window) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside recommended dosing window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside recommended dosing window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided
This spontaneous report as received from an office manager at the physician's office via company representative refers to a patient of unknown age and gender. The reporter stated that an expired dose of ZOSTAVAX (lot# unspecified) (route, dose and location unspecified) was administered to an unspecified patient, possibly on 21-OCT-2013. No adverse effect reported. Additional information has been requested.
No adverse reaction. Pt was given Pfizer bivalent pediatric instead of Pfizer bivalent adult. Pt didn't have any reaction at the time and has yet to report an adverse event.
No adverse event; They applied the second dose on 03Apr2023, 1 year and a half after the first dose; vaccine administered on 03Apr2023 expired on 01Apr2023; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose), EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose) and EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose), EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose) and EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023).    No concomitant medications were reported.     It was reported that patient had received the first dose of the Moderna Covid-19 vaccine 1 year and a half ago.  No treatment medications were reported.
Information has been received from a Medical Technologist (M.T.) concerning a 58 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 03-DEC-2008 was vaccinated with the first 1 mL dose of RECOMBIVAX HB intramuscularly.  On 07-MAY-2009 the patient received the third 1 mL dose of RECOMBIVAX HB (Lot # 663315/1446X) (Thimerosal Free) intramuscularly.  There was no concomitant medication reported.  It was reported that on 09-MAY-2009 the patient developed joint aching, muscle aching and insomnia.  The patient also noticed her "elbow joints popping".  The patient sought medical attention via telephone call.  It was reported that the patient was recommended to take ALEVE.  There were no laboratory diagnostic tests performed.  It was reported that the patient had not recovered at the time of the report.  Additional information has been requested.
12 hours after injection I started with fever and muscle and joint aches.  Also a headache in which I felt like my brain was going to blow out of my skull--lasted about 36 hours.  They were severe enough that I could not get out of bed.  Some relief with ibuprofen and APAP.  I also have a large red mark on my left arm under the injection site that is very sore and warm. Had same symptoms after 2nd injection on 1-30-21 (Moderna 026L20A) but also had diarrhea and vomiting.  Lasted 72hrs and missed 3 days of work
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 64 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 20-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 20-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. Flu vaccine was delivered on 20-Sep-2016 at 13:30 to 14:00 and the refrigerator was reading 10 degrees Celsius that afternoon. On 21-Sep-2016, it was 6 degrees Celsius, on the 22nd it was 10 degrees Celsius and on the 23rd (morning), it was 7 degrees Celsius. One dose was given between 21 and 22-Sep-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in the refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
CLIENT CALLED ON 3/10/21. REPORTS HAS RED/WARM/SLIGHTLY SWOLLEN AREA APPROX  1 1/2- 3 1/2 INCHES ON LEFT ARM AT SITE OF INJECTION.  WANTS IT REPORTED./ 3/15/2021- CALLED TO CHECK ON CLIENT; REPORTS LEFT ARM AT SITE OF INJECTION HAS SLIGHT DISCOLERATION BUT OTHERWISE RESOLVED.  DID NOT SEEK ANY MEDICAL TX.
Within 5 minutes of receiving the shot became dizzy and felt anxious/restless. Voice became hoarse and neck began to hurt. After 20-30 minutes, these symptoms dissipated to be followed by chills and itching on forearms and knees. Called pharmacy and was advised to use Benadryl. Complied. The next morning awoke to an itchy, red, raised rash under arm, extending up inner arm and downward toward breast. Arm tingling down to fingers; three fingers with pins and needles (middle thru pinky fingers). As the day progressed, rash became painful; stinging more than itching. Around 8pm, tongue began burning, lime sunburn or as if exposed to too much citric acid. The next day went to urgent care wherein doctor believes the rash may be shingles. SJS not ruled out. No explanation given for burning mouth. Condition persists 48hrs. following vaccine administration.
78 y.o. female with history of CAD, HTN, HLD, DM, seizure disorder, ovarian cancer, hypothyroidism, depression, aortic stenosis, former smoker, right eye vision impairment, spinal stenosis who presented to Hospital on 1/12/2023 with left sided weakness, found to have a right MCA M1 occlusion s/p mechanical thrombectomy.