chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abnormal menstrual cycle.; Ultrasound finds large cysts; Late one month by 5 days, then Arrived two weeks late- otherwise always 28 days.; This is a spontaneous report from a contactable physician. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 06Feb2021 at 11:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09 Jan2021 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, the patient experienced abnormal menstrual cycle, late one month by 5 days, then arrived two weeks late otherwise always 28 days and ultrasound finds large cysts. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 10Apr2021, the patient underwent nasal swab color test and the result was negative. The clinical outcome of the events abnormal menstrual cycle, late one month by 5 days, then arrived two weeks late otherwise always 28 days and ultrasound finds large cysts were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Left arm from elbow to shoulder hard and painful - also red "bands" noted. Lasted about 4 days.
Numbness in her arm that has progressed to her shoulder, elbow, and now in her jaw; Numbness in her arm that has progressed to her shoulder, elbow, and now in her jaw; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 28May2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28May2021, patient experienced numbness in her upper arm that had progressed, it started in her shoulder and down to her elbow and the part of her jawline just started recently the rest of it had been from the beginning. Patient stated her concern was that she was due to get the second dose on Friday and she wanted to make sure everything was okay to take it and what she was having was typical. Patient was advised to follow up with primary care physician or local health care department for treatment recommendations and medical advice. The outcome of the events was unknown.   Information about batch/ lot number has been requested
Varicella vaccine breakthrough. Developed rash 2-1-06, no fever. Seen in our office 2-3-06 and diagnosed with chickenpox. Had approximately 50 papular and vesicular lesions on trunk, face & neck, 2 scabbed.
Fever up to 102 within an hour after immunization jerking or constant movement of the body awake and asleep around midnight after shot not eating, chills 8-27-15.
11:15 - presents c/o "itching all over", no rash or hives noted. Denies shortness of air. Administered BENADRYL 25mg PO observed x15 min. 11:35 - student remembered getting vaccine this a.m. States itching is getting worse, throat feels numb. Red raised circular areas , approx. 5cm ea, hive like rash noted to right upper arm. Administered oxygen at 4L face mask. 11:40 - administered epinephrine 1:1000 0.5ml IM. 11:58 - transported to hospital via EMS.
Info has been received from a health professional concerning a female pt who in Nov 2002 was vaccinated with pneumococcql vaccine 23 polyvalent (Lot #643782/0675M). Hours after vaccination the pt experienced a red, warm lump at injection site. At 4 days post-vaccination, the lump was still present and measured about 2.5 x 3 x 3 inches in size. Follow up info has been received from a registered nurse concerning a 52 year old female pt, with "stable asthma", who on 11/11/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643782/0675M). It was reported that the vaccine was administered subcutaneously into the right deltoid at 0830 and sometime later that day "in the PM" the adverse event occurred. Reporter indicates that the pt recovered. Additional info is not expected.
Pt. states On/Off nauseous, fatigued, pain at injection site, 2am groin heaviness/bloated 0-fever
swollen lymph nodes under left arm; Arm got red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left arm) and VACCINATION SITE ERYTHEMA (Arm got red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left arm) and VACCINATION SITE ERYTHEMA (Arm got red at injection site). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left arm) and VACCINATION SITE ERYTHEMA (Arm got red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-089091 (Patient Link).
Signed        Patient here for first dose of Covid Vaccine. At about 0730 patient stated that she felt "winded like she ran a marathon". States that she is not short of breath and that she does not have a rapid heart beat. Patient denies any difficulty breathing or itchy throat. Asked patient if she is anxious. Patient states that she does not feel anxious. Upon observation does not appear that she is struggling to breath at all. No rash noted.  Did apply pulse ox to patient. Pulse ox is 92% and heart rate is 72. Patient states that she has extensive allergies and has had this happen before. States that she has had to have benadryl in the past which usually helps. Discussed with lead staff and patient was given 25 mg of oral benadryl. Patient was told that it was recommended that she have a ride home due to taking benadryl. Assessed patient after twenty minutes. Patient states that she feels completely better. States that she lives close and understands that ride is recommended but is fine to drive.
The day following my second dose of the vaccine gave me severe body aches, chills and a massive headache. The 2nd day after the dose the body aches were gone but still had chills and headache and felt weak and short of breath. 3rd day after dose back to normal.
Intermittent episodes (5) of vomiting lasting 10 to 15 miniutes.  Episodes began 2 days prior. Todays episode lasted 30 minutes. History of reflux. On Zantac.  Admitted 6/7/07 to Hospital through the ED. Testing includes Abdominal x-ray, US of abdomen ans CT of abdomen.  On IV fluids to rest bowel at this point.  07/30/2007 Hospital records received for DOS 6/8-12/2007 for a Malrotation Correction.  Child initially presented to PCP with persistant emesis and decreased intake.  Sent to ER for eval and treatment.  PE revealed mild dehydration, protruding tongue,2/6 systolic murmur. GI consult  Infant taken to surgery for an exploratory lap, right colectomy, and LADD procedure. D/C Dx: Malrotation.
I experienced muscle fatigue, severe head aches, joint soreness and an upset stomach for about 24 hours from the onset of muscle fatigue at 2 am on 4/6. My side effects were severe enough I missed one day of work.
Around the 08/18/2021 I thought I was having allergies, I started feeling like my chest and throat were congested. I started having a mild to moderate headache. I started feeling weak and tired. After that I lost my taste and smell and the abdominal pain came on. I went to a mobile clinic and tested positive for COVID 19 on 08/25/2021. On 08/27/2021 I went and had another test done with a positive result. My symptoms have gotten better.
I personally began developing left eye symptoms (eye pain, redness, decreased vision and seeing halos around lights in my left eye only)  on February 21 and was subsequently diagnosed with pretty severe, acute left eye anterior uveitis on February 23. (Thankfully, it appears to have fully resolved with a course of ocular steroid eyedrops.) I received my initial Moderna vaccine on January 4, with my second dose on January 27.   I have never had anterior uveitis before, and of course I have no idea if it is related to my vaccination. I am at increased risk for anterior uveitis as I have psoriasis and I am HLA B27 positive.
Pt has extensive swelling to right upper arm and extending to scapula area with redness.  Pt has difficulty raising arm-has no MD, sent to ER for evaluation.  12/01/03: Attempted numerous times to contact mother per pager # given by her.  No response.  Unable to locate for follow up on ER visit.
VACCINE ERROR: DOSE GIVEN OVER 6 HOURS AFTER VIAL PUNCTURED
Feeling of jitters about 10 minutes after vaccine administration, history of anxiety. Patient refused transport. vitals stable.
IMMEDIATELY AFTER GETTING THE COVID VACCINE, PATIENT BECAME VERY DIZZY AND LIGHTHEADED.  THE IMMUNIZER OBSERVED THE PATIENT FOR NEARLY 45 MINUTES TO AN HOUR TO SEE IF SHE WILL FEEL BETTER. BUT THE PATIENT COMPLAINED THAT THE SYMPTOMS WERE GETTING WORSE. WE REFERRED THE PATIENT TO GO VISIT THE URGENT CARE CLINIC NEXT DOOR AND SEE A PHYSICIAN. LATER, THE PHYSICIAN, TOLD US THAT HE TREATED THE PATIENT WITH PROMETHAZINE AND ONDANSETRON BUT THE SYMPTOMS WERN'T IMPROVING. HE ORDERED MECLIZINE 25MG CHEWABLE TABLETS AND THE PATIENT'S MOM CAME IN TO PICK UP THE MEDICATION. THE PA THINKS IT IS PSYCHOLOGICAL RATHER THAN AN ANAPHYLACTIC SHOCK SINCE ALL THE VITALS WERE NORMAL.
I started to have headaches, there very constants after the vaccine. I kept having headaches weekly and never had before, I saw my doctor because I keep having Tylenol everyday. I went to a doctor and gave me botox, I have another appointment to check on everything and get more of the botox. I still have headaches even after the botox.
Patient reported to Clinic on 5/15/19 w/ 5 day history of conjunctivitis, cough, runny nose and fever. Rash onset the morning of  report- 5/15/19. Patient assessed in walk-in clinic, but specimens not collected. Testing facilitated through Emergency Department the evening of 5/15/19.
This spontaneous report was received from a physician via company representatives and from a support services director, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. There were no concomitant medications provided. On 28-JUL-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "PFS 6x1 10mg/1ml w/o SftySyr" (dose, dose number, route and anatomical location were not reported) lot # J010164 and expiration date 03-MAR-2016. On an unspecified date, the RECOMBIVAX HB had one temperature excursion of 4320 hours. The lowest recorded temperature was 20 degrees Fahrenheit (-6.666666667 degrees Celsius). No adverse effects reported. No product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "Refrigerator (R)". This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a other certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patient were vaccinated with a doses of incorrectly stored ROTATEQ lot # K015816, expiration date 29-MAY-2016, orally. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Hives-gave Benadryl orally. 6 hrs after immunizations-resolved.
The morning after vaccination (about 18 hours post-vaccination), I woke up very dizzy, had a fever, nearly fainted, was weak, and lethargic. This subsided by about 24 hours post-vaccination. My first period following vaccination came one week early, the second period was two weeks late and my period have not been regular since receiving the vaccine. I have always had regular period prior to vaccination.
Information has been received from a pharmacist concerning a 59 year old male who was vaccinated with a dose of PNEUMOVAX 23 (lot 649692/0371P). Subsequently, the patient developed redness, warmth, soreness and swelling at the injection site. Unspecified medical attention was sought. The patient was treated with Augmentin and recovered. It was noted that the patient's physician thought it might be cellulitis. No product quality complaint was involved. Additional information has been requested.
This spontaneous consumer report (initial receipt: 20-Sep-2012) concerns a male patient in his late 60s or early 70s. On an unknown date the patient received a flu vaccine (manufacturer, brand name and lot number were not provided). On an unknown date he also received ZOSTAVAX at a dose of 0.65 mL. A few days after receiving flu vaccine, the patient developed shingles. He sought medical attention. No lab diagnostic study was performed. The event outcome was not recovered.
Patient developed a rash on the arm opposite the injection and generalized itching. EMS was called and patient was given an EpiPen injection at 2:05 PM.
Information has been received from a licensed practical nurse concerning a female who was vaccinated as a child with measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, an antibody test shows that she is not immune to rubeola. Medical attention was sought in the office. No product quality complaint was involved. Additional information has been requested.
shingles in neck forehead and arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced shingles on her neck which has expanded to her forehead and eyes.  The patient was taking an antiviral and was getting better. The reporter consented to follow up and allows contact with HCP.
No adverse reaction. Administered Moderna vaccine for a 17 year old when only authorized for 18 years and older.
72 yo F presented for second dose of Moderna COVID-19 Vaccine.  She had no issues with previous dose. She was on her normal medications and used a single dose of her rescue albuterol inhaler with in 15 minutes of receiving her vaccine.  Immediately following the administration of the vaccine, she began to feels lightheaded. She also felt flushed and her heart was racing.  She started to have feelings of anxiety as well. She was placed in a 5 deg head low position.  On initial exam, her speech was slow and difficult to hear.  She was coherent and able to answer questions and give sxs.  On initial exam she was pale.  Non-labored breathing.  He had a irregularly irregular pulse with a mild tachycardia with a rate in the 110's. She was hemodynamically stable with a BP in the 150's/90's. At this point EMS was called to transfer her to a location which could better assess her.  further history was obtained from the patient including the recent dose of albuterol PMHx of CHF w a-fib and  COPD  She was moved to the procedure room via wheel chair and placed on pulse ox monitoring while leads were placed for an ECG. Her initial pulse ox was 93% and she was placed on O2 at 3l via NC.  Her f/u BP was 120's/70's.  EMS arrived, report was given and she was transferred to their care for transport to ED.
Extreme Chills, Low Grade Fever, Runny Nose, Aching in Legs Motrin and Tylenol
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 09-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 had six temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 256 hours, 0.55 Celsius Degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius Degrees (30 Fahrenheit) for 288 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, -0.55 Celsius Degrees (31 Fahrenheit) for 552 hours, and 1.11 Celsius Degrees(34 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for heart failure within 6 weeks of receiving COVID vaccination.
This spontaneous report as received from a nurse refers to 4 patients of unknown age. No concomitants were reported. On 19-MAY-2014, the patients were vaccinated with VAQTA INJ, lot K000943, expiration date 26-SEP-2016 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 at phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837, 1405USA013338 by the same reporter link. Additional information is not expected.
Client received Moderna (4/2021) for her first series  and now received Pfizer for her second series (7/15/2021)
admitted for indigestion and weakness. Found to have covid. Treatment includes admission, hydration.  assessment,
Information has been received from a medical assistant referring to an unknown of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patient was vaccinated with doses of MMR II (lot#, expiration date, dose and route not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
dry throat; soreness in middle of back; tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat), BACK PAIN (soreness in middle of back), FATIGUE (tired) and MYALGIA (muscle pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter .  Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DRY THROAT (dry throat), BACK PAIN (soreness in middle of back), FATIGUE (tired) and MYALGIA (muscle pain). At the time of the report, DRY THROAT (dry throat), BACK PAIN (soreness in middle of back), FATIGUE (tired) and MYALGIA (muscle pain) outcome was unknown.            Patient did not take any medication to treat symptoms