chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse for the Pregnancy Registry for GARDASIL concerning a 21 year old female with no medical history or drug allergy who on 05-DEC-2008 was vaccinated with the second dose of GARDASIL (0947X). There was no concomitant medication. The patient's LMP was on 14-NOV-2008 and then the patient came into the clinic to receive the second dose of GARDASIL. Before the second dose of GARDASIL the patient was given a pregnancy test which came back negative and therefore the patient was given the second dose of GARDASIL. The patient came back into the clinic on 29-JAN 2009 and the patient found out she was pregnant. The nurse reported that the patient was approximately about a week to three weeks pregnant at the time she received the second dose of GARDASIL on 05-DEC-2008. No AE involved. The patient performed urine pregnancy test. The patient sought medical attention. Follow up information has been received from a registered nurse, concerning the patient with no illness at the time of vaccination or no pre-existing allergies or birth defects on 13-AUG-2008 received the first dose of GARDASIL and on 05-DEC-2008 AM received the second dose of GARDASIL IM on deltoid. The patient with 5 previous pregnancies had 1 full term delivery at 42 weeks from LMP, no pre-term delivery, 1 spontaneous abortions at 16 weeks from LMP, 3 elective terminations at unknown weeks from LMP and no fetal death. There was no birth defects in previous pregnancies. It was unknown if there any infant complications in previous pregnancies. Concomitant therapy included vitamins (unspecified). On 05-DEC-2008 the patient did a colposcopy pasts due for the second dose of GARDASIL. On 05-DEC-2008 pregnancy test was negative - specific gravity of urine was 1.025. The patient returned to office on 29-JAN-2009 and pregnancy test positive. On 23-MAR-2009 the patient did ultrasound for fetal structure scan and results indicated no abnormal findings. On 02-JUL-2009 the patient was treated with KEFLEX 500 mg 4 x/day for 7 days for infection and MONISTAT vaginal suppository x 7 days for yeast. And on 23-JUL-2009 the patient was treated with KEFLEX 500 mg 4 x/day for 7 days for infection. On 15-AUG-2009 the patient delivered a normal boy at 39 weeks from LMP. The boy weight 3628gm, length 15cm, Apgar score 8/9 and head circumference 33. The baby developed tachypnea and presumed sepsis. Course of IV antibiotics for 10 days, the baby was discharged on 25-AUG-2009. The patient developed perianal abscess/troakd during pregnancy. The patient developed severe chorioamnionitis, acute vasculitis and funisitis of umbilical cord during labor/delivery. All prenatal testing were normal during pregnancy. At the time of the report, the outcome of the patient was unknown. No further information is available. The baby's experience has been captured in WAES 0902USA02182B1.
Patient got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19) 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 28-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced COVID-19 (Patient got COVID-19). At the time of the report, COVID-19 (Patient got COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication information was provided.  It was reported that patient earlier received her primary series and 1st booster dose of the Moderna Vaccine.  Treatment was provided as unknown.
Everything was fine until the next day at 11am, when I started feeling foggy, achy, heachahe, chilled, and feverish. Now coming up on Wednesday, 5 days later, I still have a fever that will only stay down if I take ibuprofen, and as soon as that wears off, 2-3 hrs later, I?m having chills and the fever spikes back up to 102.5.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of VARIVAX (Merck). The patient was then inadvertently vaccinated with the first dose of ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of VARIVAX (Merck), "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Eighteen hours afterwards, I kept passing out. Blood pressure and oxygen were low. Stayed on bipap. Poor vision, severe weakness. Slurred speech. Took 120 my mestinon, fluids. regained vision and awareness. Couldn?t stay awake until 6 hours later. Second day, weakness and short of breath.  I should have gone to ER, but need mestinon and fluids. Cannot speak. Felt safer still home. Very confused.
7 out 10 pain at injection site, with noticeable soreness 50 hours later;  headache and body ache; chills, fever (24 hours later: 101.7F); swollen glands;  extreme fatigue: spent most of next 30 hours in bed; intermittently light headed; loss of appetite; elevated pulse.   All symptoms appeared within several hours, and resolved within 2-3 days.  Except that about a week or two later I noticed that my right nostril fills with mucous (snot) 10-20 times a day, ongoing  for past 5 months.
5/17/21 body aches and fatigue in evening,  Slept all 5/18/21.  5/19/21 broke out in rash/hives/itching on neck and head.  Took Benadryl and rash and itching went away after 2 hours.  5/20/21 rash returned on head, neck, torso, arms.  Took 2 Benadryl and symtoms resolved in about 2 hours.  Continue to break out every day including today (resolves with Benadryl).  PCP notified today 5/27/21.
First office visit on 11/19/21-acute frozen shoulder (left), hypersensitivity to posterior shoulder and medial scapula, adhesive capsulitis 11/19/21 start course of prednisolone (8 days total), home mobilization exercises Second Office Visit on 12/8/21- minimal relief with prednisone, pain persists, range of motion has improved with home exercises for frozen shoulder prevention,  myofascial distribution of rotator cuff and trapezius. trial of nortriptyline for pain relief,
Rash spread on back and neck; Rash on her chest; Soreness; Chills; soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills), PAIN (soreness) and RASH (Rash spread on back and neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills) and PAIN (soreness). On 05-Feb-2021, the patient experienced RASH (Rash spread on back and neck). At the time of the report, RASH (Rash on her chest), MYALGIA (Soreness), CHILLS (Chills), PAIN (soreness) and RASH (Rash spread on back and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl.
Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2015, the patient was vaccinated with an improperly stored dose od M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report has been received from a medical assistant regarding a 3 year old male patient. The patient's medical history and concomitant medications were not reported. Concurrent conditions included soy, peanut, egg allergy. On 03-AUG-2017 at 3 pm, the patient received second dose of improperly stored VAQTA lot # N005796 with expiration date: 26-MAY-2018, (dose and route were not reported) in the left arm for prophylaxis (Incorrect product storage). The patient was vaccinated at private doctor's office/hospital and the vaccine was purchased with public funds. No adverse symptoms or reactions were reported.; Sender's Comments: US-009507513-1708USA001493:
Information has been received from a health care worker concerning a 10-12 year old male who in approximately 1996 was vaccinated with Varivax. Recently, the patient experienced chicken pox breakthrough. Additional information is not expected.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided.
Headache, chills, sweats, body aches, fever 102 that lasted 24 hrs-ibuprofen alternated with Tylenol.
redness & swelling began p/pt arrived home in PM 11JAN93; swelling worse, itches; lt thigh-12x10 cm erythema w/faint bluish color in center; warm to touch; referred to family MD;
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/29/2021.
After receiving the moderna vaccine #1, the patient was advised to be seated in the waiting area of the pharmacy. She was accompanied by her father. She passed out while sitting on the chair and her father lifted her legs and called out her name so the other pharmacist on duty and myself immediately ran to the area she was seated and attended to the patient. I brought her a bottle of water and removed her mask. She woke up after a minute, took a couple sips of water and passed out again a second time, minutes later. She was communicating with us and even said she had a dream. She was alert and responsive. I called 911 and asked for assistance. After about 10 minutes or so, the fire department came, checked her blood pressure while seated and standing, monitored patient, and then released her to go home with her father. At 3:45 PM, the second pharmacist called the parents to inquire about her well-being, and they assured us that she was doing well. No follow up is needed at this time.
Information has been received from a medical assistant referring to unspecified number of unspecified patients. Information regarding medical histories and concurrent conditions was not reported. On unknown dates the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency, route and lot# were not reported) which underwent a supported temperature excursion. No adverse experiences were reported. This is one of three cases (MARRS# 1504USA003189, 1503USA005652 and 1504USA003190) from the same reporter. Additional information has been requested.
Burned going in, arm swelled up like a tennis ball, red and hot, tired, chills, sickly
patient recieved adacel today and had also received it on Sep 29, 2019, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 12 years old female patient who recieved DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and had also received it previously the same vaccine (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 29-Sep-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site and again on an unknown date she also received a 0.5 ml dose of the same vaccine  (lot U6638AA and expiration date 12-Apr-2022) via intramuscular route in the right deltoid as prophylactic vaccination.  It was an actual medication error case due to drug dose administration interval too short.  No adverse event reported at the time of reporting.  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 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.; Sender's Comments:  US-SA-2020SA251424:same patient
Within a week after receiving the first round of vaccine I have developed two blood clots in my left leg.; This is a spontaneous report from a contactable consumer (patient)  A 53-year-old male patient received first dose  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 21Jan2021 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient didn't have medical history or concomitant medications. On an unspecified date in Jan2021 within a week after receiving vaccine patient developed two blood clots in his left leg. As treatment patient was currently on blood thinners. At the time of the reporting event outcome was unknown.
Extreme fatigue, whole body muscle aches, hot and cold flashes, migraine, fever, extreme pain at injection site, dizziness and light headed
Pt recvd vax & exp accentuation of Lyme's sx; w/in 2 wks of vax pt c/o fatigue, fever, joint aches & head & neck pain; sx lasted for more than 2 wks;
15 minutes post vax, mom noticed 1 hive on forehead 45 min. later whole body red with hives. Subsequently developed pallor and dusky lips which spontaneously resolved.
21JUN97 noted aching muscle-felt like the flu;c/o pain lt shoulder & elbow & pain in both hips & knees, dry mouth & swollen node in neck;sx gone now x/for pain in lt shoulder;saw MD 23JUN97;
Fever, Nausea and vometing, mental confusion.This is info taken from the patients mom. Stated pt recovered and is now @ her travel destination. Attempted to call the mother back X3 for more specific information without success.
Brand and lot of vaccine: EL9267 Pfizer 2nd dose, CN6200 Pfizer 1st dose given 2/26 @1400 at stadium  Date and time adverse event started: 3/19/2021 @1400  Did the adverse event start after the first or second vaccination?  arm started getting sore in the evening, then legs feels achy, lower back pain, 99.6F, pain in armpit in injection arm left arm, itching to back then dizzy
Patient was vaccinated with Pfizer #1 on 3/28/2021 per his vaccine card.  He received a second dose of Moderna 4/19/2021.  When the scribe applied the sticker to the vaccine card, it showed that the actual dose was Pfizer. This dose was also given a week too early. Troubleshooting: This was missed in screening two times; the scribe and vaccinator did not ask birth date and did not ask to see the vaccine card prior to injection., and the site is doing two different vaccines today. MD counseled the patient.
Redness, swelling, pain, erythema and tenderness 3 inches below (deltoid administration site) in left arm and towards her biceps.  Gradually enlarging over several hours and into the next day.  Pt was administered influenza vaccine same day/time to the right deltoid.  She was seen at follow-up on 10/14/14 at 3:30 PM, and found to have s/sx consistent with cellulitis.  She was given IM Rocephin 1 Gram and oral Bactrim DS one every 12 hours for 10 days and Ibuprofen 800 mg three daily prn pain. Cellulitic margins were marked and pt advised to go to the ER if celullulitis continued to spread beyond the margins.  With treatment the erythema and pain have diminished and the patent is healing without further incident.
Pfizer-BioNTech COVID-19 Vaccine EUA The day after the injection, in the afternoon (so about 36 hours after the injection of the second dose), I started to develop slight chills and fatigue, but no fever. This was accompanied by a mass that developed under my right armpit, about 4-5 cm in diameter and bulging out to the point that I felt it touching my upper arm before I even saw it in a mirror. It was not red, and it was malleable with a small, hard nodule in the center. I used an ice compression and some ibuprofen over a few days, and it has receded about 95% of the way, almost back to normal.
Periodic chest tightness; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 28Apr2021 at 02:00, approximately 36 hours after second dose of vaccine the patient experienced periodic chest tightness. These episodes lasted a second, and occurred randomly. It seemed to get worse when laying down. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as the result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event periodic chest tightness was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had swelling in arm in shich vaccine was administered x 3 per Mom and arm remained swollen x 3 days
I went to the hospital with severe stomach pain that was radiating to my back. It was causing me to have diarrhea, nausea, vomiting. At some point a stool had turned black so they thought I had a GI bleed, but they did a CT scan and they said my colon and my intestine were severely inflamed. I was hospitalized for 3 days so they could give me round the clock antibiotic treatments.  When I was discharged they put me on a 7 day antibiotic. I followed up with my PCP and made him aware of the situation and now I am just waiting for  September 2nd to get a colonoscopy performed.  I am still experiencing the same symptoms. No vomiting, no black stools, stomach and back pain are not as bad.
It was reported that this 50-year-old male received vax on 10/23/98. That same day, the pt complained of fever, achiness and chills.
Pt received additional booster dose of Pfizer, Wife stated that pt hadn't received his second booster.
temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lymph nodes
Pt had injection site rxn following admin. trted with hot/cold compress tneu and APAP. About 2 wks later had dizziness and headache. She attributes this to the PREVNAR 13. Went to ER got DECADRON shot/BENADRYL... then later saw reg MD and told her to just cont BENADRYL saying its still occurring as of 12/19/14.
Fever body ache. headache. drank water & took ibuprofen. went to wrok next day, but got more sick and had Nausea and headache and worsening body ache. developed confusion - brain fog. Then yesterday night s/s got even worse. dizzy, almost near blackout Narrative:  post 2nd dose of Moderna vaccination - employee developed body ache.  headache. drank water & took ibuprofen. went to work next day, but got more sick and had Nausea and headache and worsening body ache. developed confusion - brain fog. Then yesterday night s/s got even worse. dizzy, almost near blackout and felt extremely fatigued. yesterday, 100.4. Today, had ha, extreme fatigue, today, 99.6 and bad body ache and joint pain.
Patient fainted or passed out less than a minute after receiving vaccine.  Heard him asking to get help.  Verified patient was not having an anaphylactic reaction.  Patient had lost some teeth when he hit the floor.  Technician called emergency response number.  Pharmacist sat with patient until they arrived.  Patient stated he still felt dizzy and tired.  When paramedics arrived they evaluated him, but he refused to go with them.  His fiance came and they were going to the hospital on their own.  Pharmacist called patient two days later, and he stated he felt much better, and that he went to the hospital that day to get evaluated and was told he was ok.
only first dose was received/not been able to take the second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only first dose was received/not been able to take the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (only first dose was received/not been able to take the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only first dose was received/not been able to take the second dose) 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.
Had local reaction (redness and swelling) to right arm and left arm at injection sites. Tylenol 120mg PO, Benadryl 5mg PO given with instruction to alternate Tylenol and Motrin. Also to place ice pack on swelling. Also instructed to monitor breathing and temp and redness. Instructed to take pt to local ER in case has any trouble. Redness subsided prior to leaving.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: patient said she began to feel her heart racing and chest tightness during her 15minue observation. paramedics were called to evaluate patient. could be anxiety related but said she did not experience this with first dose.
pt recvd vax 22JUN95 & 17JUL95 pt exp 6-12 lesions all over the body & ulcers in mouth;no further details were provided;
Patient admitted due to worsening depression and suicidal ideation in the context of stopping her outpatient medications. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID-19 vaccine.
pt recvd vax in MAR89 & 8 days later devel t105 & convuls; No further details were provided;
Got the flu shot around 08:20 and then 30-40 minutes later, pt "felt funny"; like she had taken something too strong for her. She was lightheaded and could not drive. She called the health dept. about 10:00 and was advised to see MD. MD placed her on Depo-Medrol and instructed that if she was not better by night, to go to the ER.