chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 004m20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Family history included Hypercholesterolemia (cholesterol increases in pregnancy). Concurrent medical conditions included Sulfonamide allergy and Herpes simplex. Concomitant products included VALACYCLOVIR [VALACICLOVIR] from 2020 to an unknown date for Herpes simplex, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2020 to an unknown date for an unknown indication.   On 29-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Dec-2020 and the estimated date of delivery was 08-Sep-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy. The patient gave birth to 1 neonate.  For neonate 1, the delivery occurred on an unknown date. For neonate 2, the vaginal delivery occurred on 15-Oct-2018, which was reported as Full-term. The outcome was reported as Delivered NOS. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2021, Pregnancy test: positive (Positive) Positive pregnancy test. On 25-Feb-2021, Ultrasound scan: normal (normal) normal growth. On 25-Mar-2021, Prenatal screening test: normal (normal) Normal. On 07-May-2021, Ultrasound scan: normal (normal) normal growth.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception was on 20-DEC-2020 Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow up received on 06-AUG-2021. pregnancy report form  received provided patient demographics, second dose details, concomitant medications, lab tests, pregnancy details and medical history.
Muscle aches.  Nausea.  Cold chills.  Elevated heart ragte.  Dizziness.  Intestinal pain.  Fever.  Headache.
Pts wife stated pt experienced feverish 99. 9, diarrhea, shortness of breathe, cough, and running nose/congestion on 07/05/21. Pts isolation expires on 07/15/21 symptoms resolved. On 07/05/21,Pt was admitted to hospital for shortness of breathe, choking and abnormal color of urine (Red) . At that time, Physicians performed exams and administrated a Covid test and found a positive result for Covid-19 at the hospital. Pts wife continues to share the call to 911 was for abnormal urine , shortness of breathe and choking. Pts wife stated they were not aware of the pt having covid and that there were no close contacts. Wife has been vaccinated. . Pt was transported to another Hospital on 07/06/21 and released on 07/16/21. Pt has not traveled outside/country/state within 14 days of illness.
I experienced the symptoms of brain swelling; Very little, very minor, just tiredness until that time/ Extreme tiredness; I slept for almost 24 hours on and off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 17Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; barbital (BARBITAL), from 17Oct2023 (Batch/Lot number: unknown) to 17Oct2023 at single (dose number unknown, single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN OEDEMA (medically significant), outcome "unknown", described as "I experienced the symptoms of brain swelling"; FATIGUE (non-serious), outcome "unknown", described as "Very little, very minor, just tiredness until that time/ Extreme tiredness"; HYPERSOMNIA (non-serious), outcome "unknown", described as "I slept for almost 24 hours on and off". Clinical course: Patient only got that reaction with that (Barbital) thing. Patient took three vaccinations all at the same time; took Shingrix, Pfizer COVID Vaccine and also took the flu (Unspecified Flu Vaccine); Another one was Comirnaty. Patient wanted to know if there was any barbital in the ingredients whether it was in the actual medicine, vaccine or in the push system and does it had a push system. Patient did not had any flu reaction at all. What they had was like an allergic reaction to a histamine or barbital ingredient and it caused brain swelling and they had a pretty severe reaction (Intent: History). So, wanted to know was there any barbital in the medication for the push system. Patient's current vaccination was on Tuesday. Took barbital, there were everything from caffeine to morphine. So, they had to be very careful but did not expected it in the vaccination. But they thought there was one, because they only got that reaction with that (Barbital) thing. And was trying to find what it was. So, didn't take it again. Patient experienced very little, very minor, just tiredness until that time. Extreme tiredness, slept for almost 24 hours on and off and experienced the symptoms of brain swelling. And was just trying to figure out. was that because they took three at the same time. which they have not done before.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
fever/chills, body aches, relentless headache, nausea for a day, headache for another day
Information has been received from a registered nurse (R.N.) concerning a 4-year-old male who on 04-MAY-2006 was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Four days after the patient received the vaccine, on 08-MAY-2006, the patient experienced swelling and tenderness on the side of his throat. Unspecified medical attention was sought and he was diagnosed with mumps after throat swab was performed for mumps culture. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for COVID 05Mar2023; Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for Covid 05Mar2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mixed Connective Tissue Disorder" (unspecified if ongoing), notes: History of Mixed Connective Tissue Disorder.; "Immunosuppressived" (unspecified if ongoing), notes: Immunosuppressived. Concomitant medication(s) included: MYCOPHENOLATE; PREDNISONE; PANTOPRAZOLE; ATORVASTATIN; NIFEDIPINE XL; CETIRIZINE; CALCIUM. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Mar2023, outcome "unknown", described as "Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for COVID 05Mar2023"; COVID-19 (medically significant) with onset 04Mar2023, outcome "unknown", described as "Body aches, mild fever, sneezing and coughing started 04Mar. Tested positive for Covid 05Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2023) Positive, notes: Tested positive for COVID 05Mar2023. Clinical course: The patient experienced body aches, mild fever, sneezing and coughing started 04Mar2023. Tested positive for COVID 05Mar2023. The patient was taking Multivitamin and Calcium 500mg. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Hives all over, swelling of hands and feet. BENADRYL and DECADRON injections. Now oral BENADRYL and steroid.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not provided. On an unknown date, the patient was inadvertently vaccinated with a single dose of PNEUMOVAX 23, lot # M032635, expiration date 05-MAY-2018 (dose, route and site of administration were not reported) instead of PREVNAR 13. No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received on 03-JAN-2017. Letter attempt to obtain follow up information had been unsuccessful. The letter was returned undelivered. Additional information is not expected as all attempts to contact health care professional were unsuccessful. Sender's Comments: MERCK 1611USA000992:Mfr number.
C/O 2 months of Lt deltoid pain. Pain with sleeping on shoulder and raising arm.
Information was received from a pharmacist who reported that multiple "newborn unknown patients" were administered improperly stored pediatric RECOMBIVAX HB ("2.5/0.5") on 13-JAN-2017 (lot number and route of administration not provided). No adverse effects reported. Temperature range/time frame reported as: > 32F but < 36F for 2 hours, and 1 cycle below 32F for 30 to 45 minutes. No further information provided. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009402.
A few minutes after immunization,  patient stood up from chair and fainted after he fell to the ground on knees; then  hitting left cheek on the ground. He quickly regained conscious in 3 seconds and was oriented to person, place and date. He was able to move all extremities and neck well and 5/5 strength; no misalignments, asymmetry or defects. Left cheek was slightly swollen and slightly tender.  Breath sounds clear and abdomen soft and non-tender.  He remained lying on the ground for 15 minutes BP 100/70 HR 120. An ice pack placed on his cheek. After  sitting in the chair for 15 minutes and drinking approximately 12 oz of water, he stood for 2 minutes and was without dizziness BP 100/80. Patient declined going to the ER at this time; discussed warning signs and when to go to the  ER and when to f/u. Patient walked out of the clinic in a stable condition with father.
This spontaneous report as received from a male consumer of unknown age refers to himself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. The patient reported that he received the ZOSTAVAX vaccine being immunosuppressed from CLL (Chronic lymphocytic leukemia) Leukemia was now needed X-rays for an unspecified reason. Additional information has been requested.
Information has been received from a healthcare professional and a RN concerning a 46 year old white female receptionist with no known drug allergies who on 12/06/03, at 08:10, was vaccinated IM in the right deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). Concomitant therapy included "routine unnamed medications". There was no illness at the time of vaccination. The RN reported that on the evening of 12/09/03, the pt developed arm pain. On 12/10/03, the pt developed increased pain and redness in the left upper arm. The pt went to a healthcare facility and was subsequently hospitalized as a diagnosis of cellulitis was made. At that time, the pt was started on IV Unasyn. While hospitalized, a CBC and blood cultures were performed (results not available). The pt remained hospitalized for 3 days and was subsequently discharged from the hospital to home on Augmentin. At that time, the pt's cellulitis was considered to be resolved. It was noted that the pt's physician was concerned about this particular lot #. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The health care professional also reported that another pt developed swelling of the arm after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0312USA01690).  No further information is available.
Immediately felt like he was going to pass out.. But drove home and went to bed. Went to Doctor for reg check on 9.1 when he went to the Doctor for his reg check... He'd lost about 35lbs. He drives few hours that day... Was told not to worry, to go ahead and get 2nd shot but to wait a few addl weeks before doing that. Thursday 9.2, very bad tendinitis in rt leg... Had to use a walker to walk around the house.. Fri 9.3, that cleared up, but jaws were very sore and very difficult to open mouth. Saturday 9.4 that better, but rt shoulder and arm were very sore and heavy.. Unable to move them. Cancelled his trip traveling. Sunday that cleared up, but still not feeling well.  Stayed in bed most of the time, drank only water and ate chicken noodle soup.. Occasional watermelon. On mon 9.13 fell off of bed.. Too weak to get up... Fire Dept had to assist. Slept almost constantly that week.. Didn't answer phone or text.. When he did answer he was very weak and said he was going back to sleep.  concerned that he wasn't eating /drinking much.. began adding Pedialyte to his water. Night sweats... Fan off and on 4 or 5x night. Unable to even get up to go to bathroom. not doing well, too tired, weak to go to Dr.  Night sweats continued.  Urine output was decreasing and darkening in color. .. He hardly got out of bed.  Someone always stayed at home with him. Ran fevers up to 102, but ox was always in the 90s 9/27 he  attempted to go to bathroom and  collapsed onto the floor with his knees buckled under him.  After several attempts to get him up, called 911. When they got to the bedroom he fell once again before getting into bed.   The next day called Dr just to see his advice. He said we could come in or go to er., probably best to go to  ER. unable to get him to car, called 911. EMS transported to ER. Additional symptoms after being admitted. Paralyzed tongue, Inability to swallow Difficulty talking Sever pain and swelling in feet legs Delirium Inability to get legs to function Severe swelling redness hot to touch and painful  on leg that would move to waist and back areas. Did not test positive  as an infection.
pt vax a few yr ago subsequently exp a rash & ``a very high fever''. pt sought unspecified medical attention
STARTED HAVING REDNESS, SWELLING, ITCHING, AND 5/3 AND FEVER ON SATURDAY ; WENT TO ER 5/6/07; ALSO STATES HAD COLD AND FEVER YESTERDAY; WAS GIVEN ANTIBIOTICS-BACTRIM; AND BENADRYL
Arm soreness began a couple of hours after injection. Tiredness, mild headache and chills began around 9pm. Fever of over 103 by 3am the 27th. Severe headache, nausea, fatigue and fever remained for multiple days after. Sunday the 28th extreme all over body muscle pain, soreness and sensitivity to the point any touch seemed painful. Fatigue (severe) and headache persisted throughout the next week with shortness of breath starting on Tuesday the 30th. Thursday morning 12/2 shortness of breath was so severe couldn't speak or walk much without feeling as if chest was being crushed and lungs couldn't fill with air. Body felt extremely heavy as if it were difficult to move or raise arms. Dr had me come in to his office and called ambulance for transport to hospital after seeing me. ER completed chest xray that was normal, ruled out heart attack with blood tests that were mostly normal with the exception of somewhat low calcium, along white and red blood cell counts etc. I was released from ER that night, advised to rest and go back with any worsening symptoms. Also recommended a viral panel and Covid test be ran of which my PCP completed on Friday 12/3 with all showing negative. Fatigue, headache, nausea and low grade fever continued through Monday 12/6. Fatigue and low grade fever again 12/7 and today but not as severe. Headache was pain but also felt dizzy and lightheaded.
Initial report was received from a healthcare professional on 15 November 2011. A 59-year-old female patient had received an Intramuscular (IM) injection of FLUZONE; lot UT492AB in left deltoid on 27 September 2011. On the same day of the injection, the patient developed a sore arm and unable to move or lift arm without discomfort. The reporter stated that the patient felt "a snap" when the needle was inserted; she thought that the injection "was too high" in her arm. The patient has not seen her own health care provider. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Severe side effects & worse after the second one & i have blood / side effects; For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe side effects & worse after the second one & i have blood / side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe side effects & worse after the second one & i have blood / side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car). At the time of the report, VACCINATION COMPLICATION (Severe side effects & worse after the second one & i have blood / side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (For the past 2 weeks unable to go to work & For the past 2 weeks I am unable to drive my car) outcome was unknown.            No concomitant medications were provided.  No treatment medication were provided.   This case was linked to MOD-2021-239039.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up information received  contains non-significant information
Patient experience dizziness following 2nd pfizer covid shot while sitting down during the 15 mins observation period.  Patient advise to lie down and subsequently felt better although paramedics were called as a precaution
Administered Menactra vaccine,  seconds  later  patient  stated she  felt "woozy", laid her head back against  the wall  and had syncope. Lasted approx 20 seconds and she came to.
2hr p/vax mom reported that pt had an episode of apnea;this was followed that noc by t106.7;
A healthcare professional reported that a 26 year old female patient received an injection of Flu Shield on an unspecified date. Approximately 12 hours after receiving the injection she developed an elevated temperature and an injection site reaction characterized by redness and swelling. The reporter indicated that the patient was treated with Tylenol and ice packs. The patient's concomitant medications include a birth control shot for contraception.
Patient received Moderna COVID19 Vaccine on 8/31/22 that was expired on 8/27/22.
pt received vaccine on 1/7/2021. He had soreness at the injection site following the injection. He has been having fatigue, malaise, decreased appetite and low grade fevers that occur at night since the injection. He feels fine most of the day but after leaving work mid to late afternoon, feels very fatigued and no interest in evening meal. Low grade fevers in low 100's in the evening and night sweats. has been self medicating with Tylenol for symptoms. No URI symptoms. Hx of COVID 19 virus in July 2020
Moderna COVID-19 Vaccine EUA administered at 10:59 am on 1/16/21. Felt ok for the remainder of the day. Awoke at 1:25 am ith severe pain in left arm injection site, headache, nausea, fatigue, muscle and joint pain throughout body, chills and low grade fever.  these symptoms persisted until mid-afternoon on 1/17/21 and gradually subsided i took ibruprofen and drank water.  Finally ate a slice of toast at 5 pm and noticed the pain at injection site was improving. 12 hours later, feeling ok but still fatigued.
Patient came to the pharmacy on June15, 2019 complaining of a couple of small blisters under his left armpit that looked like shingles blisters. Patient stated that they started developing on Wednesday, June 12, 2019. He also claimed he was suffering from a headache at the time of presentation. Patient did not state that the blisters were itchy or painful. Patient went to an urgent care clinic and was prescribed Valtrex and prednisone.
Onset of lightheadedness 4/10/2021 and has continued since. The feeling is constant, from the time I awaken in the morning until I fall asleep again in the evening.
pt states the same day she took the vax when she went to bed she had the chills.  When she woke up she still had chills, had 100.1 fever and was very fatigued.  Pt took Tylenol and Emergent C packet and a throat lozenges.  She had a sore right arm that was red and warm.   She used cold compresses on it which helped.  Pt says her symptoms were gone by  the first day.  On 3/31/20221 pt had a herpes simplex type rash develop  all over her body and on this inside of her palms.   Pt started using Acyclovir medicine to treat this.  Pt still has these symptoms.
1/15/23 I had a cough and congestion, like a cold. Shortly after that I lost my taste and smell. It progressed. I went to the doctor, and he felt it was just allergies and told me to continue to take my allergy medication and allergy spray. I went to my ENT doctor on 3/31/23. He started me on AUGMENTIN to clean up the infection in my face and I go back to the ENT doctor on 4/21/23.
Initial and follow up information has been received from a registered nurse concerning a 15 year old female patient who on 30-APR-2010, was vaccinated IM in the left deltoid with the third dose of GARDASIL (Lot No. 665607/1333Y) at 14:30 PM. It was reported that the patient was nervous before vaccine administration. The patient was sitting up during administration and the patient "passed out" and lost consciousness for 10-15 seconds. The patient was observed for 10-15 minutes. The patient's blood pressure reading during the loss of consciousness was 78/50 with a pulse rate of 60. The patient was alert but slightly disoriented immediately.. The patient was placed supine, and orange juice was given. ON the same date, the patient recovered from the event. By the time the patient left the office, the blood pressure reading was 96/70 with a pulse rate of 80. The patient was discharged with mother in stable condition. Additional information is not expected.