chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 70-year-old female with past medical history significant for hypertension, CKD stage 3, PE/DVT/Coumadin, diet-controlled diabetes presents to the hospital on 11/03 with complaints of cough.  Apparently her husband also was diagnosed to have COVID-19 and she has noticed increasing shortness of breath cough and weakness and hence presented to the hospital. Patient was noted to have COVID-19, home with the test, chest x-ray showed pneumonia consistent with COVID-19, she was hypoxic needing supplemental oxygen.  She was also noted to have acute kidney injury on top of her chronic kidney disease. COVID-19 pneumonia along with acute hypoxic respiratory failure:  Patient is vaccinated.  Patient was started on Decadron which she received 5 doses of and will finish 10 day course post discharge.  She was started on remdesivir which she received 3 doses of prior to discontinuation.  With supportive therapy, patient was able to be weaned down to room air prior to discharge.  She did have other associated symptoms of poor appetite, poor oral intake (also complicated by the fact that she hated hospital food), generalized weakness etc.. Physical therapy did see her in consultation and recommended subacute rehab which she declined.  She was counseled about risks of falls with home discharge.  Care management arrange home health physical therapy. Acute kidney injury resolved with IV fluid resuscitation, she was strongly encouraged to keep up with oral intake after discharge.  She had poor oral intake while in the hospital. I was not able to speak to her husband who also is admitted in the hospital with COVID-19 and did not seem be doing well as he  sounded distressed. I obtained son's phone number from patient's phone and reached out twice to leave a voice message requesting a call back if any questions. Patient is alert oriented well and is her own decision maker, she seemed insightful of her health issues.  She makes the decision about going home today with physical therapy in spite of my above counseling regarding rehab.  I went over her discharge instructions including following up with PCP in about a week to obtain follow-up labs including INR at that visit. Patient would resume all her home medications, in addition she will take dexamethasone for 5 days. On the day of discharge, patient appeared to be much more clear, which is improvement from 2 days back.  She was aware of her health issues, medications etc.. Only thing she is focusing on the day of discharge is that she wants to go home.  She declined subacute rehab.  She is somewhat irritable, confrontational and really not open for any counseling. Tried to reach out son, left a voice message saying that patient is being discharged per her request
pericardial effusion; pneumonia; UTI; colitis; fully vaccinated with a combination of Moderna and Pfizer vaccines; tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 93-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "unknown" and all described as "tested positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "fully vaccinated with a combination of Moderna and Pfizer vaccines"; PERICARDIAL EFFUSION (medically significant), outcome "unknown"; PNEUMONIA (medically significant), outcome "unknown"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI"; COLITIS (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive, notes: tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19, pericardial effusion, pneumonia, urinary tract infection, colitis. Clinical course: patient was tested positive for COVID on 30Jan. She's fully vaccinated with a combination of Moderna and Pfizer vaccines. Since testing positive, she's had other issues, colitis, a UTI, pneumonia and pericardial effusion. She is moving to palliative care this afternoon. Reporter was not sure if this is necessary to report, but reporter understood that reporter should bring this type of information to light.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On March 18th, 2022, Patient presented for a booster vaccine. Admin staff checked her in and assigned her a "Booster" sticker for Pfizer. Staff saw that today was her 4th vaccine. The other vaccines were given on:  April 27, 2021 Pfizer EW0172   May 14, 2021  Pfizer EW0179   Dec 3, 2021     Pfizer  FJ1620      RN screened recipient and says that the recipient did not disclose any medical history (including immunocompromised condition), medications or allergies. RN said that her first two vaccines were the only ones listed in the documentation system so she believed the recipient was eligible for and was receiving her 3rd dose, which would be a booster as requested. While logging the vaccine in documentation, RN did not see any warning from the system that this vaccine was given only 3 months and 15 days after her 3rd vaccine. CDC guidance says boosters must be given at least 5 months after the previous dose and that an "additional" dose can only be the third immunization, not the 4th.  I contacted the recipient to ensure that this was indeed her 4th and not 3rd vaccine and she confirmed it was. I apologized to her and explained our error according to CDC protocol. I informed her that a VAERS report would be filed.  She replied that she feels fine so far. She also disclosed that she is on prednisone for an immunocompromised condition she declined to disclose.
Heart palpitations occurred four days after injection, went to emergency room on the fifth day. In the emergency room for three hours.  Doctors recorded heart rate and I was given two bags of NaCl. Still occurring but are decreasing in frequency.
Starting at midnight after receiving the vaccine I was vomiting for 20 minutes. I had diarrhea for about two days. I was very achy and nauseated during the next day. The nausea has continued and am unable to eat since given the vaccine. No fever. This has been going on now for 2 weeks. CT done today, with contrast, no abnormals noted.
Red, warm rash under site of injection that appeared the morning of 3-31 that appears to be worsening.  No overall fever or chills.  rash is sensitive to the touch.
Diagnosed with Post vaccine Viral Pleurisy; Chest pain; Not feeling well post vaccine #2; I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath; This spontaneous case was reported by a nurse and describes the occurrence of PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MALAISE (Not feeling well post vaccine #2) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) (seriousness criterion medically significant). At the time of the report, PLEURISY VIRAL (Diagnosed with Post vaccine Viral Pleurisy), CHEST PAIN (Chest pain), MALAISE (Not feeling well post vaccine #2) and DYSPNOEA (I was not prepared for the shortness of breath/ I was having significant air hunger.  am still dealing with abnormal breathing, as well as the sensation of needing to take a deep breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram thorax: normal (normal) No blood clot found in the lungs.. In 2021, Fibrin D dimer: high (High) Very high level..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medication reported.  There was no treatment medication reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swollen, sore rash occurred at injection site; sore rash occurred at injection site; sore rash occurred at injection site; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 05Apr2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On14Apr2021, exactly 9 days after the vaccination, the patient experienced swollen, sore rash that occurred at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen, sore rash occurred at the injection site were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Received vaccination 1/16. Arm was sore for a couple of days. On 1/18 developed red, sore spot on arm, approximately two inches long and wide, located a couple of inches below injection site. That spot went away after a day or two. Then on 1/23 that same spot came back, but itchy and bumpy. The following day on 1/24 it had doubled in size, was still red, and was swollen. By that evening, it had progressed futher down my arm. It is now 6 1/2" long and 4" wide. It is red, raised, slightly itchy, not painful.
?Moderna COVID-19 Vaccine EUA  Nausea onset approximately 19 hours after injection, worsening 21 hours later to frequent vomiting.
It started with a cough that progressed worse as the day went by. I noticed my heartrate was elevated and I was having trouble breathing. I developed a fever of 104 that lasted for 2 days. After that broke, I noticed my cough was still around and my heart rate was still high. A day later I went to the ER where I was diagnosed with Afib and COCP. I had a runny nose and a stuffed up head but not sore throat.
Inadvertently gave expired ACTHIB vaccination to child. Mother informed immediately and she will return patient to clinic on 6-21-18 for revaccination with valid dose of ACTHIB. Mother did not report any adverse effects in the child to this nurse.
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that on 17-MAY-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (Lot L009212, Exp 17-MAR-2017). No adverse effects reported. Additional information has been requested.
On 4/8/21 morning, I woke up and felt a sore arm at the injection site. I started to get a body aches and mild chills in the morning. I was extremely fatigued. Then by lunchtime, I got a stomach ache, and nausea and vomiting. I was nauseous and vomitted from 3pm to 4/9/21 around 6 am. . I took emetrol and drank gatorade to ease the nausea and vomitting symptoms. By 4/9/21 at 8:30 am, I felt normal but a still fatigued, no more nausea, vomiting, and soreness
Redness, swelling, warmth of injection site approx 8cm x 4cm with itching and induration. Appeared about 1 week after injection of Dose 1.
Received meningitis vaccine and PPD. A few hours later, developed hives on legs. Confirmed by doctor's exam the next day.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L023936, exp. date: 15-MAR-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, & Fever Narrative: 1/26/2021 Temp 101.0 Body aches, headache, stuffed up nose, know on arm in location of vaccine.
Pt recvd vax & devel pruritus; w/in 2 hrs pt began to devel hives which eventually covered pt's entire body approx 8 hrs later;
Pt. states that after receiving the 2nd dose of Phizer 03/31/2021, started experiencing symptoms 04/22/2021 of testing Covid=Positive.
9/21/2021 - 4am - 101.4 fever 9/22/2021 - large itchy welt red, warm at vaccination site
Fever, sweating, Migraine headache, rapid heart beat paresthesia in fingers and toes, localized swelling at injection site. Pt was not examined at hospital - went to clinic and NP examined - completing this report based on phone conversation with pt. and NP. Prescription for midrin given to pt. Sent home from Dr. office.
Vaccinations administered im as per protocol. Bilat thighs immediately turned red. Pt awake, alert, crying. Observed pt for 30 min in office. Redness subsided without intervention. 9/10/05 Bilat thighs still reddened around injection sites. Recommended Tylenol infant gtts 1 1/2 gtt fulls every 6 hrs and warm compresses several times this day.
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient.Patient's parent reported no adverse events other than typical ones from covid vaccine. Patient's parent will consider the offer for a replacement booster dose.
Information has been received from a physician assistant concerning a patient who on approximately 25-JUN-2012 (reported as "within a week") was vaccinated IM with a dose of MMR II, 0.5ml, which expired in April 2012. No adverse event reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Patient complains about pain around injection site. Concerned about damage to muscle area. States pain is fairly constant. No visible marks. On follow up call says pain on arm area and is fairly constant. Told patient to see her family doctor and contact us with results.
I received my first dose in December. I conceived around Christmas. I received my second dose 3 weeks later 1/5/21. I subsequently found out about being pregnant on 1/15/21 with an EDD of 9/21/21. On 3/12/21 I underwent early prenatal genetic screening/testing at 12 weeks pregnant, which showed several severe anomalies such as severe micrognathia, absent femurs and underdeveloped/missing lower extremities, skin edema, enlarged nuchal translucency. FISH testing was normal, microarray testing was normal.
I had a heart inflammation in the middle of sleep so I woke up. Had hard time breathing for a bit. I drank some water and went back to sleep.
Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
discomfort at the injection site for a couple of days; lethargy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort at the injection site for a couple of days) and LETHARGY (lethargy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort at the injection site for a couple of days) and LETHARGY (lethargy). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort at the injection site for a couple of days) and LETHARGY (lethargy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment information not provided.    This case was linked to MOD-2021-200328.
Information has been received from a physician concerning a female patient who on unspecified date was vaccinated with her second dose of GARDASIL (Lot not reported).  After vaccination the patient developed injection site reaction, fever, nausea, shortness of breath, muscle aches, weakness and lump in her back.  On unspecified date the patient recovered.   Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; disease recurrance; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 15Feb2021 as dose 1, single (Lot number: 013M20A), in left arm and on 15Mar2022 as dose 2, single (Lot number: 038A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PROPECIA; TRUVADA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "recovering", described as "disease recurrance". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: felt completely better, started to test negative; (Aug2022) Positive, notes: positive rapid covid tests returned. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical Course:Initial COVID symptoms stopped, felt completely better, started to test negative, 48 hours after stopping Paxlovid, mild symptoms returned. 48 hours after that, positive rapid COVID tests returned.  No follow-up attempts are possible. No further information is expected.
Mother reports, 7/17/09 Pt. had redness, swelling, tingling of left arm approximately from elbow to slightly below shoulder, area was very hot. Pt. was lethargic and had a head ache. Most symptoms resolved by 7/19/2009 am. Pt still has pink around injection site as of date of report.
I received my Moderna covid booster shot at Walmart on Mon Nov 8. It was over 6 months since my 2nd Moderna shot (4/1/21).   On Tues Nov 9th notice some upper right chest tightness , it continued each day, but doesn?t get worse. Overall would describe as slight tightness.    Fri Nov 12- Mon 15 noticed some upper left chest tightness, the left tightness went away.   Nov 15 to Nov 22 I noticed the right chest tightness more at night when I first go to bed. Felt a little hard to take deeper breath, it was worse more I thought about it.   I called the office about chest tightness after the booster , forgot exact day, told to go to the hospital if it got worse. Didn't go to the hospital.   ~Tues Nov 23 chest right chest tightness goes away.   Friday Nov 26 thru  Tues Nov 30 noticed some middle/inner right chest tightness. Tightness is in a different location on the right.  Wed Dec 1   noticed some left middle chest tightness. Thur Dec 2 to Dec 3 noticde some upper right chest tightness Sat Dec 4 notices some left inner middle chest Chest tightness moves to from different areas and sometime side to side.  Overall tightness is slight.  I sometime notice it and sometime don't notice.  Throughout I've been able to continue to do my normal daily schedule and exercise (run and sports). Doesn't get worse during exercise.
Woke up in the morning (a.m.) of 04/18/2021 with two breakout lesions/welts on left backside of lower abdominal region, along with one rash on the front of the lower abdominal region of what appeared to be a Shingles (herpes zoster) outbreak/reactivation.  I have never had Shingles before in my lifetime.  I did experience the chickenpox at age 5.  I have not received the Shingrix vaccination because I am under the age of 50 years old.  I instantly went to the nearest Urgent Care and, shortly after 9:00 a.m. I was diagnosed with having a Shingles (herpes zoster) outbreak/reactivation.  The doctor prescribed valacyclovir 1 gram to be taken 3 times a day for 7 days.  I took all doses on time and never missed or skipped a dose.  I completed this course of valacyclovir on 04/24/2021.  The reason for my reporting this adverse event is because I read an article.
Muscle Ache, cough, headache, diarrhea, loss of taste and smell, congestion