chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20/F presents to post vaccination area at 3:23 (1st dose) 5mins (3:28) after she reports feeling very weak, tired, "hot" and some dizziness. Pt AOX4, resp even, skin pwd, speaks in clear complete sentences, denies any other symptoms.  VS#1- 90/50, 100%, 75, 16.  3:58- VS#2 100/70, 99%, 88, 16. Pt AOx4, no signs and symptoms of distress, ambulates with even gait. Able to go home with a problem. RN
This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 14-JUL-2015 the patient was vaccinated with improperly stored M-M-R II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (< 46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with ZOSTAVAX at a university as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt reports onset of R thigh erythema and pain approximately 5 hours after receiving J&J COVID-19 booster dose.  Pt was seen in the ER and diagnosed with superficial thrombophlebitis in a small branch of the greater saphenous vein in the right thigh.  She was treated with ibuprofen and heat. Of note, she does have a history of superficial thrombophlebitis of her left leg that was diagnosed January 2021. Symptoms at that time were not associated with COVD-19 vaccine.
Swelling/Swelling started at the injection site and traveled to the consumer's elbow; Redness/Redness and Swelling started at the injection site and traveled to the consumer's elbow; injection site continues to be sore; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema of extremities were unknown and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient experienced redness and swelling that started from injection site and had traveled to the elbowand injection site soreness, after receiving the 1st dose of Shingrix. The reporter di not have all the information available. The reporter consented to follow up.
first dose of Shingrix over a year ago. / was given on 13Mar2020 / second dose had not been given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th March 2020, vaccine powder lot no: G72Z4; expiry date:13th March 2022, adjuvant lot no:X4225, expiry date: 10th September 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The patient received first dose of Shingrix over a year before day of reporting. The reporter called for information regarding the administration of a late second dose of Shingrix. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The limited patient data shared due to caller having few documents at hand due to records being moved. The reporter did not consent to follow up. As per sales data sheet reported batch number of vaccine powder was changed from G7224 to G72Z4.
she felt a little better but didn't have energy to walk to the car.; her arm got a little sore, hard; her arm got a little sore, hard; total fatigue; a headache that kept getting worse and worse through the day; lymph nodes was very sore; extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.), VACCINATION SITE INDURATION (her arm got a little sore, hard) and VACCINATION SITE PAIN (her arm got a little sore, hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), VACCINATION SITE INDURATION (her arm got a little sore, hard), VACCINATION SITE PAIN (her arm got a little sore, hard), FATIGUE (total fatigue) and HEADACHE (a headache that kept getting worse and worse through the day). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.). On 31-Mar-2021, HEADACHE (a headache that kept getting worse and worse through the day) had resolved. On 01-Apr-2021, FEELING ABNORMAL (she felt a little better but didn't have energy to walk to the car.) had resolved. At the time of the report, LYMPH NODE PAIN (lymph nodes was very sore), DIZZINESS (extreme dizziness), VACCINATION SITE INDURATION (her arm got a little sore, hard), VACCINATION SITE PAIN (her arm got a little sore, hard) and FATIGUE (total fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
20OCT itching & redding of site;21OCT more itching & redding of site w/fever on site;softball size (site) cont for 24OCT;26OCT smaller approx size of pea or little large probable given time
For 3 days after receiving the vaccination, patient was incapacitated. She experienced fevers up to 101, muscle aches, chills, and neuralgia. She went to clinic, and was told to take Tylenol/Motrin for her symptoms. She suspected she had COVID and got tested. It has since been a week and patient is mostly recovered. Although she actually had shingles before, she will not be coming back for the second shot in the dose series.
C/O intense pain to shoulders and arm, headaches and muscle spasms. Went to Dr who diagnosed it as brachial neuritis and gave her pain meds - will be going back to Dr for f/u.
Wakening up around 3AM. Check BP.. always around 151/95. Taking 20mg of Lisinopril AM and PM.. still high with head ache. this morning  a little better 140/88. Just took an aspirin to see if it helps. i have not been taking Aspirin with Xarelto.
Fever; Fatigue; Abdominal cramps; Diarrhoea; Sweating; shortness of breath came with the cough; shortness of breath came with the cough; elevated heart rate; cramping; This is a spontaneous report from a contactable consumer or other non-HCP.   A 73-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6203) via intramuscular route of administration on 03Mar2021, as a single dose for COVID-19 immunization. The patient's relevant medical history included Parkinsons disease and Generic of Parcopa from an unspecified date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Fever, Fatigue, Abdominal cramps, Diarrhoea, Sweating, shortness of breath came with the cough and elevated heart rate. Additional Information: The reporter stated that she was actually calling about for husband. Well, the debate was the reporter wanted to get some advice about husband getting the second dose of the Pfizer vaccine for the COVID-19. She confirmed that it was the Covid19 vaccine of Pfizer. When probed for side effects, she stated that yes, began on the second day from the vaccine, the husband experienced fever, fatigue, abdominal cramps, diarrhea, sweating and also he had cough. Associated with the cough, had shortness of breath. He was sitting and not coughing he was okay, but the shortness of breath came with the cough. Also, he had somewhat elevated heart rate, it was not over a 100 but it was around 99 to a 100 and she did mentioned that, he had a fever right. She stated that he did not had any treatment. She stated that expiration date was not listed on their card. It just list the day that they received it but it did not have an expiration. She also stated that they did went and had the COVID-19 test, the nose swab that was negative. The patient underwent lab tests and medical procedures on an unspecified date which included Body temperature with unknown results and Covid-19 Nasal Swab Test which showed negative result. The clinical outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. .
Muscle aches from (L) shoulder down to his (L) hand. Unable to lift arm without extreme pain - unable to sleep.
strong reaction, lost her kidneyfunction. She's on dialysis; This case was reported by a consumer via interactive digital media and described the occurrence of impaired renal function in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced impaired renal function (serious criteria GSK medically significant). On an unknown date, the outcome of the impaired renal function was unknown.   The reporter considered the impaired renal function to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient lost her kidney function from the vaccine. She was on dialysis for 3 months.  The patient had a very strong reaction and it would never be the same. Follow-up would not be possible as no contact details available.
This spontaneous report as received from a healthcare worker/certified medical assistant refers to 4 patients of unknown demographics. Approximately in September 2015 (reported as within the past 2 weeks) the patients were vaccinated with improperly stored ROTATEQ (lot # K023535, expiry date: 22-MAY-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to MARRS# 1510USA000389 (same reporter link). Additional information is not expected as the reporter did not wish further contact.
Severe headache - persistent x 3 weeks - started after 3rd dose of covid19 shot, persistent back pain/myalgias, and feels her whole body is swollen x 3 weeks. Not improving. Has been taking ibuprofen, naproxen, acetaminophen for pain x 3 weeks w/o improvement.
Pt recvd Engerix-B (vax dates unk) subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Moderna COVID?19 Vaccine EUA Left upper arm pain started mid to late morning on 4/3/21.  Pain increased as the day went on and by evening had limited arm  movement.   Upper arm was not feeling warm and had no swelling or rash at injection site.  Took ibuprofen (600mg) at bedtime.  Pain in arm not as severe but still present on 4/4/21 and 4/5/21 and still very limited movement due to pain upon movement of arm.
22JAN97 fever of 100 to 101-rash;23JAN97 fever of 103.1 was seen in ER-had sz while @ ER-fever was recorded in ER as 104.8;MD states febrile seizure;24JAN97 was seen by MD minor rt ear infect;28JAN97 t102
Discharge Provider: MD Primary Care Provider: PA Admission Date: 9/26/2022 Discharge Date: Sep 30, 2022  PRESENTING PROBLEM: Shortness of breath [R06.02] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: 60 year old male with past medical history of AFib on Eliquis, heart failure preserved ejection fraction, history of severe aortic stenosis status post valve replacement, right bundle-branch block, non-insulin-dependent type 2 diabetes with neuropathy, anxiety/depression, physical deconditioning secondary to peri-prostatic hip fracture who presented to the hospital complaining shortness of breath for 1 week.   In the ER, patient was found new have low heart rate 42, need oxygen 4 L O2 initially.  White count 12.7.  Found to be COVID positive.  CT angiogram was performed rule out thrombotic disease.  CT came back negative for pulmonary embolism but showed showed multifocal patchy central lobular nodules with surrounding ill-defined ground-glass throughout the lungs, most suggestive of small airway infection, a few larger solid nodules at the right lung apex, short-term posttreatment noncontrast CT chest is recommended to ensure expected improvement.  EKG with QTC greater than 500 milliseconds and right bundle blanch block.  He was admitted to the hospital for acute hypoxic respiratory failure secondary to COVID pneumonia.   After admission, patient was started on dexamethasone and remdesivir.  He complained about shortness of breath preceding COVID diagnosis.  Did consult pulmonology who recommended continue with current care of steroids and remdesivir.  Pulmonology also recommend checking sputum culture and procalcitonin level.  Procalcitonin level came back elevated 0.3 and sputum culture came back showing Gram-positive cocci in chains/pairs.  Was started on antibiotics for pneumonia.  MRSA screen collected and ID consulted.  Sputum culture finalized as normal flora.  MRSA screen came back negative.  Id recommended stopping antibiotics.    In terms of low heart rate, heart medications Cardizem and beta-blocker were held and Cardiology was consulted.  Initially Hospital consult but patient follows with provider for his history of aortic valve replacement and therefore was admission cardiology was consulted as patient continues to want to follow with provider after discharge.  Heart rate did improve after holding of his heart medications.  Echo was performed showing normal ejection fraction, no wall motion abnormalities. Losartan 100 mg daily was added for BP control.  Also, added amoldipine 5 mg daily and lopressor 12.5 two times daily for ectopy on tele.    Patient weaned to 2L o2 at discharge at night.  Set up with home O2 at night by rehab.  PT saw him and recommend outpatient PT.   Did send with 5 more days of steroids for covid.    2 week Zio placed at discharge per Cardiology recs. Could also consider nuclear stress outpatient once convalesced from COVID. Hospital said would defer to patient's primary cardiologist.
I had shortness of breath and rash on both arms and left leg as well as both sides near my stomach with intense itching in all the rash areas; I had shortness of breath and rash on both arms and left leg as well as both sides near my stomach with intense itching in all the rash areas; I had shortness of breath and rash on both arms and left leg as well as both sides near my stomach with intense itching in all the rash areas; This is a spontaneous report from a contactable consumer (patient himself). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 06Apr2021 18:30 (at age of 53-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included hypertension and blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE) and losartan (LOSARTAN) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Apr2021 08:00 the patient experienced I had shortness of breath and rash on both arms and left leg as well as both sides near my stomach with intense itching in all the rash areas. The adverse event resulted in physician office visit. Patient had received treatment for AEs; prescription for the itching (treatment/drug not specified). Since the vaccination, patient has not been tested for COVID-19. The outcome of events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Information has been received regarding a case in litigation which concerns a male pt who during the period from the time of his birth through 9/99, was unknowingly injected with Hep-B vaccine recombinant (yeast) (Mfr Unk), Hib conjugate vaccine (Mfr Unk), DPT vaccinations containing the highly-toxic mercury-based preservative thimerosal. The alleged result of 3 vaccinations is that the pt suffers and will continue to suffer the toxic neurological and physical effects of mercury poisoning, extensive pain and suffering, emotional distress, subsequently reduced ability to enjoy life, diminution of future learning capacity and his injuries will cause future expenditure on medical, hospital and related care. Upon internal review, toxic neurological and physical effects of mercury poisoning were determined to be "Other Important Medical Events". No further information is available.
1. IMMEDIATE HEADACHE. DIZZY. AND TIGHTNESS OF THROAT  FOR 15 MINUTES
Headache in about 20 minutes after Vaccination. Next day had headache and diarrhea and by 3rd day has vomiting, chill and weakness which lasted 6 days
Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.
Possible rebound COVID infection. Patient diagnosed with COVID 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022.; Possible rebound COVID infection. Patient diagnosed with COVID 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022.; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 25Feb2021 as dose 2, single (Lot number: EL9267), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "Possible rebound COVID infection. Patient diagnosed with COVID 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: Patient diagnosed with COVID 19May2022; (29May2022) Positive, notes: Had positive test again 29May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: It was reported that, the other medication in 2weeks was Unknown. Adverse event: Possible rebound COVID infection. Patient diagnosed with COVID on 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022. Started with nasal congestion on 30May2022. Never had negative COVID test. no Known allergies.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Initial misuse report received from a healthcare professional on 06 August 2013. An expired dose of MENACTRA vaccine was administered to a patient. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Swollen red and hard area at injection site about 2 inches in size right upper arm possible where DTaP administered per mother per telephone call. Mother did not feel MD follow-up necessary at this time, will monitor arm.
Chronic spontaneous idiopathic urticaria (Hives) covering my entire body, angioedema in lips and fingers, has been continuous since start date.
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 26-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date:30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Left thigh presented w/redness, swelling. Came in office and measued area, receive medications will come back for a follow up.
No adverse symptoms after pt. was administered extra dose of VARIVAX. Pt. received 2 previous doses on 10-16-17 and 5-16-08.
Since the vaccine I have had an increase in duration and times of bouts of Symptomatic Atrial Fibrillation.  I am now having to have surgical treatment of this and before never had symptomatic a-fib.  I have also now been diagnosed with a leaking heart valve which was not present in the past.