chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee who received 1st dose of Covid vaccine 2 weeks ago and then she came down with Pneumonia; This is a spontaneous report received from a contactable other Health Care Professional reported for herself via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that swap from agency. RN (Registered Nurse) had an employee (patient) who received COVID vaccine 2 weeks ago and then she (patient) came down with Pneumonia. The patient was put in antibiotics and Prednisone and they were wondering if the medication that she was on will decrease the efficacy of the vaccine. Relayed information and transferred has 26 calls ahead. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided and considering a plausible temporal association, the causal association between the event Pneumonia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once more information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
(R) deltoid region, red, hot swollen with small circular about 7 mm area with blister like lesions at site of Td booster with larger red, hard tissue surrounding inj site.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old female. Initial information was processed along with additional information received on 23-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: myositis, interstitial lung disease, hypertension, and drug allergy (Drug name was not reported), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered in left arm for prophylactic vaccination. The batch number was not reported and has been requested. On 01-JUN-2022, the patient also received Pfizer drug (unspecified name) for treatment of covid-19 till 05-JUN-2022. Concomitant medications included celebrex (celecoxib), cardura (doxazosin mesilate), prednisone, and verapamil for drug used for unknown indication.  On 05-JUN-2022, Laboratory data included: COVID-19 virus test Negative. On 08-JUN-2022, the patient tested positive 3 days after testing negative (suspected covid-19 infection), and had suspected clinical vaccination failure. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product quality complaint number: 90000237123.; Sender's Comments: V0: 20220640915-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was with a dose of VARIVAX (Merck) 0.5 ml, intramuscular injection. No adverse effects were reported. Additional information has been requested.
after vaccine given by LVN, PATIENT PLACED IN OBSERVATION ROOM. I WAS CAALED BY THE OBSERVATION STAFF. THE PATIENT COMPLAINED OF LIGHT HEADED. I CHECKED BP WITH A FIRST CHECK 230/130 AND A PULSE 115. SUGGESTED FOR THE PATIENT TO GO TO ER, PATIENT DECLINED. KEPT PATIENT UNDER OBSERVATION TILL 0823. BLOOD PRESSURE RECHEKED FOUND 170/85 AND PATIENT ASYMPTOMATIC AT THIS TIME. PATIENT SENT HOMW TO FOLLOW UP WITH HIS DOCTOR
8/16/2021: admitted. Chief Complaint: shortness of breath.3 days of shortness of breath, moderate, worse on exertion, associated with dry irritating cough, also nausea/vomiting, poor oral tolerance, feeling hemorrhoids are irritated. He had some mild cough on 8/11, was at dialysis at the time, underwent covid testing, apparently he was told it was positive just before he was about to go for dialysis on 8/13, was unable to get dialysis, so has missed a dialysis session as well. Diagnosed with Covid 19 viral pneumonia, acute hypoxic respiratory failure.  Discharged 8/23/21. Note: previously received J&J COVID-19 vaccine on 03/10/21 Lot Number 1805029
Site pain radiating down arm tightening in chest and difficulty breathing - treated with albuterol Swelling on entire R side that looked like edema
Patient complains of a "buzzing" feeling in arm/tingling. He states it started immediately after the shot
Per ER RN assessment-chief complaint/Patient perception of problem-Patient states had flu shot this afternoon and thinks he may be having a reaction. C/o mild sore throat, increase in chronic SOB, swelling in lips, red eyes, appears in no acute distress. Has COPD with frequent flare-ups. States is gradually feeling better over last 30 min. Patient left w/o assessment by ER physician. Was not authorized by staff to leave. Symptoms 1. Fever, 2. Angioedema, 3 Tachypnea, 4. Cough wheeze, 5. Hypertension, 6. Tachycardia, 7. Dyspnea; Edema of face ; red eye; fever.
Received Shingles and pneumonia vaccine at 2pm on June 2, 2008 in left deltoid.  (I Had first pneumonia vaccine 5-10 years earlier with no adverse event.  This was first and only Shingles vaccine, so I am assuming the reaction was form the shingles vaccine.  This was my routine yearly Dr. Visit,  I was entirely well,  have had many vaccines with no adverse reactions.)    My fever started at midnight on June 2,  and lasted 3 days,  102.9 and 103.6 orally ,  would break with alternating doses of Ibuprofen and tylenol.  Arm was swollen ,  hard, red and painful into my left arm pit and no rash but itching down over the veins of my left forearm and left wrist.  The last of the fever was in the late afternoon of June 5th 2008.  I had Profuse sweating from start of fever on June 3rd through June 8,  assoc with weakness, I forced fluids and ate small amts. food during the illness,   I had no vomiting or diarrhea during the illness.  Routine labs were drawn on meon the way out of the Dr. Office that day since I was still fasting and my Dr. reported to me that all were normal except I have elevated cholesterol.   I feel fine today June 10 except for weakness but am able to do ADL's.  I did ask my Dr.'s nurse to report this event to VAERS.
Summary of the event: Vaccine was administered after storage at room temperature for greater than 24 hours and greater than 12 hours after first puncture.   Summary of details: Date vaccine moved to refrigeration:01Jun2023 Date/time vaccine was moved to room temp: 08June2023 12:25pm Date/time of first vial puncture: 08Jun2023 at 1:44 PM Date of administration: 09Jun2023 3:48PM Total time at room temperature: 27 hours and 57 minutes Total time past first puncture: 26 hrs and 4 minutes Lot: AS7185B  Fussy and did not sleep well the first night after vaccine, but otherwise doing well.
very hot 101 to 105  temperatures at times but keep down to 101  blood pressure  140 118 80  injection arm hurts a lot massive headache  more on the front " sensitive  to bright lights can't really go outside
Patient tested positive for COVID on 11/23/2021 and died on 11/29/2021
Patient reported difficulty swallowing within 15 minutes of vaccination.  Difficulty increased; patient was transported to ER by EMS.
Febrile seizure; fever. Rushed to ER. Series of test performed. No infection found. Diagnosis was febrile seizure caused by fever spike from vaccinations.
Stomach ache/pain LUQ x 4 hours: no treatment.  resolved on its own Fever and chills between 101.6-102.6 intermittently for 40 hours, treated with q4hours ibuprofen, acetaminophen,plus  increased fluids, sleep, rest, inactivity Light-headed and balance issues with extreme weakness and fatigue: treated with sleep, rest, inactivity Severe aches and pains entire body including all joints: treated as for fever. Especially severe headache with photophobia: treated as above plus wearing sunglasses indoors and closing all drapes, avoiding all light. Most acute symptoms resolved within approximately 40 hours although I continued to have exagerated fatigue, muscle aches and intermittent temperature spikes for the next 08 days beyond initial severe reaction.
One day after receiving second dose of Pfizer COVID-19 vaccine, patient reported chills, muscle aches, headache, diarrhea, breast tenderness/uterine cramping, dizziness. Patient was tested for COVID-19 and was negative. Patient is not currently breastfeeding, pregnant, or menstruating. Patient self-medicated with acetaminophen and ibuprofen. Fever and diarrhea resolved later on 1/8.
Arm is red, hot to touch, and swollen from shoulder to elbow. Called Dr. office, nurse told me to put cold compress on it, and give Tylenol.
Left thigh edematous. Cellulitis status post immunizations. The child was treated in the hospital with IV antibiotics. Upon discharge, the area was slightly red and swelling was still present on left thigh.
Patient received 11/1/06 started with rash 11/2/06 - admit to hosp 11/2-11/3 dx with hsp with arthritis. Later developed hematuria and proteinuria hsp nephritis with nephrotic syndrome. Required renal biopsy. Tx with Prednisone an then Cellcept. Pt also hypertensive requiring Isradipine and Lisinopril.  5/8/07 Received medical records from reporter/provider which reveal patient experienced rash & pain of her buttocks & legs w/swelling of her ankles & knees on 11/2/06  Hospitalized 11/2/06 for HSP.  Rash, pain & swelling improved but continued as of 11/20/06.  Labs revealed hematuria/proteinuria.  Patient had slight weight gain, HTN & decreased albumin.  During this time patient also had several severe nosebleeds & blood noted in stool.  Patient readmitted to hospital on 11/27/06 for kidney biopsy.  Continued to experience HTN & headaches severe enough to be seen in ER.  6/29/07 Received hospital medical records which reveal patient experienced HSP beginning 11/2/06 & was admitted to hospital 11/27-11/29/06 due to worsening creatinine & albumin for a renal biopsy & eval & treatment.  Treated w/steroids & low Na diet.  Initial eval in Renal Clinic 11/22/06 note reveals patient developed purpura, arthritis & abdominal pain on 11/2 following 2 days of LE pain & cramping.  Fatigue, pallor & blood in stools developed few days prior to initial eval along w/puffiness esp of eyes & LEs.  FINAL DX: Henoch-Schonlein purpura nephritis; nephrotic syndrome; s/p left renal biopsy. 1/4/2010 At the time patient off medicaton but still being followed closely by nephrology.
Patient reporting  worsening chest pain x 3 days, headache x 3 weeks, dizziness today
Patient developed aches, chills, sweating, fatigue, and dizziness starting approximately 12 hours after vaccination. Patient reported the dizziness the morning after vaccination resulted in a fall and minor head injury.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Disoriented/Couldn't walk/no balance-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Patient got 2 vaccines (shingrix & flu) on 9/10/22 and felt fine. later on that day he got dizzy and felt disoriented, couldn't walk straight, off balance. The next day 9/11/22 he went to ER bc he thought he was having a stroke and got admitted into the hospital. Patient stated he still does not feel the same and seems like he wants compensation. He wants corporate to reach out to him.
Patient gets pneumonia. Information from 60 day follow-up report states: Patient still has a deep cough! Per the follow up report-Patient now gets pneumonia after bad colds. Lungs have been permanently weaken. Patient never had pneumonia before taking the vaccine. Symptoms started within 3 days after taking the vaccine with pneumonia developing in the left lung.
In the evening after started feeling slightly ill.  In the morning felt flu like but had to go in to work. At that time, achey, headache. Then about 1pm got chills, felt a lot worse. At one point took temp that evening and it was 101.8.  Slept from about 2pm-6:30pm and then from 9pm to 8am.  Fever was gone in morning, felt better. Still feel slightly achey next evening. Do have ache/cramp feeing in left calf.
NAUSEA, VOMITING, FEVER, BODY ACHES LASTING APROXIMATELY 36 HOURS
tachycardia for one week. Resting HR was 120-135, HR increased with activity. highest HR 170.
Sore arm; Chills; This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself. The age at vaccination was not reported. The patient had received 1st dose of Shingrix in September 2020 (date unknown) and she experienced a sore arm and chills.  The reporter did not consent to follow-up. For tolerance to the 2nd dose of Shingrix, refer case US2020250654.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020250654:Same reporter, same suspect, same patient, similar AEs
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 11-NOV-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
outbreak on her right ankle; This case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 16th August 2020, 2 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The patient received dose on Shingrix and on the day of reporting patient experienced a small outbreak on her right ankle of what looks like shingles. The patient asked could the vaccine had cause that.
Information has been received from a women working in a physicians office concerning a 9 year old male who on 5/9/1997 was vaccinated with a first dose in the left arm of varicella virus vaccine live (lot 616498/0417E). On 5/10/2005 the patient experienced and adverse event. The patients sister experienced an adverse event following vaccination with varicella virus vaccine live (WAES0505USA02301). Additional information has been requested.
Stimulation of the Immune system, Palpable Spleen, decreased platelet count from my previous 90,000 to 30.000. Rashes on both legs.
no adverse effects reported- the age of the patient is 17 which is currently not within the guidelines of Moderna
Syncopal episode with four extremity tensing and "jerking" movements. Episode lasted about 90 seconds. Pt. recovered fully following rest and oral intake of liquids.
Itchiness and hives in arms, hands, legs and feet for around five days. I called the hospital to make an appointment. Instead I talked to a nurse, she recommended me to take loratadine. I took loratadine for two days and itchiness and hives were gone.
At 7:15 pm I developed a migraine, chills and low grade fever (99.9) on 01/22/2021.Also, The incision site was red, and hard. Continued to have a migraine, chills and raised fever (101.0) on 01/23/21. Fever went down through out the day on 1/23. Chills and migraine continued. Incision site was more swollen, and redness had expanded to 1.5 inches around injection site. On 1/24/21, woke up at 8:00 am with a low grade fever (99.9). Chills subsided, however migraine continued. At 1:00 pm fever was 100.1, 6:00 pm 101.1, 9:00 pm 99.8. On 01/25/2021, I still have a migraine. Fever is down this morning 98.9 and chills have subsided. Also, the redness on my injection site had gone down. There is still hard area at the injection site. I have been alternating between Tylenol, Motrin for fever and Imatrex for migraines.
Patient began to have fatigue, body aches, and headache 4 hours after vaccine given and intensified over the next 24 hours.  She then developed fevers/chills approximately 12 hours after the dose that continued for 48 hours. These symptoms resolved at approximately 48 hours, but then she noticed a warm, red, itching rash on the inside from shoulder to elbow on the left arm. This rash continued for 2-3 days. During this time she applied diphenhydramine cream and hydrocortisone cream. Rash did resolve. She notified the pharmacy that gave the injection 4 days after vaccine was given about side effects. They recommended benadryl orally, but patient refused.
Shoulder pain; Tenderness under the biceps; This is a spontaneous case, initially received from other health professional on 20-Nov-2018, concerning a 73-year-old, elderly, female patient.  The patient had no medical history and did not receive any concomitant medications.  On 16-Oct-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252663 and expiry date: 31-May-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in 2018, reported as few days later after vaccination, the patient experienced tenderness under the biceps and pain in the shoulder. The patient had no redness and swelling.   At the time of this report, the patient was recovering from the events (reported as feeling better now).   This case is linked to 201805709, due to same reporter.  The reporter assessed the case as non-serious.; Reporter's Comments: A 73-year-old, female patient developed shoulder pain and tenderness on an unspecified date (reported as few days later) after administration of Flucelvax QIVc. The company assessed the causality of the events as unassessable due to lack of information regarding the onset latency. The case will be further assessed upon receipt of follow up information.
No additional AE/No PQC.; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (mL) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W029555, expiration date reported and validated as 14-MAR-2024) as prophylaxis, that was improperly stored and experienced a temperature excursion (product storage error). No adverse effects reported. No additional adverse event (AE).  This is one of several reports received from the same reporter.
Pulsating pain at injection site greater than or equal to 6 days. (Ongoing).
sore arm/arm pain,sore right arm; patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours) and VACCINATION SITE PAIN (sore arm/arm pain,sore right arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours). On 10-Jul-2021, the patient experienced VACCINATION SITE PAIN (sore arm/arm pain,sore right arm). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient received his first dose of Moderna from a vial that was punctured and left in room temperature for more than 12 hours) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm/arm pain,sore right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information was received and Reporter information, patient initial and Date of birth, Vaccine information was updated. On 29-Jul-2021: Follow up received and contains no new information. On 29-Jul-2021: Patient Demographics were updated.Outcome of the event Sore right arm update from Unknown to Recovered.