chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pulmonary embolism; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821AA) for COVID-19 prophylaxis.    Co-suspect product included non-company product APIXABAN (ELIQUIS) for Pulmonary embolism.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient started APIXABAN (ELIQUIS) (unknown route) 5 milligram twice a day. On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) outcome was unknown. Not Provided          Treatment medication was not provided by the reporter.  It was reported that eliquis 5mg that was tampered with and is missing 2 pills. she got three 60 count bottles from Walgreen's pharmacy, and on this bottle the safety seal was pulled off and there were 2 tablets missing.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 56-year-old patient female, with body mass index of 37.029, with relevant medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI Pulmonary embolism on an unknown date after receiving the mRNA-1273 vaccine as 2nd dose. Clinical course and treatment details were not reported. The outcome of event was unknown. Patient's high body mass index and concurrent rheumatoid arthritis could be considered as risk factors and co-suspect Apixaban as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 56-year-old patient female, with body mass index of 37.029, with relevant medical history of rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI Pulmonary embolism on an unknown date after receiving the mRNA-1273 vaccine as 2nd dose. Clinical course and treatment details were not reported. The outcome of event was unknown. Patient's high body mass index and concurrent rheumatoid arthritis could be considered as risk factors and co-suspect Apixaban as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
Imaging and labs did not reveal anything obvious except COVID-19.  She was started on remdesivir on admission with the final dose on 3/29 evening.  Patient was safe to discharge from the hospital with supplemental oxygen on 3/28, but ultimately family appealed discharge.  After decision for insurance, patient was ultimately discharged from the hospital on 3/30 completing course of remdesivir.  On the day of discharge, patient had acceptable saturation oxygen without supplemental oxygen at rest.  Supplemental oxygen was delivered to the home on 3/28 and will remain there until proven she does not need oxygen with ambulation.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX. On 7th March 2018, the patient received SHINGRIX. On 7th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and slight temperature. In March 2018, the patient experienced poor sleep. On an unknown date, the outcome of the injection site pain, poor sleep and slight temperature were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, poor sleep and slight temperature to be related to SHINGRIX. Additional details were provided as follows: The patient received her SHINGRIX injection and said that it hurt at the injection site and it still hurts at the time of reporting. The patient was running a slight temperature, it was running 99 and she normally had 97. On the day of reporting, the patient also said that she did not sleep well last night because of the pain.
A nurse reported that a 56 year old female received an injection of Flu Shield (1999-2000 Formula). Subsequently, she developed an injection site reaction characterized by redness, soreness, and warmth which extended to her elbow. The symptoms resolved in 5 days.
I had the PFIZER EW0167, at @1pm on 5/5/2021. Thé second dose was scheduled for 5/26/21; however, I canceled it because of what I went through. Three days after taking the vaccine, Saturday, May 8, 2021, I had four mini-strokes simultaneously. 911 was called and was taken to Hospital. On Friday, May 14, 2021, I had another stroke. After being discharged on Tuesday, May 18, 2021, I returned to the hospital on Wednesday, 28, 2021, with weakness and unable to stand or walk without two assists.  I was very happy it was not another stroke, but my potassium and magnesium were so depleted, that the doctors were trying to figure out what happened. I had three treatments of potassium, two orange drinks and one through intravenous, and four treatments of magnesium with two pills each time. I am afraid to take the second vaccine as I now had six strokes; also, the cardiologist have found that  my heart was spitting out lots of blood clots at an alarming rate, so they had to give me I.V Heparin, now I am on Eliquis. I am asking to look into this, as the vaccine is new. I was excited to get the vaccine, now I am honestly scared. Thank you,
client complained of dizziness after receiving 1st dose of Moderna. Client was sitting in post vaccine waiting room when he alerted EMTs he was feeling dizzy. EMTs  did first assessment. Vitals 0958: blood pressure 110/50, pulse 92, oxygen 97%. Client diaphoretic, face flushed. EMT gave client water. Vitals 1003: blood pressure 130/70, pulse 94, oxygen 97%. Per client feeling better.  joined EMTs. Per client no pertinent medical history or current medications. No history of allergies. Per client had completed 15min waiting time and was getting ready to leave when he felt dizzy. At this time dizziness improving, flushing resolved. Vitals at 1008: blood pressure 140/90, pulse 92, oxygen 97%. PHN asked client if he has hypertension, per client does not regularly follow up with provider. Client alert and oriented, denied chest pain, headache, dizziness improving. 1015 vitals: blood pressure 140/90, pulse 103, oxygen 98%. Per client no complaints, previous symptoms all resolved. Last vitals at 1024: blood pressure 140/70, pulse 104, oxygen 98%. Client alert and oriented, feeling fine, ready to leave. Client did not drive, here with family. Client advised to see primary doctor to follow up on blood pressure and to follow up with them prior to second dose. ER precautions given as well. Client left facility at 1025 with steady gait.
Fever X 2 days 3/15/03, rash 3/17/03, moderate-severe maculo-papular  rash on trunk and neck.
I got Moderna vaccine #2 at around 11:30 am. That day, I felt tired and my arm was sore and felt really hot then really cold. That night, starting at around 11:30 pm, I woke up every hour and was unable to stay asleep, that continued through the morning. Toward the morning, around 3:30 am, I fainted in the bathroom and came to on the floor, luckily, I didnt get hurt on the way down.  I felt crummy that next day and back to normal within 3 days.
Within the first 7 minutes my tongue started to swell and hard to breathe. I was giving benydral and Claritin. Since the vaccine I started having really bad allergies. I also started having issues with hives.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "OSA" (unspecified if ongoing), notes: OSA; "known allergies: Sulfa and all sulfa products" (unspecified if ongoing), notes: known allergies: Sulfa and all sulfa products; "RA" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received covid-19 treatment with anti-viral product, brand Pfizer from 28Dec2022 till 01Jan2023. Increased nasal congestion progressing to fever, chills with severe headache. Tested positive for COVID-19 for second time.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Patient noted to have redness and swelling around inoculation site 1 day after vaccine.
Information has been received from a physician concerning a 15 month old female with no medical history or concurrent condition who on 04-AUG-2009 was vaccinated subcutaneously with the first 0.5 mL dose of MMR II (lot # 663877/0356Y). Second suspect vaccine included a dose of VARIVAX (Merck) (MSD) on the same date. Concomitant therapy included a dose of DTAP on the same date. "About 13 days later (on 17-AUG-2009) the patient "developed a measles-like rash that covered about 80% of her body." The patient sought medical attention by visiting the physician's office. The outcome was unknown. Additional information has been requested.
mom brought pt to clinic 14AUG96 pt lt arm red/swollen @ inj site;t102;instructed to go to MD;pt taken to MD-MD stated pt had excellent immune system that there was some left over from last time;ATB ordered by MD;no pertussis in future;
Patient became ill approximately 2 weeks prior to presentation to the ED. Initial symptoms were cough and fatigue. Patient presented to ED with complaints of hemoptysis and shortness of breath. Patient tested positive for COVID-19 on 10/20/21 as an outpatient. Patient has received a fluid bolus and will be admitted to the hospital.
The Flu Vaccine was administered at 11:30am on Wednesday, 2/18/2009.  On the way home from her CF appointment, I stopped at our Chiropractor's and had her adjusted at 1:00pm. By 3:00pm, patient started with a fever of 100.3.  By 5pm, the fever was at 102.3 and held there until 2:00am, 2/19, when it spiked to 103.4.  At 9:00am on 2/19, it was 104, she was complaining of not being able to breath and that her heart was splitting in two. I took her to the Chiropractor's again and had left messages with her pediatrician and the Pulmonology Dept. She had short rapid breaths and was weak and had no energy to move.  I was instructed by telephone to give her an Albuterol/Pulmocort breathing treatment and then I took her back down to hospital at 1:00pm 2/19 (it's a 2 hour drive), and Dr. did a thorough examination.  Her lungs were clear and open, (probably due to the breathing treatment.)  Dr. could not say if her symptoms were the result of the flu vaccine and said that she probably had the virus before the vaccine was administered, as they have been seeing children in the hospital with RSV, the flu and strep throat.  They gave patient a dose of Children's Motrin, 1 1/2 tsp (for 35lbs), and told me to alternate Motrin and Tylenol every 4 hours.  At 3:15pm when we got home, her temp was 101.7, and went back up to 102.7 by 6:30pm.  After a dose of Tylenol at 6:30pm, her fever dropped to 99.4 by 8:30pm.  As of 7:00am today, 2/20, her fever is at 100.2.  She is still weak, she is having difficulty eating, saying that the food tastes and smells funny.
Patient was getting shorts of breath. Heartrate got elevated. Office had to call paramedics. While getting benadryl paramedics were on the way to the clinic.
Member reported to Staff Immunizations on 24Jul2018 requesting her second dose of Hepatitis A. After reviewing the member's file for immunizations and labs, member was given the Adult Vaccination Screening Form. Member answered "yes" to "Do you have allergies to any medications, food (especially eggs) or any vaccine?" Member's answer: "Ibuprofen". Member also answered "yes" to "Have you taken cortisone, prednisone, other steroids or anti-cancer drugs or had radiation in the past 3 months?" Member answered: "Prednisone, for some nerve issue concerning dental work". Member cleared to receive Hep A. Patient received vaccine without complaint, instructed to wait 15 minutes before leaving. After 15 minutes, member was checked on, who then stated that she was feeling "dizzy and lightheaded". Member attempted to stand, but had an unsteady gait and sat down. Member showed no signs of itching, hives, redness, raising of the site, shortness of breath, chest pain or any other allergic reaction symptoms. After consulting with Health Center nurses, patient was taken into Treatment Room for observation and vitals. Over the course of 3 hours, patient's blood pressure dropped from 109/68 to 99/67. Member stated she was cold, nauseous with sensitivity to light while still feeling lightheaded and dizzy. Patient slept, and noted she felt better afterwards. Vitals retaken to be 110/76. Member received ZOFRAN for nausea. Dr. was the overseeing provider for this encounter, and determined the patient fit to go home Sick in Quarters for the remainder of the day. Patient left with stable vitals.
a red rash appeared on my arm, which was very tender and sore.; It is still tender, although most of the rash is gone; chills; fever; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: En6205 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 26Feb2021 at 01:00 PM (age at vaccination: 76 years), as unknown, a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies Penicillin. Concomitant medications included acetylsalicylic acid (ASPIRIN), paracetamol (TYLENOL ARTHRITIS), vitamin D NOS, and glucose. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Feb2021, the patient experienced chills, fever, nausea, and headache. Two days later on an unspecified date, a red rash appeared on my arm, which was very tender and sore. I had this rash for a week. It was still tender, although most of the rash was gone. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Dose 1: Beginning during the night following the vaccine and lasting about 24 hours: Tenderness and aching around the injection site Dose 2: Beginning during the night following the vaccine and lasting about 24 hours: Tenderness and aching around the injection site, loss of appetite, nausea, lack of energy, headache, cough, sinus congestion. Headache began mid-day and sinus congestion began late-day, on the day following the second dose of the vaccine.
Pt with chiken pox after two dose of vaccine received 11/3/2000 and 6/22/07
About a week after my injection , I woke up with a red swelling on my left arm on Thursday I telemed with my doctor she prescribed a strong antibiotic, On Saturday I spoke to a  2nd telemed because it wasn't getting better,  who added a second antibiotic. On Monday it was definitely larger, about 4 inches by 10 inches, red, swollen, and hot to the touch but not itchy and I contacted Dr., she prescribed the Zyrtec in addition to the antibiotics. It started going down, but it took 2 weeks to go away.
Pt recvd vax in 1988 or 1989 &  did not seroconvert; No further details were provided;
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2015 (reported as during the month of February 2015 vaccine exposed to 48 F) the patients were vaccinated with ROTATEQ (dose, lot number was unknown) which was improperly stored, exposed to 48 F for 26 days during the month of February 2015 (incorrect product storage). No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. No further information was provided. This case linked several cases with the same reporter link. Additional information has been requested.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 74-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 14-MAY-2012, the patient was administered the ZOSTAVAX by a healthcare provider at a physician's office (lot number, dosage and route of administration not provided). On or about 20-APR-2017, the patient was treated by a healthcare provider (not further specified) at a dermatology office for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 24-SEP-2014, the patient was vaccinated with an expired dose of M-M-R II (lot # H017437 exp 20-SEP-2014) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
R upper arm became red and swollen, redness about baseball size. R upper arm swollen lasted approx 2 days. Used ice therapy ibuprofen and loratadine/BENADRYL.
A nurse reported that a 9 mt old female received her 1st dose of Prevnar in her left thigh on 2/24/03. On 2/25/03, the infant developed hives at the inject site. She was treated w/Motrin. No further info was available at the date of this report.
Herpes break out severe and raw  in vaginal and labia area - started taking PRN Valcyclovir for 3 days post breakout which started two days after vaccine.   Severe fatigue four days after vaccine Sore arm day after vaccine Breathing SpO2 dropped to 84% four days after vaccine
30 min. after vaccine developed hives on face, neck, legs and feet. Intense itching on trunk, scalp and arms. Frequency and volume of hives increased throughout the evening and next day. After call to clinic began 10 mg of Zyrtec and made same day apt. to see Dr. Dr. confirmed wheel hives and suggested continued Zyrtec, Benadryl at nighttime, and an H2 blocker. If Hives are still present after two weeks we might begin steroid treatment. Dr. recommends not getting flu shot again.
Body rash 2-3 days following administration of DTaP vaccination. Seen in clinic 12/19/07 wiht improved but persistent rash. Treated with short course of oral steroid.
A report has been received from a Health Professional concerning a Male patient, who had received Nasal FLUMIST (intranasal) on 07-Nov-2015. On 09-Nov-2015, it was reported that patient was not feeling great (Preferred Term: Malaise). Patient further stated that he had FLUMIST on Saturday and thinks this may be contributing. The outcome of the event of not feeling great was unknown. The report was considered to be non-serious by the company physician. Corrected Report 27-Mar-2017: Key ingredient corrected for FLUMIST from FLUMIST to Q/LAIV. Mandatory vaccine reporter and null flavor added. Product type corrected from drug to vaccine. Causality added on associations as per patient's statement. Narrative updated.
VAMS ID 100781798. On the day following vaccine administration, the wife of named individual called to report non-allergic symptoms that occurred approximately 7 hours after vaccine administration. Wife reports that after husband awoke from a nap that lasted about 2 hours she observed him to have bilateral "whole body" muscle stiffness including "legs crossed and could not uncross them" and stiff jaw like a "lock jaw". Lasted 20 minutes and then he was well the following day and beyond. He has a known but unspecified, well controlled seizure disorder but symptoms did not resemble usual seizure activity. Reporter notified usual health care office, and patient was seen by Dr. on 2/8/21. I spoke with his wife who reported symptoms to our office. Wife advised that per Dr. he classified it as a post-vaccination "adverse neurological event". Wife further advised that per Dr., patient can proceed with getting his second dose of Moderna COVID-19 vaccine.
Painful at site, also swollen, itching, hot, and red. Swollen to "size of orange" per patient. 10/26 - felling much better and no longer swollen.
Info has been received from a pharmacist who received a report from an MD concerning a PT who was vax'd in the buttock w/a dose of Hep B vax recombinant and not the buttock has an indentation in it, "just like laying an egg." Unspecified medical attention was sought. Add'l info has been requested.
Bad reaction; Bad reaction/ been feeling sick; Feeling very tired all day; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) on unspecified date for COVID-19 immunisation. On unspecified date patient mentioned that she had a bad reaction after getting 2nd Pfizer vaccine. She has been feeling sick and she was feeling very tired all day. The outcome of the events was reported as unknown. Information about batch/lot number has been requested.
Fever, chills, muscle ache on July 13. On July 17th, chest pain, shortness of breath, pulmonary embolism, bilateral.
generalized body twitches and weakness for 2 days.  HPI  pt is 57 y/o female with PMH of anxiety came in to ER with generalized weakness and body twitchessince yesterday pt tested positive for COVID 19 infection 4 days ago
Moderate/severe swelling, redness and warmth around injection site (diameter of an orange).- lasted 7 days dizziness, sweating, near syncope and tachycardia/palpitations- 2 episodes lasting 1-2 minutes