chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Chills; Headache; Arm Soreness; Dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 11:45 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Sinus" (unspecified if ongoing), notes: Other medications in two weeks: Sinus-Allergy; "Allergy" (unspecified if ongoing), notes: Other medications in two weeks: Sinus-Allergy. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, product=COVID 19, brand=Pfizer,, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=Mar/2021, dose number=1, administration time=11:45 AM, dose number=1, vaccine location=Left arm), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunisation, reaction(s): "Chills", "Fatigue", "Headache", "Arm Soreness". The following information was reported: FATIGUE (non-serious), outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious), outcome "recovered" (2021), described as "Chills"; HEADACHE (non-serious), outcome "recovered" (2021), described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "Arm Soreness"; DIZZINESS (non-serious), outcome "recovered" (2021), described as "Dizzy". Therapeutic measures were not taken as a result of fatigue, chills, headache, pain in extremity, dizziness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a "23 year old female" with unknown medical history, who was vaccinated intramuscularly with a first dose of Gardasil (Lot # unknown).  Subsequently on an unknown date, the patient experienced nausea and vomiting for two days and was diagnosed with fever (of 101 degrees) after receiving the first dose.  Outcome reported as recovering.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested. 02/17/2010 On 10-OCT-2007, the patient experienced nausea and vomiting and a fever of 101 x 2 days. The signs and symptoms went away without any problems. Unspecified medical attention sought. No product quality complaint was involved. Additional information is not expected.
Breakthrough case admission after 2 vaccines Janssen 5/7/21 lot# 205A21A;  Moderna 12/21/21 lot# 032H21A
redness at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on 28th February 2019, refer case US2019098228).   On 28th May 2019, the patient received the 2nd dose of Shingrix. On 28th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site swelling was recovering/resolving.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient planned to follow-up with her physician. The reporter consented to follow-up.
Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onset of dizziness, nausea, and feeling flushed. He went to Emergency Department for treatment.  He was discharged from the Emergency Department to home.  On 1/12/21 he states nausea and dizziness gone. Slight headache. Feels better.
p/vax pt devel pox;pt had multiple lesions on face, trunk & extremities;pt required a visit to MD office;it was also reported that vaccine failed;
Within 30 days my blood pressure rose to 184/90. I was unaware that my blood pressure had risen, as i only had a constant headache and because I donate blood, I have my blood pressure checked every 60 days or so. I sought treatment from my physician and was placed on Losartan.
Patient complained of extreme arm pain for 3 weeks after shot. Went to doctor who said shot was not given in deltoid muscle. Patient was unable to explain where shot was given. She could not lift her arm for 3 weeks and says it is still not back to normal.
The day after receiving the Moderna booster injection, she began feeling tingling sensations in her feet and legs and legs sometimes feeling cold sensation.  The tingling has persisted for more than 2 weeks, extending up to her thighs and buttocks and she has also felt tingling sensation in her chest wall and left arm.  Symptoms are intermittent and bilateral.  Symptoms have not resolved.  Lab studied pending.  She has been referred to neurology for consult
Facial and lip swelling with increased drooling 3-4 hours after vaccination. Seen in ER, given inhaled and oral steroids. Transferred. No further problems noted but kept overnight for observation. Given oral steroids on 7/29/06 and released. Diagnosis anaphylaxis to MMR/Varicella. 08/23/066-records received from hospital for DOS 7/28-7/29/06 DC DX: Allergic reaction to MMR and varicella             Down's syndrome Symptoms: allergic reaction likely to vaccines that were administered day of admission. Lips swelling, horse voice and drooling. Treated in ER with prednisone, Benadryl and epi/decadron nebulizer. Stridor and wheezing reduced.  Hospital course: continued on room air pulse Ox 96-100%, no respiratory distress and vitals stable. Admitted for observation and discharged. No labs or diagnostic testing performed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: 6n6205), in left arm and on 24Mar2021 as dose 2, single (Lot number: 6p7534) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 18Nov2021 as dose 3 (booster), single (Lot number: 031h21a), in left arm and on 29Jun2022 at 14:30 as dose 4 (booster), single (Lot number: 060a22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Addisons disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient had no known allergies. The patient took Hydrocortisone, Prednisone, omeprisol and Florinef in 2weeks (lot number for all products: Unknown). The patient took COVID 19 Treatment with Paxlovid (Treatment start date: 21Jul2022, Treatment start date: 26Jul2022, Lot number: unknown, Indication: Treatment of COVID-19).
Patient received full COVID vaccine series on 3/9/2021 and 3/30/2021. Patient became symptomatic with COVID symptoms on 7/13/2021. Symptoms include mild productive cough, fatigue, muscle aches, decreased smell. patient was tested for COVID-19 on 7/20/2021 via RT-PCR which returned positive. Patient was offered monoclonal antibody therapy and declined. Patient was seen in Emergency SErvices on 7/23/2021 for increased nausea, vomiting and diarrhea and increasing lethargy. She received IV fluids and Zofran. Oxygen saturations in mid-90s on room air. Patient discharged home. Patient returned to emergency services on 7/24/2021 and found to be significantly hypoxic requiring supplemental oxygen via nasal cannula at 2 Liters. Patient was subsequently admitted to the hospital for additional treatment. Chest x-ray with bilateral patchy infiltrates, being trearted with dexamethason/remdesivir.  Patient remains admitted to the hospital at the time of this report.
Pt reports feeling shaky after receiving this injection of vaccine.  EMT stayed with patient and spoke with her, offered her a cookie and some juice and patient reported feeling better, no concerns. Was sent home with her friend, who drove her to the clinic.
A 12-year-old patient came in with parent for booster dose. He was given the Pfizer pediatric formulation 0.2mL (10mcg/0.2ml). The error was noted while doing data entry. A health department nurse was consulted. She advised the patient be given 0.2mL of the Pfizer 12+ formulation (30 mcg/0.3mL) to get a full dose totaling 30mcg. Nurse and pharmacist apologized to the patient and parent. The second injection (0.2mL of the Pfizer 12+ formulation) given the same day. Patient monitored for another 15 minutes after the 2nd injection and did not have any reactions during the observation period.
healthy pt made funny face, face turned red, appeared to be holding breath; mom determined not breathing, gave couple puffs, dialed 911; pulmonary artery & aorta w/fibromuscular thickening & stenosis; cardiomegaly; pulmonary congest & hem
On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started to used my inhalers and it would give some relief but I was using it more than normal. I had not had asthma attack for more than a year. My asthma is very controlled that I don't use any inhalers whether daily or as needed. I went to work as usual since at that time my symptoms weren't getting worse but also not getting better. On 1/19/21, I was feeling more out of breath and having more dry hacking cough that when I called EH I was told to do the Covid testing. That same day I called my Asthma doctor and did a video call and was prescribed Breo inhaler, spiriva inhaler, xoponex nebulizer treatment and xoponex rescue inhaler. I couldn't go to work because of my shortness of breath and coughing. The treatment didn't work. On Tuesday 1/26/21, I called my asthma doctor again and another video call was made. She changed my inhaler to symbicort, still continue spirirva inhaler and nebulizer treatment. I also contacted my primary doctor who asked that I schedule an appointment with him so he can see me. On 1/28/21, I saw my primary doctor who did blood works to see if I have any blood clot and to see how my heart was doing. I was given phenergan with codeine to help with my coughing and it did help me to go to sleep. My blood works came out negative and he ordered CAT scan of my chest since I can't get rid of my SOB and coughing. I had the CAT scan on 2/3/21. He called me the next day and I was told that I had mucous plugging. He told me to go home and he prescribed Duoneb nebulizer treatment 4x a day and spiriva inhalers 2x a day. I started to get rid of the mucous that I had and started to breath better. It took 4 days of 4x a day nebulizer treatment and inhalers before I started to feel
Patient received a vaccine past the 30 day storage on the refrigerator; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL for an unknown indication.    On 13-Apr-2022 at 1:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 1:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no No.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any known allergies. Patient was not COVID-19 positive withing last month. On 25-Feb-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Patient did not experience any side effects yet. No Treatment information was reported.
This spontaneous report as received from a nurse refers to an 8 months 9 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dos and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. 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 is not expected, no contact details were provided.
No adverse reaction.  Flumist vaccine was administered at 21 months instead of 24 months of age.
2 days after vaccination, patient spiked a temperature of 104 and had a febrile seizure. She stopped breathing and had to be brought by ambulance to ER. Was treated and spent 1 night in hospital.
myocarditis; feeling pain in my body/ pain all over her body; My ribs pain me; can't sleep; sick; I can't hardly use my arms/ I almost lose my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: MYOCARDITIS (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "feeling pain in my body/ pain all over her body"; MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "My ribs pain me"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; ILLNESS (non-serious), outcome "unknown", described as "sick"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I can't hardly use my arms/ I almost lose my legs". The event "myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging heart: myocarditis in my heart; Positron emission tomogram: find it in my heart.  Clinical course: The caller requested information on what to do with myocarditis that happened after receiving the Pfizer Biontech COVId-19 vaccine. Patient got two shots of the Pfizer vaccine and she got one shot of the booster. Every time she went to the ER like she got a heart attack I never get one. Patient had been going on feeling pain in her body. Her ribs pain her. Every real pain just pain. Really can't sleep(?). They did MRI in her heart and they find the myocarditis in her heart they did a PET scan and they found it in her heart. The myocarditis almost killed her. Pfizer should tell people you can get that. She almost lost my life. (Unintelligible) When she took the first vaccination she could walk, the second one she creep. She almost lost her legs. When she took the booster she was so sick. Patient could not hardly use her arms. The caller proceeded to complain about the pamphlet not being sent with the vaccine so people who get it know what could potentially happen to them. Caller mentions that on Tik Tok and you tube are people complaining about adverse events of the vaccine and how they got sick from it. Caller got 2 vaccines and booster, had myocarditis, calling to have that reported. She had myocarditis, in heart, got from Pfizer. She stated, the only thing she called for was to report and saw what she can do for it. Has disease on her body, germs and, pain all over her body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272054 same patient/vaccine, different vaccine dose/event;US-PFIZER INC-202300272055 same patient/vaccine, different vaccine dose/event;
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional (hcp). This hcp reported the same events for 2 patients. This is the first of two reports.  A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 21Dec2020 at a single dose on left deltoid for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient reported to have received the vaccine 3 weeks ago and was scheduled to receive the vaccine yesterday (11Jan2021) but tested positive last Saturday 09Jan2021. He mentioned that he had subsequent symptoms of COVID on 01Jan2021. He and his significant other (S/O) got tested last 05Jan2021. He got a negative result while his S/O got a positive result. He had symptoms throughout the week until he confirmed positive last Saturday. As of this report, he is still in quarantine and is experiencing residual congestion and tiredness. He asked when he should schedule to receive the vaccine. The patient underwent lab tests and procedures which included COVID-19 test: negative   on 05Jan2021, and then positive on 09Jan2021. The patient has not recovered from the events.; Sender's Comments: Based on the available information, a causal relationship between event positive "COVID-19 test with symptoms" (coded to coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021030850 same drug/events/reporter, different patients
arm hurts; felt poorly more than the first time; chill, bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot (Seemed to have trouble breathing and didn't reported anything like that. Like congested.). Past adverse reactions to the above products included Unwell with Flu shot.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills). At the time of the report, PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) had resolved.            No concomitant medications reported No treatment medications reported.   This case was linked to MOD-2021-314548 (Patient Link).
Dizziness; Mild headache; Body aches; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-213958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event outcome was updated.; 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
Shortness of breath, couldn?t walk (legs felt like in cement), lightheaded, and hard to keep eyes open.
FIVE DAYS OF SISTOMES,HEADACHE,MUSCULAR PAIN, CHILLS GANGIOS INFLAMATION ,SWELLING OF LIPS.
Expired covid vaccine give on 9/1/22- Vaccine expired 8/31/22
Patient had two ED visits 3/9/21 and 3/11/21, then presented to the ED on 3/28/21 where he was subsequently hospitalized with severe sepsis.
Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; This is a spontaneous report from a contactable consumer (patient). An 82-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) administered in right arm via an unknown route of administration on 14Feb2021 at 09:45 am as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications in two weeks included Esomeprazole (ESOMEPRAZOLE), Simvastatin (SIMVASTATIN), Ramipril (RAMIPRIL), Amlodipine (AMLODIPINE). Prior vaccination, patient was not diagnosed with covid. On 18Feb2021 at 15:30 pm, the patient experienced severe cramp, left leg at least 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting about 1 hr.  cramps lasted approximately 3-5 minutes each time. The outcome of the events was unknown. No other vaccine was received in four weeks. Post vaccination, the patient was not tested for covid. The patient had known allergies only to Typhus vaccine many years ago.
pt recvd vax & approx 2-3 hrs p/vax pt became red in color, sweating & limp; pt was rushed to MD; MD reported pt to act as though "drugged"; no fever w/color pink to red; observed x 2 hrs in office;
I had a sore throat and a lot of congestion in my nose and the back of my throat. Then I took a home COVID-19 home test on 12/07/2022 and it was positive. I called the doctor and they called in a prescription for PAXLOVID for me. I did have to treat diarrhea after starting the medication. After I started to take the medication, my symptoms improved within 2-3 days. I have completely recovered with no lingering symptoms.
Headache Tiredness Dizziness Nausea Vertigo at night during bedtime.  It would wake me up.  The room would be spinning.  By morning, I was still dizzy, but I was able to function. After 2nd vaccine, I have had SEVERE vertigo 2 weeks after the 2nd injection that has caused me to miss work.  My primary care doctor called in Meclizine.  I also spoke with a vestibular physical therapist who instructed me on the Epley maneuver.  I had 2 days of severe spinning then 6 days of mild spinning and dizziness then a return of severe spinning.  I am on day 12 of these symptoms.