chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a certified medical assistant, for the Pregnancy Registry, concerning a 25 year old female with anxiety, herpes, and no drug allergies, and with a history of pyelonephritis (reported as phylonephritis), caesearean section in 2002, chlamydia, 3 previous pregnancies, 1 full term delivery, 2 elective terminations, who on 29-NOV-2007 was vaccinated IM with a first dose of GARDASIL (lot # 659437/1266U) and on 05-FEB-2008 was vaccinated IM with a second dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included EFFEXOR, KLONOPIN, and VALTREX. The patient was pregnant. The patient's last menstrual period was 06-FEB-2008 and her estimated delivery date was 13-NOV-2008. The patient saw her physician for medical attention. On 19-MAR-2008 an ultrasound was performed for viability and the results were viable, the fetal heart tones were positive. On 25-MAR-2008 an ultrasound was performed for a threatened Ab and the results were viable. On 07-APR-2008 an ultrasound was performed due to first trimester bleeding and the results nonviable and a probable spontaneous abortion. On 07-APR-2008 at 8 4/7 weeks from her last menstrual period the patient experienced a spontaneous abortion. The products of conception were not examined. It was unknown if the fetus was normal. The complications during the pregnancy was first trimester bleeding. Illnesses during the pregnancy were Herpes and Ureaplasma urealyticum. The patient's outcome was unknown. A product quality complaint was not involved. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
administration /  of a dose of Menveo to a / patient who was meant to receive the second dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva55da, expiry date 28th February 2022) for prophylaxis.   On 1st July 2021, the patient received Menveo. On 1st July 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were reported as follows: The patient was meant to receive the second dose of Bexsero but received a dose of Menveo, which led to wrong vaccine administered. No further events were reported. The healthcare professional gave consent to follow up.
pt devel clinical chickenpox 1 1/2yr p/vax;dx confirmed by MD;
Light-headed; Pulse rate is higher than what normally was/ from maybe 55 to 65, now, it's running into the 70's; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included being on long time care facility, has hearing problem, and pulse rate abnormal. Concomitant medications included metoprolol tartrate for pulse rate abnormal. Patient got first dose yesterday. Patient felt very good all day long; got the dose in morning and had a good night sleep. But when patient woke up, patient felt so light-headed. Patient took blood pressure several times and it was normal. The other thing that was different a little bit was the pulse rate, which is higher than what normally was with the medication that patient takes for it. Patient takes metoprolol and usually, when patient takes it, pulse rate is anywhere from maybe 55 to 65, now, its running into the 70's. It is not great difference but patient just reporting experience when blood pressure was checked. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Wrong vaccine given. Pt was supposed to receive Moderna 2nd vaccine booster but received Pfizer 1st dose instead. No signs or symptoms noted during observation period.
Extreme fatigue, headache,  dizzy, backache, cold sore.  General weakness especially in lower extremities - started 7-10 days after injection.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 1.0 ml injection, lot#L027432, expiration date 22-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt experienced redness, rash, bruising and a temperature of 101-102F for 3 days. MD told the mom to give her Benadryl and call within 3 days.
A patient received ADACEL instead of Daptacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00551959).  This case involves a five-year-old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot u6621ba and expiry date: 21-Mar-2022) via an intramuscular route in the right thigh for prophylactic vaccination on 25-Feb-2021 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  This was a case of actual medication error due to wrong vaccine administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Got really sleepy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Got really sleepy) and PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) and CPAP (C-pap mask). Concurrent medical conditions included Seasonal allergy, Lupus syndrome since 1997, Scleroderma and Heart valve regurgitation. Concomitant products included PREDNISONE, TRAZODONE, DIAZEPAM (VALIUM), OMEPRAZOLE and LOSARTAN for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced SOMNOLENCE (Got really sleepy) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SOMNOLENCE (Got really sleepy) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.   This case was linked to MOD-2021-193529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.
pt recv vax 26JUL96 & exp n/v w/local rxn;began itching; was worse w/severe n/v & uncontrollable itching-unbearable;when returned to clinic had rash all over body;given DPH & has shallow breathing & responded only when spoken to x 1hr;
arm soreness; redness; itchiness; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (arm soreness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PRURITUS (itchiness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Allergy. Concomitant products included LEVOTHYROXINE for Thyroid activity decreased.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (arm soreness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PRURITUS (itchiness). At the time of the report, INJECTION SITE PAIN (arm soreness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included anti-itch cream.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 14-Jan-2021, DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
angioedema, Not just with the pfizer with other things; lupus flare; smelled the metal I taste; This is a spontaneous report from a contactable nurse (reported herself). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. She had unspecified allergies. The patient medical history and concomitant medications were not reported. The patient experienced angioedema not just with the Pfizer with other things, lupus flare and smelled the metal she tastes on an unspecified date. The patient stated that she had angioedema, not just with the Pfizer with other things (Unspecified Medication), that she probably need to hold up and take the injection and she was trying to make sure when she could receive. It was reported that she was just trying to find out if she was qualified to get the injection because she had angioedema. Patient reported that she has a lot of health issues. She has high dose of metal that she smelled (looked at the ingredients: Mercury) and two hospitalizations with severe reactions. The report was not related to the study program. The outcome of the events was unknown.  Information about lot/ batch number has been requested. ; Sender's Comments: Based on the limited information currently available the causal association between the reported events angioedema, lupus flare and smelled the metal she tastes and the usage of the vaccine cannot be excluded and meaningfully assessed. The case will be reassessed once the information regarding the date of vaccination and event onset, medical history and concomitant medications are reported. 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.
local reaction fo left upper arm sit of injection, 9cm x 6cm area of mild erythema and swelling
"I had a vaccine shot yesterday  booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high but it is okay. I don't know what to do."; "I had a vaccine shot yesterday  booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high but it is okay. I don't know what to do."; I am sick; my arm had blood pressure, it is little bit of high; I have terrible pain in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN0187) via an unspecified route of administration on an unspecified date as dose 3, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that I had a vaccine shot yesterday booster, the third one and I am sick today. At this age my arm had blood pressure, it is little bit of high, but it is okay. The patient underwent lab tests and procedures which included blood pressure resulted as high on an unknown date. The clinical outcome of the events was unknown.  No follow attempts are possible, no further information is expected.
I had a fever for 2 days, headache, and stomach ache. For 2 days a week I had dizzy spells. After a couple of days I reach out to my doctor to get some help. My doctor prescribe me some medicine that I take every other day. I just found out I had COVID. I did found out I had an heart murmur.
mom noticed irritability p/vax;pt recv APAP-1hr later, pt went to sleep;later when mom check on pt pt pale, unresponsive-paramedics were called;pt transfer to hosp where pt later expire (about 3hr p/1st sx)
Patient developed fever to 102 within 24 hours with decreased mentation.  Stopped eating/drinking despite aggressively treating fever.  Was DNR B status.  Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts.   Family wanted only comfort measures with no transfer to hospital.  Patient continued to have fevers to 102-103 range. Patient passed on 1/23 .  Patient did test positive for COVID in early September without significant illness.  She was in usual state of health prior to vaccination.
ER visit notes from 9/20/2019 -Pt had her shingles vaccine @ 1330 today and has felt relatively well until this evening when she started feeling like her tongue was a little thicker and when she looked in the mirror she couldn't see her uvula as well. She has had some nausea. She denies any significant hives/rash, dysphagia, SOB, stridor, chest pain, abdominal pain. Husband notes that her face appears slightly more flushed" -DX: Angioedema, allergic reaction -Treated: Solu-medrol, Benadryl, Pepcid, Epi pen (discharged)  Prednisone 40mg QD
Fever chills like rigors for several hours. Terrible head ache and body pain. Next day just very tired and sore. Third day back to normal!
Pain in left arm radiating to shoulder and chest (5 days). Lymphadenitis, headache x 3 weeks, nausea/vomiting x 3wks. Seen in neurology on zolmitriptan 20mig, ELAVIL, FIORICET, MIGRANOL.
Fever 101, Body aches, extreme fatigue, and unable to perform her daily activities due to body pain
8TH DAY AFTER THE INJECTION, MY ARM FELT HOT, ITCHY AND A LARGE 3-4 INCH HARD LUMP DEVELOPED.  OVER THE REST OF THE DAY, THE SITE TURNED DEEP RED & BLOTCHY AND HOT TO THE TOUCH.
I was diagnosed with COVID-19 on 12/7/2020. My course of symptoms lasted 16 days, meaning I started feeling healthy again on 12/23/20. I am a pharmacist with a healthcare system and they have been offering the Pfizer/Biontech COVID-19 vaccine for essential associates. I received by first dose of vaccine on 12/31/20. On 1/1/20 I woke up with very noticeable muscle aches and fairly profound lethargy, which last 18-20 hours. I was not able to do much on 1/1/21 because of the way I was feeling. I'm not sure if this reaction is normal for patients who receive their COVID-19 vaccine close to their illness/infection with COVID-19, which is why I'm reporting this to the FDA.
Lady came in and got her Covid vaccine at 11 AM. After waiting 10 minutes, she proceeded to go shopping in the store.  About 15 minutes later, she came to the pharmacy and stated she didn't feel well. She sat down.... then her seizure alert dog allerted her of an upcoming seizure. A few minutes later, patient had a mild seizure.
Started with a blister on her hand. It started to get worse I thought it was infected. Few weeks later she has a rash on her stomach and a week later it was on her legs. She was later diagnosed with psoriasis
A report was received from a health professional on 11Dec01 regarding a 78 year old female pt who experienced urinary tract infection (14Nov01), pneumonia (23Nov01), sepsis (unk date) and subsequently died on 06Dec01 after receiving Fluvirin vaccine on 12Nov01. The pt's medical history included Non insulin diabetes mellitus, hypertension, chronic obstructive pulmonary disease, bipolar disorder, glaucoma, anxiety and right hip replacement. The pt was also receiving brimonidine, tartrate, alprazolam, artificial tears, ascorbic acid, clavulin, amphebutamone hydrochloride, docusate sodium, famotidine, ferrous sulfate, furosemide, levothyroxine sodium, rofecoxib, sertraline hydrochloride, olanzapine, cetirizine hydrochloride, paracetamol and insulin. On 12Nov01, the pt received Fluvirin vaccine. Two days later, the pt was hospitalized for urinary tract infection, which resolved on 19Nov01. Then the pt was admitted to hospital for pneumonia on 23Nov01 and discharged on 28Nov01. On 06Dec01, the pt was re-admitted to hospital for an unk reason and died secondary to sepsis on the same day. No death certificate was available. The pt had received a flu vaccine last year without any problem. The reporter has assessed the relationship of study medication to the events as unrelated.
Once patient in waiting room, after a few minutes, patient verbalized feelings of dizziness after receiving Vaccine in L arm.  Given apple juice. Transferred via wheeled chair to private holding/monitoring room. Patient transferred onto gurnee. Pt began to complain of pain and feelings of heaviness in Left arm, given more juice and crackers to eat. Verbalized dizziness occurred with first dose, but one day after receiving. Patient states mild pain began at bridge of nose as dizziness begun.    VS at 1845: BP of 126/82 in R arm. Heart rate 83bpm, Pulse ox 97%.  HOB lowered to 45 degrees per pt request. At 1900, pulse ox 97%. Heart rate 77; B/P 120/80. Verbalizes lesser feelings of dizziness now, but still present..  At 1915 pulse ox 97%. heart rate 73bpm. B/P 126/80. Pt sat up to 90 degrees. Verbalizes tingling remains L arm.  at 1920 patient able to stand up without dizziness, ambulate, and only c/o L arm soreness now. Ambulated in hallway twice before sending home.   Patient stated she was Covid+ in October 2021
Patient was given Prevnar 20 at her visit on 2/1/23 instead of the recommended Pneumovax 23. Parent informed. Discussed incident with Dr. and there are no significant concerns for side effects other than the usual vaccine reactions. Reached out to manufacture for re-vaccination recommendations and they will respond via email with a response within 7 business days.
Left upper extremity extreme pain, erythema, induration. Fevers, chills, body aches. Erythema/induration spread distally towards elbow.
Symptoms onset became very weak and emotional, unable to stop crying, arm very sore, fell asleep in car, couldn't drive balance off. Spent 2 days in bed, did not seek medical advice, friend became ill with similar symptoms two days later.
Redness, swelling and pain for 2 days.  Subsided on it's own.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021 at 11:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 40.24 years. Concomitant product was not provided. On 06-Apr-2021, the vaccine with batch number 044B21A was moved to fridge. On 15-Apr-2021, 18 vials were moved to the clinic. On the same day at 09 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-May-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35-degree fahrenheit. Treatment medication was not reported. This case was linked to MOD-2022-566976 (Patient Link).
Patient complaints of tingling in left hand and tingling of lips 15 minutes after injection. BP 151-99, pulse 97, pulse ox 97%. Benadryl 25 mg 2 tabs by mouth administered. Vitals monitored for an additional hour and the patient denied tingling of lips and hands when leaving the clinic.