chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 5-10 minutes after patient received first dose of COVID-19 Pfizer vaccine she lost consciousness for a few seconds. When pharmacist got back out to patient she had already come back to (eyes opening and trying to talk), but was clearly having labored breathing and became pale, began sweating, and her pulse was very faint. Father did not mention any history of fainting at the time, but turns out patient had a similar reaction when getting blood drawn not long ago. Patient appeared to be wheezing and stated she could not breath so 911 was called. EMS took over from there.  After speaking with them, patient was okay after her blood pressure returned to normal (had decreased significantly according to EMS) and was able to lie flat for some time.
Fever, high of 101.7 lasting 24 hours Chills and shaking, lasting 48 hours Muscle pain at site of injection, lasting 6+ days (still ongoing)
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 03-JUL-2016, the patient was treated by a physician at a hospital, for the onset of a severe and painful vesicular rash, which was diagnosed as a shingles outbreak. The patient has been prescribed famciclovir (FAMVIR) for management of her painful symptoms. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Fever, terrible headache, body ache, felt like toothpicks under skin in legs, no strength,  fatigue,  diarrhea,  couldn't stay awake
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 09Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "possible lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Reglan, reaction(s): "known allergies: reglan"; Compazine, reaction(s): "known allergies: compazine"; Imitrex, reaction(s): "known allergies: imitrex". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 05Mar2023 to 09Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116589 same reporter/patient, different product/event;
PATIENT, WAS GIVEN THE 1ST DOSE OF PFIZER VACCINE. FEW MINUTES AFTER THE VACCINE PATIENT REPORTED FEELING DIZZY, PATIENT STATED SHE DID NOT FEEL VERY WELL, AND PATIENT HAS REPORTED HISTORY OF FAINTING AFTER VACCINATION. PATIENT WAS ADVISED TO LAY ON THE GROUND FOR WHILE SHE FELT LITTLE BETTER. HOWEVER SHE STATED SHE FEELING DIZZY, HAS HEADACHE AND REPORTED TINGLE /NUMBNESS IN HER LEGS. AMBULANCE WAS CALLED AND TOOK THE PATIENT.  I FOLLOWED UP WITH THE PATIENT,. PATIENT WAS IN OKAY CONDITION, I SPOKE TO THE  PATIENTS FAMILY MEMBER THEY STATED THAT THE DOCTOR SAID PATIENT FELT DIZZY DUE TO VASOVAGAL SYNCOPE. NO OTHER SIDE EFFECT WAS REPORTED.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L011846 exp. 16-JAN-2017 and lot # L014415 exp. 25-JUL-2017, (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional inofmration has been requested.
Shortly after receiving the vaccination, the patient began to complain about pain lateral to his vaccination site towards his armpit.  I applied a cold pack to the site and the pain resolved itself within 10 minutes.
1st Dose of Heplisav-B Then Received 2nd Dose Engerix-B; Initial Report Received on 13-Jun-2022  A pharmacist reported that a 41-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B as the second dose instead of HEPLISAV-B.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 30-Oct-2021, the patient received the first dose of HEPLISAV-B (Lot # 934967, expiration date 11-Apr-2022, NDC # 43528-003-05) intramuscularly in the left deltoid at a pharmacy.   On an unspecified date in Dec-2021, after having been vaccinated with HEPLISAV-B, the patient received the second dose at the doctor's office but with Engerix-B instead (Lot #, expiration date, NDC #, route, and injection site unknown). The patient did not experience any adverse effects from the doses she received.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
thickening of feet with humira (adalimumab).; psoriasis plaques on elbow and scalp/biggest; Skin fissure/ feet cracking; feet bleeding; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8737), intramuscular on 21Apr2021 as dose 2, single for COVID-19 immunisation; adalimumab (HUMIRA; Solution for injection in pre-filled pen), subcutaneous from 2000 (Batch/Lot number was not reported) at an unspecified dose (Daily dose: 1 in 2 week) for an unspecified indication. Medical history included abstains from alcohol and Non-smoker. The patient had no known allergies. Concomitant medications included pravastatin taken for cholesterol and colecalciferol (VITAMIN D). The patient previously took secukinumab (COSENTYX) and ustekinumab (STELARA). The patient historical vaccine included first dose of BNT162B2 (lot number: ER8729) on 31Mar2021 (at 64-Year-old) for COVID-19 immunisation. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. It was reported that, on an unknown date, the patient experienced thickening of feet with HUMIRA (adalimumab). In 2000, the patient HUMIRA not working. In 2006, the patient experienced hypothyroidism. On 31Mar2021, patient received 1st dose of COVID-19 vaccine. On 21Apr2021, patient received 2nd dose of COVID-19 vaccine. On an unspecified date in Apr2021, the patient experienced psoriasis plaques on elbow and scalp/biggest ones are on the bottom of feet and hands, feet cracking and feet bleeding. The patient was treated with betamethasone dipropionate cream and levothyroxin. The action taken in response to the events with adalimumab was dose not changed. The outcome of the events hypothyroidism, Plaque psoriasis was not recovered, Skin fissure/ feet cracking, feet bleeding was recovered in 2021, whereas unknown for other events. Causality for HUMIRA (adalimumab): The reporter's causality for the event of Humira not working and thickening of feet was not provided. The reporter's causality for the events of psoriasis plaques on elbow and scalp/biggest ones are on the bottom of feet and hands, feet cracking, hypothyroidism and feet bleeding with Humira (adalimumab) was no reasonable possibility.  No follow-up attempts are needed. No further information is expected.
Patient was driving home from the pharmacy when she started to feel chill, feverish and shaking  and unable to speak clearly.  She described her head was going to explode and she wanted to pass out.  She made it home, called us and her doctor.  She was instructed to take Tylenol and Advil and lying down to rest. I called to check on her around 7pm, she was doing better.  Her speak was normal, no more chills.  We will follow up with her tomorrow.
Symptoms included extreme pain in shoulder, weakness and inability to move left arm the morning following the injection. Symptoms worsened over the next 24 hours so scheduled appointment with Orthopedic. The shot administer was being trained how to give the injection, and placed the needle too high and used heavy pressure to get through what felt like impediment.  Extremely painful at the time of the injection.
Two weeks after the second shot I developed burning in my mouth (lasted 3 days), bumps on tongue, swollen tongue still 3 months later. Extremely swollen lymph nodes in neck and very painful. This lasted 5 days. Three weeks after the second shot I lost feeling/use of right arm, left side of face went numb, garbled speech, cognitive issues. Went to the hospital. MRI, ECG unremarkable. Lab work showed high Eosinophils (7x higher than my normal count). Was sent home same day. Next morning I woke up and my eyesight in left eye was blurry.  Optometrist diagnosed 20/40 vision when it was previously 10/20. ANA labs run and came back high at 1:320. I regained function in my arm after a day but have memory issues and severe brain fog some days. For a month following my ER visit I had severe heart palpitations that would wake me up while sleeping. Occasional tingling in extremities. My medications I've been on for 10 years prior to the vaccine I cannot take anymore. They trigger symptoms. I have exercise intolerance and medication intolerance.
PT received booster on 8/27/02, had a reaction from shoulder to write that started the evening of 8/27/02. It got progressively worse, by the weekend the PT was unable to raise her arm. Her mother called the doctor, (see also AR02-18), he advised them to go to urgent care. He added that it sounded like cellulitis. Her arm was red, swollen and tender to touch. Injection was taken from the same vial on AE02-18. 4 shots from the same vial were given - 2 developed reactions; this one ? AE02-18. *Follow up report on 1/22/03: Follow-up info. received on 9/18/02. PT did not go to urgent care as she had thought. PT was doing fine, her arm was still red but her mother had no concerns.
swelling, redness & heat, 9x8cm area over the site of inj persistent over past 3 days since inj started as Dicloxcillin 13OCT95 healing well
Patient became anxious and passed out. ambulance called and performed evaluation of patient at that time he informed EMT that this had happened with previous vaccine
patient was administered vaxneuvance instead of fluarix in error. reported error to family and pediatrician office. vaccine is indicated for pediatric use but was not requested in this situation. monitoring for potential adverse reactions
very large moveable lymph node on left clavicle; whole arm is sore; breast tissue is sore; whole arm and into her breast tissue is sore and into my neck; This is a spontaneous report from a contactable other healthcare professional, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, hypertension, cholesterol high, fibromyalgia. The patient had allergy with mold me flex. Concomitant medications received within 2 weeks of vaccination was reported as 'my prescribed meds'. The patient previously received cefaclor (CECLOR) and clarithromycin (BIAXIN), both for an unknown indication and experienced drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 16:00, the patient experienced very large moveable lymph node on her left clavicle, whole arm and into her breast tissue were sore and into neck. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the event very large moveable lymph node on left clavicle, whole arm and into her breast tissue is sore and into neck were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
First COVID19 shot felt fast heartbeat but seemed to subside in couple hours Second COVID19 shot same fast heartbeat seemed to subside but I was tired. Next day it felt as if someone threw a fast pitch softball at my chest took my breath away seemed to last several minutes then extreme heartburn set in. Very fatigued, heart burn lasted 9 days.  Starting on 4/5/21 joint pain also started in my new hip. On  4/12/21 jaw pain set in at which point  went to urgent care.
no additional AE informantion reported; Nurse requesting information on stability of MMRII dose that was administered after expiration date to a 20 year old female. She confirmed that the vaccine had not undergone any temperature excursions. She did not have the lot number at the time of t; MMRII dose that was administered after expiration date to a 20 year old female.; This spontaneous report has been received from a nurse and refers to a 20-year-old female patient. The patient's medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On 14-OCT-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml, lot  number T034392, expiration date reported and internal validated as 08-OCT-2022, administered for prophylaxis (strength, anatomical site of administration, and route of administration were not provided) (expired product administered). The patient was 20-year-old at the time of vaccination (product administered to patient of inappropriate age). No additional adverse event reported.
Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23; No adverse event; HCP stated they accidentally administered 2 doses after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The patient had no known conditions for relevant medical history, allergy, concomitant diseases and risk factors. The patient did not receive other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23).    No concomitant medication details was reported. No treatment medication details was reported.   This case contains information for the 1st adult patient out of 2 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716780:Patient 2-Adult
Information has been received from a pharmacist referring to 4 newborns (numbered 190, 191, 192 and 193). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperatures dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperatures was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 15-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
I first felt some symptoms on 07MAR2023 congestion post nasal drip, I took an at home COVID 19 Test-Negative, the symptoms were getting worse the congestion became so bad I could not sleep. The morning 09MAR2023 I went to urgent care I was given a flu test and a COVID-19 test the COVID-19 test was positive and the flu was negative. I was prescribed Benzonatate for cough and Flonase along with a Paxlovid prescription. After three doses of Paxlovid I got a real metallic taste in my mouth along with diarrhea, the diarrhea did not last. I continued with the prescription and everything came out ok.
Patient started experiencing chest tightness within 15 minutes of receiving the Pfizer vaccine. He was brought to a private room where he was allowed to remove his mask and drink some water. His BP was taken and was 140/91 and he was given an aspirin 81. Patient was watched for several more minutes and then his BP was taken again at 136/84. He said his throat was feeling tight like "a lump is in my throat." He was asked if he felt like it was closing and he said no and did not want an epipen. The staff offered to call an ambulance, but the patient denied and wanted to drive himself to the ER. He was informed that we wanted him to stay so we could call, but he said no and that he would call us when he got there. Patient called about 15 minutes later and told the staff that he got to the hospital and will  call and update us once he has been seen by a doctor.
Patient received Hep A, HPV & LAIV influenza vaccine at 11:30am. At approx. 2pm received a call that a red raised rash had developed over patient's trunk & extremities.
It was reported that a 20 y.o. female PT received a Menomune A/C/Y/W-135 vax, administered SC in her left arm on 9/17/01 at 7 p.m. At 8:45 p.m. that same evening the PT started itching w/hives on right hand, wrist, neck itching. Benadryl 50 mg per oral was given at 9:05 p.m. Reportedly the PT recovered from this experience.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing), notes: take cholesterol meds. The patient took concomitant medications.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 01Mar2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (Mar2022) Positive, notes: 01Mar2022 after 10 days, 5 or 6 days fine, Then reinfected/Positive antigen; (May2022) Positive; (20May2022) Negative, notes: antigen test. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. The outcome of the event was not reported. The event of shingles was resulting from zoster vaccine live (ZOSTAVAX).
Diarrhea -Currently following the BRAT diet, taking Pepto-Bismal, and drinking water with electrolytes. Day 3.
Onset of heavy, prolonged menses on 6/11/2021. Previously, pt with regular menses, and on birth control pill with no missed doses or changes
she pricked her thumb with the needle; Inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced needle injury, occupational exposure while administering product and exposure via skin contact. On an unknown date, the outcome of the needle injury, occupational exposure while administering product and exposure via skin contact were unknown.   It was unknown if the reporter considered the needle injury to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported she had an accident after reconstitution of Shingrix, she pricked her thumb with the needle. This led to occupational exposure while administering product and exposure via skin contact. The reporter did not consent to follow-up.
Redness on chest and (B) upper extremities. 30 mg Benadryl. Symptoms resolved after 30 min.