chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed visiting nurse concerning a 32 year old female registered nurse who on 30-JUN-2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # "VA304A42B") in another country. The patient has a vaccination record that reports that a varicella vaccine was administered on 30-JUN-2004. The name on the vaccination record was "Varilrix," but the record is a copy of a photocopy and not clear. The patient on 26-MAR-2007 had negative antibody titer for varicella. The patient reported that a second dose of varicella vaccine was done, but no record was documented. No symptoms or problems were reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the licensed visiting nurse who reported that the patient had received a second dose of varicella virus vaccine live (Varilrix) (lot # VA304A42B") on 23-AUG-2006 and was said to have negative antibody titer for varicella. It was reported that the patient recovered. No other information is expected.
Cold; Bloody shot eye; Burning sensation underneath her eyes; General body pain; Jaw ache; Chills; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain) and PAIN IN JAW (Jaw ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain), PAIN IN JAW (Jaw ache), CHILLS (Chills) and FATIGUE (Exhausted). At the time of the report, NASOPHARYNGITIS (Cold), OCULAR HYPERAEMIA (Bloody shot eye), EYE IRRITATION (Burning sensation underneath her eyes), PAIN (General body pain), PAIN IN JAW (Jaw ache), CHILLS (Chills) and FATIGUE (Exhausted) outcome was unknown.            Treatment Medications and Concomitant Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUNE-2021 and does not contain any new information
Child returned to clinic 2 days after vaccination with fluid filled blisters to trunk, head and arms, diagnosed with vaccine induced varicella.
Died in his sleep; This is a follow-up spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported a 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that a 16-year-old boy died in his sleep after receiving his Covid-19 vaccine per Caller. Caller thinks it was the Pfizer Covid-19 vaccine. States that people died and adverse events happen after receiving the Pfizer Covid-19 vaccine.  Regarding the 16 -ear-old male, caller is asking how could that happen to a young man that seems to be healthy? The patient died on an unspecified date. It was unknown if an autopsy was performed.  information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868538 same reporter/ drug, different AE/ patient; Reported Cause(s) of Death: Died in his sleep
arm got hard and sore at the injection site; sore at the injection site; A spontaneous report was received from a (Consumer) concerning a  71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20/Jan/2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 20/Jan/2021, The patient experienced the events list (verbatims) with seriousness criteria. Moderna Customer Care. Case Number 00030781 Patient states she received her first dose of the Moderna Covid-19 vaccine yesterday and her arm got hard and sore at the injection site and she wants to know if she can put ice at the site. Patient is a 71 year old female who received the vaccine in her left arm. She has not taken anything yet and takes Calcium, Biotin, Stool Softener, Collagen Powder. Consent for safety to follow-up was received and also to have this call documented. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  unknown outcomes: At the time of this report, the outcome of the event(s) (when there are multiple events, list out which events are being referenced here) was unknown>.; 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.
1533 Lightheaded post shot pt passed out.  BP 182/120,  1540 148/108 pt lying on the floor, responding to nurse.  Son was called to meet her at Hospital.  1542  911 called and squad arrived.  1545 Sitting in chair with EMS present.  Oriented x3. 1548 Pt ambulated to squad with EMTS.  Pt agreed to go to ER.  Pt states she passes out after shots.  She was advised to inform her PCP.
had covid within the last 2 years; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had covid within the last 2 years) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had covid within the last 2 years). At the time of the report, COVID-19 (had covid within the last 2 years) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that unlike the 8 people who were vaccinated and had covid within the last 2 years. Out of the 8 people 3 people received Moderna vaccine(S) and the others Pfizer. Patient nor product details were available for the 3 patients who received the Moderna vaccine. No treatment information was provided. This case is reported for patient 3 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748503:Master case (patient 1)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Oct2023) Negative, notes: Tested negative on 17Oct and 18Oct; (18Oct2023) Negative, notes: Tested negative on 17Oct and 18Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 11Oct2023 to 15Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335853 same patient, different drug and event;
Increased tiredness, dizziness, flu like symptoms, headaches, stomach aches, pain at injection sites
Headache, teeth ached, woke up at 4 am with headache and fever, sore throat, arm pain. Took Ibuprofen to relieve the pain. All muscles ache, pain at injection site.
Lymph nodes in right arm pit are swollen and very tender. Received Hep B and Polio in same arm right side.
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Minor damage to small airways" (unspecified if ongoing), notes: Minor damage to small airways after the first time I had Covid March 2020.; "I had Covid", start date: Mar2020 (unspecified if ongoing), notes: Minor damage to small airways after the first time I had Covid March 2020..; "Known allergies:  yes, all berries" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: I had no Covid rebound and the abbreviated dosage also resulted in a negative Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to two patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. On 08-JUL-2016 the patients were vaccinated with improperly stored doses of GARDASIL lot # K009482 expiration date 06-MAR-2017. Dose, route and anatomical location were not provided. No other suspect or concomitant medications were reported. Excursion details: cumulative time frame for two excursions between 07-JUL-2016 and 08-JUL-2016, 30.3 Fahrenheit degrees for 7 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. (1607USA006901) Additional information has been requested.
TWO DAYS FOLLOWING THE INJECTION IN THE LEFT ARM, PATIENT STARTED TO EXPERIENCE LEFT HAND SWELLING AND STIFFNESS.  HAS WEAKNESS INTO THE HAND, DROPS OBJECTS.  THE HAND IS VERY PAINFUL ALSO.  NO FEVERS OR CHILLS.  NO OTHER JOINT OR MUSCLE PAINS.  NO RASHED.  HAS SOME NUMBNESS, NO TINGLING INTO THE HAND.  NO TREATMENTS TRIED.  NO CHANGE WITH POSITION.  NO SIGNIFICANT CHANGE OVER TIME FROM WHEN THE SYMPTOMS FIRST STARTED TO PRESENT DAY TODAY 05/21/2021.
Within 5 minutes he began to sneeze then developed a moist cough, runny nose copious amounts of clear nasal discharge and drooling. Symptoms continued, he was crying. RN pulled this provider from another exam room to assess. Above symptoms noted plus tachycardia in 160's, increased respirations, wheezes in anterior lobes and hives. Sites assessed - MMR site has a nickel size welt.
From phone contact received at manufacturer on 7/18/02, it was reported that an 18 y.o. female received a dose of Menomune A/C/Y/W-135 vax on 7/16/02. Approx 2-3 hrs post vax, PT developed fever, nausea, headache, vomiting, pain in shoulders and neck, general malaise, and disorientation for a period of approx 48 hrs and continuing. PT nearly fainted. She had pain when bending her head forward.
Rash on face. ZYRTEC once a day. Lump still in arm.
tiredness; chilly; nausea; feeling unwell; dizziness; "weakness worst"; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo. The patient had no known allergies. The patient received unspecified medication within two weeks of vaccination. 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 10Apr2021 at 09:00, the patient experienced tiredness, chilly, nausea, feeling unwell, dizziness and weakness (worst). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of tiredness, chilly, nausea, feeling unwell, dizziness and weakness (worst) which included treatment with MECLIZINE. The clinical outcome of the events tiredness, chilly, nausea, feeling unwell, dizziness and "weakness worst" were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
URI symptoms, cough, vomiting. Went to hospital 5/10/2013. Treatment - TYLENOL for fever, URI resolved on it's own and with time.
Little soreness in the arm; Small knot that went away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness in the arm) and VACCINATION SITE MASS (Small knot that went away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little soreness in the arm) and VACCINATION SITE MASS (Small knot that went away). At the time of the report, PAIN IN EXTREMITY (Little soreness in the arm) and VACCINATION SITE MASS (Small knot that went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   This case was linked to MOD-2021-212827, MOD-2021-212827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up received included Outcome updated. And patient told that he is doing ok, no need to send an email, he did not share email. He did share that he did get the 2nd dose of the vaccine.
Vaccine exp: use by date 10/7/22 8 weeks & defrost exp. date: 10/31/2024
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.            Concomitant medications and Treatment information was not provided.
Bicep hurting lymph node in left shoulder neck swollen an painful big knot coming up out of shoulder which is swollen lymph node cant lift left arm more than halfway was at cardiologist office this morning having echocardiogram an showed the lady she said i need to report this that all the swelling looks like golf ball in node the pain going all the way around back of neck an into other (right shoulder) was told that by noww 22cnd april that this shouldnt be happening that side effects shoulda done be gone
On Feb 21, 2022, I experienced severe shortness of breath and I called 911 for the ambulance. They took me to the ER, tested me for pneumonia, which I had. They put me on diuretics. I was admitted, then I had fluid overload again and was transferred to a higher level of care. Hospital for a week. Oxygen but not intubated. I went home and not do well and was re-admitted 4 weeks later. Breathing got a lot worse and had more steroids and oxygen and breathing treatments. I was there 10 days the second hospital stay. I came home April 7, 2022. I am still on home O2.
FLUZONE HD vaccine from last year, which expired on 30JUN2021 with no reported adverse event; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves a 97-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was expired (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ515AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual case of medication error due to expired vaccine used (latency: same day)  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  At 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 holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. 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.
Patient recieved her 2nd moderna dose here on 8/31/21 at about 5:20pm. I recieved a call from my HCP asking us to fill out the Vaers report, she informed me that the patient had reported to hospital last night and had passed away.
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine    Pt called for follow up s/p covid-19 vaccination done on 02/24/21. He reports that he feels well. Sore at injection site but no other c/o.  He voices appreciation for our call.    APRN    Progress Notes  PA-C (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 2/28/2021  7:35 AM Expand AllCollapse All     COVID VACCINE CLINIC  2/24/2021     Date:  2/24/2021                                                                                               Subjective Patient is a 23 y.o. male who was seen at  COVID Vaccine Clinic today for his first  dose of the COVID 19 vaccination.    He was given the Pfizer vaccination.    During his 15 minute waiting period after the injection, the patient began to experience lightheadedness.  He denied difficulty breathing, difficulty swallowing, throat tightness and nausea. He states he always gets lightheaded when he gets a shot. He denies any episodes of syncope in the past.    This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to collapse, hypotension and rapid progression of symptoms.     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, facial swelling, chest tightness, shortness of breath, wheezing, vomiting and headaches    +lightheaded:     Previous Reactions: Always gets lightheaded after getting a shot. Denies other symptoms or syncope.     Objective    Vitals Vitals:   02/24/21 1406 BP: 119/67 Pulse: 58 SpO2: 100%      Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: no therapy Follow up response to treatment: Good. Lightheadedness resolved prior to discharge.  Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)   PA-C Electronically Signed 2/24/2021 2:07 PM
Information has been received from a registered nurse concerning a 12 month old female who on 30-APR-2009 was vaccinated with the first dose of VARIVAX (lot # 663802/0160Y). Concomitant therapy included a dose of PREVNAR given on the same day. On 11-MAY-2009,  "eleven days later", there was a red rash at the injection site that went from a bump to a red patch (The onset date was reported as 30-APR-2009). On 14-MAY-2009, "three days later", the bump was hard and red with no discharge. The patient came into the office and was diagnosed with cellulitis and was positive for rhinorrhea. The patient was given AUGMENTIN to treat the symptoms. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
At 1AM, I started throwing up and had diarrhea and felt like I had a temperature but didn't take my temperature at that time. I called the telehealth doctor and was prescribed Zofran from my nausea. Then I started feeling bad again on the 24th and was tested for COVID. I tested positive.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 03-AUG-2015 (also reported as 03-AUG-2016), the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, frequency, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.