chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty breathing for 2 mins; temperature has been fluctuating from 98.7 to 100.1; Chills "cold and shaking"; mild pain from the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing for 2 mins), BODY TEMPERATURE FLUCTUATION (temperature has been fluctuating from 98.7 to 100.1), CHILLS (Chills "cold and shaking") and ARTHRALGIA (mild pain from the shoulder) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing for 2 mins), BODY TEMPERATURE FLUCTUATION (temperature has been fluctuating from 98.7 to 100.1), CHILLS (Chills "cold and shaking") and ARTHRALGIA (mild pain from the shoulder). At the time of the report, DYSPNOEA (Difficulty breathing for 2 mins), BODY TEMPERATURE FLUCTUATION (temperature has been fluctuating from 98.7 to 100.1), CHILLS (Chills "cold and shaking") and ARTHRALGIA (mild pain from the shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: fluctuating from 98.7 to 100.1.         No treatment or concomitant medications reported.
48hr p/vax awakened w/1hr of high pitched, screaming cry;took 2 hr to console child;
ON 10/02/2014 AT 10:00AM, PATIENT CAME IN TO THE PHARMACY STATING THE INJECTION SITE IS RED (ABOUT 1.5 INCHES IN DIAMETER), SLIGHTLY SWOLLEN, AND THAT IT IS ITCHY. SHE DIDN'T HAVE ANY OTHER COMPLAINTS OR ANY SHORTNESS OF BREATH. PATIENT SIMPLY JUST WANTED TO LET THE PHARMACY KNOW ABOUT THE REACTIONS. FOLLOWED UP WITH THE PATIENT ON 10/09/2014, AND PATIENT STATED THE REACTION IS ALL GONE AND SHE FEELS FINE. NO MORE SWELLING, REDNESS, OR ITCHINESS.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-MAY-2008, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-SEP-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a physician concerning a 70 year old female patient with hypertension who on 21-FEB-2011 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included aspirin, hydrochlorothiazide (manufacturer unknown), multi-vitamins (unspecified), calcium (unspecified) and omega-3. The physician stated that on 22-FEB-2011 the patient experienced some redness at the injection site after receiving ZOSTAVAX (Merck). There was no treatment given for the events. There were no laboratories diagnostics performed. At the time of the report the patient's redness at the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
612PM flu vax given rt rm pt described a burning flash from arm to heas felt head would explode;extremely dizzy, apprehension, sweaty, cold, fading feeling pt stated something wrong; need to go to hosp;paleness, tem loss of consciousness;
BELL'S PALSY; SWOLLEN LIPS; SWELLING INSIDE MOUTH; SWOLLEN FACE AND JAW; SWOLLEN LEFT AND RIGHT EYE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, 1 total administered at left arm on15-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-SEP-2021, the patient experienced her whole face and left eye was swollen and described it as total distortion. Her face was huge. she went to the doctor but doctor did not know what it was and thought it was allergic reaction so patient did some research and On an unspecified date, she thought she was having bell's palsy from the vaccine. They gave her shot and put her on steroids patient was fine after 24 to 36 hours. On 05-OCT-2021, patient experienced her face started to swell up again and also her right eyes was swollen. On 06-OCT-2021, the patient experienced swelling came down to her jaw, lips and inside of the mouth. swollen lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen face and jaw, swollen left and right eye, swollen lips, and swelling inside mouth, and the outcome of bell's palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211011928-COVID-19 VACCINE AD26.COV2.S-bell's palsy, swollen face and jaw, swollen left and right eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
So a few days later I felt a lump in my neck, I went to the doctor on 03/31/2021.  The doctor said it was  a lymph node, he did blood work and a ultrasound.  I did the ultrasound on 04/01/2021.  I did the blood work on 04/02/2021.  They wanted to monitored the lymph node, they wanted me to come back in 8 weeks for another ultrasound, but I am unable to continue due to the cost of the ultrasound.  My lymph node is still enlarged.
Daughter was standing next to me and made some strange noises.  I looked and her head was cocked to the side, her eyes were rolling into the back of her head and she was shaking.  Within seconds, she hit the floor.  Doctor and nurse turned her to her side and applied a cold compress to her forehead. She came to and was gray in color.  She stayed on the floor for a few minutes and then we went into a room to sit.  She had a popsicle and her blood pressure was taken again and we walked a bit prior to finally leaving the office.
Approximately 48 hours after receiving the vaccine a red, raised rash developed across the entirety of my neck and across my shoulders. The injection site arm was not affected. There were also splotches of it on my chest and in my groin area. It was not itchy or painful. It remained for about 72 hours and became itchy as it went away and faded.
No adverse effects were reported; one dose of expired PROQUAD was administered to a patient; Information has been received from a medical assistant regarding to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, drug reactions or allergies.  On 11-APR-2019 the patient was vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number N025924 and expiration date 18-MAR-2019 for prophylaxis (dose, frequency, route of administration and anatomical injection site were not reported) (Expired product administered). The reporter confirmed that the sterile diluent used was not expired. No adverse effects were reported.
Awaken with light headedness; low grade fever (98.2); soreness at inj site; site tenderness to touch; tire and weak; loss of appetite.
This spontaneous report as received from a pharmacist refers to a currently 52-years-old male patient. Information about patient's medical history was not provided. On 28-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (refrigerated vial) (dose, frequency, route of administration and lot # were not reported). Concomitant medication was not reported. On an unknown date, the patient routinely experienced "breakouts" of rashes in an unspecified area, described as "uncomfortable and irritating". The pharmacist felt the presence of the rashes indicated recurrence of shingles and possibly vaccine failure, but this had not been confirmed by an official diagnosis. No treatment was given for adverse event. The patient did not seek medical attention. No product quality complaint (PQC) was involved. The outcome of "recurrence of shingles" and "possible vaccine failure" was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
I felt flu like symptoms that after another 6 hours worsened; I felt flu like symptoms that after another 6 hours worsened; bone/skull pain and aches; felt weakened; felt only like lying down; I had a temp that started that morning and at the highest was 102.4; I also have a spot of hives on my left temple; I feel a little off but not bad; This is a spontaneous report from a contactable consumer (patient).   A 64-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 as dose 1, single for covid-19 immunisation from pharmacy or drug store. Medical history included cancer 16 years ago (None currently) and covid 19 for around 10 days, quite mild symptoms, last fall, Nov2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. After 12 hours from vaccine,  patient felt flu like symptoms that after another 6 hours worsened and she had bone/skull pain and aches, felt weakened, felt only like lying down and went to bed after another 6 hours and slept off and on, but not well. she had temp that started that morning and at the highest was 102.4. By the next morning though it was down and by noon it was very close to normal. she felt quite a lot better that day and even better the next. Then today, the fourth day, she feels a little off but not bad. Patient also have a spot of hives on my left temple. At least she believes they are never had them before.  The patient did not receive any treatment in response to the events. The outcome of the event s was recovered with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Patient came in for separate nurse visit for 6 month vaccines d/t being sick at his 6 month appointment.  Nurse looked into the patient's chart and saw that physician wrote that patient would come back for Pediarix, Hib, Pneumo and Rotavirus.  Nurse ordered and gave all 4 vaccines. Orders state that 6 months vaccines do not include Pedvax (Hib).  Therefore receiving an additional dosage of the vaccine then what is necessary. The child is fine and there were no adverse reactions receiving the vaccine. Physician and parents were notified of the incident.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2023, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested positive for COVID after receiving two initial doses and two booster doses of Pfizer COVID Vaccine. Received Pfizer COVID Vaccine to protect from COVID but it did not work.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received flu shot on 11/6/12 called us on 11/7/12 reporting swelling, redness, tenderness in her arm. Advised to take BENADRYL and seek medical attention if things get worse.
had an abnormal pap smear; tested positive for HPV 16; This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose: 0.5 ml, two or three dose series, strength, lot# and expiration date were not reported) intramuscularly (IM) for human papillomavirus infection (HPV) prevention. There was no overdose.  On an unknown date, the patient had an abnormal pap smear (smear cervix abnormal) that tested positive for HPV 16 (human papilloma virus test positive). Date of abnormal pap smear unknown. The HCP did no specify if the completed the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The HCP did not specify patient's current status or if the patient sought medical attention based on the abnormal pap smear finding. No additional information provided. Consent granted by physician for correspondence regarding this adverse event. No additional AE/PQC reported. At the time of reporting, the outcome of the events was unknown. The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
The vaccine was given on 2/9/21. No initial pain or problems. 4 days later, my stomach felt like a feather was tickling it, then turned hot, red, itchy, a rash formed and then hives covered my torso--stomach, chest, neck, and around the injection site. On Wednesday, 2/17/21, I saw my doctor who prescribed prednisone which I began taking on Thursday. The itchy feeling subsided but hives still visible. The doctor said the reaction is not life-threatening.
On Friday morning 2/26/21, we had a 24 yo male patient who had an anaphylactic reaction after his first dose of Pfizer COVID vaccine. He was instructed to wait on the chair, but had stood up at some point but was still in the pharmacy waiting area. A team member noticed he had fainted and called for help. The pharmacist on duty and immunizing tech came immediately to help him to a chair. At that point, he was conscious and talking. Then within a few seconds he started convulsing on the chair and lost consciousness. His eyes were open and head tilted back. A team member immediately called 911 and pharmacist administered 0.3mg Epipen to the thigh. We removed his face mask to check his breathing and also to allow him to breathe more easily. We also adjusted his head more forward and he started coughing. After about 15 seconds, he regained consciousness and could answer questions. EMT arrived soon after and took over. Patient does not have allergies or any history of anaphylaxis/ severe reaction from vaccinations. He did express some fear of needles and did not eat breakfast yet.
Rash, redness extending over left arm reaching 2 inches above elbow and upper shoulder.
Pt recv vax on 4/7/99; on same day pt exp red & hot areas
DEATH Narrative: Patient passed away approximately 1 month after receiving first COVID-19 vaccination. No report of a significant reaction to this vaccine, so unlikely a correlation.
Vaccination site pruritus/Itchiness at the inejction site after moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site pruritus/Itchiness at the inejction site after moderna booster) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 10 D. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus/Itchiness at the inejction site after moderna booster). At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus/Itchiness at the inejction site after moderna booster) had resolved. Not Provided          No concomitant medications were reported.   On an unknown date, the patient experienced itchiness at the inejction site after Moderna booster. On an unknown date, itchiness at the inejction site after Moderna booster resolved. Moderna vaccine was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. On an unknown date, she received COVID-19 Vaccine manufactured by Moderna. On an unknown date, she received COVID-19 vaccine booster manufactured by Moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Progressive weakness legs and arms; numbness and tingling of fingers and toes; numbness and tingling of fingers and toes; This is a spontaneous report from a contactable Nurse (reported for herself).  A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing.  The patient was not pregnant. There were no concomitant medications.  The patient previously took codeine and experienced drug hypersensitivity. The patient experienced progressive weakness legs and arms, numbness and tingling of fingers and toes on an unspecified date. The patient was hospitalized 1 day as consequence of the events and no treatment was given. No other vaccine given in in four weeks and no other medications given in two weeks. The patient was not tested for covid prior vaccination. The patient was tested for covid on an unspecified date post vaccination, results unknown. The patient had not recovered from the events.  Information on the lot/batch number has been requested.; Sender's Comments: Causality cannot be excluded for the reported events and the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.
patient developed ~1 week of temperatures to 100 and fatigue, covid tested negative, saw in the office with labs notable for WBC 250. now in the hospital, likely CML but wonder if vaccine set off cytokine cascade that led to his symptoms
Patient received his second COVID-19 Vaccine by Moderna on 9/3/22 (his first was 7/28/22) at 9:45 AM. His first vaccine for COVID19 had almost no reaction (minor irritability day of / evening & pain at injection site). After his first vaccine, we did tylenol afterwards to help with the pain at the site. The vaccine administrators recommended the same if we had the same experience. Around 4 PM, he had pain at the injection site after his nap, so we did 5 ml's of Tylenol. He went to bed without an issue that night and without additional Tylenol. Around 2:30 AM the next day (9/4/22), he woke up crying. He was hot to the touch and his temperature (in ear) measured 101.5. We did another 5 ml's of Tylenol and noticed his heart felt like it was racing. We used our children's pulse-ox on his finger to measure that his heart rate was 160 while he was laying on the couch; his oxygen was around 98%. We called our pediatrician's office and asked for a return call. Around 3:38 AM we spoke to a nurse from the hospital answering service about the situation. She recommended that we retest patient's heart rate now that Tylenol had been on-board about an hour. His temperature had reduced to 100 degrees F, but his heart rate remained around 155. Since this was "above the normal range for toddlers (70-140)," she recommended we go into an urgent or emergency care department since we'd recently gotten the vaccine. We went to the hospital and checked in around 4:15 AM. We were seen by the triage department and emergency doctors and told that the heart rate was likely increased due to his fever. We were given ibuprofen at 5:07 AM to help and released around 5:50 AM.
Sept 7, 2021 - Had a hive on my neck thought it was a bug bite, went away the next day. Dec. 11, 2021 - had a severe pain in my chest, tight feeling, throat lump feeling, went to ER, ran bloodwork, CT, urine, I was told I was fine. Dec. 19, 2021 - Hives, welts, rashes on various body parts, contacted the doctor ; Dec. 23, 2021. Dec. 23, 2021 - Swelling of tounge, tickle in throat, was taken to ER and give Bendryl, Predazone, Pepcid AC.  Present - Continues - typically once a week have a hive or rash in various locations. Went on a low histamine diet, take Benadryl and/or Pepcid AC when needed. I have photos of each rash/hive from Sept.
White flashes in left eye, starting in the night of the booster (with fever), and subsequent dark floaters in left visual field. Symptoms did not resolve, and saw an ophthalmologist on February 3. Physician diagnosed a left vitreous detachment.
flu-like symptoms; they injected two syringes; missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), OVERDOSE (they injected two syringes) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced OVERDOSE (they injected two syringes). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (missed second dose). On 23-Apr-2021, OVERDOSE (they injected two syringes) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.