chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient who was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient did not seroconvert after the initial vaccination, and that the physician would like to revaccinate. Additional information has been requested.
77M with a history of chronic systolic heart failure from ischemic cardiomyopathy, NYHA Class III, EF <20%. He was in clinic this AM for regular follow up. Has been doing well, at baseline for last few weeks. Did well at cardiology appt. Given hepatitis A vaccine while in clinic, no other new meds. Called back to cardiology appointment 3 hours after returning home to report he was not feeling well and was becoming progressively short of air. Patient was instructed to report to ED for evaluation. Patient presented to ED where he was noted to be hypoxic. Trialed briefly on bipap but then intubated given work of breathing and hypoxia. Patient was transferred to the ICU with a primary diagnosis of Acute Hypoxic Respiratory Failure. HF decompensation was suspected, with role of hepatitis A vaccine unclear. Patient continued to deteriorate and by 11pm that same evening developed cardiogenic shock. Patient's wife made patient a DNR in event of cardiac arrest, and patient expired that evening at 11: 29 pm. Norepinephrine per titration protocol, vasopressin per titration protocol, epinephrine 1 mg once.
Information has been received from a registered nurse concerning a female with a history of seizure who was vaccinated with GARDASIL vaccine (yeast). The registered nurse reported that a patient's family is reporting a patient has been feeling "funny" since she was given GARDASIL vaccine (yeast). The patient was given 2 doses so far but the third dose will not be given due to the patient feeling "funny". The patient sought medical attention, by calling the physician office. There was no product quality complaint. Additional information has been requested.
Patient arm was very sore; sick to patient stomach; Patient was nauseated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient arm was very sore), ABDOMINAL DISCOMFORT (sick to patient stomach) and NAUSEA (Patient was nauseated) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Patient arm was very sore), ABDOMINAL DISCOMFORT (sick to patient stomach) and NAUSEA (Patient was nauseated). At the time of the report, PAIN IN EXTREMITY (Patient arm was very sore), ABDOMINAL DISCOMFORT (sick to patient stomach) and NAUSEA (Patient was nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication details were provided. No Treatment medication details were provided.   This case was linked to MOD-2021-407181, MOD-2021-407222 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow-up received on 09 Dec 2021 and does not contain any new information.
After the vaccine I started having arm aches. They progressively got worse to the point I could not move my arm and do simple things such as combing my hair. I only started taking paracetamol on the third day. The arm ache lasted four days. I was then able to do normal activities without feeling any pain, such as driving or exercising. Four more days passed and the arm ache returned. Strong enough to wake me up at night but not so painful I cannot do normal movements (aside from exercising). The pain is located right where I got the vaccine. It has been lasting for three days and I am not taking any paracetamol as I do not want to mask it and understand how long it will last.
I was exposed to COVID-19 on 5/9/2022. I started getting symptoms of a tickle on the back of my throat and thought it was allergies. I took an at home COVID-19 test that was positive. As the day progressed and the next morning, I was running a low grade fever, body aches, and chills. I had extreme fatigue. Two days later I lost my taste and smell. I did a telehealth visit with my doctor and was advised to take Tylenol, rest, and drink plenty of liquids. A week later, I had tightness in my chest so my cardiologist prescribed antibiotics, steroids, and an inhaler to prevent pneumonia. My fever and body aces was over within 3 days but the other symptoms lasted for over 2 weeks. I am still having lingering symptoms of fatigue, fast heartbeat, and the inhalers and steroids has caused an oral thrust infection. I am now on a prescription mouth wash.
Client experience pain at injection site, nausea, chills for a 24 hour period.
Face and eyes became swollen, itchy rash appeared on arms and behind knees, difficulty breathing, . Took Benadryl and 4 hours later took Nyquil; Rash comes and goes and always appears in exact same spot. Was given Z-pak by healthcare professional.
Client was seen in ER for fever, Headache, muscle aches, & malaise.  Was given 800mg of Ibuprofen and fluids.  Improved and was sent home.
neuropathy; pain in lt shoulder, neck & arm; 26MAR93 feeling much better 19MAR93; treated w/hot packs;
Patient continues to have a pinpoint superficial gray discoloration of skin at injection sites on right thigh several months s/p vaccination.
p/vax pt exp hives on the face & legs, malaise, fatigue, nausea & one episode of vomiting;pt treated w/claritin & recovered;lab eval revealed WBC 3.6, hematocrit 40%, EOS 0.7%, basophils 1.4%, neutrophils 1.7 & mono 0.2;also cough;
Patient woke up on 11/8/21 with an red, itchy patch on her left arm next to the injection site. It was also  warm to the touch.  Patient came into the pharmacy on the evening of 11/8/21.  She denied any other symptoms (no fever and felt fine). I advised her to try some Benadryl and Cortisone cream and to contact her physician if she developed any other symptoms. She took some Benadryl orally on the night of 11/8/21 and applied some Cortisone cream that night and the morning of 11/9/21.  I called the patient this afternoon around 5:45 pm to check on her.  She told me on the phone today (11/9/21) that the reaction was better this afternoon (less red, less itchy). She also told me that "about 20 years ago" she had a similar reaction when she had a Flu and Pneumonia shot.  She has not had either since that time or any other vaccination.  She does get Prolia injections every 6 months, but has not had any reaction to those. (She will be due for a Prolia shot in the next month.)
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly.  They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope).  They transferred me to the ER for further monitoring.  After a while, it stabilized more, but still continued to happen throughout the day.
Tingling sensation in arm and fingers of arm injected (left). Referred guest to call physician to assess if further treatment should be considered.
Information has been received from a medical assistant concerning a 14 year old female with no drug reactions or allergies who on 11-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On 18-AUG-2007, the patient was vaccinated intramuscularly with the second dose of 0.5 mL dose of GARDASIL, (Lot # 0211U). It was reported that the patient called the office on 05-SEP-2007, and reported that she had not had her menses since she received her second dose of GARDASIL on 18-AUG-2007. The medical assistant was unable to provide the date of the patient's last menstrual period. The patient was scheduled for a pregnancy test in the office on 06-SEP-2007. No further information was available. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of digital vasculitis in a 37 year old male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. This case was also reported by a physician. The pharmacist and physician reported that the subject is a physician. The subject had no pre-existing medical conditions. On 25Oct05 the subject received 1st dose of Fluarix in an unspecified arm (lot number not provided). Within 24 hrs after vaccination with Fluarix, on 26Oct05, the subject experienced bilateral digital vasculitis characterized as petechiae of the fingertips and fingertips that are very sensitive to touch, unable to type. At the time of initial reporting, 27Oct05, the events were worsening. The pharmacist considered the events to possibly be related to vaccination with Fluarix. Digital vasculitis was assessed as medically serious by manf (OMIC).
Headache, Myalgia, NauseaVomiting, Employee noted she had headache, pain at injection site, muscle or body aches, fatigue or tiredness and nausea Narrative:
pt recv vax 12DEC96 & 4JAN97 pt devel a gen rash;
12/19: After injection: Minor pain at injection site (L deltoid) After 30 minutes: Mild headache and single episode of feeling lightheaded (lasting few minutes): drank juice and water After 1 hour: Additional mild lower back/R buttock pain After 4.5 hours: Moderate L deltoid pain and stiffness, moderate headache, moderate eye pressure/pain, mild body ache, fatigue, moderate dull lower back pain, severe sharp and dull R buttock/leg radiating pain: limping After 6 hours (and retuning home): Symptoms continue to progress, and noted moderate swelling around eyes  12/20:  Moderate swollen lump and stiffness to L deltoid, moderate headache, mild/moderate body ache, moderate fatigue, mild swelling around eyes, moderate eye pressure/pain
very sore arm, had to take tylenol, very tired, very itchy body rash
Patient was given vaccine in pharmacy. At the time of the injection (and 20 minutes after administration, pt had no s/sx of allergy. Four days after immunization, Patient states they have swelling of throat/lymph nodes/ tonsils. However, delayed onset (4 days), so it is unclear if it is bacterial/viral pharyngitis or reaction to vaccine components. I referred patient to ER/urgent care to be evaluated for allergy or other causes, however patient still has not gone to urgent care/hospital for evaluation despite recommendation.
Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine hurt like my car accident was yesterday), severe headache with horrible eye pain, nausea, injection site pain and arm weakness, sweating at night, diarrhea, sharp chest pains (like when I had covid), soft tissue between ribs hurt, gerd (reflux, over full feeling, gas, heartburn, sour stomach, pain when eating), extreme exhaustion, inability to do daily activities or go to work for one week
department to help administered Tdap IM to patient's right deltoid per Dr.'s order. Patient's mother was notified by Dr. Patient's mother reported patient had no adverse reaction to the Tdap vaccine that was administered on 07/06/21. Dr. answered patient's mother's questions and advised mother to call the clinic if patient develops any reaction from the vaccine. Patient's mother was informed that a dose of Dtap should be administered  Patient's mother agreed and understood and had no concern at this moment.
Day after immunization, developed red, swollen, tender site right deltoid. Seen at UC. started on Augmentin. Seen 08/30/2002-still red, doubt infection. Stop Augmentin.
The second shot - I didn't have hardly any side affects at all right after - just a tiny fever and achiness which lasted two days.  Recent health event: Shortness of breath; pneumonia - I had it in August  4th -11th. and now again here in October 11th -14th.  The first time I had ER visit and they admitted to Hospital. I was there three days. I was also hospitalized the second time: four days.  They gave me IV antibiotics both times. The first time, they sent me home with a couple of days of antibiotics. This second time, they did not send me home with any medicine.  I have a follow up visit on Wednesday with my oncologist.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with post excursion doses of VARIVAX (Merck) lot K021934 Expiry date 20-NOV-2016, lot K026385 Expiry date 15-DEC-2016, lot K021485 Expiry date 03-NOV-2016, lot L001326 Expiry date 13-JAN-2017 (dose and route were not reported). There was no concomitant medication provided. No adverse effects reported and no product quality complaints (PQC) involved. Additional information has been requested.
RECEIVED VACCINES 11/28/17 11:30 AM, DEVELOPED SYMPTOMS-HEADACHE, INTERMITTENT NAUSEA, MALAISE, SIGNIFICANT FATIGUE AT 07:00PM SAME DAY. EVALUATED BY PCP IN OFFICE @ 09:00AM 11/29/17. EVALUATED AND DISCHARGED FROM OFFICE VISIT TO HOME WITH HUSBAND IN ATTENDANCE- TO STAY HOME AND MONITOR SYMPTOMS, IF SYMPTOMS INCREASE OR BECOME URGENT, TO SEEK EMERGENCY CARE.
Within 5 minutes of IM flu vaccine developed generalized itching with some mild red rash, tightness in throat. Tightness in throat worsened for several minutes. Took 50 mg diphenhydramine. Then took ZANTAC 75 mg approx. 2 hours later. Still had some scalp itching and some throat sensation. Took ZYRTEC 10 mg later that evening and another ZANTAC 75 mg at bedtime.
patient presented with vaginal pain and dysuria within one week of receiving second Covid vaccine dose.  Vaginal ulcerations (Lipschutz ulcers) noted on exam. Required treatment with topical lidocaine and steroid due to pain.
numbness to both arms and hands, face & tongue; mild dizziness , mild anxiety, elevated blood pressure
Information has been received from a medical assistant concerning a 23 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with the third dose of GARDASIL. There was no concomitant medication. It was reported that on 20-MAR-2009 the patient experienced "bad headache". The patient called to the office. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
irritable; swelling & redness & warmth @ DTP inject site rt thigh; fever to 100.2 ax; several episodes of vomiting; mild tongue swelling;
Retinal tear; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4076878-00) from a contactable female consumer reporting for herself.  A 58-year-old female subject received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 02May2021 (Batch/Lot number was not reported) (at the age of 58-year-old) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date to an unspecified date (Batch/Lot number was not reported), at unspecified dose for rheumatoid arthritis.  Medical history included retinal tear repair surgery on an unspecified date. The subject's concomitant medications were not reported. The subject previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 01Apr2021 (Batch/Lot number was not reported) (at the age of 58-year-old) as single dose for COVID-19 immunisation. The subject had retinal tear five days after COVID-19 vaccine on 07May2021 with outcome of recovered. She had retinal tear repair surgery.  The action taken in response to the event for adalimumab was unknown. The reporter's causality for the event Retinal tear after Pfizer/BioNTech Covid Vaccine was not provided. Pfizer's opinion is that there is no reasonable possibility that the event of Retinal tear after Pfizer/BioNTech Covid Vaccine is related to HUMIRA (ADALIMUMAB).  The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship the event of retinal tear is related to the suspect product BNT162B2. However medical history of retinal tear repair surgery indicates that the patient had retinal tear in the past which might have been related to underlying condition of rheumatoid arthritis and is a confounding factor for the present event.  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.
sick like a dog; nausea; fever; headache; injection site swelling; sweating; getting chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick like a dog), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache) and INJECTION SITE SWELLING (injection site swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick like a dog), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache), INJECTION SITE SWELLING (injection site swelling), HYPERHIDROSIS (sweating) and CHILLS (getting chills). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (sick like a dog), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache), INJECTION SITE SWELLING (injection site swelling), HYPERHIDROSIS (sweating) and CHILLS (getting chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-071084 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071084:
Child says about 1&1/2 hours after taking immunization that she started itching within 2 hours she was broke out in hives & had trouble breathing.  Went to ER via ambulance, was given meds in ER Medical record states flushed, warm. msv
Patient reported on 6/12/18 at 9am that after vaccination she had ate lunch at noon and shortly after lay down. Had a pounding headache, nauseated, couldn't lift hand of arm that was vaccinated and fingers were numb. Pulse of 90-100. Took Alprazolam 0.25mg to relieve anxiety and one acetaminophen tablet. Was too uncomfortable to ice and had all over aching. Had a sleepless night but it the morning symptoms began to subside. Spoke with her at 7pm on 6/12/18 and symptoms were continuing to subside.
Pt stated had vomiting 5x/yesterday, nausea constant. diarrhea 3-4 x/daily.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N005619, expiration date on 29-OCT-2019 (strength and dose number were not provided) for prophylaxis, however no adverse effects were reported. The temperature and time frame was: 9°C (Celsius) to 25 °C (8.7°C) for 12 hours and 41 minutes. There was a previous temperature excursion of 0°C to 1°C (0.6°C) for 44 minutes. The call was due to data logger. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA005489.
Diffuse red rash that started on face and spread down body.  Also had several episodes of diarrhea.  Rash resolved within 8 days.  Diarrhea lasted 2 days.
A non-serious spontaneous report of FLUMIST was received from a mother in the USA concerning a 23-month-old patient who received FLUMIST.  This case is submitted in accordance with organization's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Vaccine site muscles pain for more than a year.  Patient has tired - 2 mo of chiropractor fx (9/08-11/08) and 2nd week P.T. currently cfn 12/12/08.
BLOOD CLOT IN HEART; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered  for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter stated that " Don't trust them they made the vaccine and people still get the virus and a friend who got the vaccine died of a blood clot in her heart". On an unspecified date, the patient died from blood clot in heart. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220241243-COVID-19 VACCINE AD26.COV2.S- blood clot in heart. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT IN HEART
Information has been received from a nurse practitioner concerning a 19 year old female who was vaccinated with Gardasil. After receiving Gardasil, the patient passed out, hit her head on the tablet resulting in a concussion. Therapy with Gardasil was discontinued. As of 19-JUN-2007, the patient had improved after stopping therapy. Additional information has been requested.
Before 11:20 am while in observation after the Moderna Vaccine 1 dose, Patient started to experience nausea, Provider was notify, MA's was instructed to collect vital while she was in exam room, patient last option was to use Epinephrine, we admistrated  diphenhydramine solution 50mg/ml, around 11:25 am provider was notify that patient get worse, the MA's was with patient at all times make sure legs where above the level of the heart, asking questions to maintain patient alert, patient had normal color, good air movement, normal breath sound with auscultation. Ambulance had been called by recommendation to transfer to the hospital for following  observation. Patient was called around 5:45 pm she explain she was instructed to follow up with Dermatology after 2-3 Hours of observation in the hospital, no more medication was administer  and she still with nausea but she was feeling much better.