chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG=2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L007230, expiry date:03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Received ZOSTAVAX 1/27/09. 1/30/09 presented to our office arm pain from elbow to arm pit, "feels on fire" swollen, hard and red. Treated with OTC BENADRYL, Ibuprofen, Cephalexin and warm compresses.
Patient is pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant) and PAIN IN EXTREMITY (Sore arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (Patient is pregnant.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 26-Apr-2021. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant) and PAIN IN EXTREMITY (Sore arm). At the time of the report, EXPOSURE DURING PREGNANCY (Patient is pregnant) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.  No Treatment information for the event was provided.
Patient states she had muscle spasms in her right arm, at flu vaccine injection site,  on 10-20 and 10-21-19, and was unsure if related to getting the flu vaccine on 10-17-19.
2nd vaccination given a week early at 05/1/2021 and it should be given at 05/08/2021
Pt traveled with parents the day of vaccination. Developed runny nose en route and fever of 102. Found in crib apparent seizure, presented to ER. Treated and released. Spinal tap negative, febrile seizure.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/19/2023 Discharge Date: 2/22/2023  PRESENTING PROBLEM: Severe COVID-19 infection Acute on chronic respiratory failure with hypoxia, improving Severe COPD with exacerbation 2/2 above Primary adenocarcinoma bilateral lungs Cancer related pain Parkinson's disease   HOSPITAL COURSE: This patient is a 73-year-old woman with PMH of chronic respiratory failure with hypoxemia (on 2 L of oxygen) secondary to COPD, primary adenocarcinoma bilateral lungs status post chemoradiation, PE/DVT on Eliquis, central sleep apnea on CPAP and Parkinson's disease who presented on 02/19 with acute shortness of breath.  Patient was found to have acute on chronic respiratory failure with hypoxemia secondary to COVID-19 infection leading to severe exacerbation of her underlying COPD. She was placed on 6 L of oxygen and started on remdesivir and Decadron and inhalers.  Patient improved with above measure.  She was evaluated by pulmonary rehab recommended 2L of oxygen at rest and 3L with activity.   Patient was evaluated by PT/OT who recommended home with assistance.  Patient was discharged in stable condition with plan to follow up with PCP and her pulmonologist.
A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. Pharmacist accidently administered both doses into a single nostril in 4 children approximately 2 weeks ago. The outcome of the event of ACCIDENTLY ADMINISTERED BOTH DOSES INTO A SINGLE NOSTRIL IN 4 CHILDREN is unknown. The report was considered to be non-serious.
The pt experienced chills, fever, sore throat, and cough. Saw an MD on 11/7/00. Treated with Vantin, saw MD on 11/20/00, Erythromycin given. The pt still has chills and coughing.
Covid vaccine was administered to patient past BUD date and therefore was not valid. Patient did not have any adverse event post vaccination.
Information has been received from a nurse concerning an 8 year old female who on 10/24/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. On 10/24/05, the pt was concomitantly vaccinated with a dose of hepatitis A vaccine inactive. Subsequently, the pt developed injection site redness, a rash, fever, and vomiting. unspecified medical attention was sought. Subsequently, the pt recovered. Additional information has been requested.
SOB, dizziness & dry mouth p/4th dose of vax; 18AUG93 phone f/u: RVA given as 5th dose; titer checked=1:300
This spontaneous prospective pregnancy report was received from a Licensed Practical Nurse referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On 26-JAN-2016, the patient was vaccinated with GARDASIL 9 0.5 ml, lot # L028083, expiry date 03-SEP-2017, first dose, (administration route and anatomical site were not reported). Concomitant therapies were not provided. In 2016, after the vaccination with GARDASIL 9, the patient had a urine pregnancy test which result was positive (maternal exposure during pregnancy), the nurse reported that the patient was unaware of the pregnancy at the time of the vaccination. The last menstrual period date (LMP), due date and estimated date of delivery were unknown. The pregnancy outcome was pending at the time of this report. No adverse events and no product quality complain (PQC) were reported. Follow up information has been received from a physician on 23-MAR-2016 concerning a 25 year old female patient with diabetes mellitus type I. The patient did not have any previous pregnancies, full term deliveries and preterm deliveries. It was reported that no elective terminations or fetal deaths occurred in the past. At 10:51 on 26-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left deltoid. The patient was also on insulin pump with HUMALOG daily (strength, dose and route of administration were not reported) for diabetes mellitus type I and was taking meclizine hydrochloride, pyridoxine hydrochloride (PNV) (strength, dose, frequency and route of administration were not reported) for pregnancy. The patient was pregnant (she was in her first trimester) at the time of the vaccination, which was confirmed later by the ultrasound performed in approximately January 2016 (at 4 weeks and 2 days). The LMP date was estimated to be 14-DEC-2015 (calculated by extracting 12 weeks and 3 days from the miscarriage date). The fetal outcome was unknown. Amniocentesis or Maternal Serum Alpha-Fetoprotein Screening (MSAFP) were not performed. On 10-MAR-2016, the patient experienced spontaneous abortion <20 weeks. It was confirmed by an ultrasound performed on the same day (for dating and viability) at 12 weeks and 3 days from LMP (also reported as "at 10 weeks pregnant"). The outcome of spontaneous abortion was not reported. The relatedness between the event and GARDASIL 9 was not provided. Upon internal review the event of spontaneous abortion was considered to be medically significant. Additional information is not expected as all scheduled correspondence has been received. Reporter information, patient's demographics and narrative have been updated. Adverse event, laboratory tests values and suspect products were added.
The second dose of Hep A was given too early (one month after dose #1, instead of 6 months after dose #1).   RN explained the error, and that the dose given on 8/8/18 will not be counted, and that she should get another dose of Hep A 6 months from now on or after February 8th, 2019.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age and ethnicity. Initial information processed with additional information received from central complaint vigilance department on 26-JAN-2022. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) 1 total, dose was not reported administered at left arm on 13-MAR-2021 for prophylactic vaccination.  On 01-NOV-2021, the patient received additional booster of non-company vaccine included: mrna 1273 (Moderna) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 033F21A and expiry: unknown) 1 total, dose was not reported for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with mrna 1273 (dose number in series 2). No concomitant medications were reported.  On 16-JAN-2022, the patient experienced stuffy nose, dry cough, fatigue and body aches and had 2 antigens rapid test which were inconclusive and he took an antigen rapid test (BinaxNOW) that was positive on same day (coded as suspected clinical vaccination failure and suspected covid-19 infection) (all events in dose number series 1). On 18-JAN-2022, the patient had a telehealth consultation with primary care physician (PCP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from suspected covid-19 infection and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority. The suspected regulatory authority has been confirmed to be the reported allegation was not confirmed. The root cause was determined to be not manufacturing related based on the Regulatory Authority evaluation/investigation performed.; Sender's Comments: V0 - 20220136238- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This is a spontaneous report from a contactable other health professional.  A 59-year-old patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration in the left arm on 22Jan2021 at 17:00 at 59-years-old at a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included pneumothorax from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing (Prior to vaccination).  Concomitant medications included bupropion hydrochloride (WELLBUTRIN), desvenlafaxine succinate (PRISTIQ), meloxicam (MANUFACTURER UNKNOWN); taken for an unspecified indication from an unspecified date to an unspecified date (received within 2 weeks of vaccination).  The patient previously took diphenhydramine hydrochloride (BENADRYL) and fluticasone propionate, salmeterol xinafoate (ADVAIR diskus) and experienced allergy from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown) for COVID-19 immunization on an unknown date. On 23Jan2021 at 04:00, the patient experienced: temp 101.7 which held for 28 hrs, then 100.7 for 24 hrs, now at 99.4 (non-serious), severe back pain (non-serious), severe joint swelling in hands (non-serious), severe headache (non-serious), severe body aches and pain (non-serious), right foot felt like bones were broken when walking (non-serious), coughing (non-serious), increased phlegm production (non-serious), loss of taste (non-serious), loss of smell (non-serious); in which no treatment was received. The patient, however, went to a doctor or other healthcare professional office/clinic visit.  The patient underwent lab tests and procedures which included temperature: 100.7 in Jan2021 for 24 hrs, temperature: 101.7   on 23Jan2021 held for 28 hrs, temperature: 99.4 on 26Jan2021.  The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
On Friday patient felt fever, pain in left arm, inflammation in left arm, redness in left arm, area felt hot (site of injection). Also felt shivering. Called Sunday Sept 22 to report.
Severe autoimmune hemolytic anemia; This is a literature report  A 84 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant), outcome "unknown", described as "Severe autoimmune hemolytic anemia". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: positive; blood test: negative. Therapeutic measures were taken as a result of autoimmune haemolytic anaemia.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported event cannot be ruled out. 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.
Covid-19 positive; Covid-19 positive; passed out; near death experience; sleeplessness for a night; chest pain; anxiety; palpitation; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single and administration date 10Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2021, outcome "recovering" and all described as "Covid-19 positive". The patient underwent the following laboratory tests and procedures: blood test: (26Dec2021) unknown; sars-cov-2 test: (26Dec2021) positive. Clinical information: On the night December 25th, the patient suddenly feel ill. The patient passed out and had a near death experience and was rushed to the ER. Blood samples and nasal swab for Covid-19 testing was collected early hours of 26Dec2021. After some hours, the Doctor came back with a Covid-19 positive test result. Other events that the patient experienced were headache, dizziness, light headedness, loss of appetite, loss of sense of smell, sleeplessness for a night, coughing, chest pain, anxiety, palpitation.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.Based on the currently available information the possibility of causal association between the events near death experience and passed out and the suspect drug BNT162B2  cannot be ruled out. 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.
Fever of 102, aches, cramping legs, nausea, shivers - severe flu like symptoms
On 10/16/2021, I went to a concert with some friends and we were all vaccinated. On 10/19/2021, I started having severe allergies like a sinus thing. I thought it was a sinus infection. That night I had chills, body aches, I was shaking and shivering, I felt like I had a fever. I kept taking my temperature, and it was normal. I went to the doctor the next day because I was in such pain. I got tested for COVID-19 on 10/20/2021, and it was positive. My friends said they were all having the same symptoms. I told them I tested positive for COVID-19 so they got tested too. They all tested positive. I also developed a cough. My doctor prescribed me a cough medication which I could not take because it had red dye 40, which I am allergic to. I received the flu shot before going to the concert, around the first days of October.
4 days local pain @ inj site, then 7 days p/inj devel 2wks & urticaria & edema;
immed following vax 1 1/2 diameter area of induration devel lateral to inject site; swelling subsiding w/in 20 mins, but c.o drowsiness & h/a; had devel wheezing;
Pt reports soreness at injection site, knot under skin approx size of a quarter or less, warmth to the touch and redness.  redness is localized it is not spreading as of time of report
After having the Afluria 2014-15 injection, I had a shingles outbreak on my rear left shoulder near where I have had shingles in the past.  I have now had shingles 4 times and had the shingles vaccine a couple years ago.
Since late December she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. She also notes increased lesions following hot water bathing. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 4 December, 2-3 weeks prior to onset of symptoms. She has used oral antihistamines with some benefit. She denies constitutional symptoms. UCT score today is 19 (0, 4, 2, 2, 4, 4, 1, 2). She feels her symptoms are gradually improving. No history of adverse reactions to prior vaccines.
I can't smell anything since April 2021. Three different doctors and they don't know why. Never got COVID.
Immediate onset: Tingling and numbness in left arm down to 3 fingers on left hand with accompanying weakness of grip; sharp, deep pain at injection site.    4 hours after the injection: headache, chills, freezing cold, lethargy, cold sweats, throbbing and sharp shooting pains in left ankle.   As of 11/24, chest pain on left side behind breast.
Pt grandmother took him to the Dr 2 days after receiving DTaP for regular check up. Asked MD to look at his leg because it was swollen from the shot. He told her DTaP caused infection.
12/23 VACCINATION 12/24 WOKE UP TO ARM PAIN,  FATIGUE, CHILLS, MUSCLE ACHES. TEMP IN AFTERNOON OF 101.0 TOOK TYLENOL; 99.5.  TEMPERATURE PERSISTED 3-4 DAYS BETWEEN 100-102.  TREATED WITH TYLENOL.
Approximately 6-8 hrs after taking third pill of Vivotif on 1/12/09, pt had generalized whelps/hives.  Pt works in an ER, was seen by a fellow physician and given Benadryl, Pepcid, and 5 day course of Prednisone.  Pt took 4th pill on 1/14/09 and had same reaction exactly.  Time course for both reactions to resolve was until 1/17.
fatigue Narrative:  missed a few hours of work following 1st dose due to fatigue
Anaphylactic reaction pt had trouble breathing and went to primary care physician and was sent to Hospital from there.
waxing and waning muscle cramping; worse at night like cramping felt like achy; ear aches; dizziness; muscle aches; joint pain in my hands; headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (waxing and waning muscle cramping), MUSCLE SPASMS (worse at night like cramping felt like achy), EAR PAIN (ear aches), DIZZINESS (dizziness) and MYALGIA (muscle aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DIGOXIN, METOPROLOL TARTRATE (METOPROLOL XL) and APIXABAN (ELIQUIS) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MUSCLE SPASMS (waxing and waning muscle cramping), MUSCLE SPASMS (worse at night like cramping felt like achy), EAR PAIN (ear aches), DIZZINESS (dizziness), MYALGIA (muscle aches), ARTHRALGIA (joint pain in my hands) and HEADACHE (headache). At the time of the report, MUSCLE SPASMS (waxing and waning muscle cramping), MUSCLE SPASMS (worse at night like cramping felt like achy), EAR PAIN (ear aches), DIZZINESS (dizziness), MYALGIA (muscle aches), ARTHRALGIA (joint pain in my hands) and HEADACHE (headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.