chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Did not receive second dose in allowed time window; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Did not receive second dose in allowed time window) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Did not receive second dose in allowed time window). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Did not receive second dose in allowed time window) outcome was unknown.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
I tested positive for COVID-19 on 12/28/2022. It started off with a head cold and a scratchy throat. I had body aches, malaise, and a slight cough. It felt more like a bad cold. I took no medicine. I talked to the doctor when I was several days into the symptoms so we decided to ride it out. It was basically taking lots of fluids. The doctor said if I got worse to go to the emergency room. I still have some slight symptoms that haven't gone away. The congestion is still lingering. I would say I'm not fully recovered at this time.
Case number PHEH2014US020308, is an initial spontaneous report from a pharmacist received on 07 OCT 2014. This report refers to a 51-year-old female patient. Past medical history and concomitant medications were not reported. On 06 OCT 2014, the patient received an intramuscular dose of FLUVIRIN 2014/2015 (batch number: 1413401) from a multidose and some of the vaccine dripped out of the injection site. It was reported that some of the vaccine ran down her arm and was not sure how much dripped out. No adverse event was reported following this medication error (drug administration error).
Approx. 5 hrs after imms she began experiencing severe pain in (R) arm from shoulder all the way down to the tip of her fingers. Is unable to lift arm above her head. Denies redness or swelling at inj. sites. Advised to see MD for f/u. Pt agrees to plan of care.
An LPN at one of our sites inadvertently administered a FLUVIRIN to a 2 year old child. After the fact, the RN on duty realized that the FLUVIRIN is not indicated for persons under the age of 4 yrs old. The child has had no adverse reactions. The LPN works at one of our community health center sites. The center has a poster that explains the different dosing schedules recommended for each age group and each type of flu vaccine. However, the LPN failed to use the guidelines.
POST administration of COVID vaccine pt began to c/o nausea and not feeling well. Writer went to assess pt and noted to be a bit anxious and fidgeting, pt breathing heavily but unlabored, no wheezing audible, skin warm and stating "I have never felt this way."  Initial BP check - 80/45, HR 85, Pulse ox 100%. MD notified and arrived immediately to asses pt. Upon assessment requested NS bolus and EPI pen.   Epi pen and Benadryl were administered, BP and HR labile while waiting for code assist. 22G IV placed to R ac patent and intact. NS initiated.  Pt left w/code assist team and at that time skin was moist to touch, still hypotensive SBP 80?s, pt still alert and responsive and able to provide nurse w/ phone # of family member
Increased requirements for sleep-fatigue; arthralgia: neck pain, thumb swelled to double, knee pain, both hands painful and stiff, feet-ankles-calfs-knees painful and stiff; headaches daily.  All occurred after MMR.
Arm swollen. Discolored puss. Extreme headache. Uneasy stomach. Tenderness of arm, armpit. Loss of falling in leg. Hard/painful to swallow.
battle between Antibodies in patient body and vaccine antibody; Mini-COVID for 24 hours; This spontaneous case was reported by a physician and describes the occurrence of SUSPECTED COVID-19 (Mini-COVID for 24 hours) and VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody). On an unknown date, the patient experienced SUSPECTED COVID-19 (Mini-COVID for 24 hours). At the time of the report, SUSPECTED COVID-19 (Mini-COVID for 24 hours) and VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP described as vaccination reaction as a modified reaction of COVID-19. Concomitant medications were not provided. Treatment medication was not provided.   This case was linked to MOD-2021-294336 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Non-significant follow up information included patient demographic details. On 30-Aug-2021: Vaccination reaction Event added
The information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were reported. On an unspecified date, an unspecified number of patients were vaccinated with an improperly stored dose of VAQTA (lot#M012324, expiration date 5-APR-2018) (dosage, frequency and route were not reported) for prophylaxis(incorrect product storage). No adverse effect reported. The vaccine was stored at a temperature from 32F to 35 F for 6 days. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004001: US-009507513-1708USA003819: US-009507513-1707USA006766:
Information has been received from a physician concerning a 7 year old male who on 12/04/95 was vaccinated with the first dose of Varivax in the left arm. There was no illness at the time of vaccination On 02/23/02, the patient developed papular, vesicular, scabbing lesions (greater than 40 all over his body). There was no other information provided. Additional information has been requested.
Joint and Muscle aches, chills, Hypersensitivity of skin, Fatigue, weakness, Malise, Sweating in sleep
Pruritus to face and neck, erythema and inflammation around lips, pruritis and erythema to axilla, arms, abdomen and groin.
Crying; welts; Patient turned red; Initial information received on 31-Aug-2020 regarding an unsolicited valid non-serious case from a nurse..  This case involves child patient who experienced crying, welts (urticaria) and turned red (erythema), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ220AA) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious crying, welts (urticaria) and turned red (erythema) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.
29AUG97 fever 106 w/ h/a, diarrhea, runny nose, body aches & cough;hallucinations;ID consulted in ER w/pt & dx enteroviral illness secondary dx MMR rx;
feeling a flush in my face; was tired most of the day; Severe aching pain in both legs; Call into worksick; Severe diarrhea; Felt cold; Nasty taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), NASOPHARYNGITIS (Felt cold), AGEUSIA (Nasty taste in mouth), PAIN IN EXTREMITY (Severe aching pain in both legs) and FLUSHING (feeling a flush in my face) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 2006 and Drug allergy (Sulfer , macrobid). Concomitant products included METFORMIN from 06-Jan-2006 to an unknown date for Diabetes, OMEPRAZOLE from 2006 to an unknown date for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced NASOPHARYNGITIS (Felt cold) and AGEUSIA (Nasty taste in mouth). On 04-Feb-2021, the patient experienced DIARRHOEA (Severe diarrhea), PAIN IN EXTREMITY (Severe aching pain in both legs) and MALAISE (Call into worksick). On an unknown date, the patient experienced FLUSHING (feeling a flush in my face) and FATIGUE (was tired most of the day). On 03-Feb-2021, NASOPHARYNGITIS (Felt cold) and AGEUSIA (Nasty taste in mouth) had resolved. On 04-Feb-2021, DIARRHOEA (Severe diarrhea) and PAIN IN EXTREMITY (Severe aching pain in both legs) had resolved. At the time of the report, FLUSHING (feeling a flush in my face), MALAISE (Call into worksick) and FATIGUE (was tired most of the day) outcome was unknown.      No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up was received on 26 April 2021. Informations on patient demographics ,new events ( flushed face , feeling sick and tired all the time), other relevant history , concomitant medications and second dose information were added.
My arms, legs and back feel extremely itchy. I have bumps like hives on my arms.
vomiting; diarrhea; fever of over 101 degrees/fever of 102 degrees; weight loss (approximately to 10lbs to date); This is a spontaneous report from a contactable consumer. A 66-year-old female patient received Bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from 31Jan2021 at SINGLE DOSE for unknown indication. Patient's medical history included Mrs. (Name) stated that she has known co-morbidities, including Lupus. She has visited medical facilities several times since receiving the vaccine. Patient's concomitant medications were not reported. It was reported that Ms. (Name) states she has been vomiting, had diarrhea and had a fever of over 101 degrees for the past 6 days. Patient received her 1st dose of the vaccine on 31Jan2021 and within 24 hours began experience multiple symptoms including a fever of 102 degrees or higher temperature every day since receiving the vaccine. She has also experienced vomiting, diarrhea and weight loss (approximately to 10lbs to date), She believes that the vaccine may have contaminated or a counterfeit. She stated that she had some concerns regarding the qualifications of the persons administering the vaccine and that is why she believes may have been compromised in some way. She has been received multiple tests for COVID-19, but the results have come back negative; the HCP's treating her all believe to be the cause of her symptoms. The outcome of the events was unknown.  Follow-up (09Feb2021): New information received from a contactable consumer which includes: New clinical information reported.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
TROUBLE SEEING (COULD ONLY SEE THE WALL); LOTS OF BLOOD IN NOSE; OPEN MOUTH; This spontaneous report received from a consumer concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A12A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced trouble seeing (could only see the wall). On 01-MAY-2021, the subject experienced lots of blood in nose. On 01-MAY-2021, the subject experienced open mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lots of blood in nose, open mouth, and trouble seeing (could only see the wall). This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Dizziness, pt feeling "very slightly faint". c/o left side of neck muscle pain. Seen by Dr. To stretch, mobilize left arm. Increase fluid intake. Pt stable & released from vaccination site
IMMUNIZATION WAS GIVEN AND PATIENT HAD AN EXCESS OF BLEEDING. PRESSURE WAS APPLIED TO THE SITE AND THE BLEEDING STOPPED. THE IMMUNIZATION SITE LOOKED LIKE IT WAS STARTING TO BRUISE.
patient previously got 2 doses of Moderna covid 19 vaccines back in February and March but mistakenly got Pfizer for 3rd dose
Information has been received from a physician concerning a 6 year old male recovering from croup who on 01/22/1999 at 4:00PM was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck)(Lot#625383?031OH) subcutaneously, 0.5ml.  Concomitant therapy that day and time included a first dose of hepatitis B virus vaccine rHBsAg (yeast) Hib conj vaccine (OMPC) (MSD) (IM) and a first dose of measles virus vaccine line (Moraten) mumps virus vaccine live rubella virus vaccine live (MSD) (lot#628551/1184H) (SQ).  On 11/20/1999 the patient received dexamethasone 6mg, IM.  On 04/06/2004 the patient developed a breakthrough case of chickenpox with about 100 lesions.  It was reported that "one on left arm secondarily infected.:  Subsequently, the patient recovered from breakthrough case of chickenpox.  No product quality complaint involved.  No further information is expected.
Experienced mild bloating, mild abdominal cramping, hyperactive bowel sounds, mild diarrhea, and mild nausea starting at 0130 on 12/23, with the worse of it 12/23, improving on 12/24, and resolved by 12/25. Symptoms were improved with over the counter gas medicine.
9/7 day after shot patient presented with large red welt over most of arm between elbow and shoulder. Area was warm to the touch and patient claims fever. Patient visited urgent care and MD there decided not to give any treatment. Patient to follow up with primary doc on 9/8.
Flu vaccine given in clinic at 8 weeks pregnant, ultrasound done that day showing viable pregnancy.  Patient returned for follow up 12wk OB appointment and 11w4d and ultrasound showed no cardiac activity with pregnancy measuring 8w6d.
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown). Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch. At the time of reporting the outcome of the events were unspecified.
Felt hot, nausea, pressure in chest, difficulty breathing, tachycardia, elevated blood pressure.
Pt reported fever (temperature unknown), chills, body aches, upper respiratory congestion. More severe than with any regular flu shot in the past.
Per pt she developed rashes 5 hours after receiving H1N1 (inactivated) vaccine. On 11/5/09 pt in the clinic to show rash on face, chest, bilateral arms.
AFTER 2ND DOSE OF ENGERIX-B, PT EXP DIZZINESS, NUMBNESS IN BOTH HANDS, FATIGUE, FEVER, HEADACHE, AND QUEASINESS.
He had COVID Pneumonia; he had Covid; Got the first shot on 19Jan2021 and second shot on 27Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (He had COVID Pneumonia) and COVID-19 (he had Covid) in a 70-year-old male patient 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first shot on 19Jan2021 and second shot on 27Feb2021). On an unknown date, the patient experienced COVID-19 PNEUMONIA (He had COVID Pneumonia) (seriousness criteria hospitalization, disability and medically significant) and COVID-19 (he had Covid) (seriousness criterion disability). The patient was treated with OXYGEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first shot on 19Jan2021 and second shot on 27Feb2021) had resolved. At the time of the report, COVID-19 PNEUMONIA (He had COVID Pneumonia) and COVID-19 (he had Covid) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter. Patient stated that he will be on oxygen for the rest of his life.He went from a healthy person to an invalid.  reported patient's weight as 200  Company's comment: This case concerns a 70-year-old male patient, with no relevant medical history, who experienced the serious unexpected AESI of COVID 19 and COVID 19 PNEUMONIA. The events occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine, which was administered in an inappropriate schedule of administration. The rechallenge is not applicable considering the nature of the events. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 70-year-old male patient, with no relevant medical history, who experienced the serious unexpected AESI of COVID 19 and COVID 19 PNEUMONIA. The events occurred on an unknown date after the second dose of the Moderna COVID-19 vaccine, which was administered in an inappropriate schedule of administration. The rechallenge is not applicable considering the nature of the events. The benefit-risk relation of Spikevax is not affected by this report.
After 4 days Tinnitus started. After 14 days this became rather severe. Now at 16 days this is constant and has not gotten worse, but still is rather severe.
two days after the injection my arm start getting progressively sore with limited range of motion.  It is still hurts and I can only move it half way.    10 days later  after experiencing pan I saw my primary physician and orthopedic specialist and they attribute to "frozen shoulder"  and I am starting physical therapy on Friday, May 13th.   I never had this pain in any other previous covid vaccinations and I did notice the shot was higher on the arm this time.   I am taking naproxen and using heat.  I have a muscle relaxant but not taking that as much.
Cold symptoms; A little temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown), for COVID-19 immunization, reaction(s): "little temperature a day or two and it is gone", "spot on her arm may be red and the size of a quarter", "Cold symptoms"; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown), for COVID-19 immunization, reaction(s): "little temperature a day or two and it is gone", "Cold symptoms". The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious) with onset 2022, outcome "recovered" (2022), described as "A little temperature"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Cold symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated he and his wife have had three doses of the Pfizer BioNTech COVID-19 Vaccine, including the bivalent booster dose that they received three months ago. Reporter stated, "his wife has a terrible reaction to all of them. It takes 2 or 3 days before she gets over her reactions. Half the people they know have the same thing: cold symptoms and a little temperature a day or two and it is gone. He never had any reaction. The reporter asked for guidance to lessen her symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201377994 same reporter/patient/event, different dose;US-PFIZER INC-202201378898 same reporter/patient/event, different dose;
This is a 67y.o. male with significant past medical history of HTN, DM, ESRD on hemodialysis, BPH, nonischemic cardiomyopathy, MI, TIA, S/P AICD that presented to the hospital with chief complaint of syncope. Patient reportedly completed his HD session at his dialysis center when he suddenly loss consciousness. EMS was called and upon their arrival he was awake and conversing. Upon ED evaluation he reports feeling unwell. He states the past couple of days he has had intermittent dizziness, palpitations, non productive cough, nausea, and vomiting. He denies any fever, chills, chest pain, abdominal pain, constipation, or diarrhea.    In the ED, patient normotensive, afebrile, stable SPO2 on room air. COVID positive. CT head negative for acute process. CXR negative for acute process. He has been admitted for further evaluation and management with consultation in place to nephrology and cardiology.    Patient seen and examined only by the attending physician; NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.
Pt received routine 5 yr. vaccines (KINRIX and PROQUAD). Within 45 minutes of administration patient began having symptoms of anaphylaxis.
Hot, red cellulitis-like area on L upper arm.  5/9/11 red area measures 80 x 30 cm.
pretty sore arm; fatigue; This is a spontaneous report received from a Pfizer sponsored program. A 51-years-old male patient (Reporter husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm on Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pretty sore arm, and fatigue on Mar2021. It was reported that Caller also mentioned that her husband, (1 year older than caller) had the Pfizer BioNTech COVID-19 vaccine last March and her husband had a pretty sore arm and experienced maybe about half and hour of fatigue on second dose. The outcome of events was unknown.  Information about batch/lot number has been requested