chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose)). On 08-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose)) had resolved.        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.
Rapid onset of the following symptoms within a two hour time frame. Dizziness. Strong Migraine (First ever in life time). Light Sensitivity. Vomiting for multiple hours which did not subside with reduction of migraine or food intake. Migraine was not affected in a positive way with vomiting. Episode lasted approximately seven hours. The next 24 hours symptoms included dizziness and feeling weak.
This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, drug allergies/reactions and concomitant medications were not reported. On 30-NOV-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis, reconstituted with sterile diluent. On an unknown date in 2017, the patient experienced significant pain near the injection site. The outcome of the event was unknown. Causality assessment was not provided.
Patient inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water rather than 0.9% sodium chloride; Patient inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water rather than 0.9% sodium chloride; This is a spontaneous report from a contactable Nurse. A contactable nurse reported for a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8735 and expiry date: 24Jun2021), via Intramuscularly, in Deltoid Left, on 16Jun2021 (age at vaccination: 66 years), as a single dose, 0.3 ml, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on 16Jun2021, the patient inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water rather than 0.9% sodium chloride. She asked if the dose should be repeated and what to clinically expect from the patient who inadvertently received his first dose of the Pfizer-BioNTech COVID-19 vaccine diluted with sterile water. Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. The diluted vaccine using sterile water for injection as the diluent should be appropriately discarded and not used for vaccination. If the vaccine that was diluted with sterile water for injection was inadvertently administered to individuals, a definitive statement on the quality and usability of the vaccine diluted in water cannot be made. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. Based on this lack of information, Pfizer was unable to definitively state if the vaccine dose was valid or invalid. Therefore, we kindly refer you to discuss revaccination need or timing. It was not within Pfizer's remit to recommend revaccination from FAQ-COVID-19 Vaccine-sterile water as diluent; - Off-label disclaimer and "Table 1. Interim Recommendations for COVID-19 Vaccine administration Errors and Deviations (ACIP)/Diluent" from Revaccination after administration of Invalid Dose. Outcome of the events was unknown.; Sender's Comments: Based on the information currently available, there is no relation between the suspect vaccine BNT162B2 and  the onset of poor quality product administered,product preparation error.
Shingrix Vaccine - experienced Chills, Fever and Stomach Pain in addition to arm soreness.  Symptoms lasted approx. 8 hours from 12am to 8am.
Things tasted a little funny but I mostly noticed it with coffee; Exactly two weeks after the first vaccine I started smelling cigarette smoke and a sweet garlicky smell; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EJ1685) via an unspecified route of administration on 07Jan2021 at 09:30 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was not diagnosed with COVID-19. Concomitant medications included a multivitamin and an estrogen supplement. The patient previously received sulfa and clindamycin from unknown dates for unknown indications and experienced allergy. Exactly two weeks after the first vaccine on 21Jan2021 the patient experienced smelling cigarette smoke and a sweet garlicky smell. Things tasted a little bit funny but she mostly noticed it with coffee. She thought maybe she had a cold. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events.The outcome of smelling cigarette smoke and a sweet garlicky smell were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
This 60 y.o. female with past medical history of CLL in clinical remission and depression was admitted to the hospital yesterday for observation after she had a syncopal episode during the night after her 2nd Moderna vaccination. Patient reported that she got her vaccine on 2/12 at 8am and by that night she was experiencing chills and nausea. She then went to get up in the middle of the night as she felt she needed to vomit and became lightheaded with syncope.
Chest pain / Heart pain (localized to left side of chest). Most intense the day after the shot, but still continuing 8 days later. Was constant at first, at the 8th day it only comes on after physical activity, but does not subside for hours.
ITCHINESS STARTED ON THE CHEST AND STOMACH AND THEN SPREAD THROUGHOUT THE BODY.; RASH THAT STARTED ON THE CHEST AND STOMACH AND THEN SPREAD THROUGHOUT THE BODY; CHILLS; FATIGUE; BODY ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nickel, ore allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. On 16-MAR-2021, the subject experienced itchiness started on the chest and stomach and then spread throughout the body. On 16-MAR-2021, the subject experienced rash that started on the chest and stomach and then spread throughout the body. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fatigue on 15-MAR-2021, and had not recovered from itchiness started on the chest and stomach and then spread throughout the body., and rash that started on the chest and stomach and then spread throughout the body. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Tinnitus in left ear (shot received in left arm). It?s a constant tone. I?ve never had tinnitus previously. Tone was there when I woke up (9-apr, 0800) the morning  following the shot (8-apr, 1400). The tone increased in intensity about a week later and was consistent after that. Based on surrounding conditions, intensity of tone can be a 1/10 with background noise and 6/10  in silence.   Additionally, there is a degree of interference in sounds. If the sound is from a low quality speaker (phone/computer) the sounds generates a static sound, almost like interference or what music sounds like from low quality buffering. Also, music, even played at low volume in speakers, increases the intensity of the tone.
Patient with 3 COVID vaccinations who admitted with COVID pneumonia.  Symptoms worsened, patient and family declined advancing care to ventilator.  Patient subsequently died.
This spontaneous report as received from a licensed vocational nurse via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2016 (reported as "starting on or after 29-APR-2016"), the patients were vaccinated with improperly stored doses of PNEUMOVAX lot # M005287, expiration date: 08-OCT-2017 (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.26 degrees Celsius for 1 hour and 25 minutes and 21.04 degrees Celsius for 36 hours and 25 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt experienced immediate numbness and tingling in her mouth, No LOC or local site reaction notes.
Pt called 2/4/08 c/o body and feet pain and rash all over. Feet swollen. Seen in ER. Given prednisone, Pepcid, and Benadryl with improvement.  May have been viral exanthum.
10/30/21 77 y.o. female with a past medical history noted below presents from ED with c/o body aches, fatigue, productive cough with white sputum x 2 weeks.  Associated with poor appetite, subjective fevers, chills, abdominal discomfort.  Had 2 episodes of diarrhea.  Saw her PCP who advised her to come to the ED.  Tested positive for COVID at Walgreens 3 days ago.  Lives with son who also tested positive for COVID.  Fully vaccinated against COVID x 2 doses.  Reports dysuria x 1 week.  Denies CP, SOB, sore throat, loss of smell/taste.    On the unit, pt spiked fever of 102.9 and hypoxic at 90% on RA". Treatment: Rocephin IV, Remdesivir IV x 5 d, Decadron IV x 10 d. Pt is still hospitalized.
4th dose received 15days early. Error was noted while patient was waiting in Observation. Patient was notified. No adverse reaction reported at that time.
CT immediately felt AE to PP23 injection; itching @ site. 1.5 hours later, the site was hot to touch, sore, red, swollen. By evening, took picture and shared with PCP. Telemed conference with Dr. @1700. Recommended Benadryl, 911 if shortness of breath. CT felt rash was moving to all over arm. Took  Benadryl, slept. Site still swollen, bicep area, sore to touch, faint, nauseous, vertigo.  CT stated Dr stated her case was 'severe' and 'unusual'.  CT will confer with Dr. if does not hear back.  Dr 'visit' following AE on telemed. CT has photos of injection site.
Reaction was immediate Dizzy Blurred vision Nausea  Body felt very warm and overheated  Heavy feeling and pressure in chest when breathing Overall uneasy feeling
Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown.  Information on the lot/batch number has been requested.
Patient was administering 0.5 ml of Typhoid vaccine to a patient and the needle came off the syringe during the push. The vaccine sprayed back onto patient's face. She washed her face, flushed her eyes and consulted with her physician.
sx is described as similar to the feeling of mild intoxication & is precipitated by change in position-leaning forward or turning of head, w/dizziness occurring immed p/vax;+mild nausea & clicking in ear when swallowing;
Vaccine given at school based clinic.  Patient presented with bloody diarrhea of unclear etiology 7 days later.  May be entirely unrelated to vaccine.
My heart has never been the same ever since I got the Covid 19 shots. My heart is now fluttering many times everyday which never happened before I got the shots. It's been 5 months since I got the shots.
erythematous rash on hands b/l with skin burning sensation of posterior-lateral index finger extending to thumb b/l. Erythematous rash on nose and cheeks that is also w/ skin burning sensation. Skin burning sensation w/o rash on abdomen that is intermittent
11:30pm on day of dose 9/4, I felt nauseous. I got up from my desk to walk about 15 steps to the bathroom and lost consciousness. In coming to, I was hot and sweaty. When EMTs arrived my bp was 80/a number I don?t remember but low. Bs was 114
A five year old boy, broken out with generalized hives, throughout, welts, raised bumps, red and pt complained of itching. Mom denies any SOB, dyspne, nor any temperature. Still ongoing during report.
Severe headaches, dizzyness, leg pains.  Difficulty maintaining conciousness at work.  Was removed from workplace due to pain, close to losing conciousness.  Out of work on sick leave for 3 days.
Vomiting; Severe chills; Headache; Redness; Bump; A spontaneous report was received from a consumer for a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/chills, headache, vomiting, redness/injection site erythema and bump/injection site swelling.  The patient's medical history was not reported. No concomitant product use was reported.  On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M208) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, next day after receiving the vaccine, the patient experienced severe chills for several hours, headache, vomiting, redness and bump. She went to the hospital and had to get rehydrated. No treatment for redness and bump were reported.  Action taken with mRNA-1273 with respect to the events was not reported but patient did not want to get the second dose.  The outcome of the events, bump and redness, was recovered on 07 Feb 2021. The outcome of the events, chills, headache, and vomiting, were considered resolved on 04 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
lost of taste; ear infection; ear pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) 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: SR2583), for COVID-19 immunization.  The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "lost of taste"; EAR INFECTION (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information was received from a pharmacist concerning a patient of unknown age and gender, who on 20-APR-2015, was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously for the prevention of shingles. The pharmacist reported that she was informed by an unspecified pharmacist at another store, that this unspecified patient was prescribed Prednisone (manufacturer unknown) 5 mg, twice a day, for an unknown reason after receiving ZOSTAVAX. The pharmacist had no patient or physician identifying information. No further information was provided. Additional information is not expected.
The same afternoon, low fever that persisted for 12 hours (100.4 at highest), nausea, headache, extreme pain in left arm that persisted for about a week, swollen glands under left arm, body aches, fatigue. Red, itchy rash that began 72 hours after vaccines and lasted for about a week, primarily located on legs.
Dizziness about 2.5 hr  after injection.  Almost passed out.  Had a less intense occurrence about 1 hr later.
heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unk) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. No laboratory data was provided. No treatment information was provided.  Very limited information regarding  this event has been provided at this time. No further information  is expected at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding  this event has been provided at this time. No further information  is expected at this time.; Reported Cause(s) of Death: unknown cause of death
was fine the first few days, woke up three days later with chest and jaw pain and shortness of breath, and body aches. was given aspirin and ketorolac iv as well as some zofran
This spontaneous report was received from a pharmacist regarding an unspecified number of patients of unknown demography. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, unspecified number of patients were vaccinated with expired doses of ZOSTAVAX injection (dose, route unknown) lot # J007301 with expiration date of 20-SEP-2014. The last unspecified patient received the expired does of ZOSTAVAX from the lot # J007301 on 11-MAY-2016. No adverse effects were reported for any of the patients'. Additional information has been requested.
Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient did not take any other medications/products within two weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.  Concurrent medical conditions included Allergy.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022, the patient experienced COVID-19 (Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22). At the time of the report, COVID-19 (Negative test on 5/9/22; symptoms gone. Symptoms returned 5/13/22; tested positive 5/14:22) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 66-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred 1 month 19 days after a dose mRNA-1273 vaccine (dose number not specified). Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19 after the treatment he was tested negative for covid-19. 4 days later, symptoms returned and the next day she was tested positive for COVID-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred 1 month 19 days after a dose mRNA-1273 vaccine (dose number not specified). Patient was administered with NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19 after the treatment he was tested negative for covid-19. 4 days later, symptoms returned and the next day she was tested positive for COVID-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient was administered 0.2mL of undiluted pediatric vaccine. The parent was contacted and notified of the error. The patient experienced a fever around 101 F, for approximately 2 days. The fever was well controlled with Tylenol. No other symptoms were reported.