chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very very Tired.; Approx. 11 hours of sleep; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, pneumonia and minor case of epilepsy. The patient did not have any allergies to medications, food or other products. Concomitant medications included carbamazepine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021, the patient experienced very very tired and would go to bed as soon as got home from work, and slept until got up the next day for work. Approx. 11 hours of sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events very very tired and would go to bed as soon as got home from work, and slept until got up the next day for work were resolved on 28Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 10OCT96 & 29OCT96 & pt devel approx 20 vesicles on abd & face;presented to MD;pt had 7 to 10 dried blisters on face & chest;pt recovered;
very itchy; round circle and a hard bump; today where shot was given, arm is very hard; the rash is probably the size of a half dollar; at first only slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy), VACCINATION SITE RASH (the rash is probably the size of a half dollar), VACCINATION SITE MASS (round circle and a hard bump), VACCINATION SITE INDURATION (today where shot was given, arm is very hard) and VACCINATION SITE PAIN (at first only slightly sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (at first only slightly sore arm). On 31-Mar-2021, the patient experienced PRURITUS (very itchy), VACCINATION SITE RASH (the rash is probably the size of a half dollar), VACCINATION SITE MASS (round circle and a hard bump) and VACCINATION SITE INDURATION (today where shot was given, arm is very hard). At the time of the report, PRURITUS (very itchy), VACCINATION SITE RASH (the rash is probably the size of a half dollar), VACCINATION SITE MASS (round circle and a hard bump), VACCINATION SITE INDURATION (today where shot was given, arm is very hard) and VACCINATION SITE PAIN (at first only slightly sore arm) outcome was unknown. 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.   No relevant concomitant medication and treatment information was provided.
12/22/2022 tested positive for Covid; prescribed PAXLOVID; mild symptoms low fever shortness of breath; 12/29/2022 tested negative 12/30/2022 started having nasal congestion with fever symptoms worsened through weekend. On Tuesday symptoms dropped off 01/03-01/05 home Covid test was positive. Shortness of breathe and fatigue. Tested 01/10/2022 for Covid result were negative.
Post vax, the patient experienced hives and sought unspecified medical attention. The patient subsequently recovered. The physician also reported 4 other patients who developed hives after being vaccinated with varicella virus vaccine live. Additional information has been requested.
Varicella rash after 1 week post vaccination  Mom had Varicella zoster 1 week prior vaccines
Pt. had lightheadedness and dizziness after injection. Pt called doctor who told her to take BENADRYL by mouth. Pt. took BENADRYL and felt better. She took it at 11AM.
Localized reaction. Arm pit and surrounding area became swollen. Pain didn't occur until the middle of the night.
Give MMR-Polio-DTaP, pt and mother went to lab dept for appt child developed hives rash while down there. Given Epipen Jr-Benadryl and 0.2ml Epinephrine SQ. Admitted pt to hosp.
Swelling occurred 2 days ago after immunizations. Patient starled with swelling to her arm the evening after receiving her shots. it is warm , but not painful and she is using her arm without difficulty The client has redness erythema in the right arm . The swelling is  aggrevated by local pressure but not aggrevated by movement. The client had a poor response to cold compress. The client denies any associated  symptoms. Arm feels warm to the touch. no other complaint unless pressure is applied.
I had a really bad headache, coughing some achiness that started on the late April 14, 2023. The next day I was feeling worse, I got a fever, I used a home COVID-19 test that came back positive. I called my doctor to let her know I had tested positive and discuss my symptoms. I was prescribed Lagevrio, I started taking the medication immediately. Once I finished the medication, I felt lethargic and fatigued, I still have a stuffy head.
>35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
First dose: April 6th 2021/Third dose: Jun 8th 2021; second dose / 2 days apart form the first/First dose: April 6th 2021/Second dose: April 8th 2021; adolescent female patient received Engerix-B adult dose/  instead of a pediatric dose; adolescent female patient received Engerix-B adult dose/  instead of a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HBV (Engerix B pediatric) (batch number KC57F, expiry date 4th September 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Previously administered products included ENGERIX-B PEDIATRIC with an associated reaction of no adverse event (received 1st dose on 6th April 2021).   On 8th April 2021, the patient received the 3rd dose of Engerix B pediatric. On 8th June 2021, the patient received the 2nd dose of Engerix B adult. In April 2021, not applicable after receiving Engerix B pediatric and unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too short, overdose and adult product administered to child. In June 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short, drug dose administration interval too short, overdose and adult product administered to child were unknown.  Additional details were provided as follows: The patient received Engerix-B adult dose as a second dose instead of a pediatric dose 2 days apart from the first Engerix-B, which led to shortening of vaccination schedule. The patient received 3rd dose Engerix-B adult dose after 2months, which led to shortening of vaccination schedule, overdose, adult product administered to child. The reporter consented to follow up.    Upon QC review below correction are done on 15th June 2021: On 8th June 2021, the patient received the 3rd dose of Engerix B pediatric.  On 8th April 2021, the patient received the 2nd dose of Engerix B adult.
Nausea and threw  up a little bit after shot. Had a fever off and on for the 17, and 18th of March.  Had rapid increased heart rate off and on. very fast for a long  time on the 22sd of March. went to the ER around 12 pm. treated for a fast hear rate and enlarged thyroid. After meds my heart rate returned to a more normal rate.
Atrial fibrillation for 4 days; condition aggravated; Couldn't stand up straight or walk in a straight line during the atrial fibrillation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included WARFARIN, ATENOLOL and ATORVASTATIN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant) and GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation). On 16-Apr-2021, GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was treated with Cartia (diltiazem) as advised by their health care professional to try to alleviate the symptoms.  Action taken with mRNA-1273 in response to events was not applicable.  Company Comment: 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.   This case was linked; Sender'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. cross linked case
Patient reported to writer on 11/30/17 that his left arm still hurts from flu shot that he had received on 10/19/17. Patient thinks flu shot was given too high. He stated that he is only 24yrs old and he should not have this kind of pain from a flu shot he had a month ago. Writer did refer him to his primary care physician even though he did not want to go because he does not want to pay the deductible on his insurance. Participant claims he is having trouble with things such as putting on his own seat belt in his car. Writer spoke with patient again on 12/4/17 regarding left arm. Patient stated that he has gone to urgent care and he is taking MOTRIN for 5 days and applying ice to his arm for 5 days. Patient claims that MD at urgent care stated he had "Tendinitis".
Patient reports more joint popping since 3rd vaccine (jaw, neck, ankles). No pain, just cracking.
Severe injection site reaction: redness diameter larger than quarter size, hot/inflamed, itchiness present, bump at site, headache. Patient denied systemic effects or spreading beyond left arm. Pt took BENADRYL & applied cool dressing to area.
headache, dizziness, nausea, fatigue, sweating, extreme abdominal pain, intolerable nausea, vomitting, chills, body aches, extreme knee pain  treatment - ibuprofen 600 mg every 4 hours
The customer walked in to our store around 2:15pm on 05/11/2021 asking for the immunization report and when asked she said the pain she got from the flu shot she received on 09/15/2020 was bad. She had to see doctors and underwent treatment and feeling better now.
Patient here for COVID-19 vaccine. Stated she had had a reaction to bee pollen in the past but was not concerned. She had done well with vaccine #1 and stayed for 15 min. at that time. Vaccine was given at 1335. Pt re-evaled 15" after her #2 dose, She felt dizzy had had a high BP 191/81. Pt was advised to go to the ER and was taken by car up to the hospital at 1338, accompanied by a staff member.   Upon transport to the ED patient complained of sore throat. Epipen was administered in the ED and patient was monitored for 75 minutes. Blood pressure returned to baseline and patient report feeling like her usual self with the exception of feeling a little jittery due to the EpiPen.
Yesterday seen in ER for rash and hives, rash was dx as viral and urticaria. Pt was rx with Zyrtec.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, reported as multiple unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, anatomical location, lot# and expiration date were not reported). Administered doses of PNEUMOVAX 23 experienced temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes, on an unknown date. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female nurse, possibly in her late 40's, who on 03 Jan 2007 spilled Zostavax on her hand when she was drawing it up from the vial to administer to a patient. She developed pain ten days later on 13 Jan 2007 and lesions thirteen days later on 16 Jan 2007. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality compliant involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 49 year old female with no medical history or allergies who on 09-JAN-2007 (previously reported as 03-JAN-2007) spilled ZOSTAVAX (Oka/Merck) (lot # 656412/1476F) on her hand when she was drawing it up from the vial to administer to a patient. She developed pain ten days later on 13-JAN-2007 and lesions thirteen days later on 16-JAN-2007. It was later reported that on 23-JAN-2007 at 7:00 am the patient was diagnosed with shingles. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Headache NASAL DRAINAGE, HEADACHE, FLUSHING, CHILLS, FATIGUE Narrative: ABOUT 30 MIN. AFTER VACCINATION, PATIENT BEGAN TO FEEL OFF-BALANCED WITH A MILD HEADACHE ABOVE THE RIGHT EYE. FOREHEAD WAS FLUSHED, WATERY EYES, RUNNY NOSE, FATIGUE AND CHILLS. LEFT UPPER ARM IS SORE, MORE NOTICEABLE WITH MOVEMENT. AT TIME OF REPORT, PATIENT CONTINUES TO HAVE RIGHT SIDED HEADACHE, SORE UPPER ARM, CHILLS AND FATIGUE.
The patient presents with nasal discharge.  These symptoms began today.  He is not having diarrhea or fever.  Other comments include: Patient has been gagging and as per mom he had some involuntary movement.  Patient is also cranky.  Following nasal aspiration this Am, child began to rub the right eye for a few minutes and was then fine.  Father has seizure disorder and parents are concerned that child had seizure.  30 minutes after episode child was well.  There apparently was some gagging but no LOC.
Severe under arm (lymph node area) pain for approximately two hours in the left arm where I received the shot.   I did not take any pain medicine and the pain disappeared after I woke up around 8 am in the morning on 4/2.
strong pressure in the chest/ but feels like some pressure there; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there). At the time of the report, CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided   Reporter did not allow further contact
Hives started on 8/13/21 followed by one week later of severe panic attacks
17 year old vaccinated; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old vaccinated) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old vaccinated). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old vaccinated) had resolved.        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.   No relevant concomitant medications were provided.  Reportedly, no other side effects reported and the patient did not receive any treatment.
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L001312, expiration date 24-FEB-2017) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
expired ACTHIB was accidentally given to a patient with no reported adverse event; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 1 years old female patient and it was reported that expired HIB (PRP/T) vaccine [ACT-HIB] was accidentally given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); pneumococcal vaccine CONJ 7V (CRM197) (Prevnar); and hepatitis A vaccine INACT (Vaqta) all for Immunisation.  On 11-Apr-2023, an expired dose of HIB (PRP/T) vaccine [ACT-HIB] powder and solvent for solution for injection (batch: UJ671ABA; expiry date: 07-Apr-2023; dose: 0.5 mL; strength: standard) was accidentally given to a patient via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives appeared about 15 minutes after injection - tingly & slightly itchy skin, feeling flush, hands slightly red. Symptoms lasted about 24 hours.
Sores in mouth starting about 36 hours after the vaccine.  Some sores lasted a few hours. Others, especially those towards the back of the throat have persisted and caused pain.
patient received 1st dose on 04/27/2021. Approved in June 2021 for ages 12 years and older.
t103; 2 convuls; eyes rolled back & pt began shaking; pt taken to ER; pt exp tonic jerking, unresponsiveness; febrile sz;
On October 24, 2021, I had a 3 pm appointment at the pharmacy to receive a 0.25 mL dose of the Moderna COVID-19 booster. According to my records in the database, I was administered a 0.5 mL dose. My layperson's interpretation of VAERS policy is that this is a reportable administrative error.  After my appointment, I checked the lot number listed on the COVID-19 Vaccination Record Card using the Moderna Lot Number Lookup tool. The lot number, and several variations of it, were invalid.  (continued below)