chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 1 year old male who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/30) (lot# 657115/0417U, 656613/0414U). The patient developed a rash. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of three reports from the same source. Additional information has been requested.
Croup 1 day after vaccines. 2d later developed bilious emesis. Upper GI (-). Intussusception eval (-). Then developed severe diarrhea. Hospitalized x 9 day, IVF, NJ placement.
Information has been received from a pharmacist (Pharm. D.) concerning a 63 year old female with prediabetes and allergic to sulfa who on 25-APR-2011 was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669588/1452Z, exp: 28-JAN-2012). The reporter stated that the patient called the pharmacy on 30-APR-2011 stating she had soreness at the injection site since the day of the injection on 25-APR-2011 and that on 30-APR-2011 the area was swollen, itchy and painful. The pharmacist recommended BENADRYL and ice. On 03-MAY-2011 the pharmacist called her for follow up and the patient reported a burning sensation and a red rash with no blisters or open areas at the injection site. None lab diagnostics studies were performed. At the time of reporting, the patient had not recovered. Follow up information has been received from the pharmacist (Pharm. D.) concerning a 63 year old female allergic to sulfa who at 3:00 pm on 25-APR-2011 was subcutaneously vaccinated with the first dose of 0.65 ml ZOSTAVAX (Merck) (lot # 669588/1452Z) into right arm. The reporter stated that there was no illness at time of vaccination. The patient experienced arm sore at the first day. By Wednesday am the patient experienced arm swollen, itchy, painful. The patient applied ice and BENADRYL. There were no blisters but red rash, little burning sensation. The patient went to the doctor a few days later. The doctor determined it was not shingles. On 09-MAY-2011 the patient had recovered (it also reported "much improved"). Additional information is not expected.
Pt had vaccine 3/13 - came into the office today with a softball sized area on (L) deltoid of redness, warmth and swelling - started 24 hrs post inj. Was worse in 45 hrs. Getting better on her own. Given Rx for Oxycodone as "just in case".
Bacteriovaginosis; This spontaneous case was reported by a consumer and describes the occurrence of BACTERIAL VAGINOSIS (Bacteriovaginosis) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced BACTERIAL VAGINOSIS (Bacteriovaginosis). At the time of the report, BACTERIAL VAGINOSIS (Bacteriovaginosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on reporter's causality  the event bacterial vaginosisis assessed as unlikely related to mRNA-1273.; Reporter's Comments: Based on reporter's causality  the event bacterial vaginosisis assessed as unlikely related to mRNA-1273.
Fever 103.1F (39.5C), chills, body aches, fatigue, nausea, loss of appetite, headache
4day p/vax pt admit to hosp w/malodorous dark stool rotavirus +; surgery to correct intussusception transverse colon;
pt recv vax 25AUG97;26AUG97 mom noted rash-solid red on back, chest stomach;rash resolved by 27AUG97;mom reported to MD who said observe;
The patient got the vaccine was advised to stay for 15 minutes so that if needed we can provide medical attention. The patient felt anxiety prior to receiving the vaccine, she felt lightheadedness right after getting the vaccine. Then she proceeded to faint within the next 15 minutes. EMS was activated, store first aid team was called, 911 was called and paramedics was dispatched. The paramedics arrived and the patient was ok. The patient refused to go to the hospital and was fine after. The patient had some water and communicative afterward.
1wk p/vax pt devel numbness & tingling on rt side of face, next morning had lt face drooping, over days progressed to hands, feet, & tongue, numbness tingling weakness;went to ER dx w/Bell's palsy;neuro MD stated pt had GBS d/t vax;
2 forms of TD injection left deltoid.  Patient developed pain, redness and swelling around arm injection site.  Followed by headache.  Pain that moved to left node neck.
Asthma; This is a spontaneous report from a contactable consumer (patient). A 60-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration, in the left arm on an unspecified date in Mar2021 at 09:00 AM (age at the time of vaccination was 60-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included asthma and diabetes from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient had no allergies to medications, food, or other products. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had received other medications (unspecified) within 2 weeks of vaccination. On 10Mar2021 at 09:15 AM, patient experienced asthma. Therapeutic measures were taken as a result of the event and treatment included albuterol. Reporter considered the event as non-serious. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
heart racing so fast; dizzy; digestion not good; unable to sleep; nerve pain (pain scale 7-8); short pain in injection site leg and stomach; short pain in injection site leg and stomach; unable to sleep because pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep) and NEURALGIA (nerve pain (pain scale 7-8)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep), NEURALGIA (nerve pain (pain scale 7-8)), PAIN IN EXTREMITY (short pain in injection site leg and stomach), ABDOMINAL PAIN UPPER (short pain in injection site leg and stomach) and MYALGIA (unable to sleep because pain). At the time of the report, PALPITATIONS (heart racing so fast), DIZZINESS (dizzy), DYSPEPSIA (digestion not good), INSOMNIA (unable to sleep), NEURALGIA (nerve pain (pain scale 7-8)), PAIN IN EXTREMITY (short pain in injection site leg and stomach), ABDOMINAL PAIN UPPER (short pain in injection site leg and stomach) and MYALGIA (unable to sleep because pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient consulted couple of doctors and had blood test, endoscopy and colonoscopy and awaiting for the results. Concomitant medications not provided. No treatment was reported.
the patient had encephalitis, was on stomach steroids for 2 years and had fatigue so bad she could not get out of bed/ headache; This spontaneous report was received from a consumer, concerning a 20-year-old female patient who was also a daughter of a friend. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient developed encephalitis, had fatigue so bad she could not get out of bed, and also experienced headache (encephalitis). The patient was on "stomach" steroids for 2 years.   At the time of the report, the outcome of the event was unknown (also reported as the patient could be getting better or getting worse). The causal relationship between the suspect vaccine and the encephalitis was not reported.  Upon internal review, the event encephalitis was determined to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA000331:
Itchy, red, swollen, and sore at injection site starting 8 days after injection.  It expanded into an unusual shape rash and lasted about a week.
This spontaneous report was received from a registered nurse concerning a currently 16 months old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored doses of PEDVAXHIB lot# reported as: M047666, expiration date: 24-OCT-2019 for prophylaxis (dose, frequency, route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Data logger was involved. The outcome were unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758.
6/22/2004: Left thigh swollen, red, hot to touch. Dx: cellulitis
Called on 11/23/02, regarding red and swollen arm. No pain, itching at site, fever or drainage. Per protocol, was told to be seen in ER within 4 hours. ER advised mother this was a local reaction to DTAP and to use ice and po pain meds.
PRONOUNCE THUMPING AND RINGING IN THE EAR; SQUEEZING IN THE RIGHT LOWER LEG; RIGHT EAR ACHE; This spontaneous report received from a patient via a  representative concerned a 71 year old female. The patient's weight was 153 pounds, and height was 66.5 inches. The patient's concurrent conditions included mild case of high blood pressure, mild case of cholesterol, alcohol use 1 beer can a day, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced right ear ache. On 21-MAR-2021, the subject experienced squeezing in the right lower leg. On 30-MAR-2021, the subject experienced pronounce thumping and ringing in the ear. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from squeezing in the right lower leg, and had not recovered from pronounce thumping and ringing in the ear, and right ear ache. This report was non-serious.
This spontaneous report as received from a nurse refers to a child of unknown age. On 18-JUN-2013 the patient was vaccinated with ROTATEQ (route, dose, Lot # and expiration date were not provided). The patient was vaccinated with improperly stored vaccine. The patient experienced no adverse effects. It was reported that revaccination will be scheduled. This case is linked by same reporter to case # 1309USA006535 of a child who received improperly stored COMVAX vaccine and case # 1308USA014806 of a child who received improperly stored GARDASIL vaccine. Additional information has been requested.
08/29/2021 went in for treatment. Got sick though it was her Asthma condition. Through was swollen in size was not able to swallow, was very painful cough and hard time catching her breath and asthma inhaler was not working, so she went in for testing. 08/31/2021 received the COVID positive results. They gave her a stripe test. They gave prescription to pick up and was given dexamethasone a steroid. Patient fog. 8 Benzonatate 100mg for coughing, monoclonal antibodies infusion from the ER, 8 pills of hydrocodone for pain, Zofran for nausea, and inhaler three times a day.
SHORTNESS OF BREATH; RECURRENT PERICARDITIS; This 60-year-old, female subject (US3262125) was participating in a study (mRNA-1273-P301) and experienced shortness of breath and recurrent pericarditis.    The subject's medical history, as provided by the investigator, included anxiety, restless leg syndrome, seasonal allergies, and postmenopausal. Concomitant medications reported included fluoxetine, ropinirole, and cetirizine hydrochloride.   The subject previously experienced the serious adverse event of shortness of breath (MOD-2022-640460).  Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3, booster) for SARS-CoV-2 vaccination on 27 Oct 2021, approximately 10 months and 21 days before onset of the event.  On 16 Sep 2022, the subject experienced shortness of breath and recurrent pericarditis and was admitted to the hospital. Treatment for the event was not provided.  On 22 Sep 2022, the subject was discharged from the hospital.  On 29 Sep 2022, the subject completed the study.   No action was taken with the study drug in response to the events.   The event, shortness of breath, was reported as resolved on 22 Sep 2022.  The event, recurrent pericarditis, was reported as not resolved.   The investigator assessed the event, shortness of breath and recurrent pericarditis, as not applicable to study drug and not applicable to study procedure.  Follow-up received on 03 Oct 2022 included new event (recurrent pericarditis).   Company Comment: This case concerns a 60-year-old, female subject with a medical history of anxiety, restless leg syndrome, seasonal allergies, and postmenopausal, who experienced the unlisted event shortness of breath and the expected adverse event recurrent pericarditis. The event shortness of breath occurred 2 years 1 month 8 days after the first dose of mRNA-1273 and 10 months 21 days after third (booster) dose. The event recurrent pericarditis occurred 2 years 1 month 8 days after the first dose of mRNA-1273 and 10 months 21 days after third (booster) dose. The event shortness of breath was reported as resolved and the event recurrent pericarditis was reported as not resolved.  The investigator assessed the events as not applicable to IP. The sponsor assessed the events as unrelated to IP in the context of the limited information on subject previous pericarditis history, medical history, other diagnostic reports, reported clinical evaluations included physical exams, lab tests, EKG, Echocardiogram, and cardiologist consultation. Further information will be requested.
I felt fatigue a couple of hours after receiving the shot; approximately 7 hours after receiving the shot, my arm started getting sore; I also experienced some pain in my neck; I also experienced some pain in my neck and left leg - on a scale of 1-10 the pain was about a 2, so nothing serious; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7533) via an unspecified route of administration in the left arm on 12Apr2021 at 11:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient had no known allergies to medications, food or other products. 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 12Apr2021 at 15:00, a couple of hours after receiving the shot, the patient experienced fatigue and approximately 7 hours after receiving the shot, her arm started getting sore. She also experienced some pain in her neck and left leg. It was reported by the patient that on a scale of 1 to 10 the pain was about a 2, so there was nothing serious. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fatigue started couple of hours after receiving the shot, arm started getting sore, pain in her neck and left leg were all recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
I experienced shortness of breathe, flu like symptoms and Achiness two days after receiving the vaccine. I went to Urgent Care and  was examined (told to have the symptoms checked out if my condition worsened by my PCP). My symptoms subsided but I still have a little bit of shortness of breath that is not preventing me from working or doing my normal activities. I'm at 98 percent from the shortness of breathe and still have a bit of soreness at the injection site.
HAD VACCINE YESTERDAY AFTERNOON. IN EVENING NOT FEELING WELL AND BECOMING VERY PALE. IN MORNING WOKE UP AT 7 AM VOMITING AND VERY PALE. COMPLAINING ABOUT DIZZINESS, BAD VISION AND VOMITING A LOT THROUGHOUT DAY! MOSTLY VOMITING CLEAR FLUIDS. NOT REPORTED TO PEDEATRICIAN AS IT IS WEEKEND. FATHER MD HIMSELF AND TREATING PATIENT.
Patient with immediate complaint of itching and warmth at injection site. Given ice pack compress and monitored closely. Began to complain of itching and warmth over entire upper right arm. Given PO Benadryl. Vitals stable. At no time was distress noted. Patient denied nausea, vomiting, shortness of breath, airway swelling, tingling, or itching of airway. Continued close monitoring and ice pack compress.  After 30min of monitoring post-Benadryl administration,  warmth had completely resolved. Only remaining symptom was mild itching at vaccine site only. No further itching over remaining upper right arm surface. Continued to deny nausea, vomiting, shortness of breath, airway swelling, tingling, or itching of airway. Patient was discharged to home with instruction to dial 911 or proceed to nearest emergency room if new or worsening symptoms including but not limited to chest tightness, shortness of breath, airway swelling, nausea and vomiting.
The day of the vaccine my left arm hurt, and I got a red and itchy circle around the injection site, this lasted about 4 days. On day 8 of post vaccine, the red circle appeared again, this time bigger, and more itchy than before.  I went to the doctor following the return of the red ring and it being bigger, and was told to take some benadryl/cetrizine and that would help, I continued to take Benadryl for 3 days and it went away completely.
This spontaneous report as received from a Nurse refers to a 15 month old patient of unknown gender. On 15-OCT-2013 the patient was vaccinated with PROQUAD (Merck) (subcutaneous, 0.5 ml; dose number and lot number unknown). On the same day the patient was vaccinated with VARIVAX (Merck) (subcutaneous, 0.5 ml; dose number and lot number unknown). No adverse affects were reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Over a year ago, on an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 (dose, route and lot number were not reported). In approximately September 2013 (about one month ago), the patient received the second dose of RECOMBIVAX HB 10 (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1310USA009449 via same reporter link. Additional information has been requested.
Severe Muscular pain/stiffness. Difficulty walking. Severe pain Cortisone Treatment. Lab/Physician involvement ongoing. ESR 92 C-Reactive protein 60.
Vaccine had an expiry date on 18-Mar-2022 and patient received the vaccine on 06-Apr-2022/dispensed 28 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had an expiry date on 18-Mar-2022 and patient received the vaccine on 06-Apr-2022/dispensed 28 doses of expired Moderna Covid-19 vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Acute illnesses at the time of vaccination and up to one month before/Chronic and long standing health conditions were reported as None.     On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had an expiry date on 18-Mar-2022 and patient received the vaccine on 06-Apr-2022/dispensed 28 doses of expired Moderna Covid-19 vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had an expiry date on 18-Mar-2022 and patient received the vaccine on 06-Apr-2022/dispensed 28 doses of expired Moderna Covid-19 vaccine.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was reported as None.  The patient had never diagnosed or tested positive for Covid-19.  The patient reports no adverse event form the vaccine on 06-Apr-2022. The vaccine had an expiration date 18-Mar-2022 and a stability study has been initiated with moderna.  .   This case was linked to MOD-2022-541343 (Patient Link).
I received my first Pfizer booster for COVID-19 on 9/24/2021. On 1/29/2022, my partner and I were camping with a group of 23 other people. My partner noticed that I was disoriented at about 8 AM, so she called the paramedics. When the paramedics arrived, they took my blood pressure, which was about 240/130. They decided to have me flown to the nearest medical center. When I got to the hospital, I was put through a battery of tests, including a PCR test for COVID-19. The result was positive. I was then isolated in the ward set aside for COVID-19 patients. By the time we arrived at the hospital, my blood pressure was below 150, but I was given Ramipril to treat hypertension. Aside from the hypertension, I had no symptoms associated with COVID-19. I was released from the hospital on 1/31/2022. I was given instructions to follow up with my cardiologist in February or March 2022. He installed a heart monitor loop during this time. In June 2022, the cardiologist noticed that my heart rate was dipping to below 40 while I was sleeping, so he decided to remove the loop, and he installed a pacemaker on 6/29/2022. At the time of this writing, my blood pressure and heart rate have been normal. I am currently keeping my hypertension in check by taking amlodipine every morning and Ramipril every night.