chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stuffy Nose (A Little); Cough; Fever; Missed dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (Stuffy Nose (A Little)), COUGH (Cough), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METHOTREXATE for Rheumatoid arthritis, AMLODIPINE and LISINOPRIL for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced NASAL CONGESTION (Stuffy Nose (A Little)), COUGH (Cough), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK, q6h, 2 tablets. On 12-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. On 21-Apr-2021, COUGH (Cough) and PYREXIA (Fever) had resolved. At the time of the report, NASAL CONGESTION (Stuffy Nose (A Little)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: New events were added. On 27-Apr-2021: Patient demographic detail was updated, concomitant medications were added, treatment medication was added.
Large red patches just below injection site; Injection site burning; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old female patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products.  Prior to the vaccination, the patient was not 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 05Apr2021, three days after the vaccination, the patient experienced large red patches that patient felt like they are burning just below injection site. The clinical outcome of the event large red patches below injection site and injection site burning was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
each time I have gotten real sick afterwards; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves a patient of unknown demographic who each time have gotten real sick afterwards (illness), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route and administration site unknown) for prophylactic vaccination.  On an unknown date, (unknown latency) after initiation influenza vaccine therapy time the patient had gotten real sick afterwards (illness) following the administration of influenza vaccine.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Severe pain left arm (TDAP injection site). Decreased ROM of left shoulder. Unable to lift arm above shoulder. Strength 2/5. Pain scale 10/10. Patient crying in pain. 0 swelling; 0 erythema; 0 rash; no signs of infection.
Warm to touch immediately after, pain at injection site following 48 hours. Then red spot noticed on 2/12, noticed it was about a 4 inch band of red, mildly raised and warm 2/15. Slightly more pale in center around vaccine site. Looks almost erythematous like after an allergy shot. Has went down in color slightly today 2/16.
The patient developed ANCA-associated vasculitis, and developed kidney failure despite aggressive treatment. He had pulmonary hemorrhage as well.  He is now permanently on dialysis as a result of the vaccine.
not getting 2nd dose on time; her bottom whip was swollen; fever of 100°F; soreness on the left side of her face; increasing left side chest pain/ pain on her chest; swelling on the left side of her face; feeling really sick; heaviness on the left side of her face; arm pain / pain on her left arm within 1 hour of receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face) and SWELLING (her bottom whip was swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine). On 27-Jun-2021, the patient experienced CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), PYREXIA (fever of 100°F) and MYALGIA (soreness on the left side of her face). On 11-Jul-2021, the patient experienced SWELLING (her bottom whip was swollen). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time). At the time of the report, CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), SWELLING (her bottom whip was swollen), PYREXIA (fever of 100°F), VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine) and MYALGIA (soreness on the left side of her face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2021, Body temperature: 100 (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has not taken second dose due to fear. She had pain in her chest and lower arm. Concomitant medications were not provided. Treatment information was not provided.
Patient was given Moderna vaccination and was waiting in the post-vaccine area. Patient reported to the associate that he was feeling funny. The pharmacist was called and the patient reported feeling  light headed and dizzy. While talking the pharmacist the patients eyes rolled back in his head. The pharmacist held his shoulders and his hand and continued to speak to the patient. He regained consciousness. The patient was able to move to his knees and then to lie on his back on the floor with his feet elevated. The injection site was clear and smooth. He had no fever. After resting 15 minutes his color improved and was conversing well. He was able to sit up and his blood pressure was taken. His blood pressure was within normal range. He sat for another 15 min and drank some juice. He was feeling well enough to go home in the care of his wife.
This spontaneous report was received from a pharmacist referring to a 70 year old female patient. The patient had no pertinent medical history. The patient's concurrent conditions included allergy to Angiotensin converting enzyme inhibitors and allergy to sulfa drugs. The patient's concomitant medications included hydrochlorothiazide, metropolol, albuterol sulfate(PROAIR), canagliflozin(INVOKANA), prednisolone eye drops, bromfenac sodium(PROLENSA) eye drops, and gatifloxacin(ZYMAXID) eye drops. On 07-NOV-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N020688 with expiration date 09-MAR-2019, for prophylaxis (dose was not reported). It was stated that 4 hours later, the patient started having redness, swelling and a lump on the unspecified arm used for the administration of the vaccine. Furthermore, the patient was in a lot of pain and was unable to sleep. An unspecified treatment was given for the adverse events. At the time of reporting the outcome of erythema, peripheral swelling, limb mass, pain and insomnia was reported as not recovered. A product quality complaint was not involved. The causality assessment between erythema, peripheral swelling, limb mass, pain, and insomnia with PNEUMOVAX 23 was not provided.
Doses administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021 at 9:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:29 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 42.40 for dose administered on 15-APR-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion 15-APR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-APR-2021 and beyond use date for the vial was reported 09-MAY-2021. Product moved to clinic 15-APR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Redness, swelling, no pain at injection site. Redness approximately 3" x 5" plus induration. 1 3/4" (inches) child put on antibiotics.
body and joint aches,  fever (up to 101.4) with chills, tired.  Symptoms lasted 30 hours.  Then, like it never happened!  Had started Tylenol ( 2 tablets)  a few hours after shot.  Took around the clock, every 6 hours until fever broke.  Stayed in bed with heating pad!  Stayed hydrated with water, gatorade.
BCG-itis;   Information has been received from the authors of a published literature article, titled as stated above, regarding a female patient of unknown age who was part of the authors' retrospective study aiming to identify the molecular basis of a syndromic form of severe combined immunodeficiency (SCID) and to perform genomic, molecular, biochemical, structural modeling, and in vitro disease modeling studies to analyze deleterious effects of the PAX1 variants identified.  The patient's medical history included allogeneic hematopoietic stem cell transplantation. Concurrent conditions included combined immunodeficiency (SCID), otofaciocervical syndrome type 2, fail to attain T cell reconstitution, PAX1 gene variation, born to consanguineous parents, small, low-set malformed ears, triangular mouth, down-slanting palpebral fissures, a small nose with a depressed nasal bridge, right facial palsy, recurrent respiratory infections, chronic diarrhea, severe exfoliative dermatitis and was diagnosed with Omenn syndrome.   Un an unknown date the patient was vaccinated with a dose of BCG vaccine (manufacturer unknown) (route, and dosage information was not provided) for prophylaxis.  On an unknown date, the patient experienced regional dissemination of Bacille Calmette-Guerin (BCG-itis).  On an unknow date, reported as at presentation, the patient had the following lab data results: Absolute neutrophil count: 3.8 cells x 10^-3/uL, Absolute lymphocyte count: 46.7 cells x 10^-3/uL, Absolute eosinophil count (unknown date): 9.6 cells x 10^-3/uL, Platelets: 780 x 10^-9/liter, CD3+: 43,985 cells/ul, CD4+: 10,762 cells/ul, CD8+: 17,313 cells/ul, CD19+: 936 cells/ul, CD16/56+: 1,404 cells/ul, In vitro proliferation to PHA (unknown date): 2.5 cpm × 10^-3, Blood immunoglobulin G: 170 mg/dl, Blood immunoglobulin M: 117 mg/dl, Blood immunoglobulin A: less than 25 mg/dl and Blood immunoglobulin E: 10,080 kU/l  The outcome of the adverse event was unknown.  However, the authors reported that the patient died at 8 months of age with progressive severe pneumonitis.    Upon internal review, disseminated Bacillus Calmette-Guerin infection was considered to be a medically significant event.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature article (case no. 2305USA008478). ; Sender's Comments:  US-009507513-2305USA008478:
Breakthrough COVID-19 case. 66 year old female presents to ED with worsening shortness of breath.  Patient tested COVID positive on 8/16/21 at a Care Center.  She was started on Prednisone, Tessalon Perles and antihistamine.  She previously received Johnson&Johnson COVID-19 vaccine on 4/10/21.  Patient hypoxic with SpO2 90% on room air which improved to 96% on 3L NC.   8/22/21. admitted. Diagnosed and treated for viral sepsis secondary to covid-19, COVID-19 pneumonia.  8/26/21: discharged
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-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 VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. Patient started vomiting three days after vaccination. No treatment information given.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
large 'oval' welt on arm where 2nd shot was given. It is raised, warm and itchy. it appeared.4 days after the shot.
In response to DTaP the child experienced high pitched screaming from AM to PM. The patient will be  given DT only in the future.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: En6203) and on 23Mar2021 as dose 2, single (Lot number: En6207) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient is expected to deliver a baby(s) on 08Oct2022. Concomitant medication(s) included: SERTRALINE; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]; MUCINEX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was pregnant. Delivery date was provided as 08Oct2022. The patient received treatment from 12Jul2022 to 16Jul2022 for COVID-19.   No follow-up attempts are possible. No further information is expected.
p/vax pt has devel redness, pain, & swelling @ inj site (lt deltoid);states applied ice pack @ first & has now been applying heat;redness & swelling has decreased some but still very evident;knot, h/a;
While in OBS felt lightheaded and slid to the floor, no injury, brought to med eval.  BP 110/40 HR 48 Resp 18  Sat 98 BS 97. Offered Gatorade with cold compress, recovered supine and EMS EKG Sinus Arrhythmia 52 HR Rest and asymptomatic and  BP was 118/62 HR 58 ambulatory discharge with Mom, decline any transfer to Hospital.
PATIENT REPORTED NECK/THROAT SWELLING TO RN OBSERVER APPROX 15 MINUTES POST VACCINATION.   LEAD VACCINATOR ADMINSITERED IM EPI AS STAT/EMERGENCY RESPONSE TEAM WAS ACTIVATED.  VS  BP 171/93 HR 90 RESP 18 SPO2 96 RA @ 0905.  PT TRANSFERRED TO ED  - CHART REVIEW INDICATES PT WAS GIVEN BENADRYL 25MG IVP, SOLU-MEDROL 125MG IVP.  PT OBERVED IN ED FOR 3 HOURS, VSS, NO ACUTE DISTRESS- S/SX RESOLVED - PT DISCHARGED TO SELF, UPON REQUEST AFTER OBSERVATION.
Patient not of age for this vaccine. Patient's mom reported slight fever post Immunizations, otherwise doing well. No concerns, No further complications. Doctor advised no adverse reaction and to repeat vaccine at 1 year old.
Pressure in eyes; Pressure in  ears; soreness in complete body; sleepy; restless; bad dreams; diarrhea; This is a spontaneous report from non-contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) in the right arm on 22Mar2021 at 14:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patients medical history included penicillin allergy, grass allergy and tetracycline. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. THE patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not received medication within 2 weeks of vaccination. The past drug history included codeine (CODEINE). On 22Mar2021 the patient experienced pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The therapeutic measures and treatment were not taken as a result of the events. The clinical outcomes of the events Pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea were recovering at the time of report.   No follow-up attempts are possible; Information about batch cannot be obtained.
Seen 1 day after MMR given. Fever for 2 days, History of parotid swelling 1/31, scrotal swelling for 2 days. Possible reaction of fever, parotitis, orchitis. Sent to ER.. Mumps IgM/G and mumps culture -> urine pending.
Pt had episode of syncope directly after administration of vaccine. Pt fell off exam table and bumped his head on the floor by his right eyebrow. Pt body stiffened up for approximately 20 seconds.
Severe arm pain. Unable to lift arms up resulting in severe pain. Patient touched her skin and there was no pain. Muscles felt good. No pain. The pain localized to shoulders and the lifting mechanism that caused pain. When she twisted her wrist it caused pain too. Patient concerned the pain is because the shot was given too high in the arms (compared to the first two doses she received previously). Arm soreness after the first 2 doses but not like this pain. Patient instructed to see a doctor to diagnose if the pain is due to the shot being too high in the arm causing injury, or if it is due to the COVID-19 vaccination, which normally causes arm pain.
Atrial fibrillation started in less than 24 hours.  Uncontrollable, requiring trip to ER.
on day 10 after the vaccine my L arm got red and hot and about the size of a half dollar, now it is day 13 and the redness is larger about 3x5 in size still red and hot and a bit sore.
Information has been received from an office manager concerning a 65 year old female who on 06-APR-2007 was vaccinated with ZOSTAVAX. The office manager reported that on 10-JUL-2008, the patient had a mild shingles outbreak. At the time of the report, the patient had recovered. Additional information has been requested.
No adverse reaction. Patient was eligible for their Moderna Dose 2, but received Janssen by accident. This is considered full series and patient is aware, and will not seek additional vaccination at this time.
Reporting because 1st dose is to be given before 15 weeks of age. Infant was 6 months and 23 days old. Too old for 1st dose.
Arm Pain. That required hospitalization stay. I caught an infection and also needed blood transfusion. Doctor came back and said my Platelets had dropped down to 90,000 and things was not looking to good. So I was in the hospital for two weeks. Now I have to go and see the Rheumatologist but I have not notified my dr yet..
Lightheadedness,dizziness,fatigue,heart palpitations,hives  immediately after the vaccine was administered. I was laid on a hospital gurney for over an hour and observed by nurses and they gave me fluids and had me do some breathing exercises to slow down my breathing&placed a cool towel on my forehead.  Once I arrived at home I parked and began to walk towards my became dizzy and fell and hurt my right arm,knees&hands. I went to urgent care,my vitals were normal and I was screened for Covid and my results came back negative for Covid and influenza. The urgent care doctor ordered lab work in which I had done the next day and the results came back normal.
Awakened the next morning and could hardly walk and only by holding on with both hands to something to assist and taking about 1-inch steps.  This lasted four days when it suddenly "went away" around noon on the 4th day and I was able to move as I normally did.
swollen arm, dizzy, h/a, fever (pt reports), chills which persisted for a few days & resolved;