chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started experiencing a headache while waiting in the observation room for 15 minutes; fever; chills; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (started experiencing a headache while waiting in the observation room for 15 minutes), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced HEADACHE (started experiencing a headache while waiting in the observation room for 15 minutes), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEADACHE (started experiencing a headache while waiting in the observation room for 15 minutes), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and FATIGUE (fatigue) had not 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.   The patient reported that the fever comes back as soon as the effect of the Tylenol wears off.
pt recv vax 12JAN98 & devel varicella on 24MAR98;
swollen lymph node above my collar bone; chest tightness; issues breathing; hives; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; dizziness, headache and severe lethargy about 1 hour after the injection; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17Mar2021 at 03:30 PM (at the age of 36-year-old) on the left arm at single dose for COVID-19 immunisation. Medical history included Asthma. The patient had no allergies to medications, food, or other products. Concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Most recent COVID-19 vaccine was administered in hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache and severe lethargy about 1 hour after the injection on 17Mar2021 05:00 PM. The next day (18Mar2021), the patient felt chest tightness and issues breathing along with hives, today (24Mar2021) a week later, still have chest tightness with issues breathing, hives and now a swollen lymph node above my collar bone. The patient did not receive any treatment for the events. The outcome of the events was reported as not resolved.  Information on lot/batch number has been requested.
Patient received J&J vaccine on 3/15/21. Came to ER on 7/8/22. Found to be COVID positive on 7/6/22.  recently diagnosed with COVID 2 days ago came in with generalized body ache and diarrhea.  Unable to tolerate p.o..  Came in with AKI likely pre renal.  Febrile to 103.2.  Patient was conservatively managed for acute viral infection.  IV fluids were started.  Patient blood pressure dropped to 80 systolic and became tachycardic.  She was moved to IMC.  Started on sepsis protocol.  Empirically started on antibiotics ceftriaxone and vancomycin per level because of kidney injury.  Continued IV fluids.  Complains of chest pain with cough.  Echo unremarkable, EKG sinus tachycardia. EKG sinus tach, troponin negative.  BNP negative. CT angio ruled out PE  Diarrhea seems to be improving which is most likely due to COVID.  Electrolyte abnormalities which were most likely secondary to diarrhea corrected p.r.n..  Saturating 100% on room air.   AKI improved with IVF.  Antibiotic course completed by switching to p.o. antibiotics upon discharge.  Patient became medically stable and will be discharged home on 7/13/22
Booster administered per protocol at 11:15 am in healthcare setting. Patient monitored for 15 minutes after without issue then released. Patient experienced vasovagal syncope event when using the bathroom around 12:30 am and did not come to until 3:30 am. She awoke on her bathroom floor with a swollen lip (likely from biting it) and vomit on her back. Patient was also fatigued for the remainder of 12/18/2021. 12/19/2021 she returned to normal without any further symptoms.
R09.02 HYPOXIA 4/5/2023 HYPOXIA
Blood vessel was hit. Entire arm is black and blue. Patient went to doctor. No treatment necessary.
Pt received vaccine and within ~2 minutes started feeling woozy and reported tunnel vision.  He alerted his nurse who called for back up. Upon arrival, patient appeared pale and diaphoretic. Pt appeared lethargic but was conscious. Pt moved via stretcher to observation unit at 1601. Pt denied SOB, dizziness, palpitations, rash, itchiness, swollen mouth/tongue. Pt reported he had vasovagal response to another vaccine (tetanus) before.  Vitals: 1605 154/108, 95%, 77HR 1608 146/90, 95%, 76 HR 1620 138/90, 95%, 76 HR  At 1622 pt reported feeling 'tingly'. lungs clear on auscultation. Occasional PVCs on auscultation. Pt reported history of palpitations. 1636 151/102, 99%, 80 HR Pt reported palpitations subsided and tingling feeling subsided.  1635 141/94, 99%, 75 HR Pt escorted via wheelchair out of facility with a stop at the bathroom and was advised on follow up for additional care should palpitations return or s/s of allergic reaction.
Left jaw pain & soreness near left ear (difficult to open mouth, chew food) from 7 am day after injection (current as of 10pm, same day), mild nasal congestion (starting around 6pm day after injection, current as of 10pm),  chills (lasted about an hour 6-7pm day after injection), flush (about an hour after chills ended). AM temp  97.7 (9 AM), PM temp 101.1 (10 PM).
Patient reported rash, itching, and feeling hot around the injection site. It has faded today (3/22, 2 days after the reported event). Patient felt better after applying cold compress and hydrocortisone
Systemic: Fainting / Unresponsive-Severe, Additional Details: patient does tend to faint during bloodwork/vaccines, but this time it was much more severe, she was unresponsive and i had to give her chest compressions, i believe she had a pulse the whole time, she was down about 2-3 min and came to, ambulance came and picked her up
Fever greater than 101 for 1st day, greater than 100 2nd day; Chills; body aches; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 15Apr2021 at 23:00, the patient experienced fever greater than 101 for 1st day, greater than 100 2nd day, chills, body aches, nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 15Apr2021, the patient underwent Body Temperature and the result was greater than 101 (UNSEPCIFIED UNITS). On 16Apr2021, the patient underwent Body Temperature and the result was greater than 100 (UNSEPCIFIED UNITS). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever greater than 101 for 1st day, greater than 100 2nd day, chills, body aches, nausea was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 25-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Please note that the administration of the 3rd vaccine was given at the pharmacy location being reported. We do not have detailed information regarding the vaccine series 1-2.   An intern used the incorrect size needle to administer the Covid vaccine to the patients listed on this report. The needle size used was a 5/8 inch needle, when the correct size that should have been used was a 1 inch needle. The correct dose was given to all patients. Based on CDC recommendations, there is no need to revaccinate any patient that was administered the dose in the wrong location; in this case the vaccine was given SubQ rather than intramuscular, based on the length of the needle. All patients were notified of this error and were given advise on what to expect. All patients were informed that no harm was done, the vaccine was still effective, and no additional dose is required based on CDC guidelines. As a result of these errors, reeducation was given to the pharmacy student, and the area within the pharmacy that contains all vaccination related supplied were relabeled to make it more clear for everyone administering vaccines.
Patient started having joint problems; Patient has acquired arthritis; After the 2nd dose patient developed a rash; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Patient started having joint problems), ARTHRITIS (Patient has acquired arthritis) and RASH (After the 2nd dose patient developed a rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Patient started having joint problems), ARTHRITIS (Patient has acquired arthritis) and RASH (After the 2nd dose patient developed a rash). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Patient started having joint problems) had not resolved, ARTHRITIS (Patient has acquired arthritis) outcome was unknown and RASH (After the 2nd dose patient developed a rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: elevated (High) C reactive protein was elevated.         Concomitant medications details were not reported by the reporter. Company comment: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of Arthritis. The date of onset of the event was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. The first dose of mRNA-1273 was given 28 days prior to the administration of second dose. C-reactive protein was done on an unknown date with elevated results, patient is being treated with prednisone and other unnamed medication but his Arthritis still persisted. Details of general data, concomitant medications, medical history, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of Arthritis. The date of onset of the event was not specified in respect to the administration of second dose of mRNA-1273, hence latency could not be assessed. The first dose of mRNA-1273 was given 28 days prior to the administration of second dose. C-reactive protein was done on an unknown date with elevated results, patient is being treated with prednisone and other unnamed medication but his Arthritis still persisted. Details of general data, concomitant medications, medical history, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a physician via company representative, and refers to a patient (encounter key# 18230) of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-JUN-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 59.9 Fahrenheit (F) degrees (15.5 Celsius) (highest recorded temperature) for a total of 2976 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tinnitus on an unspecified date, the next day after receiving her first dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
migraine headache, itchy body, itch eyes, went to hospital and was given iv fluids, also went to urgent care and got steroids
This spontaneous report was received from a registered pharmacist and refers to a 1-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 28-DEC-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection, intramuscularly, lot # M024261 with expiry date 18-APR-2019 (exact dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a patient who received Flu Seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included egg allergy. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced adverse reaction and documented hypersensitivity to administered drug. On an unknown date, the outcome of the adverse reaction and documented hypersensitivity to administered drug were unknown. It was unknown if the reporter considered the adverse reaction and documented hypersensitivity to administered drug to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. In 1996, the patient received unknown brand of flu vaccine. In 1996 after vaccination, the patient experienced severe reaction due to an egg allergy, which led to documented hypersensitivity to administered drug.
for first shot, got severe headache on day one and still has headaches every day even after second dose.  wants to vomit every morning and headache starts between 12-3 everyday.
the patient was hospitalized in an unspecified hospital on an unspecified date after administration of the PNEUMOVAX 23; inflammation of the arm into which the PNEUMOVAX was administered; vomiting; headache; rash/ it is unknown where on the patient's body the rash was located; the patient experienced fever; This initial spontaneous report was received from a physician, via company representative, regarding a 66-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were unknown by the reporter.  On 28-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, in his arm, (strength, dose, route of administration and vaccination scheme were not reported; lot number: S021740, expiration date 25-MAR-2021) as prophylaxis. On the same date, the patient was injected with ketorolac tromethamine (strength, dose, route of administration, anatomical site of injection, lot number, expiration date or indication were not reported).  On an unspecified date in 2020 (reported as "within a few days after the dose was administered"), the patient experienced fever (pyrexia), vomiting, headache, inflammation of the arm into which the vaccine was administered (peripheral swelling) and a rash at an unknown location. The reporter mentioned that the patient sought medical attention.  On an unknown date in 2020, the patient was hospitalized (adverse event). The patient was treated for the events (unspecified), however it was unknown if he had  any laboratories/studies performed due to the adverse events.  The action taken with ketorolac tromethamine regarding the adverse event, rash, peripheral swelling, headache, vomiting and pyrexia, was not reported. The outcome of the aforementioned events, was unknown by the reporter. The causality assessment between the therapies pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and ketorolac tromethamine, and the aforementioned events, was not reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA003872: US-009507513-2003USA003225:
Systemic: Dizziness / Lightheadness-Medium, Additional Details: patient became very lightheaded and dizzy post administration. patient had to be sat down for a few minutes and given water to recover. patient was able to fully recover without needing additional medical attention.
hAD A FEVER FOR THREE DAYS STARTING ON THE 25TH RASH STARTED ON THE 27TH-ON THE TRUNK SPREAD TO ARMS AND LEG VERY FUSSY HAND NOW GOING TO EAR DIARRHEA FOR PAST TWO DAYS
I experienced muscle aches, lighting bolt type of muscle pain, severe joint pain, very weak, constantly sleepy, dizzy, nausea, frequent headaches, occasional fever, shortness of breath, low oxygen levels, depression, anxiety, memory loss, sharp pains in my muscles, cramps and high blood pressure.
Patient approximately 5 minutes after receiving the vaccine began to crouch in the chair and looked off balance. Began speaking to the patient and his eyes began to roll back and he started to slur his words and was very disoriented stating he could not see anything. The patients mother came over and proceeded to give  the patient potato chips. The patient began to become more alert, but was still  disoriented. 911 was called and EMS arrived approximately 15 minutes after the vaccine was administered. The EMS team took the patients blood sugar and blood pressure and his vitals all appeared normal, however the patient was still is a very disoriented state. The EMS team unsure of what caused the event placed the patient on a stretcher and took him via ambulance to the hospital. At this point care was transferred to the EMS team. We will follow up with the family to get updates on the patients condition.
potentially caused her allergic reaction; a year after vaccination experienced pain; lumps throughout body and it became debilitating; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient a year after vaccination who experienced pain, lumps throughout body and it became debilitating and potentially caused her allergic reaction while receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (DECAVAC) for Prophylaxis.  On Unknown date in 2011, the patient received a  dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot number, dose, strength and expiry date not reported) via unknown route in unknown administration site for Prophylaxis.  On Unknown date in 2012 the patient a year after vaccination experienced pain (pain), lumps throughout body and it became debilitating (generalised oedema) (latency:1 year approximately). On an unknown date the patient reported that potentially caused her allergic reaction (hypersensitivity) (unknown latency). She is requesting a list of ingredients from these two vaccines to go under allergy testing to determine what she was potentially caused her allergic reaction.  Further, it was reported that the physicians thought perhaps it was rheumatoid arthritis but that was ruled out. Reporter was not interested in any sort of compensation of threats of lawsuits, she was simply trying to gather the ingredients and have additional allergy testing.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  Outcome : Unknown.
Patient got the 2nd dose, stated she had swelling, pain and heat at the injection site. After 2 weeks pt. have a red mark at injection site, 2" in diameter. Now say she feels arm weakness.