chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pre vaccine pt reports being anxious. Post vaccine pt developed nausea, dizziness, and became sweaty. Pt transferred to meds obs at 0939 via wc, accompanied by significant other. Vitals obtained and monitored. Symptoms resolved. Per on site physician pt experienced classic non syncopal vasovagal reaction - resolved. Pt released home with significant other at 1007. Vitals as follows: 0940 Lying BP 106/71 HR 67 RR 16 SPO2 100 0948 Sitting BP 102/71 HR 64 RR 18 SPO2 100 0956 Standing BP 96/56 HR 79 RR 18 SPO2 98 (asymptomatic)
A couple hours after getting the vaccine, I started experiencing tightness all throughout my uterus. Like a Braxton hicks contraction that wouldn?t stop, although I laid down and drank water. It eventually went away. It came back the next morning, off and on, despite being hydrated. Then I started spotting vaginally. My obstetrician sent me to Labor and Delivery, where I was eventually cleared and sent home. No signs of premature labor. Cervix length was good. Was 20wks1d at time of vaccination, 20wks2d at time of L&D visits. Never had these symptoms before during two prior successful pregnancies, also received a covid vaccine without incident my second successful pregnancy, it was Pfizer.
After receiving the booster I had body aches and a headache for two days, and then after those two days I was okay until about a week later. I went to the hospital with a terrible headache and they diagnosed me with meningitis disease, they gave me midocodron, magnesium and Zahren to see if it will help.
PATIENT IN OBSERVATION AREA AND ORIGINALLY PRESENTED WITH SOB, ELEVATED HR, AND DIZZINESS.  EMT NOTED FACIAL FLUSHING AND PATIENT COULD FEEL ONSET AND ALLEVIATION OF HR.  VS 09:15 HR 125, RESP 20 . 09:24 HR 128, RR 22, BP 158/87 SITTING.  09:44 HR 130, 18, 143/85 SUPINE.  EMT PLACED MONITOR AND STATED SINUS TACH.  SHE HAD REPEATED EPISODES OF ONSET AND ALLEVIATION OVER A 45MIN. PERIOD.  PATIENT AGREED TO BE TRANSPORTED BY AMBULANCE FOR HOSPITAL EVALUATION.  FOLLOW UP WITH PATIENT 6/14/2021:  PATIENT STATES SHE WAS MONITORED AT THE ER.  CXR AND EKG COMPLETED AND WNL. RELEASED FROM HOSPITAL AFTER ALL MONITORING SHOWED VS WNL.  PATIENT REPORTS THAT SHE RECOVERED COMPLETELY BY 5PM ON SUNDAY 6/13/2021.  MONDAY 6/14 2021 SHE REPORTS FEELING TIRED ONLY.
Patient had received Johnson and Johnson vaccine on 3/24/21, but inadvertently received a dose of Moderna vaccine on 9/13/21 (today). No immediate adverse effects noted. Patient currently incarcerated and will be monitored for adverse effects. Patient reported that he had not been previously vaccinated with any formulation of the COVID vaccine, and staff did not perform due diligence in reviewing administration history. We are reporting this as error as recommended it constitutes an administration error.
Hospitalized for Acute Hypoxemic Respiratory Failure and COVID-19 Pneumonia from 2-6-22 to -2-25-22.
Mother noted left arm redness, swollen, hard, warm to the touch on back of (L) upper arm. First noted pain night of 2/23/2012. As of 2/27/12 redness is gone, but still firm to the touch.
feeling flushed, appears flushed c/o feeling light-headed; BP 118/78 denies chest tightness;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of an unspecified age, race, and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) frequency time 1 total, dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient tested positive for covid-19 virus (COVID-19 virus test was positive) and had minor symptoms (reported as suspected clinical vaccination failure and suspected covid-19 infection). On 25-JUN-2021, laboratory data included: Antibody test showed no antibodies. On unspecified date, antibody test was performed and results were unknown.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210907883. This report was associated with product quality complaint.; Sender's Comments: V0- 20210908154-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
86-year-old woman with a history of COPD who presented with complaints of shortness of breath. She was admitted with an impression of acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. She was initially started on antibiotics which were stopped due to low procalcitonin level and no evidence of bacterial pneumonia. She qualified for remdesivir and finished it. She was also getting Decadron with vitamin C and zinc and bronchodilator. Patient continued to do well and has tolerated Remdesivir well and has finished it. She is back to her baseline oxygen requirements.
Redness, swelling, itching, pain on left leg. BENADRYL oral and topical. Ice.
terrible hives; Initial information was received on 07-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient who experienced terrible hives (urticaria), after receiving 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 a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious terrible hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Patient received first dose of COVID vaccine from manufacture Pfizer and second dose was inadvertently given as Moderna.
Diagnosed with covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with covid) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (Diagnosed with covid). At the time of the report, COVID-19 (Diagnosed with covid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a 57-year-old female with a nonserious unexpected event of COVID-19. Event onset 8 days after first dose mRNA-1273. Event resolved. Based on 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.
Heart beating fast; Weakness; Headache in the front top left side of head; Redness and soreness at the injection site; Small fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart beating fast), ASTHENIA (Weakness), HEADACHE (Headache in the front top left side of head), VACCINATION SITE ERYTHEMA (Redness and soreness at the injection site) and PYREXIA (Small fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and soreness at the injection site) and PYREXIA (Small fever). On 03-May-2021, the patient experienced HEART RATE INCREASED (Heart beating fast), ASTHENIA (Weakness) and HEADACHE (Headache in the front top left side of head). On 03-May-2021, VACCINATION SITE ERYTHEMA (Redness and soreness at the injection site) and PYREXIA (Small fever) had resolved. On 04-May-2021, HEART RATE INCREASED (Heart beating fast), ASTHENIA (Weakness) and HEADACHE (Headache in the front top left side of head) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: FollowUp received on 14-JUN-2021 contains Non Significant Information; 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.
patient fainted about 10 minutes after dose, she hit her head  when fainted, bllod pressure and heart rate elevated. we elevated her legs, and put a cool pack on her neck, ems was calkled, she denied treatment. paatient was nervous about getting the shot
Slight fever Severe chills Severe body aches Fatigue Dull headache  I took a non-aspirin otc pain reliever. Symptoms lasted approximately 2 days.
p/vax pt had initial burning pain down lt & rt arm;then exp back & joint pain knees, elbows, wrist;back pain-pressure pain not exp before;insomnia;doesn't feel like getting sleep;
My ribs hurt after getting the shot yesterday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (My ribs hurt after getting the shot yesterday) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (My ribs hurt after getting the shot yesterday). At the time of the report, MUSCULOSKELETAL CHEST PAIN (My ribs hurt after getting the shot yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given  No treatment information was provided
pt recvd vax & 24 hrs later exp dizziness & poss eye problems which resolved;
CLIENT STATES SYMPTOMS BEGAN ON 2/25/21 WITH EXTREME FATIGUE AND SWOLLEN LYMPH NODES. STATES SHE BEGAN LOSING HER VOICE. STATES ONE OF THE DOCTORS SHE HAS FOLLOWED UP WITH STATES HER VOICE BOX WAS ATROPHYING. CLIENT STATES SHE WAS GIVEN A STEROID SHOT, PENICILLIN SHOT, AUGMENTIN AND A PROBIOTIC TO HELP BUT NOTHING HAS HELPED AT THIS TIME.
This spontaneous report as received from a nurse to a 77 year old female patient. The nurse reported that, on an unknown date, a 77 year old patient was administered GARDASIL (dose, frequency, lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Patient received flu vaccine. 10-15 minutes later he developed a cough and itchy throat. He was taken back to his exam room where he was examined by his provider who ordered epinephrine 0.3 mg one time dose. Patient tolerated dose well and was sent to ED for further evaluation via private vehicle as he was deemed stable enough for this by his physician.
Case number PHEH2013US026408 is an initial spontaneous report received from a nurse on 20 Dec 2013 with a follow-up received from the nurse on 07 Feb 2014. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. On 20 Dec 2013, she was vaccinated with FLUVIRIN (batch number: 1309501) intradermally in to the left forearm, at a dose of 0.1ml, instead of the serum to be used for tuberculin skin test. On the same date after vaccination, she found that the vaccination site had become red and was raised like the size of a dime, approximately three inches into four inches on the left forearm. On her return to the pharmacy on 23 Dec 2013, there was no raised area noted on the arm and it appeared normal. There was no redness. She had no complaints and voiced no concerns about her left forearm. Outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported. Follow-up information received from the nurse on 07 Feb 2014: Updated patient demographics, site and batch number of FLUVIRIN, description of the event and outcome
Angioedema (swelling around lips) and patient went to ER and received prednisone 20mg tabs 2 daily for 5 days
Day of sore arm and then over the next 2 days large area under my armpit ( called pharmacy) and explained my lymph nodes. Days following seemed to have a low grade flu feeling but ok.  Noticed more tired than usual and then nasal congestion. A cough started a few days ago but last night got worse like in my chest. Today in bed as headache and sore throat.  Not sure if all from vaccine response but took several covid over the counter tests negative.
It was reported that a 53 year old male pt received a Fluzone SV '01-'02 vaccination, lot U0S682AA, on 10/25/01. One week later, the pt experienced tingling of his fingers and legs, leg weakness and is currently being treated in the hospital by a physician.
Very sharp pain in arm a few seconds after injection. Felt  sore and strange in the evening , and fever and chills started at night. Following day high fever, chills, nausea and fatigue.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild
Patient called and said after 4 hours, of getting her flu shot (FLUZONE HD) she has localized swelling and redness. Asked pt to call her doctor and take BENADRYL meanwhile. Pt's all vitals were normal per patient.
Hepatitis B given 10/16/02 left deltoid. Started about 10/19, patient states right arm pain began. 10/26/02 blister rash eruption. Went to clinic. Diagnosed with shingles and started on Valtron.
2am next day. Stomach cramps, vomiting, sweating.  Next day, extreme fatigue and nausea.
Nausea,vomitting, pt had swollen shoulder at injection site, headache, malaise (body weakness,tired)
This spontaneous report was received from a Medical assistant via office manager refers to a patient of unknown age and gender. On 26-AUG-2014 the patient was vaccinated with LIQUID PEDVAXHIB, (lot # K000331, expiry date: 23-OCT-2016, route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
"red circle a silver dollar size" on injection site /injection site was still red; tender injection site; headache; sore arm; "feverish" injection site"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA ("feverish" injection site"), VACCINATION SITE ERYTHEMA ("red circle a silver dollar size" on injection site /injection site was still red), INJECTION SITE PAIN (tender injection site) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA ("feverish" injection site"). On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA ("red circle a silver dollar size" on injection site /injection site was still red), INJECTION SITE PAIN (tender injection site) and HEADACHE (headache). On 09-Mar-2021, PAIN IN EXTREMITY (sore arm) and PYREXIA ("feverish" injection site") had resolved. At the time of the report, VACCINATION SITE ERYTHEMA ("red circle a silver dollar size" on injection site /injection site was still red), INJECTION SITE PAIN (tender injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the injection site erythema was red circle and a silver dollar size. No concomitant medication was reported No treatment medication was reported
This spontaneous report has been received from a physician referring to a 15 year old female patient. The patient did not have any pertinent medical history, drug reaction or allergies. On 28-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9, (route, anatomical location and dose were not provided) lot # L044475, and expiration date 12-MAY-2017. The patient did not had any concomitant therapy. On 03-APR-2016, the patient experienced abdominal pain, vomiting and nausea. Subsequently to the mentioned events, on 06-APR-2016, the patient went to the physician who prescribed omeprazole for abdominal symptoms. However on 10-APR-2016, the patient went to the emergency room for persisted with the abdominal pain, vomiting and nausea, but she was not admitted to the hospital on this time. Then on 20-APR-2016, she went for second time to the physician, she complained for neck pain and weakness in left leg in addition to her abdominal pain, nausea and vomiting. On 25-APR-2016 (reported as sometime after this time, the physician could not provide the exact date), the patient went back to the hospital and an this time she was diagnosed with a cervical spine cyst, for this reason an Magnetic resonance imaging (MRI) was ordered and the result of the study confirmed the diagnosis; the physician stated that the patient persisted with abdominal pain, nausea and vomiting. Later, on an unknown date, the patient was hospitalized and had the surgery to remove the cyst. The physician could not provide the exact date of procedure or the length of the hospitalization, also reported that the patient was doing better after surgery. But she continued complaining of weakness in left leg. At the time of reporting the outcome of cervical cyst, nausea, vomiting, neck pain and abdominal pain were recovering and the outcome of weakness in left leg was reported as not recovered. The relatedness between the aforementioned events and GARDASIL 9 was not reported. Additional information has been requested.
fixed drug eruption of the left wrist which she describes as a small circular rash spot; This is a spontaneous report from a contactable nurse received via Medical Information Team. A "20" (age unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a fixed drug eruption of the left wrist which she describes as a small circular rash spot on the patient's left wrist, with no other symptoms. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On December 2nd at midnight, I awoke from a sound sleep with intense upper abdominal/chest pain.  I went to the ER and was found to have gallstones.  It was recommended that I be admitted for gallbladder removal.  My gallbladder was removed the next day, December 3rd.  I was discharged on December 4th.   I had never had previously diagnosed problems with my gallbladder.
swelling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown". Therapeutic measures were taken as a result of swelling.  Additional Information: Caller stated that ever since she took the shot (no specific formulation was provided) , she has had this swelling and she has never had this before, and the treatment and stuff she was getting, she was not happy. She said she had Contacted Pfizer a year ago for the same  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized 12/6/2021; COVID-19 positive 12/6/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider: PA-C Admission Date: 12/6/2021 Discharge Date: Dec 9, 2021  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: AKI (acute kidney injury) [N17.9] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 62 yo male with PMHx of CHF, dilated NICM, PE/DVT in March 2020 and LV apical thrombus (on Xarelto), COPD, essential tremor and OSA who presented to the ED on 12/6 with 2-4 days of n/v and diarrhea. Had associated cough, SOB and fever. In the ED, spO2 was 88% on RA. COVID PCR positive. BNP and troponins normal. He was given albuterol and started on Remdesivir. Patient was vaccinated with J&J vaccine.  Patient was started on decadron following admission due to spO2 89%. He was able to be weaned off O2 the following morning. He had no further episodes of diarrhea or emesis while admitted. Reports a normal BM the day prior to discharge. PT/OT evaluated and recommended HHPT/OT.
This case was reported by a physician via sales representatives and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date, the subject received unspecified dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the outcome of the event was unspecified.  The sales representative was told that he physician's office had four major injection site reactions (from four different subjects) over the course of a month.  No additional information was provided.  Additional cases see A0796720A, A0796723A, and A0796724A.