chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/25/2022: presenting with hypoxia and a UTI. Found to be hypoxic in the 70s,  placed on oxygen.  Chronic indwelling Foley catheters. Her urine bag is actually purple.  Coarse breath sounds bilaterally, given a DuoNeb for COPD as considered. She also had some phlegm production with cough.Will treat her for COPD with bronchitis. She was covered with doxycycline. UA does show evidence of infection. She was given Rocephin.   Principal Problem: Pneumonia due to COVID-19 virus Active Problems: COPD exacerbation, Urinary retention with incomplete bladder emptying Urinary tract infection associated with indwelling urethral catheter,   Plan ? Admit to telemetry, continuous pulse oximetry, keep on oxygen by NC 5 L/min, wean as tolerated ?IV Decadron 6 mg daily for at least 6 days ? Due to CKD 3,borderline creatinine clearance of 29.4, will hold off on giving IV remdesivir tonight and give 500 cc bolus NS to assess improvement in renal function by tomorrow morning ? Can consider resuming IV remdesivir when renal function stabilizes in AM, in consultation with ID ? Pulmonology on consult ? Albuterol as needed for wheezing via MDI, Robittusin as need for cough. Intermittent gentle suction ? Heparin for DVT prophylaxis ?Check D-dimers, ESR, CRP COVID-19 pneumonia with hypoxia: With significant oxygen requirement and desaturation on admission in 70s. We proceeded with CT chest, found to have pulmonary embolism in the right lung. -Supplemental O2, wean as tolerated -Monitor inflammatory markers intermittently -Started on dexamethasone and remdesivir. -Solu-Medrol 125 mg IV given on admission -Symptom onset approximately on 10/24/2022, isolation duration to be determined  Patient expired of covid-19 pneumonia and hypoxia 11/1/2022 at 20:40  11/2: Follow up note on hospital course: Patient diagnosed with COVID-19 with hypoxia. Patient underwent CT chest and showed right-sided pulmonary embolism. After discussion of risk and benefit, patient was started on Lovenox and dexamethasone. She also qualified for remdesivir. Patient initially was stable however started having massive GI bleeding. Patient with poor overall prognosis, poor quality of life at baseline, has advanced Alzheimer's dementia. Patient transition to hospice care after discussion.   Submitter does not have access to full medical record. If further details are needed, please contact Hospital.
Pt recvd 2nd dose of vax & exp pain @ the inject site & 10 mins later exp lightheadedness, palpitations, diaphoresis, & dyspnea;
Case number PHEH2011US01893 is an initial spontaneous report received from a health care professional (medical assistant) on 17 Aug 2011. This report refers to a 12 year old male patient. He was vaccinated with MENVEO (batch number: A10062/X10062) 0.5 ml, intramuscularly on 17 Aug 2011, which was stored out of of range temperature during shipment on 17 Aug 2011. No adverse event was reported following the vaccination.
Fever 102-104 x 3 days, inconsolable high pitched crying x 2 days, poor feeding.  Family went to ER.
Intermittent sharp, sub sternal chest pain at rest and with exertion. Spontaneously resolves. Not responsive to antacids or NSAIDs. Limit cardiovascular efforts from previous fitness baseline.
Information has been received from a physician concerning a 19 year old female patient with no medical history who was vaccinated IM with the first dose of GARDASIL (lot number 655618/0186U) into the left deltoid on 12-MAR-2007, the second dose (lot number 657621/0387U) into the right deltoid on 09-MAY-2007, and the third dose (lot number 658222/0927U) into the right deltoid on 21-SEP-2007. On 29-MAY-2010, the patient was found low grade squamous intraepithelial lesion (LGSIL) by cervical smear (PAP) with positive high risk HPV despite given 3 doses of GARDASIL 2 to 3 years ago. The patient's outcome was unknown. Additional information has been requested. This is one of several reports from the same source.
pt recieved varivax on 11-21-1997, pt presented in our office on 6-17-2009 with scattered 10-15 nacular lesions some sl papular without vesicles 2 days prior to rash sl temp elevation  dx- poss modified c-pox
Nurse reported that the patient developed an injection site reaction. This is 1 of 2 reports from this facility of adverse events following receipt of Acel-Imune lot 464-307.
pt recv vax 1998 & pt exp zoster & was hosp; MD noted lesions on lt side of face around the temporal area, fluid filled lesions approx 20-30;also two on lip & 1 on the chin;MD reported on f/u "no adverse effect"; Annual follow-up received on 11/27/00 provided no additional data.
1/4/10 1) Diarrhea. 2) Head throb. 3) Esophagus and stomach disruption.
Patient has swelling and redness with sagging skin on the inner part of the upper right arm. Skin is warm to the touch. Advise patient to seek medical attention.
Tetanus and diphtheria toxoid vaccine was refilled in hospital medication dispensing cabinet refrigerator instead of influenza virus vaccine (syringe version of product).  The wrong product selected in the pharmacy, then delivered to the ADC.  Nurse caught before medication administered.  Concern: When vaccines are removed from outer box, they look identical.  Concern for potential that this could happen again and patients could receive.  Differentiate inside packaging of products since outer box will most likely not be used in hospital settings when automated dispensing cabinets are utilized.  We separated products by storing in separate refrigerators, highlighted, shored information.
Progressively increased fatigue over the first 12 hours. 18 hours after vaccination developed headache, joint pain, muscle aches, chills and a low grade fever. Complete recovery after 28 hours.
By that afternoon 2pm or 3pm I had a severe headache and started vomiting. My supervisor told me If I felt bad not to come in the next day which lasted for 4 days . What I was feeling was similar to having the Flu. I called in to our infection control group. They advised me to go get tested for Covid and the test came back negative. The  nurse practitioner told me I may have a sinus infection and I still wasn't feeling well by day six I went to the MD and he prescribed me Keflex antibiotics to take for 10 days.  I felt better after 8 days from the time I received the injection.
This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions/ allergies and concomitant medications were not provided. On an unknown date in 2011(reported as "seven years ago"), the patient was vaccinated with GARDASIL (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. Then, approximately in 2011, the patient experienced dizziness. The outcome of dizziness was unknown at the time of the report. The causality assessment between GARDASIL and dizziness was not reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date for Fever, at a dose of UNK dosage form. On 24-Apr-2021, VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-186583 (Patient Link).
Fever 104-105 degrees for 5 days then went to 103, then 99 for another 3 days. Pt had all of the measles symptoms - rash, runny nose, miserable, little appetite, achy. Now, Oct 8, she still has lots of congestion, still isn't comfortable, still only sleeps 2-3 hours at a time.
Third dose adminstered; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment: The reporter wanted to remain anonymous, did not have Rotarix lot or expiry date. Additional supportive information: The patient received third dose of Rotarix inadvertently, which led to extra dose administered. The follow-up could not be possible as no contact details were available.
First dose of vaccine administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported by reporter.  No treatment medication reported by reporter.   This case was linked to MOD-2021-250758 (Patient Link).
pt recvd vax & 1 wk later 29AUG94 pt was hospitalized w/Hepatitis B; discharged on 2SEP94; further details have been requested;
Initially a medicine like taste in mouth. But 45 minutes later having burning sensation on my tongue that is still here today as 03-052021. Vaccine was 2-25-2021. As a side note, years ago ,my dentist described me as having Geographical tongue.The vaccine seemed to stir something maybe.
I have my first vaccine one  I had headache for 2 days and feel dizzy couldn?t concentrate  , and was difficult to stand up becouse of back pain  the second day too much pain in body and in my bone felling sick and  feel cold then high temperature I had fever all night  After 2 day feel much better
09/10/2011 chills, fever, body aches for 24-48hrs.  09/11/2011 swollen glands at base of head and large gland behind right ear for 48hrs. 09/14/2011 light rash on trunk of bodyfor 24hrs. headache daily for 1 week. 09/17/2011 right side of face tingling & numbness. 09/18/2011 blurred vision, right eye, face and lip drooping. occasional fixed stair ("in a zone") for moments. 09/20/2011 left & right arms numb for 2 hrs in the am. 09/21/2011 arm numbness worsening at times with some loss of fine motor skills. Slight right leg numbness. 10/02/2011 through 10/10/2011 numbness of left hand. No facial drooping at this time. 10/29/2011 improving.
Patient given 0.2 mL dose undiluted. Advised with PCP and pharmacist and no treatments or negative outcomes anticipated. Informed pt's mother that pt may experience fever, body aches, sore arm and fatigue, but should not be concerned of any harm.
period bleeding very intense suddenly; This is a spontaneous report from a non-contactable healthcare professional reporting for a patient. An adult female patient, not pregnant at vaccination time, received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EK9231), on 10Feb2021 at 03:30 AM at single dose in Left arm for COVID-19 immunisation. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history. The patient is allergic to sulfamethoxazole trimethoprim (BACTRIM). Concomitant medications included vitamins. On 11Feb2021 at 06:30 AM the patient experienced period bleeding very intense suddenly next morning after vaccine. The event was reported as non serious. No treatment was received for the event. The patient had not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Since 27-FEB-2015 the patients were vaccinated with VARIVAX (Merck) (dose and route of vaccination were not provided) which were exposed to temperatures outside of the recommended range on unspecified. No adverse effects have been reported. Additional information has been requested.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious.
Swollen lymph nodes under arms. Pain and swelling began under left arm and moved to both mid-day 12/30/2021.
patient had a fever and swelling of the upper arm and the chills.   She was given a prednisone dose pak today and cephalexin
Patient waiting her 15 minutes, after 5 minutes c/o tip of tongue being numb.
Information has been received from a physician concerning a 12 month old biracial female who on 17Mar04 was vaccinated SC in the left thigh with a dose of varicella virus vaccine live (lot 647521/1108N). There was no illness at the time of vaccination. The physician reported that on 28Mar04, the pt developed scattered blisters on her extremities (base to legs), cheeks and chest. A few of the blisters had scabbing. The pt was also noted to be itchy and cranky, but was afebrile. The pt was seen in the physician's office and was treated with 0.1% triamcinolone (Aristocort) cream and diphenhydramine HC1 (Benadryl). Subsequently, the pt recovered from her events. Additional information is not expected.
Up to 48 hours after: body aches, ?fuzzy? head, fatigue, arm pain, swelling at site.....improved  Day 10 arm swelling came back, redness, pain, neck pain on that side, went away within 48 hours Day 14 arm swelling back again, redness, pain
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Gardasil concomitantly with "other vaccines". The patient reported that the Gardasil injection was painful. The patient outcome was unknown. Additional information has been requested.
Face burning, weak, lightheadness, some SOB about 1 hr post injection. Seen in ER. Given IV glucose/saline & epinephrine.
Patient only received a portion of the 0.5ml dose, less than one cc is what fell out of the syringe; A spontaneous report was received from a healthcare professional concerning a 42-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and only a portion of the 0.5 ml dose, less than one cc is what fell out of the syringe.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 01 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 026L20A) for prophylaxis of Covid-19 infection.  On 01 Feb 2021, It was stated that the patient only received a portion of the 0.5 ml dose, less than one cc is what fell out of the syringe.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, the patient only received a portion of the 0.5 ml dose, less than one cc is what fell out of the syringe, were considered resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273. There were no reported AEs associated with this case.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.
missed 2nd  dose of vaccine, Day90 after the 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd  dose of vaccine, Day90 after the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd  dose of vaccine, Day90 after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd  dose of vaccine, Day90 after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: FU received but concern not provided data On 10-Jun-2021: Initial Additional-2 : To confirm a true duplicate of Initial Additional 1
Headache; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (low grade fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c2/a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, HEADACHE (Headache), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
face swelling, swelling around belly button Narrative:  Has contacted her PCP, states she has had reactions to vaccines in the past. Bursitis in shoulder and swelling in leg after Influenza vaccines in the past, bursitis caused her rotator cuff to rupture. Both times her swelling lasted for weeks. States she fell asleep this morning, when she awoke, her face around her eyes, cheeks and lips were swollen. She is not having any difficulty breathing, and states her throat is not swelling. She has been in touch with her colleagues who are all providers who have informed her that this reaction is due to her face fillers. She also mentions some swelling around her belly button where she had threading about a year ago. Her PCP is prescribing her Prednisone and an antihistamine, she has been taking Zyrtec which she believes has helped prevent her from swelling more than she already has. She is being monitored at home by her daughter and knows to call 9-1-1 or to to the nearest hospital if her reaction worsens.
Patient received vaccine past its 30 days expiry date; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Patient received vaccine past its 30 days expiry date) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022 at 4:22 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Mar-2022 at 4:22 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine past its 30 days expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Patient received vaccine past its 30 days expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Patient received booster vaccine past its 30 day expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 20-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Reporter no longer possess this lot number.
Patient came back to clinic after driving home with scratchy throat and swelling of injection area. Denied fever. Patient was seen in resource and directed to ER.
The patient fainted, about 1 minute after receiving her immunization. She expressed feeling nervous about "needles". She was in the lobby of the pharmacy, beginning her 15 minute post immunization observation period when the event occurred. No trauma resulted from, her fall to the floor which was slow, and assisted by her parent. She got up almost immediately and felt dizzy. She was clammy and pale. Within 10 minutes she reported feeling "fine". Her parent chose not to have medical attention at this time.