chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 66 yr old female with medical history significant for COPD on 2L O2 continuously, and atrial fibrillation on xarelto. She was brought in to ED by EMS due to severe SOB. On EMS arrival, she was noted to have O2 sat 80% and temp 100.3. She received duoneb and solumedrol 125mg en route, and was placed on 15L non-rebreather mask.  On arrival to ED, sat noted to be 72% on 4L with temp 100.3. She was then placed on bipap with sat up to 95%, continuous albuterol was added. Labs in ED significant for WBC 12.9 with left shift, and glucose 184 with no history of diabetes. ABG with pH 7.28, pCO2 71, pO2 120, sat 98% on bipap. Procalcitonin 0.55, LA 1.5. Pro BNP 8749. Echo 4/2021 showed EF 65-70% with moderately elevated pulmonary artery pressure. Pt has multiple family members who have tested positive for COVID, but per ER physician she tested negative yesterday, and is negative again tonight in ED. Flu is also negative. EKG shows sinus tachycardia with rate 141, QTc is prolonged at 521. CXR reveals multifocal pna. The hospitalist service was called for admission. During my exam, she was fighting the BiPAP, stating that she couldn't breathe, pulling at the mask, and stating that she needed to "get out of here". Repeat ABG done and shows pH 7.28, pCO2 69, pO2 93, HCO3 32, essentially unchanged from prior. She will likely need intubation and is a full code. Addendum: a third blood gas was done and respiratory status had worsened. She was then intubated in the ED.   PT IS INPATIENT AT THIS TIME.
Myalgia, Arthralgia, NauseaVomiting, fatigue, chills Narrative:  Nausea, myalgia, arthralgia, fatigue, chills; took ibuprofen but will get TYLENOL.  Other Relevant History:
forgot to get the second dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2019). Concurrent medical conditions included reflex sympathetic dystrophy.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to get the second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 The patient self-reported this case. The patient's pharmacy was closed, and she never received a reminder card. Therefore, she forgot to get the 2nd dose of Shingrix. The patient called for the information on how to resolve the error of not receiving the 2nd dose on time. The reporter did not consent for follow up. Till the date of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Redness area on Left deltoid noticed by nurse; about 48 hrs after immunization, warmth to touch, swollen limb, Mother/Pt denies any complaint, pain or limitation for movement. Provider noticed inst. Tylenol as indicated also Benadryl. Rx. given to parents. Inst. to c/o if worsen over weekend.
Staring around 10-12 hours after my second moderna Covid-19 vaccination dose, I began to run a low grade fever and had some body aches. The fever continued through the night and kept me awake for several hours. It never got above 100.5. My normal temp is 97.9. My temperature stayed somewhere between 99 and 100.5 degrees Fahrenheit for about 24 hours. By about 36 hours after my vaccine, the fever went away and body pain was minimal.   I took the recommended dose of acetaminophen every 6 hours, starting about 4 hours after my vaccination.
2-3min p/vax pt noted to be limp, unresponsive, pale, dec activity;color improved w/in 1-2min, inc tone, +responsive;resolved w/o intervention;child adm to hosp for 23hr observation;pt also probable bronchiolitis;
general discomfort; trouble walking; vertigo; Sore throat; redness; very sore arm; headache; phenomenal fatigue; slight swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo), OROPHARYNGEAL PAIN (Sore throat) and ERYTHEMA (redness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, AMLODIPINE and ATORVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (redness), PAIN IN EXTREMITY (very sore arm), HEADACHE (headache), FATIGUE (phenomenal fatigue) and VACCINATION SITE SWELLING (slight swelling at the injection site). On an unknown date, the patient experienced DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (headache) and FATIGUE (phenomenal fatigue) outcome was unknown and ERYTHEMA (redness), PAIN IN EXTREMITY (very sore arm) and VACCINATION SITE SWELLING (slight swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
48 hours post vaccination client reports bilateral facial swelling; left eye twitching and lips swelling and some drooling.  Symptoms lasted a few hours and relieved without any intervention.
8/28: muscle soreness starting about 2 hours after administration (experienced previously) 8/29: axillary lymph nodes swollen and painful on waking and throughout the day 8/29: around 9pm, noticed red patches below vaccination site- not raised, scaly, or itchy, but warm and tender like bruises. 4 spots between 1-3cm long, none over the vaccination site but starting about 2cm distal and ending about 8cm distal from site.  8/30: all red patches still present on waking, lymph nodes still sore and swollen. Lesion size has not changed measurably.
Complaint of throat tightness and brought to the patient room. On exam she had mild swelling of the uvula and was given diphenhydramine 50 mg orally. Patient had normal vital signs and normal lung exam. She had tingling of her hands and lips and was given a brown paper bag to help with the hyperventilation.  Vital signs remained stable. Lungs remained clear. The uvula swelling resolved.  Patient was monitored and released to go home after 2 hours feeling well but tired.
Patient attended COVID clinic on 5/4 and reported that she had never received a COVID vaccine, per her answers on the CDC Pre-Vaccination checklist for COVID-19 vaccine.  She received a dose of Moderna and it was later discovered that she received the 1st Pfizer vaccine in January 2021.  She has reported no side effects at this time.
2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.).    No Concomitant medication was reported.  It was reported that 2 pediatric siblings came in to start the Moderna Covid-19 Primary series. They both received the Moderna bivalent booster instead.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2023-710068 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-710068:Master case
Pt has baseline psoriasis but has had flares of diffuse guttate psoriasis since his shingles vaccine (given 2/18/2014).
Head ache, body aches, nausea, vomiting, diarrhea "flu like symptoms"
patient was given an IM inject when the vaccination was to be given as subcutaneous injection, patient has not had any adverse symptoms as of this time.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no pertinent medical history and no known drug reactions or allergies who on 24-MAY-2011 was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). On 27-JUL-2011 the patient was vaccinated intramuscularly with the second dose of GARDASIL (dose not reported), lot # 668229/1569Z and expiration date 05-APR-2013. There was no concomitant medication. On 23-AUG-2011, the patient came to the physician's office because she had a positive pregnancy test at home. Her last menstrual period was on 08-JUN-2011. On the same day, another urine pregnancy test was performed at the office confirmed the pregnancy. On 09-SEP-2011, an ultrasound was performed on the fetus, which found an omphalocele. Also, the left leg was missing a bone. The right leg was completely missing. On 14-SEP-2011, it was discovered by ultrasound that the fetus was no longer viable/alive (WAES1110USA00578B1). "A few days later" on an unspecified date, a dilation and evacuation was performed on the patient to remove the fetus. It was found that the fetus had no chromosomal abnormalities and that the karyotype was normal. A lot check has been initiated. Upon internal review, intrauterine death was considered to be an other important medical event. Follow up information was received from the nurse practitioner who confirmed that the patient had a "dilatation and extraction" (date not reported). The nurse practitioner did not know if the patient had recovered. The school based health nurse had reported that the patient "was having a hard time". The school nurse stated that the patient was not planning to use contraception. The nurse practitioner had been told that the patient was suffering from depression. Additional information has been requested.
No adverse reaction, but the nurse administered the 2nd dose 10 days too soon. The CDC "ask the experts," said to report it to VAERS.
patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter reported that, patient was in a nursing home and on 16Aug2021, patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine. The patient underwent the lab test and procedure which included tested for covid last Wednesday (11Aug2021) and received the positive result today 16Aug2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Strange taste; Severe itching inside throat; Numb lips; Skin rash; Dizziness; Nauseous; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Difficulty breathing, swallowing and talking; Wheezing; Full body rash; Stomach pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 15:00 (Lot number: FM0698) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Prior to 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 4 weeks prior to the COVID vaccine.  The following information was reported: TASTE DISORDER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Strange taste"; THROAT IRRITATION (medically significant) with onset 25Feb2022, outcome "unknown", described as "Severe itching inside throat"; HYPOAESTHESIA ORAL (medically significant) with onset 25Feb2022, outcome "unknown", described as "Numb lips"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Skin rash"; DIZZINESS (medically significant) with onset 25Feb2022, outcome "unknown", described as "Dizziness"; NAUSEA (medically significant) with onset 25Feb2022, outcome "unknown", described as "Nauseous"; DYSPNOEA (medically significant), DYSPHAGIA (medically significant), SPEECH DISORDER (medically significant) all with onset 25Feb2022, outcome "unknown" and all described as "Difficulty breathing, swallowing and talking"; WHEEZING (medically significant) with onset 25Feb2022, outcome "unknown", described as "Wheezing"; RASH (medically significant) with onset 25Feb2022, outcome "unknown", described as "Full body rash"; ABDOMINAL PAIN UPPER (medically significant) with onset 25Feb2022, outcome "unknown", described as "Stomach pain". The events "strange taste", "severe itching inside throat", "numb lips", "skin rash", "dizziness", "nauseous", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "difficulty breathing, swallowing and talking", "wheezing", "full body rash" and "stomach pain" were evaluated at the emergency room visit or department of urgent care. As the therapeutic measures IV Benadryl and IV steroids were taken as a result of taste disorder, throat irritation, hypoaesthesia oral, rash, dizziness, nausea, dyspnoea, dysphagia, speech disorder, wheezing, rash, abdominal pain upper. No follow-up attempts are possible. No further information is expected.
rash on legs bilaterally, arms bilaterally and back that began on Sunday (02/07/21). Pt had first round of COVID vaccine on Friday (02/05/21). Denies fever, chest pain or shortness of breath. States she has productive cough and headache that began on Monday (02/08/21). States she took benadryl this morning and zyrtec this afternoon with improvement of rash.
Redness, slight swelling, burning, itching from shoulder down to elbow (commonly referred to as "COVID arm")
Patient had witnessed syncopal episode immediately following vaccine. Patient was assessed and was bradycardic (40 BPM) and blood pressure was not able to be auscultated or palpated. Patient was questioned immediately following and was conscious and oriented but was persistently bradycardic. Patient then had a second witnessed syncopal episode at 10:55 AM and she remained bradycardic for several more minutes. Patient began to recover and at 11:012 AM her pulse was 58 BPM and blood pressure was 88/48. Her SPO2 remained 100% throughout the entire episode. Patient was never post-ictal and never had any convulsions or seizure activity.
This case was reported by a physician to a sales rep and described the occurrence of elevated white blood cell count in a 2 month old female subject who was vaccinated with combined diphtheria and tetanus toxoids and acellular pertussis, hep B recombinant and inactivated poliomyelitis vaccine combined for prophylaxis. The physician reported that, at the time of the vaccinations, on an unspecified date in April 2005, the pt had been experiencing an upper respiratory infection but no fever. On an unspecified date in April 2005, the subject received 1st dose of Pediarix. On the same date, the pt received injections of Haemophilus influenzae type b conjugate vaccine (unk manf) and 7-valent pneumococcal conjugate vaccine (Prevnar). Within 24 hours of receipt of the vaccinations, on an unspecified date in Apr 2005, the subject experienced an elevated white blood cell count of 36,000 and a fever of 103 degrees F. The subject was hospitalized. During the hospitalization, on an unspecified date in Apr2005, a septic workup was negative, a spinal tap was negative and a urinalysis was negative. The fever resolved within 24 hours after the onset, on an unspecified date in Apr2005. The outcome of the elevated white blood cell count was not reported.
This spontaneous report as received from a pharmacist refers to an 87 year old female patient with allergy to ciprofloxacin. The patient's medical history included shingles. On 14-SEP-2012 the patient was vaccinated with ZOSTAVAX 19400PFU (dose, route, lot number and expiration date not reported) to prevent shingles. Concomitant therapies included Budesonide, Symbicort, Proair, Losartan potassium (+) hydrochlorothiazide (manufacturer unknown) and Levothyroxine Sodium (manufacturer unknown). On 07-NOV-2013 the patient developed another case of shingles after being vaccinated with ZOSTAVAX. The patient sought for medical attention and contacted pharmacist. Bactim was the treatment given for the event. The outcome of developed another case of shingles after being vaccinated with ZOSTAVAX was reported as recovering. Additional information has been requested.
On 5/3/01, child has red rash all over body. No fever. On 5/4/01, child brought into HD with nausea and vomiting and feverish and was referred to PMD. Child seen by MD. Zyrtec prescribed. On 5/5/01, mom took child to ER. No change in rash. On 5/7/01, rash remains. No nausea, vomiting or fever.
Pt received injection and by next morning felt pain/soreness to area of injection. 48 hours after injection Pt. noticed a swelling an redness starting two inches below and separated from injection site. 72 hours after injection (today) Pt has same reddened area, warm to touch and raised. Doctor prescribed BENADRYL cream to area. Return to MD if symptoms worsen. Area was approx. 10cm x 4 cm.
Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot; Today I got the 4th shot. He has taken a whole 4th shot this morning; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot) and EXTRA DOSE ADMINISTERED (Today I got the 4th shot. He has taken a whole 4th shot this morning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 23-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2022, the patient experienced OVERDOSE (Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot). 23-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Today I got the 4th shot. He has taken a whole 4th shot this morning). At the time of the report, OVERDOSE (Patient received a fourth full Moderna Covid-19 booster dose instead of the half dose booster dose after receiving 3 fill Moderna Covid-19 primary series dose. The booster I got was a full shot) and EXTRA DOSE ADMINISTERED (Today I got the 4th shot. He has taken a whole 4th shot this morning) outcome was unknown.            No Concomitant Medications were provided by the Reporter. It was reported that the patient received third full dose Moderna COVID-19 vaccine a few months ago, as directed by his physician. It was also reported that the booster received was full dose as same as the first three doses No Treatment Medications were provided by the Reporter   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2022: Follow up received included reporter details and patient initials was updated.
Report described hives in a 49 year old female who received hep A vaccine. Reportedly, the vaccinee had no allergies or medical history. She took no concomitant medications and there was no illness at the time of vaccination. The vaccinee stated that she had never had hives before this occurrence. On 02/16/2001, the vaccinee received her first IM dose of Havrix. Within 24 hrs post vaccination, she experienced hives over her whole body. She received Benadryl starting on 02/17/2001. She was seen by the physician on 03/24/2001, and then started to take Benadryl daily. The reporter stated that the hives were of moderate intensity. As of 04/20/2001, the outcome of the event was ogoing.
AFIB and congestive heart failure.  Worsened after second vaccine.  Required two hospital stays and three heart cardioversions.  Required long-term medicine and the use of oxygen.