chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/8/2023 Discharge Date: Feb 11, 2023  PRESENTING PROBLEM: Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin [E11.65, Z79.4] Stage 3 chronic kidney disease, unspecified whether stage 3a or 3b CKD [N18.30] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is an 84 year old woman who was in the E.D. one day prior to admission with a fib rvr and was cardioverted in the E.D. She then presented again with shortness of breath, congestion and productive cough. She was found to be positive for covid in the E.D. one day prior. She was rx'ed paxlovid but didn't start it due to contraindication with xarelto. She returned to the E.D. with ongoing respiratory symptoms with weakness and fatigue along with watery diarrhea.    In ED, CXR significant for bilateral opacities consistent with pneumonia. Labs significant for leukocytosis, BNP 2561, procal wnl, electrolytes and LFTs wnl. Pt given albuterol inhaler which she feels slightly improved her symptoms. Pt admitted under general medicine for further management.   She required up to 2L oxygen nasal cannula. She was tx with remdesivir and decadron. She quickly weaned off oxygen. She was diuresed with iv lasix. Echo showed severe aortic stenosis. This has been progressing in the past few years. She is no longer established with cardiology.    She was given lasix 40 mg po daily on discharge. Will need f.u. bmp in 3-5 days. Fu with pcp. Out pt referral to re establish with cardiology and structural heart for discussion of severe aortic stenosis as well as a fib management.
Mother came in for another appointment a week after vaccine administration  and mentioned pt has been complaining of pain and swelling at injection site. Mother had not medicated. Informed mother to give Tylenol for pain, mother voiced understanding.
I had a 3rd Shingrix shot.; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter inadvertently had a 3rd dose of Shingrix, which led to extra dose administered. The reporter asked if that was dangerous. The follow-up would not possible as no contact details were available.
Early on the 8th day after the injection, COVID arm developed at the injection site. Sore like a bruise, warm and swollen about 3" diameter with rash, occasional itching.
MOTHER LIED ABOUT AGE OF CHILD, CHILD 11 YEARS RECIEVED FIRST DOSE
Acute bronchitis cough  Nasal Congestion  -     predniSONE (DELTASONE) 20 mg tablet; Take 2 tablets (40 mg total) by mouth daily  for 5 days -     azithromycin (ZITHROMAX) 250 mg tablet; Take 2 tabs (500 mg) by mouth today, than 1 daily for 4 days. -     amoxicillin-pot clavulanate (AUGMENTIN) 875-125 mg per tablet; Take 1 tablet by mouth 2 (two) times a day  for 10 days
High CRP Lab 28.02; This spontaneous case was reported by a consumer and describes the occurrence of C-REACTIVE PROTEIN INCREASED (High CRP Lab 28.02) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced C-REACTIVE PROTEIN INCREASED (High CRP Lab 28.02). At the time of the report, C-REACTIVE PROTEIN INCREASED (High CRP Lab 28.02) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, C-reactive protein increased: 4.03 (normal) normal. On 16-Mar-2021, C-reactive protein increased: 28.02 (High) Very high.         Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided.
Rash on upper left arm and more fatigue than usual.  Took Ibuprofen and put cream on the rash.  Rash dissipated over 4-5 days.
Patient stated that the day following the vaccination his face, lip, and right leg swelled up.  His BP has been slightly elevated as well.  The day of the swelling he took benadryl and the swelling subsided.  Today, almost 30 days later,  he woke up and his face and lip were once again swollen.  Advised him to take benadryl again and if it did not get better than  to speak with his doctor.
administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 173 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains primary reporter address updated.
Rash and fever 8-10 days after administration of vaccines, resolved after a few days.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 30-MAY-2014, the patient was vaccinated with PROQUAD (Merck) (dose, strength and route was not reported) (lot # J002302 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck).
pt recv vax; large area of erythema 5x6cm rt deltoid area; swollen, tender & itchy;
Awaken at 5 am with severe shivering, entire body aching, & headache.  Lasted several hours.  On 3rd day symptoms had improved but felt very tired and short of breath.  Injection site ached for 3 to 4 days.  Had same adverse side affects with 1st vaccine given in February.  Discussed it with my doctor but said I should continue to take 2nd shot.  2nd shot symptoms were more severe than 1st vaccine taken.
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller was a patient who reported that she was seen by her gynecologist recently and her gynecologist reported to her that she received Shingrix and experienced arm pain. The reporter did not consent to follow up. The caller declined to provide any contact information.
Had mild hives after the first dose. Following the second dose I immediately had flu-like symptoms. I had diarrhea for a month after. After the second dose I also began having a racing heart, chest pressure, dizziness when sitting up, I fainted and developed a twitch/jerking in my arms (predominantly in the right arm). I went to the ER when I fainted and a second when the heart symptoms continued (via ambulance). I have seen my PCP, a cardiologist, and a neurologist. Due to the severity of symptoms I had to take an incomplete in my degree program with only one trimester left.
Lump - Near Injection Site; Hot to Touch - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus, Blood pressure high, Heart disease, unspecified, Drug allergy (Novocaine) and Iodine allergy (iodine IV).   On 13-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 12:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and HYDROCORTISONE ACETATE (CORTIZONE-10 [HYDROCORTISONE ACETATE]) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) had resolved.            Concomitant medications included a Continuous Glucose Monitoring (CGM) device for Diabetes.  It was reported that, delayed reaction, 5 days after vaccine injection. Itching, rash at site of injection from shoulder to elbow. Redness around CGM worn on right arm. Rash faded over the next 8 days.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added patient demographics, medical history and updated events outcome.
1st  dose pfizer vaccine was given to patient on 07/06/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window.
10 days after injection of Varivax in right thigh, developed a cluster of lesions at site only. No vesirula.
Mixed vaccine series error occurred, patient received moderna 7/17/2021 however had received pfizer 4/8/21 other location, no adverse events reported
Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis.  The patient medical history was not reported.  There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.
Subtle tingling left earlobe and left jaw Narrative:  Patient complains of occasional tingling "pins and needles" sensation in left ear, left jaw starting 2 days after vaccination . No other complaints. Has not followed up with physician. States sometimes "it feels like its getting better"
dose of Shingrix on December 22, 2019, and the second dose a month later on January 22, 2020; has bad shivering all of the time /  started out as chills and she would use her blanket and "later on would be okay; started feeling "awful"; This case was reported by a consumer via call center representative and described the occurrence of chills in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced chills and feels awful. On 22nd January 2020, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the feels awful and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills and feels awful to be related to Shingrix.   Additional details were provided as follows: On 22nd December 2019, the patient received 1st dose of Shingrix and 1 month later received 2nd dose of Shingrix, which led to shortening of vaccination schedule. The patient stated that sometime in January 2020, she started feeling awful and had bad shivering all of the time. She stated that at first it started out as chills and she would use her blanket and later on would be okay. She stated that at the time of reporting, it was worse and was happening all of the time. She had visited her doctor who took blood work and the lab results were okay. She had no fever or anything else. She was asking if this was going to last forever and if there was anything that she can take. The reporter consented to follow up.
Patient signed up and checked in for Janssen first dose. Vaccinator card has Janssen documented, with Janssen alert card. Vaccinatore gave Pfizer dose after speaking with patient. Incident explained to patient.
No additional AE reported; extra dose of GARDASIL-9 administered; This spontaneous report was received from a consumer referring the reporter's granddaughter, a female patient of unknown age. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 22-OCT-2022, the patient was vaccinated with extra dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (product circular number: uspi-v503-i-2108r013, product quantity: 1; strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis (extra dose administered). No additional adverse events (AE) were reported (no adverse event).
PATIENT CAME TO THE PHARMACY ON 04162022 FOR COVID 2ND BOOSTER AND REPORTED THAT SHE STILL HAS PAIN AND SLIGHT INFLAMMATION TO THE ARM THAT SHE RECIEVED FLUBLOK. SHE SAID SHE HAD TERRIBLE PAIN WHEN THE NEEDLE WENT INSIDE THE MUSCLE WHILE ADMINISTERING THE FLUBLOK AND FELT BLACKED OUT ON THAT TIME. TERRIBLE PAIN FOR SEVERAL DAYS AND  COULDNT MOVE THE ARM FOR FEW MONTHS, STILL CANNT SLEEP ON THAT ARM. VISITED NEUROPHYSICIAN AND BEING TREATED. SHE COMPLAINED MILD INFLAMMATION AND LIMITED MOBILITY TODATE.
Fever on 5/6/06, fussy. Red spots on trunk, face and neck.
Symptomatic and tested positive for COVID-19 on 9/2/2021 after being fully vaccinated back in February 2021. Extremely healthy, active, young 25 year old female with zero pre-existing conditions.  Booster shots are needed to save our community.
congestive heart failure; Myocardia; I went into afib; Experienced chest pain minutes after shot was administered.; Shortness of breath; Coughing started hours after the dose; High heart rate/heart right went to about 180 bpm; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 17Jul2021 at the age of 31 years as single dose for covid-19 immunisation. Medical history included high blood pressure which he was medicated for and was under control, patient had recent tests done and had no issues with his heart, hypothyroidism, covid-19 prior vaccination. Concomitant medications included metoprolol; amlodipine; hydrochlorothiazide; levothyroxine sodium (LEVOTHYROX). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chest pain minutes after shot was administered. Chest pain, shortness of breath, and coughing started hours after the dose. Patient was admitted 2 days later to the emergency room with chest pain and high heart rate. Patient went into afib, at the hospital where his heart right went to about 180 bpm. Patient was diagnosed with myocardia and congestive heart failure. Adverse event start time was 17Jul2021 05:00 PM. Duration of hospitalization was 1 day. Treatment received included pill to slow heart rate 3 times, medication change. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
low grade fever, chills, exhaustion/fatigue, headache, injection site pain & warmth
C/O knot on right side where injection was given of DTaP and Polio - red, swollen and fever is present, around site. Area where shot was given was hot to the touch, hard and spread over entire top part of arm on ride side.
Anaphylactic reaction within a few minutes of receiving three vaccines. I began giving immunizations at approximately 10:20am. I started wiht Td, then hep B & MMR. Immediately after giving final immunization, the pt's eyes rolled back and her head dropped forward. When ask if she was okay, then she stated, "No." I was attempting to help her lay down when she began to have convulsive like movements of jerking arms and sever arching of the back. She then collapsed in my arms. I placed her on the floor in a supine position with her feet elevated. She complained of chest and throat tightness with difficulty breathing. She displayed both raspy and stridor breathing patterns. When asked to swallow, she was able to complete the task, but it appears to require great effort. Her speech was slurred, and her skin became very pale. heart rate was was assessed at 82 and her pulse was thready. Our staff attempted to get a blood pressure but was unable to get a reading. 911 was called and pt was given one dose of 'Epi Jr.' (0.15mg epinephrine) at 10:25am. After Epi injection pt began to feel relief. She stated her breathing had improved and her throat and chest tightness had decreased. The color returned to her face. The ambulance arrived at approximately 10:30am and transported her to the ER. I called the pt's mom at 1pm. Mom stated the pt was home from the hospital now. While at the ER then she was given Benadryl and some other medication that mom was unable to remember the name of. Mom stated pt is now sleeping.
Administered as off-label use of covid vaccine for patient under 18 years of age but over 16 years of age.
Papular, pustular rash on back occurring approximately 6-10 hours after injection of vaccine.
A non-serious spontaneous report of administration to 6 month old was received from a health professional concerning a six-month-old female. Neither the patient's medical history nor the concomitant medications were reported. On 05-Dec-2011. FLUMIST was administered to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes, hypertension; "hypertension" (unspecified if ongoing), notes: Other medical history: Diabetes, hypertension. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid for Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe fatigue, unable to work more than 2 hrs per day, 2 hrs per week.  In bed for 2 to 3 days after working 2 hrs.  Vertigo, dizziness, strange skin sensations feeling like armies of ants crawling upwards on legs and scalp.  Frequent skin chills.  Terrible brain fog and difficulty remembering things.  Physically and mentally exhausted. Body aches and pains.