chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: , MD at 3/18/2021  7:58 AM Expand AllCollapse All     COVID VACCINE CLINIC   66612 3/17/2021    Patient:                                                                                 Date:  3/17/2021                                                                                             Subjective  is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and nausea and tingling down left arm where she got her shot. .  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency .   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of frequent throat clearing, vomiting (nausea), muscle aches (left arm), dizziness and headaches   CONT negative Eyes negative Respiratory negative Skin negative     Previous Reactions: Nausea with first Covid shot    Objective    Vitals Vitals:   03/17/21 0140 03/17/21 1332 03/17/21 1407 BP: 134/82 (!) 144/87 135/74 Pulse:   93 89 SpO2:   97%          Physical Exam Constitutional:      Appearance: Normal appearance. She is well-developed.  HENT:     Head: Normocephalic.     Jaw: There is normal jaw occlusion.     Right Ear: Hearing normal.     Left Ear: Hearing normal.     Nose: Nose normal.     Mouth/Throat:     Lips: Pink.     Mouth: Mucous membranes are moist. No angioedema.     Pharynx: Oropharynx is clear.  Eyes:     General: Gaze aligned appropriately.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Musculoskeletal:     Cervical back: Full passive range of motion without pain.  Neurological:     Mental Status: She is alert.  Psychiatric:        Behavior: Behavior is cooperative.         Assessment/Plan  Treatment included: water and pepcid, zofran and Ibuprofen Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Released to go home with sister.  No driving tonight. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) 2:30 pm        Electronically Signed 3/17/2021 2:30 PM
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days; (2022) Negative, notes: I continued testing negative for 6 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID Vaccine Details: vaccine brand: Pfizer / BioNTech, vaccine brand unknown: false, vaccine lot unknown: false, vaccine dose number: 3 vaccine dose number unknown: false. Reported Event: Rebound infection of COVID. After completion of my course of paxlovid, I tested negative for COVID I continued testing negative for 6 days, after which point I began having symptoms again, and testing positive with antigen tests
8 hour after administration began to have symptoms of possible viral illness including sore throat, fever, night sweats, chills. Presented to ED, found to have elevated troponins. Admitted for myocarditis. Suspect viral etiology but due to timing of his flu vaccine, cannot rule out vaccination causing myocarditis.
Fever & NauseaVomiting Narrative:  EMPLOYEE STATES: TEMP UP TO 100.4 F GI UPSET MUSCLE ACHES NECK AND ARM WARM TO TOUCH NASAL PASSAGES FEEL FULL  Other Relevant History:
second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021.; Second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021; pneumonia; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200), and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EN6202), both as a single dose for covid-19 immunization. The patient's medical history included blood pressure high and diabetes from an unknown date, and brain aneurysm from 2006. Patient has no family history. The patient's concomitant medications were not reported. On 21Mar2121, the patient experienced on the second vaccine on 16Mar2021 patient tested positive for covid on 21Mar2021. It was further reported that the patient took the 2 shots and the last shot was on 16Mar2021. In-between 16Mar2021 and 21Mar2021 the caller developed a cough (given Quercetin to take for it)  and went to the urgent care on 21Mar2021. From the urgent care the patient was sent to the hospital and admitted because she was covid positive. Patient was admitted in the hospital from 21Mar2021 to 23Mar2021. The patient underwent lab tests and procedures which included chest x-ray: pneumonia  on 21Mar2012 (pneumonia of left lower lobe due to infectious organisms). The outcome of the events was unknown
11:00A received flu vaccination. 11:50A pt presents to vaccination table w/ c/o: SOB, dizziness, weakness, diaphoretic, headache, shaky hands, chills, "can't breathe good". VS 162/100 P 76 R 24. 12:07P 150/86 P 70 R20. 12:15P 148/88 P 72 R20. 12:20P Spoke to someone: instructed to give EPI PEN. Notify POC for transport to hospital. 12:22P EPI PEN given. 12:30P Spoke to someone else. 12:45P transport per EMS to hospital.
some blood came out the injection site; she could received 95% of the dose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 64-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   On 3rd August 2020, the patient received Boostrix. On 3rd August 2020, immediately after receiving Boostrix, the patient experienced injection site hemorrhage and accidental underdose. On an unknown date, the outcome of the injection site hemorrhage and accidental underdose were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Boostrix.  Additional information was provided as follows: The patient received Boostrix vaccine and some blood came out the injection site so the patient was concern about not received the full dose. She believed that she could received 95 percent of the dose, which led to accidental underdose. The reporter consented to follow up. No further information provided.
SHORTNESS OF BREATH pneumonia weakness acute CHF GAIT PROBLEM WEAKNESS - GENERALIZED
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female with mild asthma, cervical dysplasia and migraine and no history of pervious pregnancies who on 10-SEP-2007 was vaccinated with the first dose of GARDASIL (lot# 657868/05230). On 07-DEC-2007, the patient was vaccinated with a second dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) daily for routine health maintenance. Subsequently, she became pregnant on approximately 20-NOV-2008 (LMP: 06-NOV-2007, estimated delivery date: 12-AUG-2008). On 05-FEB-2008, as routine screening a serum alpha-fetoprotein test (MSAFP) was performed at first trimester and the results showed low risk pregnancy. On 06-MAR-2008, as routine screening a modified serum MSAFP was performed and the result was negative. On 10-Mar-2008, was performed to the patient an ultrasound as routine screening which showed normal anatomy. On 29-JUL-2008, the patient delivered a normal, healthy female baby at 38 weeks from LMP. The baby had a face presentation at time of delivery (mal presentation). The baby's weight was 2977 grams, with a length of 18 inches, apgar score was 9/9 and a head circumference of 34. Additional information has been requested.
Sore arm, large rash (10 inches+) that it itchy and tender to the touch
Petechiae on hip/upper thigh area. Noticed the afternoon of May 8th. One area has a bruise whereas the other has no pain or bruise- just the red dots. The site with the bruising is tense and my stomach feels bloated.   Fatigue is also a symptom I?ve noticed
The nurse came in to get her Pfizer booster. She affirmed that it had been 6 months since her second dose.  She did not have her vaccine card. I have a new coworker who is learning how to check people in. The nurse said she received her second vaccine at the end  of April. I prepared to give her the booster. This was November 4th (Thursday). She was actually working on this day. The dose was to expire at 2:10. She received her dose at 2:01. About the time I gave her the dose, I was told her date was actually May 7th. Which at 30 days per month would have been 26 weeks minus 1 day. After vaccinating her we discovered that her second dose was actually May 28th. We were 21 to 24 days shy of her correct booster dose date.
[ 89-year-old with past history coronary disease congestive heart failure diabetes pacemaker presents to for altered mental status.  Patient was be confused this morning at his nursing blood glucose was checked was 50 so was given dextrose.  Also noted be hypoxic.  Apparently patient did have a COVID exposure recently had a fever yesterday however is COVID test was pending.  At time of evaluation patient is now alert still little confused is A&O x2.  No chest pain, abdominal pain vomiting or diarrhea.  Of no, EMS found him to be in V-tach at 1 point during transport.  This seems to have converted spontaneously.]  Patient hospitalized in ICU from 11/12/21 through 11/22/2021 Patient expired on 11/22/2021
Flushing, hives, rash, itching, lips swelling tingling, high BP dose 1 - 209/107 high BP dose 2 188/87. Symptoms began 30 -40 minutes after vaccines.
10/30 Patient admitted to hospital with hyperglycemia and STEMI. Angiogram:  Drug eluding stent to proximal LAD, PEA arrested.
Vaccine and humaira effects/Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine and humaira effects/Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION COMPLICATION (Vaccine and humaira effects/Side effects). At the time of the report, VACCINATION COMPLICATION (Vaccine and humaira effects/Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Patient developed fever of 102 degrees farenheit. Injection site with increased swelling and erythema next day.  Treatmnent included OTC antihistamine and icing to area.
I don't remember the exact timing. I had a red itchy bumpy rash on my chest for a few weeks. The itch disappeared but it took weeks for the red bumps to go away. I had bumps under my hair line, back of my neck. A red spot on my left pinky. Pain in my right shoulder. The onset was within a week.
Large red mark on upper left arm. Swelling followed. Large hard baseball size swelling. This lasted 6 days. Redness still there after 7 days. Swelling gone!
Patient vomited 6 times on date of service 05/09/07 and poor appetite.The day before, he vomited 3 times.We administered Phenegran 0.3ml for the vomiting.He was given pedialyte and gatorade at home.He was admitted to the hospital.He was placed on IV fluids.He had one loose stool with a little red color, the day after admission,child was distended.X-Ray suggested Intussusception and barium enema comfirmed it. surgery was done shortly after 06/05/07-records received from facility for DOS 5/9-5/11/07. DX:Intussusception. Dehydration, Left Otitis Media, Upper Respiratory Infection, Vomiting.  Surgery:explaratory laporotomy with reduction of intussusception and incidental appendectomy. 48 hours prior to admission had progressive abdominal distention, vomiting and two episode of bloody stools. . Initially admitted for feeding difficulites and fever since previous night. During course of hospitalization developed diarrhea and vomiting and abdominal distention.
About 16 hours after receiving vaccine woke up with chills and abdominal pain, pretty bad headache. By morning chills subsided but fatigued and still with headache, abdominal pain on and off. That night had diarrhea. Abdominal pain and diarrhea has persisted to 3rd day after vaccine.
Moderna COVID-19 Vaccine: patient hospitalized for diuretic-induced hypotension acute kidney injury  two days after immunization. Patient's medications adjusted, administered IV fluids and steroids, and discharged to home medically stable.
Severe burning pain from neck down to wrist on injection arm.  Pain started on 3/5, about 16 hours after injection and is ongoing as of today (3/08).
Patient fainted and hit his head. We called 911, elevated his feet, and have him an icepack for his head. The EMTs assessed him, and determined him to be okay, and had a friend come get him to drive him home.
Normal post vaccine symptoms for 2 days, then on day 3 I developed: Tachycardia at baseline in the low 100s which worsens when vertical and/or active (120's when standing, up to 170's when active), dyspnea and diaphoresis when vertical, body aches, headache extending into neck, low grade fever, severe fatigue, night sweats & brain fog. Symptoms worsen with: eating, staying vertical for longer than a few minutes, exercise, not enough sleep, dehydration. Symptoms improve with: increased fluid intake (>4.5L/day of Gatorade), increased salt intake & rest/laying down.  Symptoms have forced me to quit working as an ICU nurse and move home with my parents.  I am now awaiting an appointment with a dysautonomia specialist out of town.
Information has been received from a physician concerning a 10-year-old patient who in 2001 or 2002 was vaccinated with a dose of varicella virus vaccine live.  In November 2005, the patient developed a case of break through case of chickenpox.  The patient had bumps on the body.  Unspecified medical attention was sought.  A product quality complaint was not involved.  It was also noted that the patient's 12-year-old sibling had a similar reaction after vaccination with varicella virus vaccine live (WAES 0601USA00310).  It was noted that each patient received vaccine from a different lot number.
hives that came on the next am and have come and gone since, no other symptoms or difficulty breathing
This spontaneous report was received from a registered nurse concerning a 43 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2018, the patient was vaccinated with M-M-R II, lot number N027779, expiration date 08-AUG-2019, subcutaneously in the left arm for prophylaxis also reported as "vaccination of measles, mumps and rubella" (dose and strength were not reported); administered in combination with sterile diluent (manufacturer unknown). On the same administration date, the patient experienced a lump and tenderness at the injection site, no laboratory diagnostic studies were performed, the patient did not seek medical attention and no treatment was given for the event. Product quality complaint (PQC) was not reported. At the reporting time, the patient had not recovered from the reported events. The reporter did not provide causality assesssment between vaccination with M-M-R II and the reported events.
Minimal Change Kidney Nephrotic Syndrome- was hospitalized on 3/3/21 - 3/6/21.
Pt reports pain in her legs from her knees down to her ankles. She states she was a little sore on 08/03/2007, but on the morning of 08/04/2007 pain was worse and has gotten progressively worse since then.  SHe has be taking Tylenol and Ibuprofen but the pain has not gone away.  Pt states she can barely walk and when she stands up there is pain and cramping in her lower extremities.  She says the pain is causing her to have chills and SOB. She said the pain was worse in the right leg in the beginning but pain is now bad in both legs.
Redness, slight swelling, slight itch. Site around 4 inches in size 2 weeks plus,after receiving vaccine
Patient presented to the ED on 12/9 for pneumonia of both lungs due. Patient presented to the ED on 12/20 and was subsequently hospitalized for aspiration pneumonia of left lower lobe. These visits are within 6 weeks of receiving covid vaccination.
pt recv vax & that same day exp a h/a, fever of 103, aches which lasted off & on for approx 48 hr;
Swelling and pruritus (L) arm after 2 shots 7/11/14. Resolved in 48 hrs.
A few hours after the vaccine I developed a very severe Migraine and begin throwing up. I was up the entire night with a severe headache, severe pain and throwing up and dry heaving because I didn't and couldn't eat. I only got about 2 hours of sleep because of the throwing up, sick feeling and Migraines. I took a Nurtec and Maxcil to help with the headache because it was so severe. I have always suffered from Migraines but they were controlled and I only received them maybe once or twice a week and did not have any throwing up or anything associated with them. Now I have been dealing with them more off and on, they're so much more severe and have increased to daily and more frequently throughout the day.
Several minutes after vaccine administration, patient was flushed and diaphoretic.  No shortness of breath, No chest pain.  No dizziness.  Has history or DM and HTN.  Denied nausea. PCP had changed his DM medication and he took the new prescription this morning. Felt better after 22 minutes and discharged home.
Erythematous papular areas on upper arms, back ears and lower extremities, 5-10 in number.
A physician reported that a male received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed a fever and rash. He also developed an injection site reaction characterized by redness and swelling, lasting for more than 4 days. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 470535.
Patient telephoned pharmacy 11/4/20 to state that she had been experiencing arm pain at the injection site since the time of administration. She stated that she had notified her primary care provider but the office made no intervention or diagnosis.
Information has bee received from a pharmacist concerning a 27 year old male who was vaccinated with a dose of hep b virus vaccine rHBsAg (yeast). Subsequently the pt experienced pericarditis. Unspecified medical attention was sought. No product quality complaint was involved. No further information was available. Additional information has been requested.
Swelling hands; Worsening psoriasis; pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling hands), PSORIASIS (Worsening psoriasis) and PAIN (pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PERIPHERAL SWELLING (Swelling hands), PSORIASIS (Worsening psoriasis) and PAIN (pain). At the time of the report, PERIPHERAL SWELLING (Swelling hands) and PAIN (pain) outcome was unknown and PSORIASIS (Worsening psoriasis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used steroid cream for treatment.   No concomitant medications were reported.
PATIENT CAME AND ALREADY HAD AN APPOINTMENT MADE, VACCINATOR AND VACCINATOR SUPPORT DID NOT COMMUNICATE WELL ENOUGH AND DID NOT REALIZE PATIENT WAS STILL A MINOR AND THE VACCINE HAD ALREADY BEEN GIVEN. PATIENT WAS FINE AND FELT NORMAL.
A 11 years-old patient was vaccinated with Flublok/ no AE; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist (Reference number- 00327558) and transmitted to Sanofi on 23-Oct-2020.  This case is linked with case 2020SA301053 (same reporter).  This case involves a 11-years-old male patient who was vaccinated with 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2029 expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 17-Oct-2020 for prophylactic vaccination (Product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  No concomitant medication was given.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Presents for SOB. Admit for COVID & uperimposed bacterial pneumonia. Tx: multivitamins & steroids, O2, abx. DC to home.
I experienced a fever, red face, ringing in my ears, body aches all over, swollen gland in my right armpit and it hurt anytime I moved my arm.
Initially appeared a hot round red spot around the area where the vaccine was applied and the child complained of pain. After a few hours, the affected area has expanded taking the hole region of the arm (biceps and triceps) becoming completely swollen (3 times normal size), red, hot and very, very, very hard. The child can not lift the arm. He is currently taking Tylenol and making compress with cold water.