chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Progress Notes (Nurse Practitioner) ? ?  Cosigned by: MD at 3/18/2021  2:57 PM Expand AllCollapse All    COVID VACCINE CLINIC 3/16/2021    Date:  3/16/2021    Subjective Patient is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle in the medical bay by staff given prior allergic rxn to unspecified eye gtt.   During her 30 minute waiting period after the injection, the patient began to experience headache.  She denied rash or SOA   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to red flag findings.   PMH anaphylaxis to unspecified eye gtss, prompting vaccine to be given under observation in medical bay. During 30" observation period, pt developed mild headache. Pt treated with Tylenol 500 mg tab x 2.      ALLERGY REVIEW OF SYSTEMS:  Patient complains of headaches    Mild headache during 30" observation period: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Musculo negative     Previous Reactions: anaphylaxis to an unspecified eye gtt as a teenager        Objective    Vitals Vitals:   03/16/21 1522 BP: 110/68 Pulse: 55            Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: No oropharyngeal exudate.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Behavior: Behavior normal.    Clinically, pt developed a mild headache during 30" observation. She was administered her vaccine Dose #1 of 2 in the medical bay after reporting having anaphylaxis to an unspecified eye gtt as a teenager.     Assessment/Plan  Treatment included: observation, Tylenol, snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)         Electronically Signed 3/16/2021 3:23 PM
Within an hour of her Covid shot on the way home, she began experiencing vision problems in her left eye, which have continued for the past two days but are slowly improved. Symptoms include intermittent double vision, blurring and dimming. Symptoms temporarily  improve with an anti-inflammatory pain medication like ibuprofen. Eye dr. concluded she is having ocular migraines as a side effect of her Covid vaccine.
TDAP (ADACEL) 0.5cc admin RU arm IM 11/16/10 felt feverish arm reddened fever (R) axillary area tender Rt neck blotchy.
Initial unsolicited report received from a pharmacist on 09-Oct-2017. This case involves an 87-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HD (batch number: UI808AB) in left deltoid via intramuscular route on 30-Aug-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced still soreness in the left arm. It was stated by reporter that the patient stated he sleeps on his left side. The patient's laboratory data and corrective treatment were not reported. The event outcome reported as unknown. List of documents held by sender: none.
Exposed to COVID19 and presenting symptoms; Child was part of Moderna's clinical trial; This spontaneous case was reported by a health care professional and describes the occurrence of SUSPECTED COVID-19 (Exposed to COVID19 and presenting symptoms) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was part of Moderna's clinical trial) in a 10-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Exposed to COVID19 and presenting symptoms) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was part of Moderna's clinical trial). At the time of the report, SUSPECTED COVID-19 (Exposed to COVID19 and presenting symptoms) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was part of Moderna's clinical trial) outcome was unknown.        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.   Concomitant medications were not reported. Treatment medications were not reported.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281636, 2018SA279979, 2018SA281632, 2018SA281692 (Same reporter). This case involves a 17 years old male patient who was vaccinated with 0.5 ml dose of MENACTRA (lot U5984AB, expiry date: 14-Aug-2019) in the left deltoid (dose in series and route of administration were not reported) on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. 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. Documents held by sender: none.
On 4/28/02 had joint pain, "feverish" feeling, pale, anorexia, nausea, weakness, shaking, difficulty breathing (has asthma), which continued until 4/30/02. On 4/30/02, had itching on arms but no rash. On 5/3/02, client recovered, when event reported.
Sore arm; Severe headache, headache was bad enough where the patient stated in the bed all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Severe headache, headache was bad enough where the patient stated in the bed all day) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROGESTERONE, ESTRADIOL (ESTROGEN) and TESTOSTERONE for an unknown indication.    On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Severe headache, headache was bad enough where the patient stated in the bed all day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Severe headache, headache was bad enough where the patient stated in the bed all day) outcome was unknown.            The patient reported that the side effects from the second dose were not as bad  as after the first dose . The treatment with Tylenol did not help the patient and the patient was not sick as bad either like the first time.   This case was linked to US-MODERNATX, INC.-MOD-2021-142441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142441:Dose 1
I received the RECOMBAVAX HB 1st dose on 9/11/2008 from an Urgent Care Center. Within a couple of days after the vaccine, I started to develop a headache with vertigo and blurred vision, as well as an acute onset of fatigue with a sense of muscle weakness. The intensity fluctuated over the course of the following month, and I received the second dose on 10/18/2008. Since then, I have suffered with severe, debilitating migraine type headaches, blurred vision, vertigo and a positive ANA homogenous pattern - previously negative-, and fatigue with mild tingling in hands. I went to see a Neurologist today and he believes that these symptoms are a adverse autoimmune reaction to the vaccine and has advised that I forego the last dose which was scheduled for March 2009 even though I am in the medical field. He advised that it would take months before the headache starts to clear up and is recommending Botox to see if it helps alleviate the nerve pain. The first vaccine was RECOMBAVAX Lot # 0398X/Expiration date of 11/2010. The second was RECOMBAVAX lot # 0866X/Expiration date of 04/04/2011.
Slight flu symptoms the following day- headache & fatigue.  Only lasted 1 day.
Abdominal Pain, Nausea still occuring Swollen Lymph node under left arm- 7 days High fever for 48 hrs low grade fever on and off since vaccine
Hives to arms and abdomen; headache; vomiting x 1; heart rate to 130.
Redness, swelling and erythema of right arm - upper arm. This occurred two days after injection (Tdap) was administered in right arm.
Fibromyalgia symptoms: excruciating pain-back, chest, neck, arms, hips and legs, headaches, muscle weakness, generalized swelling-all over body, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility, limited range of motion. Symptoms started in Sept 2009, at onset was mainly back pain with  symptoms progressively worsening to date. Treatment Oct 2009, diagnosed with thoracic sprain, pain med and prednisone prescribed. Primary care physician, Oct 29, 2009- ordered Mobic, Lortab, and Flexeril. Nov 11,2009 Dr stopped Mobic and Flexeril and ordered Zanaflex and ibuprofen. Also ordered physical therapy. started 11/12/2009. After several sessions stopped physical therapy due to increasing pain and inability to tolerate therapy. 11/25/09 MRI cervical and lumbar. Several weeks of chiropractic care- stopped due to inability to tolerate and not improving. Spine clinic- Dr evaluated and referred. 12/16/09 Rehab Several visits - trigger point injections, lidocaine patches, nortriptyline, Lexapro-no improvement. Psychologist-psych eval. - started in March 2010-Has tried several meds without success- Diagnosed with fibromyalgia and referred to another Dr. April 19, 2010, 1st appt with Dr and fibromyalgia diagnosis confirmed. Patient is taking several medications to try to help control symptoms-Neurontin, Savella, Klonopin, and Ultram but so far still no improvement. She still  remains in excruciating uncontolled pain along with increasing weakness, generalized swelling, muscle knots, muscle spasms, insomnia, difficulty concentrating, limited mobility and limited range of motion.
Pt woke up with rash in under arm area. Placed cortisone topical cream on area. Pt is in no pain currently.
Right after the nurse administrated the vaccine to my daughter, she complained about having numbness on her feet, flurry eyes, was not able to hear very well, dizziness and fainted for a short time.
it is getting worse; kidneys are not working like they should be; urine is pretty dark when  was never like that before; he waited a little (about 6 weeks) before he received his second dose; rash on chest\Rash: Generalised; On and off chills\chills; fever; nausea; exhaustion; Pain at injection site; Skin feeling warm; No energy; Itching; Flushing; feeling hot\Prickly heat; numbness; Prickling/Tingling sensation; Abdominal cramping; mild brain fog; DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (it is getting worse), RENAL DISORDER (kidneys are not working like they should be), CHROMATURIA (urine is pretty dark when  was never like that before), SKIN WARM (Skin feeling warm) and ASTHENIA (No energy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced SKIN WARM (Skin feeling warm), ASTHENIA (No energy), PRURITUS (Itching), FLUSHING (Flushing), FEELING HOT (feeling hot\Prickly heat), HYPOAESTHESIA (numbness), PARAESTHESIA (Prickling/Tingling sensation), ABDOMINAL PAIN (Abdominal cramping), FEELING ABNORMAL (mild brain fog), DIARRHOEA (DIARRHEA), VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea) and FATIGUE (exhaustion). On 23-Jul-2021, the patient experienced PYREXIA (fever). On 24-Jul-2021, the patient experienced RASH (rash on chest\Rash: Generalised) and CHILLS (On and off chills\chills). On an unknown date, the patient experienced CONDITION AGGRAVATED (it is getting worse), RENAL DISORDER (kidneys are not working like they should be), CHROMATURIA (urine is pretty dark when  was never like that before) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he waited a little (about 6 weeks) before he received his second dose). At the time of the report, CONDITION AGGRAVATED (it is getting worse), RENAL DISORDER (kidneys are not working like they should be), CHROMATURIA (urine is pretty dark when  was never like that before), SKIN WARM (Skin feeling warm), ASTHENIA (No energy), PRURITUS (Itching), FLUSHING (Flushing), FEELING HOT (feeling hot\Prickly heat), HYPOAESTHESIA (numbness), PARAESTHESIA (Prickling/Tingling sensation), ABDOMINAL PAIN (Abdominal cramping), FEELING ABNORMAL (mild brain fog), DIARRHOEA (DIARRHEA), RASH (rash on chest\Rash: Generalised), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever), CHILLS (On and off chills\chills), NAUSEA (nausea) and FATIGUE (exhaustion) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he waited a little (about 6 weeks) before he received his second dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-273339 (Patient Link).
Patient had external administration for vaccine.  From chart review, patient saw PCP last month on 5/10 complaining of progressively worsening dyspnea on exertion as well as abdominal and lower extremity swelling. Outpatient workup was suspicious of CHF so she was started on lasix and TTE. Since starting diuretic, she has lossed a significant amount of weight and has felt better. She went for TTE on 5/22 which was recently read by Cardiologist with new findings of HFrEF of 27%.  After review of TTE today, patient was contacted by Dr. to go to ED for urgent evaluation.   BNP elevated. CXR pending. BP elevated.   TTE (5/22)  Summary  Delay in reporting as the study was not assigned for reporting. Reviewed  today prior to scheduled consult  Severely reduced left ventricular systolic function with an ejection fraction of 27 % using biplane method.  Global left ventricular hypokinesis  Grade II diastolic dysfunction with elevated LA pressures.  Dilatation of cardiac chambers suggests dilated cardiomyopathy.  The estimated RVSP is 43 mmHg.  Moderate tricuspid regurgitation.  A trivial pericardial effusion is present.
Information has been received from a nurse concerning a female patient who on an an unspecified date were vaccinated with GARDASIL vaccine (yeast). It was reported that the patient fainted within the 15 minute period following vaccination. No specifics known about the patient. At the time of reporting, the patient had recovered. The patient sought medical attention in office. This is one of several patients received from the same source. Additional information has been requested.
Patient was given Tdap, Hepatitis A, HPV, and MCV4. When the fourth vaccine was administered, patient passed out.  Her eyes moved to the back of her head. LOC for a few seconds. When she "came to" she was startled and shook her head. Legs were elevated. Ice pack put to the back of her neck.  When she felt able, cold water was offered and cookie was given. Stayed seated for several minutes.  When she felt able, legs were put down. Color returned to her face. Had patient stand with assistance.  She felt well.  Patient left with instructions to drink alot of fluids today and stay out of the heat.
Patient and his wife stated that he has had a history of fainting when recieving shots and requested to lay down on the floor. He laid down on the floor prior to recieving vaccines. He recieved 3 vaccines at this time and was speaking while he recived the first 2 (Typhoid and yellow fever). During the administration of the  3rd vaccine (Hep A) pt turned pale and stopped speaking. Pt was breifly unresponsive, but was having labored breathing. Ammonia tablet used to help pt become alert. 911 was called for help. Pt became alert and oriented after being unresponsive for about 30 seconds. Pt was alert and oriented to person place and time. BP was 117/60 and pt's breathing was normal at this time. EMS arrived and monitored pt's BP for about 30 minutes. Blood glucose leverl was taken and was stable. PT was stable and was not complaining of any syncope at this time. Pt declined to be taken to the Emergency department for evaluation. Pt was driven home by his wife. A follow up call was made several hours after the incident and pt stated that he was feeling fine.
persistent pain in arm for 4 1/2wk since inj;now having some weakness;25APR96 no addtl info provided on f/u;MD unable to recall pt name but recalls referred to unidentified neurologist;
Symptoms progressive; taken back to doctor on 11/18/2015 when illness presented didn't pass. Treated for bacterial infection with antibiotics. Returned on 11/26/2015 when new symptoms arose (hearing loss/ear infection). Unintentional weight loss, rash, low grade fevers, headaches, muscle pain and weakness, multiple joint pain, exhaustion. Received 3rd dose of Gardasil on 02/03/2015 followed by worsening of symptoms following immunization on 10/13/2014. Chronic pain, inability to walk without support, neuropathy. Treatment has been unsuccessful to date.
Patient reported she developed red, itchy spots all over her body and on the tops of her feet sometime between getting the vaccine and 9-23-2017. I recommended she take BENADRYL or come in to see our nurse practitioner. She came in to our clinic and the CNP prescribed hydroxyzine 10mg 1-2 tablets every 8 hours as needed and diphenhydramine 12.5mg chewable tablets 2 tabs at bedtime as needed. CNP agreed that the reaction might have been from the vaccine even though the patient received the same vaccination the previous year with no problems.
He has had several asthma incidents since the vaccine. It starts as cold symptoms and escalates to asthma type symptoms. He has had to have prednisone and other medications to halt the symptoms. Inhaler was changed to Symbicort to battle symptoms. The most recent visit for asthma treatment was on January 05, 2022. He was administered another round of prednisone. The issue is ongoing. The doctor is referring him to as pulmonologist if he has another incident.
Awoke about 40 hours after vaccine with intensely pruritic raised rash involving his chest arms and abdomen. + dermatographia
Violently ill with vomiting and diarrhea and severe abdominal cramping, sweating, uncontrollable body chills and headache. Large painful lymph nodes remain on April 17, 2021 with headache and stiff neck.
27AUG93 pts grandma called to report had had a reaction to MMR vax on 1 7AUG93; c/o numbness of feet & h/a; also had a fever although did not check it w/a theromometer; dx w/GBS completely paralyzed;
c/o soreness to flu vax site; area red about 3" in length, 1 1/2" side, area warm, some itching;
Runny nose; Scratchy throat; Loss of voice; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and APHONIA (Loss of voice) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 07-Sep-2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and APHONIA (Loss of voice). In 2021, RHINORRHOEA (Runny nose), THROAT IRRITATION (Scratchy throat) and APHONIA (Loss of voice) had resolved.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Staff reported experiencing headache and body aches for 2 days that initially started about 6 hours after receiving her second dose of the vaccination. She felt ill enough to warrant absence from work following  vaccination.
Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of a prior seizure (on an unk date about a year ago during a hair cut) who on 11/6/06 was vaccinated IM in the deltoid with the second dose of HPV vaccine (lot not provided). It was reported that the pt had no difficulties when the first dose of the vaccine was administered on an unspecified date. On 11/6/06 the medical assistant administered the vaccine, then turned to discard the needle. The pt fainted, fell from the exam table, hit her head on the floor and had a seizure. Paramedics were called, a cervical collar was placed on the pt and she was transported to the ER. The pt was evaluated in the ER, a CT scan was performed which was reported as normal. The pt was discharged to home from the ER and instructed to follow up with neurology. The medical assistant stated that the physician felt that the pt had a vasovagal response after receiving the vaccine and that the seizure was a result of the head trauma which the pt suffered from the fall off the exam table. It was reported that the physician felt that the seizure was related to the head trauma and not related to the vaccine. The medical assistant also reported that the physician felt the pt had recovered from the event. Upon internal medical review the seizure was felt to be an important medical event (OMIC). Additional information has been requested.
This spontaneous report was received from a physician via company representative refers to a 15 year old male patient. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with GARDASIL 9, (subcutaneous, dose not provided). No concomitant therapy was reported. The patient experienced syncope after vaccination. The outcome of syncope was reported as recovering. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish further contact.