chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID tongue; gastrointestinal distress; intense neck pain; herpes zoster virus; re-activation of herpes zoster virus, with cold sore; re-activation of herpes zoster virus, with cold sore and red spots on face.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 12Apr2021 at 15:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy, herpes zoster. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any medications within two weeks of the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 16:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021, within two days the patient experienced intense neck pain and gastrointestinal distress. On 15Apr2021, within three the patient experienced COVID tongue. On an unknown date in Apr2021, the patient experienced re-activation of herpes zoster virus, with cold sore and red spots on face. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense neck pain and gastrointestinal distress, COVID tongue, herpes zoster virus, with cold sore and red spots on face was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt stated there was no noted discoloration, pain or swelling @ the site of inject; then a dull pain started w/no external signs; nerve injury & gave APAP;
swelling of both arms; itchy rash on left arm that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on left arm that comes and goes) and PERIPHERAL SWELLING (swelling of both arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced RASH PRURITIC (itchy rash on left arm that comes and goes). On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling of both arms). On 24-Mar-2021, PERIPHERAL SWELLING (swelling of both arms) had resolved. At the time of the report, RASH PRURITIC (itchy rash on left arm that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Abd cramps, diarrhea, nausea followed by bilateral leg burning. Local erythema at injections site and circumference of proximal humerus with L axillary adenopathy.
June 1st: My finger tips were beginning to turn purple. It started on my left hand index and middle finger. Then it spread to my pinky, then following the same route on my other hand. I went to my GP and he had suspected Raynauds but wanted to refer me to a Vascular doctor since it seemed a little odd to see a Raynauds case in June.  The next day I was able to see a Vascular doctor. He diagnosed me with a possible embolism and put me on Eliquis and recommended a cardiac workup which I scheduled right after that appointment. The doctor mentioned that if it does not get better to give him a call within the 2 week window of my recheck.  A week and a half in it was not getting better, I called the office and he mentioned to go to the ER .   June 17th: I went to the ER and explained my situation. Seeing my symptoms they admitted me. They started a Heparin drip IV to keep me on the thinners and ran a whole cardiac workup included an enormous amount of bloodwork. I spent less than 24 hours in the hospital because my cardiac workup was normal, bloodwork did not show any signs of emergency. In the hospital I saw the doctor on call, Vascular, Hematology/Oncology, Diabetic Educator, & Cardiologist. They discharged me with  Xarelto to start and told me to see a Rhematologist. Every doctor there suspected a Rhuematoid issue.   After being discharged I made an appointment with PA on July 1st. Upon arrival she ordered what had to be 10 or more vials of blood which included some Rhematoid testing as well as a special panel called Avise which narrows down the Rhematoid issues. While we waited for that bloodwork she then put me on Amlodipine 5mg once a day.   In between that I went to do the check up with the Vascular doctor that I saw in the hospital and he said that it is not a vascular issue.   At my recheck with PA, My bloodwork showed my thyroid number was elevated. She ordered a thyroid ultrasound in which I am still waiting to get done. All of the Rhematology bloodwork showed no diagnosis. She then raised my Amlodipine to 2.5mg in the morning and 5 mg at night as well as Nitroglycerin Cream to put on the top of my hands 3x a day if needed. I have been taking that medication and the cream as well and nothing seems to be helping.   On my left hand specifically I have ulcers forming from the beginning of this ordeal. They are getting extremely worse and larger.  The pain and inflammation that comes and goes in all of my fingers are unbearable. No medication that any doctor has given me from the beginning to now has helped me.
14MAY92 DTP/HIB recvd; 15MAY92 mom called c/o t104 & breathing problems; 15MAY92 pt brought in w/inc temp & breathing problems; t101.6-103.7, p200, R88; pt adm to PICU where t105
DRAMATIC IMPROVEMENT OF MULTIPLE SCLEROSIS SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included squamous cancer removal on forehead, and concurrent conditions included multiple sclerosis. The patient was previously treated with fingolimod hydrochloride for multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced dramatic improvement of multiple sclerosis symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dramatic improvement of multiple sclerosis symptoms was not reported. This report was non-serious.
High blood pressure; drugged sleep, very deep than her normal sleeps; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) and SLEEP DISORDER (drugged sleep, very deep than her normal sleeps) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug and Blood pressure abnormal. Concomitant products included ALPRAZOLAM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High blood pressure) and SLEEP DISORDER (drugged sleep, very deep than her normal sleeps). At the time of the report, HYPERTENSION (High blood pressure) and SLEEP DISORDER (drugged sleep, very deep than her normal sleeps) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: significant follow up received on 23 JUL 2021,  new event (sleep disorder) added, event outcome for high blood  pressure updated,second dose information was added
Projectile vomiting once, but irritable for the next couple days and mild fever 99.0. Sensitive to noise and environment with loss of appetite and sleep. Sleeping pattern were short, about 2 hours  during the night with excessive crying which is not normal for her. These were the 6 month shots.
pt recvd vax 30DEC92 & exp high pitched crying elevated fever; mom took pt to ER where pt given Tempra & sent home;
This study case was received from the investigator in a trial on 08 April 2013. A 25-year-old female subject had received the following vaccination on 11 March 2013 in the left arm: ACAM2000 (lot number, and route not reported). Three days later, the subject experienced sharp/mild chest pain during a light jog following intense exercise (running stairs). This reoccurred on 2 subsequent days and stopped. The subject recovered on 16 March 2013. The subject did not seek care. Rapid/lab troponin levels from 18 March 2013 were normal (Result < 0.10 ng/mL). The electrocardiogram from 18 March 2013 was normal. The subject did not have any medical history relevant to the event and took no medications to treat the event. According to the reporter, there was a lower suspicion for myopericarditis, but could not rule out cardiac etiology. The subject was referred for care but did not go. The subject's outcome was reported as recovered on 16 March 2013. According to the Investigator, the event of chest pain was considered an important event and possibly related. Documents held by sender: None.
pt recv vax & tenderness up arm into neck;pain got so bad that pt went to ER-pt told inflammation in arm;pt pvt MD states inflammation of nerve ending;pt had diff grasping & lifting anything w/lt hand;
Within 5 minutes, first symptom was R hand numbness and tingling, then traveled up arm to 4" above wrist. No change in hand color or temperature. No difficulty with movement. 5 minutes later right side of mouth with numbness and tingling. No trouble speaking. No difficulty breathing. No facial asymmetry. Mouth only tasted about 5-10 minutes. Hand started feeling better within 30 minutes, completely gone in an hour.
pt recvd vax; devel fever & myalgia;sx lasted short time & resolved;
Discharge Provider: DO; Primary Care Provider at Discharge:  PA-C; Admission Date: 10/22/2022; Discharge Date: 10/24/2022; PRESENTING PROBLEM: Hypoxia [R09.02]; COPD with acute exacerbation (HCC) [J44.1] Chest pain, unspecified type [R07.9]; COVID [U07.1]; HOSPITAL COURSE: A 76 y.o. female who presented to the emergency department with complaints of shortness of breath.  Patient has a past medical history of persistent atrial fibrillation, vertigo, chronic obstructive pulmonary disease, hypertension, GERD, hyperlipidemia, depression, seasonal allergies, and obesity. Patient states that she awoke this morning with chest pain.  She has additional complaints of worsening cough, shortness of breath, and sore throat.  She denies nausea, vomiting, diarrhea, fever and chills.  She presented to the emergency department for further evaluation.  In the emergency department, patient was tachycardic, but was afebrile, and did not require supplemental oxygen at rest.  Complete blood count was unremarkable.  CMP was unremarkable.  BNP was 1054. Troponin was 25 with a blood pressure of 18. Patient tested positive for COVID-19 on 10/12/2022.  EKG showed atrial fibrillation with RVR.  CTA of the thorax showed no evidence of PE, but there was emphysema changes as well as patchy ground-glass opacities peripheral E in the right upper lobe.  Suspect chronic obstructive pulmonary disease with acute exacerbation combined with COVID-19.  Patient has been admitted for further evaluation and management of chronic obstructive pulmonary disease with acute exacerbation.  Patient remained stable throughout her stay.  She had no chest pain at rest and chest pain seem to be exacerbated most with palpation and deep breathing.  Because of her COVID status we were unable to arrange for cardiac stress testing during this admission.  Her respiratory status stabilized with aggressive pulmonary toilet steroids and respiratory support.  We were able to wean her off supplemental oxygen.  She was seen on the day of discharge doing well and discharged home to follow-up with her primary care provider.  She was to continue her steroid taper, she could return to diet and activity as tolerated.  She is out of severe respiratory isolation from COVID now.  She could resume the rest her medications as previously ordered.  She understood all these instructions and was discharged home in stable condition.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a five-years old male patient who received a 0.5 mL first dose of QUADRACEL (one dose) lot C5325BA, expiry date: 14-Nov-2019 in right leg on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that QUADRACEL that had a temperature excursion and the vaccine should not be used. The vaccine was set aside, but someone took out a dose and gave it to a patient. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Fever: (102 degrees) Day 7 till currently Day 12. Rash: Flushed Red & Raised Bumps starting Day 12. Unusually cranky, upset, sleeping more.
Right after second vaccine I started sweating and throwing up and severe abdominal pain and then blood in stool.  Months later I noticed my heart beating rapidly.  My blood pressure has gone up.  This never happened to me prior to the test.  I also have developed arthritis.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization at the pharmacy/drug store. The patient's medical history was not reported.  Concomitant medication included influenza vaccine for immunization. The patient experienced swelling at the injection site that lasted 5 to 7 days on an unspecified date, reported to have occurred a few days ago but exact date was unknown. It was reported that the patient also had a flu shot that was administered on the same day at a different injection site. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017427867 different patient, same reporter, product, event.
Severe muscle pain experienced since initial shot on 11/05/2021. Expected to last between 1-3 days, is now just as severe on 12/19/2021. I have difficulty in lifting my arm to put on clothing. Shoulder pain as well. Pain is not subsiding. No bruising, no fever, no redness, so I assume I have no infection. I worry that this vaccine has caused permanent muscle damage.
Patient's arm became red, hot to touch and swollen. Reaction worsened over 2 days with symptoms subsiding on 3rd day.
Yesterday she received pneumonia & Tdap. Tody she call to the clinic because arm was swollen war, Rash was 11x15cm. Ranitidine & Benadryl given. If worsen patient will come back.
Initial report was received on 03 July 2012 from another manufacturer who considered the report as serious (overdose), report number WAES 1206USA05327. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a registered nurse concerning a patient who on 26-JUN-2012, was vaccinated with a dose of Hib conj vaccine (CMPC) (dose, route and lot number not reported) and during the same visit the patient was vaccinated with a dose of PENTACEL (dose, route and lot number not reported). There were no adverse reactions reported. Additional information has been requested. Documents held by sender: none.
Patient received vaccine and escorted to monitoring area . Developed chest tightness and headache several minutes after administration. she reported multiple allergies, took own Claritin. VS stable, airway patent, no erythema or edema. speaking clearly. 911 called, she declined transport. Watched for 30 minutes and went to ER by private car
Fever 101.5, mild headache Started about 24 hours after shot Taking tylenol
Rheumatoid arthritis recurrent flare up; bacterial pneumonia; Worsening Health; Increased Pain; Felt a drop in support; Drug effect decreased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4382680-00 (Abbvie).  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis recurrent flare up"; PNEUMONIA BACTERIAL (medically significant), outcome "unknown", described as "bacterial pneumonia"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "not recovered", described as "Worsening Health"; PAIN (non-serious), outcome "unknown", described as "Increased Pain"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "Felt a drop in support"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased". The action taken for adalimumab was dosage permanently withdrawn. The event had not abated after stopping drug. Other relevant history was not reported.   The reporter's assessment of the causal relationship with the suspect product(s) BNT162b2 for "rheumatoid arthritis recurrent flare up", "increased pain" was possible, "bacterial pneumonia", "worsening health", "Felt a drop in support" and "drug effect decreased" was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's causality for the event(s) of Worsening Health was not related, bacterial pneumonia, Rheumatoid arthritis recurrent flare up, Increased Pain, Felt a drop in support and Drug effect decreased from Humira was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Red rash on right arm; Itchiness on right arm; Hotness in right arm / Hot and warm face; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on right arm), PRURITUS (Itchiness on right arm) and FEELING HOT (Hotness in right arm / Hot and warm face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PERINDOPRIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on right arm), PRURITUS (Itchiness on right arm) and FEELING HOT (Hotness in right arm / Hot and warm face). At the time of the report, RASH ERYTHEMATOUS (Red rash on right arm), PRURITUS (Itchiness on right arm) and FEELING HOT (Hotness in right arm / Hot and warm face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included application of  ice on arm.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 30Mar2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 27Sep2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 16Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: Synthroid; Zoloft; Sumatriptan. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 26May2022, outcome "unknown", described as "Pfizer / BioNTech dose / COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 26May2022, outcome "unknown", described as "Pfizer / BioNTech dose/ COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical information: Other medication in 2weeks product: Claritin. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.