chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flat splotchy non-itchy red rash across upper abdomen; This is a spontaneous report received from a contactable other hcp. A 46-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported),via an unspecified route of administration, administered in Arm Left on 15Feb2021 15:30,at the age of 46 years old,as Dose 2,single for covid-19 immunization.Medical history included asthma,osteoporosis,anxiety,attention deficit hyperactivity disorder and food allergy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient previously took bnt162b2 for covid-19 immunisation, biaxin and bactrian [cetrimonium bromide] and experienced drug hypersensitivity.The patient experienced flat splotchy non-itchy red rash across upper abdomen on 17Feb2021 05:00.The patient didn't receive any treatment for the adverse event.The patient was not tested for covid19 prior vaccination and not tested prior vaccination.The patient had not received any other vaccine within 4 weeks prior to covid19 vaccine.The outcome of the event was not recovered.  Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information is expected.
Swelling and redness of 2/3 upper outer right arm. Improved, but light  erythema still present after 2 weeks. swelling resolved.  Never had a fever. Area was hot to touch. Occasionally felt tender, no pain or limit in use of arm. No significant itching.
On Sunday December 04, 2022, I went to bed with a sore throat and chills. The next day, the sore throat and chills were gone, but I was coughing and had a runny nose. The next day was more of the same. I called the doctor on Tuesday, December 06, 2022 and spoke with the office about my symptoms. They had the doctor call me back. The doctor said I could take PAXLOVID and supplements. She told me to isolate for 5-7 days and told me to call back if I wanted the prescription of PAXLOVID. I decided against PAXLOVID. I took vitamin C, vitamin D, and zinc with quercetin instead. On Thursday, the cough was gone.
Started to feel unwell; fever of 100.7; muscles and body aches; back pain; chills; cough; headache; weak; muscles and body aches; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 19Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to PCP hair dye. The patient did not receive any concomitant medications within two weeks of vaccination. 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 vaccination. On 19Mar2021 at 13:00, the patient started to feel unwell, got a fever of 100.7 (unspecified units), muscles and body aches, back pain, chills, cough, and headache through the next day. After 2 days the patient still felt unwell and weak. On 20Mar2021, the patient had undergone PCR via nasal swab test for COVID-19 and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever of 100.7, muscles and body aches, back pain, chills, cough, felt unwell, weakness and headache were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Swollen legs, feet, hands, lymph nodes, decreased kidney function lasted about 6 weeks.
fever 100 deg Far aching joints all over even when lying down. worse when moving such as bending, climbing stairs fatigue  slept 14 hours 10/22, and dozed off most of 10/23
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot #669692/0615AA expiration date 02-JUL-2012) that was expired on 03-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The report was received from the same reporter with the other 3 cases, and their MARRS# are 1207USA003758, 1207USA003759, 1207USA003760, respectively. Additional information is not expected.
injection site bruising; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE BRUISING (injection site bruising) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included Shoulder injury. Concurrent medical conditions included Osteoporosis and Drug allergy (Allergic to Keflex - Manifested by Rash). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, SULFASALAZINE, BUDESONIDE and BALSALAZIDE for Ulcerative colitis, BISOPROLOL for Ventricular contractions premature, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 01-Dec-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE BRUISING (injection site bruising). On 22-Mar-2021, INJECTION SITE BRUISING (injection site bruising) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medicines were reported  Patient is an Non-Tobacco user and Abstains from Alcohol
Increased osteoarthritis pain; Vaccination site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Increased osteoarthritis pain) and VACCINATION SITE PAIN (Vaccination site tenderness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (Increased osteoarthritis pain) and VACCINATION SITE PAIN (Vaccination site tenderness). At the time of the report, PAIN (Increased osteoarthritis pain) and VACCINATION SITE PAIN (Vaccination site tenderness) outcome was unknown.            No concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality for Humira was given as the reporter's causality for the events of vaccination site tenderness and increased osteoarthritis pain were not provided. No Treatment information was not provided.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 29-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Adult received Pediatric dose; Adult received Pediatric dose; This case was reported by a physician via call center representative and described the occurrence of underdose in a adult male patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.       Additional Information: GSK Receipt Date: 19-Jan-2023 Reporter's Comments: The physician reported that an adult patient received pediatric dose of Engerix-B.  The reporter consented to follow up. There was no further details available but agreeable to recontact for additional details. Additional supportive information: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
blisters on the mouth and fingertips; blisters on mouth; This non-serious case was reported by a physician via call center representative and described the occurrence of blister in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced blister (Verbatim: blisters on the mouth and fingertips) and blistering of mouth (Verbatim: blisters on mouth). The outcome of the blister and blistering of mouth were resolving.   It was unknown if the reporter considered the blister and blistering of mouth to be related to Arexvy.     It was unknown if the company considered the blister and blistering of mouth to be related to Arexvy.   Additional Information: GSK receipt date: 03-NOV-2023 The employee called on behalf of an HCP (MD).  The reporter reported that approximately 1 month ago, a patient received AREXVY. The 5 days later, the patient went to the HCP's office with blisters on the mouth and fingertips.  At the time of the call the blisters had subsided, and the HCP was still monitoring the patient.  The reporter consented to follow up.
patient described a nerve pain like feeling about a day after receiving the vaccine. he is unsure if its related. the nerve pain is still ongoing but comes and goes. it is not constant
nausea, headache, pain in MCP joints of both hand - like trigger fingers. Lasted 4 hours.
2 other children received Flublok immunization/no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA287163 (same reporter).  This case involves two Child patients who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.
Had a PS23 vaccination on 10/12. Felt achy that evening. The 13th more of the same with some chills. On the 14th, I began having body aches, fever of 101, and a erythemic rash at the injection site. The 15th brings a bigger rash, loss of appetite, continued aches.
On 12/4/01, the pt had pain in her right arm and injection site. On 12/17/01, she had intermittent low-grade fever and body aches X 3 weeks.
Breakthrough case admission after 2 vaccines Pfizer 5/10/21 lot# EW0168;  Pfizer 5/31/21 lot# EW0183
swelling & hot @ that noc;exedrin PM p/school-Friday 29MAY98;Sat/SUn warm @ site-weekend took temp nl-underarm could lift;1inch-1 1/2 swelling-icy/hot anti-inflammatory started yesterday;
pt was taken to ER for treatment; rt thigh was very red & swollen; skin warm to touch, crying for approx 7 hrs; fever 104; seen by MD;
6/13/11 Routine well visit Hep A/PREVNAR 13. 6/28/11 Seen in our office with petechiae/bruising. Platelet count low = 6. Admitted to medical center (Heme-Onc Dept.) for immediate treatment. Later diagnosed with ITP (idiopathic thrombocytopenic purpura).
6 1/2 x 2 1/2 inch swollen erythematous reaction to left leg lasting greater than 48 hrs.
I was unable to walk; I was completely out of balance; This dizziness continued until today and gradually got better day by day; It was like I was light headed or had Vertigo; It was like I was light headed or had Vertigo; This is a spontaneous case is received from a contactable consumer. A 69-year-old female patient received BNT162B2 (Batch/Lot Number: EL9262) dose 2 via an unspecified route of administration, administered in Arm Right on 14Feb2021 09:30 as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, hypertension, hypothyroidism. Concomitant medications included amlodipine besilate (AMLODIPINE BESILATE); apixaban (ELIQUIS) ; clobetasol (CLOBETASOL) ; levothyroxine sodium (LEVOTHYROXINE SODIUM). On 17Feb2021 07:30, the patient experienced i was unable to walk (gait inability), i was completely out of balance (balance disorder) , this dizziness continued until today and gradually got better day by day (dizziness), it was like i was light headed or had vertigo (dizziness) , it was like i was light headed or had vertigo (vertigo). The outcome for the events was recovered.  No follow-up attempts are possible. No further information is expected.
A vial was potentially diluted with less diluent than it?s suppose to be, but no less than 1.5 ml. I called Pfizer and they said the dose would have been 34.6 mcg at most and said it would not be harmful and should be no issues. After speaking with patient to let her know the potential that she got a slightly higher dose and what Pfizer confirmed, she said she felt fine so far, just a sore arm. Patient was instructed to call the pharmacy if any other symptoms occur.
Fever that wouldn't respond to TYLENOL or MOTRIN. Mom reported temp 103 degrees F axillary. 101 degrees F tympanic in office today. PA saw patient, re-assured parent that pt. seemed well. Reviewed concerning signs and symptoms. Continue alternating TYLENOL and MOTRIN as directed.
Was diagnosed with bells palsy, vision blurred and sensitive to light, was prescribed Prednisone 40mg a day.
Severe muscle cramp with pain across back and through chest into right arm, down into hand (fingers tingly/numb, also lips) lasting several minutes.
while sleeping experienced what was described as a seizure taken to hospital by ambulance CT scan on arrival showed no indication for the seizure later in day EEG and MRI performed, no abnormalities found keppra (500 mg, twice per day prescribed)  waiting for follow up appointment
extreme pain in the arm; low grade fever; nauseous; arm is very, very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is very, very sore), PAIN IN EXTREMITY (extreme pain in the arm), PYREXIA (low grade fever) and NAUSEA (nauseous) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MESALAZINE (ASACOL), URSODIOL, AZATHIOPRINE and GABAPENTIN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is very, very sore). On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (extreme pain in the arm), PYREXIA (low grade fever) and NAUSEA (nauseous). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 12-Feb-2021, PYREXIA (low grade fever) and NAUSEA (nauseous) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is very, very sore) and PAIN IN EXTREMITY (extreme pain in the arm) outcome was unknown. Not Provided      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.
Patient felt dizziness and shortness of breath after 15 minutes of vaccination. P.O fluids given (water), BP went up to 124/86, HR 71, O2 98%. Patient was observed for 45 minutes. Reports feeling better and was discharged home.
Dizziness, light headedness throughout the day since jab.  Aches, nausea.
shingles herpes zoster in the trigeminal nerve  and nerve pain also on right in leg
Parents report 2 episodes within 24 hrs of seizure like activity. Body arched back and stiff, hands fisted. Episodes lasted a few seconds. Sent to ER, admit for obs. - everything negative. Did develop temp while in ER. Later seen by neuro - neg as well.
UrticariaPruritus  SWOLLEN ARM, CHILLS  Narrative: EMPLOYEE STATES: ARM WAS RED, SWOLLEN, AND  ITCHING; EXPERIENCED CHILLS AND SWEATING STATES WAS SEEN  AT AN EMERGENCY ROOM AND TREATED FOR SYMPTOMS
No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 09-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1621931, expiration date 26-JAN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
After rec flu vax, started experiencing soreness at site. After a few days, soreness did not go away, some days a little better, some days more aching and tenderness with pushing with pain and any movement. Still have spot on arm that is sore and hurt when try to move arm up or down, left or right.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age . No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the healthcare provider, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Immediately after receiving dose patient began to feel dizzy, light headed and nauseas. He looked pale and sweaty. Upon further examination his BP was low at 70/53. He stated he had not eaten that day. We gave him water, juice and pretzels and he began to feel better in 10 minutes. His BP was retaken 15 minutes later and it re-elevated to 122/78. He phoned a family member for a ride home and the supervisor was notified. Pt was instructed to go on V-Safe to report and was counseled.
Have a reddish where I got the shot; Achy body; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and general body pain. On an unknown date, the outcome of the injection site erythema and general body pain were unknown.   It was unknown if the reporter considered the injection site erythema and general body pain to be related to Shingrix.  Additional details were provided as follows:    The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient self reported the case. The patient had achy body and reddish where the patient got the shot, had no fever. The oxygen was 98 and heart rate was 70.
Within 2-3 minutes of receiving vaccine c/o pain at site radiating into upper arm and back of neck. Mod/sev lasted approx. 10 min  and stopped.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. No information about patient's medical history, concurrent condition and concomitant medications. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 from lot # M042785 with expiry: 17-JUN-2018 and lot # N011305 with expiry: 20-JAN-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine lot exposed to a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit for 2 hours 25 minutes. It also had previous temperature excursion of 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours 45 minutes. The call was due to data logger. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1708USA012148:
- Red, warm at injection site - no itching on (R) arm, - About 6 inches in diameter, - Recommended ice pack to patient to relieve redness.
Headache every day since vaccine, blood pressure irregularities (low then high), lightheaded/dizzy