chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 2 weeks of shot, my left arm became sore and my range of motion was diminished; it has continued to get worse. Chose influenza choice above, but do not know the type--it made me choose one.
ADMINISTRATION ERROR. Gave Pfizer Bivalent booster instead of Pfizer monovalent for patient's 1st dose in primary series.  Patient has had no adverse side effects due to this administration error.
numbing of lt side of face drooping lt lip, lt eye not blinking & sensitive to hearing;dx by MD w/bells palsy;
slurred speech, RUE weakness and deteriorating penmanship.  Demyelinating disease on MRI.  Further workup pending.   SN 796709720427 exp 2024/10
body pain; fever; Nausea; aches; diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), DIARRHOEA (diarrhea), MYALGIA (body pain), PYREXIA (fever) and NAUSEA (Nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (aches), MYALGIA (body pain), PYREXIA (fever) and NAUSEA (Nausea). In March 2021, the patient experienced DIARRHOEA (diarrhea) and VOMITING (vomiting). On 06-Mar-2021, PYREXIA (fever) had resolved. On 10-Mar-2021, PAIN (aches), DIARRHOEA (diarrhea), MYALGIA (body pain), NAUSEA (Nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Clinical staff reviewed immunization record and saw pt was behind. She asked dad if he had any immunization records. He told her no.  According to the Registry and pt's clinic record, she needed vaccines. She had vaccines ready to update her including the Pentacel and administered them. After the administration, dad took out an immunization record that showed many of them had been already completed. Pentacel had already been administered and it now shows an invalid dose of Pentacel. She was already update on the Pentacel.
PT RECIEVED VACCINE AT 09:30 AND DEVELOPED AN ITCHY RASH AT THE INJECTION SITE.
1.5 hrs after 1st dose of covid19 pfizer vaccine, pt developed pruritic rash on neck and upper back, swelling beneath eyes bilaterally and SOB noticed as increased use of rescue inhaler. States is "not having that hard a time of breathing".
hallucinations; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 HALLUCINATION (hallucinations) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Patient states that the nurse who gives the vaccines at her medical facility told her that 6 people who had the Moderna Covid-19 Vaccine had hallucinations.  company comment This case concerns an unknown age and gender patient with no relevant medical history who experienced serious unexpected event of hallucination on an unknown date after receiving a dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-317637, US-MODERNATX, INC.-MOD-2021-318104 (E2B Linked Report).; Sender's Comments: This case concerns an unknown age and gender patient with no relevant medical history who experienced serious unexpected event of hallucination on an unknown date after receiving a dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2021-317637:Same reporter and Patient but different patient US-MODERNATX, INC.-MOD-2021-318104:Same reporter and Patient but different patient
PATIENT REPORT THAT THEY EXPERIENCED EXTREME PAIN IN THE VACCINATED ARM RESULTING IN A DIAGNOSIS OF FROZEN SHOULDER.
P/vax administered client had arms raised finger stiff & separated & trembling; Eyes rolled upward, skin clammy; Ammonia inhalant used; BP 84/70, P56;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about the patient's past medical history, concurrent conditions, or concomitant medication was received. The patient was inoculated with ZOSTAVAX vaccine on or about 11-JAN-2008 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 25-AUG-2016, the patient was treated by a physician for a painful outbreak that was diagnosed as herpes zoster, or shingles. On or about 05-SEP-2016, the patient was treated again for continued and worsening symptoms of shingles outbreaks, which was diagnosed as post herpetic neuralgia. The patient has been prescribed VALTREX and Lidocaine for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Got severe chills and a fever that lasted for about 6 hours. Was feeling sick and weak for the next 4 hours and then I was feeling back to normal.
On 4/21 patient was seen at urgent care with symptoms for several days: history of fever up to 101, abdominal pain, nausea, vomiting, diarrhea and body aches, 1 week post 2nd dose of vaccine. Patient admitted to ED on 4/30 with high fever up to 104, generalized body aches and a lack of energy.  Patient was diagnosed with AKI on CKD, secondary to sepsis and polycystic kidney disease, patient was given fluids and ceftriaxone.  discharged 5/3
Nursing home called 911 for decline in condition.  Patient transported to ER where she was admitted to inpatient care and expired 1/30 at 16:13
Very swollen and tender at injection site for 3 days. Bumpy, itchy rash the size of a silver dollar for 2 weeks (at injection site).
pt recv vax 18DEC98 7 1wk later pt devel diaper dermatitis w/blistering;the pt reported that pt diapers emitted an acidic smell;
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age and gender was not reported) who was received a dose of FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration was not reported) which was slushy and was thawed and exposed to temperatures below 0 degree Celsius. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to deteriorated drug administered and incorrect product storage. The vaccine should be discarded. It was unknown if the patient had any 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. List of documents held by sender: none.
felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus, Emphysema (minor Emphysema w/ fibrosis), Blood pressure high and Arthritis. Concomitant products included CARVEDILOL for Hypertension, METFORMIN for Type II diabetes mellitus, ATORVASTATIN CALCIUM (LIPITOR), RAMIPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (felt dizzy). At the time of the report, DIZZINESS (felt dizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: upto 283 (High) Blood glucose increased Blood sugar went to upto 283 checked again in minutes to be sure the meter was functioning properly and it was 280., 135 (Inconclusive) He drank a gallon or so of water and took a walk; the blood sugar is now 135 (7:46 PM CT). and 195 (Inconclusive) at 6PM glucose was down to 195.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment with water and walk were reported by the patient, pertained to the events .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25MAY2021, added information about patients medical history and concomitant medications.
Information has been received from a registered nurse (RN) concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included prednisone.  The RN reported that the patient subsequently had reaction to Zostavax (Oka/Merck) because she was also given prednisone on the same day.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  The RN noted that the vaccine was stored properly.  This is one of several reports from the same source.  Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2021 as dose 1, single, in Jul2021 as dose 2, single and in Feb2022 as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19 "; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral COVID 19 Treatment from 28Oct2022 to 01Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Received an expired dose of the Moderna booster, after 30 day use by date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day use by date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day use by date) had resolved.      No concomitant Products were reported. No treatment information was reported. Patient received Booster and patient questioned the Pharmacy, they said it may be a typo or someone put the manufacturing date instead. Patient had concerns about the efficacy of the vaccine and what they should do.
No known adverse effects; a patient received an expired dose of PNEUMOVAX; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 15-AUG-2019, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (Expired product administered) lot number N019837 with expiration date on 21-FEB-2019 (dose number, frequency, strength and route of administration were not reported) for prophylaxis. No known adverse effects.   The outcome of expired product administered was unknown.
Patient requested Moderna booster at check-in and received Pfizer booster. Pharmacist explained to patient and counseled on the different mRNA vaccines and how it's able to be interchanged. Patient verbalized understanding.
Narrative: Patient received two COVID (Moderna) vaccines from our facility on 4/2/21 and 5/27/21. Patient incidentally hospitalized for COVID on 2/20/22 where he tested positive prior to admission. No medications were indicated for treatment. Patient was discharged 2/23/22
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 05-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
After first vaccine: -Head ache , NSAID, 3 days resolved -Tinnitus, no treatment to date, constant.
Information has been received from a registered nurse concerning a 22 months old female patient with no pertinent medical history and no drugs reactions or allergies who on 17-NOV-2009 was vaccinated subcutaneously in left arm with a dose of VARIVAX (Merck) (Lot number 665191/1047Y). Concomitant therapy included ENGERIX-B, IM in right arm; and ACTHIB. The nurse reported that on 11-OCT-2010 the patient had an outbreak of chickenpox on the left arm and back. No laboratory diagnostics studies were performed. The patient sought medical attention. She was given acyclovir 200mg/5mL (1/2 teaspoonful 4 times daily for 5 days) and ZORIVAX OINTMENT (3 times daily for 5 to 7 days). At the time of report, the patient had not recovered from chickenpox on the left arm and back. Follow up information has been received from a registered nurse concerning a 22 months old female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination who on 17-NOV-2009 received a first dose of VARIVAX (Merck) (Lot number 665191/1047Y), SC in the left arm. Concomitant therapy included a fourth dose of ACTHIB (Lot # UF707AB), IM in the left thigh, and a third dose of ENGERIX-B (Lot # AHBVB708BA), IM in the right thigh (The registered nurse reported that the vaccines were given at p.m). It was reported that on 11-OCT-2010 the patient developed a rash on left arm and left side of back. It was diagnosed as shingles. At the time of the report, the outcome of the patient was not reported. Follow up information has been received from the registered nurse who reported that on an unspecified date, the patient had recovered from shingles. Additional information is not expected.
After my 1st Pfizer COVID 19 vaccine on 3/15/21, I experienced abnormal vaginal bleeding on 3/16/21 about 24 hours after the vaccine. I went to Urgent Care. They did a CBC to rule out internal bleeding, an ultrasound of stomach and an internal vaginal ultrasound. These tests were normal and they referred me to an obgyn, for an Endometrial Biopsy. This biopsy was completed on 3/17/21 and on 3/20/21, the results came back as normal. I am post-menopausal and have not had my period for about 10 years. I also submitted a report today to document the adverse event after my 2nd Pfizer COVID 19 vaccine that I got on 4/5/21.
Patient was waiting in chair about 5 minutes after the vaccine when I heard him say he didn't feel too good. His skin color was pale and when I went up to see how he was he bent over and vomited. After he vomited he said he felt a lot better. I asked him to remain seated and asked for my tech in the pharmacy to call 911, but he then said no and that he was feeling better. He said he felt clammy just before he vomited. I asked him to stay seated and got him some cold water. He remained in the waiting area another 15 minutes after to make sure no further problems. After 15 minutes he was feeling fine and I reassessed and his color returned to his skin and I noticed some redness around inner portion of both thighs, but he said that was from his eczema and that it was there already.  Allowed him to leave at 1:15pm and told him to seek medical attention right away if he felt any issues regarding trouble breathing. I called him an hour later to check up on him at 1:30pm and he was feeling fine. He thanked me over the phone.
Fever next day: not measured. Five maculo papular rash 5d later. Pt generally well and asymptomatic.
Reports that the rash started as little pimples all over her body which then progressed to large erythematous patches.  The rash is most prominent under her breasts and on her lower back.  She also has extensive erythematous patches on her legs and upper arms.
This spontaneous report as received from a female consumer on an unknown age. In May 2012 the patient was vaccinated with ZOSTAVAX, injection (dose, route, lot number and exp date not reported). On an unknown date also reported as recently the patient had been tested positive for genital herpes. The outcome of event was unknown. Additional information is not expected.
One minute after receiving her vaccination, she started feeling itchy nose and her throat, then subsequently started feeling swelling in her town. Evaluation by physician so no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s. She remains normotensive. One minute after receiving her vaccination, she started feeling itchyness in her throat, then subsequently started feeling swelling in her tongue. Evaluation by a physician showed no swelling of the tongue. Her lungs were clear auscultation bilaterally. Her heart rate initially was in the 130s. She was taken to a private section of the arena and monitored. Her heart rate gradually decrease to the 110s, then to normocardia. She remains normal tensive. Prior to monitoring, she already taken a 50 mg dose of oral diphenhydramine (which she brought herself). Recommended she switch to J&J vaccination instead of getting the 2nd dose of Pfizer.
bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin; bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin; bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  An 85-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, SINGLE MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3, BOOSTER, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: CONTUSION (non-serious) with onset 2022, outcome "recovering", PETECHIAE (non-serious), SKIN DISCOLOURATION (non-serious) all with onset 2022, outcome "unknown" and all described as "bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin". The events "bruising; had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin" required physician office visit.  Additional information: Patient states she is calling about the Pfizer Covid vaccine, booster number 2, and she is also taking Ibrance. she states that she had the bruising evaluated at her health center at (withheld) and states that the vaccine did not bother her, and she did not have any side effects. she had a big bruise, and it was ugly, looked purplish black, and like there was blood under her skin. she got her vaccine on 28Apr2022. she states it is getting better, and she took a picture of it. Patient states she is on an Ibrance trial, through the patient assistance program, and she just happened to mention it to agent, who calls and checks on her. she states that other people who were not healthcare professionals told her it was nothing to worry about and states she had health care professionals look at it as well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen joints; Pain abdominal; Generalised joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swollen joints), ABDOMINAL PAIN (Pain abdominal) and ARTHRALGIA (Generalized joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS) in a 51-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) for Rheumatoid arthritis. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second 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) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced JOINT SWELLING (Swollen joints), ABDOMINAL PAIN (Pain abdominal) and ARTHRALGIA (Generalized joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS). At the time of the report, JOINT SWELLING (Swollen joints), ABDOMINAL PAIN (Pain abdominal) and ARTHRALGIA (Generalized joint pain/AFTER SECOND COVID-19 VACCINATION PAIN EVERYWHERE IN JOINTS) had not resolved.    No concomitant medication was reported. It was reported that patient felt pain after the first COVID-19 vaccination, Humira not working/ not effective and pain did not go away. No treatment medication was reported. This case was linked to MOD-2022-627432 (Patient Link).