chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site; She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson Vaccine (Dose 1) on 09-Mar-2021 and Johnson and Johnson Vaccine (Dose 2) on 30-Oct-2021. Past adverse reactions to the above products included Bruise with Johnson and Johnson Vaccine; and No adverse event with Johnson and Johnson Vaccine.    On 09-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site). At the time of the report, INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745104, US-MODERNATX, INC.-MOD-2023-745188 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745104:Master case for SPIKEVAX 2023-2024 PFS US-MODERNATX, INC.-MOD-2023-745188:Bivalent Dose
Patient received only the AS01BAportion; Patient received only the AS01BAportion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number 2F9M5, expiry date 19th May 2023) for prophylaxis.   On 2nd March 2022, the patient received the 1st dose of Shingrix. On 2nd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that the patient received only the AS01BA portion of the Shingrix vaccine in right arm which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The case has been linked with the case US2022039281 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039281:Same reporter.
66 yp, states hes having shortness of breath.  Pt is CAO x 3, airway is patent and self maintained.  Pt was moved to exam area and vitals were stable.  Patient has a history of anxiety, and denies any swelling rash or hives.  Present crew determined patient had a panic attack.  Crew was able to calm the patient, and care was transferred to ambulance unit.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 years old male patient for whom the needle must not have been attached securely and needle must not have been on appropriately as part of the vaccine came out of the side was reported, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE. The patient's past medical history, medical treatment(s) and family history were not provided. No other vaccines were given concomitantly. On 11-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA expiry date 30-Jun-2019 via unknown route in the right deltoid. The patient developed a non-serious the needle must not have been attached securely unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient developed a non-serious needle must not have been on appropriately as part of the vaccine came out of the side. Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data not reported. Final diagnosis was needle must not have been on appropriately as part of the vaccine came out of the side and the needle must not have been attached securely. It was not reported if the patient received a corrective treatment. The outcome of event of needle must not have been on appropriately as part of the vaccine came out of the side. and the needle must not have been attached securely were not applicable. 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.
ACUTE NON ST ELEVATION MI 12/14/2022 &  1/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
According to clinic, patient had receivied J&J primary vaccination 4/1/2021. Pfizer MV was given 1/12/2023 and again 1/30/2023.  Bivalent was the recommended instead of MV.  Bivalent was given today 4/13/2023.
expired vaccine was administered with no reported adverse event; Initial information received on 10-Jun-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a one years old male patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [expired product administered] vaccine.  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE).  On 10-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported via unknown route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the same day].  At the time of report no adverse event was reported.  It was not reported if the patient received a corrective treatment for the 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 the 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.  There will be no information available on the batch number for this case.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient (gravida 5, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 30-Nov-2020 and the estimated date of delivery was 05-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
lymph nodes under the armpit and base of the neck on the right side are swollen and painful, intense fatigue, and malaise started approximately 8-10 hours after administration. symptoms began to improve approximately 28 hours after administration,
Dizziness; Nystagmus; chills; General body pain; low grade fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NYSTAGMUS (Nystagmus), CHILLS (chills), MYALGIA (General body pain) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (stroke 5 years ago.) and COVID-19 in October 2020.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (General body pain), PYREXIA (low grade fever) and FATIGUE (Tiredness). On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness) and NYSTAGMUS (Nystagmus). On 06-Feb-2021, CHILLS (chills), MYALGIA (General body pain), PYREXIA (low grade fever) and FATIGUE (Tiredness) had resolved. At the time of the report, DIZZINESS (Dizziness) and NYSTAGMUS (Nystagmus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: fever (High) Low grade fever. On an unknown date, Computerised tomogram: negative (Negative) negative for recurrent stroke. On an unknown date, Magnetic resonance imaging: negative (Negative) negative for recurrent stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  Treatment information was unknown.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L029266, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
SHE STATES THAT SHE HAD MASSIVE SWELLING STARTING WITHIN 24 HOURS OF GETTING THE VACCINE. AND WAS SORE FOR 3 DAYS STRAIGHT. HER LEFT WRIST STARTED TO SWELL STARTING ON DAY 3. ON DAY 6 HER RIGHT WRIST, KNEES, ANKLES STARTED TO SWELL TO THE POINT SHE COULD NOT BEND. SHE ALSO DEVELOPED A RASH ON HER STOMACH.
Within 30 minutes of receiving the vaccine, I started getting a tingling sensation in my lips and cheeks. It lasted approximately one hour. Felt tired the rest of the day. I awoke at around 2am the next morning with diarrhea, extreme chills and bodyaches, and a headache. My right arm was very sore, but I expected that. I went back to bed and awoke for work at 6am. My injection site was red, puffy, and heat to the touch. My body ached as if I had a bad case of the flu. The next morning, I awoke with nausea and vomiting. It lasted until around 9am.  The aches have eased up, but I remain very tired and my injection site is still very red, puffy, and warm to the touch. It feels as if there are knots under the skin.
This spontaneous report as received from an unknown reporter from an immunization program refers to a patient of unknown age or gender. On an unknown date the patient was vaccinated with GARDASIL (dose and route not reported, lot # J003727, expired date 07-NOV-2015). It was reported that GARDASIL was improperly stored vaccine. Additional information is not expected.
Pt had dizziness, a syncopal event, and a SZ. Vitals: 98/66, 53, 12, 100% -- > 110/50, 75, 18 No hx of SZ disorder.  Symptoms self resolved.  Pt was observed for an additional 15mins.  Father instructed to notify the pt's pediatrician.  Pt stable and released from the vaccination site.
Patient received 1st dose of COVID-19 vaccination and immediately after became pale with upward eye deviation and loss of consciousness for approximately 10 seconds. Patient aroused and was noted by nurse to be nauseous, confused, sweating, and shivering. Patient's vitals were obtained and patient was given Gatorade and a snack. Patient was monitored for an additional 30 minutes and repeat vitals obtained. Patient was discharged in stable condition to mother.
Patient called pharmacy at 12:32 pm on 8/12/19 to report his injection reaction that he received last month. He said that his arm is still sore. He said at first the soreness lasted about 2-3 days then it stop. However when patient tried moving his arm, he can still feel the pain there. He said with his first dose that he received in April, he also have pain. He complained that it would hurt for over 1 week then it trends down. Patient said he went to see his doctor and they did x-ray to check up. Patient is still pending for his x-ray results w/ his next doctor appointment. I suggested patient to use some ice pack or take some NSAIDs to help with his pain until further follow up with his doctor.
This activated POTS in my system. I have been having  tachycardia with standing and minimal activity, dizziness, nausea, near syncope, intolerance to heat, fatigue ever since getting the vaccine. I am 38 years old and very healthy and active. I am a Registered Nurse and I work full time. I have been unable to live my normal life since getting the vaccine. I have missed work and I never miss work. I am unable to exercise! I am so fatigue I can barely make it through a whole day without a nap. I have lost 8lbs since getting the vaccine and I have a poor appetite.
After receiving her vaccine client stated that she has headache and dry throat.  Vital signs obtained by EMS BP 163/83, HR 79, O2 sat 96% Client states she feels better.  Client discharged home by EMS.
The patient received her first dose of the Pfizer vaccine at 12:02PM.   At 12:07, the RN checked on the patient to see how she was doing.  The patient complained of feeling dizzy with a slight headache.  She stated that she also felt nauseous.  The patient stated she did not have any food or drink all day prior to vaccination.  The treatment provided was giving the patient ice packs that she applied to the back of her neck and on her belly.  She was encourage to drink water and was given crackers and a protein bar.  Her BP was taken - 124/74, HR - 74.  The patient remained in the observation area until 12:40pm when she was feeling better and felt safe to drive home.
Severe full body itching; Immediate headache; Mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19266) via an unspecified route of administration in the left arm on 21Feb2021 at 12:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and thyroid removal. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ezetimibe; simvastatin (VYTORIN), dexlansoprazole (DEXILANT), levothyroxine sodium (UNITHROID) and azilsartan medoxomil; chlortalidone (EDARBYCLOR), all from unknown dates for unknown indications. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 21Feb2021, the patient experienced immediate headache, mild nausea and 4 days later on 25Feb2021, the patient experienced severe full body itching lasting over one week. It was severe enough to require medical intervention. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with prednisone of dose 40milligram for 5 days. The clinical outcome of the event severe full body itching was recovered on 04Mar2021 while the outcome of the events immediate headache and mild nausea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever, aches, nausea, chills, headache, pains, fainting
No additional adverse effects; A thin female patient was administered GARDASIL 9 in her buttock; This spontaneous report as received from a medical assistant via a company representative refers to a 23-year-old female patient. This case concerns 1 patient and 1 combination product. The patient was thin. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-MAR-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R002344, expiration date 16-NOV-2020 in her buttock instead of her arm or thigh(dose and route of administration were not reported) for prophylaxis. There was no adverse event reported. 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: R002344; expirationdate: 16-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recv vax 19JAN89 exp transient pain in both feet & lt wrist which did not r/t vax;Annual follow-up dated 11/27/00 provided no addtional data.
This spontaneous report as received from a nurse practitioner refers to a 16 year old female patient. The patient was vaccinated with, a 0.5 ml dose of VARIVAX (Merck) (Lot # not reported) on 09-JUL-1998. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on an unknown date, the patient went to the office with rash that was identified as shingles. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M007124, expiration date 05-OCT-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 33.4 degrees Fahrenheit for 60 hours and 35 minutes. There were no previous excursions. It was unsure if data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA008871.
Patient felt nauseous at first, so he tried to go to the bathroom, but then felt dizzy and lightheaded. Patient also was pale and had a very sweaty face.  When asked he said he was not diabetic. However, he did not eat since 11 o'clock.
Patient was unable to get out of bed the whole day and missed all three meals.  Patient had a fever of 100.6 and had generalized weakness and malaise.  Patient was also confused.  Patient was experiencing tachypnea and shallow breathing.
Swollen lymph nodes under both armpits; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 09Jan2021 at 10:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included ibuprofen and lorazepam. The patient previously took the first dose of BNT162B2 (Lot Number: EK5730) on 18Dec2020 at 06:30 PM (intramuscular in right arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 15Jan2021 at 12:00 AM, the patient experienced swollen lymph nodes under both armpits a week after administration of the vaccine. It was unknown if treatment was given for the adverse event. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the event.