chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6198), on 26Mar2021 as dose 2, single (Lot number: EP6955), on 18Oct2021 as dose 3 (booster), single (Lot number: FF2588) and on 11May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "crohns disease" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: HUMIRA; OMEPRAZOLE; ATORVASTATIN, stop date: 21Sep2022.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) positive, notes: started paxlovid 1st day of positive antigen test which was 1.5 days after symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 22Sep2022 to 26Sep2022.
I was diagnosed with cervical insufficiencies on November 14, 2022, and it was treated with Progesterone vaginal suppositories and a cerclage surgical procedure with bedrest for the remainder of the pregnancy. My due date is March 11, 2023. Due to my clinical details, I have a delivery date scheduled for February 25, 2022. The ultrasound was completed on November 14. They said the surgical procedure was successful, but I am still required to be on bedrest.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vials were stored at frozen storage at the time of the excursion. The Lot number which were expired are 065K21A and 045L21A. The vials reached a maximum temperature of 30 Fahrenheit Degrees and minimum of -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April 2022, both lasted less than 1 minute,  they were now stored in frozen condition and no vaccine state change was observed.  No treatment drug details was reported.   This case was linked to MOD-2022-591989 (Patient Link).
Patients wife, noticed a red and slightly swollen, slightly warm spot on Patients right arm this morning around 9am. located in the spot where he received his shot.   He did not complain of discomfort.  He did not not complain of being tired.   We do not know when it first appeared.  It was not there the first few days, then we quit checking.  As of now, 5pm, it seems less red than earlier today.
Information has been received from a physician concerning a 16 year old female patient who the last month, in approximately June 2009, was vaccinated with the second dose of GARDASIL (Lot number not reported) 0.5 mL. The last month, in approximately June 2009, the patient experienced syncope with chronic movements that lasted for about 2 minutes after getting the second dose of GARDASIL. Subsequently, the patient recovered. The patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse who stated that they could not pull the chart to provide event details. The Health Care Professional contacted during telephone follow-up could not supply the following information: (patient name, date of birth, dates of vaccination/therapy, date of event and recovery status. No further information is available at this time.  Additional information has been requested.
New onset bilateral tinnitus, severe headaches and joint pain.  3 weeks after the injection while the headaches had resolved, the joint pain and tinnitus were unchanged.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). On 13th December 2018, the patient received the 1st dose of SHINGRIX. On 13th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, upset stomach and tiredness. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the upset stomach and tiredness were unknown. It was unknown if the reporter considered the injection site pain, upset stomach and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. The age of patient was reported as 70 plus. A day before reporting, the patient received SHINGRIX on an unknown arm and experienced sore arm at injection site, some stomach upset and general tiredness which does not required medical attention. This case has been linked with case US2018GSK227321 (patient's husband).
Patient called the pharmacy the morning after her flu shot and said she can't lift her arm and it is beyond sore. No signs of redness or bruising reported.
Mild erythema at site of injection in less than 10 min after injection. Benadryl given in office and Mother of child to re dose after 6 hours.
flu vaccine was given SQ instead of IM. called mother on 1/21/20 and mother reported small lump. no fever/no problems.
10 days following this infant's shot, she had a mild rash on her chest, back and neck; fever- not monitored, sleeplessness, and irritability lasting 2 days.
Swollen arm; Swollen vagina with lesion that appear like herpes; Got pretty sick; Nausea; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes), ILLNESS (Got pretty sick), NAUSEA (Nausea) and VOMITING (Vomiting) in a 25-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 information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). 21-May-2021, the patient experienced VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes), ILLNESS (Got pretty sick), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. On 23-May-2021, PERIPHERAL SWELLING (Swollen arm), ILLNESS (Got pretty sick), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had resolved. At the time of the report, VULVOVAGINAL SWELLING (Swollen vagina with lesion that appear like herpes) outcome was unknown.            No concomitant product use was provided by the reporter.     This case was linked to MOD-2021-182771 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-jun-2021 contains No new information
Arm VERY sore and tender; Red mark several inches from injection site; Pt says raised and itchy and tender.
Fever 99.9 F, Body aches, headache, fatigue, slight throat soreness, and mild cough.  Treatment: Stayed home sick for 2 days and slept it off.
This spontaneous report was received from a supervisor, referring to a currently 5 year old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 21-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000684; US-009507513-1903USA000685.
Information has been received from a registered nurse concerning a 9 year old male who was vaccinated on 04/26/1996 with a dose of varicella virus vaccine live (Oka/Merck).  The patient was seen on 03/22/2004 with questionable chickenpox.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality compliant.  The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox breakthrough/shingles.  No further information is expected.
abnormal ease of bruising and bleeding when bumped or light cut.  Happened on my hand.
Red rash on arms and itchy. Headache and nausea reported.  Dismissed from ED with prescription for Prednisone.
Patient received first dose of Moderna vaccination and soon after felt tingling in left upper arm. Patient received medical attention and refused to go to hospital. Patient advised he felt better at the time of this report.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working with the Public Health on a compliance improvement plan and has been reinstated vaccination privileges.
Flu like symptoms; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
feeling nervous; shaky body; feet felt very hot; This is a spontaneous report from a contactable consumer, the patient, received from the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Jan2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021 (a week after vaccination), the patient experienced a shaky body, feeling nervous, and her feet felt very hot. The clinical outcome of a shaky body, feeling nervous, and her feet felt very hot was unknown.  Information about lot/batch number has been requested.
Arm was red following shot. On 1/5/21 the redness expanded down arm and became warm. Physician prescribed Keflex on 1/5. I had surgery for thyroidectomy on 1/6. On 1/8 the redness became worse - expanding with more warmth.  Healthcare provided suggested Benadryl. On 1/9 I also started application of triamcinolone topical cream.
Swollen wrist-arthritis like pain entire wrist. Arm elbow, (right hand) unable to use right hand and arm.
Patient felt hot, had nausea, and passed out transiently. She woke after approximately 2-3 seconds and felt well after lying down for 1-2 minutes.
Third Pfizer shot reaction for NINE days (3"diameter red spot, tiredness, chills, nausea, muscle pain, headache, stomach pain, brain fog, sore throat, coughing, back pain, left lymph node in left arm pit sore).  Previous Pfizer shots: first dose -no reaction, second dose - one day reaction.
Patient arrived at the pharmacy to receive a second dose of Moderna COVID19 vaccine and received a Pfizer dose instead. There has been no adverse event since receiving the vaccine, and the patient was okay when leaving the pharmacy after the required wait time (15-30 minutes).
received only diluent portion; received only diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 21st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 age at vaccination was not reported. The patient received only diluent portion of Menveo, without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked with case US2022040278, reported by same reporter for different patient.
Swelling of face and fingers. Redness to bilateral cheeks with noted mild puffiness. Benadryl 25mg PO given, another 25mg PO given 15 minutes later. Reported symptoms better. No swelling in face, decreased in hands 15 minutes after second dose of Benadryl.
Patient called on 4/2/2019 to report an adverse event that she thinks is related to her second SHINGRIX shot. Patient felt achy, arm hurt, and ear felt full of wax build up the next day after the shot. She called her MD, and he advised her to use DYMISTA. When patient called me, she was still having ear pressure and head hurts. She came in that afternoon to pick up a prednisone prescription that was sent in to her that same day (4/2). I told her we would follow up with her in a week to assess how patient is feeling. I also told patient I would report her symptoms to CDC for reference. On 4/8/2019, I called patient and left voice mail to follow up with her. Patient called back and indicated she is now on antiviral, steroid injection and fluid tablets. She was going to have an MRI and CT scan the same week. She still experiencing ringing in the ears. She feels better but not back to normal hearing.
Pt went to work after receiving the meningococcal vaccine and started getting dizzy and unsteady on feet. Also very tired. Went to the ER and saw Dr the following day. Asthenia.
Information has been received from a lawyer concerning a patient who on 12/14/2000 was vaccinated with a dose of varicella virus vaccine live. Eleven days after, on 12/25/200, the patient experienced seizures. No product quality complaint was involved. Upon internal review it has been determined that seizure is an other important medical event (OMIC). No additional information was available.
Elevated viral load; 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 VIRAL LOAD INCREASED (Elevated viral load) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VIRAL LOAD INCREASED (Elevated viral load). At the time of the report, VIRAL LOAD INCREASED (Elevated viral load) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient Six weeks after the second shot, patient vl is the highest since 1985. concomitant medications and treatment information was not provided by the reporter.
Mom stated that patient was given 4 month vaccines at another clinic. There is no documentation on registry or in patient chart of previous vaccines being given. At this time patient is not having any signs or symptoms of adverse reaction.
EE vaccinated 1/28/21 and 2/25/21. tested positive for COVID-19 10/20/21
Raised red bumps, very itchy.; Raised red bumps, very itchy.; This is a spontaneous report from a contactable consumer, the patient. This 60-year-old  non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: ER8727) on 27Mar2021 at 10:45 (at the age of 59-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: ER8731), both in the left arm via unspecified route as single doses for COVID-19 immunization. Patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. Patient reported hyper reaction to topical gel product (store brand) in May2021 and then hyper-reaction (same type) to facial after having same products used pre-vaccine (Aug2021). Raised red bumps, very itchy. First time all over right upper body back and front; second time on face (jawline to forehead hairline and across to before ears). The onset date of the events was reported as 11Aug2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment for events included prednisone oral/cream for first reaction; oral second reaction. The outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up (25Aug2021): Follow-up attempts are completed. No further information is expected.
First seizure occurred Friday 2/27/17 at 5:45 PM lasting 1.5 minutes, included body tensing up, eyes rolling back, foaming at the mouth. Immediately following the seizure, the patient babbled for 30 seconds and then her body went limp and she fell into a deep sleep. The patient was taken to the hospital, had bloodwork done and was discharged at 2:10am on 2/28/17. Second seizure occurred on 2/28/17 at 6:45 PM. Seizure lasted 1.5 minutes and included body tensing up and going rigid, eyes rolling to the back of the head and foaming at the mouth. Again, the patient babbled for 30 seconds and immediately fell into a deep sleep. The patient was taken to the hospital where bloodwork was performed, a VEEG (for 60 hours) and EKG, all came back with  normal results. Patient was discharged from the hospital on Tuesday 1/31/17 at 2 PM. Patient was taken back to the hospital on Thursday 2/2/17 for an MRI of the brain (without dye) and results came back normal.
Paperwork was incorrectly filled out saying the child was 12. After further investigation, the child turned out to only be 11.
Ever since second covid shot she has been feeling dizzy. Told her to visit with her doctor.
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose, frequency and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
10 hours after the vaccine, muscle pain at the vaccination site, 16 hours after the vaccine, fever and general discomfort, treated with acetaminophen. Today, April 25, the general discomfort has disappeared, but the pain persists in the place of the vaccine
The day I got the vaccine, about 2 hours later I was in severe pain. My pain medicine was not helping at all. I dealt with that for a few days. I had to go to the hospital and I had to get a couple of shots of morphine. I saw my pain management doctor. I was taking Tramadol at the time so he put me on Oxycodone. I had to go back to using my wheelchair and walker. I could not do anything I could do now. The pain was really bad. By the time I went to get the second shot on 04/15/2021 I even asked my pain management doctor about the effects of the vaccine in people with Guillain Barre but there was no information about that yet. He recommended to take the second vaccine. I started feeling better on June or July. Interestingly enough I got the booster 12/31/2021 and 3 days later I was diagnosed with Covid. It seem to lingered more. I thought it was never going to go away. I had to take antibiotics and an inhaler. The severe pain came back again. I could not figure out if it was from the Covid or the vaccine. Every time I had a vaccine something happened.  Between the time of the second vaccine and the time I started to feel better on June or July, I had to go to the hospital to have something additional for the pain. I started feeling better this week.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not provided.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experienced adverse event.