chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10-20-2020 - Child received HPV and MCV today.  During the 15 minute observation period, the child's mother came out stated that her son was dizzy and fainted. Translation required. Upon entering the room, he was coming to and his mom was helping him sit up.  The clinic Supervisor was paged, and arrived.  Per his mother, he did not eat or drink anything this morning; child states that he felt warm.  He was given a juice box, granola bar, and a cool pack for his neck.  The mother was advised that we would continue to monitor him for an additional 15-30 minutes depending on how he was feeling.  Mother acknowledged and agreed.  1050 Check-in:  Child was laying down on the exam table and stated that he was feeling better.  With translating, the child was asked and assisted in sitting up slowly.  He denied feeling dizzy, light headed or hot at this time.  He also denied having any vision changes.  We explained that we would continue to monitor him while sitting up and if he was able to tolerate this for 15 minutes, we would have him stand for awhile and see how he is doing.  Child refused juice / granola bar at this time.  1105 Check-in:  Child was laying back down on the exam table.  With translators help, mother explained that he started feeling dizzy again and laid back down.  His mother requested more juice for him, and translator provided her with another juice box and granola bar.  We explained that we would check back in on him shortly.  1120 check-in:  The patient was sitting up in a regular chair next to his mother.  He denied being dizzy or light headed.  Patient was asked to stand up slowly; he denies having any issues at this time.  He was then asked to walk around the room; no issues.  Patient and mother left without further incident
No adverse event, Vaccine used was after beyond use date. Spoke with Mom today 1-3-23 and explained that patient received an invalid dose and is not fully protected. She has agreed to have her daughter re-vaccinated.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.
Within 24 hours of second dose of GARDASIL - noted significant hives all over - mom gave PEPCID and BENADRYL to treat symptoms - after appearance of hives.
Patient with two Pfizer COVID vaccinations, not up to date with last vaccine on 08/18/21, who incidentally tested detected for COVID upon admission after a fall.  Patient asymptomatic for COVID throughout stay.  Provider discharge note below:  "Reason for Admission: 74-year-old woman with history of hypertension and depression here with humeral and fibular fractures and diffuse bruises after being found down at home.  she was found to have mild rhabdomyolysis, a comminuted left humeral neck and head fracture, and an oblique fracture of the distal fibula.   Brief Summary of Hospital Stay:  The patient had ORIF of her left ankle on 02/23/2022 with Orthopedic surgery who were consulted.  Per orthopedic surgery, management of the humeral head fracture to be conservative and nonsurgical.  Nonweightbearing left upper extremity with sling and nonweightbearing left lower extremity with boot per orthopedics. Will continue BID ASA until pt seen by ortho, and leave continuation of this therapy up to their expertise.    She was noted to have asymptomatic COVID infection while hospitalized and no treatment was required.    She had LFT elevations which have nearly normalized but should be followed to normalization."
4/10/21: Woke up and experienced severe vertigo when I tried to get up out of bed.  Slight nasea.
About 8:30 PM, the back of my neck started hurting which then spread across to each shoulder and down both arms and spine. By 8:50 I developed a headache, fever, shivers and dizziness. These lasted until 1 AM. I then slept until 8 AM but for the next whole day I was exhausted. After sleeping that night I was back to normal with the exception of the injection still being inflamed, swollen and hot and after 4 days and 12 hours, it still is very pink and warm to the touch.
Fever 103, 12 hours after MMR-V and KINRIX and vomiting.
Within minutes after vaccine administration the patient came to consult window experiencing flushing in the face and hands/fingers. She was not experiencing any itching or trouble breathing. Due to concerns of a histaminergic reaction to the vaccine we offered a dose of 25mg Diphenhydramine which she accepted. Symptoms improved while we were monitoring so patient left pharmacy  roughly 15-25 min after diphenhydramine was given. Follow up call at 2pm that day said symptoms continued to improve and patient went into work
Patient was given undiluted Pfizer age 5-11 vaccine. Pharmacist forgot to dilute the kid Pfizer with 1.3ml of diluent. Pharmacist withdrew 0.2 ml of undiluted vaccine.  This pharmacist then gave the vaccine to a second pharmacist who then administered to the child.
This was my second vaccine and my second adverse reaction.  An attack of vertigo came on suddenly, and I managed to get to a chair where I sat for over an hour not moving.  When my husband and son came home, they helped me walk to a couch and I was very weak and dizzy for the rest of the day. It took me a few days to feel back to normal.  I started taking physical therapy sessions a few weeks later which helped me become stronger and able to balance better, but did not eliminate the chronic dizziness.  In September, I had another severe attack of vertigo and was transported to the hospital.  I came home that night.  Dizziness continued and anxiety increased.  Another attack occurred on Thanksgiving which was the most severe.  I was very weak for several days.  In January I was diagnosed with PPPD andprescribed Venlafaxine for anxiety and dizziness.  The doctor said it would help alleviate the inflammation in the brain.  It has helped with the anxiety and dizziness, but I still experience the dizziness at times.  I have made progress, but am not cured.
Narrative: Patient received flu shot and Covid vaccine today. she instructed to sit in the monitor room to wait for 15 minutes. but the patient left early and waiting in front of clinic to see by Doctor. during that time she had palpitation and dizziness. (Privacy) find her and inform me I went there and the time I reach there she said she is fine her HR was 90 on her smart watch and she said she is hungry need some juice and crackers. she refused to go to ER in the first place. patient provided with water and then she said she is having blurred vision for a minute. CVC staff assisted her to the ER. Patient transported to ER by 2 RNS without any complications
The following day I had gotten tested (Rapid/PCR-based tests) and the results for both experiments came back positive.; The following day I had gotten tested (Rapid/PCR-based tests) and the results for both experiments came back positive.; body fatigue; muscle soreness; This is a spontaneous report from a contactable consumer reported for himself. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3247; Expiration date was not reported), via intramuscular, administered in Arm Left on 16Feb2021 11:15 (at the age of 26-years-old) as DOSE 2, SINGLE and first dose via intramuscular, administered in Arm Left on 26Jan2021 11:15 (Batch/Lot Number: EL3247; at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history, known allergies, concomitant or other medications the patient received within 2 weeks of vaccination, other vaccines within 4 weeks prior to the COVID vaccine included none. Patient did not have covid prior vaccination and had not been tested for covid post vaccination. The patient started to feel symptoms on 28Jul2021 17:00. Had fever, cough, body fatigue and muscle soreness that rapidly appeared. The following day (29Jul2021) patient had gotten tested (rapid/PCR-based tests) and the results for both experiments came back positive. The patient underwent lab tests and procedures which included two sars-cov-2 tests: positive on 29Jul2021. Event seriousness criteria included none and the event was not serious. No treatment was received. Conclusion stated that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective or preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the event covid-19, Fatigue and muscle pain was recovering and other event was unknown.
Information has been received from a physician concerning a 17-week-old male who in January 2007, was vaccinated PO with a second 2mL dose of Rotateq (Lot # "1116S"). Concomitant therapy that day included a dose of PEDIARIX, a dose of PREVNAR, and a dose of Hib conj vaccine. On 20-MAR-2007 the patient experienced diarrhea. Unspecified medical attention was sought. Subsequently, the patient recovered from diarrhea. Therapy with Rotateq was discontinued. No additional information was provided. There was no product quality complaint. Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED Doses of Modern ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71468) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 12:02 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 dosage form. On 26-Sep-2022 at 12:02 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Doses of Moderna  bivalent vaccine have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         Concomitant medications details were not reported by the reporter. Anatomical location for vaccine administration was reported as deltoid.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. On 07 Sep 2022 vials moved from freezer to refrigerator. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle. It was unknown patient had been ever diagnosed with or tested positive for COVID-19. Treatment details was not reported by the reporter
Increased heart rate and 'shaking' feeling inside was first symptom, then tingling/numbness/burning/pins and needles in hands and feet, pain in lower back/spine and feeling of heaviness in legs, difficulty walking, weakness in arms and legs, squeezing feeling around ribs, chest pressure/pain, increased heart rate when not at rest, fluctuating heart rate, pressure in neck and head, pins and needles feeling around body.  This all has progressed over a 5 week period.
Intense abdominal pain resulting in multiple doctor and hospital visits. Symptoms began 9 days after second dose. In 6 weeks, I was admitted to the hospital for 4 days. There is still no diagnosis for the chronic inflammation with ulcers in my large intestine. There is still intense pain throughout entire abdomen.
Pt woke up 13 days after her first vaccination with complete anosmia, cannot smell or taste food.  No other symptoms.  No other sick contacts at home, has been tested twice and both times negative for Covid.  Feels perfectly well other than this.  Anosmia is from both sides of nose, and very dense.
Right armpit nodules swollen  sharp aching pain striking and radiating in armpit towards right breast
Pain in lt upper arm. Also shooting pain down arm and fingers feel cold. Lt radial pulse strong and hand slightly cool to touch. States at this time (2 hrs after vaccine) symptoms starting to subside. Puncture site appears in appropriate area. Advised to use Tylenol/Ibuprofen and ice and return to EHS if symptoms worsen or persist. All symptoms now resolved.
DIZZINESS; JOINT PAIN; ARM SORENESS; CHILLS; MUSCLE PAIN; NAUSEA; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced arm soreness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced muscle pain. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, chills, muscle pain, and fever on 12-APR-2021, and fatigue, and headache on 13-APR-2021, was recovering from dizziness, and had not recovered from nausea, and arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210430703.
herpes zoster; postherpetic neuralgia; balance issues; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unspecified date, after receiving Defendants' zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff  suffered multiple outbreaks of a painful rash, herpes zoster, postherpetic neuralgia and balance issues. As a result of these symptoms, Plaintiff was seen and treated by medical providers in Oregon and is still under their care. As a direct and proximate result of defective zoster vaccine live(ZOSTAVAX)vaccine, Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiff also experience mental and emotional distress due to resulting physical imitations and seriousness of Plaintiff' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiff have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was reported as not recovered. The lawyer considered the reported events to be related to zoster vaccine live(ZOSTAVAX).
PT RECV DOSE 1ST PFIZER DOSE AT 1015AM,AT 1052AM PATIENT STATED THAT HE FELT THAT HIS TONGUE WAS SWELLING. PT STATED HE HAD TONGUE SWEELING WITH A FLU SHOT SEVERAL YEARS AGO. ASSESSED TONGUE, DID NOT NOTICE ANY SWELLING BUT TOOK PATIENT TO TRIAGE AREA TO ASSESS VITAL SIGNS. BP 138/103 SITTING ,134/90 LYING. PT STATED THIS WAS HIS NORMAL RANGE AS HE TAKES TOPROL XL 25MG PO DAILY. TEMP REMAINED 98.0 HR 64,RR 12, 96% ON RA. NO SHORTNESS OF BREATH,FLUSHING,DIAPHORESIS NOTED,NO DIFFICULTY SWALLOWING.  AT 1102 ADMIN 50MG BENADRYL PO. PATIENT WAITED ANOTHER 30 MINS, STATED TONGUE FELT NO WORSE BUT THAT HE NOTICED NO FURTHER CHANGES. ADVISED PT TO NOTIFY MD OF REACTION AND IF WORSENING OCCURS TO HEAD TO ER.
Back inflammation; Intense back pain; Shooting pain in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN, PAIN IN EXTREMITY (Shooting pain in legs and feet), and INFLAMMATION in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced BACK PAIN and PAIN IN EXTREMITY (Shooting pain in legs and feet). On 27-Mar-2021, the patient experienced INFLAMMATION. At the time of the report, BACK PAIN, PAIN IN EXTREMITY (Shooting pain in legs and feet), and INFLAMMATION outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details included Steroid injection 4mg steroids twice a day.
feeling like fainting/ dizziness; blood pressure went down; headache; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced headache and injection site pain. On 16th May 2019, the patient experienced dizziness and blood pressure decreased. On an unknown date, the outcome of the dizziness and blood pressure decreased were not recovered/not resolved and the outcome of the headache and injection site pain were recovered/resolved.   It was unknown if the reporter considered the dizziness, blood pressure decreased, headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's spouse. On the first day of receiving Shingrix, she experienced headache and soreness at the injection site. The next day after receiving Shingrix, the patient experienced dizziness and felt like fainting. Her blood pressure also went down to even 90/60 at some point. At the time of reporting, the patient still experienced the symptoms. It was reported that before receiving Shingrix and till the time of reporting, the patient received beta blocker and a blood pressure medication to reduce her blood pressure. The patient did not have high blood pressure but just received the medications to control blood pressure due to blockage. The reporter declined providing her information and provided only the patient's information.  The reporter declined to provide further information and closed the conversation.
Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included ADD. Concomitant products included BAMLANIVIMAB from 14-Jan-2021 to an unknown date for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form. On 24-Feb-2021, CHILLS (Chills) had resolved. On 25-Feb-2021, MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicine for ADD.
Gave 0.5ml for the 3rd dose instead of the 0.25ml.
Patient fainted then immediately regained consciousness, became pale and was sweating. Called 911. They examined the patient and offered to take him the emergency department. Patient refused. He was slowly improving. He waited a few hours then left the pharmacy on his own.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site rash and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site lump were unknown. It was unknown if the reporter considered the injection site erythema, injection site rash and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX intramuscularly on left arm and later a red baseball size spot developed at the injection site. On 15 February 2019, the patient reported that they developed little bumps or sores at the site. No additional details given.
Baby was uncomfortable. Took temp to find that it was 103.0  Even with Tylenol, it has been hard to bring down. Her nose also began running today.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 07-DEC-2012, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from batch/lot # 0610AE (dose and expiry date unknown) (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information ahs been requested.
Headache, soreness at site, dizziness. Dizziness begun within 10 mins, lasted a few days. Headache started about 4 h, lasted 1 wk.