chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute myopericarditis c pleuritic chest pain, abnl EKG 24 Feb; transferred to hospital 26 Feb; elevated cardiac enzymes, Normal echocardiogram and cardiac catheterization; oropharyngeal and anal swab for PCRs-enteroviruses and vaccinia-negative. Rx'd methylprednisolone, indomethacin, made uneventful recovery, discharged 1 Mar.
Injection given 8/24/2021. Sore at injection site 8/25-8/27/2021. Sore arm lessened but injection site remained very tender. 9/1/2021, injection site became red, swollen, itchy and warm to the touch.
This is a spontaneous report from a noncontactable consumer (patient). A 24-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 24, via an unspecified route of administration, on an unknown date, for COVID-19 immunisation. Medical history and concomitant medication not reported. The patient previously took the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization; and experienced sore arm. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On an unknown date, patient experienced extremely sore arm, heavy body, fatigue, chills and minor fever. The events did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. The outcome of extremely sore arm, fatigued, heavy body, chills and minor fever: unknown (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Expired 5 doses had been given; Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022 at 3:19 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In January 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-2022). On 16-Jan-2022 at 3:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point. BUD date reported as 15 Jan 2022.  On 31-Jan-2022, Moderna responded revaccination was not required.  Patient denied any adverse effects.  No treatment medications were reported.
I had hives all over my body for 4 days - and my pupils were dilated the afternoon the day after the injection. This is typical of allergic reaction I have to corn. Every single time it is in my body. Hives and a negative affect on the nervous system  As this is an allergic reaction, and it gets worse as I get older, this is a problem. Particularly when I am being injected with ethanol - a corn product
Mom noticed redness and swelling around injection site on left deltoid after school on 09/14/2017. Circular area of erythema to left lateral arm. Treatments - cephalexin 250 mg/5 mL; take 5 mL QID x 10 days.
Seizure whole body seized  Obsessive vomiting  Sweats Vertigo   no balance Migraine
The day of the first injection and the following day, I had a sore arm only.  On day 8 after the Moderna vaccine, my left arm at the site of injection started itching.  I also developed a bright red spot about 2 inches in diameter around the site of injections and it was warm to the touch.   My left eye was also itchy on the lower left lid, but I honestly don't know if that can be attributed to the vaccine or the fact that we were painting the inside of our house.  It might have been the paint.  On day 8, I did have a little bit of a rapid heartbeat, but noticed this before I noticed my arm itching and being red.  Not sure if that was related to reaction or not.
Information has been received from a licensed vocational nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, frequency and route unknown, lot # K000943, expiration date 24-SEP-2016; lot # L034381, expiration date 21-DEC-2016; lot # L018499, expiration date 25-FEB-2017). No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
getting COVID/Contracted COVID after vaccination; getting COVID/Contracted COVID after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (202041). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "getting COVID/Contracted COVID after vaccination".  Clinical course: Patient mentioned being fully vaccinated and boosted with Pfizer's COVID-19 vaccination and still getting COVID in Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had a fever day after shot was given. Also developed a rash on her knees and axilla. Went to MD on 8/9/2017 for evaluation.
Headache; dizziness; feeling shakiness of hands; This is a spontaneous report from a contactable Pharmacist. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El8982), via intramuscularly in left arm on 02Feb2021 at 10:00 AM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El1283), via intramuscularly in left arm on 12Jan2021 as 1st dose, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMIN) received within 2 weeks of vaccination. Patient had no allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 10:00 AM, patient experienced headache and dizziness reported immediately after vaccine. Patient also reported feeling shakiness of hands. No treatment was received for the adverse events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
patient was extremely allergic to the flu shot, nearly died from it; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who was extremely allergic to the flu shot, nearly died from it (allergy to vaccine), while he/she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. At the time of the event, the patient was extremely allergic to egg.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was extremely allergic to the flu shot, nearly died from it (allergy to vaccine) (Unknown latency) following the administration of INFLUENZA VACCINE.  The patient was reported that he/she did not know it was incubated in egg white which he/she was extremely allergic to.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
presents with a potential reaction to the COVID19 vaccine. Patient-reported a small hive on her left hand scattered erythema on the upper chest. She had no airway symptoms and mild tachycardia. She was given oral Zyrtec and monitored closely.  Patient with scant urticaria which resolved after oral Zyrtec and monitoring. Tachycardia resolved as well. The patient returned home at baseline.
Rash on the back; Joint ache; Muscle ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the back), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (Rash on the back), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache) and FATIGUE (Fatigue). At the time of the report, RASH (Rash on the back), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. No relevant concomitant medications were reported.   This case was linked to, INC.-MOD-2021-027707 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up received on 28-APR-2021and contains non significant information. Reporter details was updated. On 19-Jun-2021: follow-up received on 19-JUN-2021 and contains No new information; Sender's Comments: INC.-MOD-2021-027707:cross link.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). The patient was treated with OMALIZUMAB (XOLAIR) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) outcome was unknown.            No concomitant medication details was reported.
Administered after expiration date,vaccines were administered on 7DEC2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after expiration date,vaccines were administered on 7DEC2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after expiration date,vaccines were administered on 7DEC2021). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered after expiration date,vaccines were administered on 7DEC2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021. The vaccines were moved from the freezer to room temperature on the date of administration for all vaccines given.  Date(s) of administration for the vial(s) moved to refrigerator on October 5 , 2021. Date(s)of administration for the vial(s) moved to refrigerator on November 4, 2021.  No Concomitants and Treatment medication were reported.   This case was linked to MOD-2021-407151 (Patient Link).
Patient left a message at office of Dr. regarding a severe reaction to the flu vaccine he had on 12/12/12. Patient requested a VAERS report be filed but did not give any further information. I contacted the patient to get further information regarding the type of reaction he had but the patient refused to talk to RN or given any further information. Patient hung up the phone on RN. Form has been completed with the information I have in his chart. Dr. has been made aware of the incident and the patient's response.
Patient received the Pfizer vaccine on 5/18/2021.  When she presented for her second vaccine, she inadvertently received the Moderna vaccine.
Noticed excessive particulate matter in influenza vaccine pre-filled syringes which does not resuspend upon agitation of the syringe. Contacted the manufacturer on 10/23/2017 requesting information on integrity of product. Have been told they are looking into it, have offered to provide product for evaluation. Hospital MD and Nurse, after observing product, have suspended all vaccination with product awaiting quality review and communication from manufacturer.
Break through bleeding from 2 days after the vaccine until today (3 weeks plus); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 as dose 3 (booster), single (Lot number: P40173) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL [ASCORBIC ACID;FERROUS FUMARATE;FOLIC ACID;RETINOL]. Past drug history included: Ibuprofen, reaction(s): "Known allergies : Ibuprofen", notes: Known allergies : Ibuprofen. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FC3182, Location of injection: Arm Left), administration date: 24Sep2021, when the patient was 31-year-old, reaction(s): "Covid-19 immunization"; BNT162b2 (Dose Number: 1, Batch/Lot No: FC3182, Location of injection: Arm Left), administration date: 03Sep2021, when the patient was 31-year-old, reaction(s): "Covid-19 immunization". The following information was reported: HAEMORRHAGE (medically significant) with onset 25Jul2022, outcome "not recovered", described as "Break through bleeding from 2 days after the vaccine until today (3 weeks plus)". Therapeutic measures were not taken as a result of haemorrhage.  Clinical information: Other vaccine in two week was Prenatal and probiotic.  Follow-up attempts are completed. No further information is expected.
Case number PHEH2014US022018 is an initial spontaneous report received from a health care professional on 31 OCT 2014. This report refers to a 40 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412501) art a dose of 0.5 ml intramuscularly in the arm on 10 OCT 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
Eight days after I received the vaccination I noticed a quarter sized red mark on my right arm, at the injection site. The red area larger by the end of the day and part of the next day.  There was a small raised bump and it felt slightly warm to the touch.  Sunday evening it began to fade, and by Tuesday it was completely gone. It did not hurt or itch, it was not uncomfortable.
My son had a sports physical appointment on 08/02/21 where it was discovered that he had high blood pressure. I don?t recall him ever having a high reading before. The Dr. chopped it up to him being nervous about the visit, so I kind of brushed my worry off, and against my better judgement, and on the advice of my son?s Dr., got him his 2nd dose on 08/07/21.  Ever since then my son continues to have high blood pressure readings. He would always have good check ups, and nothing was ever brought up that was a concern. I?m not sure of the exact date, but a year or so prior, I got my son a full heart work up, because he was going to start playing high school sports, and I wanted to make sure he was in good heart health. I was told that everything was perfect, and that his heart looked beautiful!  He has a follow up appointment on January 6, 2022 with his primary care Dr.  I thought the high BP would have worn off by now, but it hasn?t. I will be demanding he be sent to a cardiologist for further evaluation.
patient felt nauseous before passing out- patient was given water, an ice pack and snack- was alert before EMS arrived
Approximately 2 hours after leaving the pharmacy, patient was home and throat became tickly and itching. Then it became itching extensively everywhere. Her throat was so itchy she started coughing. No rash, but there was a red welt on the arm where the vaccine was received. Patient chlorpheniramine 4mg to help and that helped side effects subside. Took Wednesday evening and Thursday as well. Itchy throat and insides ears still present but not severe.
Information has been received from a Certified Nurse ("CN") from a physician's office concerning a 23 year old female patient with asthma and cold who on 15-JAN-2008 was vaccinated IM at 01:30 PM into the left arm with a first dose of GARDASIL (Lot # 659653/1448U). Concomitant therapy included montelukast sodium. The physician's office reported that the patient called approximately one hour after the first injection to report that on 15-JAN-2008 at 02:35 PM she had fine red rash over face. she also reported red itching of her cheeks. She contacted the following day and informed that the stated symptoms resolved after approximately one hour. No further sequelae noted. Additional information is not expected.
EAR INFECTION; WALKING PNEUMONIA; This spontaneous case report (PVX2019-2529) was received from a nurse on 09-Oct-2019. It described a male consumer who developed walking pneumonia (PT: Atypical pneumonia) and an ear infection (PT: Ear infection), while being on oral Vivotif one dose every other day for typhoid fever.  Case report: The consumer took three doses of Vivotif as per schedule.  On an unknown date, he was diagnosed with walking pneumonia and an ear infection and it was getting worse. He was prescribed an antibiotic, but he did not started it.   Action taken with Vivotif with respect to reported events was unknown.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, the patient developed walking pneumonia and an ear infection after receiving Vivotif vaccine. Due to the fact that walking pneumonia and an ear infection are infectious in etiology the causality of the event was assessed as unlikely with Vivotif. ; Sender's Comments: Company's Comment: In this case, the patient developed walking pneumonia and an ear infection after receiving Vivotif vaccine. Due to the fact that walking pneumonia and an ear infection are infectious in etiology the causality of the event was assessed as unlikely with Vivotif.
Patient complained of severe left eye itching. He self treated with OTC Benadryl and said it subsided. Saw patient today and the itch has resolved.
Patient reported the second dose ofGARDASIL was due and she has not gotten it yet because she may have to pay out of pocket for it; Patient reported the second dose ofGARDASIL was due and she has not gotten it yet because she may have to pay out of pocket for it; Patient reported her physician recommended Gardasil 9 at the age of 50; This spontaneous report as received from a 50-year-old female pharmacist referring to herself. The patient's medical history included carcinoma in situ and papilloma viral infection. (HPV). Her concomitant medications and her drug reactions or allergies were not reported.       On 20-OCT-2019 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) (product administered to patient of inappropriate age).    In December 2019, the patient reported that she not gotten to vaccinated with second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) because she had to pay out of pocket for it (product dose omission and circumstance or information capable of leading to medication error).
1) Acute myopericarditis 8/8/21 - Had Pfizer COVID vaccine 8/6/21 -- > He started having CP 2 days later and found to have acute pericarditis - On 8/20/21 he started methylprednisaolone --- and then started prednisone 8/27/21 (taking 50 mg today).  - On 8/27/21 -  I told him we'd prefer to avoid using steroids given higher risk of recurrent pericarditis associated with steroid use.  I told him guidelines recommend a low dose slow taper of steroids if steroids are used.  I ran case by colleague who recommended stopping steroids quickly -- I discussed options of how to handle steroids with patient (stop now, finish short course he has, vs slow taper)- and he prefers to complete the short steroid course he has over the next couple of days.   If symptoms recur, I told him every effort should be made to avoid steroids  - Will continue Indomethacin 50 mg TID for 2 weeks and then lower dose to 25 mg TID - continue famotidine for GI protection   - Continue colchicine 0.6 mg BID for 3 months at least (longer if recurrent symptoms)  - Echo today 8/27/21 shows resolution of pericardial effusion seen at hospital - On 9/13/21 - Again emphasized importance of avoiding steroids (he took prednisone past couple of days).  Will have him continue indomethacin 25-50 TID for now and colchicine 0.6 BID and add Protonix for GI protection.   - On 9/28/21 - Still having break through pain -- > try to increase indomethecin to 50 mg TID and continue colchicine 0.6 BID and use Tramadol for breakthrough pain.  And will also refer to another doctor for possible immunosuppressant therapy.  - On 10/19/21 - He saw doctor-- no changes in meds.  He is doing better past couple of weeks.  Will continue colchicine another month - to get him 4 months of therapy.  Can wean off of indomethacin in a couple of weeks.  - Will check a cardiac MRI