chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine - Ran 103.8 fever first night, 100.0 fever, body aches, nausea second day, third day and beyond Covid arm, fever in injection site area and lymph node swelling/pain for several days, shortly after that Shingles appeared under my neck near the site of the swollen lymph nodes pain area. (Dr said mild case, thankfully, and was already inactive when I saw her on 4/28.)
Patient is a 15 year old female who has completed a 30-minute observation period with the following signs and symptoms of an adverse reaction: other - itching throat and tonsil swelling. Pfizer-BioNTech COVID-19 vaccine # 1 in series administered.  o Action(s) taken: Another drug administered - 25mg Benadryl cap  o Allergy to COVID-19 vaccine documented in Allergies activity: No, Referral entered for allergy provider o Patient advised to discuss second dose considerations with a clinician o Patient held for observation for 30 minutes after administration of 25mg  Benadryl capsule.  o Dr. from urgent care contacted and instructed to d/c patient when 30 minute waiting period is completed after benadryl was given and if patient is feeling better.  o Patient held for a total of 2 hours for observation and stated she was feeling better. o Patient left in stable condition with Mom     Vital Signs:   1430: BP: 115/71 P: 82 Map: 81 O2: 99% R:  18     1455: BP: 108/63 P: 77 Map: 78 O2: 100% R: 18     1545 BP: 119/62 P: 87 Map: 81 O2: 100% R: 20
Information has been received from a physician concerning a female nursing student in her early 20s with a negative varicella titer, who in second week of September 2004, was vaccinated with her first dose of varicella virus vaccine live (lot # 649262/0588P). On approximately 10/02/04, the patient developed chicken pox. Unspecified medical attention was sought, but the patient had not yet seen a doctor. At the time of this report, the outcome was unknown. Additional information has been requested.
I regularly swim a couple of hours 4 days a week. I have a water aerobic class in shallow end and deep-water class in deep end. I also have a running class in the water. I always recover within 30 seconds. On Tuesday October 11 following the flu vaccine I didn't feel in the pool. I was fatigued and my body ached. I didn't take the second class that day. Thursday, October 13, 2022, I went for the running class in the water. (13th) I missed the warm up for the class. I started swimming and did the first lap. At the end of the second lap, I was out of breath which was abnormal for me. I started swimming again but was having trouble catching my breath. I was near the deep end of the pool. My friend had to pull me to the end of the pool and could not catch my breath. From temple to temple, I had a headache which is normal sometimes when I swim. I was unable to swim any more laps. I just didn't feel right and my husband took me to the ER. I was triaged and did an EKG, chest x-ray and other tests. All tests were ok except my blood pressure. It was 220/73. My blood pressure is usually 118/59. I was discharged from ER. Over the next two days my blood pressure started to lower. I went out of town but continued to monitor my blood pressure and it has continued to stay within normal range. The ER told me to stay out of the water. I have other tests scheduled for November.
ADMINISTERED VAXCHORA THAT WAS EXPIRED; This spontaneous case report (PVX2019-2745) was received from a nurse on 04-Nov-2019. Additional information was received on 06-Nov-2019. It described an adult female consumer who was in her mid-forties "administered Vaxchora that was expired" (PT: Expired product administered). The consumer was receiving Vaxchora (lot number: 700015 and expiry date: 31-Oct-2019) for an unknown indication.  Case report: The consumer administered Vaxchora on 01-Nov-2019 that was expired on 31-Oct-2019. It was reported that the consumer also received Japanese Encephalitis vaccine (inactivated Japanese Encephalitis virus protein) and MMR booster (measles, mumps, and rubella viruses) an unknown date.  The consumer had no medical history.  Past vaccination included typhoid vaccine and cholera vaccine, administered when she was in another country 3 years ago. The consumer stated that she travelled often.  Action taken with Vaxchora with respect to reported event was not applicable.   The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "administered Vaxchora that was expired" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "administered Vaxchora that was expired" was considered as not applicable.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported. It was stated that the date of refrigeration was 19-08-2021
When the vaccine was administered, I felt a warm sensation move up my neck and then approx 3 hours later I started having left sided facial muscle twitching.  Then I started having muscle twitching all over my body.  To this day (3 weeks after vaccine) I am still having muscle twitching.  It has improved some.
A FEW MINUTES AFTER INJECTION PT BEGAN ACTING DIZZY AND COMPLAINING OF SOUNDS AND VISION LOSS. PT HAD INDICATED THAT SHE HAS A HISTORY OF PASSING OUT DURING VACCINATION AND BOYFRIEND ACCOMPANIED HER. PUT HEAD ON TABLET AND WAS SWEATING.  EMERGENCY SERVICES CALLED PER PT REQUEST. CHECKED VITAL AND LET HER GO HOME UNDER HER OWN POWER 30 MINUTES LATER
Pt recv vax on 2/24/99; 25 min post vax pt exp cough, hives on face &upper body, runny nose, watery eyes, crying; tx=Benadryl; dx=vax rxn or allergy to eggs &gelatins
Breakthrough case admission after 3 vaccines Pfizer 4/24/21 Lot# Ew0175 ; Pfizer 5/15/21 Lot# Ew0179;  Pfizer 12/19/21 Lot# FD0809
Shortness of breath and chest pain. I went to the ER on April 15, 2021. I went to the urgent care on April 20th because my shortness of breath and chest pain got worse. I have not been able to work since April 19th due to the shortness of breath and chest pain. I was diagnosed pericarditis
Developed a hard lump in her arm; Itchiness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (Developed a hard lump in her arm) and VACCINATION SITE PRURITUS (Itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Developed a hard lump in her arm) and VACCINATION SITE PRURITUS (Itchiness). At the time of the report, VACCINATION SITE MASS (Developed a hard lump in her arm) and VACCINATION SITE PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up document received on 09/Jul/2021 and contains no new information.
8 hours after receiving the vaccine, Patient got up from couch, stepped forward and momentarily lost consciousness (fainted). She recovered right away. It took several moments to gather her wits and then was able to stand up. She did not seek treatment. She twisted her ankle, bruised ribs, and bruised right hand.  She did call primary care physician and is going to follow up with them.
a 57-year-old female patient received Daptacel instead of Adacel by a nurse/no AE; a 57-year-old female patient received Daptacel instead of Adacel by a nurse/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 57 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication.   On 30-Sep-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via intramuscular route in the right arm.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether patient experienced any delayed adverse reaction.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Mom states she noticed patient tilt forward while sitting on the exam table.  No LOC but did faint and dizzy.  Patient was laid down by MA. Patient was pale. He was oriented. Then able to sit up and take some sips of water.  He laid down again after about 5 min of sitting up .  about 10 min later, able to walk to waiting room where he sat for about 10 min. BP checks during this time showed improving systolic BP.  Patient was able to ambulate on his own.
This spontaneous report as received from a nurse practitioner student refers to a patient of unknown age. On 14-JAN-2014, the patient was inadvertently vaccinated with ROTATEQ dose 2 orally. On 17-JAN-2014, 3 days after receiving dose 2 of ROTATEQ series, the patient was vaccinated with the third dose of ROTATEQ orally. No adverse effect was reported. Additional information has been requested.
received the powder vial reconstituted with a non approved diluent; received the powder vial reconstituted with a non approved diluent; This case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Menveo where powder vial was reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
A sebaceous cyst on the left arm has become sore and sensitive to touch since the vaccination.
beeing Sick; Unable to stand; Shivers; Sweating; "Felt like dying"; "Felt like horrible case of flu"; Unable to walk; he had to miss a day of work due to symptoms.; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk, activities of daily living impaired and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness, difficulty in standing, shivers, sweating, feeling unwell, influenza-like symptoms, unable to walk and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix over a year ago and unable to remember the date when he got the first vaccination.  The patient had been sick, unable to stand, shivers, sweating, feeling like he was dying, feeling like he had a horrible case of the flu and being unable to walk and had to miss a day of work due to symptoms.  The reporter had questions about receiving the 2nd dose after the 6 month. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Provided him with CDC guidelines to receive 2nd dose as soon as possible. The reporter consented to follow up.
Pt fainted immediately after injection, regained consciousness after about 15 seconds.  Reported feeling uneasy and weak for 20-30 minutes following injection. Provided supportive care with water. Pt was able to leave on his own after about 45 minutes.
Narrative: Rash no lupus or thrombocytopenia flare up, ANA above 2,000 Pt is choosing not to get second dose
The first night, I had mild diarrhea and a fever.  The next day, I had mild soreness in my arm near the injection site, chest discomfort and gas, largely concentrated in my chest, on the same side as my heart.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/27/21pfizer,Lot#ER8732 2nd dose: 04/17/21 Pfizer,Lot# EWO167 Diagnosed covid positive:08/10/21 Symptom onset:08/08/21 Exposure: Symptoms:cough fatigue, headache, sore throat, muscle aches
Hematomas on my tongue.  I first started getting oral hematomas after 2003 subsequent to several vaccination and medical errors; for example, there were dosage errors in the Anthrax and Pneumovax vaccine administered to me. Also in 2003, I was given the wrong dosage for the malaria medication Lariam (once daily instead of once weekly). I also have photographs I took of my hematomas after the Moderna and J&J vaccines. Also, I had no outbreak of hematomas between 2016 and and my J&J vaccine in 2021 after I started supplementing with vitamin D3/K2. However, these hematomas came back after receiving the J&J vaccine, and also after getting the Moderna jab in December 2021.  I have not had a COVID vaccine since getting  the Moderna vaccine in December 2021. Additionally, the frequency of hematomas has gone down from twice a month since getting vaccinated, and the size of the blood blisters has likewise gone down.
This spontaneous report as received from a pharmacist refers to himself (male patient of unknown age). The patient current condition includes hypertension and arthritis (due to running). The patient is reported as non diabetic. On an unknown date in May or June of 2012, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included ibuprofen and antihypertensive agent. On an unknown date the patient developed shingles. On an unspecified date, the patient began to feel like he had mosquito bites on his back. He stated that the next day he had a rash on the side of his body, and the rash extended from his back to his armpit. Patient sought medical attention. The patient was treated with ZOVIRAX. No lab diagnostics were performed. He did notify his healthcare provider, who prescribed ZOVIRAX for him. The pharmacist declined receipt of VZVIP for two reasons: he is taking ZOVIRAX, and he does not want to involve his healthcare provider. He states that his condition of the shingles has improved drastically since he started using ZOVIRAX. The outcome of shingles was reported as recovering/resolving. Additional information has been requested.
Pt. received 2nd varicella within 24 hours a red welt developed at the injection site. Approximately 3 inch diameter red and raised.
Had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had side effects) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had side effects). At the time of the report, VACCINATION COMPLICATION (Had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD-2021-042112 (Patient Link).
SICK WITH SOME SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sick with some symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick with some symptoms was not reported. This report was non-serious.
Neck was in extreme pain on the side that received my shot on for a full week.  It spread into a headache after about a week for a day. I took Advil and Tylenol to help me sleep at night. Now it just feels like I slept on my neck wrong.
Flu vaccine was inadvertently administered to a one month old in place of Hep B vaccine.  Patient is doing well with no adverse effects at this time. Parent was informed.
HEADACHE AND CHILLS. TOOK MOTRIN 200 MG @ 12PM 1/13/2021 TYLENOL 500 MG @ 9PM 1/13/2021
Lymphadenopathy 48 hours later; Fever 24 hours later; Body aches 24 hours later; Malaise 24 hours later; The patient received third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 05Nov2021 at 13:15 (at the age of 38-years old) as a single dose for COVID-19 immunisation. The medical history included hypothyroidism and allergy to sulfur drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El8982) via an unspecified route of administration on 23Jan2021 at 12:00 (at the age of 37-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration on 13Feb2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 15:00, 24 hours later, the patient experienced fever, body aches and malaise. On 07Nov2021, 48 hours later, the patient experienced lymphadenopathy. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymphadenopathy, fever, body aches and malaise were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Patient came in the office requesting second dose of Pfizer, 5-11 monovalent to complete dose number 2 in his series. First monovalent Pfizer dose was administered on 08/02/22.  Due to medication administration error, patient received dose number one of Bivalent (+12 yo-adult) dose of 0.3 ml instead.  Patient is 5 years old and was due for his 2nd monovalent dose approved for his age, at the time of the visit.  There were NO side effects or adverse events at the time of administration . Patient has not reported any side effects or reactions at the time of this report. Follow up will continue with patient by Nurse Manager to determine any needs or reactions.   Medical Director obtaining data on the steps to follow regarding counseling the patient on status of COVID-19 vaccine series moving forward.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 031L20A maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Patient complains of hallucinations a few times throughout the day on the day after receiving vaccine. On the evening she received the vaccine, she experienced arm and shoulder pain and severe headache/pain above the eyes.
Has never had reaction to flu-injection 5 min. after mouth tingling -10 min. later shaky hot flash faint and flushing -BP 138/82 P88 O2 100%. Repts carry her own BENADRYL 25 mg as she often gets like this with different medications. Took 25mg ate lunch wanted 25mg more of BENADRYL -2 hrs later drove herself home. Called nursing supervisor feeling good.
In the beginning i was very tired and exhausted and dizzy. I was delusional the first day and very out of it on the second day, by the third or fourth day my arm stared to swell and I had a phone doctor visit the doctor prescribed doxycycline. my ears starting ringing really bad and my vision got weird. the top of my head was burning and had only a low grade fever. My hands and fingers are tingling. and My chest has been hurting. The pain in my hands and feet feel like nerve pain.