chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via a social media 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. It was unknown if the patient had adverse events after primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported batch number: unknown, expiry: unknown) dose was not reported,1 total, administered on an unspecified date in 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 in mid JAN-2022, the patient experienced mild case of Covid-19 and symptoms mild, sort of like head cold, lost taste for couple of weeks (suspected covid-19 infection) which led to suspected clinical vaccination failure (dose number in series 2). The reporter stated "Had JJ and booster last year. Got mild case of covid mid Jan. this year. Symptoms mild, sort of like head cold, lost taste smell for couple of weeks. Happy for this protection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000216212.; Sender's Comments: V0: 20220213377-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient had an argument about some issues, so he got excited while he was waiting for observation in the post vaccination area. He had a complaint of feeling of light headed and anxious . No SOB, no chest pain, no headache, no dizziness, no visual problems. Vital signs: BP-142/90 HR-84 O2 Sat-99% He had good color, good O2 saturation and was alert and active, Oriented X3 in NAD. I told him to relax ,take deep breaths and was watching him for almost 30 minutes after he reported feeling light headed. Lungs was CTA and heart rate was normal. H/O HTN. Informed patient to relax gave him  post vaccination care instructions  and told him to  drink enough fluids and take Advil or Tylenol PRN for pain relief.
Indigestion; tired easily; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing). The patient was treated with CITRIC ACID, SODIUM BICARBONATE (ALKA-SELTZER HEARTBURN RELIEF) from 30-Mar-2021 to 03-Apr-2021 for Indigestion, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Indigestion), FATIGUE (tired easily) and DYSPNOEA (difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Alka-Seltzer or Alka-Seltzer plus Concomitants were not provided.
First Day: fatigue, headache, stomachache, inability to eat, lightheaded and week;  same symptoms for four hours on day 9 and again for four hours or so on day 11.  13 days later: May not be related, but thought should report: Broke out in itchy rash on feet, toes and finger tips, bright red, raised bumps. Itching was so intense I was unable to walk on day 14. Day 15 can walk but for short amounts of time. They also had a burning sensation. Bumps were about the size of a dime, and there were about 10 in total. Never had anything like it before. Have been applying hydrocortisone cream and taking benedryl.  Keeping socks and shoes off my feet.
Syncope immediately after 4th injection/vaccine, brief LOC; pallor, dizziness, nausea upon regaining consciousness, HR 72 BP 100/64, given Pedialyte and fully recovered w/in 20 minutes; pt did not eat in AM prior.
Narrative: Pt at DOM received 2nd dose of Covid-19 Moderna vaccine on 2/2/21. On 2/3/21. pt. reported to RN station with complaints of mental fogginess; denied lightheadedness, dizziness, SOB, or difficult breathing, Vital signs stable. Encouraged increased fluid intake and rest as needed.
Pt recv vax on 9/21/98; on same day pt exp red, hot, tender LA w/ pain, sore throat, nausea, vomiting; tx=cough syrup & antibiotic
Certain varicella diagnosis at Hospital. Symptoms: fever, generalized (face, scalp, trunk, extremities) macular papular rash, unknown number of lesions.
The evening of the day of vaccine, I began feeling unwell.  The middle of the night and all of the next 2 days I had severe Flu-like symptoms, fever (100*), achy, body felt hot all over, had sweats, really tired, all I could do was sleep.  Wife said I told her it felt like death!
Woke up the morning after my second vaccine dose with small red dots all over my upper back and chest, with a few also on my face.
syringe malfunction. Patient did not receive complete dose. Dose will be repeated in opposite arm
he had inadvertently had the MMR-varicella vaccine (MMRV, ProQuad); Contraindicated product administered;   This literature marketed report was received from the authors of a published literature article, and refers to a 4-year-old male patient. The patient's medical history included end-stage kidney disease (ESKD) secondary to kidney dysplasia, peritoneal dialysis and hemodialysis prior to transplant. His post-transplant course had been complicated by recurrent Clostridium difficile colitis, which had responded well to treatment. He had no history of rejection. He had demonstrated positive varicella, measles, mumps, and rubella IgG titers prior to his kidney transplant and after his primary vaccinations, which were given at one year of age, with a second dose 7 months later. Both were given while the patient was receiving maintenance dialysis.  On an unknown date, the child inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # and expiration date were not reported) at a routine well-child visit 16 months after receiving a living donor kidney transplant (vaccination error) which was contraindicated for children after solid organ transplantation. The patient was admitted with rash and documented disseminated varicella infection 5 weeks later. He was treated with intravenous acyclovir followed by oral therapy and recovered fully. The outcome of vaccination error and contraindicated product administered was unknown.
fuzzy headed - not 100% herself mentally, efer to as brain fog.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (fuzzy headed - not 100% herself mentally, efer to as brain fog.) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (fuzzy headed - not 100% herself mentally, efer to as brain fog.). At the time of the report, FEELING ABNORMAL (fuzzy headed - not 100% herself mentally, efer to as brain fog.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported Treatment information was not provided
MUSCLE ACHE; TIREDNESS; GENERALIZED SWELLING ALL OVER HIS BODY; DIZZINESS; COLD SWEAT; RAPID HEART BEAT; INJECTION SITE REDNESS (UPPER LEFT ARM); HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included similar allergic reaction to tetanus shot.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 16-MAR-2021 at upper left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced generalized swelling all over his body. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced cold sweat. On 16-MAR-2021, the subject experienced rapid heart beat. On 16-MAR-2021, the subject experienced injection site redness (upper left arm). On 16-MAR-2021, the subject experienced hives. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021, the subject experienced tiredness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized swelling all over his body, dizziness, cold sweat, rapid heart beat, injection site redness (upper left arm), and hives on 16-MAR-2021, and had not recovered from muscle ache, and tiredness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
I have developed a rash at injection site on my right arm. It is  swollen, itchy, raised and red.  Approximately 6 inch diameter area.
Imm. on 7-23. On 7-27 at night arm was hurting and had a red raised area. Since then has been spreading and swelling. Very sore.
The 11th of May, I had a scratchy throat and head congestion and headache. I am achy with a small fever. Today is my 6th day and it feels the worst. My dx was confirmed via home test.
Fever, screaming/crying for hours at a time, swelling on thigh, diarrhea. Adverse reactions lasted 3 days. We were told to give Tylenol and Ibuprofen, and had 2 follow up appointments in the office.
Patient received Pfizer vaccine dose 1, after receiving vaccine advised to wait in store for 15 minutes, mom said they were going to walk around. Mom came back to pharmacy saying patient fell. Dad had caught her in the isle, she bumped her head. Seemed like classic syncope reaction. Checked patients blood pressure, confirmed with dr that patients BP usually runs low.
10/10/2012 No reaction to eggs but rash reaction after flu 1-3 days for last 2 years.
Fever, muscle aches, muscle cramps, muscle fassiculations, lethargy, fever, chills, nausea, joint pain, weakness, rash, head/ nasal congestion.  Started around 7:00pm day of the vaccine( given at 8:00am). Unable to sleep at all that night due to concerns over breathing and due to maladies and general body pain. Rash erupted ~4:00am.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from an unknown date in May2023 to an unknown date in May2023. Clinical course: No adverse event experienced. Patient's physicians nurse was persuading her from not taking Paxlovid due to potential of rebound. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6 months after receiving the second dose of the Pfizer COVID19 shot I started getting irregular heart beats that are lasting 2 days at a at a time. After undergoing several tests I was diagnosed with AFIB. My cardiologist recommended Ablation to try an correct the AFIB. He performed the Ablation process on 12/13/2021. It is still to early to tell if the Ablation has worked. The reason I am reporting this is because my husband was diagnosed with AFIB on 12/10/2021. We both took the COVID 19 Pfizer vaccination on the same days/time. My opinion is the COVID 19 vaccine caused us to both have AFIB. We did tell our doctor our feelings on this.  He had no opinion.
LARGE RED AREA THAT IS HOT TO THE TOUCH AND SLIGHT LUMP 2 DAYS POST VACCINATION LOCATED ON LEFT FRONT THIGH.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patient was vaccinated with an improperly stored PNEUMOVAX 23 lot # M037533 with an expiration date of 17-MAY-2018 (dose and route of administration were not reported). No adverse effects were reported. Administered vaccine underwent the temperature excursion between 8 degrees Celsius to below 25 degrees Celsius (reported as ">8°C but <25°C") for 10 minutes which was detected by a data logger. There were no previous excursions reported. Additional information has been requested.
No additional AE reported; the vaccine was administered after expiration; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 12-OCT-2021 the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 ml; lot # R036912 was confirmed to be valid, expiration date 23-SEP-2021 (route of administration, anatomical location were not reported) for prophylaxis. No additional adverse effect was reported. The vaccine did not experience a temperature excursion.
5-10min p/vax devel pallor, SOB, diaphoresis, dec hearing & numbness;was placed trendelenberg position & given 02;rapidly improved;
itching around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not selected as per vaccination indication. The patient received his/her Shingrix injection and had severe itching around the injection site.  The reporter asked if it was okay to apply cortisone to the area?
This case was reported by a consumer and described the occurrence of swelling arm in a 66-year-old patient who received SHINGRIX for prophylaxis. On 10th November 2018, the patient received the 1st dose of SHINGRIX. On 11th November 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, unstable feeling and injection site itching. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty and unstable feeling were recovered/resolved and the outcome of the injection site itching was not recovered/not resolved. It was unknown if the reporter considered the swelling arm, extremities hot feeling of, fever, joint pain, walking difficulty, unstable feeling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient initially felt fine the day of vaccination. However, approximately 24 hours after vaccination, patient said arm become swollen and hot, developed low grade fever, and developed joint pain. Patient felt unsteady and had trouble walking, needing to hold onto surroundings for support. Patient did not seek treatment for symptoms but did stay home from work up to 12th November 2018 because of the symptoms. On 13th November 2018, the patient was still bothered by symptoms but felt well enough to return to work the following day. As of 28th November 2018 (reporting date), symptoms were fully resolved except for a remaining itchiness at the injection site.
Extremely swollen lymph nodes in armpit. Same arm where shot was given. Severe pain and tenderness on the armpit area.
57 year old was given RSV vaccine- not recommended for under 60 years old. No adverse events
Pt with known seizure disorder and cerebral palsy got vaccines 10/31/14. 11/3/14 had T-C seizure was admitted to hospital.
Extreme sore arm, bruising on arm,  Migraine,  chills, fatigue, body aches, nausea, pain in muscles, pain in joints, fever, lighted symptoms all lasted lasted 24 hours.
Patient previously concerned regarding reaction to pneumococcal vaccine.  Patient recieved first dose without incident.  About five minutes after receiving second dose of vaccine, patient complained of buring at injection site.  Assessment revealed a generalized rash in the upper arm.  Ice pack and benadryl provided to patient.  25 minute later, patient was feeling better and wanted to leave.  Review of site was improved but not resolved.
My arm started hurting and became exhausted. I tested positive for COVID-19. I had low grade fever. I starting to have headache. I had very love oxygen level. The ache and chills I feel. I didn't lose my taste or smell but did not want to eat.
per parent baby cried gasp stopped 5 sec repeated sx then was limp in dads arms not sure if lip blue. mom thought she passed out. Ok with ambulance crew Ok in ER except temp 38 crying vigorous. ?? fever pain or hyporesponsive episode.
might have been given intradermally around one-tenth of a milliliter, with no reported adverse event; Initial information was received on 22-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient).  This case involves 40 years old male patient who have been influenza quadrival a-b intradermal vaccine [Fluzone] taken intradermally around one-tenth of a milliliter with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient might have been received a dose around one-tenth of a milliliter suspect influenza quadrival A-B intradermal vaccine Solution for injection in pre-filled syringe (lot number: UT5570BA, strength, administrative site, expiration date: Unknown) via intradermal route for Immunization (immunisation) with no reported adverse event (incorrect dose administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event might have been given intradermally around one-tenth of a milliliter, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hospitalized with Hypoxia, shortness of breath, and black tarry stools. Covid positive PCR
Varicella - Information has been received from a registered nurse concerning a 4 year old female who on 09 May 2000 was vaccianted with one dose of varicella virus vaccine live.  On 10 May 2000 the patient experienced chickenpox.  The patient had blisters on her foot which lthe patient's mother had assumed were caused by shoes.  The patient had been exposed to chickenpox at school then days prior to vaccination.  Unspecified medical attention was sought.  Follow up was received which indicated this did not appear to be an adverse reaction to varicella virus vaccine live.
No Adverse Event occurred Patient was given a booster of Moderna 2.5ml, in which this lot number just expired. We contacted the manufacturer to determine stability of vaccine. Was informed: The vaccine administered on April 4 , 2022 from lot number 059H21A maintained the activity necessary to  protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Pityriasis rosea or pityriasis rosea-like eruptions. 28 weeks pregnant at onset. Due date is May 6, 2023. No pregnancy complications to date.
Breakthrough case admission after three vaccines: Moderna 7/21/21 Lot# 048C21A;  Moderna 8/01/21 Lot# 006D21A; Moderna 5/13/22 Lot# 049L21A.
Arthralgia w/joint swelling & fever begining 48-72 hrs p/vax;
Pt was in the ED the previous day and was positive for COVID.  Returned for admission due to altered mental status likely due to UTI.
Patient says the immunization was extremely painful, then within 3 hours, she had developed a quarter sized bruise and redness/light lacey rash about 2 inches wide going from the injection site to her elbow.  Today, which was 6 days later, the bruise and redness had not subsided,
Woke up crying and having urticaria around 4AM on the night after receiving of Hepatitis A vaccine, resolving with Benadryl.
Slight light headedness right after vaccine during 15 minutes wait period. Next day (the 5th) headache & extreme fatigue--felt "drugged" when I woke up. Evening of next day (5th) chills, continued fatigue. On the 6th still very tired, still some chills. On 7th still tired.