chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 8/21/02 at 3am pt having seizure ~ 4mins in duration. Seen at ER for work-up. Pt was febrile to touch prior to sz.
Mom reported pt with fever starting 4-24-14 and started having spots. Pt to HU 4-28-14, fever lasted 1 d per mom with spots starting to spread. Pt with varicella-like rash with > 20 spots to back, chest, arms and legs, itching noted.
Had flu shot and 1st ever dose of Altace, Developed facial, oral and throat edema after about 45minutes. Denies fever, difficulty breathing or other problems, Started Benadryl on own, Notified my office 24 hours later reported swelling much improved and only c/o sore throat. Saw in office 10/2/02 with no residual swelling
Patient under age 18 inadvertently administered 1st dose of Moderna covid 19 vaccine.
administered an expired menactra to a patient with no reported adverse event; Initial information received on 28-Apr-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 18 years old female patient who was administered an expired Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA]to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection of lot U7273BB and expiry: 24-Apr-2023 via unknown route in unknown administration site for Immunization.  On an unknown date, the patient developed a non-serious event administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) Vaccine to a patient with no reported adverse event (expired product administered) (latency: 1 day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired menactra to a patient 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.
I received my first two Moderna doses in February 2021. My Moderna booster was 11/12/2021, as reported earlier on this form. Evening of 11/19 symptoms started: sore throat, muscle aches, runny nose, cough. Negative rapid COVID-19 test on Monday, 11/22.  Symptoms persisted, sought care from PCP on Wednesday, 11/24. Tested negative for COVID-19 (PCR test) and negative for strep. Cough, congestion, aches persisted. Had another PCR test on Sunday, 12/5, prior to traveling which came back positive for COVID-19.
I21.4 - NSTEMI (non-ST elevated myocardial infarction) CHEST PAIN
On April 8th my Lymph Nodes in my left arm pit and left side of my stomach started to hurt and swell. I went to the Dr. On 4/14/2021 because pain became worse. On 04/15 I got a rash with severe pain. I went to the ER and was diagnosed with  Shingles
This spontaneous report as received from a registered nurse refers to a 18 years old patient (gender unknown), who on 16-SEP-2013 was vaccinated with PROQUAD (lot number were not reported) 0.5 ml, subcutaneous (outside of prescribing information). Concomitant medications were not reported. No adverse effects reported. Nurse noted that patient was new to the country of the report. This case is linked to case 1309USA008084 via same reporter link. Additional information has been requested.
Within 4 hrs patient went to ER with swelling of throat and difficulty breathing ER treated with BENADRYL.
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. Since February 2018, the patients were vaccinated with an inappropriate storage dose of VARIVAX (strength, dose, route of administration were unknown) with lot # N030571 and expiration date of 31-OCT-2019 for prophylaxis, which were stored at a temperature range from -14 Celsius degrees (°C)  to -10°C for 15 hours. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
Asymmetrical swollen spot around injection site. Slightly red and very itchy. Approx. 2.5 in across so far.
After the Pfizer booster shot, I developed pain in my upper abdominal area.  I had extremely swollen lymph nodes in my right armpit area for 3 weeks.  I kept having this upper abdominal area pain for months afterwards  until one evening I developed severe abdominal pain.  I was rushed to the ER and diagonsed with a  right portal vein thrombosis.  I am now on Eliquis.
Patient rec'd  Pfizer COVID vaccine dose 1 on 2/26/21; dose 2 on 3/18/21. He began to have substernal chest pain on 3/20/21, took Tums with partial relief. He had additional episodes of chest pain over the next 2 days and came to the ED on 3/22/21. EKG was abnormal and troponin was elevated, so he was admitted with a diagnosis of myopericarditis .
2 hours after administration of vaccine developed fever up to 103 F. Was taken to hospital where fever was documented at 104.9 F and patient had febrile seizure, simple lasting 1 minute. Admitted for observation.
Case number PHEH2013US010470, is an initial spontaneous report received from a physician on 08 May 2013. This report refers to a 20-months old infant female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO, (batch number: not reported) intramuscularly on 08 May 2013. No adverse reaction was reported following this administration error.
Nausea and chills, then add general aches in rib cage, loose stools, by evening violent vomiting. I only vomited that night, but other symptoms remained until 9/14/2010 - I was unable to eat solids during this time, and unable to do much more than rest.
Shortness of breath; dizziness; numb tongue; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199), dose 1 via an unspecified route of administration in Right arm on 05Mar2021 at 01:00PM (at the age of 81 years) as single dose for COVID-19 immunization. The patient's medical history included known allergies to the Opioids. Concomitant medications taken within two weeks included, Gabapentin 300 mg, paracetamol (TYLENOL 500), Acetylsalicylic Acid (ASPIRIN) 81mg, all were received for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the suspect vaccine. She did not have Covid prior vaccination. On 05Mar2021 at 01:15 PM patient experienced, Shortness of breath, dizziness and numb tongue. Patient received treatment for the events. She had not been tested for covid post vaccination. Outcome of all the events were recovered.  No follow-up attempts are possible. No further information is expected.
Headache on crown, pain going down left arm to elbow. BP 160/102, pulse 84. Declined ED visit.
Swelling, redness and pain of left upper arm. Seen in office. Resolved on its own.
Rash all over the body, Temp 101. Pt given Benadryl Elixir 1/2 tsp Q hrs. Calamine Lotion apply QD to rash, Pedialyte, Tylenol supp. 60 mgs. DX allergic reaction to DTaP #4 vs. Urticaria.
More than 3 months away from first dose and now scheduling the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose). On 15-Jul-2021, PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose) had resolved.            No concomitant medications were provided. Treatment medications were unknown.
no adverse event; inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report has been received from a health care professional (also reported as other) referring to a patient of unknown gender and age. The patients' concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 16-JUN-2022, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (lot # T035379 with expiry date 31-MAY-2022) (strength, dose, and route of administration were not provided) for prophylaxis (expired product administered). There was no symptomatic adverse event reported and no additional adverse event details (no adverse event).
Initial unsolicited report received from a consumer on 22 March 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (INFLUENZA QUADRIVALENT) (batch number, expiry date, site of administration were not reported) on 29 October 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient had experienced hip pain, fever, chills, muscle weakness and general weakness. Laboratory investigation and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Site of injection was sore, which was expected. But shoulder joint, upper arm pain worsened and range of motion impaired. Pain has not lessened at all and at times is intense. Cannot pick up anything heavy with left hand and cannot sleep on left side. Pain sometimes radiates down my arm. Had full cardiac work up last year and all was normal. NSAIDs help but relief does not last long.  .
Information has been received from a 28 year old female patient with irregular heartbeat and no allergies who in June 2007, was vaccinated with the first dose of GARDASIL. In September 2007 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. In October 2007, the patient developed two ovarian cysts, vaginal discharge and vaginal bleeding after receiving GARDASIL. The patient's two ovarian cysts and vaginal discharge and vaginal bleeding persisted. She has not yet received the third dose. The patient sought unspecified medical attention and saw a physician. No further information is available.
Moderate edema 1 day post immunization. Recommended ice and ibuprofen/acetaminophen and monitor.
Cloggeal ear; flu like symptoms; Skin hot touch; feeling really hot,then really cold; Sweating; Eustachian nose inflammation; Exhausted; Pain all over body; Systemic Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Systemic Inflammation), EAR DISCOMFORT (Cloggeal ear), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (Skin hot touch) and FEELING OF BODY TEMPERATURE CHANGE (feeling really hot,then really cold) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting hypersensitivity, Drug allergy, Drug allergy, Drug allergy, Fibromyalgia, Complex regional pain syndrome and Pituitary tumor NOS. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for Gastroesophageal reflux disease, HYDROCODONE for Pain.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INFLAMMATION (Systemic Inflammation). On an unknown date, the patient experienced EAR DISCOMFORT (Cloggeal ear), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (Skin hot touch), FEELING OF BODY TEMPERATURE CHANGE (feeling really hot,then really cold), HYPERHIDROSIS (Sweating), NASAL INFLAMMATION (Eustachian nose inflammation), FATIGUE (Exhausted) and MYALGIA (Pain all over body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Systemic Inflammation) had resolved with sequelae and EAR DISCOMFORT (Cloggeal ear), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING HOT (Skin hot touch), FEELING OF BODY TEMPERATURE CHANGE (feeling really hot,then really cold), HYPERHIDROSIS (Sweating), NASAL INFLAMMATION (Eustachian nose inflammation), FATIGUE (Exhausted) and MYALGIA (Pain all over body) outcome was unknown. Not Provided      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.   Had done lots of blood work done. Blood work all normal   This case was linked to MOD-2021-031548 (Patient Link).
Late in the day on 8/31/22, the administration rescinded the order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the Federal Government to DHS staff and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this, and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Patient developed recurrent episodes of apnea, bradycardia, and desaturations in blood oxygenation.  He eventually had to be intubated and placed on a ventilator to control his apnea.  He currently remains on ventilator support.   He is an ex 27 week premie with chronic lung disease who had been weaned down to 0.2L of oxygen prior to his vaccinations, and then he developed the listed symptoms the next day.
A spontaneous report has been received from a Health Professional concerning a 1 year old, male patient, who had been receiving nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on an unknown date. On 13-NOV-2014, the patient was inadvertently administered FLUMIST Quadrivalent. The outcome of the event of inadvertently administered FLUMIST Quadrivalent to 7 children under 2 years of age is unknown. The report was considered to be non-serious by the reporter.
fine red rash on chest, look flushed;BP 144/98;weak & lightheaded;fine w/in the hr
Sudden increase of asthma symptoms that required use of rescue inhaler. Hives appeared on right hand and hive rash appeared on both cheeks of face. Headache. Headache stared midday and continue to increase in severity till onset of asthma symptoms and hives/rash that started about 06:00pm and lasted for about 3 hours. Took rescue inhaler and dose of Benadryl.
a few minutes after receiving the flu vaccine the patient complained of a change in vision, ringing in ears and passed out unconcious.  patient was clammy /sweaty.  supported patient to prevent injury and used ammonia inhalant to awaken patient.  checked blood pressure and obtained a normal reading.  had her breathe in thru nose and out thru mouth to stabalize breathing.  when she was able to sit independently gave some water to drink and had her sit until felt steady to stand and walk.
Patient received second dose of COVID Vaccine 1 week prior to recommended return date. Recommended return date was for 04/20/2021 and patient secured an earlier appointment on 04/13/2021 where they received the second COVID vaccination. Medication error. Patient did not have any adverse symptoms to receiving an early vaccination.
Shingles rash under left breast; topical anti-itch medications and covered with foam dressing to protect from bra;  still some redness remaining but all lesions healed.
Two weeks after my first vaccine I started with symptoms. Joint swelling in both hands/wrists and knees. Joint pain and aching with water retention in my body. 5 pound weight gain within 3 weeks. These symptoms lasted for 8-10 weeks and finally slowly subsided. I did complete both vaccine injections.  My doctor has recommended for me NOT to get a booster if it comes out later.
This spontaneous report was received from a consumer (patient's mother) regarding a 12 year old male patient. Information on patient's concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.On an unknown date in 2007 (reported as 12 years ago), the patient was vaccinated with M-M-R II for disease prevention and sterile diluent (dose number 1, dose, frequency, anatomical location, lot# and expiration date unknown) for prophylaxis. On the same day (reported as3 hours after onset of therapy), the patient experienced a high fever and a seizure episode. It was reported that the patient went back to the clinic where he received the vaccine to seek medical attention.The outcome of the events seizure and high fever was reported as recovered.The causal relationship of the events with M-M-R II and sterile diluent was unknown. Upon internal review, the event seizure was determined to be medically significant.
Pt received vaccination though she is under the recommended age. Pt was watched for 15 minutes and had no adverse reaction.
On or about the end of 07/2019 child was experiencing nonspecific swelling.  On or about 08/23/2019, mother noticed child's face was puffy, child was seen by this office and received the DTaP vaccine on 08/27/2019. On 08/30/2019 mother noticed child was bloated with swelling and contacted this office. Advice given over phone regarding symptoms.  On 09/03/2019, mother noticed child's scrotum was swollen. Swelling did not go down overnight so next day child was taken to ER. Child was transferred to Hospital and underwent extensive testing.  Testing results revealed serious condition and child was placed on high doses of diuretic and steroids. Child diagnosed with nephrotic syndrome.
Unexplained vaginal bleeding. I do not ever bleed. I?ve been in birth control since 17 and no bleeding past my 20s aside from postpartum month (yes I got pregnant on the very first ovulation after I came off birth control and went back on after my baby) nothing has changed in diet or stress as I?m chronically ill and am used to being home and mask wearing.
Patient reported symptoms similar to multiple sclerosis 2 days after vaccination administration. Patient is having lower extremity weakness and neurologic issues. Patient has been continually followed by neurology for an ongoing workup and is now on IVIG. All of patient symptoms started after COVID-19 booster.
Patient had a presyncopy Episode , diapheretic, flush, clammy, nausea, within 30 sec - 1min of administration
Receiving expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. The vial was initially stored in the refrigerator on 02 Feb 2022 and it didn't undergo any temperature excursions.
Pt reports red, hot, swollen arm at site of injection with general malaise and fever. Went to local ED 2 days after for IV to PO Antibx.
flu symptoms; unable to eat; diarrhea; coughed hard; vomiting; Pneumonia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia), INFLUENZA (flu symptoms), DECREASED APPETITE (unable to eat), DIARRHOEA (diarrhea), COUGH (coughed hard) and VOMITING (vomiting) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. In January 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and DIARRHOEA (diarrhea) (seriousness criterion hospitalization). January 2021, the patient experienced INFLUENZA (flu symptoms) (seriousness criterion hospitalization), DECREASED APPETITE (unable to eat) (seriousness criterion hospitalization), COUGH (coughed hard) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 4 days due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), INFLUENZA (flu symptoms), DECREASED APPETITE (unable to eat), DIARRHOEA (diarrhea), COUGH (coughed hard) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In Jan 2021 patient had experienced immune system shut down and had several infections and was in the hospital for four days with pneumonia. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medication was not  provided.  Concomitant product use was not provided by the reporter.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of RECOMBIVAX HB (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
I?m get my period between 27-31 days. Period came early and extraordinarily heavy with a lot of clots after first dose. (Which I don?t have a history of getting). Period has been abnormal ever since (coming late in June with normal flow, July and August  only slightly late (was not concerned ) with regular flow and September late with extraordinarily light flow. It may be helpful to know that after my second dose I also had the listed/expected side effects (fatigue, etc)