chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 24-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000862: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
About 5 minutes after the vaccine, patient complained of feeling loopy and a burning sensation in her chest that was going up to her throat. Patient then complained that she could feel her throat closing. Adminstered epipen x1. Patient says she is prone to anaphylactic reactions - so much so that her allergiest refused to keep seeing her. She carries around an epipen as well. Also gave her 4 benadryl, she requested 8 per her allergist - but did not feel comfortable. Refused 911 and an ambulance due to cost. Had her daughter take her home. Said she was feeling better and could feel everything relaxing. Called patient about 10 mins after she left - said her chest still felt tight but she was feeling better. She refuses to go to hospital again.
adult patient received childhood polio vaccination and childhood haemophilus type b vaccination, no AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves an adult patient who received a childhood dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE and a childhood dose of suspect POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer (lot number not reported) via unknown route at an unknown administration site for prophylactic vaccination (PT: Product administered to patient of inappropriate age).  Past vaccination and family history were not provided.  At the time of the event, the patient had ongoing cancer  Concomitant therapy included chemotherapy(for cancer)  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 23-MAY-2015, the patient was vaccinated with the first dose of a RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient received as the second dose a ENGERIX-B (lot # BT248 and expiration date 24-SEP-2015, dose and route were not reported) and PEDIARIX (dose, lot # expiration date and route were not reported) as the third dose on 21-SEP-2015. No concomitant medications were reported. No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complain was involved. At the time of the report, the outcome of interchange of vaccine products and the relatedness with RECOMBIVAX HB, ENGERIX-B and PEDIARIX were unknown. Additional information has been requested.
Pt states felt sore on date of vaccination (3/12/15), but became worse the next day, running a fever of 102, experiencing stiffness in her neck, developed a knot at injection site which bled after a shower, began experiencing generalized itching, blurred vision, and dizziness; denies any difficulty breathing or swallowing at any time; visited ER on 3/15/15; was treated with Benadryl 25mg and Ibuprofen 800mg; told to continue taking Benadryl 25-50 mg q 6 hrs until S/Sx have been relieved x 24 hrs; pt states she is feeling much better today except for some continued itching on her right hand and the presence of the knot at the injection site.
A legal complaint was received from an attorney alleging that a male child received a series of Hib-Titer and Tri-Immunol vaccines was well as a dose of hepatitis B vaccine during the time period 4/20/94 through 9/98. According to the legal complaint, the child now suffers and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. The events were considered medically important. (OMIC)
received a third dose although she was not immunocompromised; normal side effects; diarrhea; fatigued; nauseas; vomiting; fever; muscle ache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included LOSARTAN, Lexopril, bisoprolol/HCTZ and vitamin D.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever), MYALGIA (muscle ache), OFF LABEL USE (received a third dose although she was not immunocompromised) and VACCINATION COMPLICATION (normal side effects). At the time of the report, DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown, OFF LABEL USE (received a third dose although she was not immunocompromised) had resolved and VACCINATION COMPLICATION (normal side effects) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.   This case was linked to MOD-2021-335664, MOD-2021-335665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Significant follow up received at 1-OCT-2021 :Narrative concomitant medications, event updated.
Heart ?flutters? March 10 around 7 :15 pm.  March 11, these continued.  Blood Pressure.  156/102.  8:50 am. Took daily meds as listed.  Appointment with Cardiologist at 10:45 am.  echocardiogram was normal  and blood pressure normal. 117/76 at 9:50 am.   Flutters continues at home.  Rested and drank water.
I was contacted by physician assistant who informed us that patient was at HCF being treated for clotting believed to be secondary to having received the Janssen Covid19 vaccination. He said that she was diagnosed as having a focal dural venous thrombosis in the superior sagittal sinus and was being treated with Eliquis. He requested that we report this event to VAERS.
Thrush, dry mouth, cheilitis.  Continuous since first 2 shots. Bleeding by retina, multiple large floaters. After booster: red arm, itching, swelling.  ALL AFTER GETTING THE SHOTS.  NEVER HAD ANY OF THIS PREVIOUS.
Information has been received from a 62 year old female patient with medical history of breast surgery and sulfonamide and codeine allergy who on 25-MAR-2011 was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: LEXAPRO, simvastatin (manufacturer unknown) and EVISTA. On 27-MAR-2011 the patient experienced a rash two days after vaccination. She said the swelling had progressively gotten worse since the day of the injection on 25-MAR-2011. The patient had lab tests as "annual check-ups" without result reported. The patient did not seek medical attention. At the time of report the patient's status was not recovered. Follow up information was received from the registered pharmacist concerning the 62 year old female patient who on 25-MAR-2011 was vaccinated suncutaneously with a 0.5 ml dose of ZOSTAVAX (Merck) in the pharmacy where the pharmacist worked. The pharmacist was requesting information regarding the VZVIP program. He was made aware of our program when reporting the case to the agency. She reported that she experienced a red, itchy hot rash after being vaccinated with vaccinated ZOSTAVAX (Merck). On 01-APR-2011 the pharmacist reported that the patient came back into the pharmacy and he was able to look at her rash. The rash was red, warm and there was a firm mass at the injection site. She was treated with BENADRYL and "declomethasone" and was experiencing relief. Additional information is not expected. This is one of several reports from the same source.
Hyperglycemia & ketoacidosis that lead to insulin resistance and type 1 diabetes.
had the flu shot but it didn't keep me from getting this lousy flu that's going around; Initial information received on 25-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via Social Media page.  This case involves adult patient of unknown age and gender who had influenza vaccine but it didn't keep patient from getting this lousy flu that's going around.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, route, administration site, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient had the flu shot but it didn't keep patient from getting this lousy flu that's going around (influenza) (unknown latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Chills, beginning at 9 PM and ending at 12 AM, not treated with medicine but went away after lying under a thick blanket for a few hours  Pounding headache, beginning at 12 AM and ending sometime after 4:30 AM, ibuprofen was taken at 4:30 AM and the headache was gone upon waking up the next morning  Nausea, beginning at 11 PM and ending at 4:30 AM, very minimal at first but became severe around 4:30 AM, went away after throwing up once  Vomiting, 4:30 AM, very minimal and only happened once  Insomnia, 9 PM to 4:30 PM, may have been a result of the pounding headache, went away shortly after taking ibuprofen
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029220A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021 at 7:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details were not provided  .
"ARM JUST ABOVE MY ELBOW WAS EXTREMELY SORE AND HURTING. LATER THAT NIGHT MY ENTIRE ARM HURT SO BAD I FELT IT SHOULD HAVE BEEN IN A SLING. TOOK ADVIL, ALEVE, CELEBREX DR VISIT SEVERAL WEEKS LATER. REFERRED TO ORTHOPEDIC SPECIALIST. WENT OCTOBER 12TH RECEIVED CORTISONE SHOT. PAIN WENT AWAY AND CAME BACK. ANOTHER APPOINTMENT WITH ORTHOPEDIC SPECIALIST NOVEMBER 2
Erthema multiforme-minor  09/18/2002 to 09/20/2002
Lot of allergy; Itching on her eyes; Face was flushed, it looked red; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 09Mar2021 (batch/lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included COVID from Apr2020 (had COVID before the vaccine), high blood pressure, cholesterol (abnormal), diabetes, and circulatory problems. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 in the morning of 09Mar2021. She was monitored for half an hour and she was fine. An hour later, the patient started feeling itching on her eyes, and later that evening, her face was flushed, it looked red like she had "a lot of allergy". The patient went to the hospital and she received 3 medicines for 4 days. The patient still had some flush. The doctor told the patient she cannot get the second dose. She had COVID in April before the vaccine. The patient wanted to know if she had antibodies left. Besides, she has high blood pressure, cholesterol, diabetes, and circulatory problems. The patient needed to travel and therefore needs the 2 doses, but if she can't get the second, she wondered what will be written on her vaccination card. The second dose was scheduled for 30Mar2021. The outcome of the event flushed face was not recovered while the outcome of the remaining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Very large red indurated area 7.5 x 10.5 cm painful, itchy around vaccine site. Rx with Benadryl and ice packs.
husband reporting that the day following pt having her first covid vaccine when she woke up she had an episode of dizziness, syncope, and falling.   had a few seconds of loss of consciousness after using the bathroom and felt better afterwards.
Got the booster vaccine on December 17, I had side effects for 4 days (body ache, fatigue, arm pain), on December 27 I began to feel a sore throat, fatigue and body ache, I took acetaminophen. On December 30 I did a rapid test at home, I tested positive for COVID. I started to get a headache, shortness of breath, chest pain, dry cough, body aches, and tiredness. I got tested again on January 3 (my doctor asked for it) this time it was a PCR test and I tested positive. The symptoms I have now are chest pain, joint pain, and tiredness. My doctor prescribed an Albuterol, Acetaminophen, and Benzonatate inhaler. I have used the inhaler for 3 days and it has helped a little
pt recv vax;c/o tongue feeling funny,face feeling warm,shaking of rt hand & uncomfortable feeling in rt leg;c/o dizziness;BP was nl;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Oct2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: The patient was symptomatic 19Oct and tested positive 20Oct2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Drug ineffective and COVID-19 cannot be ruled out
This spontaneous report was received from a physician's assistant via company representative and refers to a 16 year old female patient. Patient had no pertinent medical history, allergies or drug reaction. Concomitant medication and current conditions were not reported. On an unspecified date in 2007 ( reported as "when they were 4 year old"), the patient was vaccinated with VARIVAX  2 doses (frequency, strength, route of administration, Lot # and expiration date were not reported) (It could not be confirm if the doses were given together or separately) for prophylaxis. On an unspecified date in January 2019, the patient went to an unspecified emergency room and two days later on  04-JAN-2019 (reported as a "month ago") , the patient was seen by the physician's assistant and  diagnosed withchickenpox (Varicella), on the same date, she visited the emergency room and was admitted to the hospital for 2 days. The patient received treatment for the event and also was reported that an "Assisting a pustules" was performed  , however, the results were nor provided. The patient was recovered on an unspecified date in 2019. The reported did assessed the relation causality between Varicella and VARIVAX.
Patient admitted to hospital after 6 days worsening of shortness of breath after testing positive for Covid.
Allergic reaction: swollen lips and tip of tongue.  *Swollen veins in arms, hands, chest, and feet progressively getting worse as of 9 days after vaccination
Fever, chills, headache, diarrhea.  Diarrhea progressivel worsened in the next 48 hours with blood and mucous present.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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 product use was not provided by the reporter. Treatment information was not provided.  This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Not Provided)  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow-up  were received on 24-MAY-2021 , HCP had stated that he have spoken to several people from Moderna who followed up. he was told this is not an expired vaccine use and it was viable.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Not Provided)  with no associated AEs.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/19/2022 HYPOXIA 1/15/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/19/2022 HYPOXIA 1/15/2022
After immunizations, developed fever > 101.1 degrees F, arm soreness, abdominal pain. Treated with ibuprofen, acetaminophen.
pt recv vax 25JUL95 & MAY97 pt exp chickenpox disease & was seen by MD 28MAy97;lab eval revealed positive varicella zoster;pt recovered;
Right Arm turned red underneath running up toward the lymph nodes in the arm pit. Arm was sore
Had all 3 shots at once......about 2 minutes in patient started saying how his right arm hurt....like he was flexing his muscles but he wasn't...... At 3 minutes he said he wasn't feeling good.....and at about the 5 minute mark he said he was feeling dizzy and he just passed out. I ran and got a nurse and they all rushed in..... Took his blood pressure which was elevated....and said it was more than likely his blood sugar(which they didn't check) and just being nervous about getting the shots in the first place. They gave him orange juice, some crackers, and a sicker. It all happened in a matter of seconds.....he passed out in seconds.....woke up in seconds....very scary.
Shortness of breath. Diagnosis: Reactive airway disease, secondary to a highly elevated Eosinophil lab test. Treatment: Montelukast P.O. and Asminex, a steroid inhaler, forever
SHE FELT BAD FOR A COUPLE OF DAYS, RUN DOWN AND TIRED, BUT THAT WAS EXPECTED.  ON SATURDAY SHE NOTICED A RASH ALL OVER TORSO, BOTTOM, AND LEGS.  IT IS ITCHY.  SHE USED CALAMINE AND ORAL BENADRYL.
8/9/21 pt admitted to hosp with AHRF secondary to COVID PNA; positive COVID test 8/9/21; treated with dexamethasone, O2 supplementation, remdesivir, zinc, Vitamins C/D; pt's condition worsened with no clinical improvement; O2 needs increased; DNR/DNI; transitioned to comfort measures; pt passed away in the hospital