chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A female patient, whose concomitant medication and illness at the time of vaccination was not reported and allergies was reported as "none known", received a dose of FLUZONE vaccine (Lot number: Uh756AB, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that the patient received 0.5 ml dose of FLUZONE vaccine instead of age appropriate dose of 0.25 ml dose. The patient also experienced rash at injection site which resolved a "couple days" later on an unspecified date. Laboratory details and corrective treatment were not reported. On an unspecified date, patient outcome of the event was reported as recovered. Documents held by sender: none. Follow-up information received from a Healthcare professional on 31 Jan 2013. The patient had no illness at the time of vaccination. The case was medically confirmed.
1st dose: 31Jan2021 & 2nd dose: 11Feb2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 31Jan2021 & 2nd dose: 11Feb2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 041L20A and 030M20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Nausea and Heartburn, PREDNISONE for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID), ACETAZOLAMIDE, GABAPENTIN, BENZONATATE, CLONAZEPAM, FOLIC ACID, LEFLUNOMIDE, FAMOTIDINE (PEPCID AC), MILNACIPRAN HYDROCHLORIDE (SAVELLA), RITUXIMAB (RITUXAN), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and ZINC for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 31Jan2021 & 2nd dose: 11Feb2021). On 11-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 31Jan2021 & 2nd dose: 11Feb2021) had resolved.            No Treatment medication were reported.   This case was linked to MOD-2021-406584 (Patient Link).
rash throughout body. rash is extremely itchy, located on face, bilateral arms, front and back of torso, bilateral thighs and feet including the soles. rash is asymmetric, with well defined borders, pink-red, greater than 1 cm in width/length. rash started on hands, then appeared on my feet, then arms, then torso, then face. on going for more than 2 weeks.
The following day I felt exhausted and I couldn't get up. I am more tired than I have ever been. I went to the doctor last week and she ran tests and everything came back normal so we don't know what it could be. I had a similar reaction to my second shot but it was way worse with the booster. I am still tired until this day.
Extreme chills and shaking for several hours followed by three days of fatigue, body and headaches.
2 Hours after vaccine - spreading erythema from site across chest, face. No wheezing; Rx; Benadryl 25mg.
Abdominal pain; A spontaneous report was received from a physician on 20MAR2023 regarding a patient (patient 2) of unknown age and gender who experienced "abdominal pain" (PT: Abdominal pain) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that on an unknown date in 2023, "last month", the patient experienced abdominal pain with no other symptoms due to Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Based on the information available in the document three individual case safety reports 23000101 (patient 1), 23000102 (patient 2) and 23000103 (patient 3) were created and cross-linked into the database.  Company comment: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment. 23000103:Linked case (Patient 3) 23000101:Linked case (Patient 1)
had an immediate reaction of dizziness, lightheadedness and throat closing within 10 minutes of getting the Pfizer vaccination. Was given two zyrtec and that improved. She did have the symptoms for about an hour after and then was completely back to normal. States she has had a reaction to Miralax in the past and has not taken it since that reaction. States she is also allergic to Sulfa medications. Will refer to allergy
Patient is fully vaccinated. COVID + on 11/26/2021. Hospitalized from 11/26-12/02, 2021. Admission DX: fall, hypokalemia, hypomagnesaemia, facial contusion, COVID 19. 74-year-old female with significant known history for non-insulin dependent diabetes mellitus type 2/hypertension/COPD, who presented status post fall/syncope; she states that she went in to use the bathroom yesterday and had syncopal event, was on the floor for approximately 15 hours and was found by her son; at this point, she really denies any chest pain/shortness of breath/fevers or chills; no other complaints, denies any seizure-like activity or aura prior to the fall/syncope, denies any similar events. CT PE: negative for PE; trace BL pleural effusions. BL venous duplex negative for DVT.  Completed 4 days vancomycin.  Echo: EF=60%, Left ventricular diastolic function is abnormal. No indications for remdesivir at this point. Continue with pain management for left upper extremity injury; x-ray images have been negative for any fracture. Severe neutropenia with WBC of 2.5--3.5-3.9; monitored for any fevers. Discharged to home.
The patient was due for a bivalent Pfizer vaccine but was given a dose of the comirnaty vaccine (the primary series). No specific adverse events are known, however they were not given the correct vaccine.
Tongue felt funny with metallic taste in mouth. Then several hours later developed "bumps" inside mouth with swollen lymph node in jaw line. Self medicated with 50mg Benadryl.
Pt c/o blurring vision shortly after vaccination (30 minutes). Pt is 8 months pregnant also. Symptoms resolved on its own with no further problems.
Got a hot temperature; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Got a hot temperature) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Got a hot temperature). At the time of the report, BODY TEMPERATURE INCREASED (Got a hot temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 27-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Got a hot temperature) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Got a hot temperature). At the time of the report, BODY TEMPERATURE INCREASED (Got a hot temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
mom called morning of 22MAR96 stating pt rt arm was very swollen where had the shot;mom said it was a little swollen 21MAR96 but that it was the size of a baseball;pt did not have a temp;seen by FNP on 22MAR96&was told to put warm compress
Following the vaccine she was at the grocery store around 5:00 PM, her granddaughter asked her why her mask was red, and she noticed that she had a dripping nose bleed, and left and by the time she got home it was done.   Then, 2/21/21, she had another nose bleed, was at a pizza place in the car, and felt like she had to spit and it was blood and had a smaller nose bleed that did not last night.  The next one 2/26/21, was in the store and had a dripping nose bleed again, took a while to get it stopped, but by the time she left the store she was fine.  Then Saturday 2/27/21, she kept getting up in the night and had nose bleeds off and on, and managed through the night and the morning.  She went to the ER in the morning on 2/28/21, and her nose was packed with dissolving packing and gave her a prescription for 3 pills to take to prevent her from getting an infection.    During the night Sunday night she had a very bad night and went to the ER again on 3/1/21 at around 5:00 AM.  They then packed her nose with a balloon and then got the first prescription filled that she took.  On Wednesday she went back to the ER and they removed the balloon and now has been fine.  Her Coumadin has been up and down during this period of time.  Her INR reading was 4.5 on 2/28/21, and subsequently has gone down to where it is quite low.  No issues with the injection site.  She has never had nosebleeds prior to the vaccine.   In October/November she had a procedure she had a hernia repair and had a COVID test and since then she has had a tinge on tissue, but not a nose bleed.   These were mainly on the right until she had the profuse one, and then it was both nostrils as well as coming out of her mouth.   Has an appointment with the ENT on 3/18/21.
Dizzy, pale, clammy skin - decreased B/P - pt layed down - elevated feet - juice given - cold compress to head - B/P - HR monitored by MD and nurse.
Arm was really sore; This a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 04Feb2021 at 16:00 as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient's arm was really sore. When the shot went in, the patient did not feel the shot. She was doing fine. The outcome of event was unknown.  Information on Lot /Batch Number has been requested.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Hiccups; couldn't sleep all night; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (Hiccups) and INSOMNIA (couldn't sleep all night) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 007B21A and 032M20A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER (IM left deltoid) on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER. Concurrent medical conditions included Depression (started after father died Condition: No change reported) since 2001 and Migraine (condition: No change reported) since 2012. Concomitant products included SUMATRIPTAN, LEVOTHYROXINE, TOPIRAMATE (TOPAMAX), PROPRANOLOL, VENLAFAXINE, BACLOFEN, CLONAZEPAM (KLONOPIN), MELOXICAM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), IRON, MAGNESIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 09-May-2022, the patient experienced HICCUPS (Hiccups) and INSOMNIA (couldn't sleep all night). At the time of the report, HICCUPS (Hiccups) had not resolved and INSOMNIA (couldn't sleep all night) outcome was unknown.            The concomitant medications reported as Women's Multi-Vitamin.  The patient started experiencing hiccups with the "same pattern". The patient for treatment she tried a spoonful of peanut butter, but it didn't help. The patient also reported that she drank carbonated cherry water very fast, and the hiccups went away for about one hour and then returned. The patient couldn't sleep all night because of the ongoing hiccups.
temperature excursions; Patient was administered expired Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) 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.   No concomitant medication information was provided. No treatment medication were provided.
Large lump (2"x1") at injection site and bruising. Swelling and soreness/bruise lasted approximately 1 week. Then 9 days post vaccination glands on right side of neck have been extremely swollen and putting pressure on right ear and right sinus.
Contracted COVID 19 virus after being fully vaccinated. Had to get the antibiotic infusion.
WHILE GIVING VACCINE MOTHER LET GO OF PATIENTS ARM AND NEEDLE SCRATCHED PATIENTS LEG
Pt was brought down to the floor, his head made some movements 3-4 times like twitching. After abour 30-45 seconds, he responded when asked his name. Pulse 90/ min regular, Heart RRR, no murmurs. 911 called; they took him to ER for observation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 ( booster), single (Lot number: GH9694) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxilovid for covid-19 from 07Mar2023 to 12Mar2023.
Redness, swollen, itchiness, throbbing pain. All occurred where vaccine was injected (upper arm) and spread to under the armpit.
This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Apr2021 09:00 (at the age of 31-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization. The patient had no past drug event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 03Jun2021, the patient experienced Blood clot in right arm. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with prescription for Xarelto. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovered with lasting effects in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
achy/ sore arm; extremely tired for two weeks; headachy; arm hurts; arm is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), PERIPHERAL SWELLING (arm is still swollen), HEADACHE (headachy), MYALGIA (achy/ sore arm) and FATIGUE (extremely tired for two weeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 1989 and Diabetes since 2010. Concomitant products included ATENOLOL for Blood pressure high, GLIPIZIDE from 2020 to an unknown date for Diabetes, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Pre-diabetes, HYDROCHLOROTHIAZIDE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurts). 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is still swollen). On 05-May-2021, the patient experienced HEADACHE (headachy). On an unknown date, the patient experienced MYALGIA (achy/ sore arm) and FATIGUE (extremely tired for two weeks). At the time of the report, PAIN IN EXTREMITY (arm hurts), HEADACHE (headachy) and FATIGUE (extremely tired for two weeks) had resolved and PERIPHERAL SWELLING (arm is still swollen) and MYALGIA (achy/ sore arm) had not resolved.            No treatment medication were reported. Other concomitant products include HCL for High Blood Pressure since 1989. Dose 2 anatomical location is Mid bicept.Patient height is 68,weight is 205   This case was linked to MOD-2021-317897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received: Added, patient demographics, medical history, concomitant product indication. Updated outcome of event
anaphylactic reaction; lost consciousness; She did stop breathing and came to right away, she was just out; vomiting; difficulty breathing; Respiratory distress-specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FE3592), via an unspecified route of administration in left arm on 12Sep2021 in the afternoon (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included respiratory issues (already had respiratory issues before). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181), via an unspecified route of administration in right arm on 08Aug2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization and had a little bit of issues with the first one, but she already had respiratory issues before. The patient previously received H1N1 vaccine for Influenza immunization about 10 years ago and ended up in the ICU with neuropathy and myopathy. This was probably when it first came out about 10 years ago and she has complications due to that. The patient's concomitant medications were not reported. Patient received no other vaccines on the same day. The patient experienced anaphylactic reaction, lost consciousness, she did stop breathing and came to right away, she was just out, vomiting, difficulty breathing, respiratory distress-specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker on 12Sep2021. The events resulted in emergency room and physician office visit. It was reported that with second dose, within 15-20 minutes patient experienced vomiting and lost consciousness, difficulty breathing, and the ambulance was then called. She did stop breathing and came to right away, she was just out. She does remember being in the back of the ambulance and going to the hospital and they treated her with medication there to slow things down. Patient was there a couple of hours and discharged home since there was not anything more, they can do for her. She has not improved at all and was still being monitored and has a hard time with breathing and running out of breath a lot quicker. Still has breathing issues. The events required medical intervention. In the emergency room, they treated her to slow things down. Multiorgan involvement included respiratory: Respiratory distress; specifically had difficulty breathing; has a hard time with breathing and running out of breath a lot quicker. Potential anaphylactic reaction was reported to be recovering, but still has breathing issues. Patient was taking medications prior to the event being reported (details not reported). Patient still has not improved at all and is still being monitored. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
COVID-19 infection resulting in severe ARDS requiring intubation and ultimately death from COVID-19 infection.
the day of injection had usual vaso vagal response but very lightheaded. 4 hours after injection headache and backache began. took tylenol and they subsided. no rash at injection, but next day arm was sore but it passed.  11 days after injection, rash about 1.5 inches in diameter appeared at site. is warm to touch and tender to touch.
EXPIRED VACCINE IS ADMINISTERED DUE TO MISUNDERSTANDING WHEN STABLISHING THE EXPIRATION DATE IN THE REPORT.