chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history and concurrent conditions were not informed. Concomitant therapies were not informed. On an unknown dates from 01-JUL-2016 through 02-OCT-2016, the patients were administered improperly stored doses of RECOMBIVAX HB lots # M039201 and M027339 with expiration dates 04-NOV-2018 and 31-MAY-2018 respectively, (dosages and therapy routes were not provided). (unknown dosage, lot # M013638 expiration date: 19-NOV-2018 and M017521 expiration date: 12-OCT-2018). No adverse effects were reported. No product quality complaint (PQC) was involved. The minimum temperature reported was of 0.09 Celsius. No previous temperature excursions or digital data logger. This is one of several reports from the same source. Additional information has been requested.
Suffering from Diverticulitis; Soreness for a day; Little fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIVERTICULITIS (Suffering from Diverticulitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Soreness for a day) and FATIGUE (Little fatigue). On 18-Apr-2021, the patient experienced DIVERTICULITIS (Suffering from Diverticulitis) (seriousness criterion medically significant). On 25-Mar-2021, PAIN (Soreness for a day) and FATIGUE (Little fatigue) had resolved. At the time of the report, DIVERTICULITIS (Suffering from Diverticulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient went to emergency.  Treatment for the event included IV ciprofloxacin and metronidazole.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Nurse injected second Pfizer COVID-19 vaccine into injection site in right deltoid and immediately there was swelling to the size of a 50 cent piece. Area was skin color, no redness or heat or rash. Medical director assessed patient and patient was observed for 15 minutes. Area of swelling remained the same size.
Patient began feeling facial swelling after 20 minutes and felt like something was in her throat. 6 days after injection, patient experienced redness and swelling and itchiness at injection site.
Patient c/o tightness is face and feeling lightheaded. Patient was instructed to take mask off. V/S assessed T97.7 P63 R20 BP118/83 SPO2 99% on room air. Skin is warm and dry to touch. Patient remains alert, verbal with clear speech. No change in LOC. Patient given ice pack to neck at this time. Encourage to take slow deep breaths, patient did comply. Patient stated, "I am feeling better already." Patient noted to ambulate to trash can without difficulty. Also noted to eat a snack and drink water without issues. Denies SOB. V/S reassessed BP115/86 T97.8 P67 R18 SPO2 97% on room air. Patient monitored x45minutes.
Pin-like pains all over body Burning under skin all over body Small pains all over body
Severe muscle spasms in both shoulders and lower back. Nerve pain and numbness in both arms and hands. Nerve pain in right leg and numbness in right foot. All areas affected lasted for one week. Afterwards,  conditions alternated areas until present day.
After receiving the second dose I still felt itchy, but this time the itching was a little stronger; After receiving the second dose I still felt itchy, but this time the itching was a little stronger; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 28Apr2021 as DOSE 2, SINGLE for covid-19 immunisation (at the age 56 years). Medical history included, limb operation from 22Apr2021 to an unknown date and hypersensitivity from 2021 to an unknown date. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced i still felt itchy, but this time the itching was a little stronger an unknown date in 2021. He received both doses of the Pfizer Covid 19 vaccine, on April 28th he received the second dose. After the first dose, almost at 3 weeks he began to feel mild itching between his fingers, between the joints. behind the ears, behind the head, on the feet and knees. Not everywhere at the same time. Before the second dose, on April 22nd I had surgery on one of the fingers in his left hand, at first he thought the anesthesia had caused him allergy. After receiving the second dose he still felt itchy, but this time the itching was a little stronger. Therapeutic measures were taken as a result of event included allergy medication. The patient went to the doctor, to the ER and they gave him allergy medication but it didn't work for him. He still had the itching and if he got hit anywhere on the body, instead of feeling pain, he felt itching. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a male who on approximately 14-MAR-2008 (reported as on an unspecified date about a week ago), inadvertently received a dose of VARIVAX (Merck) instead of zoster vaccine live (Merck) (MSD).  The patient had no adverse symptoms.  The pharmacist stated that the error was due to product confusion.  There was no product quality complaint.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 3-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-DEC-2022, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)  intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2023, administered intramuscularly for prophylaxis (strength was not provided). and with and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) orally, Lot# 1892784 with expiration date on 03-DEC-2023.  The administered doses of the vaccines experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009088:
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
Erythematous, warm, raised induration 3x4 inches at right anterolateral thigh.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-JUL-2016, the patient was vaccinated with an incorrectly stored dose of (Oka/Merck) VARIVAX lot # L042266 (dose and route of administration were not reported). Additional information has been requested.
Case number PHEH2016US028841, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to a 71 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscularly in left deltoid on 13 Sep 2016. The patient was vaccinated with FLUVIRIN that had experienced several temperature excursions prior to administration (minus 2.7C for 6 hours and 4 minutes minus 3.6C for 21 hours and 48 minutes minus 3.4C for 21 hours and 2 minutes minus 3.3C for 21 hours and 3 minutes minus 3.3C for 8 hours and 4 minutes 1.2C for 1 hour and 1 minute 1.7C for 1 hour and 5 minutes was not frozen). The nurse also stated that, the patient had been notified and would be revaccinated. No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
had a stroke and is now unable to take care of himself after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: CEREBROVASCULAR ACCIDENT (medically significant), described as "had a stroke and is now unable to take care of himself after receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diagnnosis: Bell's Palsy,  right ear ache, right peripheral facial palsy,  and corneal injury. March 29 to April first.  Treatment by Opthomologist: eye drops every hour and eye lubricant before bed.
Within 24 hours of receiving DTaP and IPV in left arm, the left deltoid became very swollen warm to touch and a rash appeared in the injection site area.Child was taken to Medical Center on Sunday where he was given prescription for Qdryl qid, Cephalexin qid and Tylenol prn.  Child was seen at Health Center on Monday for follow-up, where the doctor diagnosed it a reaction to DTaP and ordered DT for future diphtheria tetanus injections.
I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; I have been having frequent PVCs and some runs of SVT starting a week post my second dose of Pfizer. Some dizziness and shortness of breath.; This is a spontaneous report from a contactable Nurse (other hcp). A 33-years-old female patient received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: ER8279), via an unspecified route of administration, administered in Arm Left on 19Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6208) in left arm on 17Mar2021 (at the age of 33-years-old) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 25Apr2021, patient reported that she had been having frequent PVCs and some runs of SVT starting a week post her second dose of Pfizer. Some dizziness and shortness of breath. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event with Propranolol and further testing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
The patient requested a 3rd dose (0.5mL) of Moderna Covid-19 vaccine due to his immunocompromised status. When administering the vaccine to the patient, the vaccine began to leak from the connection between the needle and barrel. An unknown amount of vaccine was administered to the patient. The vaccine manufacturer (Moderna) and the patient's primary care physician were contacted to report the event and to inquire about how to proceed.
Bump at Tdap injection site on right arm, hot red circle about 3 inches around, lasted 3 days, then diarrhea, then sneezing and constant cough.
Fever of 103.5, fatigue, dizziness lasting 3-4 days.
Client called stating that on day 2 she developed a local reaction at injection site. (red, hot to touch). She also stated that she has three "bumps" on her left side. She stated that on day 3 she developed "2-3" more small raised bumps in a cluster on her leg and back. She denies any blister like appearance. She stated they itch a little. She stated she took benedryl and that helped the itching. She stated they have not gotten worse but have not gotten better. Client was instructed on "breakthrough" chickenpox post vaccination. Client was instructed to contact her PCP for any testing or diagnosis. client verbalized understanding.
On or around Sept 1, which was 8 or 9 days after the third vaccine, I became aware that my Right ear canal felt congested and clogged and it was getting noticeably worse each day, although there was no pain.  Ear wax oil/syringe treatment produced no results or change.   On 9/13 I saw an ARNP from my doctor's office because I was alarmed that my hearing was muffled by then.  She diagnosed congested ear tubes, and prescribed a 2-week course of Azelastine.  This produced no change at all, after a week of two sprays in both nostrils twice a day.  On 9/19 I followed online techniques to equalize pressure in the ear canals, which was effective.  I still feel congestion, but the hearing  in that ear has returned, and the feeling of constant extreme pressure has receded significantly.  My right eye has been tearing-up excessively since then, however.   NOTE:  my right sinuses have historically been prone to congestion when the left is clear.  In discussing different nasal spray solutions with the nurse, I recalled trying Flonase a few years ago at this same time of the year, probably for sinus congestion and tearing-up of the right eye.  The extreme ear canal congestion, discomfort, and loss of hearing was something new and alarming.
COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CKD (Chronic kidney disease) stage 3" (unspecified if ongoing); "Left bundle branch block" (unspecified if ongoing); "hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Penicillin, reaction(s): "Known allergies: penicillin". 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 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset Sep2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Sep2023 to 18Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308043 same patient, different drug/event;
Bad kidney pain on right side vomiting drained achy fever lasted 3 days and still doesn't feel great very sluggish and still some pain.
the patient experienced no symptoms; incorrect product storage; This spontaneous report was received from healthcare worker and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided.   On 14-MAY-2020, the patient was vaccinated with an improperly dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscular (dose and frequency not provided, lot # reported as R028658 is NOT valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiration date 27-JUL-2021). The patient did not experience any symptoms.   The dose administered had been improperly stored (product storage error) at a temperature of 37 Fahrenheit (F) degrees for 3 hours. No previous temperature of excursion was reported and there was a digital data logger involved.
Nausea, fatigue, dizziness, swelling of the area, redness , itchy, body aches, joint pain, abdominal pain
Chills, shaking, body aches about 12 hrs after shot.  Body aches 3 days total.  Injection site itchiness day after and continues.
Pt oculd not be awakened 30 minp/receiving DTP; Rec'd continuous verbal & tactile stimuli over a period of 45"; Finally cried spontaneously. Hospitalized for observation for 23 hrs because he turned red & coughed, pale & sweaty.
Sore left injection site arm after second dose; Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after second dose) and PYREXIA (Feeling feverish) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after second dose) and PYREXIA (Feeling feverish). The patient was treated with PARACETAMOL (ACETAMINOPHEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after second dose) and PYREXIA (Feeling feverish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-387737 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: follow-up contains no new information
This spontaneous report as received from a licensed practical nurse refers to a 55 year old female patient with allergies to erythromycin, sulfa, codeine, KEFLEX and CELEBREX and no pertinent medical history. Sometime within the last week (approximately between 15-JUL-2013 to 19-JUL-2013), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route were not reported) on the triceps area at a pharmacy. Same day of the vaccination, the patient developed redness, induration, and severe tenderness at the injection site. The patient sought medical attention by seeing her physician. No treatment was given. No lab diagnostic studies were performed. At the time of reporting, the patient was recovering. This is one of several reports from the same reporter. Additional information has been requested.
A few moments after receiving the vaccination, patient fainted and had some tremors afterwards. We picked her up off of the floor and placed her in a chair. She was pale and had some discoloration around her nose area. She was able to speak to us. She felt cold and was sweating at the same time. Her body temp was 97 degrees F. According to her mom, she's had a previous reaction similar to this but not to this extreme with the HPV shot. We called 911 to have her assessed by the paramedics
( Child had one dose of Dtap @ 3 months of age, today was 1st Pediarix) Mother returned with child to the clinic approximately 20 minutes of receiving vaccines for symptoms of full body rash and itching, no trouble breathing noted, patient alert and active. Administered 1 dose of Epipen Jr. 0.15 mg IM to left thigh @ 11:28 am. Lot #3GN002 exp. 7/2024. Patient tolerated well. Monitored patient for 35 minutes, vital signs normal and stable. Rash and itching completely resolved by 35 minutes. Child and Mother left clinic, advised to go to the ED if any new symptoms arise.
The evening of 9/21 I started experiencing sore arm, chills, achiness and fatigue. The following day I had a stomachache that continued thru Sunday morning. Visited urgent care and was prescribed a cocktail of a medication and MAALOX. I am feeling somewhat better now I have a follow up with my primary physician on 9/30/2022.
SAME DAY AS VACCINATION PATIENT EXPERIENCED DIZZINESS WHICH SHE STATES HAS CONTINUED UNTIL THE PRESENT TIME. 1 WEEK AFTER THE VACCINATION SHE EXPERIENCED 24 HOURS OF VOMITING WHICH RESOLVED AND WENT AWAY.
Patient received vaccine 4 month before 18th Birthday No adverse event reported F/u by Provider 3/23/21
Sore arm, spotting, irregular period and then after seven days extremely heavy  period. Leading to bad case of menorrhagia  bleeding for another week and a half. Caused me to be anemic. So now taking iron, colace, and possibly progesterone if it comes back.
I am immune compromised and contracted delta. I have been off work at home isolated. Fever, cough, headache, diarrhea, vomiting
PATIENT WAS NOT TRUTHFUL AND HAD US ADMINISTER A THIRD COVID VACCINE. PATIENT WAS LOST TO FOLLOW-UP AFTER MULTIPLE ATTEMPTS. UNKNOWN SYMPTOMS, SIGNS, AND TIME COURSE
Post-menopausal vaginal bleeding. I've also just thought of something else that may be connected, I collapsed in a faint and was unconcious for several seconds 0n 8/3/21. Was directed to Hospital by 911
1. COVID-19  2. Productive cough  3. Painful cough  4. Nasal congestion  5. Acute bronchitis, unspecified organism  6. Acute non-recurrent pansinusitis