chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Registered Nurse refers to an approximately 7 years old female (child) patient. The patient's medical history and concurrent conditions were not reported. On 18-DEC-2014, the patient was vaccinated with the first dose of VAQTA "Lot number K18181 has been verified to be an invalid lot number for VAQTA" and on 05-MAY-2015, the patient received the second dose of VAQTA, 0.5 ml, intramuscular in the right arm both doses (Inappropriate schedule of drug administration). The patient's concomitant therapies were not reported. No adverse effects were reported. Product quality complaints were not involved. Additional information is not expected since not permission to contact was given.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient received vaccine. directly after administration patients pupils were dilated, she was pale, and was not answering questions. Patient was placed on floor with legs elevated, we called 911. after a couple minutes patient said she felt fine, so we sat her up in chair and gave her glass of water, which she drank. Patient again reported feeling light headed and her pupils were dilated. medics took her the hospital
Vomiting every morning for weeks and consistent hiccups/reflux when there had been none.
tingling in the arm; achy; fullness in her throat; This case was reported by a physician via sales rep and described the occurrence of tingling of extremity in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   In November 2019, the patient received Bexsero and MENACTRA. In November 2019, less than a day after receiving Bexsero, the patient experienced tingling of extremity, pain and throat swelling. The patient was treated with steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the tingling of extremity, pain and throat swelling were unknown.   It was unknown if the reporter considered the tingling of extremity, pain and throat swelling to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and Menactra and within hours patient experienced tingling in the arm that Menactra was administered.  The patient was also achy and she had fullness in her throat.  The patient visited and was given a steroid pack.  The physician also tested the patient for mono.
2 lumps 4 inches under injection site lumps 4 inches apart on a diagonal  painful ~ aprox dime size with bruising
Sore arm at injection site. Muscle weakness for approximately 3 days, continually diminishing. Back to normal 72 hours later.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several report received from the same source. Additional information has been requested.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:MOD-2022-646512: Master case
On January 3, I developed severe pain behind my right scapula.  The pain lasted about a week.  I subsequently developed right triceps and wrist/finger weakness.  I sought care from my orthopedist, physical therapist, and eventually was referred to neurology.  Yesterday I received a diagnosis of Parsonage Turner syndrome which may have been caused by the vaccine.
Patient developed severe shoulder pain and stiffness less than 24 hours after the injection was administered.  Over the course of the next month she did not have resolution with conservative treatment and this resulted in her having to see her orthopedic doctor; she was started on NSAIDs physical therapy and was given cortisone injection of her shoulder at her first visit.  She is undergoing treatment at this time for the shoulder.
red area was 3 inches or more in diameter and very red, very puffy; getting a really red and really itchy area around the injection site; getting a really red and really itchy area around the injection site; stuffy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset Sep2023, outcome "recovered", described as "stuffy"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 30Sep2023, outcome "recovered" and all described as "getting a really red and really itchy area around the injection site"; VACCINATION SITE SWELLING (non-serious) with onset 01Oct2023, outcome "recovered", described as "red area was 3 inches or more in diameter and very red, very puffy ". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site swelling.  Additional information: On the morning of 29Sep2023, caller received the most recent Comirnaty 2023-2024 vaccine.  She has had 4 previous Pfizer covid vaccines without incident and didn't even get a sore arm. The day after receiving the 2023-2024 vaccine, she started getting a really red and really itchy area around the injection site. At the end of second day after receipt of the vaccine, the red area was 3 inches or more in diameter and very red, very puffy and itchy, but not hot. The area was dark red and almost bumpy. She tried to treat this reaction with cold compress, but it didn't help, She tried all kinds of oral antihistamines and also antihistamine creams and these didn't help. Approximately 7-8 days after receiving the vaccine the reaction was predominately resolved. She noticed that she had also been stuffy for the duration of this reaction and the stuffiness went away about day 8 when the reaction had also resolved. She is allergic to shellfish. She tried to treat the reaction with cold compresses but it didn't work, so on the 4th day she tried warm compresses twice per day and they made a little bit of difference. She wants to know if this new vaccine is different than the previous vaccines as she had no problems with the previous Pfizer covid vaccines.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Second Moderna vaccine was administered too soon. The child was due for the second Moderna vaccine on 11/18/2022. The child was accompanied by his mother. The mother was made aware at the time of visit. The child was assessed and no adverse reactions were noted. An appointment for the 2nd Moderna vaccine was scheduled for 12/03/2022. The director of the pediatrics department was notified on 11/07/22 and instructed the nurse to contact the patient. The patient was contacted and as per the mother's report, the child was stable, no adverse reactions or side effects reported by the mother.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 46-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 26-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR061580:same reporter US-GSK-US2023AMR062067:same reporter US-GSK-US2023AMR061582:same reporter US-GSK-US2023AMR061583:same reporter US-GSK-US2023AMR061581:same reporter US-GSK-US2023AMR062059:same reporter US-GSK-US2023AMR062065:same reporter US-GSK-US2023AMR062063:same reporter US-GSK-US2023AMR063143:Same reporter US-GSK-US2023AMR063144:Same reporter US-GSK-US2023AMR063145:Same reporter US-GSK-US2023AMR063146:Same reporter US-GSK-US2023AMR063148:Same reporter US-GSK-US2023AMR063147:Same reporter US-GSK-US2023AMR063143:same reporter US-GSK-US2023AMR063144:Same reporter US-GSK-US2023AMR063145:Same reporter US-GSK-US2023AMR063147:Same reporter
Guardian said he had baseball size welt at injection site, developed headache on Friday (4/10) which continued on Saturday and Sunday.  Developed rash on arms and legs on Monday (4/16).  Physician prescribed Zyrtec on 4/16/2015.
pt started with flank pain on 3-29-21, went to the ER on 3-29-21 diagnosed with UTI, developed shingles rash on right side on 4-1-21, diagnosed with shingles per provider on 4-1-21. prescribed Neurontin, Lidocaine patch and Valacyclovir.
High fever, night sweats, chills, headache, overall achy feeling, extreme exhaustion. Arm was red at injection site and whole arm was swollen. The systems lasted approximately 36 hours. I'm not sure but I possible took Tylenol for headache and pain.
High fever started within 2 hours after vaccine, at 11:30 PM it was up to 101.5.  Tylenol given and fever continued to rise.  Up to 104.6 at 2:30 am.  Remained 102.8-104.4 until about 30-34 hours after vaccine.
Had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later; A spontaneous report was received from a consumer, concerning himself, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later.  The patient's medical history was not provided. Concomitant medications reported included flu quadrivalent shot.  On 22-Jan-2021, prior to the onset of event, the patient received his first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 12-Jan-2021, the patient received flu quadrivalent shot and 10 days later, on 22-Jan-2021, the patient received the Moderna COVID-19 vaccine. Patient also claimed that he was feeling fine. No further information was provided at the time of this report. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later, was resolved on 22-Jan-2021.; Reporter's Comments: This case concerns a male of unknown age who received his first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection and had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of product administration.
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 05-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892790, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose were not provided); diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7205AA, expiration date: 23-OCT-2024, administered intramuscularly for prophylaxis (strength and dose were not provided); and pneumococcal vaccine conj (PCV 13) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (strength, dose, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA007838:
Pt was laying on his back while giving vaccines.  As vaccines were being given, patient started to cry.  He cried so hard that he stopped breathing.  I picked him and gave him some firm pats to patients back and he then opened his eyes and was breathing again.  We noticed a rash all over his body appear that lasted for about 15 min and then went away.  He was monitored for about 20-30 minutes by Dr. who assessed him.
Approx. 12:30am I awoke to a leg cramp. I arose from bed and stood up till the cramping muscle relaxed.  Then I walked to the restroom and during the short distance,I felt a sudden "flush".  Upon entering restroom, I felt I was getting faint.  Feeling that I was about ready to faint, I tried to easily lower myself to the floor without striking my head or body.  Feeling very dizzy and faint, my stomach instantly felt nauseous and then vomited.  After vomiting, I  suddenly started to "shake very violently" (chills?).  The shaking was uncontrollable and went on for approx. 10 -15 min.  I tried to relieve the violent shaking by covering up with bath towels, that I was able to reach from the floor, where I was still sitting; but that did not seem to help.  After I did not feel so faint, I called for help to have my husband help me back into bed to try to warm up.  By that time the shaking (chills) were no longer so severe, and I was gradually able to fall back to sleep with no further problems the remainder of the night.  The following morning, and ever since that night, I have had no other adverse reactions.   For many years, I have received the yearly flu vaccine and have never had any kind of reaction, accept some minor soreness at the injection site (muscle).
I know who got the shingles vaccine, got shingles/suspected vaccination failure; I know who got the shingles vaccine, got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know who got the shingles vaccine, got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I know who got the shingles vaccine, got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by the patient via interactive digital media. The patient had stated that everyone he/she knew who got the shingles vaccine, got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  Follow-up would not possible, as no contact, details were available. This case was one of the three case reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR025312:Same report/Other patient US-GSK-US2023AMR025323:Same report/Other patient US-GSK-US2023AMR069107:same reporter
4 years patient received vaccine in his left thigh; throat pain; abdominal pain; vomiting; hives on back and abdomen; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 4 years old male patient who experienced abdominal pain (abdominal pain), vomiting (vomiting), throat pain (oropharyngeal pain) and hives on back and abdomen (urticaria), while he received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing Food allergy.  Concomitant vaccination included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD]. The patient received this vaccine in same visit and had no adverse reactions.  On 06-Jan-2020, the patient received a dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [lot C5656AA, expiry date: 13-AUG-2021] via unknown route in the left thigh.  On 06-Jan-2020, the patient developed a non-serious abdominal pain (abdominal pain), vomiting (vomiting), throat pain (oropharyngeal pain) and hives on back and abdomen (urticaria), 5 minutes following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  It was also the case of actual medication error due to vaccine administered at inappropriate site. Patient received vaccine in his left thigh (product administered at inappropriate site).  Details of laboratory data not reported.  Final diagnosis was urticaria, oropharyngeal pain, vomiting and abdominal pain. All events were reported as severe reaction.  It was not reported if the patient received a corrective treatment.  Outcome of the all reported events was unknown.  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 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.
Pt received her 2nd Moderna dose 14 days after her first one (too early). No immediate adverse events noted.
2/11/04 red, hot, swollen upper arm extending posteriorly to scapula and interiorly to elbow. Low grade fever (99) treated with Ibuprofen and Benadyrl. Rechecked 2/12/04 arm improved.
My next menstual cycle (and all of the ones since) have been absolutely horrible.  I did the math, and my periods are 6x heavier than more normal heavy cycles.  The cramps feel the same as when I had an ovarian cyst rupture back in 2016.  It is debilitating, and I refuse to take another Covid vaccine.
Upon administering the Moderna COVID vaccine to the patient, our intern experienced a syringe failure. The intern described injecting the needle into the patient's arm and pushing the plunger when the medication expelled out of the barrel and onto the patient's arm. The patient was revaccinated in the opposite arm.