chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exposed under temperature excursion; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis A vaccine for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and RABIES VACCINE (RABAVERT) for prophylaxis.   On an unknown date, the patient received DTaP vaccine, Hepatitis B vaccine, Hepatitis A vaccine, Kinrix, Kinrix Pre-Filled Syringe Device, Twinrix, Twinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device and RABAVERT. On an unknown date, unknown after receiving DTaP vaccine, Hepatitis B vaccine, Hepatitis A vaccine, Kinrix, Kinrix Pre-Filled Syringe Device, Twinrix, Twinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not applicable to this report. The reporter stated that the vaccines were exposed under temperature excursion, which led to incorrect storage of drug. The reporter stated that there were actually a lot of vaccine included DTaP and Kinrix and there were also few of them which was the Hepatitis B vaccine for pediatric and adult, Hepatitis A vaccine for also pediatric and adult, Twinrx, RabAvert, Pediarix and Bexsero. The reporter further did not clarify if the vaccines were administered to any patient after the excursion and wanted to know if they were still viable. The reporter did not have any further information.
Patient noticed 2 red "dots" on R wrist with progression to body wide "red dots" by the end of the day.  No pruritis, no drainage. Pt also had cellulitis extending from site of small pox vaccine ~ 9cmX5cm, for which he went to the emergency room and was treated with 1 gram vancomycin and 1 gram ancef.  Pt was sent home with Septra and prednisone.  Pt was instructed by myself NOT to take the prednisone.
Patient developed blisters and had fever. On 5/12/2021 She contacted her primary MD, Dr  and received Solumedrol. She was not better on 5/13/2021, so she went to Urgent Care and saw Dr.
inadvertently administered an expired Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug used in a 70-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27-OCT-2023) for prophylaxis.   On 06-NOV-2023, the patient received Boostrix. On 06-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired drug used (Verbatim: inadvertently administered an expired Boostrix). The outcome of the expired drug used was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2023 The registered nurse called to inquire how to proceed, if the dose was still good The patient was inadvertently administered a Boostrix on 6th November 2023, which was expired on 27th October 2023, Which led to expired vaccine used. The reporter did not consent to follow-up from safety
No adverse event; Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Cancer staging and Atrial fibrillation.    On 17-Feb-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022) 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 WRONG PRODUCT ADMINISTERED (Patient took Bivalent vaccine on 17-Feb-2022 but Bivalent approval date was 31-Aug-2022).    Patient had cancer in the past and atrial fib and was taking Blood thinners(ANTICOAGULANT III) Patient had 6 vaccines, but only one bivalent booster dose. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734458 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734458:Husband case
Initial report received from healthcare professional on 24 OCTOBER 2013.  A female patient (age unknown) whose medical history and concomitant medications were not reported received FLUSONE (lot number UH895AB and expiration date unknown) intramuscularly in left deltoid (dose number not reported) on 18 SEPTEMBER 2013.  On an unknown date, the patient has experienced left shoulder pain, with pain upon movement of arm in forward direction, following vaccination to today 24 OCTOBER 2013.  Laboratory investigation and corrective treatment were not reported. As of 24 OCTOBER 2013, outcome of event was not recovered. Documents held by sender: None.
I had to take Ibuprofen 600mg and lay down because I had a headache after the vaccination on March 9. I went to the urgent care on March 11th and was referred to the neurologist and prescribed Cyclobenzaprine. I went to the neurologist March 22nd  and suggested I journal when I have headaches and prescribed  Indomethacin. It continued for two weeks before subsiding.
I started experiencing long COVID. I went to my doctor in August with internal medicine. She ran blood work and it showed I had had COVID-19 because I had antigens. She did a chest x-ray and that came back completely normal. That's what we expect is long-COVID. Some symptoms include fatigue, weight loss, and no appetite. I am still experiencing these symptoms.
Pt recvd 1st dose of Hep B vax 30JUL91 & on 1AUG91 exp migraine h/a & flu-like sx; By 2AUG91 pt recovered; On 15NOV92 pt recvd 2nd dose of vax w/no adverse rxn;
Chills; Stomach issues; Fever of 100.4; Sort of feeling achy; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the left arm on 25Jan2021 (13:45) at a single dose for COVID-19 immunization at the university clinic (not a military facility). Medical history allergy to penicillin; allergy to bees; allergy to environmental grass and ragweed; and was in muscle relaxant therapy. Concomitant medications included cannabidiol (CBD OIL) as muscle relaxer; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously took SHINGRIX on 18Oct2019 (when the patient was 71 years old) for shingles vaccine, and had subacute thyroiditis, enlarged thyroid and glands, rash from wrist to arm and shoulder, swollen and sore arm, and swollen neck glands and thyroid around left side. The patient previously took codeine, and had allergy. On 25Jan2021 (20:00), the patient had sore arm. The sore arm improved the next day. On 30Jan2021 (between 18:00 and 19:00), the patient was "sort of" feeling achy. On 30Jan2021 (23:00), the patient had fever of 100.4 (unit was not provided). The patient took paracetamol (TYLENOL) as treatment for the fever, and started getting better. The patient got tested as a precaution, and was negative for COVID-19 test on 31Jan2021. On 31Jan2021 (between 08:00 and 09:00), the patient had stomach issues. On 31Jan2021 (13:00), the patient had chills. The outcome of the events, 'sore arm', 'achy', 'fever', 'stomach issues' and 'chills', was recovering. The patient was due to the second dose of vaccination on 15Feb2021, and wanted to know if it would be okay for her to get it.
Patient's left arm started hurting and radiated from the site of injection (left deltoid down to finger tips) ten days after she received the first dose of SHINGRIX. Patient's pain was reduced with use of NSAID but arm continued to hurt and patient's range of motion was reduced. Patient visited doctor two months after the pain began and found out she was experiencing bursitis. Prescriber gave patient a course of steroids (MEDROL dose pack) to help with the inflammation and she will be going to physical therapy.
Headache, Fever,   INJECTION SITE PAIN, SWOLLEN LYMPH  NODE (GROIN)/TENDERNESS   Narrative:   Other Relevant History:
tc 3AUG94  1230PM from mom; stated pt was flushed but not warm the evening of 2AUg94; today 3AUg94 pt has temp 104 ax; rash on face, & sleeps most of the time; instructed mom to call MD & to given APAP as ordered by MD;
Pt received vaccine, woke up following morning with swollen, red arm. Upon Dr. visit pt. was told she had cellulitis. Put on observation and antibiotics.
patient received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received Monovalent Moderna Vaccine past the manufacturers expiration date).    No concomitant drug information was provided.  It was reported that there were 3 lot numbers. Lot 022D21A with expiration 20Apr2022, Lot 033F21A with expiration 08Apr2022 and Lot 037C21A with expiration 2Jan2022.  In total 30 doses were administered with 13, 11, and 6 different doses from different lot numbers.      No treatment medication information was provided.  The case was reported for 7th out  of 30 adult patients who had received the vaccine as reported by the reporter.
This spontaneous report was received from medical assistant regarding multiple unspecified patients of unknown age and gender. The medical history of patients, concurrent conditions and their concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of VAQTA lot, dosing details unknown. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
The month after receiving my booster shot in left arm, I started having pain and limited range of motion.  It has affected my daily life as I live alone and do all housework and yardwork myself.  It is painful trying to put on a bra everyday and painful to close the car door and put on my seatbelt.  I tried Advil and Tylenol to ease the pain but it didn't help at all.  My NP prescribed  Diclofenac Sodium 1% gel and it didn't either.  To-date nothing has helped.  I am now seeing  Dr. who is a shoulder specialist.  MRI is scheduled in the near future and then he will plan a course of treatment.  I never had any problems with my shoulder before getting this shot.
pt recvd vax; devel fever & local rxn of soreness, swelling & rash at inject sit;
Patient stated she had, joint pain, low fever (~100 degrees F) chills and headache, also presented with a 2 inch band around the arm which was warm and painful. She felt bad for 4 days but only 2 days where it affected her day to day activities. Started the day after the shot.
Arm pain 6 hrs after injection.  Fever, chills, myalgia symptoms, fatigue  12-24 hrs after injection
WITHIN FEW HOURS OF RECEIVING VACCINE, CHILD HAD FEVER OF 102.0.  MOTHER GAVE MOTRIN FOR RELIEF.  CHILD ACTING FINE NEXT DAY.
Immediately burning down arm, bruising, swelling intense pain, muscle stiffness, could not moves arm.
I have a mass growing in my left nostril. I can't prove it, but I highly suspect this is a result of this vaccine I was mandated to get.
Fever for 2 days and red area and feels hot in left arm where the two vaccines were administered.
Dr. placed Hep A vaccine for patient. I discharge patient. Patient should get Hep A 0.5ml. But I got Hep A 1ml and administered to patient. Verified vaccine with Dr. before administer. Notified Dr. right away when error occurred. Dr. explained to patient's parents.
VOMITING; GOT SICK; DIARRHEA; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced got sick. On MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 23-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting, and the outcome of got sick was not reported. This report was non-serious.
Pt presented w/H. Flu meningitis 2 wks following PROHIBIT; Also exp vomiting & diarrhea followed by signs of meningitis;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (fever and injected limb mobility experienced after receiving 1st dose on 15th May 2018, case US2018145493).  On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and fever. On 8th August 2018, the patient experienced injected limb mobility decreased. Rechallenge with SHINGRIX was positive. On 7th August 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The patient had her shot of SHINGRIX in the unknown arm. The patient experienced those same two symptoms which experienced after the 1st dose (felt soreness at the injection site and the next day she had pain in her arm and could not raise it), with the same time frame. The patient also felt little feverish after the 2nd shot like a very low grade fever. The patient had shot in the morning and felt feverish in the afternoon and it was resolved by bedtime. This case has been linked with case US2018145493, for same patient reported by the same reporter.
S/P revision of total knee. Surgery and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
PER FATHER, SLIGHT FEVER WITHOUT USE OF THERMOMETER BY 7:55PM. BY MORNING OF FEB 21, CHILD WAS LIMITING MOVEMENTS WITH LEGS AND USING SUPPORT TO WALK. BY 11:30AM ON FEB 21, CHILD ABLE TO STAND BY SELF WITHOUT SUPPORT. BY 1:15PM, PER FATHER, CHILD WAS MOVING BETTER AFTER WRM BATH AND SECOND DOSE OF CHILD MOTRIN. CHILD EATING AND PERSONALITY IS NORMAL.PARENT CONFIRMED CHILD LAUGHING IN BACKGROUND WHILE I WAS ON PHONE WITH PARENT. WILL FOLLOW UP WITH PHONE CALL ON FEB 22.ADVISED AT ANY TIME PARENT WAS CONCERNED ABOUT CHILDS HEALTH TO CALL MD OR GO TO ER.
NAUSEA, GENERALIZED ACHING, HEADACHE, FATIGUE, RED ITCHING RASH UPPER BODY, MILD COUGH, MALAISE, ITCHING SORENESS AND SWELLING IN ADMINISTRATION SITE.  ITCH FINALLY GONE AS OF 10/9.  STARTED FEELING BETTER 10/01/ 2019. NOT TOTALLY GONE UNTIL 10/ 5-6 EXCEPT FOR RASH
Pain at site. Range of motion issues. Cannot lift arm up when stretched out straight up from side of the body and internal rotation. Severe tingling pain that shots down arm with elbow burning when attempting to raise arm from the side.
6 YR OLD PATIENT RECEIVED A FLU HIGH DOSE 0.7ML. MOTHER INFORMED. MD INFORMED AND ADVISED TO MONITOR FOR ADVERSE VACCINE REACTIONS. MOTHER REPORTED PATIENT STABLE. OFFERED PHONE APPOINTMENT WITH PROVIDER-MOTHER DECLINED.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 36-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 27-Jun-2018.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Oct-2021. On 18-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 18-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Internal review on 19JUL2021 resulted in updates to pregnancy details.
I got a headache around 2 hours after the vaccine.  I woke up with a much stronger headache and chills around 6am with some dizziness when standing.  Chills and headache continued to worsen with the addition of body aches.  I spiked a fever for 100 around 2pm, which broke around 5pm (with the use of Tylenol and Advil).
COVID 19 Treatment; COVID 19 Treatment; Dose 1, 2, 4: Pfizer/BioNTech; Dose 3, 5: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0165), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in right arm and on 26Sep2022 at 19:00 as dose 5 (booster), single (Lot number: ASH63B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: ALENDRONATE, start date: 01Jul2021, stop date: 21Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Dose 1, 2, 4: Pfizer/BioNTech; Dose 3, 5: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: Tested negative; (unspecified date) positive, notes: tested positive; (05Apr2023) positive, notes: Tested positive for 2 more days; (unspecified date) positive, notes: Tested positive for 2 more days. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient had 9 apgar score,  after first weight check away from mom and bandaids on legs, she stopped eating well.  turned purple, shook with convulsions, stopped breathing a couple minutes at a time, vomit, acquired a stiff muscle tone.  episodes worsened april 6, discovered she was administered a second hep b according to digital medical records.  She was put into NICU on this day.  Nurse warned to keep a suction bulb nearby to help her breathe to "prevent a bad outcome".  Patient remains in a stiff posture for the rest of her life until this day.  Left ventricle hemorrhage was discovered at 3 mths old, the side of her brain that seizures where begin.  Her convulsions were eventually diagnosed as epilepsy ,   she had multiple apnea events the first 3 months of life requiring 911 serivices and emergency room visits.   She failed to develop myelin  at a proper rate, and suffered a global loss of white matter at 4 years old.  Speech was delayed , and eventually lost after a severe seizure at 20 months old..  Autism level 3, wheelchair dependent, nonverbal, feeding tube dependent .  Feeding difficulties never improved, stomach is paralyzed,   she is disabled for life