chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neck pain L arm swelling numbness tingling.  Dizzy Burning L temple and Mid back in spots.  Lasting about 6 hours.
Patient stated that a rash formed on the site of injection the next day and it started spreading on body today.
Mom stated that pt, has redness & hardness @ area of vax of rt leg; mom denies any fever or limitation of ROM/sensatin of rt leg; pt was taken to hosp for eval on 10FEB92 & mom was told that pt had an infection on area above rt leg;
No additional adverse events; HCP reports that the patient  missed her normal dosing schedule of GARDASIL 9. Patient received first dose in  November 2022 ( exact date unknown) and her second dose on 05/21/2023( this is  beyond the recommendation of dosing schedule). Exact date; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       In November 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL/series, for prophylaxis. Then,  on 21-MAY-2023 the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL/series, for prophylaxis (strength, route of administration, lot # and expiration date were not reported). The reporter stated this was beyond the recommendation of dosing schedule (inappropriate schedule of product administration). The exact date patient the should have received her second dose was unknown. No additional adverse events were reported.
Redness, swelling and warm to the touch at injection site.  Tylenol given at home.
The headache started first they were not very severe - I would take 1 Tylenol and I could get rid of it. Then they moved up to 2 Tylenols then it became 3 Tylenol headaches. These were regular strength Tylenols. And then one day I woke up and it was so severe I needed to go to the ER. They came and transported me to the ER. I remember them coming, locking the ambulance door, next thing I woke up and I was being discharged from ICU after 3-4 days. I had been intubated because of the seizures, according to what I was told at that time my blood pressure was high enough for two people. What caused the blood pressure to be out of control but I think it had to do with the adjustment of medications at the time but I'm not positive. I was treated by the ER staff.
24 hours after vaccine: headache, chills, fatigue 24-36 hours after vaccine: injection site rash, swelling, tenderness
Shaking, breathing fast lasted about 1/2 hour. No rash or hives.
(1) left axial lymphadenopathy lasting days 2-5 after the shot (resolved) (2) amenorrhea in the month following the injection (I had my period the day or two after the injection but would have already ovulated--I did not have my period in January; I took a pregnancy test and it was negative; note that I did have COVID in early-mid Jan, as well; unknown whether resolved) (3) vertigo and tinnitus (started mid-Jan but coincided with COVID infection; not resolved)
Patient was injected with Gardasil Vaccine. I left the room and within 30 seconds, she was yelling help. I entered the clinic room and found her on the floor. She did not know how she got there. Within a few minutes she was feeling better.
Left upper shoulder, warm, tender, erythema and induration symptoms.  TD booster that location 09/04/2003.  Otherwise doing well, afebrile. (?) reaction range vs ailvers reaction vs doubtful cellulitis.  Benadryl, Motrin, Keflex,
Severe stomach pain; Throwing up; Onto the sides it's very painful; Terrible, wrecking the health; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 04Mar2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced severe stomach pain, vomiting ("Throwing up"), pain ("onto the sides it's very painful") and malaise (was feeling terrible, wrecking the health). Clinical outcome of the events was unknown at time of this report.   No follow-up attempts are possible, information about batch number cannot be obtained.
Bilateral cyanosis of feet occurring about 3-5 days after 2nd dose.
In the first few days following his first vaccine, my 5 yr old son appeared more easily short of breath, but I chalked it up to him needing more exercise. At his 5 year well check visit with his pediatrician, exactly a week after his vaccine, a heart murmur was diagnosed for the first time ever.
Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 17 months old female patient who received a 0.5ml 4th dose of DAPTACEL batch number: C5117AA, expiration date: 19-Jan-2019 via intramuscular route in the right thigh on 23-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. A patient was injected with DAPTACEL after the expiration date on the vial. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
The patient presented to the off complaining of feeling weak in the legs on Monday, March 1, 2021. She had been moving over the weekend and was over-exerting herself and stated she had fallen on a rug at the old house and then had lain down on the floor to sleep with her dog in the new home,  had difficulty getting up and needed help. No symptoms of fever, chills, sweats, headache, myalgias. The next day she passed away at her home, sitting in her chair.
Developed hives approx 48 hours after dose 6 anthrax vaccine administration.  patient with hx of episodic hives prior to more acute episode.
Reaction that patient having; soreness in the arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Reaction that patient having) and VACCINATION SITE PAIN (soreness in the arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), RAMIPRIL, OXCARBAZEPINE, METOPROLOL SUCCINATE, UBIDECARENONE (COQ10 [UBIDECARENONE]), CALCIUM AMINOACETATE;CALCIUM CITRATE;CALCIUM MALATE;COLECALCIFEROL;COPPER GLYCINATE;MAGNESIUM CITRATE;MAGNESIUM GLYCINATE;MAGNESIUM MALATE;MAGNESIUM OXIDE;MANGANESE GLYCINATE;MENAQUINONE-7;SODIUM BORATE;ZINC GLYCINATE, VITAMIN C [ASCORBIC ACID], CENTRUM SILVER ADULTS 50+, BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE), LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLE FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE;METHYLSULFONYLMETHANE]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction that patient having) and VACCINATION SITE PAIN (soreness in the arm). At the time of the report, VACCINATION COMPLICATION (Reaction that patient having) and VACCINATION SITE PAIN (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also include Astioviflex. No treatment medication details was reported.   This case was linked to MOD-2021-363477, MOD-2021-363478 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25 OCT 2021 contains Reporter occupation and reporter type and additional event was added.
No adverse event; administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Sep-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine).    Concomitant medications details were not reported by the reporter.  It was reported that the patient intended to receive a booster dose from the bivalent presentation, but did not.  No additional doses, medications or treatments had been administered at this time.
Case number PHEH2013US013447 is an initial spontaneous report received from a nurse on 19 Jun 2013, and with a follow up report received from nurse on 09 Jul 2013. This report refers to a 13-year-old male patient. His past medical history and concomitant medication were not reported. He received only Men A lyophilized component of MENVEO (batch number: M12024, expired date: Dec 2014) reconstituted with a sterile diluent (not with Men CYW-135) intramuscularly into left deltoid on 17 Jun 2013 at 11 AM. No adverse event was reported following medication error. Nurse reported that he will be revaccinated. No further information was provided. Follow up report received from nurse on 09 Jul 2013. Updated site of vaccination and patient demographics.
A report was received from a health professional on 09/14/01, concerning a 35 year old female patient who was hospitalized due to anaphylaxis after receiving a Fluvirin vaccine on 09/11/01. On 09/11/01, the patient experienced anaphylaxis including redness / itching, difficulty in breathing, and chest pain. 10 minutes after receiving a Fluvirin vaccination. Therapeutic measures taken as a result of this event included Diphenhydramine 50 mg IV and Epinephrine 1:1000, which were administered IV. The patient then became blue, developed red welts on her chest and extreme whiteness of extremities, with no breathing for about 30 seconds. Oxygen was administered and the patient was admitted to the hospital on 09/11/01, with symptoms abating but continuing through. The patient recovered on 09/13/01, and was to be discharged from the hospital on 09/14/01. The reporter has assessed the relationship of the study medication to the event as possible.
SUDDEN CARDIAC ARREST - ONLY SURVIVED DUE TO QUICK ACTION OF CO-WORKERS AND FIREMEN.  IN ICU FOR OVER A WEEK TRYING TO FIGURE OUT WHAT WAS GOING ON.  NO BLOCKAGE.  DETERMINED HE NEEDED A PACEMAKER DEFIBRILATOR.  HAD NOT HAD HEART ISSUES BEFORE COVID IN JANUARY.  WHEN HE HAD COVID IN JANUARY THEY NOTICED HE HAD AN ENLARGED HEART AN HE HAD JUST BEEN TO A CARDIOLOGIST THE WEEK BEFORE THIS EVENT.
lethargy post vaccinations  3 weeks (march 16) after 2nd vaccination admitted to hospital for stroke
Arm has a huge redness around injection site.  "Not feeling well."  "hot/cold sweats"
Patient received 1st dose out of vial that was improperly thawed. Manufacturer recommendations for vial stored in freezer are to let frozen vial sit for 1 hour and 30 minutes at room temperature before administering to patient. Vial was stored at room temperature for 30 minutes before administering to the patient. Pharmacist has contacted Moderna for further assistance for validity of this dose. At time of this reporting (9/17/21 7:47 am CST), Moderna has not responded to this inquiry.
Information has been received from a physician assistant concerning a 69 year old male who on 02-FEB-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The physician assistant felt that the similarity in names (varicella virus) confused him and he checked the wrong box on an order form. There were no problems reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Vaccine administered on 02/04/2022 was expired on 02/03/2022.
States she had rash on neck to hairline/chin all around. Red small bumps on neck/chin. CLARITIN, BENADRYL 25 mg HS.
administered infanrix /, Date of birth Jan 25th 2010; administered infanrix,/Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 49TN3, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered infanrix to a patient of age 11 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter
The evening of the vaccine, at about 10pm I suddenly was unable to get up from the couch and I had an episode of incontinence.  I had to shout for my husband who was asleep in the bedroom to come help me.  He had me hold onto his neck and he lifted me, transferred me to a chair, pushed me into the bedroom and transferred me to the bed.  Overnight I experienced incontinence again, was still not able to stand or walk and my husband had to help me to the bathroom.  The next morning I was not able to walk and was very tired and weak.  My husband pulled me into a chair and pushed me to the dining room.  I had a small amount of yogurt and after 2- 3 hours needed to go bad to bed and slept to evening.  After waking I was still weak and had not appetite.  During the second night I was able to go to the bathroom unassisted. After three days I was feeling back to normal.
I asked the patient what vaccines he and his daughter were here for and he said Flu and Pfizer. I asked if he would like to get both vaccines in the same arm and he said yes. After I gave him the Flu vaccine, I was about to give him the COVID vaccine and he said that he had already received the Flu shot at another location. He was fine with getting two flu shots and we went over how this can increase his immunity.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Injection was administered at 1248pm on 2/10/2022.  Approximately 10 minutes after the injection, my chest began to itch.  I noticed I had hives.  I drove to the hospital. Arrived at 1:02pm.  Upon arrival, my chest, neck and back were covered in hives and my chest was beginning to feel heavy.  I had taken Benadryl and Famotidine  by mouth two hours prior to injection as I have had allergic responses to the flu vaccine.   I take Zyrtec and Singulair nightly.  I was told that I had no choice but to receive the vaccine because of agency rules and that the previous history of adverse reactions and idiopathic urticaria we?re both qualifying medical exemption reasonings.  In route to the ER I administered myself my rescue inhaler (Xoepenex)   In the ER I was immediately given IV  Benadryl, Solu Medrol & Famotidine.  I did get relief.   I was discharged with a prescription for 20mg  prednisone.  At 8:00pm this evening, I had to to take 25mg of PO Benadryl and the prednisone.  As of 9:18 I am still having  break through hives, itching, coughing, sneezing and now some diarrhea.
Swelling of face and face felt warm to myself. However, via temperature gauge no fever was present. This lasted for approximately two hours. No medication was taken to combat the symptoms. Overall it was manageable, but I have never experienced something like that after a vaccine injection.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant medications details were not reported by the reporter.  Reportedly, the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment details were not reported by the reporter.  This case was related to patient number 13 out of 77 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:
Muscle spasms in neck; upper back stiffness; Pain in both arm (from shoulder to hands); numbness & tingling in both fingers/hands; numbness & tingling in both fingers/hands; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 27Jul2021 at 11:00 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. Medical history included wolff-parkinson-white syndrome (WPW) and enlarged aortic root. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any other medications within 2 weeks prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jul2021 at 09:30, the patient had experienced muscle spasms in neck/ upper back stiffness and pain in both arm from shoulder to hands, numbness and tingling in both fingers or hands. Since the vaccination, the patient had not been tested for COVID-19. The events had resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events muscle spasms in neck/ upper back, stiffness and pain in both arm from shoulder to hands, numbness and tingling in both fingers or hands and included treatment with tylenol, motrin and valium. The clinical outcome of the events, muscle spasms in neck/ upper back, stiffness and pain in both arm from shoulder to hands, numbness and tingling in both fingers or hands was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.