chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 doses of Boostrix administered; Adult Engerix B instead of Pediatric dose; Adult Engerix B instead of Pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number yr7aa, expiry date 4th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 20th August 2022, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 17th July 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 17th July 2022, not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device and unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On 20th August 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, accidental overdose and adult product administered to child 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 Information: GSK Receipt Date: 22-AUG-2022 Reporter's comments: This case was reported by the pharmacist. The patient was administrated with 2 doses of Boostrix. No adverse event was reported. The 1st dose of Boostrix was given on 20th July 2022 having Lot/batch number 997k, expiration 7th April 2024. The patient received a dose of Adult Engerix B instead of the appropriate pediatric dose according to the age. The reporter consented to follow up and then in later report did not consent to follow-up. Additional Supportive Information: The patient received a dose of Adult Engerix B instead of the appropriate pediatric dose, which led to accidental overdose, adult use of a child product. The patient had received 2 doses of Boostrix, which led to extra dose administered. This case was linked to US2022122099 for Same reporter.; Sender's Comments:  US-GSK-US2022122102:Same reporter US-GSK-US2022122099:Same reporter US-GSK-US2022122099:Same reporter
Pt states that she developed a dozen lumps underneath her right arm the day after her second shot of vaccine. She also developed an eye infection and a sore on her lip the day after as well.
hypertrophic cardiomyopathy; he just suddenly fell; lost his sense of taste; excruciating pains all over his body; General body aches like he got ran over by a truck/excruciating pains all over his body; Headache; Chills; Fever; Nausea; Pain; Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies, causal relationship cannot be excluded..This spontaneous case was reported by a consumer and describes the occurrence of hypertrophic cardiomyopathy in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination.   The patient's past medical history included Angiogram (Was told they had an excellent heart and no surgery was needed)   Concomitant products included acetylsalicylic (E.C.) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 23-Feb-2021, the patient experienced pain, headache, chills, fever and nausea.   On 24-Feb-2021, the patient experienced lost his sense of taste, excruciating pains all over his body and myalgia (general body aches like he got ran over by a truck/excruciating pains all over his body).   On 06-Mar-2021, the patient experienced hypertrophic cardiomyopathy (seriousness criterion death) and he just suddenly fell.. An autopsy was performed.    Consumer reported on behalf of spouse. Ambulance was called and patient was pronounced dead. Awaiting toxicology report.  Most recent FOLLOW-UP information incorporated above includes:  On 26-Mar-2021: Major narrative update - outcome of events, additional events reported; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of pain, headache, chills, fever , nausea, loss of sense of taste, excruciating pains all over his body and myalgia and excluding other etiologies, causal relationship cannot be excluded. There is not enough details to assess the fatal event of hypertrophic cardiomyopathy and the administration of the product. Additional information has been requested.; Reported Cause(s) of Death: hypertrophic cardiomyopathy
Information has been received concerning a 4-year-old female who on 03-DEC-2003 was vaccinated subcutaneously in the right thigh with her first, 0.5 mL, dose of varicella virus vaccine live (Oka/Merck) (Lot # 646137/0474N). It was noted that the patient woke up with a rash, and presented to the pediatrician's office on 01-MAR-2007, when she was diagnosed with varicella. Outcome not reported. No additional information available. Additional information has been requested.
Redness, swelling in right upper arm, started on 9/20/18 when patient woke up- has spread upwards somewhat since this morning.
This spontaneous report as received from a pharmacist refers to an infant of unknown age. On an unknown date the patient was vaccinated with ROTATEQ. Dosage and administration information were unspecified. At the reporting time (21-OCT-2013), the patient was now an in-patient in hospital and had a jejunostomy tube (J-tube). The cause of hospitalization was unspecified. The outcome of events were unknown. Upon internal review, jejunostomy was determined to be medically significant event. Additional information has been requested.
Tingling in my left arm, hand, and foot after vaccine/Tingling in left arm has continued and now I have tingling randomly in other parts of my body. i.e. right hand, cheek; This is a spontaneous report from a contactable consumer (patient). An adult patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9810), via an unspecified route of administration in left arm on 04Feb2021 at 18:30 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included one a day Women's Vitamin. Other vaccine in four weeks was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that tingling in my left arm, hand, and foot after vaccine on 04Feb2020 at 19:00 and tingling in left arm has continued and now I have tingling randomly in other parts of my body. i.e. right hand, cheek. The patient did not receive any treatment for the event. The outcome of the event was not recovered. It was also reported that post vaccination, the patient had not been tested for COVID-19.
Patient was given a dosage of Moderna vaccine by error. The patient had already had two previous dosages of Moderna vaccine at another facility, but told the Medical Assistant after the vaccine was administered. THERE WERE NO ADVERSE REACTIONS, THIS ONLY TO REPORT AN EXTRA DOSAGE  ADMINISTRATION.
4 months pregnant due Feb 19th 2022,  not breathing while sleeping, shortness of breath, dry cough
Heart palpitation; Swelling; Dizziness; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date the patient experienced heart palpitation, swelling, dizziness. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
The pt experienced a syncopal episode about 15-20 minutes after flu shot and about 5 minutes after blood was drawn complicated by difficulty accessing vein X 3 attempts. The pt felt dizzy prior to episode. The event was attributed to vasovagal reaction.
Information has been received from a consumer concerning her 12 month old daughter with no known history or allergies who on 07-MAR-2007 was vaccinated with a dose of ProQuad. Concomitant therapy included amoxicillin. Eight days after vaccination, on 15-MAR-2007, the patient broke out in a measles-like rash all over her entire body. She had more than 300 "flat red spots" and a fever as high as 103.4 degrees. Her face was also very swollen. Unspecified medical attention was sought. At the time of the report, she was recovering. There was no product quality complaint involved. The reporter considered her daughter's experiences to be disabling. Additional information has been requested.
pain at the injection site; Pain in her legs/pain; insomnia overnight; feeling some fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2021, the patient received the 1st dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, pain in extremity, insomnia and fatigue. On an unknown date, the outcome of the injection site pain, pain in extremity, insomnia and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain in extremity, insomnia and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received the shingrix vaccine in her left arm. After getting the vaccine she experienced pain at the injection site and pain in her legs. She also experienced insomnia overnight and was feeling some fatigue. The reporter consented to follow up.
Pfizer-BioNTech Covid-19 Vaccine EUA  24 hours after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine EUA, I broke out in systemic hives from my neck to my legs. The hives were singular dots that caused very intense itching. 4 days after the occurrence, the itching and hives were still present and taking Benadryl around the clock was not resolving the side effects. I called the pharmacist that provided the shot at the Pharmacy and reported the side effects that I had been experiencing. The pharmacist highly recommended filling and reporting this adverse reaction as well as going to an urgent Care/following up with my health care provider. I went to an Urgent Care on Thursday, August 19, 2021. I was administered a one-time dose of Solu-Medrol to try and help the situation. I was told to continue to take the Benadryl and follow up with my provider within 7-days for a follow up or report back to the Urgent Care sooner if any side effects worsened or the problem did not resolve with in the 7 day time frame. As of Friday, August 20, 2021, I am still taking Benadryl and experiencing hives and intense itching.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got COVID 1.5 weeks ago) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 004F21A, 013620A and 039K20-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022, the patient experienced COVID-19 (I got COVID 1.5 weeks ago). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I got COVID 1.5 weeks ago) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2023, SARS-CoV-2 test: (Positive) on Saturday.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that, Patient started with nasal congestion about 1.5 weeks ago and COVID-19 home test was positive on Saturday. Patient called the doctor and doctor kept patient on Paxlovid.
PATIENT'S ARM SWELLED UP AND WAS RED AND SORE.  IT RESOLVED ITSELF IN ONE WEEK.
pt recvd vax & p/ 2 hrs had fever 102; was shaking for 7 min; blue lips; & extremities;
Arm injected was swollen with heat in it.  In arm pit of the same arm it was also swollen & hurt like it was rubbed raw for 5 days.  Day after vaccine I felt like I was tired, fever,  & very bad headache.  By Saturday the heat in arm was gone but still very tender
Gradual onset of Lyme disease-like symptoms: joint pain, numbness and tingling in the extremities, headache, flu-like symptoms, back pain, memory loss, etc. Ongoing treatment for Lyme disease.  Follow up on 08/06/03: "Vaccine recipient did not recover from adverse events.  Still has all symptoms."
Dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Dizziness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy.    On 30-Jan-2021 at 11:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021 at 11:30 AM, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.
Information has been received from a licensed practical nurse who from between 1987 and 1992 was vaccinated with a primary series of RECOMBIVAX HB (manufacturer unknown).  In June 2007, the patient had a negative level of anti-HBs when tested.  No symptoms were reported.  Unspecified medical attention was sought.  The patient's present status was unknown.  There was no product quality complaint.  Additional information has been requested.
elevated blood pressure wanting to faint; elevated blood pressure wanting to faint; Sweating; extremely nauseous; palpitations; shortness of breath; dizzy; This is a spontaneous report received from a contactable consumer (patient). An unspecified gender 48-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: ER8737) via an unspecified route of administration to left arm on 01Apr2021 13:00 at single dose for COVID-19 immunization. Patient medical history included allergies: Wheat, Nuts. Concomitant medications included dexlansoprazole (DEXILANT), paracetamol (TYLENOL), vitamin D3 and diclofenac sodium (VOLTA). Patient previously took Erythromycin, Restasis, Flonase and Nasacort for all which the patient was experience with allergies. On 01Apr2021 13:00 patient reported with sweating, extremely nauseous, palpitations, shortness of breath, dizzy, elevated blood pressure wanting to faint. The patient did not receive any treatment for events. Outcome of events was not recovered
vaccine reaction. Headache, bodyaches, nausea and fever since last night. Has not take any meds for those symptoms. Had a J&J vaccine yesterday.  HPI:20-year-old male with chief complaint of vaccine reaction. he received his Johnson & Johnson coronavirus vaccine yesterday.  He reports starting last night he began to have headache bodyache fevers chills and nausea.he could not sleep well due to the symptoms.  He has not taken anything for the symptoms.
Rash in the lower abdominal area, itchy skin all over, sore joints,
itchy; swelling; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. No treatment details was reported.
Feeling a little bit of tingling in my hand; Felt tired; A lot of pain on my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Feeling a little bit of tingling in my hand), FATIGUE (Felt tired) and MYALGIA (A lot of pain on my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient medical history was not provided by the reporter.     On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Feeling a little bit of tingling in my hand), FATIGUE (Felt tired) and MYALGIA (A lot of pain on my arm). At the time of the report, PARAESTHESIA (Feeling a little bit of tingling in my hand), FATIGUE (Felt tired) and MYALGIA (A lot of pain on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
On approximately 10/4/21 the patient began experiencing nausea and vomiting, cough, and shortness of breath. On 10/7/21 the patient began feeling associated dizziness and lightheadedness with his shortness of breath. Per EMS report, the patient's O2 sats were in the high 80s with bilateral wheezing when they arrived. The patient received a Duoneb treatment in the field. Patient was found to have A-fib with RVR in ED (HR in the 150s on initial presentation) and patient has no known history of A-fib. Patient was febrile to 103 F. Patient was started on anticoagulation, fluids, and a diltiazem drip. Patient is requiring high flow O2. Patient is positive for COVID-19 by rapid test. The patient will be admitted to ICU.
sore arm at time of injection                                               next day (Fiday)temp after tylenol ran between 100 and 101 during day Headache started about 10 min after injection       bodyaches and joint pain headache got worse as day wore on                                tylenol did nothing for headache, unable to take ibuprofen due to stomach pain chills during night then spiked fever of 101.7            Saturday temp down to between 99.4 and 100 Headache less                                                                                                                 right arm below injection site red warm to touch and sore
Patient woke up crying and continued to cry during the night, waking up frequently and feeling uncomfortable. High fever started on 6/3/2017, she broke out in rash on 6/4/2017, continued to cry inconsolably on and off.
ran a fever of over 103 degrees, through the day, on the day after the shot; did not seek medical attention since Tylenol helped the fever go down intermittently. Fever was gone two days after shot. Two days after shot, woke up with swollen armpit (on side of injection); armpit swelling has gone down but is still present on third day after shot
The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Jun-2022 and was administered on 11-Jul-2022).    No concomitant medications were reported.  The Beyond use date (BUD) (refrigerator) was reported as 01-Jul-2022. It was reported that 10 days past expiry date the patient received the vaccine. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursion.   No treatment medications were reported.
This non-serious medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 16 year old patient. On the 05-Nov-2014, the patient received AFLURIA injection (batch number not reported) in the left arm. The patient was given the Influenza vaccine accidentally instead of the PPD (purified protein derivative) in the left forearm. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
THE PATIENT HAS NOT REPORTED ANY SYMPTOMS, BUT HE HAS HAD 2 DOSES OF THE MODERNA COVID VACCINE FROM 2 DIFFERENT LOCATIONS ONLY10 DAYS APART INSTEAD OF THE RECOMMENDED 28 DAY WINDOW.