chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Quadracel rather than intended Daptacel; with no reported AE; Initial information was received on 05-Oct-2020 regarding an unsolicited valid non-serious case from nurse.  This case involves a nine-month-old patient (gender unknown) who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5772AA, expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination on 02-Mar-2021 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was reported that, the patient receiving her six-month series late. The office was out of Pentacel, so they administered HIB-PRPT with Quadracel vaccine in error (intended Daptacel) and Prevnar-13. Nurse reports that they typically use Pentacel for children's 6-month vaccines.  This was a case of actual medication error due to wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  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. 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.
I95.9 HYPOTENSION 4/21/2023 CARDIOMYOPATHY, UNSPECIFIED T78.40XD ALLERGIC REACTION, SUBSEQ 3/21/2023 CARDIOMYOPATHY, UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED T78.40XD ALLERGIC REACTION, SUBSEQ 3/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Patient received the dose beyond the recommended expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the dose beyond the recommended expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the dose beyond the recommended expiration date). On 11-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the dose beyond the recommended expiration date) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Patient had arm pain, arm swelling, nausea, and headache the next day after receiving the vaccines. She did not visit a doctor.
Student states started having pain at R "armpit" 45 minutes after receiving the H1N1 vaccine in R deltoid. Came to school nurse office on 10/27/09 to report it. Had not seen Dr prior to visit to my office. Called mother and referred family physician. Axilla area had an enlarged lymph node.
pt recv vax & devel SOB & wheezing w/in 5min of vax;hx of asthma;felt like throat is closing over;seen in ER given med;observed in hosp under 23hr but pt refused & signed out;condition resolved as of 18OCT96; also recv 2 proventil rx
Myalgia, malaise, severe diarrhea with Abd Pain onset day approx 3 with WBC's and Blood in Stool sc Neg faint.
pain; swelling; itching; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Jan2021 10:45 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included HTN (hypertension), osteoporosis and Allergies to sulfa. Concomitant medication(s) included macrogol 3350 (MIRALAX); metoprolol; hctz; donepezil; alendronate sodium (ALENDRONATE) all was taken for an unspecified indication. The patient previously took hydrocodone and experienced allergies. on 27Jan2021 05:00 patient experienced pain, swelling, itching. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, was the patient did not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. Outcome of the events was not recovered.
Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 15-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of itching in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included NIACIN. On 8 April 2013 at 15:45 the subject received 1st dose of TWINRIX (1 ml, intramuscular, left deltoid). On 10 April 2013, 2 days after vaccination with TWINRIX (described as "a couple of days later"), the subject experienced itching and lesion on back (described as "described as lesions on his back and butt cheeks"). Per the pharmacist, the subject "described the lesions as not pustules but looking more like mosquito bites or chicken pox." Per the pharmacist, the subject "thought these may be from his Niacin so he discontinued it. When the itching and lesions did not go away, the [subject] thought it was from the TWINRIX." The pharmacist considered the events were clinically significant (or requiring intervention). The subject was treated with steroid. On an unknown date, the subject returned to the medical center and was given an unknown steroid injection and an unknown steroid dose pack. At the time of reporting the events were improved. The itching and lesions both improved after receiving the steroid treatment. Per the pharmacist, as of 1 May 2013, the subject still experienced some itching and still has a couple lesions. The pharmacist stated that the medical center was considering whether to administer the second dose in the TWINRIX series "next week." The pharmacist considered the events were possibly related to vaccination with TWINRIX.
his mother's temperature rise to 98.1/ she had temperature of 99.0; headache; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer said he was calling for his mother who received the 1st dose of the Covid-19 Vaccine. He said that after receiving the vaccine, his mother's temperature rose to 98.1 and also experienced headache and chills on an unspecified date. Consumer wants to know if these side effects have been reported. Today, he was looking at pamphlet that they gave her when she got the shot. She called them and they said they had to look for the # number. He sees on here that there may be injection site pain tenderness, muscle pain, joint pain, fever and chills. He says right now, she had temperature of 99.0 and she took Aspirin or Tylenol at 12. He says he was just checking on her health to make sure what do they do. She also said she had a headache and she took Aspirin. He clarified that she took Tylenol, she did not take Aspirin. He has been hearing if there were side effects to just rest. She was saying she had some chills and she took Tylenol 325 mg.  He says he would have thought that the hospital where she got the vaccine would have explained to them what to do if she experienced anything but he was thinking that this was just side effects. He asks if he should just call the physician talk with them. He would like to know how often these side effects have been reported with the vaccine. He pretty much understands the process, he was just looking out for his mom and just wanted to know if she needs to go into the hospital or if she was fine. Outcome of events was unknown.  Information on the lot/batch number has been requested.
shortness of breath; tightness in the chest; swollen throat; heaviness on chest; when she eats something the heaviness on her chest gets worse; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9265, Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 14Apr2021 at 10:30 AM (at the age of 30 years), as a single dose for covid-19 immunisation. The patient medical history included ongoing asthma. She has had asthma since she was about 7 years old. Concomitant medications included salbutamol sulfate (VENTOLIN HFA) taken for asthma from an unspecified start date and ongoing. There was no History of all previous immunization with the Pfizer vaccine considered as suspect.There was no additional Vaccines administered on same date with the Pfizer vaccine considered as suspect. There was no prior vaccinations within 4 weeks. There was no AEs following prior vaccinations. On 14Apr2021, about an hour later, the patient had developed shortness of breath, tightness in the chest, swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse and she still has to gasp for breath. She is calling to ask if she should get her second Covid 19 vaccine. She went to an Immediate Care and to the emergency room. She received medication for her asthma. She does have a history of asthma. She received a nebulizer with albuterol and a steroid inhaler called budesonide. She feels like she has to take in a deep breath to breath when she eats something. She also received something for her chest to calm her chest down from being cramped up and inflamed. She received Prednisone 20 mg, take 2 tablets for 2 days, then take 1 tablet for 2 days then take half a tablet for 2 days. The Prednisone was prescribed at the Immediate Care on 17Apr2021 and the emergency department prescribed it again on 21Apr2021 with the same directions. She was not admitted to the hospital, she was discharged from the emergency room. The patient underwent lab tests and procedures which included blood test: unknown results on 21Apr2021, chest x-ray: unknown results on 17Apr2021, chest x-ray: unknown results on 21Apr2021, electrocardiogram: unknown results on 21Apr2021. The outcome of event shortness of breath, tightness in the chest was unknown and Swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Itching for 1 day; Rash that has increased in size 4 inches in diameter; Injection site was painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching for 1 day), RASH (Rash that has increased in size 4 inches in diameter) and VACCINATION SITE PAIN (Injection site was painful) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LANSOPRAZOLE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and MONTELUKAST SODIUM (SINGULAIR BABY) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site was painful). On 29-Mar-2021, the patient experienced RASH (Rash that has increased in size 4 inches in diameter). On an unknown date, the patient experienced PRURITUS (Itching for 1 day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date for Rash, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PRURITUS (Itching for 1 day), RASH (Rash that has increased in size 4 inches in diameter) and VACCINATION SITE PAIN (Injection site was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and FEXOFENADINE HYDROCHLORIDE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-262305 (Patient Link).
Patient admitted with Symptomatic bradycardia. He was given a dose of atropine at facility, monitored in CCU on admission. EP was consulted and he underwent PPM placement. Due to his low BP and complete heart block, carvedilol and amlodipine were discontinued on admission. Will continue to hold for now until PCP and cardiology follow up. BP is fairly stable. He was seen by PT and OT, recommended home. ED visit and hospital admission were within 6 weeks of receiving the COVID vaccine.
BlurredVision, Dizziness, Diarrhea, NauseaVomiting & Tachycardia Narrative:  Other Relevant History:
severe allergic reaction; difficulty breathing; swelling of face and throat; swelling of face and throat; fast heartbeat; a bad rash all over the body; dizziness; weakness; pain at injection site on left arm/left arm started hurting; tingling hot pins all over; tingling hot pins all over; nausea; swelling on opposite shoulder on the right; back pain; chest pain; a cold sore on her lip; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that side effects began on 27Feb2021. Side effects included tingling hot pins all over, nausea, pain at injection site on left arm/ left arm started hurting, swelling on opposite shoulder on the right, back pain, chest pain and a cold sore on her lip. She went to the doctor a couple times and reported to her doctor that all her symptoms stopped on 04May2021. She was scheduled to go back to the doctor on 14Jun2021 and they are going to test her for antibodies. She would like to know since her side effects lingered for so long, if she should receive the second dose? She wants to receive the vaccine and be fully vaccinated but she doesn't want to go through this all over again. Everyone in her family was vaccinated and they did not have any side effects. Her doctor didn't want to tell her yes or no if she should receive the second dose. After reading the severe allergic reaction side effects that include difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over the body, dizziness and weakness, the patient stated that she has all of those side effects in the middle of the night and worse. Her doctor told her that a lot of stuff happened to her and it lingered for so long in a person that doesn't usually have reactions so she should hold off and mask up and social distance and come back for her appointment in June where she will be tested for antibodies. Her doctor did blood work and took pictures and made a report and told her to call and make a report as well. Outcome of the events was recovered on 04May2021.  Follow-up attempts are needed. No further information is expected.
Chicken pox vaccine, first dose, given to me on 1/7/2015 (I have not had chicken pox before, and titer done/proved that so vaccine preventative). My body aches starting afternoon of 1/20, continued for 2 days. Rash and soreness appeared 1/21/2015 at the site where the vaccine shot was given. Went back to doctor 1/23 and she confirmed shingles outbreak at site of where shot was given.
My cheek, my left cheek seems a little bit swollen; This is a spontaneous report from a contactable consumer. A 50-years-old patient of an unspecified gender received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine: Solution for injection for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on an unspecified date as dose number unknown, single for covid-19 immunisation. No medical history. Concomitant medication included iron (IRON) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On an unspecified date patient experienced my cheek, my left cheek seems a little bit swollen. Consumer stated, I had the Pfizer vaccine (Covid Vaccine) yesterday afternoon in Massachusetts, and I am experiencing like my cheek, my left cheek seems a little bit swollen, is that normal. I am just little bit nervous, so I am making sure that everything is okay. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
my life was on pause with the vaccinations; illness; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness and impaired quality of life. On an unknown date, the outcome of the illness was recovered/resolved and the outcome of the impaired quality of life was unknown.   It was unknown if the reporter considered the illness and impaired quality of life to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient reported that after taking shingles vaccine his/her life was paused with the vaccinations and was ill for 9 months. For the tolerance of 2nd dose refer case, US2021AMR202892.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202892:same reporter, same patient, same suspect, different dose
PATIENT WAS ADMINISTERD PROQUAD PATIENT WAS PAST ADVISED AGE GROUP FOR PROQUAD VACCINE. NO ADVERSE REACTION TO VACCINE. HEALTH DEPARTMENT IS REACHING OUT TO MERCK FOR CLINICAL GUIDANCE TO SEE IF PATIENT NEEDS TO BE REVACCINATED WITH SINGLE DOSES.
Little tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hepatic dysfunction NOS and Kidney dysfunction. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM (REMODULIN) from 01-Jan-2005 to an unknown date for Pulmonary arterial hypertension.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Little tired) and CHILLS (chills). At the time of the report, FATIGUE (Little tired) and CHILLS (chills) outcome was unknown.            No concomitant medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: New Event : Chills that night reported.