chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I'm concerned that I DID NOT have any reaction to this second dose of the Pfizer vaccine. Usually my arm is extremely sore after receiving any type of injection. Neither the injection site nor my arm ever got sore or was painful like it was after I received the first dose. I normally watch the injection actually go into my arm, but for the second dose I didn't look to see it go into my arm. The lack of pain and soreness from the second shot leads me to be fearful that I didn't really get injected with the vaccine. Is this possible, or am I just being paranoid?
while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 76 years old male patient and while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out with no reported adverse event while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2022, the patient, while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out at dose of 0.7 mL TOTAL via intramuscular route in the left deltoid (lot - UJ882AB, expiry date: 30-Jun-2023) for Immunization with no reported adverse event (incorrect dose administered) (latency : same day)  Caller reporting while administering a dose of fluzone high dose quadrivalent the needle popped off of the prefilled syringe resulting in about 1/2 of the medication to leak out of the syringe. Caller reporting they have since discarded that entire batch of needles and have not had any further issues.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Narrative: 89yo male patient died on 12/10/2021. No information about pt's death available. Last chart note from 9/16/21. Per chart (dated 4/22/21): PROBLEM LIST: Restrictive lung disease (SCT 36485005) Shoulder pain (ICD-9-CM 719.41) Postsurgical Aortocoronary Bypass Status Erectile dysfunction due to general medical condition (SCT 10954100119101) Anemia (ICD-9-CM 285.9) Vitamin B 12 Deficiency (ICD-9-CM 266.2) Anemia, Folic Acid Deficiency (ICD-9-CM Occlusion and Stenosis of Carotid Artery, without Cerebral Infarction (ICD-9-CM 433.10) AF - Atrial fibrillation (SCT 49436004) Insomnia (SCT 193462001) Hearing impaired (SCT 15188001) Presbyopia (ICD-9-CM 367.4) Male erectile disorder (ICD-9-CM 302.72)Coronary Artery Disease (ICD-9-CM 414.9) Essential hypertension (SCT 5961000) Hypothyroidism (ICD-9-CM 244.9) Dyslipidemia (ICD-9-CM 272.4) Pt had received 2 covid vaccines from outside site on 1/11/21 & 2/8/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
After injection arm was sore for ~ 3 days then soreness changed into weakness. Weakness gradually increased. Before vaccination could do 35 push-ups. As of 10/28/10 can only do 3 due to weakness of left arm. Divot noticed in left deltoid area of injection 10/27/10. Pain "2" on 0 - 10 scale.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-DEC-2015, a dose of PROQUAD (Merck) lot/batch # reported as L014405, expiration date 23-OCT-2016 was improperly exposed to - 8.1 degrees Celsius for 2 hours and 35 minutes. Then on dates from 22-DEC-2015 to 28-DEC-2015, the same dose of PROQUAD (Merck) was improperly exposed to - 2.1 degrees Celsius for 144 hours. Then on 30-DEC-2015, this dose of PROQUAD (Merck) (dose not reported) was subcutaneously administered to the patient. No known adverse effects. Additional information has been requested.
arm very sore; can barely pick anything up; chills; rash under arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm very sore), MOBILITY DECREASED (can barely pick anything up), CHILLS (chills) and RASH (rash under arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm very sore), MOBILITY DECREASED (can barely pick anything up), CHILLS (chills) and RASH (rash under arm). At the time of the report, PAIN IN EXTREMITY (arm very sore), MOBILITY DECREASED (can barely pick anything up) and CHILLS (chills) outcome was unknown and RASH (rash under arm) had resolved.            no concomitant medications are provided.. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  rash under the arms was due to eczema not the vaccine, and its resolved, they denied further follow up.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: new event is added rash under the arm and it is resolved.
MIGRAINES; CHEST PAIN; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 48 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808609 expiry: unknown) dose was not reported, frequency time 1 total was administered on 23-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient had confirmed covid-19 infection. She started experiencing symptoms which included heavy congestion of the nose and sinuses, loss of smell and taste. On 24-SEP-2021, the patient started experiencing diarrhea and nausea. On 25-SEP-2021, the patient underwent COVID-19 rapid test and COVID-19 PCR test which was found to be positive, stated as breakthrough infection (confirmed clinical vaccination failure). On 26-SEP-2021, the patient also experienced shortness of breath and chest pain. On 27-SEP-2021, the patient experienced migraines. The migraines had been treated with the over the counter medication Excedrin (acetylsalicylic acid/caffeine/paracetamol/salicylamide). On 27-SEP-2021 and 28-SEP-2021, the patient stated that the chest pain was pretty significant. The patient visited physician office for all the symptoms/adverse effects she was experiencing. The action taken with covid-19 vaccine was not applicable. The patient recovered from diarrhea, was recovering from heavy congestion of the nose and sinuses, shortness of breath, chest pain and migraines, had not recovered from nausea and loss of smell and taste and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195072.; Sender's Comments: V0:20210955502-COVID-19 VACCINE Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
REDNESS ON ARM, STARTED ON SATURDAY AFTER INJECTION, AND ON TUESDAY SEEMED TO BE GETTING LARGER
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient describes "arm feeling heavy"
VOMITING; DIFFICULTY IN SWALLOWING/ COULD NOT KEEP ANY FOOD DOWN; FACE HAS BROKEN OUT; HEADACHE; DIZZY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced difficulty in swallowing/ could not keep any food down. On 10-MAR-2021, the subject experienced face has broken out. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, difficulty in swallowing/ could not keep any food down, face has broken out, headache and dizzy was not reported. This report was non-serious.
feel Sleepy; Feeling tired; Soreness of Right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of Right arm), SOMNOLENCE (feel Sleepy) and FATIGUE (Feeling tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of Right arm). On 16-Mar-2021, the patient experienced SOMNOLENCE (feel Sleepy) and FATIGUE (Feeling tired). At the time of the report, PAIN IN EXTREMITY (Soreness of Right arm), SOMNOLENCE (feel Sleepy) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included unspecified medicines for blood pressure and diabetes.  Patient did not take any treatment for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received: No new information.
1 shot- fatigue only 2nd shot- hard to tell I was diagnosed with a UTI and told to start on Macrobid that night- I definitely did not feel well for several days but am not sure which was the cause.  skin issue started 11 days later  ( I did have a massage the day before)
Reporter states pt did not seroconvert p/recvd Engerix-B series; all injects were administered IM;
Shot area started to itch shortly after shot was administered. On 9-17 the left arm was red and itched. On 9-18 the arm was slightly swollen and warm to the touch in the red area. I went to the pharmacy to have the pharmacist take a look at it and he said to take Benadryl and Benadryl ointment for the itching. He said to watch it closely to draw a circle around the red area to see if it moves. If it does to contact my provider for further evaluation.
pt stopped breathing;did CPR called EMT;had 3 sz was cyanotic;EMT gave 02;had another sz, t102.9;iced @ hosp;given med;pt quiet, not as verbal;MD said no more DTAP or DT;
Other complications following immunization, not elsewhere classified, initial encounter on 2018-12-11.
ADVERSE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex (local case). The patient's height, and weight were not reported. The patient's concurrent conditions included: pulmonary embolism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had adverse effects was not reported. This report was non-serious.
+5 inch diameter rash at injection site with additional rash of 2 inch diameter on inside arm. Left arm.
Possible seizures, eyes rolled back, fussy, no jerking. Referred to Pediactric Neurologist.
MOTHER STATES PATIENT DID NOT HAVE PERIOD SINCE SHE WAS VACCINTED WITH HPV. PATIENT STARTED HAVING PERIOD IN 12/2021
flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp ( non-health care professional ) .  This case involves an unknown age and unknown gender patient who had flu after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown   dose of suspect INFLUENZA VACCINE produced by unknown manufacturer ( with unknown strength, form, route, batch number and expiry date ) at  unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of  flu (influenza) (unknown latency)   No lab data included  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome : Unknown
Information has been received from a pharmacist concerning a female patient with no history of chickenpox who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed shingles. A product quality complaint was not involved. No further information is available.
After 15 min. (4:10 p.m.) I left the Dr. office to go to the store in the same  town.  While there (about 4:15 p.m.) I started a bad headache, neck hurt and feeling "strange".  While waiting in the check out line I felt hot and weak.  After a few min. when I got home  ( about 5:15 p.m.)  my face felt tight and I became itchy on all parts of my body except not as much on my legs.  The next day  the headache was not as bad but still itchy especially on my face, head and back.  My arm was not any more sore than with a flu shot.  The next day the headache was gone, the arm was not sore, but I was still itchy.  The itching would come and go for about a week.
Patient advised she is still having a lot of pain and discomfort in her arm after receiving the injection back on 9/13/2016. She sought medical care and was prescribed muscle relaxer.
4/2/21 Fever, chills, joint pain (hips, knees, wrists, neck, ankles, some fingers), injection site pain, fatigue, thirst, headache. Fever and event onset 7am. Rested and fluids until 6pm. Took 1 dose (2 tablets) 500mg each  Acetaminophen. Fever broke at 7pm.  4/3/21-4/5/21 minimal injection site pain, minimal joint pain 4/6/21 fatigue,  thirst, increased joint pain 4/7/21 no adverse effects 4/8/21 increased joint pain
I woke up at 3 am with a massive gout attack in my right ankle. It was so painful I couldn?t put my foot on the floor.
No additional AE; A vaccine coordinator called to report an AE where improperly stored dose of  were administered to a patient on 24 OCT 2022. No adverse effects were reported. No additional information was provided to further clarify these details. No additional AE.; This spontaneous report was received from vaccine coordinator, referring to an 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions  and concomitant therapies were not reported.  On 24-OCT-2022, the patient was vaccinate with hepatitis a vaccine, inactivated (VAQTA) (lot #w023937 has been verified to be a valid lot for VAQTA, expiration date 06-DEC-2023) (strength, dose regimen, route of administration and anatomical location were not provided). In addition the vaccinate with hepatitis a vaccine, inactivated (VAQTA) underwent to temperature excursion of 33.6 degree Fahrenheit for 3 hours and 46.9 degree Fahrenheit for 1 hour and 48 minutes (product storage error). The time frame of temperature excursion was 4 hours and 48 minutes. On an unknown dates, there were previously temperature excursion of 34.3 degree Fahrenheit for 48 minutes, 34.3 degree Fahrenheit  for 1 hour and 42 minutes, 34.9 degree Fahrenheit  for 1 hour and 18 minutes and 34.3 degree Fahrenheit  for 1 hour and 18 minutes. No additional adverse event was reported.
Information has been received from the authors of the published literature article concerning to an 18-day-old patient (gender not reported) who was exposed to measles when taken by the police to authors ED after being abandoned. On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (strength, route of administration, lot number and expiration date not reported) for prophylaxis. A large debate ensued about whether appropriate isolation could occur in a group or foster care setting. The neonate was ultimately sent to a home with an immune family, shortly before the index patient was determined to ultimately have the vaccine-induced rash. The patient's outcome was not reported.   This report is linked to case US-009507513-2008USA013592 from the same literature article.  A copy of published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2008USA013592:
Some problem tried to communicate and report any signs and symptoms for treatment and time of course with the administered and some the provider.
About a week after receiving the vaccine, a sudden red splotch has appeared around the injection site. Red splotch is warm to the touch and tender.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No treatment medications were reported.   This case was linked to MOD-2022-501575.
received Moderna COVID-19 Vaccination 1/25/21 first in series 2/22/21 2nd in series. Testing using POC 4/11/21 symptomatic felt feverish, Temp 100.0 muscle aches and headache. Household contact COVID + case 4/9/21.
Shortness of breath; Hot flush; Wife has been sweating for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Wife has been sweating for 4 days), DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0780214) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021 at 10:30 AM, the patient experienced HYPERHIDROSIS (Wife has been sweating for 4 days). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush). At the time of the report, HYPERHIDROSIS (Wife has been sweating for 4 days) had not resolved and DYSPNOEA (Shortness of breath) and HOT FLUSH (Hot flush) 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.   No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Added patient details and new events and event outcomes were added
a patient received an expired MMR II; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 02-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S010704 with an expiration date on 08-APR-2021) for prophylaxis (expired product administered).  Strength, dose, anatomical location, and route of administration were not reported.
Injection site pain, hardness, and swelling of lymph nodes in same arm as injection, about 4 hours after injection. Bruising on underside of arm. Chills, lightheaded about 6 hours after vaccine.