chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; got shingles.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles.). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got shingles a year after he/she got the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR066806, reported by the same reporter , for a different patient.; Sender's Comments:  US-GSK-US2023AMR066806:same reporter
I experienced COVID-19 on February 2023. I experienced a cough which became very bad, sore throat, body aches, runny nose, fatigued, productive coughing. I went to the ER where chest x-ray was performed and a physical exam. I was told by the ER doctor I had pharyngitis secondary to my COVID symptoms and they gave me a cough medicine. I took a COVID rapid test at home on 02/01/2023 and it was positive. I have recovered from my COVID symptoms.
the next day in the am  headache and nausea , diareahhe ,on the 14aug on migraine meds. every day after you had headaches. Headache did not go away. Everything ended 2 days later except the headache
SEVER SWELLING. COULD NOT WALK FOR THREE DAYS DUE TO SWELLING AFFECTING LOWER BACK. LEFT SIDE OF BODY IS STILL SWOLLEN. SEVERE CHRONIC FATIGUE STILL AFFECTING ME. I NOW HAVE DIABETES. LAST 5 YEARS OF PHYSICALS SHOW BLOOD SUGAR NORMAL. DAILY HEADACHES.
This is a spontaneous report from a contactable consumer, reporting for himself. This 91 year-old male patient received the second single dose of PREVNAR 13 06Oct2016 for immunization. The patient was inadvertently given this second dose as he had already received for immunization a first single dose of the same vaccine on 11Aug2015. Relevant medical history and concomitant medications were reported as none. On 06Oct2016 in the evening at 11 pm the patient had bleeding through the urinary tract. That evening he also felt nauseated, he got up, blacked out and was unconscious for a couple of hours. Due to these events he was hospitalized from 06Oct2016 to 08Oct2016. On an unspecified date the patient also experienced a lung condition for which received a treatment with ALBUTEROL inhaler. An unspecified laboratory work was done on 07Oct2016. Outcome of events was unknown.
lot of pain in the left side of injection arm; Chest felt incredibly heavy like someone or several people is sitting on it; Muscle pain in back and legs; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm left on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation and also second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included adalimumab (HUMIRA) for an unknown indication, from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 the patient experienced a lot of pain in the left side of vaccinated arm, chest felt incredibly heavy, like someone or several people were sitting on it and had muscle pain as well in back and legs. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events lot of pain in the left side of vaccinated arm, chest felt incredibly heavy and muscle pain in back and legs were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
8 days post vaccine red round rash at injection site that is itchy and uncomfortable to touch.  No big deal or anything, but considering the newness of the vaccine I thought you might want the information.  I am just putting lotion on it to keep it moisturized because it seems a little dry in that area.
Diagnosed with oral candidiasis of the mouth./ gross mouth; Diagnosed with localized bacterial infection at the injection site on the right arm.; Few hours later developed sore throat.; Few hours later developed pain in the right arm at the injection site. / Arm became painful to light touch.; Few hours later developed an urticarial rash below the injection site.; Few hours later developed fever.; Few hours later developed chills.; Few hours later developed myalgias.; Few hours later developed bodyaches; This spontaneous report was received from a physician referring to a 37 year old female patient with a history of sinus infections. The patient's concurrent conditions, concomitant medications, historical drugs, drug reactions and allergies were not reported.   On 18-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) by intramuscular injection in the right arm (strength, dose, and frequency were unknown) with lot # S004548 and expiration date reported as August 2020, but upon internal validation established as 12-AUG-2020. Fewhours later after the vaccination, the patient developed pain in the right arm at the injection site, an urticarial rash belowthe injection site, fever, chills, myalgias, bodyaches, sore throat and the right arm became painful to light touch.  The physician reported that on 23-JUL-2019, the patient was seen at an unspecified urgent care facility and was diagnosed with oral candidiasis of the mouth, and a localized bacterial infection at the injection site on the right arm. The patient was treated with nystatin reported as via "swish and swallow", azithromycin and ibuprofen (MOTRIN) reported as "around the clock".  At the time of the report, the outcome of oral candidiasis, bodyaches, myalgia, sore throat, chills, fever, urticarial rash, injection site pain and localized bacterial infection was reported as not resolved.   Oral candidiasis and localized bacterial infection were determined to be disabling by the the physician because the patient had not been able to return to work due to these symptoms. Causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
PT states that the pharmacist went to high on her shoulder when giving the vaccine. After a few hours she couldn't move her arm, she still cant lift or rotate her shoulder. She is in intense pain and believes it is due to vaccination given
exposed via breastmilk; hives; This is a spontaneous report received from contactable consumer (mother) reported for baby (patient). A 17-month-old breastfed female patient exposed BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via transmammary on 14Apr2021 (at 17-month-old) at 1st dose, single and on 05May2021 at second dose, single for COVID-19 immunisation. No patient history (medical history, family medical history), other products, and other vaccines within 4 weeks. The patient broke out into hives after caller received each dose of the vaccine. The first time that she noticed the hives was on 18Apr2021. They thought it was a rash but then learned that it was hives. They took the baby to the emergency room on 23Apr2021 but they thought it was unlikely that it was from the vaccine because it's not a live vaccine. They had her do loratadine (CLARITIN toddler chewable) once daily and it worked for 2 days. She stopped taking the Claritin and then the hives would come back. The hives did eventually stop, maybe five days before the second shot. Then the second shot was on 05May2021 and the hives were there the next morning. The baby still had the hives, and the loratadine was helping but it seems like every time she skips a day of loratadine it comes right back. She did ended up seeing a dermatologist for the baby after her second shot. They gave her Baby diphenhydramine hydrochloride (BENADRYL) but it did not work at all. She tried oatmeal baths, and that did not help. The dermatologist said because of the timing it has to be related. Hospital admission was not required for her baby. The only thing caller took directly following her vaccines was the paracetamol (TYLENOL). The hives did not bother the baby at all, they just looked bad. They were warm to the touch, and the baby was warm. They were on her face to just past her knees. They got better only with loratadine. If she misses a day of the loratadine, the next morning they would be bad. They ended up worse under her arms and chest and back - are the worst. The outcome of the events was not resolved.  Communication: PC filed. The caller was provided with company phone number of #, option 3, and hours of operation of Monday through Friday, 8AM to 8PM, Saturday and Sunday 9AM to 3PM for COVID-19 vaccine inquiries, prior to warm transfer. Warm transferred  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547082 same reporter/drug, different patient/event (baby case)
1ml dose given instead of 0.5m, patient contacted, no adverse reactions reported by patient. Patient advised to call office or go to ER if any adverse reactions occur such as SOB, tachycardia, elevated fever
Patient recieved vaccine on Friday. Complained about knees swelling on Saturday morning and then hand swelling on Sunday.  Patient would take some Tylenol to help with the pain and it helped alleviate the pain.  Came in on Tuesday Sept 3rd and showed the hands and knees which looked like it was a little swollen.  Advised patient to take some ibuprofen as it would help bring down some of the swelling and also to call his doctor.  I also told him that I would also contact his doctor as well.  But that he should call his doctor if the pain and swelling continues.  I also told him that I would report this incident to VAERS.  Doctors office was closed when we tried reaching out as it was already past thier hours when he came in.  Will reach out to them tomorrow.
Patient presented on 3/7/11 at 11:00am with warmth, swelling and redness at injection site. Pt noticed hardness of arm approximately 12 hrs after injection given. Advised pt to apply cold compress to injection site and take Acetaminophen.
Hot Flashes started two weeks after 2nd dose and continuing for the next couple of weeks.
Myalgia, Fever, Nausea Vomiting, Chills, pain @ injection site, Narrative:
On the day of the vaccine (5/7) I just felt tired and pain on my arm.  The next day (5/8) I had a pounding headache that wouldn't go away. Pain in all my joints. Pain in my lower back. Neck pain. Low fever. Exhaustion. Felt extremely cold. Pain in the shot area. I took an Aleve and rested all day, symptoms were better but didn't completely go away. 5/9 Strong lower back pain. Headache (mild) . Felt angry and exhausted all day as if I had PMS, but it can't be PMS since I had period the week prior to the vaccine. 5/10 developed a big red bump with hives on the vaccine area and also pain. Been having headaches on and off all day. Little blurriness of vision, feeling a little bit dizzy. Strong lower back pain. Took aleve and put voltaren on back. Feeling a little bit of heart palpitations every now and then. Will take benadryl to see if it helps with the bump/hives.
Generalized hives, worse on legs and buttocks, started ~30 minutes after injection. Never had allergic reaction to vaccines in past. Treated with 2 50mg Benadryl. Symptoms began improving ~30 minutes after Benadryl. No cough, difficulty swallowing or shortness of breath. (No other symptoms other than hives)
Headache; Chills; uncomfortable; Nausea; Night sweat; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea) and NIGHT SWEATS (Night sweat) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea), NIGHT SWEATS (Night sweat) and ASTHENIA (Weakness). At the time of the report, HEADACHE (Headache), CHILLS (Chills), FEELING ABNORMAL (uncomfortable), NAUSEA (Nausea) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Tylenol
COVID + on 11/2/2021;  cold like sxs, runny nose, sore throat, achy and HA.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date- 22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
On June 6, 2021 client], 13 yr old female (DOB: 8/17/2007) was getting her 2nd Pfizer dose (Lot# ER876; Exp 7/2021) on left arm by vaccinator at 10:20am. According to nurse at 10:00 AM she drew up 3 doses of Pfizer from vial prior to administration. She stated she placed the 3 drawn up vaccine syringes in a black glove to shield it from light and placed the other 3 empty syringes and the vial under a chucks pad. Nurse stated she checked the syringe prior to administering the first and third dose but does not recall checking the syringe during the 2nd administration. Nurse realized that after the  3rd person was vaccinated that she still had a syringe with a full dose and 2 empty syringes under the chucks pad. nurse stated that she is certain it was the 2nd client that she vaccinated that received an empty dose stating the "plunger felt weird". Client was observed for 15 minutes and no vaccination symptoms was noted.
PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 10ML. PATIENT SENT TO ED.
Swollen lymph nodes; Hot at the injection site; Red at the injection site; Swollen at the injection site; Chills; Was not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), CHILLS (Chills) and MALAISE (Was not feeling well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), CHILLS (Chills) and MALAISE (Was not feeling well). On 23-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 23-Jan-2021, CHILLS (Chills) and MALAISE (Was not feeling well) had resolved. On 28-Jan-2021, INJECTION SITE WARMTH (Hot at the injection site), INJECTION SITE ERYTHEMA (Red at the injection site) and INJECTION SITE SWELLING (Swollen at the injection site) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment provided
redness & swelling 3 1/2" x 3" @ inj site;
After vaccine administration patient became unconscious for 20 seconds. Patient turned red. Stopped breathing and became limp. Pt returned to consciousness and assessed by Dr. normal vital signs and behavior returned.
Around the 8th of March I had intestinal problems. I could not eat, walk, diarreha, dizziness, balance issues, dry heaves, overheating. Doctor said it sound like a viral gastroenteritis. About mid April, I had muscle weakness, fatigue, overheating, could not care for myself. I was very weak. In between episodes I get little thing happens, my skin burning, circles on my back, shocks that go down the sides of my feet, and numbness in my feet. I was referred to a neurologist. I also had a UTI.
Patient received moderna vaccine on 4/2/21 and 5/7/21. Presented to ER on 6/26/22 and found to be COVID positive. Presented to the ED with complaints of diarrhea that started 4 days ago. In the emergency room patient's blood pressure was on the softer side at 99/69.  She received 2 1 L boluses.  She was found to have a creatinine of 3.4, and a BUN to creatinine ratio 15. CBC was within normal limits.  Lactic acid was normal.  Procal was elevated at 0.25.  Blood cultures, stool culture, C diff, and should go were collected in the ED.  Patient was also found to be positive for COVID.  Lungs were clear on examination. She remained afebrile and vital signs stable throughout hospital course.  Diarrhea resolved.  Before discharge blood culture showing no growth for 1 day stool culture showing no growth for 1 day.  C diff was negative.  Urine studies were consistent with a pre renal etiology for her AKI.  There was no respiratory compromise at any point.  Discharged on 6/28/22.
Patient stated that she got two tiny pustules in the left upper scapula area that were on a pain scale of 6/10. She said her primary care doctor did diagnose them as shingles but the pain was way less than when she had the shingles in 2010. She said that the pain has gone away but every once in a while the muscle of injection site feels fatigued.
This case was reported by a physician and described the occurrence of vaccination failure in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose, 3rd dose and 4th dose of ENGERIX B (unknown). On an unspecified date, four years after 1st dose, 2nd dose, 3rd dose vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject then received a Booster dose, one month after the Booster (4th) dose of ENGERIX B the subject experienced presence of DNA PCR load (hepatitis b dna detectable), possible hepatitis b or vaccine not effective. This case was assessed as medically serious by GSK. At the time of reporting the outcome of vaccination failure, possible hepatitis b, not responding to therapy and hepatitis b dna detectable was unspecified.
Patient's father was holding child when child became "clammy" feeling.  Parents of child checked out at retail store and exited store.  Mother of patient noticed child losing color.  Father of child held the child out and noticed the patient lose all color, lips turn purple and child became unresponsive.  Child was rushed back into the retail store where 911 was notified, clothes of patient were removed and several attempts to alert the child were made.  The patient became cognizant but appeared drowsy as the ambulance arrived.  Patient's color slowly resurfaced.  Child was transported to Hospital, where patient was admitted for 24 hours.
hotness; injection site pain; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hotness), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017821A) for COVID-19 vaccination.     Concomitant products included OXYBUTYNIN for Bladder disorder, OMEPRAZOLE for Gastrointestinal disorder, LEVOTHYROXINE for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (hotness), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (hotness), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown. Not Provided      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.   Treatment details were not provided.
Itching of bilateral hands and right side of forehead. Small red spot noted right side of chest. No rash on hands or forehead . Patient denies SOB
third dose may have been full dose instead of half; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (third dose may have been full dose instead of half) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (third dose may have been full dose instead of half). At the time of the report, ACCIDENTAL OVERDOSE (third dose may have been full dose instead of half) outcome was unknown.            No concomitant and treatment drug information was provided.