chrisvoncsefalvay/vaers-outcomes huggingface dataset:
increased myopia and cataract growth; increased myopia and cataract growth; vision exam in Jun2021 detected significant change; bladder/urinary tract infection resistant to antibiotics; bladder/urinary tract infection resistant to antibiotics; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EK5730), via intramuscular route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunization (Age at Vaccination was 60 years). The patient medical history included Occasional high blood pressure and borderline cholesterol. Concomitant medications included multivitamin (MULTIVITAMIN (VITAMINS NOS). She was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. She had no known allergies. She was not a pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685), via intramuscular route of administration, administered in Arm Left on 02Mar2021 16:45 as dose 1, single for COVID-19 immunization (Age at Vaccination was 60 years). On an unspecified date in Jun2021, the patient experienced increased myopia and cataract growth, vision exam detected significant change, bladder/urinary tract infection resistant to antibiotics. Therapeutic measures were taken as a result of events includes surgical removal of cataracts and antibiotics. Patient visited emergency room and physician office as a result of events. The seriousness of the events was serious and disability. The outcome of the events was not recovered.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 28 year-old female patient. On 22-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
urticaria 3 days p/vax treated w/DPH;lasted approx 24hr;
A little Discomfort in Triceps Area on the Left Arm; Very Itchy Injection Site; Warm to the touch Injection Site; Red from Shoulder to elbow; Swelling on the Injection Site; Pain on the Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE REACTION (Red from Shoulder to elbow), LIMB DISCOMFORT (A little Discomfort in Triceps Area on the Left Arm), INJECTION SITE PRURITUS (Very Itchy Injection Site) and INJECTION SITE SWELLING (Swelling on the Injection Site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE SWELLING (Swelling on the Injection Site) and INJECTION SITE PAIN (Pain on the Injection Site). On 19-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE REACTION (Red from Shoulder to elbow) and INJECTION SITE PRURITUS (Very Itchy Injection Site). On 26-Feb-2021, the patient experienced LIMB DISCOMFORT (A little Discomfort in Triceps Area on the Left Arm). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 mg four times per day. At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE REACTION (Red from Shoulder to elbow), LIMB DISCOMFORT (A little Discomfort in Triceps Area on the Left Arm), INJECTION SITE PRURITUS (Very Itchy Injection Site), INJECTION SITE SWELLING (Swelling on the Injection Site) and INJECTION SITE PAIN (Pain on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Other treatment medications include Benadryl cream and  Ice pack on the area for an unknown indication.
Patient had chills, fatigue, and sweating.  Did not have shortness at this time. Instructs patient to take Tylenol or Motrin.  If shortness of breath does occur, patient needs to call 911.
Initial report was retrieved from the scientific literature on 12 September 2013. This case also involved misuse (drug administered to patient of inappropriate age). This case is linked to case numbers 2012-10777, 2013-09581, 2013-09582, 2013-09583, 2013-09584 and 2013-09603. A 67-year-old male patient had received an injection of FLUZONE Intradermal (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced anaphylaxis. Outcome was reported as recovered. Documents held by sender: None.
Extreme fatigue - began at about 2:00 pm on day of vaccine and got gradually worse. Went to bed at approximately 9 pm.  Severe chills - started around 7 pm and was really bad at 9 pm when I went to bed.  Woke up several times during the night: 1:30 am; 3:00am; 4:30 am ; 5:00am; and 6:00am. All side effects were gone at 1:30am
after my hour drive home I started to feel tingling sensation in both legs and pain at the front where my foot meets my leg ankle, some chest pain, labored breathing for about 3 days and on the 6th day leg pain has come back. I am currently struggling with my right leg in pain hard to walk sometimes.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no information regarding concomitant medication, concurrent condition and medical history. On an unspecified day, the patient was vaccinated with 2 doses of VARIVAX (lot #, expiration date and route were not reported. No adverse symptoms were reported. Additional information has been requested.
Today I gave a Tdap vaccine to a 24 year old regular patient of pharmacy. About 15 minutes later he returned to the counter stating that he "felt funny". Specifically his head and vaccination arm felt numb. Convinced him to stay in our lounge area with his grandmother who was with him. I checked his blood pressure every 10-15 minutes for about an hour. He maintained a flushed appearance and had a slightly elevated BP. (145/95 ish when he typically runs a little low normally). At one point he mentioned a sore throat and chest tightness, but denied any swelling or SOB. We discussed calling a squad and he wanted to give it a few more minutes. I was personally on the border of calling 911, but decided to give it 5-10 more minutes per his request, and I did not feel it was an emergency at that point. At that point it did start to subside. About 1 hour later his color suddenly returned to normal. I checked his BP and it was down to 130/90 mmHg. He reported numbness, sore throat, and chest tightness were gone. He went home with his grandmother with instructions to call 911 if symptoms returned, especially if SOB occurred.
Initially after getting second dose I experienced swollen lymph nodes, body aches, and inability to move which subsided in about 2 days. I started experiencing severe cramping, pain in pelvis, and abnormal bleeding which has yet to subside as of this date.
As vaccines were being administered pt went from crying to soundless crying holding her breath. Pt's eyes opened with blank stare and open mouth. Took pt, jiggled her in my arms, gave her a squeeze she took a sharp breath. Within 10 min pt was "back to normal" was kept overnight in hospital for observation.
"Covid Arm" - Redness, pain, slight swelling and mild itching on upper arm. Has been present for three days so far with no lessening in intensity.
pt received flu and shingrix on 10/3/20. pt's family member stated the site of the injection is swollen on 10/4/20. and today on 10/5/20 pt woke up vomiting with hives on face and a fever. pt went to er and dr prescribed cimetidine, benadryl and prednisone.
No additional AEs; a pregnant patient received a GARDASIL 9 vaccine by mistake instead of the scheduled TDAP; a pregnant patient received a GARDASIL 9 vaccine by mistake instead of the scheduled TDAP; This spontaneous prospective pregnancy case has been received from  an office manager concerning to a female patient of an unknown age. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not provided.   On 27-FEB-2023, the patient was vaccinated by mistake with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, vaccination scheme frequency, route of administration, anatomical site of application, lot number, expiration date, and route of administration were not provided)(exposure during pregnancy) for prophylaxis; instead of scheduled TDAP vaccine (wrong product administered).   No additional adverse events (AE).   By the reporting time, the outcome of the event exposure during pregnancy was unknown.  The patient's last menstrual period (LMP), expected date of delivery (EDD) (due date) and the fetal outcome were unknown. The pregnancy outcome was outcome pending.
Received the vaccinations on 09/05/2023. Increased coughing less than 24 hours later, fever less than 24 hours. These symptoms lasted until 4 days after the vaccine when the patient was found deceased at home.
Fever 103F. Violent chills/shakes, swollen and alternately tingling and numb tongue. I took 50mg dyphenhydramine and went to bed with five covering quilts fully expecting to die. Awakened 3 hours later feeling more-or-less normal. Have since (now Dec 13) developed monster cold sore lower lip extending to chin, slightly jaundiced eyes, soreness liver area. I'm checking "life threatening illness" below. I believe it was. Dead viruses are still foreign proteins ... and that was one hell of an immune reaction.
30 min to 1 hour after vaccine is administered, patient became thirsty, then she throw up. Patient has chill but no fever.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 3:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 3:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with COVID-19.  The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been.  The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator.  The vials were returned to the freezer/refrigerator, or maintained at room temperature.   The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.  No vaccine state changes were noticed. The vaccine was never refrozen.  None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Mom states pt started with redness at injection site and then rash started on trunk and spread "pretty much" all over body.  Would go away with Benadryl and return with in a few hours.  Pt still had rash at office visit on 11/25.
This spontaneous report was received from a physician via a company representative and refers to an 11-year-old female patient. No information regarding the patient's medical history was provided. She used mometasone furoate (NASONEX) for seasonal allergies (it was unknown if she was taking the drug when the vaccines were administered). On 11-OCT-2018, the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly in the right arm, lot # R008163, expiration date 18-NOV-2020 for prophylaxis; MENACTRA in the right arm, ADACEL in the left arm and influenza virus vaccine (unspecified) in the left arm. Within minutes after receiving four vaccines, the patient experienced a systematic bilateral rash on upper part of her body, which was described as a red, blotchy shirt". The patient was given diphenhydramine hydrochloride (BENADRYL) and the Emergency Medical Service (EMS) was called. The patient's blood pressure, oxygen levels and temperature were monitored and they were all good. The patient seemed to be recovering so the parents declined to use EMS. The patient was taken home about one hour after vaccination. Causality assessment between the event and GARDASIL 9 was not reported.
Although patient has had seizures before 3. He had a seizure 75 hours after his last vaccination shots, it was different than the other 3 which is the reason for submitting this report. He was given Valium to stop it. He is not on any medication.
PT c/o headache, pain 6/10, and dizziness.  vitals temp 98.5, pulse 66, BP 125/66, resp 17, pO2 98, glucose 94  seen earler in day for headache but no c/o headache on assessment,, apparent change in mental state, health care provider decided to transfer child,  transported via EMS to Hospital- dx bradycardia, treated and realeased back to EIS
Rash, erythema multiforme and urticaria pruritus. Diphenhydramine 25 mg qid, Prednisone 25 mg every day, Ranitidine 150 mg bid.
This spontaneous report as received from a nurse practitioner refers to an unspecified patient of unknown demographics. On an unknown date, the patient was vaccinated with an expired dose of ROTATEQ (strength, lot#, dosage unspecified) via oral route. The patient sought medical attention. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Started with uncontrollable shaking for about an hour, then followed with muscle aches, chest congestion, stuffy nose, fever, extreme fatigue which lasted approximately 24 hours
Nothing happened for about three weeks, but then without warning, I woke up and I had tremendous pains and stiffness in my shoulders, wrists, ankles and fingers. I could hardly move or get out of my bed. I took some Advil and tried to loosen up my joints a bit and it seemed to be successful. It went on okay for a few days, but it started to get worse. I started having trouble going up stairs and I wasn't able to do push-ups anymore. I felt like I was deteriorating and so I saw my doctor. I was given a steroid prescription to help get rid of the inflammation. I am being treated as if I now have arthritis. I am at a stage where I have to have pain relief assistance all the time. I can't even pull my milk out of my refrigerator without it. I have a follow-up appointment in two weeks to find out my results and the next steps to be taken.
I came down with Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: I came down with Bells Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.   It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that please beware of shingles vaccine. The patient had shingles vaccine and came down with bell's palsy two years later. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR061465, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR061465:husband´s case
10/6/2022 I had been in contact with COVID. I had negative COVID tests for 2 days. I was congested, felt really tired, had chills and was coughing. I began spiking a fever and felt awful. My fever was 102 that afternoon and I tested positive on the rapid COVID test. On 10/7/22 my fever was down to 101. I was vomiting, felt tired, still coughing, congested, chills and sore throat. I was unable to eat. I contacted my doctor and had a virtual visit. She prescribed azithromycin. 10/8/22, I had all the same symptoms except vomiting, but had diarrhea. 10/10/22 everything tasted strange, even water tasted funny. Today is the first day I have been out of bed. I still have the taste issues, cough and am very tired.
Lethargy, body aches, head ache, lose of apatite, nausea. Lasting 3 days.
Initial report received on 06 February 2007, 07 February 2007, and 08 February 2007. This 15 month old subject (gender not reported) experienced vomiting, while enrolled in a study. The subject received four doses of study vaccine (Daptacel, and ActHib), last doses prior to the events was administered on 29 January 2007. Per the parent, in the afternoon on 01 February 2007, three days post immunization, the subject experienced several episodes of vomiting and was taken to the emergency room. The subject was transferred the following day to another facility where "he" was treated with intravenous fluids for vomiting. The subject recovered and was discharged from the hospital on day four. Per the parent, a day after hospital discharge the subject was noted to have a fever of 100.1 degrees Fahrenheit and was taken to the physician's office. The physician assessed the subject as having an upper respiratory infection and was prescribed Amoxicillin, Prelone, and Albuterol Rotavirus gastroenteritis was considered a possible diagnosis, yet at the time of the initial report there were no available details on investigations performed. The event of vomiting was reported by the investigator as related to the study vaccine due to the short time to onset of the event. Documents held by sender: Doctor notes.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and allergic reactions were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX dose 0.5 ml, subcutaneously (Lot #M044349 with expiry date 04-NOV-2018, lot #M012991 with expiry date 14-MAR-2018) for prophylaxis. The nurse could not provide the lot number and expiration date for the properly stored sterile water diluent used to reconstitute the doses of VARIVAX. The vaccines were exposed to a temperature 23 F for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. Digital data logger was involved.  No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA005344.
Itching on face, neck, scalp with urticara & errythema. Site of injection was not red or swollen. Benadryl 50mg orally & Zantac 150 mg orally & Solu Medrol 125 mg IM.
Information has been received from a 26 year old female nurse who on 02-FEB-2009 was vaccinated with the first dose of GARDASIL (Lot # was not provided). Subsequently, after she received the first dose of GARDASIL she started to experience headaches. On 01-APR-2009 the nurse received the second dose of GARDASIL (Lot # was not provided). The nurse reported she still had a headache and took medicine (name and manufacturer unspecified) almost everyday to help subside the headache. At the time of the report, the patient had not recovered. It was unspecified that the patient sought medical attention. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 19JUN90 & 17JUL90 & 11DEC90 & failed to convert to protected levels;
Cluster of two adult female patients who each developed axillary pain following the administration of ADACEL (lot number C3837BA). Initial report received on 14 July 2011 from a health professional. A 37 year old female patient, with no known allergies and no medical history, received a first left deltoid intramuscular injection of ADACEL (lot number C3837BA) on 07 July 2011. The patient had no concomitant medications. She had no illnesses at the time of vaccination and had received no other vaccines within the four previous weeks. She had no adverse events following prior vaccination. Three days later, on 10 July 2011, the patient developed axillary pain and swelling. She was seen by a physician and sent for an ultrasound, which showed enlarged axillary lymph nodes. At the time of the report, the patient had not recovered. The events for the other patient are captured in case 2011-04670. Follow-up information was received from the healthcare professional on 01 September 2011. The pain and swelling was on the left side where injection was given, left deltoid. Treatment included RICE (rest/ice/compression/elevation) and acetaminophen prn. An ultrasound was performed of the left axilla. Symptoms lasted 7-8 days and then resolved. Documents held by sender: None.
Systemic: Chills-Medium, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Flushed/Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild.
Broke out in hives on chest, back, arms and stomach. Itchiness, and hives. Took Benadryl.
Patient was generalized anxiety disorder. Onsite EMS was called vitals BP 164/94  99% O2 room air  HR 92 . Patient refused evaluation/care  and released agianst medical advice.