chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of rotavirus in an 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and AMOXIL suspension for sinus infection. Concurrent medical conditions included sinus infection. Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on an unspecified date; ACTHIB (non-gsk); Sanofi; unknown; unknown given on an unspecified date; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on an unspecified date. There were no concurrent medications. On 26 August 2009 and 28 October 2009 the subject received 1st dose and 2nd dose of ROTARIX (1 ml, oral). On 25 February 2010 the patient started Amoxicillin trihydrate (oral), unknown dosing. On 25 February 2010, the same day the subject started Amoxicillin trihydrate for sinus infection,  4 months after 1st vaccination with ROTARIX, 6 months after 2nd vaccination with ROTARIX, the subject experienced diarrhea. A few days later, the subject developed bloody diarrhea and mucous diarrhea. On 04 March 2010, the subject experienced vaccination failure with a positive rotavirus test. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the rotavirus, bloody diarrhea, mucous diarrhea, diarrhea was unspecified. The healthcare professional considered the diarrhea was almost certainly related to treatment with AMOXIL. HCP reported that the infant received 2 doses of Rotavirus vaccination, but has tested positive for rotavirus on March 4, 2010. The patient was treated with AMOXIL and developed diarrhea one week ago on February 25, 2010. After a few days of antibiotic therapy he developed bloody diarrhea with mucous. Stool cultures and diagnostic tests were completed and the patient tested positive for rotavirus despite previous vaccination.
Severe joint pain, fever of 102 Diarrhea, nausea  Chills Still having severe joint pain  Tylenol
Arm pain did t start until the end of 2 days later, so more than 48 hours. Was pretty extreme and could not lift arm or move arm. Needed pain medication to sleep. Arm pain is still happening now over a week after the injection. It was worth the vaccine, but I have not had this kind of arm pain so many days after an injection before. No other side effects, just surprised the arm pain kicked in after 48 hours because the first 48 I felt completely fine, no arm pain at all.
child was 7 and a half and they sent the child to get the TD but they gave him an ADACEL instead; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 7-year-old male for whom it was reported that child was 7 and a half and they sent the child to get the TD but they gave him an ADACEL instead (DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE) (lot U6807BB, expiry date 10-Sep-2022), (PT: Wrong product administered)  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the wrong product administered. It was reported that the a child who just came from country to clinic to get the TD (Tdap vaccine) but was given Adacel instead. Nurse stated the child was 7 and a half years old  almost. Given dose intramuscularly in the right deltoid. Lot number was U6807BB exp: 10-Sep-2022. It was reported that they do have an 8 year old that the school needed the injection but do not want to send that child if they are going to give Adacel which was not recommended at this age.  At the time of reporting, the patient had no adverse 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 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.
Patient felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient felt dizzy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Kidney cancer.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Patient felt dizzy). At the time of the report, DIZZINESS (Patient felt dizzy) outcome was unknown.            No concomitant medications were reported.  Patient's weight was reported as 142.  No treatment  medications were reported.   This case was linked to MOD-2022-538915, MOD-2022-538920 (Patient Link).
Patient fainted for a brief second and appeared to have seizure for a couple seconds. Patient was given benadryl and allowed to rest in store for about 30 minutes.
Midline facial tingling/number starting 30 min after administration. Tingling extends to tongue.; Midline facial tingling/number starting 30 min after administration. Tingling extends to tongue.; On exam pt is neuro intact but has mild right sided facial swelling; This is a spontaneous report received from a contactable physician. The physician reported for a female patient.  A 43-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EW0172) intramuscularly, in left arm on 01May2021 at 20:00 as dose 2, single (at the age of 43-years-old) for COVID-19 immunization. The patient medical history included hypercholesterolemia, Covid-19. The concomitant medication of the patient included phentermine (PHENTERMINE). The patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via intramuscularly, in left arm on 10Apr2021 as a dose 1, single for COVID-19 immunization. On an unspecified date prior to vaccination, the patient was diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. On 01May2021 at 20:30 the patient experienced midline facial tingling/number starting 30 minutes after administration. Tingling extends to tongue. On examination patient was neuro intact but had mild right sided facial swelling. Patient had emergency room visit for the reported events. Patient received the treatment of prednisone 60 mg, diphenhydramine 25 mg and famotidine 40 mg for the reported events. Outcome of all the reported events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt received FLUMIST without provider knowing she was pregnant. This is an off-label use and pt's PCP was notified. No adverse reactions have yet occurred to our knowledge.
A lump in my arm started 2 days after injection (booster). It was a hard lump that was warm to the touch. It got smaller each day. I am on day 5 and it?s much smaller. Started the size of a tennis ball, at day 5 it?s the size of a quarter.
Approx 1515 noted a dry cough and trying to clear throat. Approx 2100 constantly clearing throat and then sought ER treatment. No SOB. Swelling.
Reoccuring unexplained skin rashes post anthrax vaccination. Pt has received 3, Sept & Oct of 1998.
This spontaneous report was received from a registered nurse and refers to a 68 year old male patient. The patient's had no pertinent medical history. The patient's concurrent conditions included allergy to CRESTOR, LIPITOR, pravastatin and ZOCOR. The patient's concomitant therapies were not reported. On 16-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml intramuscularly in the right arm, lot# N022703 and expiration date: 27-FEB-2019 as "preventative". In October 2017, the patient developed redness and swelling that started from the deltoid and traveled down the arm from his bicep to his elbow on his right arm. The patient did not receive any treatment for the event. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. The event of "allergy to ZOCOR" was captured in the MARRS # 1710USA014478. Sender's Comments: US-009507513-1710USA009764.
Child was given the Pfizer Covid 23/24 vaccine for age 6 months to 4 years instead of the correct Covid vaccine for ages 5 to 11
moderate redness & swelling over deltoid area @ site of DT (10cm site);DPH;
Had painful, indurated red spot.  Today, 6/22/11, she only has a 25-cent size area of nonpalpable faded erythema.  No longer painful.
AFTER 5 MINUTES PATIENT HAS RECEIVED THE VACCINE, SHE STATED THAT HER TONGUE IS TINGLING AND HER LIPS IS ALSO TINGLE.  PATIENT WAS CONTINUE TO MONITOR TO SEE IF PATIENT HAS DIFFICULTY BREATHING.  AFTER 15 MINUTES SYMPTOMS NOT RESOLVED, PHARMACIST GAVE PATIENT 1 DOSE OF BENADRYL 50MG AND CONTINUE TO MONITOR FOR 30 MORE MINUTES.  PATIENT FEEL FINE AFTER PATIENT WENT HOME AFTER 1 HOURS OF OBSERVATION.  FOLLOW UP CALL BY PHARMCIST AT 5:30PM ( per patient: I'm feeling better after I sleep off.  No more tingling on the tongue and lips)
I woke up feeling ok just a little tired. When I got into the office I had low back pain, chills, abdominal pain, pain behind left ear, head ache. nausea. I got up and tried to shake it off, I got this sensation of weakness like I was going to pass out and laid myself on the floor everything got a little foggy and I don't remember everything because I passed out.  The Doctors I worked with helped me up and called my husband, he took me to the ER and kept me there for a while, my BP was really low. They gave me Tylenol and IV fluids until my BP got better. I went home and felt wiped out, I was able to walk with assistance.  The following day I was fine almost like it didn't happen or I was faking it.  I didn't get an arm rash like the first dose.
Pt had some redness to site of varicella injection..  No shortness of breath, rash, trouble breathing, or other symptoms noted.  Unable to check pulse as patient would kick and hit with each attempt.  Admin 1/2 teaspoon of Benadryl per protocol and monitored patient for 1 hour.  Advised mother to take patient to ER if she has any other problems.
Entered hospital on 3/22/21 At around 8am in the emergency room. Had ultrasound of left leg and was placed in ICU for a massive blood clot in the left leg. Had surgery at around 4pm on 3/22/21 and placed back in ICU until the next surgery on 3/23/21 to remove the blood clot. Was released on 3/25/21.
patient returned to pharmacy after 40 minutes and stated that she was having itching in her arms and forehead. asked the patient to wait by the pharmacy for a brief observation. patient stated after 10 minutes that she had a headache at which point 911 was called. the patient then almost immediately progressed to nausea and vomiting and 1 Epipen was administered. EMS arrived 10 minutes later and provided support and determined patient was stable and took the patient to the ER.
25FEB clear nasal discharge-sl rash in line w/navel; scattered rales; 26FEB rash on body gone-rash on face appears; 27FEB low fever; 28FEB high fever; 1MAR hospitalized;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 8 weeks old patient of unknown gender. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Initially, I experienced typical symptoms of mild injection site pain, fatigue and muscle/joint pains that quickly went away after a day. About a week later, I developed persistent chest tightness and SOB, similar to previous asthma attacks that I have experienced in the past when exposed to things that I am allergic to. These symptoms are constant and don't respond very long to Advair with breakthrough Albuterol. I have also started taking anti-histamines as well with short term relief. The symptoms are moderate, but not life limiting as I am still able to work, but as stated, they are recalcitrant to treatment and it has been about 5 days at this point.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L008996, expiration date 06-NOV-2017 and lot# M025563, expiration date 01-DEC-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1 degrees Celsius for 30 hours. Data logger was involved. There was previous excursion reported as 8.6 degrees Celsius for 11 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011947: US-009507513-1611USA011948: US-009507513-1611USA006995.
Pt.had fever and fussing the night after vaccination was given and was given tylenol. Pt. then woke up at 2:30 am screaming and mother was able to console and get back to sleep. The same day he woke up from nap at 6:30 pm and wouldn,t stop screaming, so mother took him to ER then 6-16-04.  Pt was running temperature of 100.2 degrees in the hospital.  They were discharged from hospital with diagnosis of immunization side effect, told to continue with tylenol for 24 hours and to call or come back if continued or worsening symptoms.
Estimated start time 3 am post 2 pm shot: fever, severe body aches and headache that lasted 2 days.
Caretaker called clinic to report that site was red and swollen 2 days after vaccine.
I went to bed with a fever. I awoke at four in the morning with chills. If I did not get chills I would have not tested. I had a at home test, it was positive. My Wednesday evening, I had not symptoms. It was like 24hrs or less. I felt fine. I stayed positive for three weeks. I called my doctor, I was normal, but I knew it would be hard to get that medicine. I demanded the medicine of PAXLOVID, but never used it.
Red, circular rash; slightly raised appearing approximately 10 days after vaccination; not painful or itchy
Patient fainted and fell to the floor, hitting her head. Patient also began shaking. Patient was unconscious momentarily and regained consciousness. Pharmacist held her while sitting on the floor, patient was given water, blood pressure and pulse were also measured. Patient also answered questions to ensure she was alert and oriented. Authorities were notified and arrived promptly with EMS. Vitals were checked again and was given option to seek further care, but patient denied and stated she was fine with no issues.
starting post injection day one, I had a fever , severe body aches and lethargy for 3 days. joint pain and impaired ROM in fingers and toes began post injection day 4. since that time, joint pain has continued and spread to wrists and ankles.
Approximately 20 -30 minutes after, flushed, rapid heart rate, loss of consciousness.
swelled up top of shoulder to 1 to 2 inches above the elbow; a lump in the center size of golf ball-hot to touch-diameter of reddness approx 5in; applied ice; seen by MD 24AUG92;
Little sore arm/soreness in her right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: 20 years ago. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal. Vaccination history included: Comirnaty (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: Jun2023, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Nov2023, outcome "recovered" (02Nov2023), described as "Little sore arm/soreness in her right arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: Patient would like to know if Pfizer manufactured smaller pill size of Paxlovid. Patient received the Pfizer COVID-19 vaccine the other day and reported that she received all Pfizer vaccines. She did not have COVID but would like to know if she got the infection and she had to take the medication Paxlovid, she might not be able to take it. She stated that her entire life she had difficulty in swallowing medications. Her pharmacist showed her the pill size of Paxlovid. There was no way that she would be able to swallow that pill. Patient stated that no, did not have any problems with covid, she had masks, she had no covid problems. That was out covid booster, the updated covid booster that she had two days ago at the pharmacy, she had no problems with any other Pfizer Covid shot. Her concern was only, if she came down with covid at some point of time she could not swallow the pills that she had seen. She did not have any problems with any of shots, she had received the original shots, she received the other 2 boosters. She also received the shot in June and she had to tell that she did not have any problem with any of the Pfizer shot. She had no side effects or issue after it. She was fine afterwards except a little soreness in her arm.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA - The injection site was hard and hot for four days after the injection and I have had muscle pain/soreness in my left arm the whole time. Each day the soreness has expanded and has included joint achiness. Then on Friday, April 23rd my arm started to itch and became red and hard at the injection site, about the size of a silver dollar. The spot was bigger on Saturday April 24th and itched more. I took two Benedryl and the itching eased up. Today is Sunday, April 25th and the spot is bigger and itches if I do not take Benedryl a few times a day. My arm also becomes fatigue quickly.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by the Medical Center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7643A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 27-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 26-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated).    No concomitant medication information was reported.  No adverse effects were noted. Appropriate vaccine was scheduled or given as indicated by the CDC.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case