chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: know 4 ppl myself you got shingles FROM the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 11-JUN-2023. The case was received from the consumer interactive digital media. The reporter stated that he/she know 4 people and himself/herself who got shingles from the shot and in one instance they lasted over a year, debilitating for sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This was 2 of the 4 cases, reported by the same reporter. Sender's Comments: US-GSK-US2023AMR082854: same reporter; US-GSK-US2023AMR082853: same reporter; US-GSK-US2023AMR082797: same reporter.
hepatitis B nonresponder;  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 21 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 22 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 9. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
tested + for COVID on 8/12 after fully vaccinated with Moderna vaccine on 1/06/2021 and 2/03/2021
This spontaneous report as received from a medical assistant refers to a currently 11 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX dose, route, lot # and expiration date were not provided. On an unknown date the patient experienced an unspecified reaction post receipt of (Oka/Merck) VARIVAX. The outcome of the event was not provided. Relatedness between the event and (Oka/Merck) VARIVAX was not reported. This case is linked to MARRS # 1412USA002017 (same patient link). Additional information has been requested.
This spontaneous report as received from a medical assistant in physician's office, refers to a patient of 17 years old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. On 17-APR-2014 the patient was vaccinated with first dose of GARDASIL lot # J009788 expiration date 17-MAR-2016 and on 17-JUL-2014 with second dose of GARDASIL lot # K004204 expiration date 12-JAN-2017. Approximately on an unknown date in 2014 (also reported as unable to state when these events started for the patient), the patient experienced nausea, fatigue, stomach pains and frequent periods, dizziness. The outcome of stomach pains, dizziness, fatigue, nausea and frequent periods was reported as not recovered/not resolved. This case is linked to the 1409USA007180, 1409USA013917 cases via same reporter link.  Additional information has been requested.
Erythematous area with slight swelling and warmth. Initial redness 5 3/4 cm x 5 cm at 8 AM on Tues. Nov 3rd. By 8 AM on Wed. Nov 4th the area of redness was 6 1/2 cm x 8 1/2 cm. No other rash or breathing difficulty.
HEADACHE AND VESICULAR RASH ON BILATERAL ANTERIOR UPPER ARMS AND MIDLINE OF CHEST.
Patient's wife called this evening, stated her husband received his flu vaccine yesterday. He woke up this morning with cheeks, forehead, and nose red. It started to fade in early afternoon, but not has gotten redder again.  He has eczema, but this is different and she thinks it may be from the flu vaccine.  He has had the flu shot in the past, but never had a problem before.
HORRIFFIC HEADACHE FOR 24 HRS. THE NEXT DAY FELT GREAT, THEN ON THE EVENING OF 4/10 HAD SEVERE STABBING ABDOMINAL PAINS THOUGHT THAT HAVING BOWEL MOVEMENR=T WOULD MAKE ME FEEL BETTER BUT UNABLE TO GO. A FEW HOURS LATER ABLE TO PASS SOLID STOOL THEN WENT TO MASSIVE UNFORMED STOOL IN LARGE AMOUNTS WITH VOMITING. CONTINUED STABBING PAIN BUT NOW FEELS LIKE MY INSIDES ARE BEING TWISTED., PAI HAS TRAVELED FROM LOWER ABDOMEN  AND MOVED UP TO UPPER ABDOMEN. UNABLE TO EAT AND ONLY DRINKING WATER. . DAY 6 AND STILL HAVING PAIN
Development of a shingles-like rash on left arm and lower back. Noticed approximately one and a half days after the vaccine.
no adverse event; Administration of improperly stored VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.   On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA lot number S021092 and expiration date of 18-MAY-2020  intramuscularly, for prophylaxis (dose was not provided). No adverse symptoms were reported.   The vaccine was exposed to a temperature excursion with a total time and lowest temperature above 47°F / 2°C FOR 37 minutes. There was no previous temperature excursion and it was called because of a "data logger".
Sores in mouth and within 3 days it traveled to throat and esophagus. She had trouble eating and elevated blood pressure. She now suffers from severe memory loss.
Arm a little sensitive; warm red good sized spot appeared around the injection site which has gotten larger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Blood pressure medication for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger). At the time of the report, VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
On 10/28/16, she came into the pharmacy and stated her arm was still painful and had a red area that expanded down into her armpit and lymphnode area. She asked if the pain, which was not at the injection site, but on top of her shoulder, could be from the vaccine.
blurry vision after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision after the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (blurry vision after the vaccine). At the time of the report, VISION BLURRED (blurry vision after the vaccine) outcome was unknown.            No concomitant medication were reported.  Reporter mentioned that she contacted her pharmacist, who informed that a patient have experienced blurry vision after the vaccine.  Reporter doesn't believe that visual changes was attributed to the vaccine.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675825, US-MODERNATX, INC.-MOD-2022-675632 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675825:Other patient case US-MODERNATX, INC.-MOD-2022-675632:
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. The patient's medical history and current conditions were  not provided. On an unknown dates, the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot #, expiration date, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No medical history, allergies and drug reactions provided by the reporter. On 28-APR-2014 the patient was vaccinated with RECOMBIVAX HB (1 ml, intramuscular, second dose, anatomical location and lot number not reported). The first dose of RECOMBIVAX HB (1 ml, intramuscular, anatomical location and lot number not reported) was administered in September 2012. No concomitant medications were reported. Lab diagnostics studies not reported. No adverse effects were reported. Additional information has been requested.
Evening of the shot the right arm at the site of the injection swelled as well as the right armpit and right breast, hip and right knee also have pain and swelling.
Feeling bad; feeling rocky; Feeling really weak; Woke up with 102 fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), FEELING ABNORMAL (feeling rocky), ASTHENIA (Feeling really weak) and PYREXIA (Woke up with 102 fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Coronavirus infection in January 2021.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad), FEELING ABNORMAL (feeling rocky), ASTHENIA (Feeling really weak) and PYREXIA (Woke up with 102 fever). At the time of the report, FEELING ABNORMAL (Feeling bad), FEELING ABNORMAL (feeling rocky), ASTHENIA (Feeling really weak) and PYREXIA (Woke up with 102 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  The patient told those adverse events were similar to what when he had coronavirus in January, 2021. The patient also told that he will do to see a doctor.   No treatment information was provided by the reporter.
Patient had fever develop evening of 2nd shot, then chest pain early AM on the day of presentation to Urgent Care, 9/2/21.  Patient was worked up and found to have elevated Troponin to 347-417 ng/L (checked twice) and C Reactive Protein of 37.4 mg/L.  Patient had a normal ECG and observed in ED.  Case discussed with Cardiology at Clinic and patient discharged on NSAIDs and rest.
patient presented to emergency department on 12/9/21 with nausea and vomiting patient was admitted for further management of covid-19 patient was found to be covid-19 positive on 12/9/21 patient  did not require treatment for symptoms associated with covid-19 infection patient was discharged to home on 12/15/21
faciaI swelling and blotches on her face.; faciaI swelling and blotches on her face.; This spontaneous report was received from a consumer via Pfizer and refers to a female patient of unknown age. The patient concurrent condition included "bad reaction to eggs". There was no information about the patient's concomitant therapies or medical history provided. On an unknown date in 1999, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). On an unknown date in 1999, the patient had bad reaction to an measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine, that resulted in faciaI swelling and blotches on her face. The patient was admitted to the hospital on an unknown date. The outcome of swelling face and rash macular was unknown.  The reporter considered swelling face and rash macular to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).
I had a sore throat and some congestion. I don't think I ever had a fever but I think I had a headache. My symptoms were real mild. I took a home test. My husband had COVID so I got it from him. I called the Telehealth doctor and got the Paxlovid and isolated for a couple days.
Oral Suspension intramuscularly; left leg thigh area is red; Warm to the touch; lump that has grown since the injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number nl2rk, expiry date 18-FEB-2025) for prophylaxis.   Concurrent medical conditions included injection site lump.   On 19-JUL-2023, the patient received Rotarix lyophilized formulation (intramuscular, left thigh). In JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced injection site erythema (Verbatim: left leg thigh area is red), injection site warmth (Verbatim: Warm to the touch) and condition aggravated (Verbatim: lump that has grown since the injection). On 19-JUL-2023, the patient experienced inappropriate route of vaccination (Verbatim: Oral Suspension intramuscularly). The outcome of the injection site erythema, injection site warmth, condition aggravated and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and condition aggravated to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.     It was unknown if the company considered the injection site erythema, injection site warmth and condition aggravated to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter was the mother of the patient. The reporter reported that the patient received Rotarix oral suspension in her left thigh by intramuscular route which led to, inappropriate route of vaccination. The reporter stated that her left thigh area was red, warm to the touch and there was a lump that had grown since the injection was administered. The reporter did consent to follow up.
This spontaneous report was received from a 69 year-old female patient referring to herself. The patient did not have concurrent conditions, medical history or concomitant medications reported. She reported "she always get sick from vaccines", the only vaccine the patient specified was an unspecified flu vaccine and she did not clarify what she meant by getting "sick from vaccines". On an unspecified date in February 2016 (reported as "about one year ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml one time, route reported as injection; lot # and expiration date were not reported) for prevention of pneumococcal disease. On an unspecified date in 2016 (reported as "exactly 2 weeks after the vaccination"), the patient "got kind of sick" (malaise) and she heard "bubbling" when she breathed. The patient not sought medical attention and no treatment was given to her. On an unspecified date, she recovered from the mentioned adverse events. No product quality complaint (PQC) was involved. The causality between the mentioned adverse events and PNEUMOVAX 23 was unknown. Additional information is not expected, as there was no consent to contact.
Minor rash on chest; This is a spontaneous report from a contactable health professional, the patient. A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 22Dec2020 at 02:00 or 14:00 as reported, pending clarification (at the age of 20-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Dec2020 at 08:00 the patient experienced a minor rash on chest. The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the minor rash on chest was resolving.   Information about lot/batch number has been requested.
looks like an apple under my skin / Redness of the arm; Hotness; Covid arm with swelling; Swelling of arm; Soreness at injection site; Chills; Tired; low grade fever; Muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced MUSCLE FATIGUE (Muscle fatigue), VACCINATION SITE PAIN (Soreness at injection site), CHILLS (Chills), FATIGUE (Tired) and PYREXIA (low grade fever). On 16-Feb-2021, the patient experienced ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. On 14-Feb-2021, PYREXIA (low grade fever) had resolved. At the time of the report, MUSCLE FATIGUE (Muscle fatigue), VACCINATION SITE PAIN (Soreness at injection site), CHILLS (Chills) and FATIGUE (Tired) had resolved and ERYTHEMA (looks like an apple under my skin / Redness of the arm), VACCINATION SITE WARMTH (Hotness), PERIPHERAL SWELLING (Covid arm with swelling) and VACCINATION SITE SWELLING (Swelling of arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Follow-up information received on 17-Feb-2021 contains no new information.
rheumatoid arthritis flare ups right wrists mainly focus/on right leg; vaccine caused sore arm for an hour; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4364525-00.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis; adalimumab (HUMIRA), first regimen (Lot number: 1160839) and second regimen (Lot number: 1160838), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "rheumatoid arthritis flare ups right wrists mainly focus/on right leg"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "vaccine caused sore arm for an hour". The action taken for adalimumab and adalimumab was unknown. Clinical course: Causality for Humira (Adalimumab): The reporter's causality for the event(s) of rheumatoid arthritis flare ups right wrists mainly focus/on right leg and vaccine caused sore arm for an hour was not provided. The reporter's causality for the events 'Rheumatoid arthritis flare up' was not Reported & causality for the events 'Vaccination site pain' was Possible.   The reporter's assessment of the causal relationship of "rheumatoid arthritis flare ups right wrists mainly focus/on right leg" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "vaccine caused sore arm for an hour" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the limited information available, a possible contributory role of the Comirnaty vaccine cannot be completely excluded for the reported events.The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.