chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Talking caused SOB & nauseous/vomiting; Talking caused SOB & nauseous/vomiting; Fatigue after vaccination; fatigue increases.; Passed out at end of trip (confirmed ventricular tachycardia); Passed out at end of trip (confirmed ventricular tachycardia); Unable to walk > 10 ft/During trip, difficultly walking uphill; By midMay tolerates walking but gets SOB on staris/talking caused SOB & nauseous/vomiting/By midMay tolerates walking but gets SOB on stairs; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias.; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias; Continued to worsen; Right ventricle pumping inadequately; Cardiogenic shock; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration, on 23May2021 (at the age of 60-years-old), as unknown dose, single dose for COVID-19 immunization and varicella zoster vaccine RGE (CHO) (SHINGRIX) on 27May2021 for immunization. Medical history was not reported. Concomitant medications included Furosemide (LASIX). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 after vaccination, the patient experienced fatigue and it was increased. By mid of the May the patient tolerates walking but got shortness of breath (SOB) on stairs. On 20May2021, the physician doubled Furosemide (LASIX) dose for unspecified trip. During the trip, the patient had difficulty walking uphill. It was reported that patient passed out at end of trip, it was confirmed with ventricular tachycardia. On an unknown date, the patient underwent echocardiogram, and the ejection fraction was 25%. On 04Jun2021, the patient admitted to hospital in 100% atrial fibrillation & significant ventricular arrhythmias. The patient was treated with Intravenous heparin and he was kept for 2 nights in the hospital. It continued to worsen. On 08Jun21, the patient was unable to walk more than 10 feet, while talking caused shortness of breath and nauseous/vomiting. The patient was admitted to another hospital. On an unknown date, in hospital the patient had an esophageal echo to rule out (R/o) any clots in heart or lungs. On 09Jun2021, a cardioversion and on 10Jun2021, an angiogram was performed, it did not show any blockage or valve problems but showed the right ventricle pumping inadequately. The patient was advised new medications which included amiodorone. The patient was currently diagnosed with cardiogenic shock and expected to remain in CCU (cardiac care unit) until end of week. It was also reported the patient was hospitalized for Life threatening illness (immediate risk of death from the event). Seriousness criteria was reported as life threatening and prolonged hospitalization. The outcome of all the events was unknown.  Information on Lot/Batch number has been requested.
suspected vaccination failure; Got the shot and had shingles; it's a pain like no other constant 24 hrs a day; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got the shingles shot and had shingles. The patient reported that it was a pain like no other constant 24 hrs a day no ease and no rest at all worst than having a baby. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation was not reported.
Pfizer vial not diluted before preparing syringe. Patient received entire vial. Patient monitored for 1 hour post injection with no reactions. Patient contacted x 3 days post injection with no reactions noted.
24 hours after injection I felt I had a very mild case of the flu. Mild chills and mild aches. No fever. Lasted about 36 hours. Took Tylenol.  72 hours after injection a mild rash appeared around the injection site.
She received PCV13 vaccine around 10am and she started to have chills in the afternoon, then fever, fatigue, nausea, body shaking, loss of appetite.
Recieved the vaccine and the following morning around 5am had a seizure which lasted for about 20 minutes. Was transported by ambulance to medical center and recieved care until he was stable and able to go home, but told to follow up with his neurologist as soon as possible. The neurologist saw him within 2 weeks and increased the dosage of his Vimpat and has ordered for him to have a 3 day EEG as soon as possible.
representative; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 05Oct2021 15:09, outcome "unknown", described as "representative". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt stated pneumonia shot hurts from shoulder to elbow; denied any problem w/flu vax; pneumonia vax area is swollen; 26OCT93 ER MD told pt arm was infected & gave medication;
Two days after taking second Moderna vaccine, patient started having tingling sensation that started at fingertips which radiated up her arm.  She went to her primary care physician and it was recommended that she ice her arm and start on a Vit B6 regimen.  She continues to do these things but still has tingling in her index and middle fingers on her left arm.  She states that it has improved over time, but tingling stills persists.
received ADACEL PFS on 20Dec2021, but the product expired on 09Dec2021 with no reported adverse event; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who received Adacel pfs(prefilled syringe) on 20 Dec 2021, but the product expired on 09 Dec2021 with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Dec-2021, the patient received a primary dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, prefilled syringe, via intramuscular route, (with an unknown frequency, strength) lot number C5687AA, expiration date: 09-Dec-2021 in the left arm.  On 20-DEC-2021 the patient developed a non-serious event "received Adacel pfs on 20 Dec2021, but the product expired on 09 Dec2021 with no reported adverse event "(expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received ADACEL PFS on 20Dec2021, but the product expired on 09Dec2021 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received Adacel pfs on 20 Dec2021, but the product expired on 09 Dec2021 with no reported 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
REPORTED BECAUSE PT IS NOT 18 YRS. PATIENT ONLY HAD MINOR SORNESS IN ARM FOR 2 DAYS
01/07/22 presents to ED for "1 week of ongoing appetite loss, myalgias, chills and fatigue".  "Tested positive for Covid19 infection.1 week ago" PMHx of "kidney transplant currently on CellCept and Prograf"
Chronic right shoulder pain up her neck.  Pain makes it hard to lift arm and perform some daily activities like cleaning, hair brushing. Very painful to lift arm.  Cannot sleep on that side without pain.
Developed a Maculopapular rash with some areas of pustules that have a burning more than itching feeling 11 days s/p smallpox vaccination
3pm: Immediate body-wide, internal feeling that can only be described as "intoxication." Felt loopy & woozy -- not lightheaded or dizzy. Felt as if I were floating to chair. Sat for 20mins, legs weak, odd sensation across shoulder blades & cervical spine. "Slow" & woozy for duration of evening. Physically moved slow, cognitively slowed down, inability to focus. Internal body-wide sensation difficult to define. All very similar to immediate effects I have from alcohol. Passed out (sleep) 9hrs later & woke 100% fine at 8am.
Patient awoke with shivering at 03:00 AM this morning, later developed diaphoresis, swelling of the eyes, lips, and tongue at 08:00 AM. Patient presented to the emergency department and was treated for allergic reaction; received prednisone and famotidine per patient MAR. Symptoms resolved and the patient was discharged with a prescription for a prednisone taper.
On August 22, patient received immunizations.  On August 24 mom brought patient into clinic with complaint of swelling, redness in left arm which she noticed on August 23rd.
inconsolable crying for 5 1/2hrs w/periods of shrill cry;nl temp non-ASA product given q 4 hrs;
I had a heart rhythm that was abnormal along with a high heart rate, I requested the booster half dose of Moderna and just found out that they gave me a full dose. I only had approval to get half a dose.
Information has been received from a woman concerning her niece who was vaccinated on an unspecified date with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On an unspecified date, shortly after receiving the vaccination, the patient experienced an inability to walk for a few weeks and diarrhea. Unspecified medical attention was sought. On an unspecified date the patient recovered. No product quality complaint was involved. Additional information is not expected.
Narrative:  Patient had a Break Through covid infection with confirmed Covid Positive Test. Patient had been feeling lousy with on/off fevers.
The site of injection is real itchy; Injection site was round; Injection site hard underneath; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The site of injection is real itchy), VACCINATION SITE URTICARIA (Injection site was round) and VACCINATION SITE INDURATION (Injection site hard underneath) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (The site of injection is real itchy), VACCINATION SITE URTICARIA (Injection site was round) and VACCINATION SITE INDURATION (Injection site hard underneath). At the time of the report, VACCINATION SITE PRURITUS (The site of injection is real itchy), VACCINATION SITE URTICARIA (Injection site was round) and VACCINATION SITE INDURATION (Injection site hard underneath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A 17 year old male patient experienced fatigue after receiving post exposure treatment with RabAvert following a dog bite while traveling to Peru. The patient received 5 doses of RabAvert, the first dose on 07/16/2004 and the last dose on 08/13/2004. During and after the entire rabies vaccine series the patient was very fatigued, sleeping 12 hours a day during summer vacation and continued to be very fatigued after returning to school. Laboratory tests revealed a billirubin of 4.1 mg/dl and urine protein of 100 mg/dl. The patient had no other associated symptoms. The patient reportedly had grown over four inches during the summer and liked to sleep 12 hours a day. At the time of this report the patient continued to be fatigued and the billirubin remained elevated. Epstein Barr Virus and Cytomegalovirus test results were both negative. The patient was sxheduled to see a liver specialist.
Information has been received from a nurse concerning her 12 year old daughter who on 02-MAR-2007 was vaccinated IM with the first dose of GARDASIL.  On 27-APR-2007, the patient was vaccinated IM with the second dose of GARDASIL and on 17-AUG-2007, the patient was vaccinated IM with the third dose of GARDASIL.  The patient reported pain in the arm at the injection site for 3 days after the vaccination was given.  The pain in the arm included not being able to lift the arm.  The nurse also reported that since multiple patients (3 patients) reported pain in their arms, they started giving the vaccination in the buttocks to an unspecified number of patients.  Unknown medical attention was sought through contact with the nurse.  Patient outcome was unknown.  No product quality complaint was involved.  This is one of the multiple cases from the same source (WAES # 0805USA01521 and 0805USA01522).  Additional information has been requested.
vomiting, diarrhea when woke up at 5:30 am achiness, dizziness, tiredness throughout rest of day
P/vax MTR noticed fine rash over thorax & lower legs. Came to clinic p/having rash 3 day.
Improvement of a previous condition of CLL leukemia; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (since 2016).   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 mg. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Improvement of a previous condition of CLL leukemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: normal (normal) white cell count decreased to normal levels.         No concomitant drugs were reported. No treatment drugs are not provided by reporter.
1/2hr p/vax pt exp nausea couple of hr later exp SOB, gen aching & h/a;awoke @ 4AM 24OCT w/severe back pain & ha/;didn't take temp but feels has low grade temp & ears hurt;
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter. NDC- 80777-273-10   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live non significant follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
WHO: VR-See above, Vaccinator-, Admin-SPC OIC- Medical Provider- WHAT: Day 21 vaccination of Moderna WHERE: WHEN: See above WHY: Pt had both a Pfizer & Moderna documented as her first dose. Pt was 100% sure she had received Moderna, this correlated with her CDC card. Moderna verified with admin,  allowed for the dose to be documented BEFORE vaccine was administered. After admin, it was noticed the pts initial date of vaccination was on 4/7/2021, which is only 21 days post (today). At this time the VR had left, was called and informed. Pt was not concerned. (See continuation page)
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 30-NOV-2018, the patient was vaccinated with an expired dose of VARIVAX (dose and route were not provided) lot# M046929 expiration date 28-NOV-2018, for prophylaxis. No adverse effect was reported. Lot# M046929 is not valid for VARIVAX.
This spontaneous report was received from a pharmacist, and refers to a 70 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In 2013, the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, Lot # and expiration date were unspecified. The reporter stated that, the patient had been experiencing shingles every 2 months since she received ZOSTAVAX. The outcome of the singles was unknown. The relatedness between the shingles and ZOSTAVAX was not reported. Additional information has been requested. -
No additional AE; Caller reported AE for inadvertent administration of PROQUAD following a TE.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 08-JUN-2023, the patient was inadvertently vaccinated with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA))(PROQUAD) injection (0.5 ml, lot # X011437 has been verified to be valid, expiration date reported as established as 18-JUL-2024; strength, and route of administration were not provided) for prophylaxis following a temperature excursion (TE) (product storage error). The storage temperature of the vaccine was 6.4 degree Celsius for a time frame of 191 hours. There was no previous temperature excursion. TE assessment was not evaluated, and products were not back in recommended range. No symptoms were reported. No additional adverse event (AE)/product quality complaint (PQC).
2"x 2" reddened area. Very itchy appeared 10 days at injection site. Alavert 1 tablet given po for itchy feeling.
upper respiratory infection; sick; sick in bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of upper respiratory tract infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JUL-2023, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upper respiratory tract infection (Verbatim: upper respiratory infection), sickness (Verbatim: sick) and bedridden (Verbatim: sick in bed).  The outcome of the upper respiratory tract infection, sickness and bedridden were not reported.   It was unknown if the reporter considered the upper respiratory tract infection, sickness and bedridden to be related to Shingrix.     It was unknown if the company considered the upper respiratory tract infection, sickness and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 This case was reported via (social media) interactive digital media. The reporter informed that his/her mother was sick in bed with an upper respiratory infection plus side effects from Shingrix vaccine.  The follow-up could not be possible as no contact details were available.
21MAY92 informed that p/recvd inject on 21JUN90 pt was seen in ER about 630PM; parents found pt passed out, pale & hot in gravel of basement of new home; eyes were rolled back in head & temp was about 105 @ ER;
Woke up shaking with chills but no fever--had those for approx. 6 hours. Also woke up with nausea--had that for approx. 6 hours.
Blackout; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FD8448) as dose 1, single for COVID-19 immunisation. Medical history included Open heart surgery. Concomitant medications included pentoxifylline, atorvastatin, omeprazole, metoprolol, warfarin sodium (JANTOVEN), lisinopril and aspirin (ACETYLSALICYLIC ACID). No prior vaccination was given (within 4 weeks). The patient's doctor told her to call and report the side effects that she had. Ten (10) days after her first dose, on an unspecified date, she had a blackout and dizziness for about 4 hours. No treatment was given in response to the events. The patient had an MRI on an unspecified date to make sure she did not have any stroke when she blackout and she did not have one. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
After shots and patient walked out of immunization room, he then collapsed and fell face first hitting a hard object. Did not loose consciousness but appear weak. Was transported to hospital by ambulance staff.