chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse drawing up Moderna doses drew up and administered 0.3mL doses instead of 0.5mL. Patient was notified 10/06/21 and offered to received the additional 0.2mL to receive the full dose.   Alert about age was bypassed, patient was 15 years old.
This spontaneous prospective pregnancy report has been received from a registered nurse referring to a 28 year old female patient. The patient had no drug and allergy history to be reported. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On 04-OCT-2017, the patient was vaccinated with VARIVAX lot # N008829, expiration date 16-MAR-2019, subcutaneously (strength was not reported) for immigration purposes.  Other suspect therapies included M-M-R II, lot # N005774, expiration date 17-FEB-2019 (strength, route of administration were not reported) for prophylaxis. The patient became pregnant with a last menstrual period (LMP) approximately of 13-SEP-2017 and estimated due date (EDD) of 20-JUN-2018. Initial exposure to VARIVAX and M-M-R II was at 3 weeks of pregnancy (first trimester of exposure). At the time of this report, the pregnancy outcome was unknown. On an unknown date the patient experienced and no adverse event. The outcome of exposure during pregnancy was unknown. No adverse events were reported. At the time of this report, the causality between the event and M-M-R II and VARIVAX was not reported.
On February 15, 2023, I had a fever I have, acute stomach pain, elevated blood count. I went to the emergency room where they ran bloodwork. I was given antibiotics to take for ten-day course, AUGMENTIN. The AUGMENTIN helped keep the flare cleared up for about a week to a week and a half then I had another flare, I was put on another ten-day round of AUGMENTIN. My doctor also ordered a CT scan where is was discovered I have acute diverticulitis of transverse colon. I am dealing with a third flare.
On 20 Mar 07 I woke up with pain and redness. Over the next 24 hrs the redness had spread almost covering my entire upper arm and was hot to the touch and had signs of swelling around tricep and elbow. 21 Mar 07 I was seen in the ER and was given Benadryl.
was vaccinated. Is recovering from shingles/suspected vaccination failure; awful shingles on face; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comment: This case was reported by a consumer on behalf of his/her mother via interactive digital media. The patient received a dose of Shingles vaccine and she was now recovering from shingles on her face. The reporter reported that it was awful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
PATIENT WAS STANDING TALKING WITH CLASSMATES AFTER RECEIVING H1N1 VACCINE. STATES STARTING FEELING DIZZY AND THE NEXT THING PATIENT REMEMBERS IS WAKING UP ON THE FLOOR. STAFF HEARD NOISE AND NOTED STUDENT LYING ON THE FLOOR,STARING INTO SPACE. NURSE TALKING TO PATIENT AND PATIENT RESPONDED VERBALLY AND CRYING SAYING HIS HEAD HURT. 2CM CONTUSION NOTED TO LEFT UPPER OCCIPITAL AREA OF HEAD. ICE PACK APPLIED BY NURSE. HEART RATE 88 RR 16 BP.88/64. PATIENT ALERT TO ORIENTED TO PLACE, PERSON AND TIME. PARENT NOTIFIED, PARENT TOOK CHILD TO PMD.  PARENT LATER RETURNED TO SCHOOL AND STATES "PHYSICIAN SAID CHILD WAS FINE"
CMA, STATES THAT DR. TOLD HER THAT PATIENT WAS DUE A TDAP TO WHICH SHE ADMINSTERED.   SHE WENT TO DOCUMENT THE VACCINE AND A DTAP WAS ORDERED (TDAP SHOULD NOT HAVE BEEN GIVEN DUE TO PATIENTS AGE).  MOTHER WAS CONTACTED AND INFORMED OF ADMINSTRATION ERROR AND ADVERSE EVENTS TO WATCH FOR.
Subsequent to receiving vax, the pt developed a fever of 102.3F and had one large vomiting episode. The fever persisted as of 09/28/2000. A copy of this report has forwarded to Merck, manufacturer of MMR.
Seventeen hours after vaccine, woke up at 5:30 am to extreme dizziness, vomiting, nausea, sweat, chills, and headache.  These symptoms lasted all day and into the night with some minor relief.  Following morning woke up to light-headed, headache, and some dizziness.  Throughout out the second day symptoms diminished some what and was able to get up out of bed and walk around.  Still feeling light-headed.  The following days experience ligh headedness in the morning and serious dizziness when laying down for the night.  After about an hour of getting up, feel almost normal but not fully.
approx 4 hrs p/vax pt exp episode of paleness, limpness, cyanosis; rechecked adm for observation; all labs nl;
Sudden onset severe joint pains - shoulders and hips - 24 hours/day minimal relief of symptoms with ibuprofen. ongoing. crp 39.  very similar presentation to PMR except for the sudden onset
This spontaneous report as received from a healthcare professional (healthcare worker) refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients were vaccinated with improperly stored M-M-R II (lot # K011317, expiration date: 13-AUG-2016; lot # K022285, expiration date: 12-NOV-2016; lot # K004948, expiration date: 04-APR-2016; lot # L001336, expiration date: 13-JAN-2017; lot # L012479, expiration date: 10-APR-2017; dose, frequency and route of administration were not reported). No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Redness at corner of left eye indicating an onset of a break out of herpes of the eye.  I usually take Valtrex when I have an onset but decided to wait because of taking the shingles shot.  I called Pharmacy where I got the shot and they said that I'm not suppose to take an antiviral medicine for 14 days after the shot so I waited until Sunday the 15th of April by that time my eye had gotten alot worse and my left arm was really red where I had the shot so I deceided to start my Valtrex.
A non-serious spontaneous report of administered expired FLUMIST was received from a health care worker concerning an eight year old child. No medical history was provided. The reporter indicated that outdated FLUMIST was administered to two children on 24-Oct-2008 (expiration date 10-Jan-2008). The patients were re-administered a flu shot. upon follow-up, no adverse evens were associated with this expired vaccine usage; therefore, treatment and causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 24-Mar-20 included Product Complaint Investigation results.
Patient got the immunization on 6/9/15 and is complaining of her left arm tingling and going to sleep (6/12/15). Didn't notice redness or pain at injection site.
Fever between 99-100°, chills, soreness at Injection site, muscle aches
ACUTE MI 2/9/2022 MODERATE FALL RISK    RIGHT INCARCERATED INGUINAL HERNIA HYPOTENSION 2/9/2022 MODERATE FALL RISK    RIGHT INCARCERATED INGUINAL HERNIA ACUTE MI 2/9/2022 ATRIAL FIBRILLATION, UNSPECIFIED HYPOTENSION 2/9/2022 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE MI 2/9/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA HYPOTENSION 2/9/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE MI 2/9/2022 ATRIAL FIBRILLATION, UNSPECIFIED HYPOTENSION 2/9/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Patient presented with blood in his stools approximately 48 hours after vaccination. He has continued to have bloody stools for the following few days.
I retired in January. I was required to take vaccines for my job, but I continued taking them after retirement. I received my fourth dose of my Moderna vaccine in May of 2022. In June, I began to notice something off with my health. I was short of breath and was retaining water and gaining weight. I finally went to the doctor who did an array of tests. When they did an EKG, they admitted me to the emergency room immediately. They ran an EKG at the emergency room where they discovered that I was in heart failure. They admitted me and did a cardiac catheter and an echocardiogram the following Tuesday. The following Thursday they did an MRI and couldn't find anything and were confused as to what has caused these issues. They sent me home with a cardiac vest and will continue monitoring and plan to do some genetic testing. I am also on a wait list for cardiac rehab. I am seeing a doctor weekly for medication monitoring and adjustments.
Left arm (upper arm) swelling & redness & bluish discoloration that didn't go away for 3 weeks, now swelling & throbbing of (L) arm.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and had sore arm for a few days but would take that over the shingles anytime. The patient prayed that the next one would be easier. The follow-up would not possible as no contact details were available. This case has been linked with US2022AMR014049, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR014049:Response to same post
She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; She was not feeling well and was very flush, weak, lightheaded; Felt the vaccine running through her body; This spontaneous case was received on 16-Dec-2020 with additional information received on the same day (being processed together) from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05804) and concerned an adult, female patient. At the time of this report, the patient was 63-year-old.  The patient's medical history and concomitant medications were not reported. The patient was receiving the flu vaccine for 10 years and never had a problem.   On 29-Oct-2018, the patient vaccinated with Afluria (TIV) (influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 333332418107 and expiry date was 22-Jun-2019.  On the same day, within two minutes after receiving Afluria (TIV), the patient was not feeling well and was very flush, weak, lightheaded and felt the vaccine running through her body. She went to the emergency room but began to feel better. There, she sat in the waiting room about a half hour and all symptoms resolved.   On the same day, the patient recovered from the events.   The reporter did not provide a causality assessment.  Company comment: The patient developed all events on the same day after receiving the suspect product, Afluria (TIV). Chronology is suggestive.The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events on the same day after receiving the suspect product, Afluria (TIV). Chronology is suggestive.The patient's medical history and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).
after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body); The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body; had feelings of "prickers" throughout my body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body), PARAESTHESIA (had feelings of "prickers" throughout my body) and PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body) (seriousness criterion medically significant) and PARAESTHESIA (had feelings of "prickers" throughout my body) (seriousness criterion medically significant). On 14-Aug-2021, the patient experienced PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (The "pricker" sensation in my calves was extremely painful,feelings of "prickers" throughout my body) and PARAESTHESIA (after a week but returned in full fource after a rigorous uphill hike (prickers throughout my body)) outcome was unknown and PARAESTHESIA (had feelings of "prickers" throughout my body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Two hours after patient had feelings of prickers throughout the body. It subsided after a week but returned in full force on 8/14 after a rigorous uphill hike. The pricker sensation in calves was extremely painful.       Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Patient father who is a Pediatric Physician brought child in for 2nd does of vaccine after putting the wrong birth date on the first consent form, and the birth date was changed in the chart, the error was not caught and the 4 year old was given second dose of vaccine. The father was contacted and informed of both the errors, and he stated he had made a mistake on the first consent form and the child had just turned 4 and not 5. He stated that the child was fine and had no adverse reactions.
Patient began to have a metallic taste in mouth.  Then mouth started itching and tongue felt like cotton.  Patient was given 25 mg of Benadryl and later 0.3mg of epinephrine and taken to the hospital where she was admitted with trouble breathing, swelling, and low oxygen.
Information has been received on 06-DEC-2017 from a lawyer regarding a case in litigation concerning a female patient. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 13-MAR-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration are unknown) subcutaneous as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contact a persistent strain of shingles. On or about 09-AUG-2013, the patient was treated by a physician, for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient experienced persistent symptoms that afflicted her so severely she lost her employment because of her condition. The patient has been prescribed valacyclovir hydrochloride (VALTREX) and acetaminophen, hydrocodone bitartrate (VICODIN) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Severe herpes zoster/persistent strain of shingles was considered to be disabling. Additional information has been requested.
The patient stated after the shot it was itchy and the shot was on the back of the arm and could not see it. On 3/13 the patient their grandchildren to look at it they stated there was a red rash on the back of the arm. The patient presented to the pharmacy and showed me the back of the arm where there was a rash on the back of the arm. Recommended the patient take benadryl and apply hydrocortisone cream to help with the reaction. Also made a mark around the rash and asked patient to keep an eye on it to make sure it does not get bigger. Asked patient to notify us if anything changes.
Chief Complaint: Patient is an 84 y.o. with PMH Alzheimer, ESRD on HD MWF, HTN, hypothyroidism, and DM II presented to Hospital after a fall and sustained a right hip fracture.   I was called for complaints of pain. Patient is fully awake, AOx1. She was able to verbalized right hip pain and crying. Patient is also currently on HD at bedside. No other complaints, VSS, NAD.
pt recv vax 8SEP98 9AM-2PM call from mom w/report of breaking out lt arm pit;by that eve T102 w/stages papules, vesicles, pustules filled & ruptured-confined to lt axillary region from axilla to waist;dx chickenpox;lesions still present;
Admission Date: 10/6/2022 Discharge Date: 10/17/2022  PRESENTING PROBLEM: Pneumonia, unspecified organism   HOSPITAL COURSE: 76 y/o male s/p single right lung transplant (4/26/2016) presents with increased DOE, fatigue and cough. COVID positive 9/15, s/p MAB 9/17. Initally felt better and has since progressively worsened. CT consistent with viral process. Initially started on prednisone burst, broad spectrum abx, but Bronch cultures completed 10/6 concerning for mucor. Steroids stopped, ID consulted, recommended posaconazole. Repeat TBBx 10/12 with A1B0, evidence of organizing pna. High dose prednisone started with significant improvement in symptoms. MMF resumed at 250mg BID given A1 biopsy, with goal of 500mg BID. Patient was evaluated by pulmonary rehab and qualified for 2L home oxygen therapy with activity. Will plan to dc home today with home nursing, therapy, follow-up labs Thursday, clinic visit next week.
Overall declined in health since he was forced to get these shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 23Oct2021 as dose 1, single (Lot number: 32030BD) at the age of 52 years, in right deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Had COVID 6 weeks before being forced into getting first shot. There were no concomitant medications. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset 2021, outcome "not recovered", described as "Overall declined in health since he was forced to get these shots".  Additional information: The patient did not have any family medical history relevant to the adverse event. The patient received first shot at mass medical event through battalion. The patient had COVID 6 weeks before being forced into getting first shot. Sense of taste and smell came back after that and was pretty good and everything was normal. Everything was pretty good after being forced to take first shot. The patient had overall declined in health since he was forced to get these shots. The patient wanted to know how long the side effects would last. The patient stated that he was wondering about the longevity of the side effects. No investigations were done. The case was reported as non-serious.
c/o localized erythema, swelling, pain starting p/vax & cont x 6 days;pt sought attention today 1APR97;
Patient received expired FluMist. Expiration date was 01/09/2023 and vaccine was given on 01/10/2023.
Guillain-Barre syndrome (GBS) - started with a headache and numbness in hands.  Numbness spread to arms and legs over the next 2 days and weakness started on the 3rd day.
"Adverse" isn't a proper description, I just wanted to let you know that it appears that the Moderna vaccine has caused my long standing melanoma on my face to disappear.     Something to do with triggering the immune system?
Injection site sore; injection site red; injection site big,hot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE WARMTH (injection site big,hot) and INJECTION SITE SWELLING (Injection site sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historic conditions reported.).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE WARMTH (injection site big,hot). On an unknown date, the patient experienced INJECTION SITE SWELLING (Injection site sore). At the time of the report, INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE WARMTH (injection site big,hot) and INJECTION SITE SWELLING (Injection site sore) outcome was unknown.            no concomitant medication and treatment provided   This case was linked to US-MODERNATX, INC.-MOD-2021-024646, US-MODERNATX, INC.-MOD-2021-024767 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024767: US-MODERNATX, INC.-MOD-2021-024646:MOD21-023085