chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PFIZER COVID # 3 VACCINE GIVEN 8/19/21, LOT #EW0172; 1/23/22 pt brought to ED via EMS with increasing SOB; states took at home COVID test 2 days prior to coming to ED and it was positive; has been checking O2 saturations at home and they've been between 88-92%; productive cough, mild chest pain; poor oral intake; positive test for COVID; O2 supplementation; CXR showed multifocal pneumonia; given Decadron, Remdesivir, Baricitinib; respiratory status worsened requiring intubation; vasopressor requirements increased; progressively worsening shock; pt lost pulse; CPR x 3 rounds; pt pronounced dead in the hospital
My right arm had been hurting since the day of vaccination. It still hurts up to now. I have a lump on my deltoid and there are certain arm movements that cause me excruciating pain. My arm seems to be getting worst and I am limited with what I can do at work and at home. My right arm is my dominant. I have had an xray which was negative. I have an order for an MRI which will cost me over $900. I am holding off in doing that but my pain is getting worst.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was inadvertently administered with VARIVAX (Merck) (subcutaneously, lot # unspecified) instead of ZOSTAVAX on 28-SEP-2012. No adverse effect reported. The outcome was unknown. Additional information has been requested.
6 hours after shot: fatigue day 1: fatigue, muscle ache across whole body (back, legs, arms) day 2: fatigue, muscle aches, headache, chills day 3: muscle aches, headache, low grade fever (99.6), chills during day, waking up sweating at night, sore throat day 4: muscle aches, headache, low grade fever (99.6), chills during day, waking up sweating at night, sore throat, intermittent thump on chest like missing a breath day 5: sore throat, headache, chills, intermittent thump on chest like missing a breath day 6: sore throat, headache, intermittent thump on chest like missing a breath day 7: sore throat, headache day 8: mild headache
The feeling of passing/blacking out when standing. No loss of consciousness occurred. As well as dizziness with postural changes.  Headache.
13 doses administered on 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment drugs are provided.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However, the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 24 Oct 2021. The expired vaccine was administered to patients on 25 Oct 2021 and 26 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Information of first 2 doses and outcome was updated from previous source document.
April 2-3 2021: fever up to 103. Strongly swollen, red left ankle and lower leg; swollen painful knuckle of 4th finger, right hand. All symptoms except left leg subsided April 3-4. Consulted urgent care physician  about left ankle Apr 6, 2021; cellulitis diagnosed. The injury related to the cellulitis had taken place many days earlier. I have to suppose that the infection was dormant until the vaccine distracted my immune system (sorry, I don't know the right terminology). An ongoing stomach infection, which abated prior to the date of the vaccine, returned after the vaccine.
slight bronchial swelling; Bleeding; bloody stools; pain/body aches unable to get out of bed; nausea; tired; Projectile Vomiting burning; Stomach pain; Face swelling eyes; Face swelling eyes; esophagus pain burning; Immediately Tongue swelling; Chest pain; diarrhea burning; This is a spontaneous report from a contactable consumer (patient self).  A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:00 (Batch/Lot number was not reported) (at the age of 56-year-old, not pregnant) as dose 1, single for COVID-19 immunisation.  Medical history included ehlers danlos syndrome, ulcerative colitis, rheumatoid arthritis (ra), known allergies sulfa some local anesthetic. Concomitant medications included chlordiazepoxide (LIBRIUM); clonidine; fluticasone propionate, salmeterol xinafoate (ADVAIR); azelastine hydrochloride, fluticasone propionate (DYMISTA); cycloben.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other.  Since the vaccination, the had not patient been tested for COVID-19. On 23Apr2021 14:15, immediately tongue swelling/face swelling eyes, slight bronchial swelling, pain, nausea, tired, projectile vomiting burning, diarrhoea burning, stomach pain, esophagus pain burning, body aches unable to get out of bed, bleeding, bloody stools, chest pain. It was horrendous.  The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].  Therapeutic measures were treatment 28 days prednisone several medications. heart 'mon'.  Outcome of the events was not resolved.  Information on Lot/Batch information has been requested.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 09-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot# K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 200, 320, 128, 120, 64 and 88 hours. The lowest recorded temperature was 32 F (0 Celsius degrees), 31 F (-0.555555556 Celsius degree), 30 F (-1.111111111 Celsius degree), 29 F (-1.666666667 Celsius degree), 33 F (0.555555556 Celsius degree), 34 F (1.111111111 Celsius degree) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Approx 5 minutes after I received the IM injection I developed SOB,  Heart rate was in the 160's, b/p-158/90.  I was lightheaded and thought I was going to pass out.  My blood pressure has never been that high.  Nor have I ever had a HR like that. My body was shaking so much that I couldn't hold on to the water bottle they gave me( d/t developing a very dry mouth.)   This lasted about 8 min and then my HR started to go back down.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 87-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. Previously administered products included  SHINGRIX(1st dose received on unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved. The reporter considered the injection site bruising to be possibly related to SHINGRIX. Additional details were reported as follows: Approximately 3 days after administration of the second dose of SHINGRIX, the patient experienced large bruised area around the injection site.
This spontaneous prospective pregnancy report has received from a nurse referring to a female patient of unknown age with clindamycin allergy. Patient's concomitant medications was unknown. The patient was pregnant and she was vaccinated with a dose of VARIVAX (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis on 27-OCT-2016. The date of last menstrual period (LMP), estimated date of conception (EDC) and estimated date of delivery (EDD) were unknown. The patient was now receiving "monthly growth scans and seeing a high-risk doctor." No adverse effect was reported. No treatment was given for the patient. The pregnancy outcome was pending. Additional information has been requested.
Felt as if I were going to pass out on the drive home. About an hour later I had ringing in my left ear.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox that consisted of approximately 100-115-lesions on the face, scalp, back, stomach, legs and a few elsewhere. Pt was treated with Benadryl, oatmeal baths and calamine lotion for itching.
After receiving the shots I developed joint pain (diagnosed as rheumatoid arthritis). I'm on medication which helps a lot but I still have the joint pain.
On 12/6/2022, I began to have a sore throat at around 8 or 9 AM. I knew that wasn't feeling well, but I went about my normal activities. Over the next three to four hours, the sore throat continued to get worse. At about 1-2 PM, I arrived at my physical therapy appointment, and I was wearing a mask. I didn't feel very well, but I did my therapy. Over the two hours I was there, I could tell that I was getting sicker, as I had fatigue and soreness. I felt like I was starting to get a fever. I finished my appointment, and my condition continued to get worse and worse by the minute. I came home and had a little bit of soup. I knew I was sick at this point, but I wasn't sure exactly what it was. I went to bed and woke up around midnight with coughing, fever, sweats, body aches, malaise, runny nose, fatigue, and eye pain. I couldn't even get out of bed. I remained in bed and tried drinking some water and getting some sleep, but it didn't help. My symptoms all got worse. I didn't have an appetite. At about 10 AM on 12/7/2022, I was able to take a home antigen test, and I got a positive result. I called my cardiologist for advice, and I was told that if my condition worsened, I was to either see my PCP or go to the ER. I went to the ER on 12/8/2022. I had tried to combat my symptoms with OTC medicines, but nothing worked. At this point, I was too weak to stand, so a neighbor (who also had COVID-19 and was less ill) took me to the ER. At the ER, I underwent blood work and was put on a breathing machine. I was given various intravenous fluids and medications. After about nine hours, I felt a little better. The hospital was overcrowded, and no hospital beds were available, so I was released with prescriptions for PAXLOVID and an albuterol inhaler. They told me to come back to the ER if I had any more issues. I took the medicines and spent two and a half weeks in bed. I tested negative on day 14 and day 16. It was a slow recovery, but I did eventually recover.
Numbness in chin, face, mouth; severe headaches; permanent "brain freeze" in forehead and face; freezing cold eyes; brain fog; dizziness; blurry vision; heart pain - chest pressure, left arm and shoulder pain, heart palpitations, heart skipping; hurts to breathe through my nose - air feels freezing cold all the time, extremely painful in nose, face, eye, forehead, and all over head; tooth pain and jaw pain; nausea; fatigue; chills; ear clicking
9 x 7cm erythemous area around injection site. Cellulitis right upper arm. Rx'd Augmentin 875mg BID for 10 days.
Redness developed that evening of 06/07/02. By 06/09/02, developed blisters, increased redness and swelling on left leg. Seen 06/10/02: left ant thigh: 8cm x 10cm erythema, induration.
No additional AE reported; nurse calling to report a temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-FEB-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number U026796, expiration date 28-JAN-2023 (dose and route of administration not reported) as prophylaxis, which had undergone a temperature excursion of 48.8 Fahrenheit for 96 hours. No adverse event was reported.  No previous temperature excursions were reported.  This is one of 4 cases received by the same reporter. ; Sender's Comments:  US-009507513-2203USA000257: US-009507513-2203USA002143: US-009507513-2203USA002144:
Area of shot started itching that evening - hard core center surrounded by red. It continued for 2 wks. Redness extended from crook in my rt. arm up to my shoulder. Redness encircled rt. arm almost completely. Arm was hot and swollen. Pain and weakness continues. This is the very first time in 75 yrs, that I've had an adverse event to a shot.
Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 30-OCT-2012 09:57, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
12-month old patient was given Menactra, Adacel in error, pulled from inventory for administration to a different patient, and there was a mixu-up and they were given to the wrong patient, not due for DTaP with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old and unknown gender patient who was given menactra(DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE), adacel (MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE) in error, pulled from inventory for administration to a different patient, and there was a mix-up and they were given to the wrong patient, not due for dtap with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jun-2022, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Prophylactic vaccination. The lot number was requested.  On 28-JUN-2022 the 12-month old patient was given menactra, adacel in error, pulled from inventory for administration to a different patient, and there was a mix-up and they were given to the wrong patient, not due for dtap with no reported adverse event (wrong patient received product) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable for both suspects.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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 experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.
Right arm is red, swollen, hot to touch, itching, fatigue, stiffness in neck. Redness has spread past injection site to entire upper arm and wraps around to inner arm.
J96.00 ACUTE RESPIRATORY FAILURE 7/1/2023 URINARY RETENTION J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/1/2023 URINARY RETENTION J96.00 ACUTE RESPIRATORY FAILURE 7/1/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/1/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION J96.00 ACUTE RESPIRATORY FAILURE 7/1/2023 ATHEROSCLEROSIS OF AORTA J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/1/2023 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 7/1/2023 ACUTE HYPERCAPNIC RESPIRATORY FAILURE J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/1/2023 ACUTE HYPERCAPNIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 7/1/2023 ATHEROSCLEROSIS OF AORTA J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/1/2023 ATHEROSCLEROSIS OF AORTA
He became ill Thursday night with general s/s. Friday he was  still ill. Today his arm is so swollen he can't move it and the pain is  excruciating 10/10. There are red streaks from under his arm pit down his  rib cage.
Developed redness and itching down entire arm and up neck to head that lasted for 2 days. Resolved with benadryl.
Patient came in today to receive vaccines. They are trying to get him up to date and only do one vaccine at a time. Staff went over the vaccines that he was due for and Mom agreed to get varicella and MMR.  She wanted to do the combined vaccine ( ProQuad).  Staff drew up the vaccine and gave to the patient.  After they left staff entered the vaccine into system and at that time she got a alert that the patients age was outside the recommended age.  At that time we brought it to Dr. and our supervisor attention.  I called Merck and was informed that this was an off label use, But would be counted as a valid dose. Supervisor called the parent and notified of the error.
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 15-MAY-2015, the patient was vaccinated with expired dose of ZOSTAVAX vial of strength 19400 plaque-forming units (PFU) given in unspecified route (lot # K000326 which is valid and expiry date: 27-FEB-2015). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of expired product administered was unknown. The reporter considered expired vaccine administered to be not related to ZOSTAVAX. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Memory loss; ACHE ON ARM; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss) and PAIN IN EXTREMITY (ACHE ON ARM) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced AMNESIA (Memory loss) and PAIN IN EXTREMITY (ACHE ON ARM). In 2021, AMNESIA (Memory loss) had resolved. At the time of the report, PAIN IN EXTREMITY (ACHE ON ARM) outcome was unknown.            NO KNOWN ALLERGIES. No relevant medical history. In 2021, the patient experienced MEMORY LOSS and ACHE ON ARM. In 2021, the MEMORY LOSS resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of MEMORY LOSS and ACHE ON ARM was not provided.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Aches in all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches in all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches in all over the body). At the time of the report, MYALGIA (Aches in all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Adverse event: hot flashes & sweating, severe cystic acne on upper torso, mood swings, menstrual cycle was 7 days late & persisted for 4 days longer than usual for me (which is typically 3-4 days long). I am still spotting (blood) daily, but typical flow has halted (I am on day 11 since the start of menstruation) .  Treatment: very strict diet, daily exercise, increase water intake to try and flush excess hormones from the body Outcome: symptoms are subsiding, but I have now declined the second vaccine dose to these effects