chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of sharp chest pain that worsened very quickly.  Patient also experienced SOB and dizziness.  HR 96, regular on initial check, 5 minutes later, 80, regular.  Skin cool to touch. Placed patient in wheelchair and transported to the ER in the facility.  Placed on monitor immediately, EKG completed, Chest x-ray, nitro, and baby aspirin administered. Zofran for nausea.
This spontaneous report was received from a licensed practical nurse and refers to a 57 year old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 27-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K007262, expiration date 25-NOV-2015, (dose, frequency and route were not reported). The patient had not reported any adverse experience. No concomitant medications were reported. No product quality complaint was involved. Additional information has been requested.
Although an RA patient, after receiving shot, the pain and swelling intensed in hand and wrist of same arm as shot.
Noticed injection was high.  Experienced progressive immobility of shoulder, weakness, and extreme pain.  Problem persists.
Shortness of breath after 15 min, 30 min after could not speak I was very short of breath, cough for over 15 min. Tachycardia, was admitted to ER for the day.
Abdominal discomfort and nausea approximately 5-6 hours after taking the vaccine.  There are 4 pills:  the first had the worst reaction, the second was much milder, the third and fourth had no reaction.  No treatment other than rest.
Half dollar size reddened raised area at point of injection. Lasted several days and was treated with 25mg Benedryl.
At about 6:45AM on March 2, I fell unconscious to the floor while cooking oatmeal on the stove. I woke up with burns from the oatmeal on my left hand and arm, right hand and left thigh.( I felt light headed just before losing consciousness. ) I was examined by a doctor at the local burn center and was told I had 2nd and 3rd degree burns.  I was admitted to the hospital and had surgery on the 4th of March to excise the burns and application of a skin substitute.  On March 18 i had surgery for a skin graft to all burn sites.  Tests had been performed to make sure there was not a problem with my heart and all tests were normal
I had a temperature about a week after taking the vaccine that was 102, and I had a cough. I tested for COVID and was negative. My cough persisted all month and has not gone away. My doctor prescribed my a cough suppressant. It kept me awake, and I need to be taking night time medicine to help me sleep. Some days I feel better then others, however the cough is light somedays and heavier the others. It depends on how much I talk. I am drinking a lot of water, larger then normal, because it eases the cough. It does not seem to interfere when I move around, just when I talk.  I took the flu vaccine at the same time as I took this vaccine.
Received VARIVAX on 3/18/08 at 10:30 AM. By 10:50 AM, arms, lips, ears, face started swelling. Mom gave 1/2 tsp Benadryl and called office. Was instructed to give another 1/2 tsp Benadryl and take to urgent care. Arrived at urgent care at 11:50, was discharged at 1:30. Was given oral steroids. 3/26/08-records received for DOS 3/18/08-DX: anaphylasis rection to varivax, angiodedma to vaccine. C/O lips tingling, scratching, eyes swollen. Seen in PCP office on 3/19/08-recovered, but eyes remain swollen. referred to allergiest.
This spontaneous report was received from a physician via company representative, referring to a 1 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On 15-DEC-2018, the patient was vaccinated with PROQUAD lot# R013126, expiration date 04-NOV-2019, for prophylaxis (strength, dose, route and frequency were not reported) and with VAQTA lot# R006210, expiration date 22-APR-2019, for prophylaxis (strength, dose, route and frequency were not reported). On 05-JAN-2019 to 07-JAN-2019, the patient was admitted for unspecified reasons (adverse event). On an unknown date in January 2019, the patient was diagnosed with Henoch-Schonlein Purpura (HSP) at the hospital. The patient sought medical attention but was unknown if the patient received treatment or if diagnostic laboratories were performed. At the time of reporting, the outcome of henoch-schonlein purpura was recovering. The outcome of adverse event was recovered on an unknown date in January 2019  (reported as the patient is fine now). The causality assessment was not provided.
Foot surgery; This spontaneous case was reported by a consumer and describes the occurrence of FOOT OPERATION (Foot surgery) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Colesticol for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FOOT OPERATION (Foot surgery). On 21-Apr-2021, FOOT OPERATION (Foot surgery) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also include antibiotics and pain mediations for foot surgery.
This spontaneous report was received from a consumer (patient father) refers to a 18 year old female patient. On 18-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported). On 19-FEB-2014, 2 days after onset of therapy, the patient experienced injection site soreness, a red swelling area approximately 4 inches diameter and flu-like symptoms. The patient sought medical attention and contacted the physician to determine how long the events will last. The outcome of the events was reported as not recovered. The reporter did not provided the causality between the event and the suspect drug. Additional information has been requested.
Six months later, she tested positive for covid for a second time; Six months later, she tested positive for covid for a second time; Shortness of breath/hard to breath; bad cough; voice gone; respiratory; taste not back; pain in center of chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Six months later, she tested positive for covid for a second time"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath/hard to breath"; COUGH (non-serious), outcome "unknown", described as "bad cough"; APHONIA (non-serious), outcome "unknown", described as "voice gone"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; AGEUSIA (non-serious), outcome "unknown", described as "taste not back"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in center of chest". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Six months later, she tested positive for covid for a second time. Lasted about a week, but still have residual symptoms. Event took place after use of product.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
1:42pm - took shot on upper right arm, felt needle and medicine go in, arm hurts and sore  4pm - arm hurts and sore, body starting to feel achy, start of headache  4:26pm - muscle that was injection feels vibratey, center of chest a little heavy and sore  6pm - arm hurting a little more, completely sore, a little itchy near top of right shoulder  6:46pm - bit more itchy all over, headachey, feeling hot  8pm - bad headache, warm to touch but having chills, soreness and aching, arm sore/hurts really badly, inside of nose hurts  10:23pm - woozy, pain and sore all over, burning up/fever, chills/shaking, heart fast, extremely dry mouth  11pm - thinny racing heart that was hurting, every time i tried to calm down then my heart got fast again, every muscle hurts down to feet to my neck  6:15am - still hot but not too hot, headache moderate, woke up covered on sweat possibly fever and tasting vomit a little, right arm sore, walking around weak but not feeling like im gonna fall over, ear pain on left ear, inside of nose hurts  12:42pm - no longer super hot, walking fine, right arm hurts bad and itches a little, moderate headache, body aches and esp in abdomen, vaginal itching
I am a 65-year-old male physician, board certified in internal medicine and emergency medicine. I received the Johnson & Johnson (Janssen) vaccine on 07/30/2021. Following the immunization, there was no systemic manifestations of fever, achiness, fatigue, soreness at the injection site, nothing. Within the week, I developed dense urticaria of the inner forearms with the most intense pruritis. The latter spread to the inner upper arms, without the urticaria. The upper arm skin felt dry but not scaly. The urticaria took weeks to resolve and none erupted elsewhere. Next involved with intense pruritis, was the anterior thighs, the most intense pruritis I have ever felt. Exacerbated by friction. Scratching it produced the most euphoric sensation, to the point of excoriation of the skin with my nails, even knowing better. Pruritis then appeared at the back of the legs, the skin of the mid abdomen and low back. Never the scalp, face, hands or feet. I changed laundry detergents and re-laundered all my clothes, no effect. My only prescribed medication is Lipitor, begun 6-months prior. I discontinued it for two-weeks, no change. Returned to daily usage, no change. Pruritis persists, even to this day, though decreased from a genuine 10/10, which lasted >6-weeks, to now 2-3/10, for the past month, 1-2/10, and clearly stimulated by contact friction. Cetirizine 10 mg once/day seems to reduce it to about 1/10 ? but never gone. My self-induced skin excoriations are slowing healing, though not completely gone. I apply petroleum jelly liberally to soften scab and reduce their irritation. I still have the constant urge to scratch chest, abdomen, upper thighs, and arms. It has been 7-months of chronic pruritis.
Confusion, Dizziness, Headache, Sedation, malaise Narrative:
Swollen arm that grows bigger each day; Red rash; Upper forearm is hot to touch; Upper forearm is sore; low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm that grows bigger each day), RASH ERYTHEMATOUS (Red rash), FEELING HOT (Upper forearm is hot to touch), PAIN IN EXTREMITY (Upper forearm is sore) and PYREXIA (low-grade fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0UUB21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (low-grade fever) and CHILLS (chills). On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm that grows bigger each day), RASH ERYTHEMATOUS (Red rash), FEELING HOT (Upper forearm is hot to touch) and PAIN IN EXTREMITY (Upper forearm is sore). On 25-Apr-2021, PYREXIA (low-grade fever) and CHILLS (chills) outcome was unknown. At the time of the report, PERIPHERAL SWELLING (Swollen arm that grows bigger each day), RASH ERYTHEMATOUS (Red rash), FEELING HOT (Upper forearm is hot to touch) and PAIN IN EXTREMITY (Upper forearm is sore) outcome was unknown.            Concomitant products included Over-the-counter vitamin for an unknown indication. No treatment information was provided
Redness to upper arm x 3 days     Pain to  left  upper arm from injection site to left shoulder that is progressively increasing in intensity
The client was given a flu vaccine 0.5cc IM left deltoid at 1115 on 11-7-05.  At 1230, she returned to the vaccine site and reported that she was experiencing itching of her left arm from elbow to shoulder and was feeling hot all over.  The vaccine site had an induration of about 15mm with redness of about 30 mm.  She denied any shortness of breath. Her blood pressure was 116/82, pulse 72; Benadryl 50 mg given IM in right deltoid and ice applied to the affected area.  She remained at the clinic site for 30 minutes (blood pressure at 1247 114/80, pulse 82; at 1305 112/76, pulse 80)and then was walked back to her work station at SDSU nursing department, where she had nurses nearby to assist if she had further symptoms.
Donor was given a Tetanus immunization at 12:45pm shortly after donating plasma. She was sitting in the lobby for 15 to 18 mins started feeling light headed, her throat felt tight, slight wheezing for about 5 mins. Calmed donor down and slowed her breathing down. Donor started feeling better. Called 911. Upon arrival , donor was doing fine.
This spontaneous report was received from a medical assistant regarding unspecified number of patients. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date in March 2016 (starting on or after 09-MAR-2016) the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L026405, expiry date 15-JUL-2017, lot # L027288, expiry date 21-JUL-2017, lot # L034367, expiry date 08-SEP-2017, lot/batch # L037565, expiry date 29-SEP-2017 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from same reporter. Additional information has been requested.
Immediately, post vax, pt began feeling sick to her stomach and at the site of the injection there appeared an instantaneous red blotching of the skin. No raised areas, however, then after about 10 minutes, redness faded away.
Vaccine leaked out entirely from the syringe; Vaccine leaked out entirely from the syringe; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe). At the time of the report, UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) to be not applicable.    This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 026A12A  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: NNI On 17-Jul-2021: Follow up received and it contains no new information.; Sender's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 026A12A  with no associated AEs.
7/13/13 1030 am (R) leg at site of injection, to ER, received Rx for BENADRYL. 7/14/13 1 am back to ER for swollen (R) leg and rash on body. Received steroid shot and BENADRYL and new Rx for steroids.
Dry mouth; No appetite; Mild cough; Nausea; Muscle aches began radiating throughout the body, starting in legs and moving to upper body; Injection site discomfort; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Injection site discomfort), DRY MOUTH (Dry mouth), DECREASED APPETITE (No appetite), COUGH (Mild cough) and NAUSEA (Nausea) in a 70-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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (Injection site discomfort) and MYALGIA (Muscle aches began radiating throughout the body, starting in legs and moving to upper body). On an unknown date, the patient experienced DRY MOUTH (Dry mouth), DECREASED APPETITE (No appetite), COUGH (Mild cough) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE DISCOMFORT (Injection site discomfort), DRY MOUTH (Dry mouth), DECREASED APPETITE (No appetite), COUGH (Mild cough), NAUSEA (Nausea) and MYALGIA (Muscle aches began radiating throughout the body, starting in legs and moving to upper body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood glucose: elevated (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up contains route of suspect drug administration was updated
Localized reaction.  Redness 3" around site lasting 10 minutes then clear.
Fever of 102, chills, shakes, dry heaves starting the night of my injection. Fever lasted 2 days.  Ate very little for those 2 days.
Erythematous hot indurated reaction at site of injection on R upper thigh presented 48 hours after injection and grew 10 x8cm . The site was painful, but itchy.
Patient fainted in the store a few minutes after receiving the shot.  EMS came to evaluate patient; after drinking water and having a snack, she felt fine enough to return home.
08/30/22 presents to ED for "increased weakness for 1 week". PMHx of "ETOH, recurrent pancreatitis, diarrhea, and PUD"
Narrative: COVID infection following COVID vaccine series 03/10, MODERNA, dose #1 04/12, MODERNA, dose #2 09/15 COVID swab, result: detected 09/15 SARS-COV-2 Variant Sequencing result: pending 09/15 pt cc: fatigue exposure: unknown
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 17-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K01104 and expiry date: 07-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one the several reports from the same reporter. Additional information has been requested.
I got first vaccine worse out day 2; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of worn out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced worn out (Verbatim: I got first vaccine worse out day 2). The outcome of the worn out was not reported.   It was unknown if the reporter considered the worn out to be related to Shingles vaccine.     It was unknown if the company considered the worn out to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case  was received from the patient via interactive digital media. The patient got the first vaccine and it wore him/her out day 2. The follow-up could not be possible as no contact details were available.
A week following the vaccine my deltoid where I received the vaccine all of a sudden swelled up extremely large and red, to the point my arm and hand feel a bit numb. I had no reaction to the vaccine at all for a whole week and then all of a sudden today it swelled out out of nowhere.
Redness, swelling soreness area approximately 3" diameter.  Hives beginning throat and inside arms and spreading to face and legs.  Duration approximately 3 days.
I got 2nd shot and everything was fine and I came home and about an hour after I got home I felt like I couldn't move and I was moving in slow motion and legs were like lead. I got extremely tired and laid down and slept 11:30-6:00PM. I woke up and felt tired but not exhausted and my head hurt and didn't feel good so I went to check fever and I had a fever of 99.6. I took TYLENOL and I guess around 10:30 I took temperature again and it was normal and I went back to bed. The next morning I felt OK but legs were sore, knees aches, and the rest of the day I was in and out of it and tired and exhausted. The day after that I was OK and I seem alright and that was the first part of April. It was a gradual thing and I was having symptoms of exhaustion and I'd get tired real fast and pushed through it and that happened about a month after the shot and it would come and go and then I got OK and that's when stuff started happening. I had gone away for a weekend trip and saw blood in my underwear and I called the doctor and he said to get a urine culture so I did and he called me and said I had red and white blood cells in urine and I've never had that. I had pressure in my bladder and they put me on antibiotics and suggested to see a urologist and I didn't see him until January 2022. I also had an abscessed tooth and it was just one thing after another. I seen urologists' and then got ahold of OBGYN and they did tests and suggested I see another doctor which was my regular OBGYN's partner. The bleeding stopped around the end of November and started up again and that's why I seen an OBGYN and they sent me tests. I went back to see her about possible hysterectomy and with that she sent me to her associate and I didn't see him until January 2022 and there was still some residual bleeding and it hadn't stopped and it was spots and drips and not normal. I went to him and he examined me and said there is bleeding but by the ultrasound they seen something going on in the uterus and wasn't sure what it was and it looked like something had grown in there since last exam. Hysterectomy surgery 03/04/22.
Patient was to get Pfizer Bival (12 yr & up) but I gave Pfizer (12 yr & up) instead. Contacted patient & left a voicemail for patient to call back