chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke; slurred speech; Almost Paralyzed (generalized weakness); headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 36-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.     The patient's past medical history included Crohn's disease since an unknown date.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), DYSARTHRIA (slurred speech), ASTHENIA (Almost Paralyzed (generalized weakness)) and HEADACHE (headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DYSARTHRIA (slurred speech), ASTHENIA (Almost Paralyzed (generalized weakness)) and HEADACHE (headaches) had not resolved. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact; 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.
My son had a fever within hours and slept the rest of the day. This wasn't surprising as I had read this would happen. The next two days he still had a fever which led to a cold and an entire month of sickness (child had never been sick before in life), followed by a double ear infection. This put us out for a month having to take off work and lose money for our family. Before receiving vaccines he was healthy, in the 95th or higher percentile and 'thriving' as the doctor described. Now he has received two rounds of vaccines over the last three months. Over the course of this time he has been constantly sick, hasn't gained any weight or grown at all during this time and both series of vaccines have led to colds and double ear infections with the cold/fever starting the same day as the vaccines and the double ear infection setting in within the week.
Around 7pm on the day that I received the 2nd dose of Moderna, I began shivering uncontrollably, had body aches, and a pounding headache. The shivering/shaking lasted for approximately 3 hours and the head ache lasted for approximately 12 hours.
sore left arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm (1st dose)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Tooth restoration (new tooth implant) in 2021 and Dental fillings in 2021. Concurrent medical conditions included Glaucoma and Blood cholesterol. Concomitant products included SIMVASTATIN for Cholesterol, LATANOPROST (LATANOPROST 1A PHARMA) for Glaucoma.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm (1st dose)). At the time of the report, PAIN IN EXTREMITY (sore left arm (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment information was reported.  Patient has no known drug or food allergies   This case was linked to MOD-2021-380388 (Patient Link).
Flu like symptoms; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu like symptoms. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Vaccinated dates: 11/15/2021, 3/19/2021, 2/19/2021. Hospitalized with symptomatic COVID 12/29/21.
Red circle 2" in diameter around injection site warm to the touch lasted 1 week, slight itching next day fatigue
Patient came to the pharmacy because he received a Pneumococcal shot on February 27, 2015 and the next day, he developed a cellulitis at the right arm where he received the vaccine.
third migraine in 5 days after receiving second covid vaccination; nausea; This is a spontaneous report received from a contactable consumer and based on the information received by Pfizer from  (Reference ID: Not provided). A male patient in his early 40's received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the second "COVID vaccination", the patient experienced the third migraine in 5 days and nausea. The patient received ubrogepant (UBRELVY) to treat migraine. The events onset date and outcome were unknown at the time of the report.  Information on the lot/batch number has been requested.
Patient states on 9/26 PM right arm (where Pneumovax was administered) was very sore and he was unable to raise it. Patient also states headache started and that lasted until 9/28. On 9/27 arm became red and swollen and this traveled from injection site to just below right arm elbow by 9/28/18 when patient reported to pharmacy. Arm is very warm  to the touch but pain is subsiding some.
Tiredness; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness) outcome was unknown and HEADACHE (Headache) had resolved.            Concomitant medications information was not provided. No treatment information was provided.
the patient received MMR II while pregnant; 41 year old patient received MMR II while pregnant; the patient experienced no symptoms; This spontaneous prospective pregnancy report was received from a registered nurse referring to a 41 year old female patient. The patient's pertinent medical history was not reported. Concomitant therapies included calcium supplement, iron (unspecified), minerals (unspecified), vitamins (unspecified) (prenatal vitamins), and psyllium husk (METAMUCIL).  On 20-AUG-2020, while pregnant, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot# S031483 (expiration date: 07-OCT-2021); poliovirus vaccine inactivated lot# R1B251M; and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid lot# 374LB, all of them for prophylaxis.  Then, on 17-SEP-2020, the patient received the following vaccines: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); diphtheria toxoid, tetanus toxoid; poliovirus vaccine inactivated; and influenza virus vaccine (unspecified), all of them for prophylaxis (additional dosage regimen information was not reported).  The patient's last menstrual period date was 17-AUG-2020. Additionally, it was reported that on 29-OCT-202, the patient underwent an ultrasound that showed her to be 10 weeks pregnant at that time. The estimated date of delivery would be 24-MAY-2021.The pregnancy outcome was outcome pending.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Concomitant Drugs Not Reported. On an unknown date, the patient experienced HUMIRA SEEMED LESS EFFECTIVE AFTER HAD COVID. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273)) was also considered suspect.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of HUMIRA SEEMED LESS EFFECTIVE AFTER HAD COVID unknown onset and HUMIRA SEEMED LESS EFFECTIVE AFTER HAD COVID unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility.  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.  Company comment; This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received 1st dose of mRNA-1273 vaccine 30 days prior to the 2nd dose. Co-suspect drug Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 that occurred on an unknown date after receiving the 2nd dose of mRNA-1273 vaccine and co-suspect drug Adalimumab. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. Patient received 1st dose of mRNA-1273 vaccine 30 days prior to the 2nd dose. Co-suspect drug Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
First Pfizer given on 10/24/22 second Pfizer given on 10/26/22
seizure; unresponsive for 20 minutes; This is a spontaneous report from a contactable physician reporting for himself. A 93-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 10Feb2021 at 15:45 (at the age of 93 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included dementia from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 (at the age of 93 years old) as a single dose in the deltoid right for COVID-19 IMMUNIZATION. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin and levothyroxine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 13:30, the patient experienced a seizure and was unresponsive for 20 minutes. Treatment for the events included careful observation and airway protection. The outcome of the events seizure and unresponsive was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Unresponsive to stimuli cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I was giving 6 month immunization to a child. When I went to the fridge to gather what immunizations were needed I intended on picking up a PEDIARIX, ACT HIB, PCV 13 and ROTATEQ. I accidentally picked up a PEDIARIX, PENTACEL, PCV an ROTATEQ. After the patient was gone and I went to chart the meds given and enter into Osiis it was realized. I went to the fridge and noticed that the Hib slot was empty and the PENTACEL was the one 1 picked up. I will fill the slot, call the parents and correct the mistake for the future. We are a private pediatric clinic.
This spontaneous report as received from a physician via field representative refers to a 13 year old female patient with no drug reactions or allergies. The patient's medical history included a history of headaches. Approximately in May 2013 (reported as about one year ago) the patient was vaccinated with GARDASIL (lot number, expiration date were not reported) dose 1, therapy route reported as injection. Approximately in 2013 (exact date was not reported, reported as within 30 days of GARDASIL) the patient's mother followed up with the physician reported that her daughter experienced increase in headache intensity and frequency after receiving GARDASIL. No labs were performed. The patient was treated with TYLENOL and Ibuprofen. Therapy with GARDASIL was discontinued. The patient was administered only one dose. The outcome of increase in headache intensity and frequency was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Pt. received a PROQUAD 0.5 ml SQ LT on 9/9/08.  Pt's mother called 12/1/08 to report a "cluster" rash on forehead @ right midline.  Seen 12/2/08 & cultured vesicular lesions right forehead does not cross midline.
Localized induration with erythema and increased local temperature on site of injection and surrounding skin,  the extent of the induration and redness is affecting the anterior aspect of the entire medial and part of the lower third of the  left thigh, irregularly shaped , looking like a large hive on some areas.  Probably child scratched the area.
pt recvd vax & devel red rash all over body & diarrhea 30 min after vax; pt taken to rural clinic & tx w/ benadryl;
Colitis; vomiting; terrible reaction in the left and right leg (pain); fall; muscle stiffness; feel cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel cold), PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness) and COLITIS (Colitis) in a 93-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.     Concurrent medical conditions included Psoriasis and Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (feel cold). On 22-May-2021, the patient experienced PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness) and VOMITING (vomiting). On an unknown date, the patient experienced COLITIS (Colitis). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-May-2021, FEELING COLD (feel cold) had resolved. At the time of the report, PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness), COLITIS (Colitis) and VOMITING (vomiting) outcome was unknown. Not Provided          The concomitant medication include Thyroid medication. Prior vaccine Psoriasis vaccine  and experienced a big lump around ribs (a year before her COVID vaccine).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 26-may-2021 contains no new information.
o the 3/2/2/ I had small rash on arm  went away in couple days. on 3/29 Didn't feel well in the evening. Tues I had chills and very weak Was in bed most of the day. Wed got up at 5am  my both arms were itchy. I had a rash from my elbow to shoulder and a little on legs and breast  I put Sarna cream and it stopped itch. A little while later I noticed rash was turning to bubble like blisters .I called hosp and they said to take Benadryl One hr or so I noticed it looked like all was going away .I woke w my husband to show him  he was worried. After a while all was gone. I am glad I showed my husband or I would have I had thought I lost my mind. My husband got his shot.  He was ok  very very scary
Moderna COVID-19 Vaccine EUA was given in right upper arm at 1:08 pm, stayed for observation for 15 minutes then left at 1:25 pm. On drive home then right hand and upper lip felt numb. (Mildly numb about a 2-3 out of 10), no swelling noted at this time, (or if so its very slight like a 1 out of 10), and still able to move hand and lips normally, despite slight numbness so decided not to go to doctor at this time but just to notify him of it. Notified health dept and asked if it was still ok to get 2nd dose or not, clinical director nurse called back and said it sounded like small reaction and was ok to get 2nd dose. Reported reaction here, and going to call regular doctor to notify him as well.
Severe abdominal pain .  He has had CT's, bone scans, and lab work to diagnose a cause and there's no answer. He is still battling this pain and is homebound taking narcotics to full the pain.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:38 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.12  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.    The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.    Temperature recordings were taken using a traceable temperature monitor at every hour.    After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.    It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Information has been received from a female medical assistant (age not reported) who on 04-SEP-2007 in the mid afternoon was vaccinated with the first dose of Gardasil, 0.5 mL, injection. Concomitant medication was not reported. On 05-SEP-2007 in the early hours of the day "around 2 or 3 am" following her first dose of Gardasil, the patient experienced dizziness, headache, stomach pain and vomiting. No laboratory diagnostic studies were reported. Subsequently on 05-SEP-2007 "around 10 am", the patient recovered from dizziness, headache, stomach pain and vomiting. Additional information has been requested.
Within an hour of arriving home from the vaccines, patient went down for a nap. He woke up screaming. As I tried to console him, give him tylenol, and make a bottle, he began his reaction. He zoned out - blank stare, and completely unresponsive. His limbs went limp. (A kid who was constantly in motion)... His temp dropped to 94.7 with goosebumps all over. His tongue quivered and his eyes rolled. He would whimper and then scream and then it would start over. This went on for about 40 minutes. He always protests his car seat, and he could only moan - no movement at all. We got to the hospital and he completely snapped out of it. He started talking and smiling and grabbing the nurse's shirt - my son was back. They didn't give him any tests or anything. Just said if the symptoms return, to bring him back.
Client developed a large reddened area (4 inches in diameter) a couple inches below the injection site by 9/24/2010.  Treatment included ice packs and 3 doses of Benadryl over the weekend.  Today, child is vomiting, but feeling a little better with that also. Home from school today.
Severe migraine 2 weeks after vaccine, and then on and off headaches or migraines that last 24-48 hours and do not respond to Tylenol.
I felt deathly ill - high blood pres, high pulse - felt very nervous - scared, hot, lot of anxiety - hospital performed a heart cath.
Complained of chest tightness but no angina/pain, left deltoid area "felt warm" after vaccine administration. Patient in no apparent distress. Checked vital signs at 1:37 pm and 1:40 pm -- all normal. Patient currently incarcerated. Correctional guards monitored patient for another 20 minutes.