chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine #2 administered on 4/3/21 Patient developed painful "knot" in her left calf on approximately 4/8/21 Presented to clinic for evaluation on 4/14/21 ven duplex ordered and performed on 4/14/21results: Small thrombus present in left distal superficial femoral vein (+DVT) Patient started on warfarin 5mg PO QD 4/14/21
pt called c/o lump under lt arm on arrival to clinic upper lt arm red & swollen, painful;
At 2:00 am on 9/30, became nauseous, dizzy, weak and experienced vomiting and headache. The dizziness and fatigue continued all day on 9/30 and into 10/1. On 9/30 also experienced intense itching of neck, face and ears. Used Calamine Lotion for itching. By 7:00 pm on 9/30, chin and neck were swollen and itching. By 6 am on 10/1, eyes and face were also swollen. Took one Advil on 9/30 at 6 am  and 11pm and on 10/1 at 6 am.
On 07/20/2001 the patient developed a rash on his chest, arms and back. On 07/24/2001 the patient developed a temperature and fussy. On 07/25/2001 the patient's temperature continued, the patient had dry heaves and remains fussy with a rash.
Had a severe adverse reaction to Moderna Covid vaccine, 2nd shot. Admitted into the hospital due to confusion, fever and loss of cognitive impairment.  (unable to walk and speak)  speech was out of context) and loss of  muscle use and fever.
I started getting symptoms of a runny nose and cough. I took a COVID-19 test that was positive. My symptoms progressed to chills. I contacted my doctor and received Paxlovid. The Paxlovid did help and I felt better. My symptoms lasted for a total of 3 days.
After I went to bed on the 25th of July, two hours later I woke up with a cough, and my body went regid! It lasted about 10 seconds. Then two hours later the same thing! This happened 5 or 6 times in the night, and lasting 10 seconds.  The next day I was exhausted all day and slept most of the day.  It took two days to get over this  I have always had some unpleasant reactions to the Covid 19 shots and vaccines.  This was by far the worst.
c/o itching and slight rash to chest region, Benadryl 25 mg po given ordered by Dr.
"All he does is sleep"; Racing heart; Swallowing difficult; severe rash on his arms, chest, back and neck; low grade fever of 99.9; he noticed a rash under the band-aid after removing band-aid (on the injection arm).; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).) and RASH (severe rash on his arms, chest, back and neck) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).). On 11-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPHAGIA (Swallowing difficult), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9). On 12-Sep-2021, the patient experienced PALPITATIONS (Racing heart). On an unknown date, the patient experienced SOMNOLENCE ("All he does is sleep"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Body temperature: 99.9 (High) low grade fever of 99.9.         Concomitant medication were not reported by the reporter.
Vomiting started approx. 2-2 1/2 hours after immunized w/ PREVNAR (#4) DTaP (#4).
Developed lightheadedness, increased heart rate and flushing within 30 minutes of vaccine receipt. She was told by a co-worker that she did not look well. These symptoms were noted intermittently over the next 24 hours, and SM reports "didn't feel good" for 2 days. Denies angloedema, respiratory or GI symptoms. Within 4 hours of vaccine receipt, SM developed a red, raised pruritic rash that was initially noted on left arm and then noted on her right arm. (She received vaccine in her left deltoid). Within 8 hours of vaccine receipt, she noted rash on her torso and legs. Rash was described as "little bumps like heat rash". She did not self-treat or seek evaluation, other than a T-con with the clinic. The rash subsided after approximately 5 days without treatment. Patient reported feeling well day of and prior to vaccinations and was taking no new OTC or prescription medications. She denied allergic reactions to drugs, foods, latex, or insect stings. She denied other known exposures-no recent changes in diet, personal/home care products, occupational exposures, or close contacts with similar rashes. Hx of urticaria w/0 systemic symptoms following TD vaccine at age 12. She has an unremarkable health history, with no prior chronic skin conditions. Symptoms: Tachycardia, Pallor, Dizziness, rash, pruritic.
Administered 0.5ml instead of the 0.25ml. Patient was not aware and never reported any side effects after injection. This error was caught while checking  the scripts a few days later.
A female patient (date of birth and age not reported) had received a left deltoid, intra-muscular injection of FLUZONE SV "2006-2007" USP, lot number unknown; and a left deltoid, intra-muscular injection of Pneumovax, manufacturer Merck, lot number not reported, on 09 October 2006. Approximately five hours post-immunisation, the patient developed redness and swelling approximately six inches below the arm pit to the elbow. She denied any other symptoms or any local reaction to the actual injection site. The patient required medical evaluation, but the diagnostics and treatments received were not reported. At the time of this report, it was unknown if the patient had recovered from these adverse events. Another patient had the same type of reaction at the same facility that is reported in case 2006-02658. Follow-up information received on 17 November 2006 from a health care professional. As per the reporter, it was "determined that it was not the flu shot, but the Pneumovax shot". Further information is not anticipated.
Cardiac pacemaker insertion; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) (seriousness criterion medically significant). At the time of the report, CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) had not resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was 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.  Company comment: This spontaneous case concerns a 77  year  old, female patient, with current condition of ankylosing spondylitis in treatment with Adalimumab, who experienced the serious (medically significant) unexpected event of cardiac pacemaker insertion, one day after the second dose of mRNA  1273 vaccine. No further clinical information was available for medical reviewing. Co  suspect product Adalimumab and patient´s mentioned medical history remains as confounder since ankylosing spondylitis increases the risk of heart disease, which could lead to a cardiac pacemaker insertion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77  year  old, female patient, with current condition of ankylosing spondylitis in treatment with Adalimumab, who experienced the serious (medically significant) unexpected event of cardiac pacemaker insertion, one day after the second dose of mRNA  1273 vaccine. No further clinical information was available for medical reviewing. Co  suspect product Adalimumab and patient´s mentioned medical history remains as confounder since ankylosing spondylitis increases the risk of heart disease, which could lead to a cardiac pacemaker insertion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt reported swollen tongue occurring one day after vaccine and resolving after about 4 days. Rph discovered upon doing a follow up call on 09/05/21 alerting Pt about second dose coming up. Pt took Benadryl and helped resolve.
Fever, dizziness, body aches, lasted roughly 24 hours.  Treated with tylonol.  Some lightheaded persisted into 5/17, but very minor
One day after the shot I started feeling weak, having a headache and really tired. The second day I felt the same only shortness of breathe as well. Then at night I kept coughing I could hardly catch my breath. My husband took me to the hospital and my right lung was collapsed.
My arm is sore; fibromyalgia; It hurts from my left hip down to my left knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is sore), FIBROMYALGIA (fibromyalgia) and PAIN (It hurts from my left hip down to my left knee) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (My arm is sore), FIBROMYALGIA (fibromyalgia) and PAIN (It hurts from my left hip down to my left knee). At the time of the report, PAIN IN EXTREMITY (My arm is sore), FIBROMYALGIA (fibromyalgia) and PAIN (It hurts from my left hip down to my left knee) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021. No newinformation
Pt received COVID-19 vaccination on 12/30. Approx 5 minutes after recieving vaccine pt felt lightheaded and reporedly had a feeling of racing heart beat. O2 sat was 98-99% on RA, Heart rate ranged between 90-119. An ice pack was given to pt and she was instructed to breathe slowly and deeply. Symptoms waxed an waned for 10 minutes. After approx 10 minutes symptoms subsided and pt was back to baseline with a heart rate in the 80s. Pt was monitoered for 30+ minutes and had no recurrance of symptoms. Of note patient was positive for COVID-19 greater than 90 days ago.
Felt severe muscle pain and aches the next day starting about 2:00 pm . Went to bed about 6:30 that night. Woke up in the middle of night and I could tell I had a "huge lump" in my Lt armpit. The lump is very sore. No redness or hot to touch. I am going to watch it over the next few days. If it gets bigger or red, I will seek medical advise. I am guessing it is a inflammatory reaction to the vaccine and my lymph nodes are inflamed there. No other lymph nodes are swollen any where else.
rash covering my back and stomach area; tested positive for Covid; nausea; fever; chills; headache; muscle pain; joint pain; extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting; blood pressure of 98/68; resting pulse of 87; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87) and RASH (rash covering my back and stomach area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting), BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 18-Feb-2021, the patient experienced HEADACHE (headache). On 20-Feb-2021, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). On 22-Feb-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced RASH (rash covering my back and stomach area). On 11-Feb-2021, DIZZINESS (extreme dizziness/weakness to the point where I wasn't able to stand without fear of fainting) had resolved. On 12-Mar-2021, BLOOD PRESSURE DECREASED (blood pressure of 98/68), HEART RATE INCREASED (resting pulse of 87), RASH (rash covering my back and stomach area), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure measurement (80-120): 98/68 Low. On 11-Feb-2021, Heart rate: 87 High. On 22-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.   This case was linked to MOD-2021-107804 (Patient Link).
After my initial vaccination series (so two shots starting in mid-March 2021), I had a lot of hives and then all of the sudden they went away. This was considered a great health outcome as I had been struggling with hives prior to vaccination. The vaccine seemed to alter my immune system in a way that I no longer have recurrent hives.
Diagnosed by my doctor as Shingles.  They appeared on the palm side of my right arm. The symptoms was blistering and sensitive to the touch.  The doctor prescribed Valacyclovir.
Pt developed a red, raised area the size of a quarter on right upper anterior thigh. It reduced in size to 1/2 a dime within 24 hours. Pt ran a temperature of 100-101 from 5/3/01 to 5/7/01. On 5/7/01 the area had a bruised look. Tylenol was used to bring temperature down. Pt also had a cough, fussiness, poor appetite and change in sleep schedule.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 9:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 9:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 55.63.  Concomitant products were not provided.  On 14-Feb-2021, At excursion time 09:00 AM, temperature was 32, total doses given for the day was 162 and at 10:00 AM, temperature was 32, at 11:00 AM, temperature was 32, at 02:00 PM, temperature was 35, at 03:00 PM, temperature was 35, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-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. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Extremely irregular periods. I'm now going long periods of time between periods and then will have two periods back to back within two week's time. And then will go another 6 weeks or so without a period. It's completely messed up and was never irregular before I got the vaccine.
Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated with the series of GARDASIL. She had two doses. Subsequently the patient experienced migraines after the doses and they had continued. It was unknown whether medical attention was sought. Additional information has been requested.
On 10/07/2020 patient called pharmacy reporting signs of significant redness, swelling and soreness in his left arm.  Patient was instructed to take Benadryl 25-50mg along with icing the area several times daily.  If no improvement  or worsening was noticed, he was to seek  medical help with his primary care physician. On 10/08/2020, pharmacist called patient  and patient reported significant improvement of symptoms.  He reported redness and swelling had decreased considerably.  He was instructed to  continue icing the area and to contact PCP as well as our pharmacy if worsening of symptoms took place.
Patient came by and stated that her left arm still hurts from  the flu shot she received in October. She stated the pains comes and goes and sometimes more painful than other times. She stated it does not hurt all the time  but when it does the pain comes from the area she received her shot. She stated that she takes Tylenol arthritis that helps sometimes. She stated she had asked her doctor about it as well and was told it can sometimes be sore for awhile.
day immediately following vaccination, watery diarrhea (too many to count), hoarseness, achy, malaise, abdominal cramping with diarrhea, uncontrolled nausea, dizziness upon standing, went to emergency center for observation, discharged home, same day with anti-nausea and anti-diarrhea prescriptions
A rash redness, begin to form yesterday on the corners of my mouth. I thought it was a burn due to citrus fruit. The rash has now spread, in one day, throughout my chin going up to my nose. It?s been treated with Benadryl and prednisone.
PATIENT RECEIVED FLUAD HIGH DOSE AND THREW UP. WAS GIVEN BENADRYL . PATIENT HAS AN EXTENSIVE LIST OF ALLERGIES
Patient came to pick up her Rx on 3/1/2019 and told us about 1 and 1/2 days delayed allergic reaction after SHINGRIX shot she received on 02/20/2019. She said 1 and 1/2 days after 2nd SHINGRIX shot she got hives all over and her both lips swelled so much her coworkers sent her to doctor. Even today (3/1/19) she still has hives and itching. She took ZYRTEC as soon as she could and also doctor gave her ZANTAC. She is still itching and using itching cream.