chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen on left side of the face; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number J75L9, expiry date 10th October 2022) for prophylaxis.   Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID 19 VACCINE MODERNA).   On 29th April 2021, the patient received the 1st dose of Shingrix. On 30th April 2021, 1 days after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were reported as follows: On 14th April 2021, the patient received the 2nd dose of Moderna vaccine. The pharmacist reported that the next day of the vaccination with Shingrix, the patient showed swelling on left side of the face.  The reporter did not know if symptoms still persisted. The reporter consented to follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster),  single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "borderline high blood pressure" (unspecified if ongoing); "Ductal carcinoma in situ" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 2 months after receiving flu vaccine, pt began having pain.  Pain started in left instep, moved to right knee, then ankles, knees, hip, back and right shoulder.  Pain felt like it was "moving around".  She was checked for lyme disease and gout.  Ruled out.  01/26/04, doing much better.
blistering to bilateral feet and hands. loss of sensation to left greater toe. sloughing off of skin. spreading of the blisters. discoloration of skin. blisters opening and wounds seeping
Headache, Myalgia, Diarrhea, injection site reaction, runny nose Narrative:  Employee reports injection site pain/discomfort and swelling, headaches, runny nose, muscle aches, fatigue, and diarrhea which began within 24 hours of receiving vaccine. Employee states feeling much better by 2/25/21 and was able to return to work. Of note, reports spouse with complaints of headache, congestion, fatigue on 2/24 (2 days after employee received vaccine). Advised to maintain distance from spouse, continue hand hygiene, and wear masks.   Other Relevant History:
Today the headache is bad; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Today the headache is bad) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced HEADACHE (Today the headache is bad). At the time of the report, HEADACHE (Today the headache is bad) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No Treatment medication was provided.  Patient received booster on Thursday. And felt good on 09 Jan 2022, but at the time of this report the headache was bad.
41 yr old female with localized rxn to Anthrax vaccination. A 5" erythematous area circling from site around back of arm. Radiating down just above elbow; + warmth. No other symptoms.
Rash all over my body, cheeks, arms, elbows, legs, knees , feet
About 1hr after receiving the vaccine. I was driving & my body felt warm, then a itchy, burning sensation started. I felt it on my neck, chest, back, legs & it were hot to the touch. It got worse through out the day. I had to take a Benadryl, it helped. But the next day it came back, I went to my PCP.
really bad headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headache) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (really bad headache) and VOMITING (vomiting). At the time of the report, HEADACHE (really bad headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   Reporter did not allow further contact
Received MENACTRA 4/8/09 at 4:15PM, close to that time. Checked the vial for how to administer, it didn't state, checked refrigerator (see attached) immunization list, it read Meningococcal Sq. but was listed under 18 yrs-next to that list was MENACTRA IM. See by Dr. on 4/9/09 - arm swelling, red. Dr. asked if I gave and I said yes, Said she had local reaction, circled site. 4/9/09 Pt saw Dr. - redness had increased - went outside circle mark - Prescribe BENADRYL - local reaction
Swelling/redness at injection sites. No wheezing, no stridor, no s/s of cellulitis.
Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received Pfizer COVID-19 Vaccine as third dose on 6 Oct 2021.  Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-344235 (Patient Link).
Patient came into pharmacy to show me her arm. There was a rash present down the arm but not directly on top of the injection site. Patient said she felt pain after injection and the area became warm to touch . She applied Hydrocortisone 1% and stated that it was better after application. I advised her to call md or go to urgent care clinic. She called me and told me she had a televisit with MD and was advised to take Benadryl and use cold compresses and to continue OTC hydrocortisone cream for now.
Hospitalization due to COVID-19 Reported per Pfizer COVID-19 Vaccine EUA
By the afternoon of the vaccination date, she had begun to run a fever and was extremely lethargic. Over the next 4 days, the fever would come and go, along with the fatigue and pain, both head and stomach (diarrhea for 2 days). Fatigue for the recipient is very unusual; the child is high energy with sleep only needed at night. She has not required a naptime to re-energize for over 2 years. Over these 4 days, the fever was treated with cool baths and skin-to-skin contact. Once the fever stopped, behavioral issues began: easy irritation, loss of use of calming techniques, easily stressed, tantrums of high magnitude and frequency way outside the norm, lack of empathy. The behavioral issues continue and some of them become milder but others still remain an issue.
Right lateral thigh with increased swelling and erythematous, warm to touch, mild tenderness with palpation. No fever.
Denies pneumonia. (R) arm swollen with red/hot - at injection site - pain for several days - hurt when arm raised.
Information has been received from a physician concerning a 9 year old white female, with no medical history and no allergies who on 30-OCT-1996 was vaccinated with a first subcutaneous dose n the left arm of varicella virus vaccine live (Oka/Merck) (Lot# 617263/0564D). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 03-SEP-2005, the patient experienced a case of breakthrough of about 50 lesions with no complications. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that on 01-SEP-2005 the patient experienced a varicella illness with approximately 50 lesions. It was reported that the patient recovered on 08-SEP-2005. Additional information is not expected.
Mom called 8/28/06. Pt had Tdap on 08/27/06. Pt c/o N/V and diarrhea.
I got super nauseous.; I really wasn't feeling well; Then I got super hot and sweaty; Then I got super hot and sweaty; I passed out.; I had a fever of up to 103.5; This is a spontaneous report from a contactable consumer (patient).  A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 08:45 (Batch/Lot number was not reported) (at the age of 23 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen. The patient previously took septra and experienced allergies (known allergies); and first dose of BNT162B2 on 31Mar2021 08:45 at right arm for COVID-19 immunization. No other vaccine in four weeks. On 22Apr2021, the patient had a fever of up to 103.5 and was down to around 102 by the time of the incident (around 4:00). The patient woke up and was standing for about 3 minutes to refill water when she got super nauseous. She was making her way to the bathroom to throw up, and the next thing she knew she was on the floor. The patient was not sure how long she was passed out for though she had no reason to believe it was long. She tried to sit up, but she really wasn't feeling well, so she laid back down and closed her eyes for a bit. Then she got super hot and sweaty. Once that passed (maybe a few more minutes), she was able to check her temperature and she was down to around 101 and was able to get back to bed. No treatment for the events. No COVID prior vaccination. The patient had not been COVID tested post vaccination. The outcome of the events was recovered in Apr2021.   Information about Batch/Lot number has been requested.
Around 4pm of the same day, patient's right arm became swollen, red, warm to touch, and painful. Patient developed chills, feverish, body aches, lethargic. Patient did not take anything for aches and fever, went to bed and slept the entire night. Patient slept the entire next day and night. Drank water throughout the day and night. On 10-19-17, patient got up around noon, took shower, and began to feel better.
Around 9am that morning which was the day after I received the vaccine. Started to feel unwell, the onset of sudden malaise, feeling really foggy brained. Head hurt and severe headache. Room was spinning and I was nauseous. Developed a fever later that day and it lasted through the night. Just felt like my bones hurt, and whole body hurt. Didn't have an appetite. Felt completely run down. I was looking at my computer screen for work, but my head was so heavy and overwhelmed. Felt unwell overall. That lasted most of the day and emailed my manager and said I couldn't continue working that day and wasn't feel well. I had to sleep. I wasn't coughing or sneezing or anything, but the feeling of malaise was overwhelming, and the fever was a sudden onset. I didn't take any medication or take my temperature. I slept the whole day and the next day I had the same symptoms. Those two days I felt completely run down. Dizzy, hot, nauseous, cold. Completely not like myself. That's when I felt like something had happened with the vaccine. From everything I read, it was possible these were from the vaccine. Fever, At the site of the injection site was very painful and swollen, my temperature that day on April 8, 2021 was 98.7, the pain was moderate, swelling was mild. symptoms: chills, headache, tiredness, muscle and body aches, fatigue. Unable to work, unable to do normal daily activities. Next day: same symptoms except no fever 04/09/2021. The one other symptom was a few days later that I got was: very swollen lymph nodes in my under arms, more on the left where I got the vaccine. tender to the touch, very swollen and I could feel them. That lasted for a couple weeks.
Approximately one month after receiving my second dose I broke out with a horrible case of Psorisis covered from head to toe with gashes on both feet and hands
This spontaneous prospective pregnancy report was received from a Licensed Vocational Nurse concerning 25 year old female patient. Medical history and concurrent conditions were not reported. On 25-JUL-2014, patient was vaccinated with the first dose of GARDASIL (Lot # K006095, expiration route 06-AUG-2015) (route not reported). On 26-SEP-2014, the patient was vaccinated with the second dose of GARDASIL (Lot # K006095, expiration date 02-FEB-2014) (route not reported). Co-suspect and concomitant therapies were not reported. The Licensed Vocational Nurse reported that after patient received her second dose on 26-SEP-2014, she sought consultation with another healthcare provider for contraception, and during that consultation, she was discovered to be pregnant. No adverse effects have been observed or reported. The last menstrual period (LMP) was reported as 01-SEP-2014, date of conception was approximately on 15-SEP-2014 and estimated delivery date would be on 08-JUN-2015. The pregnancy outcome was pending. Fetal outcome was unknown. The exposure was during the first trimester. Additional information has been requested.
pt recv vax 27NOV71 & on 4DEC71 pt exp a grand mal sz & was hosp (dates unk); extensive testing was performed & no correlation to sz disorder was found;in addition lab eval revealed negative rubella titers (dates unk);
This spontaneous report was received from a 68 year old female consumer concerning herself, via Johnson and Johnson (30000287150), on 02-JUL-2015. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown), parenteral (anatomical location, dose number, lot number and expiration date were unspecified). On an unknown date in 2015, the patient experienced a patchy area on her arm (rash). Then, in approximately 13-MAY-2015, the patient started using Band-Aid Brand (sheer plastic extra-large), one bandage once a day, total of 6, to cover the affected area. After an unspecified duration, the patient noted the bandage adhesive was so stuck on her skin that it removed her skin and caused erythema and inflammation were the adhesive was applied. She applied hydrogen peroxide, NEOSPORIN Original Ointment and PROVODINE to treat the events. After an unspecified amount of time, the use of Band-Aid Brand was discontinued. The outcome of rash, erythema, skin adhesion and inflammation was reported as recovered/resolved on 10-JUN-2015. Additional information is not expected as no contact details were provided.
Fever, vomiting, pain at site of injection, erythema bout 3 cm at site of injection. Treated with KEFLEX.
I started having worsening symptoms in March 2021. In April 2021, I experienced shortness of breath. I saw a Pulmonologist and my Internal Medicine doctor. I took some tests. I was prescribed an albuterol inhaler, but I stopped using it since it didn't help. My symptoms continued to worsen on June 25th, 2021. I took more tests and was prescribed more medication. I have been doing physical therapy, which has provided some relief.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Raised erythemic patch initially 24 hrs after injection 2cm round then 12-16" later 4-5cm round raised firm + heat and erythema. DTaP site.
Had a fever, fatigue, headaches after receiving vaccine for several days. After fever broke I got a really weird rash inflamed, blotchy, hot to touch, had different sized shapes, spread from injection site down arm and to armpit. Lymph nodes felt swollen and were sore. Lasted for several days. Took Zyrtec but did not help. Sought care from pharmacist.
Patient complains of pain at site of injection, had 15 mm of edema with 50 mm of redness around site. Treated with TYLENOL for pain.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 57 year-old female patient. On 07-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
presented redness at the site of topical administration; reporter performed a skin test using the Boostrix; reporter performed a skin test using the Boostrix; This case was reported by a physician via call center representative and described the occurrence of erythema in a female patient who received DTPa (Reduced antigen) (Boostrix) for skin test.   Previously administered products included DT vaccine with an associated reaction of cyst (cyst formation after the tetanus diphtheria vaccine received vaccine in 1979).   On an unknown date, the patient received Boostrix (topical). On an unknown date, less than a week after receiving Boostrix, the patient experienced erythema, off label use in unapproved indication and exposure via skin contact. On an unknown date, the outcome of the erythema and off label use in unapproved indication were unknown and the outcome of the exposure via skin contact was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter performed a skin test using the Boostrix vaccine to assess patient's reactivity and the initial test was negative.  The patient returned after the test and presented redness at the site of topical administration it was mentioned that this redness started from 24 - 48 hours after the skin test.  The reporter consented to follow up. The reporter agreed to follow up but mentioned that the first series, was not Boostrix. This case linked with US2020AMR234330, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234330:same reporter
Diarrhea within 6 hours and hives in 12 hours. Diarrhea resolved within 48 hours with no treatment. Hives resolved within 72 hours.
70 YEAR OLD FEMALE COMPLAINED OF DIZZINESS AFTER RECEIVING VACCINE. ONSTIE EMS/PHYSICIAN WAS REQUESTED.  HER BP WAS 138/84 AND HR 99.  SHE REFUSED FURTHER EVALUATION AND CARE
In late January 2021- she had a TIA- mini stroke. She spent 2 nights in the hospital, she changed her diet and was doing well. The medications, to lower her cholesterol and blood pressure were making her groggy and she slowly stopped taking them. She started eating healthy and lost weight. She lost about 25 lbs.  03/31/2021, the day after the vaccine. she felt chills and flu like symptoms and she took Tylenol for it. Her left index finger became stiff, the same side as the vaccination injection. and she could not move it for a few hours. The stiffness went away.  On 04/15/2021, She felt the need to go to the bathroom all the time, Like she felt bloated. When she was eating, she immediately felt like she had to go to the bathroom . She felt nausea and nervousness in her stomach. The doctor suggested to stop taking all her medications away. She was sensitive to her medications. Her stomach problems started getting better after she stopped  taking her medications.   Now she is limited to what she can eat. Her diet is very limited. She slowly learned what she could eat without having problems. She has continued to lose weight. She lost 50 - 60 lbs. She is very fragile. She is afraid to drive by herself. She is very weak.  She has had every test possible  without any significant findings.. She will have an MRI on her abdomen on 10/08/2021. And she will see her neurologist on 10/07/2021.
Pt recv vax on 10/15/98; on same day pt exp itchy hives on buttocks & thighs
Immediately following administration of VARIVAX, pt. experienced brief episode of syncope.. Pt. was drooped over in chair, unresponsive within minutes, pt. became slow in responsive and was able to talk. Pt. given water and became stable within next 15-20 minutes.
Developed redness, swelling injection site, diarrhea, nausea, fatigue within 12 hrs of injection. Tx with BENADRYL & ZOFRAN.
Localized redness & induration. No fever. Frontal headache. Onset one hr after injection in left deltoid. (examined 1 day later). Treated with ibuprofen and ice compresses.
She had covid vax in 10/21; WBC was normal in 7/21 and had dropped to 3.3 in 3/22. Colon cancer diagnosed in October/2021 by Colon biopsy and Cutaneous Mastocytosis in December/2022 by skin biopsy.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-SEP-2014 the patient received a dose of MMR II (dose, route not reported, lot # J009706, expiration date 15-AUG-2015) exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shortly after receiving the vaccine I got a Fever of 102 that lasted for about 48 hours. A couple days later I developed a huge red lump in my left underarm area that was bright red, painful and hot to the touch. I went to see my Health care provider and she did an ultrasound and mammogram. The ultrasound showed I had lymphedema. The lump has not gone away.
pt presented with with covid, uti and metabolic encephalopathy. treated with antibiotics, eeg done. Discharged to HCF