chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 5 vaccines Pfizer 1/19/21 Lot# EL3249;  Pfizer 2/9/21 Lot# El9267;  Pfizer 10/7/21 Lot# FF2589;  Pfizer 5/31/22 Lot# FM7553;  Pfizer 12/1/22 Lot# GJ6742
Information has been received from a certified medical assistant concerning a 16 year old female with epilepsy as a child (no treatment at present) and depression and no history of drug reactions/allergies, who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (Lot No. 654272/0073X) 0.5 mL, IM. Concomitant therapy included ZOLOFT. The next day, on 18-JUL-2007, the patient called to the office stating that she was having shortness of breathe and chest pain. The patient was advised to go to the local emergency room for evaluation. The medical assistant reported that the patient was never seen at the emergency room and has not returned the phone calls that the office has placed to her home. At the time of reporting, the outcome was unknown. Additional information has been requested.
Foggy feeling in head; Ankylosing spondylitis; Dizziness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499673-00 (AbbVie).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Nov2021, outcome "unknown"; ANKYLOSING SPONDYLITIS (medically significant) with onset 03Aug2022, outcome "not recovered"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Foggy feeling in head". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "ankylosing spondylitis", "dizziness" and "foggy feeling in head" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event ankylosing spondylitis and suspect drug BNT162B2 cannot be excluded. 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 woke up two days after the vaccine with a dull ache in my chest. I laid down and felt better so I went to work. When I got home, I noticed the ache again so I emailed my doctor that night. I called him first thing the next morning and went in. They told me to go to the ER. They took a lot of blood tests, I had a chest XR and EKG as well.  They determined I have acute pericarditis. Then they sent me home and gave me colchicine 0.6 mg twice daily and told me to resume my other medications and daily activities. I have had this diagnosis twice in the past.
The patient has a rash form the vaccine site upto the right side of his neck and over to the anterior right side of her chest, with pain in the same areas: beginning the next day. Suspect that this is herpes zoster recovering.
Felt Feverish, Dry Cough, Sore Throat, Shortness of Breath, Headaches, Muscle  Aches, Other  Fatigue, Nasal congestion
Resident received COVID-19 booster vaccine on 7/26 with no adverse s/s noted. on 7/31 early morning was found to be having tremors to R face and R arm. Resident was sent out to ER for evaluation. Resident returned to facility same day. Upon return, resident was still having jerking movements to right arm and right side of face with facial drooping and difficulty swallowing. After lunch, noted inability to swallow, jerking movements to right arm and now right legs. Resident sent back out to ER where she was admitted. Resident remains in hospital today. Report from hospital states she was admitted with seizures and status epilepticus with status epilepticus witnessed in the emergency room.
15 days after vaccine , child seen in ER for febrile seizure along  with fever, congestion, cough and eventually after 3 days of illness had diarrhea
Received vaccine and the following day she had severe left arm pain (vaccine site) lasting 1 week, Extreme exhaustion lasting 1 week, and brain fogginess lasting 2 days.
Due to covid restrictions didn't get 2nd shot yet; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st July 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. Due to Covid restrictions the patient did not get his/her second shot yet. The patient asked was it too late for his/her second shot now. Additional supportive information:  The follow-up would not possible as no contact details were available.
Excessive crying x 1d, verbal confirmation from hospital medical records staff that admission diagnosis and d/c diagnosis were the same persistent crying after immunization.
Client had DTaP, Varicella, and Prevnar vaccines in left leg 10/06/2005. C/O on 10/07/2005 very fussy red, swollen left leg. On 10/13/2005 still had knots at left leg. Referred to pediatrician.
1 day s/p injection, surrounding area became red and pruritic. Area measures approx 3 in x 3 in.
Patient received booster about 6 weeks after their primary series. Patient was informed and had no other adverse events. (This was vaccine administration error)
This spontaneous report was received from a social media user, as part of a marketing research program and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patient was vaccinated with GARDASIL injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported). It was reported, that the patient told his parents, that "something was wrong down there" (date and details were unspecified). The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reported @ SOB & 1039 dizziness, BP 138/90, HR 98, OSat 99%.  Pt @ 1052 BP 107/72, HR 70.  Symptoms resolved, pt left with spouse @ 1110
Fever of 101 degrees for 3 days, The day after the fever left I woke up with a severe rash all over my body on day 4 after the shot. The rash was severe with itching and stinging all over my body;  including stomach, chest, upper back and lower back. buttocks. I went to urgent care. The Nurse  Practitioner  said it was a chemical rash from the COVID-19 shot. She gave me two shots and medication.  The rash has gotten better but became localized on certain areas of my body including my arms and limbs. Itching and burning still occurring. Calamine lotion helped.
Immunization given on 06/13/2005 at approximately 3PM.  At 6:30PM developed temperature 101, weakness and by next day pain to left arm - arm hot to touch, dizzy, pale when got up, nausea.  By 06/14/2005 PM was feeling better.
Delayed hypersensitivity reaction in his right shoulder; A lot of itching; Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction in his right shoulder), PRURITUS (A lot of itching), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (The patient reports that he takes eye drops for his glaucoma.). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction in his right shoulder), PRURITUS (A lot of itching), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). The patient was treated with DIPHENHYDRAMINE HCL at an unspecified dose and frequency. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction in his right shoulder), PRURITUS (A lot of itching), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
One week after the vaccine I noticed a deep down under skin in the flesh a itch. I also had little bumps starting on right arm then went to stomach and went to vagina to knee then back up to neck and back. Symptoms are on going. Doctor prescribed hydroxyzine HCL 25 mil and Mometasone furoate 0.1 percent 45 ml.
weakness in left arm; weakness in upper body strength; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "degeneration" (unspecified if ongoing), notes: Height changed from 6'1" to 5'11" prior to the vaccine due to degeneration. There were no concomitant medications. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 21Oct2021, outcome "unknown", described as "weakness in left arm"; ASTHENIA (non-serious) with onset 21Oct2021, outcome "not recovered", described as "weakness in upper body strength". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscular weakness, asthenia.  Additional Information: It was reported that he had the vaccine and is having weakness in upper strength. Stated that his height changed from 6'1" to 5'11" prior to the vaccine due to degeneration.  Event details: Stated that it started in the left arm after the vaccine yesterday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 2-28-19 per mom via telephone L arm is warm to touch underneath injection site and earlier in am was red but is no longer red, no lump - advised to monitor - On 3-1-18 area has gotten bigger (tender, warm, itches) on exam L upper arm below deltoid with large cellulitis (stops about 2 in above elbow). 9x9cm, warm, +edema, tender w/movement but has full ROM, no streaking.
POST TIME: 2hrs - 2"x3" hot raised rash at injection site 6hrs - fever <100', chills sweating; headache, joint pain 8hrs  - rash now extremely itchy 30hrs - feel fine, clear runny nose Rash remained for 3-4 days
Information has been received concerning a 70 year old who, 2 days post vaccination developed a large amount of swelling at the injection site. The nurse reported that it was hot to the touch. the pt also developed redness which traveled down the pt's arm. The pt saw her physician who advised her to use an ice pack and observe for infection. The physician prescribed Atarax.
I experienced 2 different symptoms. One was my feet was hurting very badly in the morning when I woke up.  In the morning I was having very painful feet problems. Overtime the feet would loosen up. I had a blood test done for any immunocompromised disease I may have and it was negative. The problems I am having with my feet are still undiagnosed. I have also been experiencing dizziness all the time. I also had a blood test to see if anything showed up that could be related to the dizziness I am having. That blood test was negative for that, but it showed that I am low on Vitamin D. I was prescribed a high dose supplement of vitamin D.  I am scheduled to see an ear, nose, and throat doctor tomorrow to see if there is any correlation with my ear and the dizziness.
03Jan, 06Feb, 10Jul90 pt vax;  titer revealed that pt did not gain immunity.
Case reference number 199922996, is a spontaneous report from a RN referring to a 45 year old female. No known allergies. The pt has elevated BP which is treated with an unspecified BP medication. In 06/99, the pt received her first dose of Havrix.  3-4 days post vaccination, she felt achy. On the 5th day post vaccination, she had a large amount of bleeding from the urinary tract. She was seen by a urologist and had an IPV, cystoscopy and serologies. No abnormalities were found. The urologist recommended that the pt take the 2nd dose of Havrix. The most recent information received on 04/30/99, reports the condition of the pt as resolved.
Started with redness and swelling of right arm and which progressed almost to a size of golf ball. Very painful and itchy but no fever. Mom gave MOTRIN and applied ice.
Her symptoms started with breathing problems and extreme ear pain. Followed by chronic severe abdominal pain and chronic severe headaches. She is constantly nauseated, weak, fatigued.  She has not enough energy some days to go up the stairs in our house. Before, she was a competitive soccer player for 6 years, she could run for miles before. Now 1-2 minutes is too much and too painful for her. She gets so dizzy sometimes she cannot stand without holding onto a chair or a family member. We've taken her to pediatric specialists, had multiple blood tests, Cat Scans of her stomach, ultrasounds, she has been prescribed multiple over the counter medicines (all which do not work or make her feel worse).
2 days of being tired; achy; hot cheeks; felt crummy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-124484.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; lenvatinib mesilate (LENVIMA), first regimen from 01Sep2022 (Batch/Lot number: unknown) to 15Sep2022 at 14 mg daily and second regimen since 08Oct2022 (ongoing) (Batch/Lot number: unknown) at 14 mg daily, all oral for endometrial cancer. The patient's relevant medical history included: "endometrial cancer" (unspecified if ongoing). Concomitant medication(s) included: KEYTRUDA taken for endometrial cancer, start date: 25Aug2022. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "2 days of being tired"; PAIN (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "achy"; MALAISE (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "felt crummy"; FEELING HOT (non-serious) with onset 16Oct2022, outcome "recovered" (17Oct2022), described as "hot cheeks". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional Information: Patient had Covid booster 16Oct2022 and had 2 days of being tired, achy, had "hot cheeks and felt crummy" but much improved at the day of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bruised feeling, achiness, fatigue. Followed by maculopaoular rash on hand, vesicles, then rash on right knee, then rash abdome at waist on right only and 2 hives on face on right only, itchy, no pain.
Vaccination at 3pm, severe (her worst) headache from 10pm to ~6am (Tues to Wed). Wed - mild headache, severe fatigue. Thur - back to normal
Pt reports that he started having swelling and redness in his arm. It extended to his shoulder and armpits. It feels heavy and he has pain with lifting .
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (sulfa antibiotics). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Prenatal care, COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for an unknown indication.   On 12-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Oct-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Ultrasound antenatal screen normal: normal (normal) normal.         Treatment information was not provided. Laboratory information included NIPT test in 2021 on an unknown date, the findings are normal/ no abnormalities, female. Previous pregnancy end dates 25 MAY 2016 and 17 DEC 2018, with live birth as an outcome.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Pregnancy form attached; additional lab data reported.
Client had lost his childhood vaccine record and needed to start from scratch. He needed multiple vaccines and was agreeable to that plan of care. He was given Varicella on 9/3/21, which was only 21 days from another live vaccine (MMR) on 8/16/21. These vaccines need to be given on same day or 28 days apart. The nurse knew she had done this immediately and brought to my attention. Client without adverse reactions. Will make client aware that vaccine will need to be repeated.
Developed severe local reaction along outside of the arm from shoulder to fingers. Also developed fever and blisters on area "like a bad sunburn". Probable arthus reaction.  Edema at injection site >120 mm beyond elbow. Fever.
Information has been received from a physician concerning a 75 year old female who on 15-NOV-2007 was vaccinated IM with a dose of Gardasil instead of (diluent to reconstituted) Zostavax (Oka/Merck).  No additional information was available at the time.  There was no product quality complaint.  Information has been received from a medical assistant stating that she had no immediate knowledge of the event as she was not working that particular day.  She stated that she would check with the other nurses in the office and respond in a week, if possible.  She was faxed a B-form to submit patient details.  Follow up information was received and the physician stated "no further information to provide."
CLIENT RETURNED TO ADULT CLINIC FOR PPD READ ON 7/30/09 (IMPLANTED ON 7/28/09) WITH C/O OF ROUND MACULAR PAPULAR RASH ON FACE, NECK, BACK AND CHEST.  LESIONS NOTED TO APPEAR WITH CRUST-LIKE TOP AND STATED TO BE ITCHING.  CLIENT STATED SX STARTED ON 7/18/09 AFTER ADMINISTRATION OF TWINRIX SECOND DOSE ON 7/15/09. CLIENTS ALSO REPORTED TO HAVE EXCESSIVE SUN EXPOSURE PRIOR TO OUTBREAK OF RASH. CLIENT REPORTS NO ADVERSE RX ON FIRST DOSE ON 6/10/09.  NO RESPIRATORY SYMPTOMS. CLIENT INSTRUCTED TO CONSULT WITH HER PRIMARY CARE PHYSICIAN FOR EVALUATION OF SYMPTOMS.
Patient has experienced pain in left shoulder x12 weeks in deltoid area, especially on flexion and extension of left shoulder. Numbness of inner side of left upper arm down to little finger reported 08/10/16.
Chills; swollen lymph nodes in right armpit and lower neck; This is a spontaneous report from a contactable other hcp (Patient). A 52-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 52-year) in arm right on 28May2021 16:45 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Latex penicillin erythromycin. Since the vaccination the patient has not been tested for COVID-19 and prior to vaccination, the patient was not diagnosed with COVID-19. On 30May2021 08:30 the patient experienced chills and swollen lymph nodes in right armpit and lower neck. The seriousness of the events was reported as non-serious. The clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested. Follow up needed, further information has been requested.
Immediate reaction of rash, red wheat approx 2 1/2"x2 1/2" at injection site.
Red Spot on arm; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH MACULAR (Red Spot on arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RASH MACULAR (Red Spot on arm). At the time of the report, RASH MACULAR (Red Spot on arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.