chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute deep vein thrombosis (DVT) of popliteal vein of right lower extremity. Likely started 7/6/2021. Diagnosed via ultrasound in hospital ER on 7/12/2021. Treatment is to take apixaban. Note that patient had a PE in November 2017, but any source DVT was not diagnosed at that time.
This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of vaccine exposure during pregnancy in a 42-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included anemia during pregnancy, live birth and pregnancy. Concurrent medical conditions included pregnancy with advanced maternal age. The subject had 3 previous full-term pregnancies that resulted in 3 normal live births. The mother was not using contraception and the type of conception was normal. The subject had advanced maternal age for the current pregnancy. The subject experienced anemia with her last pregnancy in 2011. The maternal grandmother has diabetes and the subject's father had a myocardial infarct. There was no paternal history which may have an impact on the outcome of this pregnancy. On 15 October 2013 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right deltoid) and experienced vaccine exposure during the 2nd trimester of pregnancy. The gestational age was calculated to be 18 weeks. The date of last menstrual period was reported as 5 June 2013. The estimated date of delivery was reported as 12 March 2014 per the nurse. There were no adverse events reported. There was evidence of defect from prenatal testing. The nurse documented that there was evidence of defect from prenatal testing. The ultrasound results from "both ultrasounds showed evidence of increased nuchal thickness". The results of the "verified test (type of detailed genetic test)" (cytogenic analysis) were not yet available at the time of reporting. At the time of reporting the pregnancy was ongoing. The nurse reported 3 other cases with FLULAVAL. See A1050106A, A1050110A, and A1050111A for details on the other cases. Follow up was received from the nurse on 25 February 2014. The subject was pregnant with one fetus. The type of conception was normal and no in-vitro fertilization was used. The FLULAVAL was administered intramuscularly. Concurrent medications included prenatal vitamins. There were no adverse events reported. Relevant diagnostic tests included an "AFP tetra screen" (Alpha-fetoprotein tetra screen) and results were negative. At the time of reporting, the subject had "not yet delivered". 17 June 2014 - No further information was provided; patient lost to follow-up.
Exp weakness on both legs, tingling sensation & jumping p/2 days; happened p/3rd dose; PE showed good strength, neurologic reflexes good, just lost of light touch in both feet; pt recovered but not 100%; f/u MD feels not related to inject
This spontaneous report was received from a 50 year old female patient, who was also a company representative. The patient referred to herself. The patient concurrent condition included: a heartburn. The patient had a drug reaction or allergies for: BENADRYL, NEOSPORIN, POLYSPORIN, CALADRYL. On 04-JUN-2017, the patient was exposed to poison ivy and got an itchy poison ivy rash. On 06-JUN-2017, the patient was vaccinated with ZOSTAVAX subcutaneously for Shingles prevention (lot # M038864 with expiration date: 12-DEC-2017) that was reconstituted with sterile water diluent (manufacturer unknown). Concomitant therapies included PRILOSEC. Approximately on 11-JUN-2017 (reported as 5 days later), the patient stated that the poison ivy progressed severely and was affecting multiple limbs, torso, and neck. On an unknown date in June 2017, patient ankle was swelling. On 12-JUN-2017, the company representative visited a physician for the poison ivy, and was given an unspecified topical antibiotic and an oral prednisone (manufacturer unknown) (strength, dose, frequency, lot # and expiration date were not reported) titration pack to help relieve the itching. The poison ivy resolved within a few days (in June 2017). However, after the poison ivy resolved, she broke out with angry red raised bumps on both hands, one foot, and the top of the rib cage near the clavicle (unspecified date in June 2017). The patient reported that the bumps kept spreading and were not getting any better. She stated that she visited a nurse on 21-JUN-2017. The nurse stated that it did not appear that patient had a shingles. At the time of the report, as a treatment for the bumps the patient was taking ZYRTEC. The patient declined receiving Varicella Zoster Virus (VZV) packet. There were no lab diagnostic studies performed. The outcome of the event of poison ivy progressed severely and was affecting multiple limbs, torso, and neck was reported as resolved. The outcome of the event of ankle was swelling was not reported. The outcome of the events of she broke out with angry red raised bumps on both hands, one foot, and the top of the rib cage near the clavicle was reported as unresolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Woke up having heart palpitations.  They increased as days passed.  She was diagnosed  with PVC.
fainted for a few seconds; I started seeing blurry; my ears were ringing; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161, expiry date not reported), via an unspecified route of administration, administered in the right arm on 16Apr2021 16:45 (age at vaccination was 16 years) as single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient reported that on 16Apr2021 17:00, "I started seeing blurry. I stood still so my vision would clear. Then I fainted for a few seconds. When I came to my ears were ringing." The events resulted to emergency room/department or urgent care. Therapeutic measure was taken as a result of the events that was seen by a doctor. Clinical outcome of the events was unknown.  No follow-up attempts are required. No further information is expected.
tingling all throughout body after vaccination of first dose.; started having muscle spasms after receiving shot, , some are bigger spasms and others are smaller. but happening quiet constantly. still having spasms24 hours after vaccination.; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (bananas, avocados, apples), allergic to cats, adhesive tape allergy (some type of adhesive). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced tingling all throughout body after vaccination of first dose, started having muscle spasms after receiving shot, some were bigger spasms and others were smaller. But happened quiet constantly, still had spasms 24 hours after vaccination. The patient did not receive any treatment for the events. The clinical outcome of the events tingling all throughout body, muscle spasms after receiving shot, some were bigger spasms and others were smaller. But happened quiet constantly was not recovered at the of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
60 hours post vaccination I began having diarrhea, vomiting, and nausea - vomiting lasted 4 hours, nausea/diarrhea lasted 36 hours 18 hours post vaccination - low grade fever, muscle aches, fatigue, joint pain - lasted for 30 hours
lethargic; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), LETHARGY (lethargic) and FATIGUE (Tired) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Headache). On 21-Jan-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (Tired). At the time of the report, HEADACHE (Headache), LETHARGY (lethargic) and FATIGUE (Tired) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Information has been received from a health professional concerning a 30 year old female, with allergies to penicillin and aspirin, who was vaccinated with a first and second 0.5 ml dose of Varivax (Lot# 649993/0896R) on 23-FEB-2006 and 06-APR-2006, respectively. Concomitant therapies included hormonal contraceptives (unspecified) and ZOLOFT. On 31-AUG-2006 a titer was done and came back negative. It was noted that the patient had no symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
10cm x 12cm area of erythema surrounding injection site on left upper extremity onto left shoulder. Warmth, tenderness. (received doses 2, 4 and 4 of DTP in Belgium).
My child had a slight fever and a cough that made her gag, like there was something in the back of her throat, which wasn't too different than after the first set of these same vaccines. The first time she got them she went from being an easily consoled, self-pacifying baby to absolutely screaming when she was tired or for no apparent reason. However, with this second set of shots she wasn't fussy like the first time, but she threw up multiple times, starting in the evening of the day the vaccines were given and continuing over the course of 3 days. When I say throw up I mean completely emptied the entire contents of her stomach to the point I was worried about wet and poopy diapers. This was not a normal reaction. She even randomly threw up once about one week post-vaccination. Also, my child has not babbled or been vocal like she was since the day she received her vaccinations.
Patient ran fever, swelling of the axial node (left side) and experienced involuntary jerking the night after vaccination. Jerking and other symptoms have since subsided.
Report 2001017818-1 described injection site edema in a four year old male who received Infanrix. The vaccinee was described as a "well child." On 05/09/2001, the vaccinee received the fifth IM left thigh dose of Infanrix, and the fourth SC right thigh dose of IPV. On 05/11/2001, the registered nurse reporter received a telephone call from the mother of the vaccinee: the vaccinee's left leg had a red welted area slightly smaller than a tennis all, and bigger than one dollar coin size. There was no streaking. The registered nurse reported the events to the physician who ordered warm compresses and Tylenol for comfort. The mother was asked to call if streaking developed, redness increased, or symptoms did not resolve. No call back was necessary. The reporter stated that the adverse events were moderate in intensity and were possibly related to Infanrix. As of 07/20/2001, the adverse events had resolved.
Both shots administered in (L) deltoid 9/28/12 pt. has pain, swelling, erythema at injection site "hard knot, hot to the touch" will try ice pack, BENADRYL / NSAIDS first. May seek further treatment. Pt went to urgent care and received antibiotic.
Starting Friday night, 10/15/2021 I started seeing a few red spots, thought maybe they were Mosquitoes as they itched a little. On Saturday, 10/16/2021 as the day went on I noticed the red spots had turned into a full blown Rash/Hives on my stomach, chest, back and buttocks. The itching was starting to intensify. On Sunday, 10/17/2021 I awoke to find the Rash/Hives was all over my body. I then went to the Emergency Care Facility located close to my house and was seen by PA. I explained the situation and timeline to him. He prescribed Prednisone 10, 18 tablets.
(R) arm has heat & swelling - redness. Second red area under arm on tricep administered 9/24.
Vaccine given on 11/16/05 at about 11:30 AM: 9 hours after receiving the shot: hot flashes, muscle aches, cold sweats: lasting for two days. Then on 11/21/05 5 days after the vaccine: cold sweats, low grade fever, insomnia, chest pains - as if a great weight was on the chest, back pains between the shoulder blades, body aches, trouble breathing. 11/22/05 8:30 AM - went to the clinic - low oxygen in blood, blood in urine, high white and red blood count, low grade fever, body aches, back pain, chest pain. Ambulanced to hospital: Arrived about 11:30AM given oral and IV MEDS, heart monitor, nitroglycerin ointment 2% 1GM, Troponin I, Magnesium, Promethazine HCL, Sod Chloride 0.9%, Cenftriaxone Injection, Morphine injection, Lopressor 50 mg, Aceta tablets 325 mg, Darvon 100 mg, Ambien 5mg, Plavix 75mg, Hum R Per unit, Diovvan HT 160/12.5, Pantoprazole 40mgp, Travenol, Insulin Glargine, zoccar 80mg, oxygen, admitted to the hospital, continued observation, heart monitoring, antibiotics, Discharged on 11/24/05 at 2:30 PM ordered to take CEFUROXIME AXETIL antibiotics 500 mg two times daily for ten days. On 11/25/05 10:00 am the right arm began to hurt, swelling, and hot to the touch. Pain got worst till swelling got very bad. 11/30/2005 8:00 AM saw my Cardiologistist to review what happened at the hospital and told him of the pain in the arm. He dignosied it as a staff infection and told me to continue to take the medication hospital assigned but if it got worst to go back to the hospital. On 12/01/05 went back to the hospital a blood clot was found and infection in my arm: treatment included Enoxaparin, saline flush 10ml, Sod Chloride 0.9%, Septra Ds Tablet, Ceftriaxone injection: Oral medication included Augmentin, Bactrim DS, Motrin, Vicodin. On 12/03/05 4:00 pm began to feel clammy, hot with cold sweats but no fever and was gone the next day. Have been healthy since.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 01-JUL-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
NEUROPATHY 4/2/2023 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 4/2/2023 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) HYPOTENSION 2/17/2023 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND)
Received anthrax #6 yesterday (9/20/03) L arm.  Mild irritation noted.  Patiend used "heat/vibrator" on injection site last pm, noted "blister" and "redness" this am.
Patient called to report she's still having fevers to >102 F unless taking ibuprofen. She reports running out of Tylenol so she has been taking Advil and has taken atleast 3 tablets today. She reports her symptoms of high fevers > 103 F started hours after receiving Flu vax and PNEUMOVAX together at a recent office visit for presumed viral bronchitis. She believes her respiratory symptoms are unchanged compared to her office visit.  She is using her rescue inhaler occasionally which she thinks is helpful.  She denies pleuritic chest pain, increased purulent sputum, wheezing, or shortness of breath. She reports injection sites for both vaccines are red and swollen. She does not believe redness is progressing. Given 1 dose of ceftriaxone on 11/18 and given azithromycin for concnurrent pneumonia. Patient went to the ED on 11/19/17 because she felt that the cellulitis got worse, as given IV cephalexin and hydrated, given additional PO cephalexin.
Patient was given an expired vaccine which expired at 2:45pm--there was no date just a time left in the basket they were stored in.   Patient was still in the store when we discovered the dose was expired and we asked him to remain in the store while we called Pfizer to determine how to proceed.  Per Pfizer, there medical department was not open to advise on what procedure to follow until the following Monday 8-30-2021 8am-8pm Eastern.  Patient was notified we would contact him Monday after contacting Pfizer's medical team.
no adverse event; Caller reported that VARIVAX that underwent temperature excursions was administere; This spontaneous report was received from a licensed practical nurse referring to an unknown age and gender patient. No information regarding the patient's medical history, concurrent condition or concomitant therapy was provided.  On 16-JUN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U022320, expiration date 15-JUL-2023) for prophylaxis (dose, administered route, strength and frequency were not reported) that after temperature excursion of 14 Fahrenheit (F) up to 46F for 13 hours 50 minutes and minus 58F to 5F (0.0F) for 6 hours 56 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA002160:
Received phone call from school nurse and child had been in school and had swollen eyes, itching all over, blotches on hands and arms. Reaction started on 10/14/2020.Case was sent to Urgent Care for evaluation on 10/15/2020. On 10/21/2020 spoke with mother and was informed case received high dose steroid at Urgent Care  and hives were subsiding .
The rash as big blotchy red areas that itch; The rash as big blotchy red areas that itch; They are huge masses of red spots all over her body; The rash continued to spread all over the body from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (The rash as big blotchy red areas that itch), RASH PRURITIC (The rash as big blotchy red areas that itch), RASH MACULAR (They are huge masses of red spots all over her body) and RASH (The rash continued to spread all over the body from head to toe) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091O21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (The rash as big blotchy red areas that itch), RASH PRURITIC (The rash as big blotchy red areas that itch), RASH MACULAR (They are huge masses of red spots all over her body) and RASH (The rash continued to spread all over the body from head to toe). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (The rash as big blotchy red areas that itch), RASH PRURITIC (The rash as big blotchy red areas that itch), RASH MACULAR (They are huge masses of red spots all over her body) and RASH (The rash continued to spread all over the body from head to toe) outcome was unknown.            No concomitant medications were reported. Treatment Includes Prednisone Taper Therapy.   This case was linked to MOD-2021-297311 (Patient Link).
Pt was given PNEUMOVAX inj on 10/11/12. (L) arm started to get sore and swollen eyes Tuesday. Noticed rash after showering this afternoon. C/O chills earlier today. T 101, P 82 R 20 BP 110/69 O2 Sat 97% R/A.
Within 24 hrs of receiving vaccines listed in #13, client developed vesicles near MMRV vaccine site and on arms & thighs. As of 4/19/13, client had no fever or malaise. Vesicles itched.
Swelling of glands in the left side of my neck. The shot was given on the left side. The right side was slightly swollen, but the left side was extremely swollen. No treatment. The swelling went down enough so that I did not have trouble swallowing by 8:00 PM.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-FEB-2015, the patient was vaccinated with LIQUID PEDVAXHIB (lot number: K008878 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with LIQUID PEDVAXHIB was not reported. Product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Rash on the soft part of both arms/Rash on the torso; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the soft part of both arms/Rash on the torso) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, EN6203 and EM9809) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose Pfizer : EM9809) on 04-Feb-2021 and Pfizer (second dose Pfizer : EN6203) on 24-Feb-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer. Concurrent medical conditions included Thyroid disorder NOS (Thyroid). Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, ESTRADIOL (CLIMARA [ESTRADIOL]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 27-Oct-2021, the patient experienced RASH (Rash on the soft part of both arms/Rash on the torso). On 24-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, RASH (Rash on the soft part of both arms/Rash on the torso) outcome was unknown.            No Treatment details were reported Patient stated that she experienced rash but isn't at injection site and it does not itchy. Patient stated that she took the booster dose because she's a Therapist and sees patients all day.