chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and bruising; legs covered in petechiae and bruising; After 2nd dose, 1 day of headache; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK4176 intramuscular in left deltoid on 07Jan2021 as single dose (at the age of 33 years) for COVID-19 immunisation.  Patient had history of ongoing Autoimmune Thrombocytopenia from May2020, ongoing migraines, depression/anxiety and ADHD, and COVID-19 21Apr2020 to "05May2021".  Concomitant medication included Sertraline Hydrochloride (ZOLOFT), Lisdexamfetamine mesilate (VYVANSE), Lorazepam  (Ativan), Ondasetron (ZOFRAN) and Sumatriptan succinate (IMITREX).  Historical information regarding dose 1 of BNT162B2 on 17Dec2020 included a moderate injection site reaction lasting 6 days worst on day three. Reaction was characterized by redness, swelling elevated rash surrounding injection site, aching pain radiating from neck to fingers and tenderness to palpitation.  1st dose Vaccine Lot Number: EJ1685, Vaccine Lot Expire Date: Mar2021, Time the Vaccination Was given: 08:00.  After the 2nd dose the patient experienced a moderate headache on 08Jan2021 12:00 for 1 day which responded well to APAP- caffeine and resolved on 09Jan2021 12:00 Patient had a flare up of my autoimmune thrombocytopenia as evidenced by legs covered in petechiae and bruising on 09Jan2021. Emergency room and physician office were not visited however, patient does have standing CBC orders from hematologist, so she had platelet count checked. It had dropped to 109K/uL, which is low for me but not dangerous. Patient originally developed autoimmune thrombocytopenia (ITP) May2021 after COVID Apr2021. Both instances of these side effects were manageable, but patient wanted to report them as there was no data yet available on ITP with the vaccine when she met with hematologist to discuss it. Patient received Acetaminophen 650mg PO (per oral) as treatment.  Lab data included Platelets 13Oct2020 124 kiU/L (normal 140-400) and on 12Jan2021 109 KiU/L.  Event flare up of my autoimmune thrombocytopenia resolved on 31JAN2021 00:00, Platelets dropped to 109k resolved on 31JAN2021 00:00, legs covered in petechiae and bruising resolved on 31JAN2021 00:00 and headache resolved 09Jan2021.
85 recruits were vaxed w/Td & Yellow fever @ the same time; pts exp swelling & erythema surrounding vax site to a greater extent than was previously exp;
V-shaped area of bruising & redness after vaccines DTAP & HIB. No treatment other than TYLENOL/MOTRIN prn & cool compress.
Tingling/burning down L arm, similar sensation down L leg; urticaria noted on back of neck extending slightly to L side of neck. Tachycardia and hypertension upon exam.
From the onset, tingly and numbing sensation and a sensation of lethal injection. Panic and doom followed and has been with me since. A sensation that a foreign toxin is in my body.
ITCHY WRIST; ITCHY RASH ON LEFT LOWER BACK AND LEFT SHOULDER; HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies, no known medical conditions and no known current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 07- AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced body ache. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced itchy wrist. On 11-JUN-2021, the subject experienced itchy rash on left lower back and left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy rash on left lower back and left shoulder, headache, body ache and itchy wrist was not reported. This report was non-serious.
MOTHER STATED PATIENT WAS 12 YEARS OLD AND ELIGIBLE FOR VACCINATION.  PATIENT IS ONLY 11 YEARS OLD AND NOT ELIGIBLE FOR VACCINATION
vaccine leaked out during administration; connecting piece on the syringe loosened/ vaccine leaked out; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   On 17-AUG-2023, the patient received Kinrix. On 17-AUG-2023, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: vaccine leaked out during administration) and syringe leak (Verbatim: connecting piece on the syringe loosened/ vaccine leaked out ). The outcome of the incomplete dose administered and syringe leak were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Aug-2023 Nurse reported that a patient was administered a Kinrix vaccine.   Looking at advise to see if and when the patient should be revaccinated. The reporter consented to follow-up via email. The connecting piece on the syringe loosened and the majority of the vaccine leaked out during administration, which led to incomplete dose administered and syringe leak.
Patient received Moderna Covid Vaccine on 4.5.21 and 5.3.21 Exposed to Husband who tested positive for  Covid 9-21-21. Patient has had sneezing, congested nose et lethargy. Patient then tested positive today 9-21-21
swelling,urticaria surrounding site of inj;facial swelling & erythema;sx improved w/DPH & APAP
lightheadness; weakness; muscle pain in her legs; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadness), ASTHENIA (weakness), MYALGIA (muscle pain in her legs) and FATIGUE (Extreme fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included BUPROPION, ARIPIPRAZOLE, LAMOTRIGINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (lightheadness), ASTHENIA (weakness), MYALGIA (muscle pain in her legs) and FATIGUE (Extreme fatigue). At the time of the report, DIZZINESS (lightheadness), ASTHENIA (weakness), MYALGIA (muscle pain in her legs) and FATIGUE (Extreme fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient who got Daptacel instead of Adacel with no reported adverse event; Initial information received on 09-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age /gender patient who got Daptacel (Diphtheria-15/tetanus/5 ac pertussis vaccine ) instead of adacel (diphtheria-2/tetanus/5 ac pertussis vaccine) with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (formulation) and Diphtheria-2/tetanus/5 ac pertussis vaccine (formulation) (strength, dose, batch number and expiry date were not reported) instead of adacel with no reported adverse event (wrong product administered) ( latency-same day)   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I tested positive for COVID-19 on 09/05/2022 and I took a home test. My wife tested positive two days prior. I had a mild earache with a dry cough. My doctor indicated no fever or SOB. My doctor diagnosed me with mild symptoms and no significant symptoms outside of my age. I called medical practice where I got a telehealth visit and I was prescribed PAXLOVID but I never took the medication. My symptoms were not that bad. The symptoms are coughing for couple of days and every now and then I get a period of coughing in the morning or late at night. For the most part I mostly have in the mornings and during the night, my cough comes and goes, feels like a chest congestion.
discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car); muscle spasms; terrible shaking.; arm became red and swollen. She was unable to sleep on the arm; chills; pain / feeling "pinching & grabbing; felt sick; Initial information received on 10-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old female patient who experienced discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car), muscle spasms, terrible shaking, arm became red and swollen. she was unable to sleep on the arm, chills, pain / feeling "pinching & grabbing and felt sick,  while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Hysterectomy on 06-AUG-2012 and Hernia. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious discomfort when seated (reports "squirming around" to get comfortable, difficulty sitting in the car) (discomfort), muscle spasms, terrible shaking. (tremor) , arm became red and swollen. she was unable to sleep on the arm (inflammation), chills, non-serious pain / feeling "pinching & grabbing (pain) and felt sick (malaise)     (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was discomfort, muscle spasms, Shaking, Inflammation localized, chills, pain and Sickness  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  List of documents held by sender: none.
pregnant patients that have been administered a dose of YF-VAX, with no reported adverse event; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case from an Other health professional via Agency (under the reference 00899280).  This case involves a 39 years old female pregnant patients that have been administered a dose of YELLOW FEVER VACCINE - US [YF-VAX] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  Event occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The information regarding patient's previous pregnancy was unknown.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL); TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) (lot and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.   On 02-Dec-2021, the patient received a dose of suspect YF-VAX (0.5ml, total, lot UJ409AA and expiration date: 22-Oct-2022) via subcutaneous route in the left arm for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  No reported adverse event  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had fever, swollen lymph nodes, congestion and 'covid arm' aka a large round red rash on my right arm where I got the first dose of moderna. The red rash was itchy and sore. It was about the size of an apple.
Pt recvd vax & 10 days later exp a rash on trunk & arms;
Hives on back and stomach, took a Benadryl on 1/10/2021, but the hives came back on the 11th of January on my abdomen only.
Patient presents to hospital for non-COVID symptoms and is subsequently found to be COVID positive, although is noted to be asymptomatic.
Approx two weeks after vaccine, I was diagnosed 11/24/2020 with an "id reaction". Rash all over my body. Allergy tested 12/15/2020, mold was only positive. Biopsy on left arm (1/5/2021). Pathology reported type of allergic reaction.
More than 5 month after 1 dose/ was not able to get 2nd vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (More than 5 month after 1 dose/ was not able to get 2nd vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (More than 5 month after 1 dose/ was not able to get 2nd vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (More than 5 month after 1 dose/ was not able to get 2nd vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.  The reporter stated that the patient was not able to get 2nd vaccine due to unforeseen circumstances.
patient presenting with nerve pain on right side that has travelled from her shoulder down her right rib cage into her right hip area. dr said Tylenol 500 every 6 hours as needed on 12/30/2019. I spoke to nurse today and she is going to follow up with the patient again and offer her an office visit for further eval.
two red spots on her arm, one about the size of a quarter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious), outcome "not recovered", described as "two red spots on her arm, one about the size of a quarter".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented to clinic on 8/4/06 with c/o rash to bilateral hands x 2 days, fever, body aches, stiffness, and nausea. Pustular rash present to hand and arm, non-pruritic. Diagnosed as smallpox viremia vs possible insect bites. Orders given for Motrin 800mg tid with food 10 day supply provided, no refills, Claritin 1 po qd, 30 day supply given, no refills. To follow up at the clinic prn. Returned to duty.
Chronic low grade feeling : 99.f - 100.4; Severe Fatigue  Taking Asprin
Febrile Seizure- parents describe 5-6 minute episode of generalized shaking, perioral cyanosis, postictal afterwards.
keep getting sick over and over again after getting these shots; keep getting sick over and over again after getting these shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "keep getting sick over and over again after getting these shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300001877 Same reporter/drug/events, different patient.;
vomiting; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 10Mar2021, outcome "unknown", described as "vomiting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling of arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Myasthenia gravis. Concurrent medical conditions included Immunocompromised (immunocompromised with myasthenia gravis).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of arm). At the time of the report, PERIPHERAL SWELLING (Swelling of arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that after receiving first dose of vaccine, patient developed swelling of arm for about a week and a half. Patient did not experience any adverse reaction after third dose of vaccine.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-361834 (Patient Link).
Body aches, weak, feverish, bad headache, chills, hot flashes and arm was very sore - more sore than with the first shot. Those lasted 12 hours approximately. No treatment - I didn't sleep well, though, so I missed work. Left Leg pain - I have had leg pain off and on for awhile. It's a nerve-like pain and it's kind of achy. Came on several months after the vaccines. Fluid in my ear: I had to have a tube put in my ear. That was in May, I had to go in several time. Vertigo - started having symptoms and called out sick. July 22, 2021 - it started at 06:30 am and it was better the next day. Treatment: Meclizine. It occurred just that one time. Telehealth visit. Left Leg pain - still comes and goes but everything else is cleared up. I have had problems in the past with herniated disc in back etc. I have some discs that are out of whack.
Patient developed cough and SOB 1.5 weeks after 2nd Moderna shot. Saw doctor at that point and treated for cough, but due to history or previous PEs and DVT a chest CT was ordered.
After receiving GARDASIL, Tdap, Varicella, pt stated he felt hot, eyes rolled back & pt fell back onto exam table. He was lethargic, pale, MD immediately notified, vitals taken for 1st 5 minutes until normal. Pt. became fully alert 5 min after administration of vaccines. Vitals, 1420 158/68, P 48, O2 99, R-16 1423 139/64, 43, 99, 16, 1429 118/60, P 50 R 16 O2 100%.
Arm was sore, with redness spreading down her left arm with a hot sensation. Also said that a lump was under her armpit about the size of a quarter. Once she removed the bandage she stated that it looked like gel.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The reporter did not provide any patient/vaccine details. The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient get shingles a week after their first Shingrix vaccine. The reporter gave adverse event information over chat. The reporter gave permission to follow up.
From 6/9 10:00 PM: Chills, fever and fatigue From 6/10: Onset of persistent headache that does not relieve with pain medications.  No more chills and fever. On 6/12 8:30AM: Mild nose bleeding. redness on the injection side and pain when pressed. Headache with increased severity that worsens when moving head.
Complained of being hot, diaphoretic. Vomited x 2, low blood pressure. Seen in ED - told it was a vagal reaction. No hives, itching.
Patient received 1st covid 19 immunization which was Pfizer and while patient was waiting  the required 15 minutes, the patient fainted for a couple of seconds
Arm where received pneumococcal conjugate was very painful. Couldn't move arm. At 10PM developed  over 101 temperature. Fast heart race, shaking, headache, sweated profusely. Irritation of throat. Light-headed.
Client fell while waiting in line to enter the POD. Client states that he got hot while waiting in line a long time. Client states that he does not think he lost consciousness but may have hit his head. 911 was called, EMS evaluated client and found him medically stable and client declined to go to the hospital. Client received Johnson and Johnson vaccine and left on his own after 30 minutes waiting time after vaccine.
After vaccination, pt. started to develop numbness in both hands up to elbows that progressively got worse. Developed into pain, burning, pressure that would wake her at night and felt like frostbite radiating up to shoulders. Pt. states right arm is about 3 times worse than left arm. Pt. is now wearing braces daily and taking Prednisone (despite adverse reaction to Prednisone) and Xanax to help with inflammation and pain.