chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intermittent tingling of her lips; Red Bumps on tongue; Tongue became swollen; Tongue feeling "like it has hairs on it"; Red palms; Hot palms; Itchy palms; Headache; Joint pain,Ankle pain; Throwing up; Nausea; Chills; Woke up at 3 am; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Woke up at 3 am), PARAESTHESIA ORAL (Intermittent tingling of her lips), TONGUE DISORDER (Red Bumps on tongue), SWOLLEN TONGUE (Tongue became swollen) and FEELING ABNORMAL (Tongue feeling "like it has hairs on it") in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalization in Dec 2020). Concurrent medical conditions included Asthma, Epstein-Barr virus infection and Drug allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced SLEEP DISORDER (Woke up at 3 am) and FATIGUE (Tiredness). On 14-Apr-2021, the patient experienced FEELING ABNORMAL (Tongue feeling "like it has hairs on it"), PALMAR ERYTHEMA (Red palms), FEELING HOT (Hot palms), PRURITUS (Itchy palms), HEADACHE (Headache), ARTHRALGIA (Joint pain,Ankle pain), VOMITING (Throwing up), NAUSEA (Nausea) and CHILLS (Chills). On 15-Apr-2021, the patient experienced PARAESTHESIA ORAL (Intermittent tingling of her lips), TONGUE DISORDER (Red Bumps on tongue) and SWOLLEN TONGUE (Tongue became swollen). The patient was treated with NYSTATIN at an unspecified dose and frequency. On 19-Apr-2021, PALMAR ERYTHEMA (Red palms), FEELING HOT (Hot palms), PRURITUS (Itchy palms), HEADACHE (Headache), ARTHRALGIA (Joint pain,Ankle pain), VOMITING (Throwing up), NAUSEA (Nausea) and CHILLS (Chills) had resolved. At the time of the report, SLEEP DISORDER (Woke up at 3 am), PARAESTHESIA ORAL (Intermittent tingling of her lips), TONGUE DISORDER (Red Bumps on tongue), SWOLLEN TONGUE (Tongue became swollen), FEELING ABNORMAL (Tongue feeling "like it has hairs on it") and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports she was hospitalized with COVID-19 for several days and administered IV doxycycline, steroids, Remdesivir, and albuterol in December 2020.
The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.
EYELIDS SWELLED; RASH ALL OVER THE BODY; HIVES AROUND THE BELLY BUTTON, ARMS, FACE AND BODY; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and arthritis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced hives around the belly button, arms, face and body. On JUN-2021, the patient experienced rash all over the body. On SEP-2021, the patient experienced eyelids swelled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives around the belly button, arms, face and body, rash all over the body and eyelids swelled was not reported. This report was non-serious.
4 hrs p/vax on 20ARP94 exp inc pain in lt arm; 24 hrs p/inject site became reddened & when exam on 22APR which was 48 hrs p/receiving immun erythema measured 6mm x 8mm;
Within one month of the second shot, I noticed an indention in my left arm where the two vaccines were given. It is a rather large indention where presumably the muscle is atrophied. I was checked out by my employer's Occupational Health Clinic. They did not recommend a treatment at this time. There's no pain or limitation in mobility in this arm. However, there is an obvious indention. It remains there today but has not gotten any worse than the first time I noticed it.
Shortly after the shot, felt extreme muscle/body aches - "very severe Flu like" , fatigue and some coughing. developed quickly into extreme muscle aches almost unbearable. Was unable to function. Stayed in bed. Only Ketoprofen helped dull them slightly. They lasted from Wednesday afternoon until Friday morning.  Then woke up feeling completely normal.
Well visit 9/14 at which time she had flu mist. >24hr later began with fever, cough & papular urticaria later afternoon 9/15. Cough and fever resolved 9/16; rash continued. Rash itchy. One lesion on right shoulder has gradually gotten bigger as she has scratched it. Trial Zantac & Atarax & ice to shoulder lesion. To call if lesion is continuing to enlarge.
A few hours after the second Moderna covid-19 vaccine shot my arm became very sore, radiating out from the injection site, and down the lower side of the arm to the forearm, seemingly along the nerves.  By the next day the soreness was so intense that I had to just hold my arm at my side as to avoid moving it which would cause pain.  This is not to say that I could not use my arm at all, but it was exceedingly sore and painful to use.  This lasted a couple days and slowly dissipated from then.  There was lingering weakness and nerve sensitivity from the upper arm down to the lower side of the forearm for many weeks.   I have seen a massage therapist who massages the arm, which has helped immeasurably.
Light sensitivity starting 5 days after injection, and progressively getting worse by the day. Only solution I have found is to wear my sunglasses any time I am outside, and maintaining all of my indoor lights off while I am home.
fluid filled blister/bubble type thing on my arm at the exact location the injection was given; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27May2021 09:45 (Lot number: EW0186) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos disease" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included: LEVOTHYROXINE; IBUPROFEN; TYLENOL; CETIRIZINE HYDROCHLORIDE. Past drug history included: Ciprofloxacin, reaction(s): "known allergies: Ciprofloxacin". Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer, lot_number=EW0179, lot_unknown=False, administration_date=06/May/2021, administration_time=11:00 AM, dose_number=1, vaccine_location=Right arm}]), administration date: 06May2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 28May2021 17:00, outcome "not recovered", described as "fluid filled blister/bubble type thing on my arm at the exact location the injection was given". Therapeutic measures were not taken as a result of vaccination site vesicles.  Additional information: It was reported that, 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. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Stated that, 24 hours after 2nd dose, the patient had a fluid filled blister/bubble type thing on my arm at the exact location the injection was given. The reporter classified the events as non-serious. The device date was on 30May2021.  No follow-up attempts are possible. No further information is expected.
pt recv vax 28FEB96 & 17MAR96 pt devel chicken pox vesicles on abd;no further details were provided;
This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Caused epileptic seizures to her two hours after taking vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced EPILEPSY (Caused epileptic seizures to her two hours after taking vaccine) (seriousness criterion medically significant) and PAIN (Lot of pain). At the time of the report, EPILEPSY (Caused epileptic seizures to her two hours after taking vaccine) and PAIN (Lot of pain) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The patient experienced a lot of pain due to being behind on HUMIRA. Moderna Covid vaccine caused epileptic seizures to her two hours after taking vaccine. Seizures went on for six weeks. At the time of report she had them occasionally as of 08-Sep-2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for HUMIRA(ADALIMUMAB) for the event of epileptic seizures and pain was not provided. Regulatory Authority opinion was no reasonable possibility that the events of epileptic seizures and pain were related to HUMIRA (ADALIMUMAB). Treatment information was not provided. Company comment: This is a spontaneous case reported by a consumer. An elderly female patient, with concurrent medical condition of Rheumatoid arthritis, experienced medically significant event of epileptic seizure (AESI) two hours after receiving mRNA-1273 vaccine. Seizures went on for six weeks and still had them occasionally as of 8 Sep 2022. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer. An elderly female patient, with concurrent medical condition of Rheumatoid arthritis, experienced medically significant event of epileptic seizure (AESI) two hours after receiving mRNA-1273 vaccine. Seizures went on for six weeks and still had them occasionally as of 8 Sep 2022. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
24 hours after receiving MCV4 in LA pt. was experiencing nausea, vomiting, swelling at site, hot to touch, redness.
Pt was given a vaccine that had expired on 6-2-2021. No side effects occurred for pt. Offered to revaccinate pt and he is going to discuss with his doctor first.
Complete explosive liquid diarrhea for day and half. Chills, joint aches, light headed as became dehydrated. That night started IV .9% NS on self to rehydrate. Took Kaopectate and out of work 1 day.
diluent had expired with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was adminstered diluent had expired with no reported adverse event after receiving vaccines diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel], diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] and influenza quadrival a-b vaccine [Fluzone Quadrivalent].  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 influenza quadrival a-b vaccine, diphtheria-15/tetanus/5 ac pertussis vaccine, diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (dose, strength, frequency, formulation, route, batch number, expiry date, administration site: unknown) for prophylactic vaccination (immunization).  On 12-Sep-2022 the patient had a non-serious diluent had expired with no reported adverse event (expired product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine, (unknown latency) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine and (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was 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.
Patient said her arm started itching around the vaccine site shortly after the injection. However, felt it was just due to the adhesive from bandaid
Patient started having tingling in her lips 5 days after the injection, then she began having a sore throat, she started having a hoarse voice and she felt very tired.  911 was called.  In route they were transporting patient she was hypertensive had normal heart rate they gave her Benadryl 50 mg orally and then epinephrine 0.3 mg IM which did not help patient at all.
mom states cranky & fussy all day following vax; next day approx 6PM had an apparent sz; no fever; mom was giving APAP to prevent fever; was not reported to hlth unit before 14JAN93; pt has had no further problems;
Pt presented to office with redness, warmth 2cm in diameter at injection site on left thigh. Treated with Keflex 250 mg. Instructed to RTC if symptoms worsen.
Hospitalization: 1/8/2023 - 1/10/2023 (2 days) Presentation to the ED: left-sided  lower extremity weakness, dysarthria.  COVID + date: 1/8/23 Treatment: no indication for therapy.  Discharge to: Home.  Moderna 031L20A 2/21/2021 Moderna 030A21A 3/15/2021 Moderna 013F21A 11/15/2021 Moderna 038A22A 5/19/2022 Moderna BiValent AS7163B 10/26/2022
6 hr after injection, immediate onset of upset GI, diarrhea, within hour other symptoms on-set including nausea (no vomiting), extreme exhaustion/fatigue, agitated/moody, malaise. About 12-18 hr in severe headache, body ache, normal site soreness. Symptoms stayed thru Thursday late afternoon and started dissipating and not clearing until Friday morning.
A 3 months old patient was inadvertently administered Fluzone Quadrivalent, No AE; Initial information was received on 29-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional (Medical assistant).  This case involves a 3 months old female patient who was inadvertently administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 29-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7011NA, expiry date: 30-Jun-2021, strength: standard) once via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  A medical assistant was asking which adverse events are related to a 3 month old after giving the flu shot.  At the time of report, no adverse event was reported.  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 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.
Fever, chills, muscle aches, joint aches, fatigue, sleeplessness, very tender injection site, reduced strength in injection arm
Fever 102.5 4/13/21 Fever 100.6 4/14/21 Headache severe 4/13/21 Body aches moderate - severe 4/13/21-4/15/21 Fatigue 4/13/21-4/15/21 Nausea/diarrhea 4/15/21 Dizziness/lightheadedness 4/15/21 Chills 4/13/21-4/15/21 Injection site pain 4/12/21-4/14/21
Completely healthy athletic 16 y/o given menactra and 1 days later started with rapid onset LE paralysis with rapid progression to upper extremities, resulting in loss of function of bowel and bladder. Worked up and MRI confirmed transverse myelitis. Transported to highly specialized neurology at hospital. Initial Admission 9/13/22 and then transfer to hospital for 34 days: 9/14-10/19/2022.
Afebrile. Seen 11/7/03 for left finger puncture wound; since last tetanus-Dip booster was in 1993, booster dose given left deltoid. Left deltoid sore since but 11/9 left axillary lymphadenopathy (3cm x 3cm) developed. Tender, not supporative. Given antibiotic Augmentin x2 for 7 days.
presyncopal episode, assisted to ambulate to patient room, transferred to examination table in supine position, was found to be euglcyemic, normocardic, improved s/p 20minutes, given food and cup of water, reported physician's hair looked purple, which resolved following as above
49-year-old female with past medical history of diabetes mellitus type 2, hypertension, gastroesophageal reflux disease, and cardiomyopathy leading to cardiomegaly and has not resolved per patient presented for approximately 1 week of cough, shortness of breath and now chest and rib pain. Patient reports that symptoms started on Friday and when she reported to the ED she was being treated for bronchitis. Patient states the shortness of breath and cough did not resolve with over the counter medications and that is what prompted her in. She states the chest pain feels more like rib pain due to consistent coughing and that is when she feels it. She endorses fevers, body aches, diarrhea  and weakness.
second dose in 2020/ Shingles outbreak in 2021/Suspected Vaccination failure; Shingles outbreak; pain; blisters; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. On 11th August 2021, between 10 and 12 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and blister. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The age at vaccination was not reported for 1st dose. The patient received Shingrix vaccine and was diagnosed with a shingles outbreak and the patient still had pain from the Shingles outbreak, but the blisters were gone. The reporter consented to follow up. This case was considered to be a suspected vaccination failure case, laboratory confirmation for shingles was unknown at the time of reporting.
With in five minutes of administering vaccination  patient was experiencing severe stabbing pains throughout her entire core especially in her upper chest, arm, and back. Patient was not having trouble breathing and was able to talk. She wanted to go to the emergency room as a precaution so we did call an ambulance to transport her. At the time the ambulance arrived she was doing much better and walked into the ambulance.