chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PERMANENT DISABILITY; SERIOUS HEART PROBLEMS AND PERMANENT HEART DAMAGE; This spontaneous report received from a patient via social media through company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, and batch number: unknown and expiry: unknown) dose was not reported, 1 total administered start therapy date were not reported for prophylactic vaccination (Dose number in series was 1). 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 an unspecified date, the patient reported that "Thanks for the Covid Vaccine that caused serious heart problems, permanent heart damage and heart medication oh and permanent disability." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the serious heart problems and permanent heart damage and permanent disability was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0:20211260942-Covid-19 vaccine ad26.cov2.s-Permanent disability. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
blood clots right nostril; pain/discomfort right side at waistline going toward back; pain/discomfort right side at waistline going toward back; This is a spontaneous report from a contactable consumer (patient).  An 82-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot Number: EL9581), as single dose in left arm on 06Feb2021 10:30 for COVID-19 immunisation, administered at hospital.   Medical history included artificial mitral valve. No known allergies. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received concomitant medications in two weeks but were not reported. No other vaccine in four weeks. The patient received the 1st dose of bnt162b2 (BNT162B2), on ana unknown date for COVID-19 immunisation and experienced pulsatile tinnitus right ear. The patient experienced blood clots right nostril, pain/discomfort right side at waistline going toward back on 16Feb2021. The patient was hospitalized for blood clots right nostril. She went to Dr. for tinnitus, had MRI and CAT scan in 2021. All tests were negative. She received no treatment. COVID was not tested post vaccination. Right side got better after several days in 2021. Blood clots in nose lasted one morning and recovered on 06Feb2021.
DEATH; This spontaneous report received from a health care professional and concerned multiple patients of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients died of unknown cause of death after receiving Janssen vaccine. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210940869-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
pt recv vax 26OCT95 220PM & by 430PM pt began to devel chest tightness & pressure like in a vice;pt felt unable to catch breath;had sx of shakiness,profuse diaphoresis,pallor,vertigo & nausea;felt lightheaded & shaky;
Extremely ILL; Fever; Chills; Body aches; Headache; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches) and HEADACHE (Headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) 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.
IPV, DTaP, Comvax, MMR given on 9/10/03. 9/15/03 papular red rash on shoulder extended to entire ? during the next stage. Rash was itchy-Rx Atarax on 9/22/03 rash started fading. Rash first noted day after immunizations.
About 3 hours after receiving vaccine body became itchy all over and rash became present- took over the counter Benadryl and rash kept spreading all over body. I am self pay patient and tried to continue over the counter remedies but after rash kept speeding I decided to go to the clinic urgent care - local medical group and was seen by PA.
Fever (101.5), chills, body aches, headache, bloodshot eyes, general feeling of malaise, loose bowels, pain in needle site (right arm that pneumonia vaccine was given only, left arm flu shot fine), unable to lift arm above head, still extremely painful 36 hours later.
Prevnar vaccine was administered too high in the arm resulting in pain in her shoulder and neck area. Patient is using ibuprofen and ice for relief and following up with MD.
I have a rash on my arms and legs.  Pink bumps that whenever I scratch them turn dark.
I95.9 HYPOTENSION 2/4/2022 ANEMIA I95.9 HYPOTENSION 2/4/2022 POLYMYALGIA RHEUMATICA
Patient believes she had another bout of shingles. She did not go to the doctor as it looked just like her other cases of shingles. It was a much smaller area and cleared up in approximately 3 weeks with NEOSPORIN. She was told to report it.
Welt developed approx size 2" tall x 3" wide at injection site. No hot, itchy, painful.
Erythema to injection site that is warm to touch and painful. Symptoms developed approx 24 hours after vaccine administration.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were provided No treatment were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Reported high pitched shrill screaming for about 2 hrs, vomiting,glassy eyed and went limp, swollen at injection site(red & swelling of leg), drenched full of sweat in middle of the night, temp of almost 103F.
gave a 18 year old second dose of Menactra, First Menactra was in 2017/No AE; Initial information received on 10-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 18 years old female patient who received two doses of 0.5 mL dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in 2017 and Vial Lot: U5869AA, Box Lot U5869AA, expiry date: 05-Aug-2020 via intramuscular route in the right deltoid on 10-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Extra dose administered. This was the second Menactra the child has had 10-Jul-2019.  There were no side effects.  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.  Documents held by sender: none.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified dates, the vaccine experienced two temperature excursions of 48 hours each.For one excursion the lowest recorded temperature was 34 F (1.111111111 Celsius) and for the other excursion the lowest recorded temperature of 32 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Day 1 - later in teh evening pateint experiences redness, swelling, warm to the touch, and sore.  48h after vaccine patient saw it spreading, under armpit which was very sore. 4-21-22 patient came in and patient said she is not feeling herself, and feeling weak, area is still warm and red (deltoid to half way down arm)
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. No information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was reported. On an unknown dates in approximately 2014 (reported as "about two years ago"), the patient was vaccinated with the first and the second dose of GARDASIL (dose, lot #, expiry date, route of administration and anatomical location were not specified). On 29-FEB-2016, the patient would receive her third dose of GARDASIL. There were no known adverse effects. Product quality complaint (PQC) was not involved. Additional information has been requested.
Vaccination site discolouration; Vaccination site hemorrhage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Vaccination site discolouration) and VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE DISCOLOURATION (Vaccination site discolouration) and VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage). At the time of the report, VACCINATION SITE DISCOLOURATION (Vaccination site discolouration) and VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
I had extreme nausea, vomiting and fatigue that lasted for about 3 weeks. I also have brain fog as well. I went to my gastro doctor on Feb 14th. He did a blood test and said that I recently had COVID-19. I am still having some nausea and fatigue.
Patient complained of a rush of feeling hot, symptoms progressed to feeling light-headed and dizzy.  Skin was warm and dry.  Experienced hypertension which got worse when told her blood pressure was high.  Patient was transferred to the ED for further observation.
Arrived home after vaccination - felt very tired and fell asleep.  When I woke around 3:30pm  I was experiencing a very rapid heart beat (tachycardia) and my heart was skipping a beat every 10 seconds or so (arrhythmia).  I took my blood pressure several times, while seated and at rest and it fluctuated between  180/87  with a heart rate of 74, to 150/94 with a heart rate of 111, to  143/98 heart rate 107 and then to 118/77 with a heart rate of 105.  To verify the machine was working, both my husband and son used the same device and their readings were steady and did not fluctuate.  I called my GP, who told me to drink lots of water, rest and wait to see with my heart doctor.  She also said if my condition got worse to go to the ER.   I made an appointment with my heart doctor but he cannot see me until April 7.  The adverse event lasted until bedtime.  (about 6-7 hourse).  I haven't had a problem after that.  I since discovered that the CDC changed its recommendation a couple days before I got the vaccine to avoid the shot if I'm allergic to Polysorbate due to PEG being present in the mRNA vaccines.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: patient reported having tightness of chest at front of store after receiving vaccine.  asked for us to call ambulance and we did.
Room looked like it was spinning, felt nauseated, racing heartbeat, developed Afib, severe trouble breathing, fatigue, weakness, using walker, trouble standing, on oxygen, very short of breath, taking Flecainide, experiencing memory fog
Patient presented to ED with cough, SOA, low back pain, cold chills X 3 days.  Admitted due to transplant status for observation.
Fever; big rash on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (big rash on her left arm) and PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE RASH (big rash on her left arm). On 21-Apr-2021, the patient experienced PYREXIA (Fever). On 06-Apr-2021, VACCINATION SITE RASH (big rash on her left arm) had resolved. On 22-Apr-2021, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-JUL-2018 the patient was vaccinated with an improperly stored  dose of ROTATEQ (lot # N030174 exp date 13-JUN-2019) (dose not reported) orally. There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1807USA004813: US-009507513-1807USA010173: US-009507513-1807USA010174: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA010214:
Pt developed an acute shingles outbreak less than 12 hours after recieving the Shingrix immunization
double vision is reported int pt receiving fluogen vax; pt exp sx following administration of fluogen therapy;
3/19/10 - Left arm/shoulder sore and difficult to move 3/20/10 - Left arm/shoulder sore, entire deltoid region swollen, unable to freely move arm - symptoms improved with ice and Advil 3/21/10 - Swelling to deltoid region improving, area red and warm to touch 3/22/10 - Swelling continuing to improve, redness resolving, hard nodule ~3cm in diameter where injection was given, scant amounts of clear fluid from injection site 3/23/10 - No swelling or discharge from site, small amount of redness to injection area and firm nodule still present.  range of motion within normal limits.
Flu-like symptoms; Severe headache; Sore muscles; Swollen sinuses; No energy; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, headache, muscle soreness, sinusitis and loss of energy. On an unknown date, the outcome of the influenza-like symptoms, headache, muscle soreness, sinusitis and loss of energy were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, muscle soreness, sinusitis and loss of energy to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced horrible side effects like flu-like symptoms, severe headache, sore muscles, swollen sinuses and no energy. The patient asked if there was anything that she could take to relieve these symptoms.
No reaction yet, but patient is less than 90 days since last plasma infusion for COVID19 treatment.  She states she feels fine but it is only 51 days since her last infusion.
States felt lightheadness aabout 10 minutes fter received vaccination on way to post vaccination waiting area. Alerted staff. Pt to lay on cot. VS taken x3, VSS. Patient released to self without further incident
injection site is slightly swollen, red and becomes itchy at times for about 10-30 mins
Dizziness, Headache, Myalgia, pain at injection site Narrative:
4 month with history of diffuse papular rash over trunk approx 24 hrs after receiving vaccine. No fever, no other symptoms. Mom describes injection site was initially red and hard, that eventually resolved after 2 days.
Soreness at sire 1 month, jchest pain irractic.   Severe chest pain when over exerting
Chills - 1 day, injection site soreness - 2 days, muscle pain (specifically back) - 1 week +, joint pain - 1 week +, headache - 3 days.
p/vax pt exp a chickenpox rash w/approx 12 lesions;
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-FEB-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Soreness in arm, nausea, dizziness, aches and pains, headache, severe chills and 102 degrees fever.
Fatigue; Arm pain; Headaches; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 16:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There was no other vaccine received within four weeks prior to vaccination. The patient experienced fatigue, arm pain, headaches Jan2021. Outcome of the events was unknown and no treatment was given. Events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
The site of injection began to swell became very red, hard and feels like it?s in fire
Mother states child ran fever for a few days after, Then approx 07/28/02 again started running fever irritable and diarrhea.
This case was reported by a nurse and described a 43 year old male who tested positive for unspecified "hepititis B antigen" after receiving Hep-B vaccine.    On 14 SEP 2004 the patient receioved the first dose of Energix-B vaccine.  Two days later, on 16 SEP 2004, the patient tested positive for unspecified hepititis B antigen.  The outcome of the event is unknown.  The burse considered the event probably related to vacconation with Engerix-B.
5.5cm diameter soft, clear to transillumination  - US showed hypoechoic fluid pocket  - clinical picture taken  - advised monitor, if not improved in 2-4 weeks return Lump formed the day of the shot was given above the site at the shoulder. Has stayed the same size for 2 weeks. Tender to the touch.
T78.40XS ALLERGIC DISORDER, SEQUELA 4/20/2023 HYPOMAGNESEMIA
Extreme nausea, headache, weakness, mentally unawares, dizziness, and at the gym on a cardio machine, couldn't get enough oxygen circulation in the lungs, swollen inner ear in both ears, swollen hands, just overall feeling of fatigue.
hives all over the body; alligator with the injection needle only touching the skin; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves male patient (age not reported) who experienced hives all over the body (urticaria)  and alligator with the injection needle only touching the skin (hypersensitivity), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included Eczema and Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma. Notes: allergy to peanuts, and tree allergies    On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives all over the body (urticaria) and alligator with the injection needle only touching the skin (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Other relevant tests were not reported.  Final diagnosis was urticarial and hypersensitivity.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient outcome was not reported.   Information on the batch number was requested.
Severe abdominal cramps moving up towards diaphragm. Complete exhaustion.  Nausea