chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atypical chest pain, 2 hours after Anthrax #3. No prior adverse events reported by pt. Still experiencing dizziness, extreme fatigue and shortness of breath as of 2/22/2000. 60 day follow up states patient sufferes from dizziness, disequilibrium, chronice fatigue syndrome, shortness of breath, cognitive difficulty, joint pain, tachycardia and palpitations. Annual follow up report received 8/18/2003 pt states he still has chronic fatigue syndrome, fibromyalgia, dizziness, balance trouble, joint/muscle pain, cognitive troubles: concentration, memory, decision-making. All of the symptoms/problems began with the start of the mandatory anthrax vaccinations, while in the military. This (on 02/05/2000) was the 3rd and last of the series of vaccinations. Diagnosed with chronic fatigue syndrome and fibromyalgia July 2003. Per annual report-Still has all these: 1)muscle pain and weakness 2)joint pain 3)dizziness/disequilibrium 4)cognitive problems:memory, concentration, computations, decision making, etc.. 5) extreme fatique (chronic fatigue syndrome).  I operate at about 20% of normal in all areas.  6) shortness of breath 7)ringing in ears.  These problems started 8 Jan 2000 (1st shot).  Got worse 22 Jan 2000 (2nd shot).  3rd shot 5 Feb 2000 sent me to emergency room via ambulance.  2 hours after 3rd shot had anaphalaxis reaction.  I have tried a number of therapies in the last few years.  Nothing has improved my health.  - 7/2/02 Anthrax Survey states pt not recovered. Continues to experience chronic fatigue, SOB, dizzy spells, extreme irritability, concentration/memory problems, "brain fog". He's on full duty, missed 2 days work for the AE and has had no further anthrax doses as of 3/10/00.  02/05/2010 Follow up: Chronic Fatigue Syndrome-unrelenting fatigue, dizziness, disequilibrium, tinitus, shortness of breath, dry mouth/eyes, rash, sore throat, severe cognitive problems. Fibromyalgia-muscle pain/spasms/joint pain, tendinosis of rotator cuff, hip pain, neck pain, gastro problems.
super tired; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on 20Feb2021, the patient experienced super tired. It was reported that the 2nd dose was scheduled earlier (03Mar2021) than 21 days. Outcome of the event was unknown. Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Patient is a 66 y.o. male who presents to the ED for onset of substernal chest pain associated with nausea and weakness.  Pain onset around 6 PM.  Has been nauseous and weak all day.  Relates this to second  Covid shot obtained on Monday (5/11/21).  Reports feeling fine yesterday.    As the morning and afternoon progressed he noted that he was just more and more weak and was really not able to get around which he normally does with a walker. Endorses a past history of both pulmonary embolus and pancreatitis for which his chest pain feels like.  Is not currently anticoagulated.  Last PE 2 years ago.  History of Parkinson's disease.  Denies any fever.  No other symptoms reported.
RED, SWOLLEN AREA ABOUT 3CM X 4CM APPEARED AT INJECTION SITE.  IT WAS ITCHY, WARM, AND SWOLLEN.  I TREATED HER WITH ANTIBIOITCS, ZYRTEC, AND A SMALL AMOUT OF HYDROCORTISONE CREAM AS NEEDED FOR ITCH.  IT IS RESOLVING 11/8/21.
Patient experienced lightheadedness, spots in vision, and shakiness approximately 30 mins after receiving the vaccine. Was monitored for 25 mins with no resolution in symptoms and was sent to the emergency room for additional evaluation.
Initial report was received from the scientific literature on 28 December 2013. An 83-year-old female was admitted with 2 days of altered mental status, weakness and fever. She had past medical history of hypertension, ischemic stroke and diabetes. She received inactivated influenza vaccine five days ago. On exam, she was obtunded, febrile with bilateral extensor plantar response and brisk reflexes. Computed tomogram of the head was unremarkable. Cerebrospinal fluid (CSF) analysis showed protein of 136 gm/dL, glucose of 108 gm/dL with lymphocytic pleocytosis (44 cells/microliter). Broad spectrum antibiotics were started for presumed infectious meningoencephalitis. Her mental status declined further and she required mechanical ventilation. Magnetic resonance imaging (MRI) of the brain and spine showed diffuse white matter lesions involving periventricular white matter, thalamus, midbrain, dorsal brainstem, cerebellum and medulla oblongata. CSF bacterial and fungal cultures, PCR for HSV, VZV, HHV-6, enterovirus, JC and BK viruses; anti-NMDA receptor antibody and flow cytometry for lymphoma were all negative. Serum studies for viral encephalitis, HIV and Quantiferon-TB were also negative. After exclusion of infectious and non-infectious causes, we made the diagnosis of post-vaccination ADEM based on the neurologic picture and MRI findings of extensive white matter changes along with recent influenza vaccination. DISCUSSION: ADEM is a rare inflammatory demyelinating disease of the central nervous system with an incidence of 0.4/100.000. Infection is the most common etiology; post-vaccination ADEM for 5% of cases. However, ADEM that occurs after vaccination may not necessarily be attributable to the vaccine and might rather be a temporal association. In our patient, based on World Health Organization causality assessment criteria, post vaccination ADEM was very likely. Daily methylprednisolone for 3 - 5 days followed by prednisone taper is the accepted first line therapy. Plasmapheresis is recommended for steroid unresponsive patients. With early treatment initiation, full recovery is seen in 50% to 75% of patients, within 1 - 6 months. Our patient did not respond to steroids and required plasmapheresis. She showed neurologic recovery with improved MRI and was discharged to a rehabilitation facility on day 42. CONCLUSIONS: Clinicians should consider post - vaccination acute disseminated encephalomyelitis in patients with encephalopathy, multifocal neurological findings and recent vaccination after carefully excluding other causes.
A physician reported via a company representative that a 6-year-old female received an inrjection of Prevnar on 09/17/2001. On 09/18/2001, the child developed a fever, a headache, and an injection site reaction characterized by swelling and warmth. Follow-up information received from the physician on 11/12/2001 indicated that the child recovered.
immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not feeling well; blistering; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 07Mar2021 18:00 as 1st dose, single for COVID-19 immunization. The patient has no medical history and concomitant medications. No history of previous vaccinations. No vaccinations in four weeks.  On 13Mar2021, 6 days after vaccination, the patient had nerve pain, back ache, hip ache, was not feeling well, and had blistering. The patient went to the urgent care/emergency room because of the back pain and was given Capscian which burned and acyclovir. On 17Mar2021, the patient had pain and rash. The patient's visited a dermatologist due to symptoms and was diagnosed with shingles which developed on the right side of her body on 21Mar2021. The dermatologist changed the acyclovir to valacyclovir at 1 gram three times a day and Triamcinolone Acetonide: ointment Dose: 0.1%, twice a day both starting on 23Mar2021. The patient was also given Lidocaine patch and Biofreeze. Patient states steroid ointment was very amazing and that was just yesterday it was started, already her rash is disappearing, blistering is going away. Dermatologist also said she hadn't been given the right antiviral. The patient requested reassurance that the first dose received would still be effective even though the patient thinks her immune system is obviously compromised (no treatment was reported), says her immune system took away guard for other virus, triggered but not caused it. Maybe just a theory my immune system is working overtime to produce antibodies from having received vaccine and maybe wasn't protecting from dormant chicken pox virus. Patient wanted to make sure the efficacy of first shot is still intact. Patient also stated second dose is scheduled for 29Mar2021 and she was wondering if she would be able to receive the second dose or if she would have to wait a period of time. The outcome of the event immune system is obviously compromised was unknown while for the rest of the events was recovering.
Pt. developed itchy rash on both arms and legs. no respiratory complaint. site of vaccination without any rash. Treated with Prednisone, recommended OTC antihistamine and advised to apply OTC topical steroidal cream on the area.
fever; body aches; tiredness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, general body pain and tiredness. On an unknown date, the outcome of the fever, general body pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain and tiredness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-DEC-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The reporter wanted to know how long do the side effects of fever, body aches and tiredness last.
A report has been received from a Physician concerning a female subject who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that patients received FLUMIST Quadrivalent that was subjected to a temperature excursion and below the recommended storage temperature range. The outcome of the event of multiple patients received FLUMIST Quadrivalent exposed to temperatures above and below the recommended temperature range was unknown. The report was considered to be non-serious.
Loss of nerve sensation and muscle coordination. Numbness and tingling in hands, feet, and face. Condition ongoing to date. Medical records state atypical GBS, ear pain, malaise, mononucleosis. msv
This spontaneous report was received from a female consumer of unknown age who was reporting on herself. The patient's medical history included herpes zoster (twice). The patient's concurrent conditions and concomitant medications were not reported. In October or November 2014 (date unspecified), the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous; dose, lot # and expiration date were not reported). In May 2015 (reported as around the first week of May 2015), the patient contracted shingles. The patient had the rush that "hurts and itches terribly" on her face and scalp. The patient sought an unspecified type of medical attention. The patient received the treatment with ibuprofen and other unspecified medication. None lab diagnostics studies were performed.  The outcome of the adverse event was report as recovering. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
URINARY TRACT INFECTION; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 71 year old female.  The patient's height, and weight were not reported.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination on left arm (dose number in series 1). No concomitant medications were reported. the patient did no have a sore arm.  On MAR-2021, the patient experienced urinary tract infection and slight headache.  (dose number in series 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from slight headache, and the outcome of urinary tract infection was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211137873 (Dose number in series 2).
"felt bad"; "eyes swole up"; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL ("felt bad") and EYE SWELLING ("eyes swole up") in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anaphylactic reaction (anaphylactic response to carrots).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL ("felt bad") and EYE SWELLING ("eyes swole up"). On 27-Mar-2021, FEELING ABNORMAL ("felt bad") had resolved. On 29-Mar-2021, EYE SWELLING ("eyes swole up") had resolved. Not Provided      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.   Pharmacist states patient is presenting for her second dose but he is unsure to give it because of her reactions she is reporting to him now. No Concomitant medications were reported   Reporter did not allow further contact
Very Red Rash on left upper arm, which then turned into a very yellow bruise Mark which lasted few days.  Also bleeding rash on the right side hip
At injection site:  intense itch, red (2? x 3?), firm, hot skin, puffy; mild pain. (Covid Arm)  Used OTC Cordison-10 for itch; 2 Tylenol extended tablet for pain
This spontaneous report as received from Licensed Practical Nurse who is a patient (age unspecified). The patient's concurrent condition and medical history was not provided. On 05-DEC-1991, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 07-JAN-1992 with the second dose and on 09-JUN-1992 the patient was vaccinated with the third dose of RECOMBIVAX HB. The patient sought medical attention from unspecified healthcare providers to have her hepatitis B surface antibodies obtained. The result of a titer for hepatitis B surface antibodies drawn on 27-NOV-1992 was positive. The result of testing for hepatitis B surface antibodies obtained on 09-APR-2015 was non-reactive. No further information was provided. No treatment was given for the event. The outcome of the event of hepatitis B surface antibodies was non-reactive was not recovered. The casuality was not provided. Additional information has been requested.
On 3/11/2022 approximately 3 weeks post Covid booster, I suffered a first ever seizure, losing consciousness and falling.  I was taken to Hospital by ambulance with shoulder and neck injuries sustained during the fall.  1) During an MRI brain scan without contrast, there were findings related to extensive chronic paranasal sinus disease (not uncommon to a person with cystic fibrosis but unknown to me at the time).  The scan also showed no evidence of an intracranial mass lesion, acute intracranial hemorrahage or infarct however, moderate chronic small vessel ischemic changes.  Several small chronic ischemic foci involve the bilateral basal ganglia and bilateral cerebellar hemispheres.  2) A CT angiogram of the head showed unremarkable CTA of the head.  No aneurysm. No significant stenosis. No large vessel occlusion.  Moderate to marked circumferential vascular calcifications noted in cavernous and proximal supracavernous ICA.  No significant stenosis.  Mild to moderate vascular calcifications in proximal vertebral arteries.  No significant stenosis.  I was put on Keppra anti-seizure medication and will perform an EEG in the near future to discern future risk of another seizure.
pt was getting read for bed sitting on toilet must have los consciousness because next awareness was a heavy downward push on chest;pulse was very slow, felt weak afterwards, h/a since;
Discovered raw type sore under left breast on day 3,; Injection site sore and achy; chills some on the next day; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included none other than just a little high blood pressure. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril-hctz (MANUFACTURER UNKNOWN) 20-25 Mg Tab (1 Daily) and omeprazol (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route in the left arm on 27Feb2021 at 12:00(at the age of 74-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced injection site sore and achy (vaccination site pain), and some chills on the next day, also discovered raw type sore under left breast on day 3. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the injection site sore and achy, chills, and breast pain was resolved with sequelae (recovered with lasting effects) on an unknown date.   No follow-up attempts are needed. No further information is expected
Pt recv vax on 11/11/97; on 11/13/97 pt exp falling down, fever, sore throat, soreness, headache, backache, neck pain, dizzy; tx=Antivert
Patient stated the shots were given incorrectly leading to an infection in her arm, which sent her to the ER. Her physician told her Pneumovax should not be given in the same arm with any other vaccine.
approx 10days p/vax red, raised bumps started appearing on rt shoulder/arm & face of pt. on 7/10 felt little warm & has been kind of fussy. MD said they were chiggers & not a react.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 28Mar2021 as dose 2, single (Lot number: ep6955), in right arm and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "prediabetic" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "bp" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX; LEVOTHYROXINE; ALLEGRA; BENAZEPRIL; ROSUVASTATIN; METFORMIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022 at 13:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 92/61. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient got a rebound case of COVID, 5 days symptom free then runny nose started 6th day followed by stuffy nose and loss of all taste and smell which didn't happen the first time. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
she had COVID-19 but did received both vaccine shots.; she had COVID-19 but did received both vaccine shots.; This is a spontaneous report from a contactable consumer (patient) enrolled in a Pfizer-sponsored program this report regards an event part of the medical history of the patient. A 73-year-old female consumer reported that she received two single doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown dates, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had COVID-19 on an unspecified date but received both vaccine shots. Event outcome was unknown. Information on the lot/batch number has been requested.
RUNNY NOSE; SHIVERING/CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 24 year old of unspecified sex. 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced runny nose. On 08-APR-2021, the subject experienced shivering/chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivering/chills, runny nose and fatigue was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, rash and injection site swelling. On an unknown date, the outcome of the injection site erythema, rash and injection site swelling were not reported. It was unknown if the reporter considered the injection site erythema, rash and injection site swelling to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The batch number and expiry date was not reported. The patient had swelling and redness at the injection site after receipt of FLUARIX, also a rash on her abdomen and trunk. The reporter did not have any patient information, did not receive any other vaccines the day of FLUARIX administration. The reporter would report the VAERS when she had all the information. The adverse event was collected via chat.