chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; Bad taste in mouth, metal taste; Restless legs; leg cramps; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19), DYSGEUSIA (Bad taste in mouth, metal taste), RESTLESS LEGS SYNDROME (Restless legs) and MUSCLE SPASMS (leg cramps) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Product used for unknown indication: Penicillin. Past adverse reactions to the above products included Allergy with Penicillin. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 20-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced DYSGEUSIA (Bad taste in mouth, metal taste), RESTLESS LEGS SYNDROME (Restless legs) and MUSCLE SPASMS (leg cramps). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), DYSGEUSIA (Bad taste in mouth, metal taste), RESTLESS LEGS SYNDROME (Restless legs) and MUSCLE SPASMS (leg cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         The patient was the patient taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient did not receive any treatment for the events taste metallic, restless legs and leg cramps. COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old patient with medical history of started on 20-May-2022 PAXLOVID at an unspecified dose, allergy with Penicillin, concomitant products included MINERALS NOS and VITAMINS NOS for an unknown indication who experienced the unexpected events of COVID-19, DYSGEUSIA, RESTLESS LEGS SYNDROME and MUSCLE SPASMS unknown days after  receiving 3rd  dose of  mRNA-1273 vaccine. On an unknown date, SARS-CoV-2 test: positive.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old patient with medical history of started on 20-May-2022 PAXLOVID at an unspecified dose, allergy with Penicillin, concomitant products included MINERALS NOS and VITAMINS NOS for an unknown indication who experienced the unexpected events of COVID-19, DYSGEUSIA, RESTLESS LEGS SYNDROME and MUSCLE SPASMS unknown days after  receiving 3rd  dose of  mRNA-1273 vaccine. On an unknown date, SARS-CoV-2 test: positive.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
RA swollen, numbness burning @ inj site;Friday pt could not sleep;MD recommended;APAP given;
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JUL-2015, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by the patient's healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Chills; Fever 101.3; Headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 01Dec2020, the patient underwent Siliva test for COVID-19 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 21:30, the patient experienced chills, fever 101.3 (units unspecified) and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, fever 101.3 (units unspecified) and headache was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
BODY ACHES; SHIVERING; LOW GRADE FEVER; VOMITED ONCE; STAYED IN BED 2 DAYS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included nerve block, and concurrent conditions included asthma, get sick a lot, fibromyalgia, temperature normally runs 97.1 to 97.2 degrees f, non-smoker, and non-alcoholic user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced thrush allergy when treated with sulfamethoxazole/trimethoprim, and clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: Influenza virus test (NR: not provided) NO INFECTIONS. On 29-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On 08-MAR-2021, the subject experienced vomited once. On 08-MAR-2021, the subject experienced stayed in bed 2 days. On 08-MAR-2021 07:00, the subject experienced body aches. On 08-MAR-2021 07:00, the subject experienced shivering. On 08-MAR-2021 07:00, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.8 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited once, stayed in bed 2 days on MAR-2021, and body aches, shivering, and low grade fever on 22-MAR-2021. This report was non-serious.
Patient complained of chest tightness, shortness of breath "tongue feels funny", cough, weakness.  Patient monitored for 30 minutes by EMS, VSS, lung sounds clear, SPO2 100%.  Patient remained on-site for an additional 15 minutes then went home.
6 weeks after 2nd vaccine.  No side effects at the time of either shot. None till 6 weeks later  Very sore left arm (could not raise normally) Headache  Exhaustion - slept for more than 12 hours  Fever 100.5 (3 days).
FORMED A SMALL BUMP AFTER VACCINATION, THE NEXT DAY IT BECAME LITTLE DARK AND PT COMPLAINED ABOUT PAIN.  GAVE AN ICE PACK TO APPLY RIGHT AFTER VACCINATION.
No adverse event. Pt received Beyond use date Pfizer bivalent first dose. No symptoms reported.
Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax. Subsequently the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a physician refers to patients of unknown age and gender. The physician reported that he has an unspecified colleague in another state who had patients that on an unknown date, were vaccinated with MMR II (dose, duration, indication, route and lot were not reported). On an unknown date, patients were not showing as immune to mumps when titers are drawn. This is one of several reports from the same source. Additional information has been requested.
ADMINISTERED DOSE INTO LEFT ARM AND VACCINE LEAKED OUT OF SYRINGE.  BEFORE ADMINISTERING THE VACCINE, I DREW UP THE DOSE AND DID NOT NOTICE SYRINGE BEING LEAKY. BECAUSE A FULL DOSE WAS NOT ADMINISTERED INTO THE LEFT ARM, I THEN ADMINISTERED A FULL DOSE INTO RIGHT ARM. I SPOKE WITH HER PARTNER TODAY 6/17 PATIENT ONLY COMPLAINED OF ACHINESS AND SWELLING OF LEFT EAR AND MOLES.
Began having pain and swelling to site a few hours after the vaccine.  Next day it grew to "softball" size and lasted about a week.  Also had low grade fever and headache.
From initial information received on 03/Oct/2003 from health care professional regarding an adverse event occurring in the USA, it was reported that a 20-year-old male patient received a dose of Td vaccine, lot number U0991AA, administered intra-muscularly in the left deltoid and his second dose of Measles, mumps and rubella vaccine, lot number 1014M, administered subcutaneously in the right arm on 02/Oct/2003 at 2:00 PM. On 03/Oct/2003 at 9:30 AM, the patient had a temperature of 101 degrees and jerky movements of the entire body. The patient recovery status was not reported.
Information has been received from a physician concerning a female patient who was vaccinated on an unknown day with a third dose of Gardasil. The patient fainted after her third injection. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information is not expected.
Redness, warmth and induration 3 cm below injection site in 4 cm x 10 cm area over the right upper inner arm. Treated with nsaid and Benadryl, cold compresses.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a health clinic for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Injected Pediarix within 2-3 sec swelled up to a 1 inch x 1 inch area that turned red.
No other AE was reported; Administration of an expired dose of VARIVAX; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On 09-DEC-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter one time (Lot # S038175 and expiration date 26-NOV-2021) for prophylaxis (expired product administered).  The vaccine had not undergone a temperature excursion. No other adverse event reported.
Fever of 101, headache, chills, body aches. Lasted for 18 hours.
No bad reaction. Patient received 2nd booster and did not meet the age 50 requirement
Presented to hospital on 6/17 with increasing shortness of breath. Intubated  and chest tube inserted due to peural effusion. Admitted to critical care.  Test for COVID +. Started on zosyn and zyvox. and vasopressor support for septic chock. Weaned off prssors and extubated on 6/19. WBC count started to increase and escalated to cefepime and vancomycin.  Chest tube not functioning well so surgical site tube inserted and patient reintubated. Continued to decompensate. CT of abd showed abscess and drains placed. Little improvement and had radiology drain placement of chest. WBC continued to be high. Palliative care consulted. Famy changed code status to intubate only and wanted to transition to comfort care only.
The injection site hurt very bad as well as the upper left arm for over 2 days; The injection site hurt very bad as well as the upper left arm for over 2 days; Body temperature was slightly increased; Muscle pain over the entire body for more than 2 days; Administration date 10Nov2021 at 17:00, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 10Nov2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history reported as the patient was generally healthy. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did receive other vaccines within four weeks prior to the vaccination. Concomitant medication included influenza vaccine (FLU SHOT) for immunization on 16Oct2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 11Feb2021 (at the age of 32-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration in the left arm on 02Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the injection site was hurting very bad as well as the upper left arm for over 2 days, body temperature was slightly increased and muscle pain over the entire body for more than 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site hurt very bad as well as the upper left arm for over 2 days, body temperature was slightly increased and muscle pain over the entire body for more than 2 days was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer (patient) and other healthcare professional. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 11:00 (at the age of 29 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There was no patient history and no family medical history relevant to adverse event.  Reported to be no other products and no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No Adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient wanted to know if she was considered fully vaccinated after receiving just 1 dose of the Pfizer-BioNTech Covid-19 Vaccine. The patient stated that she worked in health care around people and she got the vaccine to protect herself and others. The patient reported that she had a reaction after the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on Thursday, 27May2021. She said her face became swollen, she broke out in hives, and had itchiness. The patient stated that her face began to swell 2 or 3 hours after she had vaccine and stated that she was taking Benadryl like candy and the reactions went away on Friday afternoon for good. The patient also reported that swelling, itching and hives also happened at the same time after the vaccine and went away on Friday afternoon. The adverse event did not require a visit to emergency room/physician office and the patient was not hospitalized. The patient stated that she had an EpiPen at home and Benadryl. If it got too bad, she would have taken her EpiPen and gone to the emergency room. She said her doctor told her not to get the 2nd dose. She asked if that would put her as not fully vaccinated. She was trying to figure out how that would work. Should she try another company like Johnson and Johnson even though they are not supposed to be mixed, or was she considered exempt. The patient wanted to know if she should try to get a vaccine from a different company like Johnson & Johnson, and how it would affect the Pfizer-BioNTech Covid-19 Vaccine that she previously had. It was reported that, there were no relevant tests and no investigation assessments done. The clinical outcome of the events her face became swollen, hives, itchiness was recovered on 28May2021 and event if she should try to get a vaccine from a different company like Johnson & Johnson was unknown.
Fatique, lethargy, Patient states fatigue all day ,did not take insulin because she was getting vaccine
Pt reported dizziness, light headedness in about 15-20 minutes following vaccination. Also reported feeling headache coming on 1/2 hour after vaccine.
I did not have an adverse reaction to the vaccine. In 03/2023, I lost my range of hearing. I am scheduled for an appointment is today with an ENT.
My shoulder, my arm is really hurting; My shoulder, my arm is really hurting; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had the Pfizer vaccine yesterday, and reported that "my shoulder, my arm is really hurting." The outcome of the events was unknown.   No follow-up attempts are possible. Information on Lot/ Batch number cannot be obtained. No further information is expected.
REDDENED AREA APPEARED 1 DAY AFTER INJECTION. AREA MEASURES 7.5CM X 4.5CM. AREA ALSO HAS RED STRECK INTO AXILLA AREA. AREA IS WARM TO TOUCH.
Increased blood pressure and heart rate. Chills - fever- headache - body aches - sick to my stomach - tireness - swollen and red arm at injection site along with some itching. Woke up with these symptoms next day after vaccine. Blood pressure, heart rate, and other symptoms were better by day 2 but swollen arm and redness still persists. Still have a slight headache.
3 minutes post vaccine, pt began to shake, limbs stiffened, diaphoretic, alert and verbal 5 seconds, requested water, parents present, Ambulance called, transported to hospital, released from hospital, determined reaction was a vagal response.
Chills, headache, body aches;  Took Tylenol; Symptoms only lasted one day, approximately 12 hrs
I got thrust in my mouth.  It is like a yeast infection in my mouth.  It started on Oct 20th and I am still dealing with it as of today.  I went to my doctor about this.  They did a mouth sample to confirm positive for thrust.
Monovalent mRNA given instead of bivalent. Pt with nausea  and myalgia.
ran fever, sick to stomach, diaria, started 4 hrs after shot and lasted 2 1/2 days.
8 days after the inyeccion my arm is very hot, red, swollen and painful
Headache, Myalgia, malaise, chills,  Narrative: onset of malaise, fatigue, headache, chills, and terrible ache within first 24 hours post injection. resolved within 48 hours post injection.
p/receiving vax rash on arms got worse-spread to legs & back; devel arthritis right wrist & thumb; also had some stiffness lt side of neck; went to MD; tx for poison ivy w/shot;
pt recvd vax & exp systemic lupus erythematous (SLE);reporter attempting to obtain more info concerning this case;
Information has been received from a health professional concerning an 18 year old female patient who in January 2009, was vaccinated with a dose of GARDASIL (the patient was not vaccinated at the reporter's clinic). The consumer became their patient because of the pulmonary embolism diagnosed shortly after getting GARDASIL in April 2009. The patient was treated with COUMADIN for 3 months, but then she was on aspirin daily. She has been hospitalized on several occasions due to her pulmonary embolism (one reported hospitalization lasting 10 days). It was reported that there were no other risks identified for the pulmonary embolism. At the time of the report, the patient status was unknown. The reporter considered the pulmonary embolism to be immediately life-threatening. Additional information has been requested.  9/18/09 Hospital/medical records received DOS inpatient 4/16/09 to 4/17/09 and outpatient visits to 8/24/09.  Assessment: Pulmonary embolism and infarction. Dysmetabolic syndrome X.  Patient presents with upper abdominal pain and lower chest type symptoms. Pulmonary emboli. Chest pain.  ICD-9 Codes: 415.19 Pulmonary embolism and infarction. 277.7 Dysmetabolic syndrome X.
Initial report received from a consumer's mother 08 DECEMBER 2013. Corrective treatment included TYLENOL. A 1.5 month neonate old female patient was vaccinated on an unknown date of DTAP for an unknown indication. Patient's mother stated that after first couple of days after the shot, including the day of the shot, until about 2 days after she had a fever that was up 102 degrees. She had a bad appetite, really fussy. Just seemed to be very sick, legs were tender. She was not sleeping well. The patient was recovered. No further relevant information was reported.
Patient received injection at a pharmacy, then came to my office to sit in the waiting room to monitor for reactions.  Within a few minutes of arriving, he begin to have seizures.  He was unresponsive.  His wife reported that this was not unusual for him, although he had not had one in awhile.  We moved him to a room.  After a second seizure, we called 911.  He was briefly lucid before a 3rd episode.  He had a 4th episode prior to EMS arriving.  They administered medications which appeared to resolve the seizures.  He was transported to the ED, monitored, and discharged later the same day.