chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really bad metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in the left arm on 09Mar2021, 13:15 (at the age of 36 years old), as first dose, single dose for COVID-19 immunisation. Medical history included bipolar disorder, anxiety disorder, and hepatic adenomatosis. The patient was not pregnant on the time of the report. Concomitant medications included lithium, quetiapine fumarate (SEROQUEL), dicyclomine, fexofenadine hydrochloride (ALLEGRA), alprazolam (XANAX). The patient did not receive other vaccines within four weeks prior to vaccination. The patient had a really bad metallic taste in her mouth starting approximately one hour after vaccination and lasted for 10 hours on 09Mar2021, 14:15. The patient had no COVID prior vaccination and was not COVID tested post-vaccination. No treatment was received for the event. The outcome of the event was recovered on 10Mar2021, 00:15.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Provider notes "Patient had a Fall at home and suffered a Laceration of right lower extremity.  After returning home after repair of the laceration he was noted to have an Altered mental status.  He was evaluated for possible stroke as has a history of stroke but head CT, brain MRI negative for acute findings. Carotid artery doppler with "less than 50% bilateral internal carotid arteries"  Patient mental status has returned to baseline.  Patient has permanent Atrial fibrillation but was manifesting other Cardiac arrhythmias with Sinus pauses and questionable run of ventricular tachycardia.  Cardiology consulted and felt there was only one pause of concern.  He was kept for further monitoring and no further pauses were found.  Card recommended thirty day event monitoring at discharge.Patient on ENOXAPARIN with prior to admission COUMADIN held for possible procedure.  At discharge he will have three days of overlap of ENOXAPARIN and COUMADIN.     Essential hypertension blood pressure controlled.  Dyslipidemia, goal LDL below 70 ATORVASTATIN  Gout ALLOPURINOL  Type 2 diabetes mellitus, without long-term current use of insulin on sliding scale here.    BPH (benign prostatic hyperplasia) FINASTERIDE, TAMSULOSIN.  Ankle pain.  Did not appear to be gout. Possible osteoarthritis.  Short course of PREDNISONE with improvement.  ."
Patient reports morning of vaccination that left arm was sore and all red and shiny and swollen, hard.  Patient reports it as one large area. It was raised and sore for over 2 days and by the 3rd day was able to raise arm up and not as sore.  Patient also reports fever for 2 days.  Patient took Tylenol and ibuprofen regularly for 2 days to help with pain and fever.
A few rashes on lower back 7/21/2022, more widespread 7/22/2022. PCP's note stated he gets this rash off and on. The cause cannot be ascertained. No fever at that time. No SOB. Prednisone 40 mg daily x 3 days and calamine-zinc topical BID and HS ordered. He was sent to ER 7/23/2022 for neutropenia, fever of unknown origin, tachycardia and generalized body rash. On 7/24/2022, PCP noted rash had greatly improved. No fever. No tachycardia.
Took multiple days to appear, worsened with second shot, itchy rash, mostly upper arm but extended to forearm.
Mom stated that he started hallucinating that evening and stated he was seeing bugs on the wall.  And the next day he was still not acting himself. He did have a low grade temperature but it was not high enough that it should have caused the hallucination.
I was positive for COVID-19 on 26FEB2023, I had sore throat, congested and I was very tired. I don't know if I had a fever or not, no other symptoms. I saw my doctor and he prescribed Paxlovid, I started feeling better about 3 days later.
pt recv vax 28SEP98 9AM & approx 930AM pt started shaking, eyes rolled back & started turning purple;pt was immed taken to ER;given motrin for temp of 103.8R;cooling measures;
This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.  No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant product information was not provided.Treatment information was not provided. Facility had a 20 minute excursion in the freezer where the Moderna vials were stored.
Transferred to ED.  ED documentation below.  Initial Vital Signs [01/06/21 1754] Blood Pressure 146/97 Heart Rate 78 Respiratory Rate 16 Temp 36.9 °C (98.4 °F) Temp src Oral SpO2 97 %  34 y.o. female who arrived by From on-campus presented to the emergency department for an allergic reaction to the Pfizer COVID-19 vaccine. Pt received the first round of injections at 1707 tonight and experienced adverse reactions. Pt endorses dizziness which is accompanied by central abdominal pain and itching of her left thigh. Pt states that her throat is dry, but adds that it could be from not drinking much fluids today. Pt has a hx of anaphylaxis from shellfish and angioedema. She says these current symptoms are not similar to the ones she experienced from anaphylaxis or angioedema. Pt has not started or changed any medications, but had an IUD inserted about a week and a half ago. Pt denies any fevers, chills, coughs, cold symptoms, chest pain, palpitations, shortness of breath, headaches, nausea, vomiting, bowel or bladder problems, or urinary complaints.  Clinical exam shows central abdominal pain just above the umbilicus with itching of the posterior aspect of the left lateral thigh. Will administer PO Prednisone and PO Diphenhydramine in the ED and observe the pt. No epinephrine injection was deemed necessary at this time.    DDx: allergic reaction   1910 hours: Discussed further treatment and vaccine advice with the pt. Will discharge pt to home. Provided follow up instructions to her PCP, for reevaluation. Discussed return precautions. Vital signs are stable at time of discharge.
Twenty minutes post vax, pt developed pallor, dizziness, red ears, tingling in ears and fever. She went home. Call to her was placed on 04/18, following day, to ask about tetanus shot, and she explained the reaction. She took Novasin. Pt states that she has history of fever with prior IZs. Always self-limited.
This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a adult female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date May 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On 7th October 2015, 15 min after receiving FLULAVAL QUADRIVALENT, the patient experienced pruritus. On 12th October 2015, the patient experienced injection site reaction. On 7th October 2015, the outcome of the pruritus was recovered/resolved. In October 2015, the outcome of the injection site reaction was recovered/resolved. The reporter considered the injection site reaction and pruritus to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient was also an employee of the facility. After the vaccination with FLULAVAL QIV vaccine, within fifteen minutes, the patient started to itch. The patient stated that itching was between her shoulders and felt like bugs were on her skin. The nurse stayed with the patient and provided BENADRYL for the itching. On 12th October 2015, 5 days after receiving the vaccine, the patient experienced injection site reaction. The patient was asked to contact the office if something like a reaction happened. Till the time of reporting, the patient had not contacted the facility.
This spontaneous report as received from a physician refers to a 18 month old patient of unknown gender. No concurrent conditions or medical history were provided. Approximately in May 2014, the patient was vaccinated with the first dose of VAQTA 25/05 (units not provided) injection, 0.5 ml injected intramuscularly (lot# and expiry date unspecified). On 30-SEP-2014, four months after the first dose, the patient was vaccinated with the second dose of VAQTA 25/05 (units not provided) injection, 0.5 ml injected intramuscularly (lot # K008254 with expiry date: 12-NOV-2015 (reported as: 11-DEC-2015). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Information has been received from a 72 year old male with pain from shingles side effects over the past 15 years who on 19-APR-2007 was vaccinated with Zostavax (Oka/Merck). The patient saw the physician on 10-MAY-2007 and 11-JUN-2007 because his right foot and entire leg were still very painful with a burning sensation. He was prescribed 2 different pills, none of which have done any good. The patient's painful and burning right foot and entire leg persisted. Additional information has been requested.
had Covid-19 after 1st dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (had Covid-19 after 1st dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had Covid-19 after 1st dose of the vaccine). At the time of the report, COVID-19 (had Covid-19 after 1st dose of the vaccine) outcome was unknown. 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.   no concomitant medication provided patient has taken monoclonal antibody infusion treatment
Information has been received from a medical assistant concerning a 67 year old female who on Oct 15, 2002, was vaccinated with pneumococcal vaccine 23 polyvalent (lot# 643782/0675M), in the right arm. On Oct 18, 2002, she presented to her physician's office with swelling of right arm (3x5 or 4x4area), redness of right arm and itching of right arm. The patient experienced no pain. The medical assistant did not know what interventions were recommended by the physician. The medical assistant also reported that two other patients were vaccinated with pneumococcal vaccine 23 polyvalent (lot# 643782/0675M). One patient experienced pain, left arm swelling, redness and itching (WAES0210USA02231). The medical assistant reported that the physician expressed a concern regarding the lot number and requested a lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with standards of the evaluation and research and was released. Additional information has been requested.
MS series of attacks. Lost feeling left-side below bra line and down through left foot. Dragged leg. Second attack two weeks later of vertigo.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022 at 6:41 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Feb-2022 at 6:41 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. Vaccine administration time 18:41:21 The patient was administered booster dose that went into 2 to 8 Celsius thaw state on or above 24-Dec -2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022
Sore at injection site; Headache; Fatigue; pregnant and Gestation period was 24 weeks; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 18Aug2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), endometriosis and known allergies to gluten. The patient's last menstrual date was 03Mar2021 and delivery due date was reported as 07Dec2021. The gestation period was 24 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prenatal (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN), calcium/magnesium (MANUFACTURER UNKNOWN) and vitex agnus-castus (CHASTE TREE); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Aug2021 at 17:00, the patient experienced sore at injection site, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore at injection site, headache and fatigue was resolved on an unknown date in Aug2021.
Hives across upper arm where injection administered. Red, swollen, hot to the touch, and splotchy from shoulder to elbow. Not tender or itchy according to toddler.
Hands began to itch.  Next day corners of mouth and hands itched a great deal.  The third this continued.  Seemed to subside w/ Benedryl.  It is now a week and my thorat, hands and ears are still itching but to a lesser degree.
Daughter came by and said several other friends who have had Rash from the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Daughter came by and said several other friends who have had Rash from the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Daughter came by and said several other friends who have had Rash from the vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Daughter came by and said several other friends who have had Rash from the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.
pt recv vax 9JAN97 & approx two hr p/vax pt exp the feeling that heart was racing & felt like was high;pt also devel a flat macular rash on the trunk of body & blurred vision;
Sinus problems; While blowing nose noticed blood clots and partial nose bleed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONETCH COVID-19 VACCINE; Lot Number: EL9267), via an unspecified route of administration in left arm, on 27Feb2021 at 01:30 PM (13:30) (at the age of 77 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included lung cancer and throat cancer. The patient's concomitant medications included tamsulosin, diltiazem, omeprazole, atorvastatin calcium (AZTOR), and fluticasone propionate. The patient previously took paracetamol/ pentazocine hydrochloride (TALACEN) and experienced allergies; and the first dose of BNT162B2 (Lot Number: EL8982) on 29Jan2021 at 12:30 PM (at the age of 77 years) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 28Feb2021 at 09:45 AM, the patient had sinus problems and while blowing nose noticed blood clots and partial nose bleed. The patient was also using fluticasone propionate but have never notice this before. No treatment was given for the adverse events. The patient has not been tested for COVID-19 post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of FLUMIST administered to a pregnant female was received from a company representative concerning an adult female. No medical or obstetrical history or concomitant medications were reported. There was no adverse event experienced to date. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
This spontaneous report as received from a father refers to his son of unknown age. On unknown date in May 2012 the patient was vaccinated with a first dose of GARDASIL (dose, route and lot # not reported). On an unknown date the patient missed a second dose of GARDASIL, because the reporter did not keep up with his son's follow up appointment (date unknown). By the time of the report, the father was trying to get his son back on track with the three doses of GARDASIL as recommended. Additional information is not expected as the reporter did not provide contact details.
Sudden Stiffness in neck. In ablitity to turn neck abruptly nor look down or up. Neck Pain.
Same day: some Fatigue, mild headache Day after x only 1 day : Fatigue, fever  All symptoms resolved on 2nd day after vaccine.
Last period was April 4-10. Vaccine received April 16. Period started April 22, two weeks early.
Tuesday night, felt like pinch in the ankle with slight limp. Throughout Wednesday she couldn't walk on it, severe limp. Complaining about it significantly on Wed night. Thursday morning 3am went to ER because of the pain, swelling, was given ibuprofen and norco but they didn't help. They took Xray, no issue. Currently using a boot and crutches but still can't put any pressure on it without unbearable pain. Veins are swollen with lots of pressure, has to keep ankle elevated and it still throbs. Can't walk at all on it. Saw orthopedic, he prescribed meloxicam.
lt subclavicular spasmatic feeling radiating from top lt side above the cardiac muscle numerous times on the evening of 17JUL97 & morning of 18JUL97;not present now;BP 118/78, HR 67;
Began with mild headache and chills a few hours after the shot. Next morning had a fever of 101.5 that the max dose of Tylenol brought down to 99.5. Experienced chills, mild tremor (similar to low blood sugar feeling), body aches, and loss of appetite. The fever still persists at present, (approx 32 hours after vaccine, and 26 hours after symptom onset), and remains stable at 99.5. Rather than chills, I have have been having hot flashes for the past 2 hours.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in April 2021 and the estimated date of delivery was 10-Feb-2022. In May 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Patient was found pregnant on May 2021. Patient did not have an Obstetrics and gynaecology yet. Patient had no adverse effects yet.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Causality for maternal exposure during pregnancy is assessed as not applicable.
One day prior to the clinic on 5/18/22, an email was sent with a list of patients that needed boosters. At the start of the clinic on 5/19/22, copies of vaccine cards for these patients were given to staff. All cards were checked to ensure eligibility for boosters. Vaccine administration started at 1pm. At approximately 1:20pm, after 14 vaccines were given, alerted that the copies of vaccine cards and emailed list were not up-to-date. After consulting who had an updated list of vaccine records, it was determined that six patients were given a booster shot when not eligible. Consulted with team on how to follow-up and proceed with the clinic. Going forward, each patient vaccinated had their records verified. Emailed list was cross-checked with the updated list given. Even with updated list from facility, errors were found with vaccine records not being up-to-date and inconsistencies. Photos of COVID vaccination cards were taken for records and vaccination cards were sorted.  Patient received second booster but did not qualify for second booster.
indigestion, nausea starting 1 week after, with excessive gas and bloating, on/off headaches feeling like headaches due to cold air on side of my head, increased bowel movements to 3x/day, not always firm, slight abdominal discomfort, acid stomach