chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; sense of metallic taste; sense of taste is altered; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:00 (Lot Number: EL 3249) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included very healthy (take no medicines, except topical vaginal estrogen), penicillin allergy, shellfish allergy. Concomitant medication included estradiol (ESTROGEN). The patient previously took Botox and levofloxacin (LEVAQUIN) and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that patient got the vaccine at on 20Jan2021 11 am. On 20Jan2021 at 2 pm, her tongue started burning, and progressed to her entire tongue, roof of her mouth and back of her throat. Patient told her doctor who said to take diphenhydramine hydrochloride (BENADRYL). Her tongue felt like it was on fire and that someone spilled no vaccine on it (also reported as someone spilled novocaine on it). Patient was diagnosed with burning tongue syndrome, and as of 23Aug2021, she still has a burning tongue with a sense of metallic taste in her mouth, and her sense of taste is altered. Some food makes it worse like salty foods and acidic foods. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was treated for all the events, she used a calming mouth wash, such as Closys. Patient was tested for COVID via nasal swab PCR post vaccination on 08Apr2021 with negative result. Patient had not recovered from the events, at the time of the report.  Follow-up attempts are completed. No further information is expected.
- Persistent muscle cramps (charley horse in both legs, calf and upper leg)  started 2 days after injection.  Have not subside after 24 hours - fatigue started 24 hours after injection. Have not subsided after day 5 since injection  - low grade fever started on day 4 after injection
Feeling poorly, fever, malaise.  By Oct 31 dyspnea, weak admitted to hospital. Dx with CAP. Nov 6 died due to complications of CAP.
130PM mtr called pt awaken from nap crying then was pale & limp but responding-instructed to bring pt back to ofc; 150pm seen by MD pt in shock like state secondary to pale, unresponsive, t101; transported by amb to ER for hospitalization;
Pt w/sarcoidosis did not seroconvert p/3 doses of Engerix-B because of pts disease;
Fever; Chills; Aches; Sore arm; Lots of menstrual bleeding; Cramps; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 23Oct2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norethisterone (LEENA-28) for birth control on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Oct2021 at 20:00, the patient experienced fever, chills, aches, sore arm. The patient had lots of menstrual bleeding, cramps and stomach pain. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, aches, sore arm, lots of menstrual bleeding, cramps and stomach pain was not resolved at the time of this report.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 had been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 14 years old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 11-AUG-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
Fainting; Injection site soreness in arm; nauseous; A spontaneous report was received from a consumer  concerning a 21-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced, fainting (syncope), injection site soreness in arm (vaccination site pain), and nausea (nausea).  The patient's medical history included vasovagal condition that cause heart rate and blood pressure to drop due to stress on body and dehydration resulting in fainting. Concomitant product use was not provided by the reporter.   On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Feb 2021, the patient was fine until about 11 pm after which she experienced arm soreness on the injection site and felt nauseous.   On 10 Feb 2021, at 5 am in the morning, the patient fainted. The patient assumed that shot might have added stress to her body which most likely caused her to faint.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown. There was no change planned to the dosing schedule of mRNA-1273 in response to the event as patient would be receiving second dose on 09 Mar 2021.  The outcome of events, fainted (syncope), injection site soreness in arm (vaccination site pain), and nauseous (nausea), were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events of syncope, vaccination site pain, and nausea, a causal relationship cannot be excluded. Patient's prior medical history of vasovagal reactions is considered a contributing factor to syncope.
After receiving H1N1 Intranasal, student c/o dizziness & palpitations.  Rest and observation.
p/vax pt lt arm painful throbbing throughout the day & noc;woke up the next morning & had diff turning neck or lifting head;very stiff & shooting pains occurred w/turning of head;
Tired; High fever of 100 degrees; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), PYREXIA (High fever of 100 degrees) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b218a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced FATIGUE (Tired), PYREXIA (High fever of 100 degrees) and NAUSEA (Nausea). The patient was treated with Manual therapy (cold water and ice cubes ) for Pyrexia. At the time of the report, FATIGUE (Tired), PYREXIA (High fever of 100 degrees) and NAUSEA (Nausea) was resolving.            No concomitant medication provided by the reporter    Reporter did not allow further contact
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) in a 69-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 22-Feb-2022 at 6:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Feb-2022 at 6:44 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date). At the time of the report, PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient received booster dose. Patient ethnicity reported as (Privacy). The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. We no longer possess this lot number. No treatment information was provided.
Patient's mom called on the 20th day after patient's covid vaccination.  Per patient's mom, patient complained about feeling "sensitive" on and around injection site started 3 to 5 days after vaccination.  The pain level gradually elevated over the last 2 weeks.  Today is the 20th day after vaccination and patient still feels the pain.  Per mom, there are no "bumps" around or under the arm or close to injection site.
"Difficulty breathing" that spontaneously resolved around 12 hours after administration of vaccine. Cellulitis over right lateral thigh noted by mother >24 hours after administration of vaccine. No treatment given since patient is clinically stable, active and smiling in clinic, and per mother, lesion appears to be improving. Recovering.
Moderna COVID-19 Vaccine EUA   Besides the sore arm, I was having positional vertigo which lasted approximately 13 days, also intermittent headaches and it seems like my blood pressure was running higher also during this time.
Day 1 Sore arm, Day 2 sore, hot, swollen, spread to armpit that continues to day 10, 4th day rash on forehead that spread to both eyes and made them swollen almost shut, Day 8 double vision in right eye
Immediate excessive pain at site, entire upper arm muscular ache and pain caused inability to lift my own arm. Unable to lift anything else. Redness area approximately 3 inches in diameter, fever hot to the touch in the red area. Pain continued into 4th day but much reduced. Still painful to lift days 2 and 3. 4th day redness reduced and fever-type heat at site reduced. Muscle soreness evening of 4th day, but can lift things, carefully. I normally do not react to anything.
feverish; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) and CHILLS (chills) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PYREXIA (feverish) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (EQUATE DAILY) for Cold, Flu and Sore throat, at an unspecified dose and frequency. At the time of the report, PYREXIA (feverish) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Mom called to office this AM. and claimed patient developed high fever and seizure. He was taken to ER for treatment. ER note not available.
Patient experienced a LOC for less than 10 seconds while receiving vaccine. PT. moved to private treatment area via wheelchair and monitored for 30mins. PT history and vitals obtained PT. stated this is a normal reaction for him while receiving a shot. After 30mins. PT. released and advised to call EMS w/ any further problems.
Excruciating shoulder pain resulting from what was determined by Dr. to be an improperly administered PNEUMOCOCCAL VACCINE,23-VALENT into the bursa of my right shoulder.
Patient's arm from middle of deltoid to the top of elbow is red and inflammed.  It is only sore around the site of injections and otherwise no other symptoms.
Abnormal white blood cell count, specifically elevated lymphocytes and monocytes; Fever; Bodyaches; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events abnormal white blood cell count, specifically elevated lymphocytes and monocytes/ white blood cell count abnormal, fever, body aches/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 11 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.On 11 Feb 2021, the patient experienced fever and body aches.On 25 Feb 2021, the lab test performed included abnormal white blood cell count, specifically elevated lymphocytes and monocytes. Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  On 12 Feb 2021 the outcome of events fever and body aches were resolved. The outcome of event, abnormal white blood cell count, specifically elevated lymphocytes and monocytes was unknown.
Achy, chills, mild headache. I took Tylenol and slept yesterday. I feel fine this morning.
Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.
Covid arm; itchiness on the left arm; a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PRURITUS (itchiness on the left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away) and VACCINATION SITE PRURITUS (itchiness on the left arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, RASH ERYTHEMATOUS (a circular red rash which lasted and went worse and spread a couple of days. Gradually is going away), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PRURITUS (itchiness on the left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Events and second dose details updated
2:50pm PT c/o itchy ankles and itchy throat. 3:00pm EMT and NP assessed PT. VS 143/81 HR 100 Sp02 98% NP assessed PT for rashes, swollen tongue, difficulty breathing, and mucous membranes. 3:10pm PT states he routinely takes Allegra for ankle itchiness. 3:12pm PT states his throat and ankles are no longer itchy. 3:20pm NP reassessed PT and cleared him to be released.
Pfizer vial was diluted with 0.8ml of diluent instead of 1.8ml, so only one three 0.3ml doses were able to be drawn from the Pfizer vial instead of six.  Patient ended up with a bigger dose of Pfizer than what is recommended.  Patient was called and informed of receiving the incorrect dosage.  Patient had no worries, concerns or issues at the time.
1 week after 1st Moderna shot I became dizzy every waking moment. At first, I believed to be due to loss of appetite and lack of sleep relating to depression. But it continued on for over 2 months.  1 week after 2nd Moderna shot, in addition to the dizziness, the ringing in both ears started and hasn't gone away. My primary care physician instructed me to see an ENT Specialists and so I did on 8/12/2021. They said I'm not the only one having the issue after having the 2nd Moderna shot. Please note, I have no prior case of Tinnitus. I have occassional/rare ringing for only few seconds then it goes away. Never has it stayed for so long.
1-5-07 Flu and Pneumonia admission in Right arm IM. 1-5-07 at health center patient reported to ER for bruising and redness on right upper arm. Patient was given steroid, antibiotic and Benadryl in ER. On 1-8-07 patient reported back to ER for complaining of tingling sensation from elbow to chest. Patient also states they're scared to sleep. Patient was given Valium. 1-8-07 in ER. Patient contacted health department today and states Valium didn't help. Patient referred to primary physician.
Patient brought to Healthcare Hospital on 01/06/2022 for SOB. In the ED the patient tested positive for Covid-19 and Influenza and was admitted to the hospital. CT of Head was negative for acute abnormalities, sinusitis, and mastoiditis.  Patient completed Remdesivir for 5 days. Patient was discharged on hospice and expired on 01/21/2022.
Covid-19 vaccine was administered at 0845 on 06/27/2022 in the patient's left deltoid. After administering, realized it had expired on 06/24/2022. Patient was asked to wait fifteen minutes after administering the vaccine to be observed. Patient had no reactions of the vaccine.
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles by a physician.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013, the patient was treated in a medical center, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) 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 would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Shingles; Shingles; Felt weak; rash on half of the torso; Temperature, which was 99 degree; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), the first episode of HERPES ZOSTER (Shingles), the second episode of HERPES ZOSTER (Shingles), RASH (rash on half of the torso) and PYREXIA (Temperature, which was 99 degree) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ASTHENIA (Felt weak), RASH (rash on half of the torso) and PYREXIA (Temperature, which was 99 degree). On 05-Apr-2021, the patient experienced the first episode of HERPES ZOSTER (Shingles). On 12-Apr-2021, the patient experienced the second episode of HERPES ZOSTER (Shingles). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt weak), the last episode of HERPES ZOSTER (Shingles), RASH (rash on half of the torso) and PYREXIA (Temperature, which was 99 degree) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Body temperature: 99 (Inconclusive) Temperature, which was 99 degree.     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.   Concomitant product use was not provided by the reporter.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient states she was dehydrated which caused her to be dizzy, patient states she has had history of dizziness/fainting due to dehydration. Paramedics took her to local hospital for dehydration.