chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml; right arm was swollen; had pain on his right axilla but this was not as intense and bad as the last one; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (right arm was swollen), AXILLARY PAIN (had pain on his right axilla but this was not as intense and bad as the last one) and EXTRA DOSE ADMINISTERED (got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Mar-2022, the patient experienced VACCINATION SITE SWELLING (right arm was swollen) and AXILLARY PAIN (had pain on his right axilla but this was not as intense and bad as the last one). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml). At the time of the report, VACCINATION SITE SWELLING (right arm was swollen) and AXILLARY PAIN (had pain on his right axilla but this was not as intense and bad as the last one) had not resolved and EXTRA DOSE ADMINISTERED (got another dose of the Moderna Covid-19 on 15Mar2022 - this time given at 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. Patient had the same symptoms like the one he had after he got the 3rd dose - his right arm was swollen and he had pain on his right axilla but this was not as intense and bad as the last one. He still was experiencing the symptoms at the time of the call. No treatment reported   This case was linked to MOD-2022-515692 (Patient Link).
About 7.5 hours after the shot, I had an episode of sneezing and runny nose that last 2 hours. I sneezed 20-25 times which is more than I ever recall sneezing in a whole year. I awoke at 4:00 am with a few more sneezes and about 15 minutes of runny nose. Nothing further occurred. I did not see a doctor. I have felt fine ever since.
Bivalent booster dose instead of the second dose of the primary series dose; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 2 (bivalent), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (one dose of the primary series vaccine for ages 5-11, Manufacturer unknown), administration date: Dec2021, for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset Nov2022, outcome "unknown", described as "Bivalent booster dose instead of the second dose of the primary series dose".  Additional information: A pediatrician called inquiring about the COVID-19 vaccine. He has a patient who only received one dose of the primary series vaccine for ages 5-11 in Dec2021. The second dose was given to the patient with the Bivalent booster dose instead of the second dose of the primary series dose in Nov2022. HCP wants to know how to proceed. HCP thought he was ordering the vaccine for ages 12 and up and had given the Bivalent and wanted to know how to proceed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up on 12/1/21 and felt numbness in parts of lower right leg, tingling in different parts of right leg down to toes, tingling in right arm and fingers. Tingling comes an goes. Feels like pins and needles. Injection site still  sore.  On 12/2/21, still feel same. Doctor said to report to Agency and take pain reliever.
Fever for 2.5 days generally between 101.5 and 102.7 Chills with uncontrollable muscle contractions from 2am to 6am on 4/21/2021 Muscle pains related to above Arm pain at injection site - hard lumps, redness, inflammation - pain is ongoing as of 4/24 with mild itchiness  Mild nausea 4/24/2021
the reporter stated that the patient "received VARIVAX about two months ago, but was unaware that she was pregnanct at the time"; This spontaneous prospective pregnancy report was received from the patient's friend and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On an unknown date, approximately in May 2019, reported as "about two months ago", the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis (reported as "it was recommended"), however the patient was unaware that she was pregnant at the time of vaccination. The patient's last menstrual period (LMP), and the estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending at the time of the report.
Pt reports that on 9/11 he had a large tender area of swelling with erythema around the vaccine side. There was lymphadenopathy and itching that began 2/18/03 resolving 2/20/03. Pt at time reported this to employee hlth.
Angioedema within 2 hours of vaccine involving hands/feet/elbow/knees.  Urticaria as well within 10-15 hours, extensive case.
Fever with cough, respiratory distress, tachycardia, leukopenia, lymphopenia, elevated liver enzymes, and pancreatitis; IV hydration, IVIG, ASA, prednisolone
After receiving the vaccine I experienced fatigue. I fell asleep all the time. I started having more seizures. I became unbalanced while standing up which resulted to me falling a few times and I had to see a doctor for it. Seizures are getting better due to additional medication.
onset of symptoms 1/10/2022.  Positive COVID 1/12/2022.  Hospitalized on 1/15/2022.  Placed on comfort cares and died 1/26/2022.
FEELING BAD; NOT FEELING GOOD; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (Pfizer Inc) concerned a 50 year old male. The patient's pre-existing medical conditions included: The patient had no medical conditions. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin was not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin was not reported, batch number: 213021A, expiry: UNKNOWN) dose was not reported, 1 total administered on 20-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 50 years old. Concomitant medications included lamotrigine, and sertraline hydrochloride.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received non-company suspect Pfizer Biontech Covid-19 Vaccine (tozinameran), (Dose number in series 3), (batch number: GJ5342 expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 14-OCT-2022 to right arm for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 3).   On 15-OCT-2022, the patient experienced feeling bad, and not feeling good (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from feeling bad, and not feeling good, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Breakthrough case admission after 2 vaccines: Moderna 3/27/21 Lot# 018B21A; Moderna 4/24/21 Lot# 043B21A.
Patient states that she developed a bad headache the next morning and started regurgitating. She went to the ER where she states she could barely talk because of the pain and was not able to tell the ER healthcare providers that she had just gotten the Shingles vaccine.  Patient states that she received IM ketorolac in the ER.
PATIENT STATES THROAT FEELS FUNNY. PATIENT DEFINED THIS AS TIGHT AND TINGLING NOT NORMAL. PATIENT ALSO STATES TONGUE FEELS BIGGER. AFTER DISCUSSION WITH PATIENT THE PATIENT AGREES TO URGENT CARE FOR FURTHER TREATMENT.
Hives on and off x 3 days 11/22/13 through 11/25/13. Mom gave Benadryl initially on 11/23/13 and they disappeared only to reoccur daily on 11/24/13 and 11/25/13 both days requiring Benadryl as well.
My leg was numb; Felt swollen from my right leg.; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er8727), via an unspecified route of administration in Left Arm on 26Mar2021 04:30 PM as single dose for covid-19 immunization. Medical history included allergy to fish. The patient's concomitant medications were not reported. On 26Mar2021, 04:45 pm the patient reported his leg was numb and felt swollen from my right leg. Until he took a Benadryl, the feeling in leg came back after hour. The outcome of event was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.
BP is 28/82. Hr 95. Mild bee sting allergy.First dose given today. Patient compains of Lightheadedness, nausea and dizzy. She said she has not had food the whole day.  Paramedics on site.  Patient complains of Numbness- tingling around the lips. Hyperventilating, no SOB, no chest pain HR 96. Spo2 100% on RA. Sinus rhythm. BP 92/70. 103/63. Blood glucose 103. Pt refused to go to the hospital. Education provided by paramedics. Consent/waiver signed.   Second code green was called for the same patient. Patient was still lethargic and lightheaded. This time she agreed to go to the hospital.
muscle pain; Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F; Around 7pm, a little bit of started the pain around the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Around 7pm, a little bit of started the pain around the shot), MYALGIA (muscle pain) and PYREXIA (Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Product used for unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Around 7pm, a little bit of started the pain around the shot). On 29-Apr-2021, the patient experienced MYALGIA (muscle pain) and PYREXIA (Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F). At the time of the report, VACCINATION SITE PAIN (Around 7pm, a little bit of started the pain around the shot), MYALGIA (muscle pain) and PYREXIA (Late night, around 3am, her fever is coming, 100.2F/fever a little bit down after 30 minutes but it come back now; 100.2 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were  ibuprofen and Aleve.
Diarrhea; Fever; Headache; Bodyache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 13Apr2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On 13Apr2021 at 18:00, the patient experienced diarrhea for a few hours in the night, fever, headache and body ache. On an unknown date in Apr2021, the patient experienced vomiting in the morning.  The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 13Apr2021, the patient underwent body temperature test and the result was 100.7 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, fever, headache and body ache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
I woke up at 1 am with chills and a temperature of 104. I saw my doctor on the fifth day. She did a Covid test and it came back negative. She put me in some antibiotics because I had some congestion in my lungs. I am currently alternating between Tylenol and Ibuprofen.  She concluded that my body was not strong enough to fight the vaccine. I am still waiting to hear from her to treat me for the third dose, which I received in 09/17/2021 (EW0191) . I have had temperature for about 40 days now. I am really exhausting.
I experienced soreness at the injection site and my sinus got worse. As a matter of fact I still suffer from my sinus, it constantly drains and I never experienced this problem before the vaccine. The soreness at the injection site lasted four days.
Rash all over body appeared 3 to 4 days after second dose of pfizer covid vaccine patient is not sure if it was related to vaccine.
Headache muscle aches, chills, and redness//soreness at injection site Narrative:   Other Relevant History:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 22-SEP-2014 the patient was vaccinated with improperly transported and handled (Oka/Merck) VARIVAX (lot # K005185, expiration date 10-APR-2016, dose and route were not provided. The product was en route to the office for 5 days, received in the office outside of the allowable shipping time prior to vaccination. No adverse symptom was reported. Additional information has been requested.
Information has been received from a registered nurse, concerning a 16 year old female patient with hay fever and no other pertinent medical history, who was vaccinated IM with the first and second dose, 0.5 ml, of Gardasil as follows: on 03-APR-2007 with the first dose (lot #654702/0011U), and on 19-JUN-2007 and the second dose (lot # 657622/0388U). Concomitant therapy on 03-APR-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer not specified). Noted therapy initiated on approximately 07-SEP0-2007 ("one month prior" to the event), included MIRCETTE (dose not reported). On 07-OCT-2007, approximately 4 months after the second vaccination, the patient experienced shortness of breath and chest discomfort. On 10-OCT-2007, she presented to a walk-in clinic and a diagnostic "blood test" and CAT scan of tee lungs revealed a pulmonary embolus. She was hospitalized and treated with oxygen and IV heparin LOVENOX. On 15-OCT-2007, she was discharged from the hospital. On an unknown date, enoxaparin sodium was discontinued and COUMADIN was initiated, and continued. A consultation was planned with a hematologist or oncologist to rule out any blood dyscrasia. At the time of this report, the patient was recovering. The nurse considered pulmonary embolus to be immediately life-threatening and serious as an other important medical event. Additional information has been requested. 12/13/07-records received for DOS 10/10-10/15/07-DC DX: Pulmonary embolism. Presented to ED with shortness of breath.Exertional dyspnea began last Sunday, three days ago.
Information has been received from a physician concerning a 20 year old female who in March 2007 was vaccinated with Gardasil. Subsequently the patient experienced hair loss. The patient's hair loss persisted. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with first dose of GARDASIL. On 23-OCT-2013 and on 22-NOV-2913 the patient received a second and third doses of GARDASIL, respectively. It was reported that patient received the third dose of GARDASIL too early. No adverse effect reported. Additional information has been requested.
pt recv vax 22MAR97 & devel fever 101 & papular rash & seen on 24MAR97 w/fever 101.4 & mild papular rash w/6 papules scattered on arm, legs & cheek, no vesicles;27MAR97 pt OK t100-101, diarrhea, fussy;
This spontaneous report was received from a 71 year old female patient who had animal allergies as concurrent condition. The patient had none pertinent medical history. On 02-DEC-2015, the patient was vaccinated with ZOSTAVAX (route of administration, lot# and expiration date were unspecified) 1 DF once in the arm. Concomitant therapies included ZYRTEC. On 02-DEC-2015, the patient experienced headache and stated that she had tenderness at the injection site. It was stated that none laboratory diagnostics were performed and that she did not seek for medical attention. No product quality complaint as involved. At the time of the report, the outcome of headache and injection site pain was reported as not recovered since she stated that she still has a headache and her arm was still tender. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information has been requested.
inadvertently reconstituted with sterile water; inadvertently reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640Z, expiry date 30th November 2022) for prophylaxis.   On 11th April 2022, the patient received Menveo. On 11th April 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: MENVEO powder was inadvertently reconstituted with sterile water and administered to patient. The reporter consented to follow up. Additional Supportive Information: MENVEO powder was inadvertently reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Body pain at injection site, muscles and bones, headache.  Extreme exhaustion.  Rash on chest from neck to waist.
inability to get off couch; very thirsty and cotton-mouth; unreal headache; a fever of 102; nausea; lack of appetite; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GAIT INABILITY (inability to get off couch), DRY MOUTH (very thirsty and cotton-mouth), DECREASED APPETITE (lack of appetite), HEADACHE (unreal headache) and PYREXIA (a fever of 102) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DECREASED APPETITE (lack of appetite). On 05-Feb-2021, the patient experienced GAIT INABILITY (inability to get off couch), DRY MOUTH (very thirsty and cotton-mouth), HEADACHE (unreal headache), PYREXIA (a fever of 102) and NAUSEA (nausea). At the time of the report, GAIT INABILITY (inability to get off couch), DRY MOUTH (very thirsty and cotton-mouth), DECREASED APPETITE (lack of appetite), HEADACHE (unreal headache), PYREXIA (a fever of 102) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Saw patient on 4/5/23. Moderna 12/20 and 1/21. "Biggest regret of my life."  Onset of symptoms 3/21 with flushing, tachycardia, sweats when lying down, tremors during the day.  Dr. at facility urged him to get the shots, denied the symptoms he was having were from vaccine.  Extensive workup by multiple physicians - none of them reported to the agency, tho neurologist did attribute the symptoms to the shots.  Had stress test, CT scans, PET scans, blood work, endoscopy of GI tract, 24 hour urine and extensive blood work.   Only positive results was high urinary histamine and PCP told him he had carcinoid syndrome.  Has been taking ambien to sleep because symptoms are worse at night, along with zyrtec and Benadryl.  During the day takes valium.  Hasn't tried a Beta-blocker for the tremors.  Saw neurologist, who found low copper level, EMG normal.  Seeing other Dr. who put him on IVM 6mg BID, nattokinase and a multitude of vitamins.  Also doing live O2.  Has lost significant muscle mass but apparently testosterone level is okay.  Has history of bladder reconstruction with bowel and has to self-cath through abdomen every 6 hours.  Energy level is better but having diarrhea, thinks its from the latest additions to vitamin regiment.
fever, chills, body aches, headache, sore arm 24 hrs after vaccine 2 days after vaccine, swollen arm at vaccine site with red splotches, 3rd day, red circular rash, hot to the touch
Shingles outbreak (had previous outbreak) x 8 days so far, insomnia x "few days", fever-mild x "few days", swollen gland for 8 days so far.
Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but noticed some lower abdominal discomfort. 4th day had loose stools and noticed some burning when urinating.. Late in the day had a splitting headache, i never get headaches, took Tylenol and felt better. At 2 am that night woke up with teeth chattering and limbs shaking. Urinated and noticed a pink tinge. My husband took me to the ER ( He had had a similar reaction to his first Pfizer shot)  Found to have a fever, increased heart rate and a raging bladder infection (significant amount of blood in urine). Treated with Keflex via IV . Went home with a presciption for Keflex  They are running a culture. I HAD COVID IN NOVEMBER AS DID MY HUSBAND   IT APPEARS THAT MAYBE ONE DOSE WOULD HAVE BEEN SUFFICIENT FOR US. I HOPE THIS WILL BE EVALUATED AND THE PUBLIC INFORMED OF BEST PRACTICE