chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant referring to a 7 years old male child. The patient's drug reaction/allergies and current conditions included penicillin hypersensitivity, however he did not have any previous medical history.  On an unknown date, the patient was vaccinated with the first dose of VAQTA injection 25/0.5, (route of administration, lot number and expiration date were not provided) for prevention of Hepatitis A, at another physician office. The patient's concomitant therapy was not reported. On an unknown date, (reported as six months after the vaccine was administered), the patient experienced "a four day episode of hypothermia" and developed juvenile cataracts. Therefore, the patient was hospitalized during 4 days, the patient did receive an unspecified treatment for both events, but no intervention to prevent serious criteria was performed. At the time of the reporting the patient had no recovered from hypothermia and juvenile cataracts, additionally, the causality assessment between VAQTA and the events was unknown. Upon internal review, the event of hypothermia was determined to be medically significant. The reporter considered hypothermia and juvenile cataracts to be life-threatening events. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis. Concurrent medical conditions included alpha-gal allergy (allergy to alpha galactose). In September 2016, the patient received Influenza vaccine Quadrivalent 2016-2017 season (intramuscular). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced injection site itching and injection site swelling. The patient was treated with prednisone. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site itching and injection site swelling to be related to Influenza vaccine Quadrivalent 2016-2017 season. Additional details were provided as follows: The age at vaccination was not provided. In September 2016, the patient received an unknown flu vaccination at her place of employment, and she reported that the injection site began to itch and swell. The patient went to employee health and was given prednisone and then sent the emergency room and was there for four hours. It took several days for the itching and swelling to resolve. The patient did not give consent to follow-up. The patient did not think the vaccine was a GSK product but she could not remember. She was unable to provide additional details.
Within 5 minutes of getting her immunization shots she fainted. She recovered immediately after laying her down.
Incredibly fussy after vaccine. Developed eczema 1 week later and a very bad cold/cough a few days after that. Eczema is still present.
CoughWheeze Narrative: Developed wheezing 3-4 hours after first dose. This prompted her to feel the need for albuterol. She initially used 4x puffs w/o relief and switched to a nebulizer. She continued to feel the need to use her albuterol 2/2 both SOB at rest and DOE bid-tid for ~15 days after the vaccination. This is very atypical for her. She has a h/o asthma dx'ed in childhood, which has mostly resolved as she grew older. Normal triggers are URIs/influenza or cold weather changes while traveling. The last time she used her inhaler was around 2x years ago during a trip in February (a/w cold weather change). All other s/sx of immediate allergic reaction or anaphylaxis were denied. 2nd dose was deferred in favor of an allergy referral due to concerns for an immediate allergic reaction. Further evaluation also recommended 2/2 length of feeling of need for administration of albuterol, which atypical for her.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine; Moderna Covid-19 vaccine which has undergone multiple temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Storage condition at the time of the excursion was refrigerated storage. Maximum temperature reached was 49 degrees Fahrenheit and minimum temperature reached was 37.7 degrees Fahrenheit. Vial moved from freezer to refrigerator on 3 MAR 2022. Proposed desired use by date was reported to be on 16 Mar 2022. The temperature excursions occurred on 4 Mar 2022, 5 Mar 2022, 7 Mar 2022, 8 Mar 2022, 9 Mar 2022 and 10 Mar 2022. It was not known which arm the patient received the vaccine in. Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions. The nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. No treatment medications were reported.
Chills Severe headache Sore arm Injection site pain Muscle stiffness Tiredness Fever
seizures; weakness in my legs; dizziness; in a wheelchair now, and cant walk; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the Pfizer vaccine on an unspecified date in Apr2021, and since been hospitalized with weakness in my legs, seizures, dizziness. She is in a wheelchair now and cannot walk. She has been seen by neurologist, and other specialists and no one is giving any answers and wanted to know if Pfizer has received any calls regarding the side effects that she reported and the risks of the COVID-19 vaccine. The re-porter asked if Is Pfizer is doing research for people who have the type of side effects that she is re-porting. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 MODERNA BIVALENT VACCINE - LOT # 045H22A - MED ERROR - VACCINE ADMINISTERED 3 DAYS PAST - (EXPIRATION DATE - 6-12-23). STATE DOH AND MANUFACTURER NOTIFIED (MODERNA) ON - 6-15-2023.
I had muscle aches, joint aches and a fever that went to 101.8, I had a headache, dizziness, nausea,I did not vomit. I had loose stools. I had a skin rash from breast level all the way down to my knees, and my arms. i tend to get like this with a protein based vaccine.
Case number PHEH2013US013359, is an initial spontaneous report received from a nurse on 19 Jun 2013: This case refers to a 06-month-old male patient. He was vaccinated with MENVEO (batch number: M120028 and expiry date: Dec 2014) at dose of 0.5 ml, intramuscularly on 18 Jun 2013. No adverse reaction was reported following this administration error.
Pt reported Pressure in eye, tongue felt numb and some trouble swallowing. Speaking in full and complete sentences. Able to swallow water.  Pt given Benadryl 25mg PO and stated 5 minutes after symptoms resolved. Pt educated on the importance of calling 9-1-1 is symptoms worsen at home. Pt monitored for an additional 20 minutes.
positive COVID-19 test with symptoms/ cough, shortness of breath; positive COVID-19 test with symptoms/ cough, shortness of breath; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number; unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that after the 2nd dose have been tested positive for Covid-19. experienced cough, shortness of breath and took prednisone. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021191276 same reporter and drug, similar event, different patient.
This spontaneous report as received from a consumer refers to her friend, a female patient of unknown age. Information on the patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with an unspecified HPV vaccine (also reported as miscellaneous because it is referencing adverse effects from an unspecified HPV vaccine, and a MSD product cannot be ruled out). Concomitant medication were not reported. The consumer reported, "The vaccine is a con. So many people have been injured by this vaccine! (see MARRS# 1611USA005445). A friend of mine literally has trouble walking now and she's not even 25 years old. Totally fine before this." The outcome of trouble walking is unknown. No further information was provided. This is one of two reports received from the same reporter. Additional information is not expected.
Urticaria, Hives, cellulitis to left Arm, chest, and ear. Treated with Antibiotic for 10 days.
Hypoxic; Heart arrhythmia; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After use of product on an unspecified date, the patient become hypoxic and developed heart arrhythmia. The patient was admitted and treated in the hospital on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Pregnant patient received the 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019M20A) for COVID-19 vaccination.     The patient's past medical history included Subfertility (IVF-Transfer date: Dec 13, 2020) on 13-Dec-2020, Alcohol use (1, 2 a week) and Pregnancy (Previous delivery date:06-NOV-2017). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pre-eclampsia, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 on an unknown date and the estimated date of delivery was 31-Aug-2021. On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine). On 25-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, Pregnancy test: positive (Positive) Positive. On 08-Feb-2021, Ultrasound scan: normal (normal) (Everything okay.).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  The patient had one previous pregnancy (live and full-term birth) and delivery date was 06-Nov-2017. The patient had pre-eclampsia and took aspirin to prevent that at the time of report. It was reported that there was no complications or acute illness during pregnancy to date, prenatal care was established.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Internal review on 20-JUL-2021 resulted in updates to pregnancy details. On 01-May-2021: Follow up received on 1-MAY-2021 :  second dose  was updated
Ended up in the hospital; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event (serious criteria hospitalization). On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The patient never had another shot of vaccine in the past.  The age at vaccination was not reported.  The patient had 2 flu shots and ended up in the hospital. This case was linked to case US2019AMR172636, reported by the same reporter.
>35 days since first dose - has not received second dose at this time; Tested positive for COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose - has not received second dose at this time) and COVID-19 (Tested positive for COVID after first dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID after first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>35 days since first dose - has not received second dose at this time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose - has not received second dose at this time) had resolved and COVID-19 (Tested positive for COVID after first dose) 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 action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was advised not to take second dose on scheduled time due to COVID positive Concomitant medications were not provided. Treatment information was not provided
I do not think this was reported as an adverse event. This patient has had a pain syndrome in the left arm since receiving H1N1 vaccine in the deltoid. Not full blown CPRS but features suggesting this (complex regional pain syndrome).
RECEIVED BIVALENT BUT SHOULD HAVE RECEIVED FIRST DOSE IN PRIMARY SERIES
99.7 low grade fever, extreme body aches including aches and pains in feet which made it painful to walk,  hand ached which made it hard to make a fist, all joints hurts especially hips and low back.  Extremely low on energy causing me to have to sleep longer during the night and nap twice the next day.
Felt fine after vaccine.   Approximately 9 pm, I went to bed and began experiencing paresthesia in right arm, then noticed the paresthesia in both hands, both feed and also in right leg.   The following morning, was primarily in my hands.   I went to work, and as the day progressed, noticed in my feet, and right leg again, but hands not right arm.   On Sunday & Monday, the paresthesia was more intermittent with timing lengthening between bouts.    Monday, I went out in my car, and noticed that the paresthesia was worse in my right foot,     Mid plantar to toes,  Couldn't feel the gas pedal with right right foot.  No paresthesia in left foot, left hand.     Also noticed besides not feeling well, that I felt like was in mental fog, unable to articulate some things.   That was intermittent, also (have had poor appetite for @ least a week prior to vaccine).    This morning (Tuesday) I have paresthesia from my right shoulder down to fingers, and continue with right foot from mid plantar to toes.    Mentally feel a little bit better, not as foggy.
3 days after the second COVID-19 vaccine the patient developed a large painful, red, and hot rash on the left upper arm. This included around the injection site but it also occurred lower on the arm with normal skin in between. Treatment will include ice and antibiotics due to the patient's extreme neutropenia.
Had ZOSTAVAX vaccine on 12/01/2014. Patient states that she has had no problems until this morning (12/03/2014) states that her left arm was itching a little, when she scratched her arm is when she noticed that area was warm and swollen, but was not tender. Patient does state that she has felt nauseated since receiving the vaccine but enough to produce vomiting. Denies loss of appetite. Advised patient to apply cool compress to area and MOTRIN as directed per directions on bottle and if itching increases to take BENADRYL per bottle directions.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient again received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The product was associated with Off label dosing frequency (dose number in series 3). No concomitant medications were reported.  On an unspecified date, the patient received a total of 3 doses of the covid-19 vaccine (Off label dosing frequency) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
One of my fillings came out yesterday so, I have a dental appointment; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route if administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure and knee replacement in 2014. Concomitant medications were not reported. Patient received her first shot of the Pfizer COVID vaccine 30Jan2021. Yesterday on 03Feb2021 her crown fell out. Today, 04Feb2021 she is going in for a dental appointment to get it taken care of. She is required to take antibiotics and Novocaine for the procedure later today. She mentioned history of taking blood pressure medication and a knee replacement in 2014. Second dose of the Pfizer vaccine is scheduled 20Feb2021. Patient stated that one of her fillings came out yesterday, so she has a dental appointment. Outcome of event was unknown.  Information on the batch/lot number has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On unknown date in 2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 29-JAN-2015, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
When I got the 2nd dose of the Pfizer on January 28, 2021.  About one and a half weeks later I had to go to the ER due to heart palpitation's and heart rate of over 200 per minute and went into AFIB.   I got the booster on January 28, 2022, two weeks later on February 6th.  I had the same exact thing happen to me with the heart rate and palpitation's.   I did recover fine without any treatment other then seeing a cardiologist. I do 100% believe it was a side effect from these vaccines.