chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced hives and itching over body including face, neck, back, hip, chest and knee. Called physician and instructed to give child Equate Allery Relief (diphenhydramine hydorchloride). In the morning 12/3, they appeared to have faded but returned within 20 minutes of waking.  Repeated dose of allergy medicine and sent to school with note to school nurse. Currently (12/3 @ 3:30 pm) much improved with the exception of one on his knee.
Fever; Chills; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications have not been specified.  Treatment for the events was not specified.
Shortly after receiving immunizations, child developed red blotchy fleshy papules on face. No airway obstruction, no wheezing. Observed for 25 mins. Rash faded.
Vaccine administered to a 17 years old patient; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered to a 17 years old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concomitant products included DESVENLAFAXINE for an unknown indication.    On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered to a 17 years old patient). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine administered to a 17 years old patient) 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.   No treatment medications provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non significant follow up accepted on 15-06-21
This spontaneous report was received from a patient's grandmother and refers to a 2 year old male patient. The patient had no medical history, concomitant therapies, drug reactions or allergies. On 27-AUG-2015, the patient was vaccinated with first dose of RECOMBIVAX HB in injection, for prevention of hepatitis B. On 02-JAN-2016, the patient received second dose of vaccine and on 03-MAR-2016, the patient received third dose of vaccine. In June 2016 (unspecified date), the patient received fourth dose of vaccine, but there was no explanation why the fourth dose was given to the patient. In March 2017 (date unspecified), by a mistake the patient received the fifth dose of a vaccine. It was reported that a physician assistant stated that an unspecified nurse gave the injection, and then she realized it was the incorrect vaccine. The reporter stated that both she and a mother of the child were not able to get information from the physician assistant as to how or why there was a fourth injection or if they should be concerned about the additional injections the child was given. The grandmother stated that she is concerned about long term side effects her grandson could have as a result of the medical error made. The event made patient's grandmother to sought medical attention by speaking to physician's assistant. No lab tests were performed. Additional information has been requested.
Developed "pain in left arm at injection site approximately 48 hours after vaccine administration that grew worse and began radiating out from shoulder. Only has about 50% ROM and unable to raise arm past shoulder or rotate it. Arm feels tingly upon waking in the morning and unable to sleep on left side. "
I thought I had a flare up what I believe to be eczema on my hand but I am not really 100%. I was looking at the side effect and it says rash on your body and for me it has been on my hand; Achy on all over my whole body like my joints; Soreness occurred at the injection site both times; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Lot number: EL9261) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARAVIS. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "I thought I had a flare up what I believe to be eczema on my hand but I am not really 100%. I was looking at the side effect and it says rash on your body and for me it has been on my hand"; VACCINATION SITE PAIN (non-serious) with onset 05Mar2021, outcome "recovered", described as "Soreness occurred at the injection site both times"; PAIN (non-serious), outcome "unknown", described as "Achy on all over my whole body like my joints"; FATIGUE (non-serious) with onset 05Feb2021, outcome "recovered", described as "Tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  No follow-up attempts are possible. No further information is expected.
2 pm Angioedema head to foot. Throat and nose swelling. 2:15 Epinephrine 1:1000 1 ml im
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "adhd" (unspecified if ongoing); "exercise induced asthma" (unspecified if ongoing). Concomitant medication(s) included: TRIAZOLAM, start date: 01Mar2013, stop date: 27May2022; METHYLPHENIDATE, start date: 01Mar2022; CONCERTA, start date: 01Jan2022; PRISTIQ, start date: 11May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive again; (02Jun2022) Negative, notes: I tested negative 02Jun; (06Jun2022) Positive, notes: Then 06Jun tested positive again; (14Jun2022) Positive, notes: Now 14Jun still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEVER; This spontaneous report was received from a 21-year-old female patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 201A21A, and expiry: unknown) dose was not reported,1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 (12 hours post vaccination), the patient experienced fever and felt fine after 2 days. On 18-JUN-2021, the patient experienced cough and head cold. On 19-JUN-2021, the patient experienced loss of taste, and loss of smell. The patient then realized that it could be coronavirus disease (COVID-19) symptoms and took an 'at-home' covid test which came back positive (suspected clinical vaccination failure, suspected covid-19 infection). At the time of report, the patient still had some lingering cold and her loss of taste and smell did not return. She generally felt better at the time of report and had not consulted a health care provider as her symptoms were mild. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000183672 The suspected product quality complaint has been confirmed to be not void, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210648767-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
No adverse side effects reported; expired dose of MMR-II and VARIVAX that were administered to a patient today, 4/12/22.; This spontaneous report was received from a nurse concerning a 4 year old male patient. Information regarding the patient's medical history and concurrent conditions was not reported. Patient's concomitant medications included sterile diluent.        On 12-APR-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, subcutaneously for prophylaxis (lot number T006167, has been determined to be valid for mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and established as 19-FEB-2022) (strength, and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, subcutaneously for prophylaxis (lot number T000341, has been determined to be valid for mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and established as 05-JAN-2022) (strength, and anatomical location were not provided) (expired product administered).  No adverse event reported.
On 1/24/2021 the patient  was discharged from the hospital due to swelling in the body, when they proceeded to infuse medications. She herself had passed away.
Patient presented for COVID vaccine on incorrect date and received the vaccine prior to the 3 week series due date.  The 2nd dose was administered 8 days after 1st dose.
Lower blood sugars; blood sugars stayed below 200 for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (Lower blood sugars) and BLOOD GLUCOSE ABNORMAL (blood sugars stayed below 200 for two weeks) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01IJ20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Blood sugar increased (From 200 to 500.). Concomitant products included METFORMIN, ERTUGLIFLOZIN PIDOLATE (STEGLATRO), INSULIN GLARGINE, LIXISENATIDE (SOLIQUA), INSULIN GLARGINE (LANTUS), FENOFIBRATE, LISINOPRIL and ATORVASTATIN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced BLOOD GLUCOSE ABNORMAL (blood sugars stayed below 200 for two weeks). On 03-Feb-2021, the patient experienced BLOOD GLUCOSE DECREASED (Lower blood sugars). On 20-Jan-2021, BLOOD GLUCOSE ABNORMAL (blood sugars stayed below 200 for two weeks) had resolved. At the time of the report, BLOOD GLUCOSE DECREASED (Lower blood sugars) outcome was unknown.            Treatment medication was not reported.   This case was linked to MOD-2021-163282, MOD-2021-163282 (Patient Link).
At HCF, I served as a Cold Chain Operator (CCO), who is responsible for transporting COVID-19 and flu vaccines to encampment sites. Standards for transporting these vaccines include keeping said products between 2C-8C. In order to maintain such cold temperatures requires the use of: cooler bag, 3 fridge plates, 1 frozen plate, and 2 sheets of bubble wrap. The bubble wrap serves to protect the vaccines from having direct contact with any of the cold plates. Somewhere during the transportation process, one of the sides of the bubble wrap got pushed down, causing potential exposure of the vaccines to the cold plates, which are most likely below 2C. Due to insufficient data to support the idea that the vaccines were considered active, we must assume that the 4 Moderna vaccines provided during our shift on 3/7/2022 are possibly invalid. We arrived to their encampment around 9:00 AM on 3/7/2022. We provided our vaccination services to our patient, and followed standard procedure. After observing the patient for over 15 minutes, having the patient report no adverse symptoms, we allowed them to go back to their encampment.
Information was received from a registered nurse referring to multiple unknown patients of unknown age and gender. Patients' current condition, concomitant medication and medical history were not provided. On 8,9,10 and 11-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored GARDASIL 9 (lot # M004116, expired date 12-OCT-2017, dose and route were unknown) after 78, 102, 126 and 150 hours of exposure to 53 Fahrenheit, respectively. On 15-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored GARDASIL 9 (lot #L026602, expired date 12-OCT-2017, dose and route were unknown) after 96 hours of exposure to 53 Fahrenheit. The data logger was involved, and there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014841.
Muscles aches and chills at 12:30am, then gradual fever that peaked at 101.4, taking acetaminophen at 4am
Severe sepsis causing acute hypoxic respiratory failure likely due to COVID 19 and possible HCAP. Patient was started on meropenem and vancomycin for possible hospital-acquired pneumonia.  Patient continued to improve drastically so MRSA swab was negative so vancomycin was stopped.  Patient continued to improve greatly so meropenem was switched to Levaquin and patient continued to feel fine.  Patient has already completed 5-day course of antibiotics no further antibiotics are needed at this time.  Patient was started on dexamethasone and will complete a 10-day course. Hospital admission within 6 weeks of receiving the COVID vaccine.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received SHINGRIX. Concurrent medical conditions included general body pain (the patient woke up Friday with body aches and thought she was over tired). Concomitant products included Calcium, Probiotics, COQ10, fish oil, FLONASE SENSIMIST, LEXAPRO and vitamin C plus D. On 14th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 15th April 2018, the patient experienced general body pain, shoulder pain and headache. On 16th April 2018, the patient experienced chest pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain, shoulder pain, chest pain and headache were recovering/resolving. The reporter considered the injection site pain to be probably related to SHINGRIX. The reporter considered the general body pain, shoulder pain, chest pain and headache to be possibly related to SHINGRIX. Additional details were provided as follows: At 12:00, the patient received SHINGRIX on left deltoid. The patient had a stabbing pain at the injection site and had soreness in her left shoulder and pain on the left side of her body. On 15th April 2018, 1 day after receiving SHINGRIX, the patient experienced pain localized and headache. At the time of reporting, the patient had dull ache on her side in the region near the bottom of her ribs.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Lot number: GF1701) from 16Jan2023 to 18Jan2023.
PATIENT RECEIVED FLUAD ON 9/29/21 ON LEFT ARM. PATIENT EXPERIENCED DISCOLORATION (BLUEISH COLOR, SWELLING, PAIN (LIMITED MOVEMENT DUE TO PAIN), AND WARMTH THE EVENING OF RECEIVING THE VACCINE. PT PLACED COLD PACKS ON ARM TO DECREASE SWELLING AND PAIN. THE SYMPTOMS CONTINUED ON 9/30/21. ON 10/1/21, PATIENT CAME TO PHARMACY TO INFORM US ON CURRENT STATE.  AS OF 10/1/21, THE DISCOLORATION AND SWELLING HAS DECREASED. HOWEVER, THE ARM IS STILL WARM TO THE TOUCH, REDNESS IS PRESENT, AND PATIENT STILL EXPERIENCES PAIN WHICH RADIATES TO HER ELBOW AND DOWN THE SIDE OF HER ARMPIT, THEREFORE CANNOT MOVE ARM FREELY DUE TO PAIN. PHARMACY REACHED OUT TO PATIENT'S MD, DR. THE OFFICE WAS NOTIFIED OF HER CONDITION AFTER RECEIVING THE FLUAD VACCINE. MD OFFICE INFORMED PATIENT TO GO TO MEDSTAR CARE FACILITY TO BE SEEN AS SOON AS POSSIBLE BECAUSE  DR.DOES NOT SEE PATIENTS ON FRIDAYS AND CAN ONLY BE SEEN NEXT MONDAY. PATIENT INFORMED US THAT SHE WILL SEE IF SYMPTOMS IMPROVE TODAY (10/1/21), IF NOT, SHE WILL VISIT THE MEDSTAR CARE FACILIY BEFORE MONDAY.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and unknown gender. The nurse reported that multiple unspecified patients were vaccinated with a dose of GARDASIL (lot# and dose/frequency unknown) on an unknown date which was improperly stored. No adverse effects reported. The outcome of the events were unknown. Additional information has been requested.
(1) On 11-14-2012 5:00 pm patient noticed 6" long welt, red raise and hot. (2) Went to MD on 11-15-12 9:00 AM nurse local reaction from shot. (3) At 2:30 on 11-15-12 returned to MD office. Patient was feverish, chilled, sore arm, red. MD thought maybe infection prescribed OMNICEF.
Patient received the vaccine and about 5 minutes later vomited a few times.  After vomiting, she sat for a few minutes with an ice pack and then she felt better.
HEART PALPITATIONS; DIZZINESS; SHOULDER PAIN; HEADACHE; BODY ACHES; BACK PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 or 1808928 (unsure), and  expiry: UNKNOWN) dose was not reported, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced back pain. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, back pain, and shoulder pain, and had not recovered from headache, heart palpitations, and dizziness. This report was non-serious.
Tongue swelling and posterior throat discomfort GIven 25 mg PO Benadryl with resolution
tinnitus - loud ringing started in both ears3 days after 2nd covid-19 vaccine shot and has not stopped.
Vomiting, diarrhea, 18FEB91 rash; treated 24FEB91 for dehydration @ Hosp.
Unexpected reaction (in addition to flu like symptoms during first 24 hours post injection) was a very itchy abdominal rash, lower 2/3 of back, extending around both sides of abdomen and up front and sides of next and upper arms (not near injection site).  Also experienced diarrhea during first 24-36 hours.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced developed a red area about the size of a pancake on leg and leg swelled. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced developed a red area about the size of a pancake on leg and leg swelled on an unknown date in 2010. The outcome of the events was unknown. No additional information was available at the time of this report. Follow-up (17NOV2010): This is a spontaneous follow-up from the contactable physician. The physician reported that the patient took also Connaught FLUZONE via an unspecified route of administration on an unspecified date. The developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were all within normal range. At the time of this report, the patient recovered. Patient's data and lot number updated. Follow-up attempts completed. No further information expected.