chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per vaccinating nurse RN?s written report given to this Charge Nurse, RN who was not present at the incident that occurred 09/17/2022 at 2:00pm:   Begin Report regarding patient Date of birth: This RN went to get vaccine. Instead of asking for regular dose of Pfizer vaccine, RN obtained booster. As this RN was talking to family they did not hear 2nd nurse LPN notification that she was going to get a vaccine card. This RN assumed verification was complete and administered vaccine. Wrong vaccine dose administered. Patient was due 2nd dose of Pfizer vaccine. Booster dose of Bivalent Pfizer was administered. Site Supervisor pharmacist, and MD notified. Patient?s mother notified. Orders received from MD to have patient return in 2 months for second dose. No adverse effects noted. Mother aware of error and able to verbalize need to return for 2nd dose in two months? End Report.  The pharmacist in the above report, The on-call provider MD, The Site Supervisor and RN who includes her own written statement below.   Per Site Supervisor RN?s written report given to this Charge Nurse, RN who was not present at the incident:  Begin Report related to pt ?Dr called at 1:56pm by this Site Supervisor RN with information provided above by vaccinating nurse. Provider instructions are to inform parent to return in 2 month for 2nd dose for their child and also inform that child is not fully vaccinated until then. Provider further states no safety concerns or adverse side effects noted. On-site interpreter to provide this information to patient?s parent who stated she understood and would bring the child back in 2 months. This Site Supervisor gave parent their name and number to contact with any further concerns or questions.? End report.
STARTED TO HAVE CHEST PAIN AND SHORTNESS OF BREATH IMMEDIATELY AFTER 3RD DOSE IN SEPTEMBER 2021. I TRAVELLED ON 25TH OCTOBER 2021. ON ARRIVAL WENT FOR CHECK UP AT HOSPITAL. IMMEDIATELY ON TESTING FOR CT LUNGS, I HAD FIRST EPISODE OF CHF. IMMEDIATELY ADMITTED AND TREATED FOR DEHYDRATION. AFTER 4 DAYS AGAIN WENT FOR ANGIOGRAPHY, HERE ALSO ON 10 MINUTES INTO PROCEDURE HAD SECOND HEART FAILURE. SUSPECTING DYE  REACTION ADMITTED AND AGAIN TRAETED WITH DIURETICS AND REDUCTION OF SALTS AS CREATININE LEVES WERE HIGH. AFTER  9 DAYS, AGAIN HAD 3RD EPISODE OF CHF AT HOME. RUCHED TO ER AND TREATED. THIS TIME DOCOTRS CALLED IT MYOCARDITIS AND TREATED WITH DIURETICS AND STRICT SALT AND LIQUID IN TAKES. DISCHARGED. AGAIN ON 3RD DECEMBER 2021 HAD 4TH CHF AND AGAIN ADMITTED TO ER. NOW DOCOTORS  GAVE ME STEROIDS AND DIURETICS PLUS STRICT MANAGEMENT OF SALT, DIET AND LIQUID. DISCHARGED AFTER 7 DAYS. RESTED TILL FEBRUARY 7TH 2022. TOOK FLIGHT HOME AND BEEN DOING BETTER.
MODERNA COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/2/2021 and 1/30/2021. Patient previously hospitalized for for COVID pneumonia 8/26/2021 to 8/31/2021. Patient presented to ED on 9/9/2021 for shortness of breath. Patient was placed on BiPAP for worsening hypoxia. Patient received: methylprednisolone, zosyn, and vancomycin. Respiratory condition worsened and family decided to place patient on comfort care. Patient expired shortly after at 0953 on 9/16/2021.
I felt a great deal of pressure on my chest and discomfort underneath both shoulders with slight shortness of breath. I was lightheaded and became nauseous. I went to the urgent care locally where I had an EKG performed and was transported by ambulance to a HCF. I experienced a heart attack where I had 2 stents placed in my heart. I was in recovery where I remained overnight and was released after 2 days. I am now on several medications to address the issues. I returned home and have a new cardiologist. After the initial visit and confirmation of the heart attack, I have to follow up with the provider in June. I did contract covid 1 week after my booster.
Lymph node swelling; Severe rash inside mouth and throat; Severe rash inside mouth and throat; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pollen. 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. Concomitant medication included calcium carbonate (TUMS) for an unknown indication from an unknown date and unknown if ongoing. On 13Apr2021, the patient experienced lymph node swelling, severe rash inside mouth and throat that did not go away with unspecified allergy medicine, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events lymph node swelling, headache and nausea. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph node swelling, severe rash inside mouth and throat, headache and nausea was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 26-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) as recommended for the long-term prevention of shingles and/or zoster-related conditions at a pharmacy.  Subsequent to pt.'s vaccination with zoster vaccine live (ZOSTAVAX), the pt. was treated by a healthcare provider at urgent care, for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, 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.  The outcome of the events was unknown.  Causality assessment was related.
Patient given BOOSTRIX (TDAP) instead of ADACEL (TDAP). There was no adverse reaction.
On 3/8/21 patient reports itchiness noted to injection site.  On the following day 3/9/21, swelling and redness noted to the area and feelings of slight nerve pain noted to left wrist area.
PATIENT  STATED THAT SHE EXPERIENCE SOME SIDE EFFECED FROM HER 1ST COVID 19 VACCINE. SHE SAID THAT FOR FIRST FEW DAYS SHE HAD INFLAMMATION AT INJECTION SITE ( BALL IN THE ARM), THEN AFTER SEVERAL DAYS , NOW SHE FEELS INDENTATION(DEPRESSION) ON THE ARM. SHE STATED THAT SHE DOES NOT HAVE ANY PAIN AT THIS MOMENT.
Shaking chills off and on for over 24 hours, possible fever, arm pain, all over muscle soreness
Information has been received from a physician concerning his daughter, a 15 month old female who was vaccinated with a dose of VARIVAX (Merck) 2 weeks ago (the reporter thought), on approximately 13-JUL-2009. On approximately 13-JUL-2007 the patient had a disseminated rash on her torso & face, no fever. At the reporting time the patient was acting normal and did not appear sick. The reporter was not even sure if the rash was related to the vaccine. Additional information has been requested.
Fever, body aches, chills, dizziness all the evening and night of receiving the vaccine
Occurrence of three small lesions under the lower lip consistent in appearance with cold sores, but without the itching or tingling  sensations I usually feel with cold sores.  It has been several years since I've had an occurrence of cold sores. The occurrence is of little consequence, and I do not plan to follow up with my doctor unless it changes for the worse.  I did feel it unusual enough to document it with a photograph, and also to submit this report, in case there are others like it.
Pain in stomach; Bloating; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in stomach), ABDOMINAL DISTENSION (Bloating) and DIARRHOEA (Diarrhea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diarrhea.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in stomach), ABDOMINAL DISTENSION (Bloating) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Pain in stomach), ABDOMINAL DISTENSION (Bloating) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment included nifedipine and loperamide hydrochloride (Imodium).
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was NSTEMI.
Initial information regarding an unsolicited valid non-serious case received on 03-Oct-2018 from a other health care professional. This case involves a 71 years old female patient who experienced macular papular rash (red and hot), low grade fever, chills and body aches, while she received vaccine FLUZONE HIGH DOSE, TYLENOL 8 HOUR, PREDNISONE and CEFADROXIL [BID]. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI981AA, expiration date: 16-Mar-2019 via intramuscular route in the left deltoid. On an unknown date, the patient received a dose of TYLENOL 8 HOUR, PREDNISONE 10 mg and BID (CEFADROXIL). On an unknown date, the patient developed a non-serious macular papular rash (red and hot), low grade fever, chills and body aches (Unknown latency) following the administration of vaccine FLUZONE HIGH DOSE, TYLENOL 8 HOUR, PREDNISONE and CEFADROXIL [BID]. Other relevant tests included no lab data. Final diagnosis was body aches, chills, low grade fever and macular papular rash (red and hot). It was not reported if the patient received a corrective treatment. The patient outcome is unknown for all the events. List of documents held by sender : none.
Raised erythematous plaque (3 x 3 cm). Non-pruritic in left lat arm.
Started with hives resulting from allergic reaction on 10/18/2021.  Hives began to appear on both LT and RT knee around 11:30pm on 10/17/2021.  Throughout the day on 10/18/2021 began to hives on LT and RT sides of my chest and along my belt line.  By 8:00pm on 10/18/2021 hives on the front and back legs and ankles and chest.  Very pronounced hives and red skin coloration.   Took 50mg of Benadryn before heading to Urgent Care Went to local Urgent care 9:20 pm to be treated for condition.  Was administered at urgent care:  Famotidine (PEPCID) and methylPREDNISolone Sod Succ via IV.  Monitored for till 10:50 pm when symptoms improved and skin colored had reduced to with normal tone. Discharged by Doctor at 10:50 pm.   Provided with a prescription for Famotidine and prednisone.
Mother told ER physician that she could not get the infant's fever down, was 104/3 (r) and was 100.6 on adm. to ER. Reports rash on face, crying, unable to console.
Joint/body ache, low grade fever, fatigue 2+ days Myocarditis, 115BPM resting heart rate 1.5 days
Constant, painful hormonal acne under chin and on sides of face. Have had hormonal acne before and was being treated with Spironolactone. Had best skin of my life as of right before this booster. Haven?t gone a day since the booster without at least one, usually several, massive pimples.
high blood pressure at oral surgeries; Symptoms worsened due to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure at oral surgeries) and CONDITION AGGRAVATED (Symptoms worsened due to vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy (Patient started allergy shots after receiving the vaccine for environmental allergies), Drug allergy (Allergy to codeine), Drug allergy (Allergy to fentanyl- Itching, Welts) and Blood pressure high (Start date was >10 years). Concomitant products included LISINOPRIL for Blood pressure high, ZOLPIDEM for Sleep difficult, SIMVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In March 2021, the patient experienced HYPERTENSION (high blood pressure at oral surgeries) and CONDITION AGGRAVATED (Symptoms worsened due to vaccine). At the time of the report, HYPERTENSION (high blood pressure at oral surgeries) and CONDITION AGGRAVATED (Symptoms worsened due to vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: 135/85 (High) reading was 135/85 and climbing. In March 2021, Heart rate: high (High) Patient reported her heart rate was high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient started allergy shots after receiving the vaccine for environmental allergies so thought the symptoms were due to the allergy shots, but now they suspect it was the Moderna COVID-19 vaccine. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient had never been diagnosed with/ tested positive for COVID-19. There were no diagnosis of myocarditis or pericarditis. No treatment medication was provided by the reporter.   This case was linked to MOD-2022-531903, MOD-2022-531902 (Patient Link).
No additional adverse effects were reported; The patient received improperly stored PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided.  On 20-JAN-2020, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, once, lot # reported as S033516, expiration date: 29-JUN-2021, (route and anatomical site of administration were not reported) for prophylaxis. No additional adverse effects were reported.   It was also reported the highest temperature was above  47°F/9°C (47.1F). Time frame: 15 minutes. There was no previous temperature excursion. Data logger was involved.
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 13-OCT-2015, these patients were vaccinated with doses of GARDASIL 9 (lot # L013429, expiration date 21-JUL-2015; dose, frequency and route not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Next day patient reports fever of 102 degrees F resulting in the patient staying home in bed. Spot in the right deltoid where PPSV 23 vaccine was administered was reported by patient to be red, warm, sore and inflamed. 72 hours after injection, erythema expanded. Six days after injection, patient was seen by physician, and physician noted erythema with mildly increased warmth. Affected area was from the right deltoid down to the mid humerus for a total of about 18 cm long and 10 cm wide. Physician's recommendations included acetaminophen and cold compresses. Eight days after injection, patient reports symptoms to almost be resolved.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was moved to fridge on 01-Dec-2021. No concomitant medications were reported. It was reported that there was no product complaint associated. No treatment medications were reported.   This case was linked to MOD-2022-496015 (Patient Link).
Painful abdominal cramping; diarrhea; body aches; injection site soreness.
I did not consent to this due to earlier adverse reactions. Numbness in arm and pain to the extent of not being able to lift anything. This lasted for a long time, at least a year. Also developed sensory seizures. Baby was born weighing 8 lbs 9 oz and has bowel issues. I will list those as a birth defect.
no additional AE or PQC reported; PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  Temperature excursions of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) were registered as following: on 23-FEB-2022, it was exposed to a temperature 46.4 Fahrenheit (F) for a time frame of 1 hour; on 23-FEB-2022, it was exposed to a temperature 48.4 F for a time frame of 2 hours and 25 minutes; on 03-MAR-2022, it was exposed to a temperature 49.3 F for a time frame of 2 hours and 50 minutes; on 08-MAR-2022, it was exposed to a temperature 46 F for a time frame of 30 minutes; on 09-MAR-2022, it was exposed to a temperature 47.8 F for a time frame of 3 hours and 56 minutes. There was no previous temperature excursion.      On 15-MAR-2022, the patient was vaccinated with the improperly stored haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength and route were not reported; lot # T030711, expiration date: 15-APR-2023) 0.5 milliliter for prophylaxis (product storage error). No additional adverse event was reported.
I had an injection to my shoulder, left shoulder prior to my vaccine. I experienced headaches, severe body aches, also in my hips, I did not sleep after either shot for 24 hours. I also had AS flare up that I have been fighting ever since receiving the vaccine. I've had complete lab work done. Today I still have flare ups and I am in another dose of prednisone medication.
Chills, headache, muscle ache, fatigue, fever (101.5). Chills resolved by 3am, fever lasted 4am-7am. Muscle ache and fatigue persists.
Case number PHEH2014US000597 initial spontaneous report received from a pharmacist on 06 Jan 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medication were not reported. It was reported that this patient under 18-years of age was vaccinated with FLUCELVAX (batch number: 010011A) on 04 Jan 2014. No adverse event was reported following the maladministration. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 06 Jan 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
I took the vaccine on January 28, 2021 at 10:50am. I went to work at 5pm and I started to feel a really bad pain on my right arm where I had the vaccine. By 10pm I had chills, really bad headache and nauseas. I kept working until 1:30am when I came home as soon as I laid down in bed I could feel pain in my whole body I didn?t want anyone to touch me my temperature went really high. I was sleepy and dizzy I felt the same as when I had COVID on june of last year.