chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain shooting from right ear to jaw ( went way after a couple of days). Tooth ache in several Right upper and lower teeth. ( nerve, sharp pain).
patient was administered an expired vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired vaccine) and NO ADVERSE EVENT (no adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was administered an expired vaccine).    No concomitant medication was reported. Dosage text for suspect product was reported as unknown. Expiry date of the suspect vaccine was reported as 07-JUN-2023. No treatment medication was reported.
Rec'd call from DLS re: covid pos result. Call initially taken by RN. Case discussed, Called EE, no answer. Left voice mail to call back on 10/2/21 at 0853. Instructed EE to quarantine x10 days and to call hotline back to discuss case further and offer antibodies testing. EE is fully vaccinated. EE will need to notify manager. Will complete Vaers and RL. 10/1 HX: EE reports coughing and nasal congestion that started 9/30/21. Covid swab scheduled for 10/1/21. EE to quarantine and call hotline back with results for further RTW guidance.
On 4-18-21, 17 days after 1st dose of Moderna, he developed upper abdomen pain, chest discomfort. He thought it was indigestion and treated it as such. When he got no relief he went to Emergency room where a cardiac alert was initiated. After he died I was told he had developed myocarditis,/pericarditis and they had to remove a liter of blood from the sac around his heart, but that his heart had gone into cardiogenic shock and that he died. They were prepared to insert a stint thinking he had a blocked coronary artery, but his arteries were clear and they had no idea what had caused this to happen.  When he died so soon after the vaccine there were people who wanted to blame the vaccine but I checked into it and there were NO links between the vaccine and myocarditis, pericarditis or cardiogenic shock.  Within a few weeks of his death, there began to be possible links between the vaccine and myocarditis. I know 55 is older than what is being looked at, but he had absolutely no previous cardiac history prior to this and this case should e looked at as well
Stomach distension, vomiting', retention of water, diarrhea , fatigue, cough, sore throat, runny nose, back pain
hives / itchy; hot in the injection site; pain /  in the injection site; redness / in the injection site; Injection site itchy; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received Shingrix. On 4th January 2021, several hours after receiving Shingrix, the patient experienced hives, injection site warmth, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the injection site warmth, injection site pain, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the hives, injection site warmth, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The Shingrix was administrated to the patient and some hours after the vaccination the patient had redness, itchy, pain, hot in the injection site and hives. At the time of reporting, the patient still had hive in her chest. The reporter consented to follow up. This case was linked with the case US2021015571 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021015571:same reporter
c/o swelling in the right arm from elbow to wrist. No redness. no reaction at injection site.
Headache, tingling and numbness in arms and head, slight nausea - 4 hours Muscle ache and diarrhea - diminished but continued since first shot (full body muscle aches and fever following second shot) Cola colored urine - 12 hours Sudden onset Tinnitus in left ear - continued since shortly after first shot (can wake me up at night)
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, VARIVAX, underwent a temperature excursion. On 27-AUG-2014, the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Did not get full dose; A spontaneous report was received from a pharmacist concerning a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, did not get full dose.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 27 Dec 2020, during vaccine administration, a portion of the vaccine dripped on the patient's arm due to an issue with the needle and the syringe, and the patient did not get full dose of vaccine. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, did not get full dose, was considered resolved on 27 Dec 2020.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 011J20A. There were no reported AEs associated with this case of Incorrect dose administered.
Initial misuse report received from a healthcare professional on 22 November 2013. A '2-year-old' patient (no information was provided regarding the patient) had received a dose of FLUZONE 0.5 ml dose instead of 0.25 ml dose with no adverse event, i.e. overdose. List of documents held by sender: none.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 12:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 12:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.20.  Concomitant products were not provided.  On 24 May 2021, Excursion time was 08 AM and 09 AM temperature was 35, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18 May 2021, vial was moved to clinic on 24 May 2021. 3 vials were sent to clinic. Vaccine BUD date was 17 Jun 2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD22-013597 (Patient Link).
THREE DAYS AFTER INJECTION SKIN BEGAN BURNING SENSATION WITH BLUSHING LIKE A SUNBURN, SENSITIVE TO TOUCH AND CLOTHING, LOSS OF APPETITE. IRRITABILITY, FATIGUE. CONTINUED FOR 19 DAYS BEFORE SHOWING SIGN OF SOME RELIEF.  STILL BURNING NOW AFTER 21 DAYS. 2 DR. VISITS ONLY OFFER OTC HISTAMINE TREATMENT, DID NOT USE. CANCELED SECOND SHOT APPOINTMENT 4/3/2021.
This spontaneous report was received from a pharmacist refers to a 74 year old female patient. The patient has high cholesterol, hypertension, anxiety, history of heart attack, allergy to iodine, trimethoprim, sulfa drugs, statins, tetanus toxoids, had reaction to TDap before and CELEBREX. The patient's medical history included shingles one year ago. On 28-JUL-2015, the patient was vaccinated with ZOSTAVAX lot # KL006382, expiry date 25-MAY-2016. Concomitant therapies included ZOLOFT, SINGLULAIR, LIPITOR, TOPROL XL tablets, VALTREX and hydrochlorothiazide. On 28-JUL-2015, the patient developed an area at the injection site that was red within 30 minutes. Within 24 hours after administration the patient stated that the injection site area became warm, itchy and scaly rash appeared. ON 30-JUL-2015, the patient returned to the pharmacist since the rash was spreading. Pharmacist reported that the area was 1 x 2 diameter and appeared to be getting worse. There was not treatment rendered for the events. No lab test performed. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Benadryl 25mg given by mouth
Uncontrollable shivering for 20 minutes, covered up and took Tylenol, put pen in mouth.
Fever; Fatigue; Body aches; Joint pain; Headache; Arm tenderness; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 45-years-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EI3247) via an unspecified route of administration in left arm on 19Feb2021 as dose 1, single (at the age of 45 years-old) and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: El3248) via an unspecified route of administration, administration in left arm on 10Mar2021 14:00 as dose 2, single for COVID-19 immunization. Patient was not a pregnant at the time of vaccination and at the time of reporting. Patient medical history included asthma, had prolonged fatigue, dizziness, tinnitus following covid illness last year, covid illness last year, from 2020 to an unknown date. Patient was not allergic to medications, food, or other products. The concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRIN) taken for an unspecified indication, start and stop date were not reported and it was received within 2 weeks of vaccination. The patient experienced fever, fatigue, body aches, joint pain, headache, arm tenderness on an unspecified date in 2021. patient did not received treatment for adverse events. The patient experienced these symptoms after first dose also. The events are not leads to any seriousness criteria like death, prolonged hospitalization, disabling/incapacitating, life threatening, congenital anomaly/birth defect. The patient was taken Pfizer covid vaccine in four weeks. The patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. The clinical outcome of all events was not recovering.  No follow-up attempts are needed. No further information is expected.
Chills and body aches throughout the day.  Headache began around 4pm with a worsening of chills and body aches. Took some Advil and went to sleep for the night at 9pm. Woke up at 7am feeling great with no additional concerns to report.
25 yo, male who is taking female hormone treatment but has male external genitalia, had intimate contact (including oral and anal sex) with her ex-boyfriend, a civilian contractor, on 6/15/12. The vaccinee did not have a dressing covering the vaccination site. The pt touched the vaccinated area and felt oozing fluid at least twice during the encounter. On 6/21/12 the pt developed lesions primarily over her anal/gluteal area. They started as "pimple like lesions" and "grew larger and started draining". She developed a lesion ("small pimple") on her upper lip on 6/22/12. She stated that over 24 hours the lesions grew to about the size of a dime and started oozing on 6/24/12. She also complained of feeling feverish, generalized body aches and nausea. On 6/22/12 she had anal sex with her boyfriend. She presented to the ER on 6/24/12 and was admitted (She was afebrile with no leukocytosis or electrolyte abnormalities in the ER). She indicated that she also had a lesion in her left ear which was draining. She also noted a "pimple" on her forehead on the afternoon of 6/25/12. The pt received VIG on 6/25/12. A lesion was noted on the oral mucosa on 6/27/12 which resolved spontaneously on 6/28/12. On 6/27/12 the pt complained of SOB upon awakening (no chest pain or palpitations). CXR, EKG and Troponin I were normal. The pt had no further cardiac symptoms. On 6/28/12 a swab of the lip lesion was obtained which returned on 7/2/12 positive for non-variola Orthopoxvirus. The pt was discharged from the hospital and 6/28/12. She was seen as an outpatient on 7/3 and 7/11/12. The hospital continued with frequent follow-up (education and support). On 7/17/12 the pt reported that all lesions were healed (flat, dry, slightly pink). Symptoms: Shortness of breath, Diarrhea NOS, inv skin/integumentary tissue NEC.
he experienced was tenderness/soreness at the injection site for approximately 1 day after each of the 3 doses; he experienced was tenderness/soreness at the injection site for approximately 1 day after each of the 3 doses; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101739613 (Pfizer).  An elderly male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: May2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Booster dose"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovered" and all described as "he experienced was tenderness/soreness at the injection site for approximately 1 day after each of the 3 doses". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain.  Additional information: The patient experienced tenderness /soreness at the injection site for approximately 1 day after each of the 3 doses. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device time stamp on 25Nov2021  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swelling in throat; Outer jawwas numb; Tightness in throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Outer jawwas numb) and THROAT TIGHTNESS (Tightness in throat) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to sulfa and antibiotics).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Outer jawwas numb) and THROAT TIGHTNESS (Tightness in throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 13-Mar-2021, PHARYNGEAL SWELLING (Swelling in throat), HYPOAESTHESIA (Outer jawwas numb) and THROAT TIGHTNESS (Tightness in throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075027 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075027:cross linked to Dose 2
PATIENT RECEIVED SECOND DOSE OF SHINGRIX 39 DAYS AFTER 1ST DOSE.
he has severe rheumatoid arthritis; he was having problems with his feet.; he had scratched himself so much that he has open wounds on himself; he had scratched himself so much that he has open wounds on himself; down to 135 a couple of week before; This is a spontaneous report from a contactable consumer reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), second dose via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 70 years old. The patient medical history included "he had complication from egg and orange" from an unspecified date and unspecified health conditions. The patient takes unspecified concomitant medications. The patient received the first dose of BNT162B2 on Feb2021 for covid-19 immunisation, at 70 years old and experienced itching and rash. It was reported that patient has serious health issues already. He has severe rheumatoid arthritis on an unspecified date. He has been given every rheumatoid arthritis medication (unspecified) on the market but none of them really helped him. Patient is now on an infusion of some kind of drugs (unspecified). He is on so many different unspecified medications and then he was having problems with his feet on an unspecified date, so the reporter bought the patient "Gold Bond Diabetic Lotion" (product name as reported), to put on his feet. The reporter does not know if this was all related because he is on so many medications. After the second shot, patient woke up on the morning of 19Mar2021 and he had scratched himself so much that he has open wounds on himself. The reporter talked with the patient regarding the cause of the event so the reporter said to stop using "Gold Bond Diabetic Lotion". The patient had had done that for several days and it did not seem to make a difference. Reporter stated they do not know if this is related to the COVID immunization, but they are trying to eliminate things and he is in touch with his doctor right now. The reporter stated that since the patient has rheumatoid arthritis and he is having a lot of health problems. The patient was down to 135 a couple of week before reporting time (2021). It has been about a month since he had extensive lab test because he has to go for extensive lab test every time before he has that infusion of those drugs on 03Mar2021. Patient would have gone for lab test the Friday before that, 26Feb2021 when he had extensive lab test. No treatment for events "he had scratched himself so much that he has open wounds on himself" and " down to 135 a couple of week before". Treatment was given for rheumatoid arthritis and problems with his feet (unspecified infusions and Gold Bond Diabetic Lotion). Outcome of the events was unknown.  Information about Lot/Batch number is requested.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received HAV (Havrix 720) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Feb-2023 The registered nurse stated that Havrix was administered to a patient on the day of reporting and it expired on 03 February 2023.  The vaccine administration facility was the same as primary reporter. The reporter asked please follow up via postal. Additional supportive information: The patient was administered an expired dose of Havrix 720, which led to expired vaccine used.
Information has been received from a registered nurse concerning a patient who in November 2008, was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck).  The patient mistakenly was given a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck).  The reporter had no information on whether this was product confusion or staff error.  No adverse effect was reported.  Additional information has been requested.
Chills on the night of vaccination. I felt sluggish the next day and had a sore throat. It was like laryngitis. I used a telehealth service. I had a white spot on my throat. I was prescribed Amoxicillin and took Theraflu which seemed to work. I was also tested for Covid-19 three days after the Vaccine and tested positive.  Second dose received with no problems. Second dose 030M20A
Patient had inject in left deltoid at 930 am and started to experience facial numbness on left side of face from ear down to chin around 4 pm.