chrisvoncsefalvay/vaers-outcomes huggingface dataset:
total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C/1 hour with a minimum of negative 1.8C and maximum of 1.8C (with no reported adverse event); Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 months old and unknown gender patient who experienced total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c/1 hour with a minimum of negative 1.8c and maximum of 1.8c (with no reported adverse event) while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c/1 hour with a minimum of negative 1.8c and maximum of 1.8c (with no reported adverse event) (product storage error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c/1 hour with a minimum of negative 1.8c and maximum of 1.8c (with no reported adverse event).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore throat; Allergic cough; Seasonal allergy; Allergy; Vaccination site pain / Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Seasonal allergy), HYPERSENSITIVITY (Allergy) and VACCINATION SITE PAIN (Vaccination site pain / Sore arm) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Seasonal allergy), HYPERSENSITIVITY (Allergy) and VACCINATION SITE PAIN (Vaccination site pain / Sore arm). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Seasonal allergy) and HYPERSENSITIVITY (Allergy) was resolving and VACCINATION SITE PAIN (Vaccination site pain / Sore arm) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had taken Humira drug in the form of Solution for injection in pre filled pen. No treatment information was provided.
99 degree temperature; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (99 degree temperature) and FATIGUE (very tired) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (99 degree temperature) and FATIGUE (very tired). At the time of the report, PYREXIA (99 degree temperature) and FATIGUE (very tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (Inconclusive) 99.         This case was linked to US-MODERNATX, INC.-MOD-2021-114529 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114529:Case for sister
Weakness body aches, confused, weak and groggy, nausea vomiting, decreased appetite with increased sleep.
Day of vaccination: pressure in nose, very subtle headache, numbness and weakness in the body, couldn't feel the legs, 4 whole degrees rise in temperature in 3 hours, chills and sweats. Lasted about 24 hours. Lingering effect: Strong pressure in the nose,  occasional pressure and very subtle pain in sinuses. No discharge or any other symptoms.
Arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day of the shot about an hour and half I started feeling achy pain in my knee to my toes and my leg went numb. I had a headache and felt confused, I couldn't remember what to do. The site was sore, I was dizzy, nausea and tired.  This lasted for about 2-3 days .I took the next day off.  The Dr. at my work said it should go away.
Dizzy (25 minutes after) Tingling Face (40 minutes after) Sore hard knot at injection site (24 hrs after injection)
Loose stool; Diarrhea; Terrible reflux; This is a spontaneous report from a contactable other healthcare professional. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er2613) via an unspecified route of administration in the right arm on 31Mar2021 at 10:15(at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and allergic to sunflower seed and oil(food allergy). Concomitant medications included insulin(MANUFACTURER UNKNOWN),metformin(MANUFACTURER UNKNOWN) and lisinopril (LISIPRIL),all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: En6205) via an unspecified route of administration in the right arm on 10Mar2021 at 10:30(at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced terrible reflux(gastroesophageal reflux), loose stool and then diarrhea. The patient reported that it would be day 4(at the time of the report) of the issues. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 02Apr2021, the patient underwent PCR COVID-19 test(nasal swab) and the result was negative. The clinical outcome of the event terrible reflux, loose stool and diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
When I received my second shot a few days later I started a regular period again; I take my birth control very religiously and have been spotting/ been on my period for almost 3 weeks now which is incredibly unusual; This is a spontaneous report from a contactable consumer or other non hcp.    A 30-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection(Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 as dose 2, single for covid-19 immunisation .Medical history included oligomenorrhoea, I take birth control continuously so I skip my periods and have not had my  period or any spotting for 6 months up , contraception take birth control continuously , migraine. Concomitant medication(s) included amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate; fluconazole, vitamin d. Patient previously took first dose of vaccination in right arm for covid 19 immunization.No other medications the patient received within 2 weeks of vaccination, the patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that take birth control continuously, so skip my periods and have not had my period or any spotting for 6 months up until a week after my first shot. When I received my second shot a few days later started a regular period again. And take my birth control very religiously and have been spotting/ been on my period for almost 3 weeks now which is incredibly unusual. My friend also mentioned the same thing happened to her after receiving the Pfizer vaccine so thought to reach out. On unknown date of Apr2021 the outcome of the event was not Recovered, and no treatment was received. The case has been assessed as non serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384998 same reporter/product/event, different patient
tooth pain; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient wanted to know if he can take pain medication for his tooth pain. Clarified that the pain started after he received his first covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was extremely sick; headache; every parts of the body began to hurt; Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot; couldn't eat for up to 6 to 7 days following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot), APPETITE DISORDER (couldn't eat for up to 6 to 7 days following vaccination), ILLNESS (I was extremely sick), HEADACHE (headache) and MYALGIA (every parts of the body began to hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot), APPETITE DISORDER (couldn't eat for up to 6 to 7 days following vaccination), HEADACHE (headache) and MYALGIA (every parts of the body began to hurt). On an unknown date, the patient experienced ILLNESS (I was extremely sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine , passed 49 days after the 1st shot), APPETITE DISORDER (couldn't eat for up to 6 to 7 days following vaccination), ILLNESS (I was extremely sick), HEADACHE (headache) and MYALGIA (every parts of the body began to hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt developed redness in area, fever, unable to lift arm and joint pain. Patient went to ER 11/15/14 pm and was given antibiotic BACTRIM DS. Advised probably allergic reaction but could be infection.
23NOV sinus trouble, aching all over, sl fever, throat raw @ noc, flu like sx;
Warmth at injection site; Induration at injection site; Redness at injection site; A spontaneous report  was received from a health care professional concerning a 34-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed injection site induration/vaccination site induration, injection site redness/vaccination site erythema, and injection site warmth/vaccination site warmth.     The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 28-Dec-2020, approximately one week prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch# 039k20-2a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06-Jan-2021, the patient developed delayed injection site induration, redness, and warmth. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events, injection site induration, injection site redness, and injection site warmth, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 8 years old female patient who about to inject the vaccine injection of suspect TYPHIM VI, lot N1K801M, expiry date 15 Oct 2019, dose not reported via unknown route in unknown administration site on 27-Jun-2019 and it sprayed out everywhere and was not injected into the patient. Caller states that she is certain that she screwed the needle on tightly, she did not reinject the patient. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to accidental exposure to product and syringe issue. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
No adverse event; Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022 at 2:23 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Nov-2022 at 2:23 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Bivalent vaccine on 15NOV2022 which was initially punctured at 1:35 on 14-NOV-2022/ more than 12 hours after puncture).    Concomitant medications details were not reported by the reporter.  On 06-Jan-2021, the patient received first dose of Moderna COVID-19 vaccine (Intramuscular), lot number 027L20A. On 04-Feb-2021 , the patient received second dose of Moderna COVID-19 vaccine (Intramuscular), lot number 028L20A. On 21-Sep-2021 , the patient received third dose of Moderna COVID-19 vaccine (Intramuscular), lot number 023C21A. On 28-Apr-2022 , the patient received fourth dose of Moderna COVID-19 vaccine (Intramuscular), lot number 005M21A.  The 30 day BUD for the vial was 17-NOV-2022. The vial stored post puncture was reported as predawn into syringe and stored in refrigerator. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range is less than 5 mins.  Treatment details was not reported by the reporter.
My period has changed drastically since being vaccinated.  In the month of March after my first dose of the vaccine I had a 2nd period in that month one week after my first dose.  After receiving my 2nd dose (4/13/21) my period the last 3 months has come every 3 weeks which is not normal for me.  Typically my cycle has historically been every 4 weeks and always on a normal schedule.  This vaccine has messed with my hormones and at this time it has not returned to normal 4 months after my first dose.  In addition my arm has pain in the area where the injection took place off and on.  Like a shooting pain in the area.
Patient didn't experience an adverse event. Our clinical services team at the pharmacy requested we submit a report. The vaccine had a BUD of 11/12/2021 and administered on 11/14/2021. We called the manufacturer and they said the vaccines had up to 32 days under controlled temperatures in the refrigerator and 11/14/2021 was day 32.
Within 20 minutes of receiving my vaccine (2nd dose), I had a strange sensation in my left arm and  flowing down into each of my fingers.  It was not painful, just odd.  Later that same night around 6pm (Friday), I could no longer stay awake and slept until the next morning.  When I woke the next morning (Saturday), I experienced joint and muscle ache and complete fatigue and lethargy.  I was unable to completely get out of bed until about 5:45pm that night. By the next morning (Sunday), I felt fine.
Significant Swelling; Fever; Chills; Body Malaise; lymph node was swollen to the size of an orange now it is a size of a lemon; swollen is extremely red; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MALAISE (Body Malaise), PERIPHERAL SWELLING (Significant Swelling) and LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) and ERYTHEMA (swollen is extremely red). On 27-Feb-2021 at 11:30 PM, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MALAISE (Body Malaise). On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Significant Swelling). On 01-Mar-2021, PYREXIA (Fever), CHILLS (Chills) and MALAISE (Body Malaise) had resolved. At the time of the report, PERIPHERAL SWELLING (Significant Swelling), LYMPHADENOPATHY (lymph node was swollen to the size of an orange now it is a size of a lemon) and ERYTHEMA (swollen is extremely red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information included Advil for pain relief   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: significant follow-up appendedReporter information, patient demographics, product information, new events and outcome added.
arm sore; they gave an expired shot to someone last week; fluzone/20Oct2022; fluzone/20Oct2022; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 5-year-old male patient received BNT162B2, on 20Oct2022 at 17:41 as dose 1, single (Lot number: FL2757, Expiration Date: 11Oct2022) at the age of 5 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 20Oct2022 as dose number unknown, single (Lot number: UT7744JA) intramuscular, in right deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Oct2022, outcome "unknown" and all described as "fluzone/20Oct2022"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022 at 17:41, outcome "unknown", described as "they gave an expired shot to someone last week"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2022, outcome "recovered" (2022), described as "arm sore". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: caller stated he is calling about the Pediatric Vaccine, verified Pfizer Pediatric Covid Monovalent Vaccine. Caller states he is calling from (name) because they gave an expired shot to someone last week, later clarified to two patients, and corporate told him he needed to reach out to Pfizer to get the stability information to fill out the VAERS form. Caller states he is wondering if there may be extended stability? The seriousness of event arm sore was reported as non-serious.  Follow-up attempts are completed. No further information is expected.  Follow-up (09Nov2022): This is a spontaneous follow-up report received from a contactable Pharmacist reported in response to HCP letter sent which included that: Updated information included: Co-suspect, new event and additional information.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253323 same reporter/product/AE, different patient; Report 1 of 2;