chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore; sore and swelling underneath the armpit near the breast area pain on left side; sore and swelling underneath the armpit near the breast area pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore), INJECTION SITE SWELLING (sore and swelling underneath the armpit near the breast area pain on left side) and AXILLARY PAIN (sore and swelling underneath the armpit near the breast area pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CITALOPRAM and LOSARTAN for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (arm was sore), INJECTION SITE SWELLING (sore and swelling underneath the armpit near the breast area pain on left side) and AXILLARY PAIN (sore and swelling underneath the armpit near the breast area pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (arm was sore), INJECTION SITE SWELLING (sore and swelling underneath the armpit near the breast area pain on left side) and AXILLARY PAIN (sore and swelling underneath the armpit near the breast area pain) had resolved.
Pharmacist mixed a pediatric vial of Pfizer Covid instead of the adult version. Patient received a pediatric vaccine. Pharmacist on duty contacted Pfizer and pharmacy was informed to call patient and have them return for a full dose of the adult version as soon as possible. The patient returned on 12/07/2021 and received the correct dose.
Second dose was given at 21 days instead of 28 days. No symptoms or adverse effects at this time.
Duplicate vaccine administered for 6-month check-up approximately one month apart: Pediarix (Dtap,Hep B, IPV); Act Hib; Prevnar 13; Rotateq  Vaccine series given 10/13/2021 and 11/17/2021
Patient came back to pharmacy day after second injection with large swollen lump at site of injection, complaining of severe shooting pain down his right arm.  The entire arm was sensitive to touch.
tested positive for Covid 19 last week 02Feb2021; tested positive for Covid 19 last week 02Feb2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received 1st dose of Covid 19 Vaccine 3weeks ago and supposed to get back tomorrow for the 2nd dose. Caller tested positive for Covid 19 last week 02Feb2021. Patient wanted us to know about this information. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Started as general itchiness in hands and feet, no rash at first has progressed to general itchiness all over body mainly arms, back, face with redness around neck. Has been going on for 2 weeks now
This spontaneous report as received from a pharmacist via a field representative refers to 2 unspecified female patients of an unknown age. Pertinent medical history, drug reactions and concomitant medication were not specified by the reporter. On an unknown date, the patients were vaccinated with ZOSTAVAX vial (dose, route of administration, lot# and expiration date were not reported) for shingles prevention. On an unknown date, the patients experienced a stronger than normal injection site redness, the size of a quarter. It was not specified if any treatment was given for the adverse event. The outcome of injection site redness was not reported. Causality assessment between the event of injection site redness and ZOSTAVAX was not provided. Product quality complaint (PQC) was not involved. Additional information has been requested.
Clinical zoster same arm as vaccine administered. Information has been received from a physician concerning a 15 month old female with no pre-existing allergies, birth defects, or medical conditions, who on 06-NOV-2007 at 12:32 hours, was vaccinated with a first subcutaneous dose in the left deltoid of VARIVAX (lot # 658431/1154U). Concomitant vaccination on 06-NOV-2008 included at 12:32 hours, a first subcutaneous dose in the left deltoid of MMR II (lot #666034/0182U), at 13:30 hours a first intramuscular dose in the right deltoid of HAVRIX (lot # ahavD300aa), and at 12:13 hours, a fourth subcutaneous dose in the right deltoid of PREVNAR (lot # 870141U). There was no reported illness at the time of the vaccination. On 08-FEB-2008, the patient developed zoster in the same arm as her vaccination with VARIVAX. It was indicated that the patient was seen in the physician's office and was being treated with acyclovior. VZV Analysis by PCR was offered but the physician had already sent vesicles for culture. The samples of the lesion was collected on 09-FEB-2008. Samples were obtained from unspecified site as a swab and medin at a local hospital. They were resulted on 20-FEB-2008, by the Center for Disease COntrol and Prevention NAtional VZV Laboratory as POSITIVE, and reported specimen was adquate. It was reported that as of 21-FEB-2008, the patient had recovered. A product quality complaint was not reported. Follow up by the physician provided no additional information. Additional information is not expeceted.
body aches-next day  fever 103-104   took ibuprofen fever went down fatigue
Syncope, with bradycardia, likely vasovagal? Severe arm pain at injection site. Required ED visit and hospital observation (the latter for pain management). Subsequent PCP office visit.
Vision sift then passed out, for a few seconds, water @1212, ambulatory at 1219.
113 Bivalent doses administered after the BUD to patients 12 and up. 113 Bivalent doses administered after the BUD to patients 12 and up.; No adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.), EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.), EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.), EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) 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 assessments were provided for PRODUCT STORAGE ERROR (113 Bivalent doses administered after the BUD to patients 12 and up.) and EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported. No treatment medication reported.
SEVERE HEADACHES ALL DAY EVERY DAY SINCE 1ST DOSE, DIZZY SPELLS
I did experience Covid recently; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I did experience Covid recently) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PREDNISONE for an unknown indication.    Concurrent medical conditions included Chronic urticaria, Illness and Hives.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PREDNISONE (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (I did experience Covid recently). At the time of the report, COVID-19 (I did experience Covid recently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was provided by reporter. No Treatment medication was provided by reporter.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right 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: "Asthma" (unspecified if ongoing). Patient had no Known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. 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
No adverse event; Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to patient on 15-Mar-2023 with expiration date of 13-Feb-2023).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 2nd patient out of 2 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715783 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715783:Child case (1st patient)
Patient received first dose of Pfizer/BioNTech COVID-19 vaccine on  12/21/20 and second dose on 1/11/21. Patient tested positive for COVID-19 on 2/4/21.
PT REPORTED SLURRED SPEECH AFTER SHE GOT HOME ON SAME DAY OF VACCINATION.  PT REPORTED THIS WAS AN ISOLATED INCIDENT AND WAS SELF RESOLVED.  TIME BETWEEN VACCINATION AND SIDE EFFECT UNKNOWN.
J96.00 ACUTE RESPIRATORY FAILURE 5/4/2023 ABDOMINAL PAIN
This spontaneous report as received from a registered nurse refers to 4 patients of unknown age. The patients were vaccinated with doses of (lot # 0128AE, exp date 10-JAN-2014) M-M-R II (dose and route not reported) on 02-JUL-2012. No other co-suspects and no concomitant medications were reported. The registered nurse reported that while checking temperature stability of multiple vaccines she noticed that the four patients were vaccinated with doses of M-M-R II that had been exposed to 14.9 degrees Celsius for ten hours. No adverse effect was reported. No other vaccines were administered to patients. No treatment information was reported. Follow-up information has been received from a registered nurse stated that were only to 2 children, not 4 children as previously reported. The second child was a 4 year old girl, who on 02-JUL-2012 was vaccinated with dose of M-M-R II )that had been exposed to 14.5 degrees Celsius. Any adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
sore arm; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 as DOSE 4 (BOOSTER), SINGLE (lot number: GH9694) at the age of 42 years intramuscular, in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose, via intramuscular route of administration, administered in the left arm (lot number: EN6203) as DOSE 1, SINGLE), administration date: 03Mar2021, when the patient was 40 years old, for Covid-19 immunization, reactions: "Headache" and "stomach cramping"; BNT162b2 (second dose, via intramuscular route of administration, administered in the left arm (lot number: EL3248) as DOSE 2, SINGLE), administration date: 25Mar2021, when the patient was 40 years old, for Covid-19 immunization, reactions: "Left arm soreness/my arm was just sore", "Red mark about the size of a dime around the injection site", "the injection site had a bit of a burning or stinging sensation", and "Menstrual spotting"; BNT162b2 (third dose, via intramuscular route of administration, administered in the left arm (lot number: FJ1620) as DOSE 3 (BOOSTER), SINGLE), administration date: 23Nov2021, when the patient was 41 years old, for Covid-19 immunization, reactions: "jaw pain", "sore arm", "headache", and "sinus pressure." The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Sep2022, outcome "recovered" described as "sore arm." Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine: Pharmacy or Drug Store. Patient had no known allergies: If COVID prior vaccination: Yes; If COVID tested post vaccination: No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239566 same reporter/ patient/ vaccine; different dose number and events (Dose 1);US-PFIZER INC-2021352149 same reporter/ patient/ vaccine; different dose number and events (Dose 2);US-PFIZER INC-202101654777 same reporter/ patient/ vaccine; different dose number and events (Dose 3);US-PFIZER INC-202200630423 same reporter/ patient/ vaccine; different dose number and events (LOE);
Patient experienced light-headedness nausea and vomited once. She rested, drank OJ and felt completely back to normal (about an hour later).
approx 48 hrs p/vax mom states pt exhibited uncontrollable, spastic head movements when awake; afebrile; APAP given prior to sx; MD notified;
Is pregnant: Yes; arm pain; fever; chills; headache; dizziness; muscle aches; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 14:00 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Date of last menstrual period: 20Dec2020. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 17 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Sep2021. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Covid-19 vaccine (Product: COVID 19, brand: Pfizer, administration date: 01Apr2021, administration time: 10:00 AM, vaccine location: Left arm, After dose 1: arm pain for 2 days), administration date: 01Apr2021, when the patient was 31 years old, for COVID-19 immunisation, reaction(s): "Arm pain".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "arm pain"; PYREXIA (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "dizziness"; MYALGIA (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "muscle aches"; FATIGUE (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "exhaustion"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "is pregnant Yes". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, headache, dizziness, myalgia, fatigue.  Additional information: Adverse event: After dose 2: fever, chills, headache, dizziness, muscle aches, exhaustion, arm pain, Adverse event start date:  23Apr2021, Adverse event start time: 02:00 AM, other medical history: Hypothyroid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flush red rash on face and neck, Hot to touch on face, itchy throat and mouth, Slight shortness of breath, and itchy face/skin and eyes started around 1830 hours and is still active at time of filing at 2032 hours
24 hours after the vaccine, I experience severe hip pain, down through my knees. The pain has gotten better, but is still there.
Started having chest pain/tightness that came and went throughout the day and night early/mid April.  Lasted through the middle of June.
Headache, Myalgia, NauseaVomiting,  CHILLS, FATIGUE, INJECTION SITE SWOLLEN, PAINFUL, RED Narrative:   Other Relevant History:
Localized swelling/redness to right bicep with itching; pain and swelling from right shoulder down to right elbow, problem started approx 8 hours after injection administered.
little bit sore and itched on the side for 1 or 2 days; little bit sore and itched on the side for 1 or 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little bit sore and itched on the side for 1 or 2 days) and PRURITUS (little bit sore and itched on the side for 1 or 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN (little bit sore and itched on the side for 1 or 2 days) and PRURITUS (little bit sore and itched on the side for 1 or 2 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (little bit sore and itched on the side for 1 or 2 days) and PRURITUS (little bit sore and itched on the side for 1 or 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Note: Patient is 5'1" / wgt 101lbs. / Excellent health / Age 79 / Petite on AED for Ideopathic seizure disorder Adverse Reactions: 1) 09/02 - Bleeding from site (Am not on blood thinners/never bled before 2) 09/03 - Not dizzy but felt like walking off balance (But wasn't) Temp 96.7 (AM); Normal 07.7 (Afternoon) 3) 09/03-4 Am Author - Too weak to work on writing projects spent most of 2 days feeling too tired to think clearly about writing 4) 09/03 For next 2 1/2 wks stiffness in RT upper arm "Left" ear ache (Inner ear)  Comment: Concern as a professional whether larger dose given to petite person is what caused reactions? Do I need (65+) dose 0.7 ml? Why was I not advised that dose was stronger than 0.5 mL of prior yrs?? *Thank  you for the courtesy of a response.
72-year-old male with past medical history of melanoma status post excision in 2015 and hypertension presented to the emergency department complaints of shortness of breath.  Patient reports that he was usual state of health until approximately 1.5 weeks ago when he started noticing some shortness of breath along with cough.  Patient reports that he got fully vaccinated with Moderna against COVID-19 on February 19, 2021.  Patient reports that his symptoms were worrisome therefore, couple of days later, he got tested positive for COVID-19.  Patient reports that he initially isolated and had only mild cough with congestion however, his symptoms continued to worsen.   Tested positive on 9/14/2021
seen in ED 7/1 for episode that occurred about 4 PM that day, lying in crib, "eyes rolling back and then patient having shaking of the trunk and arms.  Patient was not responsive at that time.  After shaking patient began crying immediately" Episode lasted about 10 sec and seemed normal immediately after