chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs reported; improperly stored PROQUAD was administered on 19Jan2021 to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, subcutaneously (subQ), lot # T018274, expiration date 23-NOV-2021 (anatomical location was not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of 7.5 degrees Fahrenheit (F) for 6 hours and 53 minutes, 10.9 degrees F for 12 hours and 16.8 degrees F for 1 hour and 55 minutes.  The improper storage was recorded by digital data logger. There was no additional adverse event reported.
Headache, Arthralgia, NauseaVomiting, Fatigue Narrative: Nausea, vomiting, headache day following injection. Bosy aches and chills developed later.
Had shortness of breath, coughing, itchy eyes, runny nose and congestion. Went to get tested at Clinic to ensure it was not COVID-19, doctor there confirmed it was most likely allergies and/or the common cold. Treatment: taking decongestants and painkillers as needed, resolved within a week.
Pt has developed apprx 7-8 mm veloid (R) thigh at site of Pediarix vaccine
Body aches; Fever; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 02Jul2021 at 17:30 (at the age of 52-years-old) as single dose for COVID-19 immunisation. Medical history included COVID-19 and artificial heart valve. The patient had known allergies to sulpha. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Jul2021 at 11:00, the patient experienced body aches, fever and joint pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, fever and joint pain was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild pain at site of injection; Mild pain at site of injection which switched to intense muscle aches; chill.; Intense headaches; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Dec2021 10:45 (Lot number: FH8027) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 16Feb2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 26Jan2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 10:45, outcome "unknown", described as "dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "Mild pain at site of injection"; MYALGIA (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "Mild pain at site of injection which switched to intense muscle aches"; CHILLS (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "chill."; HEADACHE (non-serious) with onset 20Dec2021 19:00, outcome "recovered" (Dec2021), described as "Intense headaches". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, chills, headache. Additional information: The patient had mild pain at site of injection which switched to intense muscle aches and chill.  This occurred the first 24 hours after injection. Intense headaches 24-48 hours post injection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ibuprofen within 2 weeks of vaccination. The patient known allergies was reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch provided.
Pt given a pediatric dose of Hep A. Pt was notified to come in  in  6 mos  to get first Adult Hep A followed by a 2nd Adult Hep A 6 mos after the first.
PATIENT ADMITTED TO REHAB FROM DR'S OFFICE   COMPLETED MODERNA VACCINATIONS THE 1ST OF FEBRUARY PER PATIENT STATEMENT  ADMITTED TO ACUTE CARE 7/19/21 WITH INTERMITTENT FEVER, SOB STILL INPATIENT
Several papules with tiny scab/excoriation at top- located on torso. One lesion on flank with ? tiny clear fluid filled vesicle. Minimal erythema on papule, none surrounding. Similar lesion on forehead and knee.
Pt. received H1N1 vaccine at 9am on 1/5/2010 and on 1/18, reported sore arm that started on four days after receiving shot. No redness, swelling or increased warmth noted at site. Pt saw MD at regular pre-scheduled appt. and told Pt. discomfort right arm 99% sure it is pulled muscle and not a reaction from vaccine.
Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022; patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 048C21A, 004M20A and 026L20A) for COVID-19 vaccination.     It was unknown whether the patient was ever been diagnosed or tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before was unknown.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered The Moderna Covid 19 vaccine after its 30-day Use By Date.) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator since 7-Mar-2022 in temperatures between 2 to 8 celcius degrees then administered on Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter states like 7 patients were vaccinated on 08-Apr-2022 and 2 patients on 11-Apr-2022. It was reported that vaccine was given beyond use date. Vaccine was administered to patient 2 days past the 30-day time in refrigerator. No treatment medications were reported.   This case was linked to MOD-2022-539590, MOD-2022-546716 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Significant follow-up received: Case was upgraded to valid. Additional reporter, patient demographic details, dosing details of other doses were added. Date of vaccination for 4th dose, event onset date, reporter causality for the event (expiry vaccine) and inarrative were updated.
This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored M-M-R II (dose, strength, dose number, route ad administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. This is one of several reports from the same source. Additional information has been requested.
pt recvd vax for prophylaxis;45 mins later exp difficulty breathing, difficulty walking,tingling in arms & swelling & hives of the upper & lower lips;3 days later exp flu-like sxs; tx w/ dph; subsided
sore arm; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     The patient's past medical history included Vagus nerve disorder NOS (exaggerated vagus nerve response about 20 years ago) and Back surgery (Patient had back surgery in 2009). Concomitant products included CENTRUM FORTE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Apr-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 116/70 (Inconclusive) 116/70. On an unknown date, Breath sounds: 18 (Inconclusive) 18 and little labored (good). On an unknown date, Heart rate: 72 regular (normal) 72 regular. On an unknown date, Oxygen saturation: 99 (Inconclusive) O2 sat = not available at the time of muscle spasm/contraction but 30 mins later was able to get an 02 sat = 99..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-176571 (Patient Link).
Pt. received 4 different vaccines w/2 in each deltoid and on the left deltoid she started having redness, swelling and pain that has spread.
On day 6,  moderate bilateral wrist pain  On day 7, moderate bilateral stiffness in legs and arms On day  8, severe  Polymyalgia rheumatica (extreme disruption to day to day activities) through legs and arms. Aleve and Advil taken, unclear if effective On day 9 symptoms began to resolve, still significant disruption to daily activities. On days 10-11 increased resolution of polymyalgia rheumatica, leg pain nearly resolved. Arm and shoulder pain still present. Development of noticable bilateral swelling in fingers and bilateral joint pain in fingers. Significant disruption  to daily activities.  Minor symptoms include moderate unilateral arm pain at injection site on days 1-2. Minor waning headaches through days 2-5
Pain and swelling under right arm two days after vaccine, then two days after that pain and selling to right hand
After she got the vaccine, patient did not feel well.  She was lethargic and had a fever.  I gave her a dose of acetaminophen, as directed by the doctors office.  She seemed fine that evening when she went to bed. The next morning, patient complained of persistent itching on her palms, arms, legs, and face.  I looked at her closely and saw that she was red and swollen, with hives on her face.  I went to the store to get her Benadryl and came home to find most of her body red and swollen.  She had large red spots on her chest and back.  We gave her a dose of liquid Benadryl and had her sit in a bathtub with warm water and baking soda.  The hives subsided with the Benadryl.
Numbness and tingling of the lips; Numbness and tingling of the lips; Inflammation of the tongue and throat; Inflammation of the tongue and throat; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine for hypothyroidism. The patient previously took Demerol and experienced allergy. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 08:30 AM, the patient experienced numbness and tingling of the lips, inflammation of the tongue and throat. No treatment was given to patient for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.  Information on the lot/batch number has been requested.?
Swelling and pain in right deltoid, armpit, upper/lower back on 10/11 and 10/12. Swelling continues in 10/14 and 10/15. Ibuprofen for pain and swelling.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia, Sjogren's disease, hypothyroidism and white blood cell count low. Previously administered products included ZOSTAVAX. On 3rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, influenza-like symptoms, feeling unwell and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had fibromyalgia, Sjogren's disease, hypothyroidism, low white blood cell count and weakened immune system (all conditions prior to receive SHINGRIX vaccine). After receiving SHINGRIX, the patient experienced fever, flu-like symptoms and did not feel well for a few days. The patient's injection site was also swollen and very painful such that she could not move it. The contact details of the physician were provided. For tolerance to the 2nd dose of SHINGRIX, refer case US2018GSK194539.
fever and generalized weakness bilateral pneumonia secondary to COVID-19 infection Failure to Thrive, Severe Sepsis   antibiotics: Levaquin, ceftriaxone and Remdesivir, insulin: Humalog and respiratory therapy: O2
Two days after shot, left arm lost about 90% muscle tone/use. Continued for the 30 days to next shot. Two days after second shot, right arm lost about 90% muscle tone/useage.  Both arms continued this condition for 30 days (60 days for left arm).  After 30 more days, (around April,) condition started to improve until June at which muscle tone and useage improved to 70%.  By July, most strength and tone have returned, except some minor weakness continues, mostly in hands and shoulder muscles.  Doctor felt I may have had COVID and didn't know it.  No other explanation seems to fit.
Needle/syringe malfunction upon administering Moderna COVID-19 vaccine to patient on 09/30/2021. Administering provider noted approximately half of the vaccine dose administered, and half wasted. Doctor was consulted via telephone, and recommended 0.25ml to be administered to the patient to complete the full vaccination dose. Patient in agreement. No adverse reactions noted after the post vaccine observation period.
REDNESS, SWELLING, WARMTH IN AREA OF TDaP IMMUNIZATION. WENT TO DOCTOR. WAS TOLD TO TAKE TYLENOL AND COMPRESSES
1st dose 25May2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 49-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (Received 1st dose of Twinrix on 25th May 2022 from lot number 4F3YY (expiration date:1st January 2023)).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 14-FEB-2023 Reporter's Comment: The reporter reported that the patient did not present back for the second dose of Twinrix until 14th February 2023. At the time of reporting, the second dose had not yet been administered. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix , which led to incomplete course of vaccination. This was 1 of 3 case, reported by the same reporter. Note: VARES details pertained to 1st dose of Twinrix in product tab; Sender's Comments:  US-GSK-US2023024467:Same reporter US-GSK-US2023024466:Same reporter
Still experiencing: Bruise: 1 inch diameter, at injection site Redness, swelling: 3 inch diameter, injection site at the top, tender, warm/feverish  Ended: Low fever, fatigue, nausea
Woke up in middle of the night with fever, temp rose to 103.8, complained of headache, being hot and cold, stomach, threw up once, was lethargic, had larger than golf ball size local reaction. Could not move arm without considerable pain that radiated to neck.
arm was red; amazingly tired; arm hurt so bad; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (amazingly tired), PAIN IN EXTREMITY (arm hurt so bad), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (arm was red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included LEVETIRACETAM (KEPPRA XR), CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), CYANOCOBALAMIN (VITAMIN B12 AAA) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FATIGUE (amazingly tired), PAIN IN EXTREMITY (arm hurt so bad) and VACCINATION SITE PAIN (injection site pain). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm was red). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. On 01-Mar-2021, VACCINATION SITE PAIN (injection site pain) outcome was unknown. At the time of the report, FATIGUE (amazingly tired), PAIN IN EXTREMITY (arm hurt so bad) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-034074 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-034074:same reporter, different patient and event
Lip began tingling at 1PM. By 8PM that night, it was extremely enlarged. Face was swollen next day. Eyes and throat began swelling. Doctor told me to use the epipen on myself since I was salivating a lot. Called the ambulance and was taken to Hospital. Doctor told me that they thought the Lisinopril allergic reaction was activated.  It is now Sunday (four days later) and I am experiencing muscle aches in my right arm and nerve pain in my right hand/fingertips. On Saturday, my right arm was twitching and cramping. Felt chills on Friday.
severe allergic reaction; A spontaneous report was received from a health care professional, concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced severe allergic reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On an unknown date, approximately 15 minutes prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced a severe allergic reaction. The symptoms were discovered during the 15 minute post-vaccination observation period. The patient had no prior history of anaphylactic reactions. Treatment information was not provided. The patient was advised not to receive second dose of COVID-19 vaccine.  The action taken in response to the event was not reported.  The event severe allergic reaction was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
1/25/2022 Patient arrived to ER with fever, increased confusion, and swelling below her right ear. She tested positive for Covid19 1/31/2022.
Day after injection, (late afternoon) pt experienced "flu" type symptoms, aches/pains. Arm and fingers felt tingly. Had to go to bed at 7 pm. Next day, arm was red and warm to touch.
The 5-11 year old Pfizer vaccine was not reconstituted with the 1.3 ml of diluent.
T=97.4 soft tissue swelling in cervical neck area on left. No rash, hives or respiratory distress mass soft & not painful LA warm to touch at injection site - no erythema.
Pain at injection site for 24 hours; redness and swelling of injection site developed 8 days later