chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (606 doses given after expiration date) and product storage error (expired vaccine stored, then administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 008C21A) for COVID-19 immunization. No medical history reported. On Dec 1, 2021, patient received second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 1, 2021, patient administered expired product (606 doses given after expiration date) and experienced product storage error (expired vaccine stored, then administered). At the time of the report, administered expired product (606 doses given after expiration date) and product storage error (expired vaccine stored, then administered) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of placed in refrigerator on Nov 4, 2021. Vaccine did not undergo any temperature excursion. No other events reported for patient.
blister like small (rt side only);730PM hives started arm, face, middle of chest;12AM t102 ear;1230 APAP;130PM t103;2AM cool bath;3AM APAP;4AM t103.5;7AM 99.5;1030AM rash fading few blister like hive only rt forearm; one rt cheek;
Patient called around 12:30pm saying her fingers were slightly tingly and was wondering if she should be concerned.
Sore around the injection site; headache; slight cold/flu like symptoms; slight cold/flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 10Feb2021 (at the age of 21-years-old), as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore around the injection site, headache, and slight cold/flu like symptoms on 11Feb2021. Patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I noticed the injection site was a little itchy, warm and pink; Left arm warm to touch at injection site/warm; Little pink at injection site; Left arm was a little itchy at injection site/itchy; Left arm was a little sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm warm to touch at injection site/warm), VACCINATION SITE DISCOLOURATION (Little pink at injection site), VACCINATION SITE PRURITUS (Left arm was a little itchy at injection site/itchy), VACCINATION SITE PAIN (Left arm was a little sore at injection site) and VACCINATION SITE ERYTHEMA (I noticed the injection site was a little itchy, warm and pink) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol in 2002. Concurrent medical conditions included Acid reflux (esophageal) (Symptoms worse summer, 2021) since 2007, Penicillin allergy and Drug allergy (Sulfa). Concomitant products included ATORVASTATIN, SERTRALINE HCL, FAMOTIDINE, METHYLCELLULOSE (CITRUCEL) and CALCIUM CARBONATE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL SLOW RELEASE 1200) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Left arm was a little sore at injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Left arm warm to touch at injection site/warm), VACCINATION SITE DISCOLOURATION (Little pink at injection site) and VACCINATION SITE PRURITUS (Left arm was a little itchy at injection site/itchy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (I noticed the injection site was a little itchy, warm and pink). On 10-Jan-2021, VACCINATION SITE PAIN (Left arm was a little sore at injection site) had resolved. On 14-Jan-2021, VACCINATION SITE PRURITUS (Left arm was a little itchy at injection site/itchy) had resolved. On 20-Jan-2021, VACCINATION SITE WARMTH (Left arm warm to touch at injection site/warm), VACCINATION SITE DISCOLOURATION (Little pink at injection site) and VACCINATION SITE ERYTHEMA (I noticed the injection site was a little itchy, warm and pink) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab data details and Treatment for the events were unknown.  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.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received: New event added and outcome was updated.; Sender'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.
Started out with a migraine at 7 am. By 9 am I had chills, body aches, joint aches, headache, fever of 102. By 12 pm my fever was 104.7. It stayed that high for three hours then came back down to 102 with tylenol and ibuprofen and eventually leveled out at 99 until later in the afternoon.  I was dehydrated despite large intake of water and gatorade. The day after the vaccine (6/18/2021) i woke up with blisters around my nostrils. These blisters were itchy, painful, and weeping significantly. Doctor diagnosed the blisters as impetigo and had to be put on antibiotics.
Vitreous hemorrhage, bilateral subdural hematomas, hypertonic dehydration; 1st sx was exophoria noted 16SEP91; Abuse suspected & being investigated;
ITCHY THROAT/SCRATCHY THROAT (VERY UNCOMFORTABLE); ANXIETY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 22-JUN-2021, the subject experienced itchy throat/scratchy throat (very uncomfortable). On 22-JUN-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy throat/scratchy throat (very uncomfortable), and the outcome of anxiety was not reported. This report was non-serious.
her 2 sisters received their second dose of GARDASIL 9 on an unknown date last week/they received their first dose of Gardasil 9 in January 2020; This spontaneous report was received from a consumer and refers to a her sister of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date in January 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. The consumer reported that the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) on an unknown date in February 2022 (reported as "last week") (Inappropriate schedule of product administration).  This is one of several reports reported by the same reporter.; Sender's Comments:  US-009507513-2202USA006120: US-009507513-2202USA005968:
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 07-JAN-2019, the patient was vaccinated with improperly stored ROTATEQ(lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # S036818 with expiration date 22-APR-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Patient came to ED with shortness of breath.  Patient admitted to the hospital with Covid and treated with remdesivir.
Initial report received from a health care professional (medical assistant) on 26 May 2010: This child was vaccinated with MENVEO (batch no: unknown), (dose: unknown) on 10 May 2010. The reporter stated that, the vaccine that was administered was not refrigerated and it was at room temperature for 16 hours. The child had no reaction following this administration.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAY-2014 the patient was vaccinated with an improperly stored dose of M-M-R II (HSA) (lot # H014991, expire date 10-AUG-2014, strength: 0.5ml, dose: 0.5 ml; route unknown). The total cumulative excursion time was 24 hours with highest recorded temperature of -14 centigrade degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
'AT APPROX 1007AM, PT C/O LIGHTHEADEDNESS AND DIZZINESS. PT WAS COLD, CLAMMY, PALE AND DIAPHORETIC. NURSE TOOK HER VITALS: B/P100/70, P 38 02 92% RA.  PT STATES SHE DOES HAVE A 'PHOBIA OFNEEDLESAND WAS VERY NERVOUS ABOUT COMING TODAY'  PT WAS BROUGHT INTO THE NURSERY ROOM WITH ASSISTANCE TO A COUCH.  PT WAS INSTRUCTEDTO LAY FLAT.  A MAKE SHIFT PILLOW WAS PLACED UNDERHER FEET TO ELEVATE HER LEGS.  PT WAS ALERT AND ORIENTED X3. PT DENIES SHORTNESS OF BREATH, CHEST PAIN,OR HEADACHE.  SITE OF INJECTIONWAS ASSESSED AS PT C/O A SORE ARM.  ARM WAS  W/O BRUISING OR SWELLING. PT WAS GIVEN WATER TO DRINK AND STATED SHE WAS 'STARTING TO FEEL BETTER'.  PT CONTINUED TO LAY FLAT FOR APPROX 40 MINUTES.  PT VITALS WERE RETAKEN: 110/78 P68 PO2 98%RA.  PT MOTEHR WAS CONTACTED BY A HOSPITAL VOLUNTEER TO INFORM HER OF WHAT OCCURED.  PT STATED SHE FELT WELL ENOUGH TO LEAVE.  PT INSTRUCTED IF CONDITION RETURNS ORSHE EXPERIENCES ANY SHORTNESS OF BREATH ORDIFFICULTYBREATHING TO CALL 911.  pT WASABLE TO SIT UP WITHOUT DIFFICULTY OR ANY COMPLAINT OF DIZZINESS.  PT AMBULATED TO HER VEHICLE WITH 2 PERSON FOR SAFETY.  PT WAS DRIVENHOME BY A FRIEND/VOLUNTEER AT THE VACCINE CENTER.   1222: VOLUNTEER CALLED TO CHECK ON PATIENT STATUS, NO ADDITIONAL ISSUES REPORTED - 3/8/21 @ 1253
Patient called complaining of a purple, red bruised area around the injection site that was the size of a grapefruit; entire bicep started Saturday evening after receiving the vaccination with itching at first and on Sunday morning it progressed to get worse.
Mom reports pt had a high pitched crying lasting >3hrs; Given APAP PRN & soaked in warm H20;
pt recv vax 10FEB98 & lt arm was sore & itchy & red x 2wk after;1wk later pt devel severe h/a (no vomiting) & pressure & strain in eyes;had to waer glasses (not dark) more than usual;
She was in her room all afternoon, lying in bed under thick blankets.  She came out saying "I feel really bad". She has hot and cold flashes, ache all over the body in the muscles and joints, serious headache, severe tiredness, debilitating pain and tiredness in the body, loss of apetite (ate only a little fruits since lunch), sensitivity to light and noise, heart rate was 92 at 8:30 PM, her temperature is 101 at 10 PM. I would like to take her to ER but she does not want to move.
High fever, Uncontrollable Chills, Nausea, Exaggerated muscle and joint pain, severe migraine and physical inability to walk or stand alone.
Customer said that her arm went numb several minutes after she had the vaccine.  She said that it lasted for 2 to 3 days.
My under arm and arm pit along with my breast have been sore. They ache on and off.; My under arm and arm pit along with my breast have been sore. They ache on and off.; It almost feels as if there is a lump in my arm pit or breast. Both on left side where I had the shot.; It almost feels as if there is a lump in my arm pit or breast. Both on left side where I had the shot.; Dose number:3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 17:30 (Lot number: RJ8762) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). Concomitant medications included unspecified VITAMINS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0168, Anatomical location: Left arm, Administration time: 16:30, Route of administration: Unspecified), administration date: 14May2021, when the patient was 39 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EW0217, Anatomical location: Left arm, Administration time: 17:30, Route of administration: Unspecified), administration date: 11Jun2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 at 17:30, outcome "unknown", described as "Dose number:3"; AXILLARY PAIN (non-serious), BREAST PAIN (non-serious), AXILLARY MASS (non-serious), BREAST MASS (non-serious) all with onset 24Dec2021 at 07:30, outcome "not recovered", and all described as "My under arm and arm pit along with my breast have been sore. They ache on and off". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, breast pain, axillary mass and breast mass.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported that it almost felt as if there was a lump in her armpit or breast. Both on left side where she had the shot. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19 and result was negative.
glucose numbers are a lot higher; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 26Mar2021, outcome "unknown", described as "glucose numbers are a lot higher". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very heavy nose bleed; Got another very heavy nose bleed; Very tired; Not feeling well; This is a spontaneous report from a contactable consumer or other non-health care professional (parent- mother). A 14-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration (at the age of 14-years), on 09Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration on 18Jun2021 as dose 1, single for COVID-19 immunization. On 12Jul2021, the patient experienced very heavy nose bleed, got another very heavy nose bleed. On Jul2021, experienced very tired and not feeling well. Reporter stated that I am calling about my son, he was 14 years old and he had his second vaccine this past Friday and two nights in a row, he has had very heavy nose bleed but he does not get these bloody noses ever but it started last night and then he just got another very heavy nose bleed. I just do not know if we need to watch for this or worry about this just because as I said he just had his second and he has never ever had nose bleeds. She stated that her 14 year old son received his second dose of the Pfizer COIVD-19 vaccine on 09July2021 and the past two nights has been having nose bleeds and is looking for any information on this, has this been reported, what to look for? She stated that her sons first and second doses were the same LOT number, EW0182, and they did not provide NDC/EXP for either dose on the vaccine card. She clarified that it was after he had the second dose, now he is having bloody noses and she would like to know if she should worry or is this normal and others have reported experiencing this. Is there a product complaint to report?-Yes, Description of complaint: This is a follow up report. Report Reference: Unknown, caller says this was not provided during the call she made yesterday. Pfizer COVID-19 vaccine: Caller says that her son's first and second doses were the same LOT number, EW0182, and they did not provide NDC/EXP for either dose on the vaccine card. Product strength and count size dispensed: not provided, second dose. Additional lot numbers: N/A. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided. Is there a medical information request?-Yes. Please describe the medical information request she would like to know if she should worry or is this normal and others have reported experiencing bloody noses after second dose of Pfizer COVID-19 vaccine?  Information on the lot/batch number has been requested.
Patient received double dose of hepatitis B instead of a hepatitis B and a Hib vaccine.  No subsequent adverse event noted.
This is a spontaneous case, initially received from other non-health professional on 16-Nov-2018, concerning a 02-year-old, child, female patient. The patient neither had any medical history nor concomitant medications. On 16-Nov-2018, the patient (age less than 4 years) was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left anterolateral aspect of thigh, dose: 0.5 ml, batch number: 252232 and expiry date: 31-May-2019]. At the time of report, no adverse event was reported. The reporter assessed this case as non-serious.
Patient is below the recommended age of 18. Patient didn't exhibit any visible side effects and upon consultation  was recommended to be given second dose of same medication when due
RAPID HEARTBEAT. LASTED FROM 7PM TO 6:45 AM NEXT DAY
Pt recvd vax on 1JUN92  & several minutes p/vax devel localized reaction consisting of warmth, tenderness & swelling;
Expired Twinrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 20-MAR-2023, the patient received Twinrix. On 20-MAR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix administered). 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: 21-APR-2023 The reporter called to report that an expired dose of Twinrix was accidentally given to a patient and wished to know how to proceed.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter called to report that an expired dose of Twinrix was accidentally given to a patient, which led to expired vaccine used.
Enlarged/Swollen Lymph nodes at left under arm (arm pit). Painful at times but not directly from swollen lymph node.  Treated with Tylenol and Motrin.  Pain reduced/gone at time of this report.