chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022; No adverse event; Received doses after its beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022).    Concomitant medication was not reported.  Reporter reported that the vial was individual vial and size was 2.5 ml. The vial was initially stored in refrigerator on 11-Oct-2022. The vial did not undergo any temperature excursion.  Treatment information was not reported.  This case contains information for the 7th patient out of 8 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-680810, US-MODERNATX, INC.-MOD-2022-680811, US-MODERNATX, INC.-MOD-2022-680808 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680810:Samer Reporter US-MODERNATX, INC.-MOD-2022-680808:Samer Reporter US-MODERNATX, INC.-MOD-2022-680811:Samer Reporter
Mild dementia; Tired and exhausted for a long while; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Mild dementia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypercholesteremia, Pain and BPH. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and OXYBUTYNIN for BPH, PARACETAMOL (TYLENOL) and IBUPROFEN for Pain.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (Mild dementia) (seriousness criterion medically significant) and FATIGUE (Tired and exhausted for a long while). At the time of the report, DEMENTIA (Mild dementia) and FATIGUE (Tired and exhausted for a long while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included 11-12 unspecified medications. Treatment information was not mentioned by the reporter.  The patient reportedly might have used lozenges after vaccination  The patient went to his neurologist for mild dementia. On an unknown date, neurologist ran a battery of tests such as heart scans and blood tests to check for things such as Lyme disease and HIV. The results from his local physician showed it was positive for HIV and his second test showed HIV antibodies but no HIV in his blood.  Very limited information regarding these events have been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-262688 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
Info has been received from a physician concerning a 31 month old male with Down's Syndrome, who on 2/20/04 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. On 3/28/05, the pt developed a breakthrough case of varicella. The pt came to the office with approximately 50 lesions and most of the lesions were on his face. There were some vesicular lesions on his abdomen. The physician prescribed an antibiotic because the pt also had a runny nose and ear infection. No antiviral medication was given. There was no product quality complaint involved. Additional info has been requested.
Client presented for first dose Pfizer which was administered without issue.  On registration form the birthdate is  making the client 16 years old.  Nurse verified by initialing age on Registration form per normal work flow.  Data entry showed that client's birthdate is different.  Was unable to contact client but mother confirmed that client's birthdate. She did not know how birthdate would have been changed. Paper registration form shows indication that birthdate was altered  for the month and the birthdate was falsified.
Information has been received from a registered nurse concerning a female patient who on 01-DEC-2004 was vaccinated with a dose if pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced an injection site reaction. The patient's outcome was unknown.  Additional has been requested.
I had the first dose on 6/18/2021 and I had a rash on my arm the day after, I was feeling feverish and flu like symptoms, and on the day I did received it too. I had to take my blood sugar and it dropped really low so they were keeping an eye on me and my husband got me things to bring my sugar levels back up. They gave me Tylenol. I basically slept the whole evening. On 6/21/2021 I went to the physical therapy and they checked me over and I talked to them about me taking my pain meds and that's when they started me on my muscle relaxer.
Patient received vaccine on 3 November 2014, reported to medical facility on 19 Nov 2014 with left shoulder pain when lifting arm over head X two weeks. Physician states left shoulder impingement.
shoulder pain; decrease range of motion on shoulder; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the right arm on 13Jan2021 at 10:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease. The patient previously took  nitrofurantoin (MACROBID) for an unknown indication on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the left arm on 23Dec2020 at 20:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medicines within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jan2021, the patient experienced shoulder pain and decrease range of motion on shoulder which was persisting 6 months after getting COVID-19 vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events of shoulder pain and decrease range of motion on shoulder was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
I had right sided chest pain that was non radiating. It was localized pain between the sternum and the right breast that would last for 5-10 seconds. It was irregular as far as when the pain would return.
Patient received Zostavax on 4/15/08, subcutaneously developed a "light rash extending all around abdomen" that was "Not painful, but a little itchy." Patient then called Dr and the nurse (No name given) said it was "nothing to be concerned about."
has a  4 inch by 2 inch rash on vaccine arm that is hot to the touch
Vaccine given on  Wednesday, March 17 at 1:20 pm and first sign was at 6:30 pm with low grade fever and arm pain that went to my shoulder/neck area.  As the night progressed I had body aches all over my body, night sweats, nausea, and diarrhea. At 6:00 am I took Tylenol and felt much better by 8:00 am.  Arm pain was the same all day.  I rested all day and the second night continued to have night sweats.  By Friday morning March 19 , all symptoms subsided and feel much better. There is still slight diarrhea when I eat but not terribly bad. I feel I am on the mend.
Received injection on 1/12/21. On Sat 1/16/21,  woke up with hives  that got progressively worse throughout end of the day.  Sought treatment at Emergency Room and was treated with cortisone and Benadryl.
pt was inconsolable for >3hr p/vax given; p/48 hr pt was back to nl routine;
Patient was administered a flu dose for a child age 3 years and up (0.5mL) instead of a dose appropriate for her age (0.25mL).
HIVES AND ITCHING ON FACE, NECK , HEAD AND BODY, WORSE THAN ON WITH THE DOSE ON 1/15/2021. LASTED  MORE THAN A WEEK, HIVES WOULD COME AND GO WITH TREATMENT OF BENADRYL, BOTH ORAL AND TOPICAL, AS WELL AS ZANTAC. IN ADDITION, VERY PAINFUL, SWOLLEN  AND RED ARM AT INJECTION SITE, VERY PAINFUL TO LAY ON OR EVEN TOUCH, DIFFICULT TO LIFT ARM.
pt recv vax 19OCT95 & 10MAR97 2wk p/exposure to varicella, pt devel 15 to 20 vesicles which were verified by MD as breakthrough chickenpox;
Initial misuse report received from a healthcare professional on 12 December 2013. The patient had received unstable ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Information has been received from a nurse referring to a 9 months old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 08-MAR-2019 the patient was vaccinated with one dose of GARDASIL 9 (lot# R017251, expiration date: 04-MAY-2021, frequency unknown) intramuscularly for prophylaxis (Inappropriate age at vaccine administration). No adverse events reported.
Very swollen and painful lymph nodes in armpit, chest, neck, and breasts; severe pain at injection site that spread to entire left arm, hand and fingers; sporadic full body muscle aches and pains; burning and itchy feet; sudden onset sweating and sporadic fever; fatigue;
tired; flu like symptoms; lightheaded; rapid heart beat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose1, via an unspecified route of administration on 28Jan2021 (Batch/Lot number not reported) as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced feeling flu like symptoms, lightheaded, tired and a rapid heartbeat. The clinical outcomes of the events were unknown  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
SkinRash, Malaise Narrative: Had moderate rash develop a few days after injection. Told to contact PCP.
Hives started on face yesterday 10/18/18; Spread to rest of body on 10/19/18.
Contacted patient 2/10 around 1812, patient informed of error and states no adverse reactions to immunization from time of administration to time of contact. Patient has no concerns for any treatment in regards to immunization error.
Did well till one week later and arm developed fever, swelling and allergic red reaction around injection site and whole arm sore and hard, tender to touch severe itching.
No noted adverses events. Patient received his second  booster 26 days early. Pharmacy provided education to staff to prevent error happening again.
Lightheaded, weak, BP decreased to 80/50, pulse faint. Had to be treated in ER with IV fluids x 4 hrs, had headache all night, recovered completely by next day.
Blood in semen upon Ejaculation 3 separate times: Beginning of December, Beginning of January, End of January. Don't know if necessarily correlated, but never had issue before. Upon meeting with Urologist and internist, both said nothing abnormal in tests.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 03-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 828 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came in with red circular area around injection site. Patient says it felt warm. I called the patients Dr. to report with them.
pt recv vax 17MAR97 & that same day it was reported that pt exp fever, diarrhea, dizziness & myalgia;
APPROXIMATELY 8 HOURS AFTER VACCINES WERE GIVEN DEVELOPED LETHARGY, MALAISE, FEVER (102 DEGREES), NAUSEA/VOMITING X 3.  THE LEFT UPPER ARM BECAME SWOLLEN AND RED.  THE SKIN WAS TIGHT.  IT WAS WARM AND TENDER.  WAS SEEN BY DR ON 3/24/07 WITH THE FOLLOWING FINDINGS.  THE ERYTHEMA/SWELLING WAS 12 CM ACROSS THE LEFT SHOULDER, 12 CM FROM SHOULDER TO MIDDLE AREA OF CHEST, AND 13 CM FROMT HE TOPOF THE ARM TO THE BOTTOM OF THE SWELLING.  WAS GIVEN ZYRTEC AND ORAPRED.  WAS SEEN BY DR ON 3/26/07 WITH SOME IMPROVEMENT.  THE LEFT UPPER ARM WAS SLIGHTLY SWOLLEN WITH ERYTHEMA. NOT OBVIOUSLY TENDER. NO BRUISING. NORMAL PAINLESS RANGE OF MOTION IN THE SHOULDER AND ELBOW.
Patient reports she developed a rash around the right axillary area of her body approximately 2 hours after receiving the 2009 H1N1 vaccine IM in her right deltoid muscle. She reports the rash continued to spread until it covered her entire body. She denied having any respiratory symptoms. She went to a local emergency room where the ER doctor told her she had an "allergic reaction" to the 2009 H1N1 vaccine and she was given a "steroid injection" and a presccription for oral medrol. Patient has received the seasonal influenza vaccine in the past without any allergic response. Her rash was not present by the time she reported the incident and she did not fill the prescription for the oral medrol as prescribed.
Shakes / chills, sore neck at around 7:45PM shot given around 1:40 PM.
Itches; Redness; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), ERYTHEMA (Redness) and PAIN (Aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (Itches), ERYTHEMA (Redness) and PAIN (Aches). At the time of the report, PRURITUS (Itches), ERYTHEMA (Redness) and PAIN (Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Paralysis left side of face, lower lip with edema and loss of sensation starting 4 days post vaccination. Treatment will be 5 day course of prednisone 50 mg daily and OTC Benadryl  for anti histamine .
Arrived to ED after fall and loss of consciousness at home. Right sided PE and pna found, all of this 2/2 COVID which was dx after admit. Rocephin/azithro, steroids, O2, zinc, heparin gtt. Deteriorated rapidly 1/21 and suffered cardiac arrest. Pt expired likely 2/2 massive PE and GIB resulting from COVID infection.
Patient received Moderna 3/17/21. She returned for her second dose, but was not in the pharmacy scheduler. Based on the pharmacy's history of giving Pfizer only the past several weeks, the technician assumed the patient received Pfizer as her first dose (she did not have her vaccination card with her). Pfizer was administered to the patient 4/14/21. No adverse reactions reported as yet.
sick for 2 weeks; Initial information was received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who stated sick for 2 weeks after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event sick for 2 weeks (illness) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 10-SEP-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 29-SEP-2016, the patient was treated at a medical university (did not specified whether admitted therefore considered an Emergency Room (ER) visit until follow-up is received) for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Onset of new atrial fibrillation per patient on 3.15.22; patient following cardiology  presently, records have not been reviewed.
Patient had 104 fever, no rash and slight congestion. Patient's fever down to 100.5 on 12/12/02.
About  8 minutes after injection, patient comes to consultation window to ask question unrelated to vaccine. Upon walking away, he gets light-headed and starts to fall.  He half catches himself on immunization booth nearby. He sits in chair in booth. I check on him. He says he is ok. He is a little pale and sweating a little. A few minutes later he says he is fine and wants to leave. he agrees to stay longer. A little later after other store team members have checked on him, I check on him again. He says he is fine and then leaves.
Syncopal episode with loss of consciousness in the parking lot.  Mother states child fell from car & hit head on asphalt.  Complained of head pain, dizziness, numbness/tingling in both arms & knees.
I had a fever was achy and it lasted for about 2 days. The first day I had some coughing. After that I was extremely tired. The doctor gave me PAXLOVID for 5 days. I then tested the first day after the medication and it was negative. Two days after when I tested it was slightly positive. This morning 9/15 when I tested it was negative.
fever, aches, red swollen lt arm-approx 6cm area, h/a;
MEDICAL ASSISTANT GAVE THE WRONG VACCINES TO PATIENT. VACCINES WERE ORDERED FOR ANOTHER PT WITH SAME FIRST NAME. NO KNOWN ADVERSE EVENTS JUST REPORTING VACCINES ADMIN ERROR.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Sep2022 at 13:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 , in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT WAS GIVEN INCORRECT DOSE. GIVEN 0.5ML SHOULD HAVE HAD 0.3ML