chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given beyond 30 days refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Bacterium allergy).   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) to be not related.    No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-353581 (Patient Link).
Patient started coughing, pulse ox read 93 at that time. Pulse ox immediately went up to 97 when she stopped coughing. Patient complained of tightness in chest stating  "Feels like hiatal hernia" and "nausea in throat" that was not present before vaccination.  Patient vitals as follows: BP 138/72, HR 86, 02 93 Patient evaluated by APN provider in house and patient refused ER evaluation and refused EKG by provider, APN.
Administered Pfizer booster vaccine after the 9/1/22 switch to the Pfizer Bivalent vaccine for the Boosters.  Unaware of any signs or symptoms of negative reaction occurred to patient.
Patient received an additional PPSV23 due to first PPSV23 not being documented in system four days previously.  Patient was called and he is feeling fine.   Patient advised to please call clinic, come into clinic, or go to nearest hospital if he starts to feel unwell.  Patient wasn't concerned about additional dose but understood he should seek immediate help if he started to feel unwell.
patient administered daptacel that expired on Jun 21, 2023 with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 2-year-old female patient administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] that expired on jun 21, 2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s)and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 03-Aug-2023, the patient received 0.5 ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: unknown) (lot: C5893AA, expiry date: 21-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On 03-Aug-2023 the patient had an event of patient administered daptacel that expired on jun 21, 2023 with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  it was unknown if any lab data/test results available.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  Outcome: unknown  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.
It started on day 8 and increased in size on day  9 with swelling around the injection site,  brusing, redness and warm to touch. I was seen by a physician that prescribed an ice pack, antihistimine and ibuprofen. It resolved in two days.
nausea; migraine; body aches; tiredness/feeling very tired; feeling stuffy; chills; wasn't feeling good; where he got the injection there's a ball on his arm right there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date 06May2021 (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: NAUSEA (non-serious) with onset 07May2021, outcome "unknown", described as "nausea"; MIGRAINE (non-serious) with onset 07May2021, outcome "unknown", described as "migraine"; PAIN (non-serious) with onset 07May2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 07May2021, outcome "unknown", described as "tiredness/feeling very tired"; NASAL CONGESTION (non-serious) with onset 07May2021, outcome "unknown", described as "feeling stuffy"; CHILLS (non-serious) with onset 07May2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset 07May2021, outcome "unknown", described as "wasn't feeling good"; VACCINATION SITE MASS (non-serious) with onset 07May2021, outcome "unknown", described as "where he got the injection there's a ball on his arm right there".  Additional information: When the patient woke up the day after he received the vaccine, he was feeling very tired, he had a migraine for two days, chills, body aches all over his body, nausea, and where he got the injection there's a ball on his arm right there.  The caller wasn't feeling good so he called out of work because he wouldn't be able to function properly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Positive maculopapular rash - forehead/face/upper back, both upper and lower extremity positive itching on rash started 5/12/2005 _ Benadryl PO and calamine lotion.
Pinkish red areas about the size of a nickel to a quarter that were very itchy going up my neck down to my chest within about a four inch area. The steroid cream the doctor gave me went helped them go away in about two weeks but now they are over my right and inside both elbows and every now and then will pop back up on my neck. I did also have long haul COVID-19 symptoms from getting COVID-19 in January 26th, 2021 but the vaccine was not available to me until March 2021. I may now have auto-immune disease and will begin testing.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No treatment medication was reported.
Fever, chills, headache, tiredness, arm pain, muscular soreness, loss of appetite, diarrhea
patient reported throat tightness.  vitals showed hypotension and tachycardia administered 0.3 Epi IM symptoms improved within 5 minutes.  Patient refused transport via EMS but did seek care at ER from which she was discharged without any lingering side effects.
This case experienced facial flushing  just after receiving the vaccination; "Felt funny"; BP values initially normal, ( 120-130/80-90) became elevated 200/100.
complained of pain in multiple joints especially left ankle knee and left shoulder that started about 4 hours after receiving 1st dose of pzizer vaccine
10-15 mins p/vax pt exp dizziness, chills, general bad feeling; Adrenalin adm & sx subsides;
upset stomach; developed rash inside elbow; broke out in hives on her right arm/hives looked like welts/hives was also under her feet; skin eruption started on the inside of her right elbow; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; difficult to walk; belched for 3 days; nauseated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.) and URTICARIA (hives looked like red, blistery, welts that itched.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Asthma.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, the patient experienced URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.), URTICARIA (hives looked like red, blistery, welts that itched.), PRURITUS (hives looked like red, blistery, welts that itched.), GAIT DISTURBANCE (difficult to walk) and RASH (developed rash inside elbow). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), ERUCTATION (belched for 3 days) and NAUSEA (nauseated). At the time of the report, URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.), URTICARIA (hives looked like red, blistery, welts that itched.), PRURITUS (hives looked like red, blistery, welts that itched.), GAIT DISTURBANCE (difficult to walk), ABDOMINAL DISCOMFORT (upset stomach), ERUCTATION (belched for 3 days) and RASH (developed rash inside elbow) outcome was unknown and NAUSEA (nauseated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. treatment medications includes Kenalog injection,oral antihistamine, prednisone.
expired Bexsero dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 12-AUG-2022 Reporter's Comments: The medical assistant called to inquire about how to proceed. The medical assistant reported that an expired Bexsero dose was administered to the patient. The medical assistant confirmed that the vaccine was administered in their facility. The reporter did not consent to follow up. Additional Supportive Information: Expired Bexsero dose was administered to the patient which led to expired vaccine used.
Experciening Body Jerks, Fatigue, heahaches and chills. Sensativity at injection site in both left and right arm. Nausea < 15 minutes after injection - 1 hour later shaking & persistent jerks - Numbness both hands about 1 hour - EXTRAPARAMIDAL symptoms (EPS)
Case number PHEH2013US018597, is an initial spontaneous report received from a medical assistant on 29 AUG 2013 with the follow up received on 28 AUG 2013. This case refers to a 10 years old male patient. He was vaccinated with expired MENVEO, batch number: A10133 and expiry date: FEB 2013, intramuscularly on 28 MAR 2013. No adverse reaction was reported following this administration error.
Non-serious case received from a healthcare professional on 18 September 2009. A 56-year-old female patient developed a two-inch red, raised "hive" at the injection site (two inches above the left elbow), one hour after receiving a left arm injection of FLUZONE (lot number U3191AA, route of administration unknown). The "hive" was hot and itchy. Patient outcome was unknown. Follow-up was received from a healthcare professional on 13 October 2009. The reporter indicated, "Swelling of the lower arm and redden - no distinct hive border." No additional details were provided. Follow-up was received from a healthcare professional on 08 January 2010. The healthcare professional reported no additional information at this time. Documents held by sender: None.
A physician reported via a sales representative that an 18 month old child received a 4th dose of Prevnar. In 12/01, the child experienced a seizure. The pt was seen in an ER where a blood culture showed Streptococcus pneumonia, serotype unknown. The child was hospitalized and recovered. No further information was available at the date of this report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 13:00 as dose 1, single (Batch/Lot number: Unknown), in left arm, on 23Apr2021 at 13:00 as dose 2, single (Batch/Lot number: Unknown), in left arm and on 22Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: Unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient relevant medical history included: "Thalassemia Beta" (unspecified if ongoing), "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Adverse event: she got sick with Covid symptoms worse 4 days after taking Paxlovid. No Received other medication in 2 weeks. Patient received COVID-19 Treatment as Paxlovid, treatment start date: 08Jul2022 and treatment stop date: 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Seizures starting 1/25/21, transverse myelitis diagnosed 3/1/21 with symptoms of transverse myelitis starting 2/5/21.  Now with diagnosis of multiple sclerosis but with atypical initial presentation
Extreme pain in the left shoulder and arm.  Became aware on the morning after getting the shot. The shoulder was throbbing and took Advil to reused the pain.
Chest tightness developed on day 3, intensity varies but is present constantly and has increased this morning (02/22/2021). Unusual sensation on tongue. These are the same symptoms I had when experiencing an allergic reaction to Repatha in Oct/Nov 2020. Those symptoms subsided after a month.
Fever, Chills, headache >36 hours, neck pain, bone/joint pain, back pain, nausea, lack of appetite.
pt broke out w/a moderate cases of chicken pox @ 1yr p/vax given;febrile x 2 days less than 50 pox;
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 07-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
did something to her heart, and if they got the second one she would die; allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (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: CARDIAC DISORDER (medically significant), outcome "unknown", described as "did something to her heart, and if they got the second one she would die"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". The lot number for bnt162b2 was not provided and will be requested during follow up.
sweaty, fast beating heart rates, swollen and yellow tongue, itchy, tight and scratchy throat, itchy all over body, severe tireness, chills, hot, stomach pain, difficult breathing.
I went to the hospital. I could not walk, joint pain, leg cramps, fever 101.0, fatigue, photophobia, headaches, loss of appetite, chest tightness. I had al symtoms for 7 days
Rash all over the body; Extreme headache; Extreme weakness; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), 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. Historical vaccine included first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced rash all over the body, extreme headache and extreme weakness on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT DEVELOPED PROGRESSIVE STRABISMUS DUE TO BILATERAL 6TH NERVE PALSIES, ABOUT 1 MONTH AFTER THE VACCINES.  UNCLEAR IF RELATED TO THE VACCINE, BUT THERE HAVE BEEN REPORTS OF 6TH NERVE PALSY FOLLOWING OTHER VACCINES SUCH AS MMR AND VARICELLA. MOM RECEIVED PFIZER COVID VACCINES DURING PREGNANCY- ON 5/9/21 AND 5/30/21
Received call from mother about three hours after vaccine that pt. c/o numbness, pain, and tingling down arm that received GARDASIL in. States also had rash that looked like hives from top of arm to elbow. Gave BENADRYL and used ice on site. States numbness and tingling subsided about 8 hours after vaccine. Still w/ arm pain the next day.
PATIENT STATED EXTREME PAIN IN ARM WITH SWELLING AND TINGLING DOWN ARM AND IN HAND.  SAYS ARM HURTS WHEN IT HANGS BUT FEELS BETTER WHEN STABLIZED.  CAME INTO PHARMACY 2 DAYS AFTER VACCINATION AND STATED STILL HURTS BUT NOT AS BAD AS FIRST DAY.  SAID ALL HE TOOK WAS 2 BC POWDERS FOR PAIN.
This spontaneous report was received from a pharmacist via company representative referring to a patient over 60 years of age. The patient's concurrent condition, medical history and concomitant therapy were unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On an unknown date the patient experienced allergy to peanut. The patient did not have a peanut allergy prior to receiving ZOSTAVAX. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Headache, Myalgia, Arthralgia, INJECTION SITE PAIN Narrative: