chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 15-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 02/08/2021 and 03/09/2021. They tested positive for COVID-19 on 09/21/2021.  They presented to Emergency Department on 09/25/2021 with primary complaints of shortness of breath and cough. The individual was found to have oxygen saturation in the low 70's and down into the 60s. They were admitted to hospital 09/25/2021. They experienced complications of acute hypoxic respiratory failure, acute kidney injury, and hyperkalemia. Their condition deteriorated and they were transitioned to comfort cares. They remained hospitalized until their death on 10/16/2021.
Vaccine exposed to temperature outside or recommended storage range. Unknown viability/potency [per manufacturer.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 1:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:26 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.95 for dose administered on 03-MAR-2021 and 74.02 for dose administered on 31-MAR-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion 03-MAR-2021 with temperature 51 degrees Fahrenheit at 09:00 AM, 34 degrees Fahrenheit at 10.00 AM and 35 degrees Fahrenheit at 1.00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-MAR-2021. Batch number 030B21A underwent temperature excursion on 31-MAR-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-MAR-2022 and beyond use date for the vial was reported as 29-APR -2021. Product moved to clinic on 31-MAR-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
First Dose  7 days later rash in the site of injection (treated with a shot of dexamethasone). Second dose 8 hours after the second dose the rash appears (red, itchy), also fever and muscular pain.
Reports "brain pain", fever, chest pain and arm numbness following the vaccine. Reports today, 6-4-2014 joint pain in entire body, and numerous dr appts over the past 2 years, client did receive all 3 doses of HPV.
No known adverse effects; A patient received a dose of VAQTA on 09-DEC-2014 and on 18-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 09-DEC-2014, the patient was vaccinated with a dose of  hepatitis a vaccine, inactivated(VAQTA), intramuscular (strength, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 18-APR-2019, the patient received another dose of hepatitis a vaccine, inactivated (VAQTA), intramuscular (strength, anatomical location, lot # and expiration date were not provided). There were not known adverse effects.
Approximately 25 minutes after vaccination patient reports lightheadedness x4-5 hours. Expierienced 1 episode approximately 10 days letter.
One week after injection, swelling, large red area and itching at injection site. Ongoing. Treating with topical hydrocortisone. Manageable and not a concern.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX  VIAL 19400 PFU, 0.65 ml, subcutaneous for prophylaxis. On an unknown date, the patient developed a cold sore 10 to 14 days after receiving ZOSTAVAX. VALTREX was given as treatment. The outcome of cold sore was reported as recovering/resolving. The pharmacist could not specify whether the patient had ever had a cold sore previously. Additional information has been requested.
Post vax the patient experienced swelling, redness and pain. The patient was treated with Cephalexin.
Initial literature report received on 11 October 2014. A 7-month-old male patient, whose concomitant medications were not reported, had received a dose of BCG (in left deltoid, batch number and route of administration were not reported) and a dose of OPV (batch number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. The patient has a medical history of SCIDS (severe combined immunodeficiency). It was reported that, after vaccination, the patient was brought to hospital emergency department in July 2013; he had a 6-week history of intermittent fever associated with draining skin lesion over the left deltoid at the site of BCG vaccination. The patient was diagnosed with acute lymphadenitis and prescribed trimethoprim and sulfamethoxazole and sent home. The patient was again brought to the emergency department with increased irritability and decreased movement of the left leg and was admitted to the hospital for the further evaluation. The patient appeared tired and anxious but was responsive to touch. The physical examination was negative for meningococcal signs, no evidence of respiratory distress was found. A firm, mobile, tender, 2x2 cm mass was palpated under the left axilla. The patient did not move his left leg spontaneously or in response to pain. Deep tendon reflexes were absent in the left leg and diminished in the right. Decreased anal sphincter tone was noted. The rest of the physical examination was found to be normal. The patient was diagnosed with VAPP (vaccine-associated paralytic poliomyelitis) after laboratory investigations. Laboratory investigations: Complete blood count- ALC-216 cells/mm3, lymphocytes subsets- CD3 6 cells/mm3, CD4 2, CD8 0, CD 19 1, CD16/56 189, HIV 1/2 was negative, Immunoglobulins- IgA and IgM undetectable, IgG 140 mg/dl. Cerebrospinal fluid test: White blood cell 83 cell/mm3, Polymorph nuclear neutrophils 50%, mononuclear cells 2%, protein 48 mg/dl, glucose 49 mg/dl. Imaging: Chest radiograph was normal, Brain and Spine MRI showed 8 mm lesion in right cerebral peduncle, prominent abnormal T2 weighted signal at cord T11 level on the left: additional abnormal signal and contrast enhancement of several nerve roots. Chest, abdomen and pelvis CT scan showed enlarged lymph nodes, left supraclavicular, and left axilla, retroperitoneal. Microbiology: Blood test showed no bacterial growth at 48 hours, later positive for AFB identified as mycobacterium bovis/BCG. Cerebrospinal fluid showed negative bacterial meningitis screen and gram stain, negative fungal smear and culture, negative PCR for HSV-1, HSV-2 and CMV. Stool analysis- enterovirus isolated, identified as immunodeficiency associated vaccine derived poliovirus type, Lymph node fine needle aspiration showed AFB stain positive. On an unspecified date, the child progressed to respiratory distress during further observation. It was reported that after consultation with multiple specialist physicians and with ethics committee review, the family chose to withdraw support and the child died shortly thereafter. Documents held by sender: None.
Pt received first dose of Moderna on 3/22/2021.  Pt began to not feel well on 4/16/2021, tired, off balance, foggy.  Rash on left side with numbness, painful starting on 4/19.  Tested positive for shingles 4/19/2021.
16 days later still have significant pain with any range of motion. Wakes me at night. Limits my activities of daily living. Also have point tenderness.
Patient came in for an updated Moderna Bivalent Booster. Upon check in, pharmacy tech on duty collected ID, insurance info and proof of vaccination records. Patient stated he has never had an updated bivalent booster prior to today's appointment (February 7, 2023) Patient was given 0.5ml of Moderna Bivalent Booster by the Pharmacist on Duty. Pt had no reaction after administration. Pt was advised to stay inside the waiting room for a few minutes prior to leaving the pharmacy. Upon billing the Moderna Bivalent Booster, patient's profile showed a shot that was administered from another store last September 2022. Pharmacist on Duty spoke to the patient to confirm if he was aware he already received it last year, but patient claims his record doesn't show that it was an updated bivalent booster. Patient believed it was just a regular booster. Patient understands that he received another dose of a Moderna Bivalent Booster from today's appointment and no protocol has been set yet by the agency or any health department regarding a second updated booster dose.
A hard lump developed in the arm and bruising developed. The lump has remained for 16 days to date. It becomes inflamed and itchy regularly.
pt recv vax & devel inj site swelling which extended to the elbow;tx w/Keflex for 5 days & recovered;MD stated that this event may have been caused by an insect bite;
pt recv vax 15FEB96 & 28FEB97 pt devel viral pneumonia;16JUN97 pt exp varicella type rash & fever of 103;
My arm starting hurting severly as soon as nurse injected medicine in my arm.  Pain was very bad.  Arm at injection site was hot to touch, and blotchy hives around the site.
pt recv vax 2JUN98 & arm was now red & warm to touch, not painful states hard no streaking;states arm was not red p/Td given until now;pvt MD states pt had infect given ATB;still had a hard knot @ inj site;
Unable to sleep after midnight night of shot.  Soreness, swelling in arm.  Stomach upset, nasuea necessitating going to bed. Continued throughout day until I went to bed at 7:00 pm.  Felt alright the next day, 11/17/2021.
Pt reported reaction to immunization on 4/18/2016, after immunization was given 12/8/2015. Reaction was observed by pt's wife, who is an RN. Hardness and swelling.
Expired drug administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired drug administration) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired drug administration). On 08-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Expired drug administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient demographics and dose details were updated.
Woke up with severe soreness in left upper arm, redness and swelling in area of vaccination that involved about a golf ball sized area of the arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: few days later he felt a rebound of covid symptoms and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient presented to COVID-19 vaccine clinic for his second dose. Clinic was providing Moderna vaccines. Pt believed that his first dose of COVID-19 vaccine was Moderna. Staff in clinic did not confirm this in the EHR before administering the vaccine. It was determined after the vaccine was administered that the first dose was in fact f Pfizer. Vaccine was well tolerated by the patient.
3 hrs after injection/immunization became fussy. Temp 98.9. Began having "seizure". Shaking of arms and legs rhythmically for 5-10 min. Seemed alert and responsive. After laid quietly in mom's arms but did not sleep. TYLENOL given just prior.
Site of injection became erythematous, edematous, tender and warm to the touch. Area = 8 1/2 cm by 6 cm on right deltoid.
I63.511 - Acute ischemic right MCA stroke  R53.1 - Left-sided weakness G51.0 - Facial paralysis on left side I63.9 - Stroke determined by clinical assessment  I63.411 - Cerebral infarction due to embolism of right middle cerebral artery
Pt with syncope about 3 minutes after her injection. Pt placed in recumbent position, returned to full consciousness after about 20-30 seconds. Vitals monitored x 20 mins, offered cool water and ice packs, pt discharged after observation period feeling well.
Varivax given 10/10/2000 then pt seen 11/15/2001 with shingles on right buttock.
3days p/vax pt exp erythematous, tender area surrounded by some bruising.
stroke; A spontaneous report was received from a consumer concerning a male patient who experienced a stroke/cerebrovascular accident.  The patient's medical history was not provided. Concomitant medications were not provided.   On an unspecified date, the patient received one of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient reported that he had a stroke.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.   The outcome of the event, stroke, was not reported/unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No further information is expected
The vaccine was expired on 01-Apr-2022, but stored in the refrigerator on 04-Apr-2022; Expired vaccine administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (The vaccine was expired on 01-Apr-2022, but stored in the refrigerator on 04-Apr-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 01-Apr-2022, but stored in the refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (The vaccine was expired on 01-Apr-2022, but stored in the refrigerator on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that when the Pharmacy received the vaccine on 23-Feb-2022, a pharmacy staff member looked up the expiration date and came up with an expiration date of June 2022. However, another pharmacy staff member looked up the expiration date of the Moderna COVID-19 vaccine in question and the expiration date was came up as 01-Apr-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
10-06-22 At about 11:00 am staff nurse #1 checked child in for Pfizer Covid series, second dose. Administered vaccine to right thigh. Nothing unusual occured. Monitored child for 15 minutes prior to them leaving the clinic. Later, about 3:30pm staff nurse #2 attempted to administer a dose of Baby Pfizer to another child, at that time it was found that the doses remaining in the vial did not appear to be correct, which meant incorrect dilution of the vaccine.   Chain of command of Health Dept was notified. Instructed to notify Pfizer, Dept of Health, VAERS and mother of child. Supervisor left message x 2 on mother's voicemail to call Health Dept and after hours number was given for her to call. Mother of the child notified later when she returned call to supervior approx 7:30pm. Mother stated she noticed child to be a little "more crabby", no temp noticed, child walking around per usual. Supervisor instructed mother if she noticed any unusual local or systemic effects to take child to ER.  10-07-22 Supervisor spoke to mother @ approx 320pm. Child remains asymptomatic per mother. She was concerned about long term side effects of too much vaccine, She wanted to speak to her pedicatrician prior to making any decisions. She was at that time waiting for a return call from her pediatrician. 10-11-22 Supervisor called to check on child at approx 2pm, left message for mother due to no answer.  10-12-22 Mother returned call to supervisor at about 10:30 am, states child is doing fine. Mother spoke to pediatrician, she advised mother to proceed with 3rd dose of vaccine when due. 10-27-22 Nursing supervisor spoke to mother of child, she states child is still doing fine. Copy of VAERS form sent to mother.
Redness, itching very bad and small bumps, hardness, swollen. Got the flu shot on a Monday. Started on Wednesday till Sunday. 5 days.
Patient complained of headache, nausea and difficulty expressing self with periods of confusion. vital sighs obtained and stable. patient continues to be monitored for any worsening symptoms. patients skin color pale. patient administered tylenol that he brought with him, with water and orange juice. patient stated that symptoms have subsided and less headache comparing to initial incident.
Upset stomach; Dizziness; Weakness; Nauseous; Vomited; Vomitive; Fevers; Labored breathing; Cramps in her calfs; Upset stomach; body aches; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Labored breathing) and MUSCLE SPASMS (Cramps in her calfs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. X51621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced DYSPNOEA (Labored breathing), MUSCLE SPASMS (Cramps in her calfs), the first episode of ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (body aches), VACCINATION SITE PAIN (Sore right injection site arm), VOMITING (Vomitive) and PYREXIA (Fevers). On 29-Jun-2021, the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced the second episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nauseous). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at a dose of 1 dosage form every four hours. On 29-Jun-2021, DYSPNOEA (Labored breathing), MUSCLE SPASMS (Cramps in her calfs), MYALGIA (body aches), VOMITING (Vomited) and VOMITING (Vomitive) had resolved. On 30-Jun-2021, VACCINATION SITE PAIN (Sore right injection site arm) had resolved. At the time of the report, last episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nauseous) outcome was unknown and PYREXIA (Fevers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  First dose  Lot number X51621A. The reporter was unsure about the X, said it looks like a 0 with a slash. And also was not sure if the 6 was a number or a parenthesis.   This case was linked to MOD-2021-268636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information included new events (vomitive, labored breathing, cramps in her calfs, body aches and upset stomach). On 08-Sep-2021: Follow Up received on 08-sep-2021 contain non significant information