chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported.; Medical assistant reported that an expired PROQUAD was administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status: rHA (recombinant Human albumin) 1 dose, lot #u006312, expiration date: 24-AUG-2022 for prophylaxis (dose, route of administration and anatomical location were not provided) with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (expired product administered). No additional adverse events were reported.
Diarrhea, NauseaVomiting, chills, injection site pain, fatigue Narrative:
Patient had sharp chest pain while running long distance after vaccine more than once. During his doctor?s exam they noticed something with his breathing that led to an EKG, which came back abnormal. They ran additional X-rays and lab work to confirm he needed to be referred to a cardiologist. Patient has past health issues and has never had Covid. He is extremely healthy and doesn?t take any medications. His weight is healthy. He is physically fit and exercises on a regular basis. Doctor suspects pericarditis related to vaccine.
can get the shot and still get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and still got the shingles, living proof, lessens the effects. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation but will not be revaccinating at this time.
It appears that this patient might of received a 2nd booster dose only 10 days after their 1st booster dose.
Blanchable erythema, itching & discomfort 3cm x 6cm of left upper arm beginning 6 to 7 hours after pneumococcal vaccination.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 11-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Narrative:  53 y/o pt presenting to the COVID-19 vaccination clinic on 5/20/21 for the first dose of the Pfizer COVID-19 vaccine. After vaccine administration, pt endorsed itching and shortness of breath. Pt became hypotensive to 89/65 and EMS staff administered 0.3mL of epinephrine due to concern for anaphylaxis. Pt was transferred to the ED with BP improved to 108/72 and mild neck swelling on physical exam. Tongue appeared normal without narrowing or airway edema. Pt was given IV benadryl 50mg IV x 1, Famotidine 20mg IV x 1, Methylprednisolone 125mg IV x 1 and discharged home w/ an epi-pen.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  On 26-Oct-2021 the vaccine placed in refrigerator. There was no temperature excursion and the patient did not experience any adverse event.
RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/16/2021 CKD STAGE 4 (GFR 15-29)  HYPOXIA 12/27/2021 CKD STAGE 4 (GFR 15-29)  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 12/16/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  HYPOXIA 12/27/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Large lymph node swelling under armpit day after vaccine booster - still present.  4 days after Covid booster severe cold symptoms.
improperly stored; NO ADDTIOANL AE; This spontaneous report was received from a healthcare business professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.    On 05-OCT-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were unknown) for prophylaxis (product storage error). Caller was unable to clarify the varicella virus vaccine live (oka/merck) (VARIVAX) the Lot# and expiration date was U020244, 28-JUN-2023 or U010395, 01-APR-2023.      Temperature excursion of this vaccine was 1.45 degrees Celsius for 6 hours. Previous temperature excursion was reported as from minus 10 degrees Celsius to 8 degrees Celsius (0.91 degrees Celsius) for 6 hours on 04-OCT-2021. No additional adverse event was reported.  Additional Excursions had occurred after patient was administered the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX): 08-OCT-2021: minus 50 degrees Celsius to minus 15 degrees Celsius (minus 14.6 degrees Celsius) for 15 Hours. On 13-10-2021: minus 10 degrees Celsius to 8 degrees Celsius (0.54 degrees Celsius) for 13 Hours.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2111USA004036: US-009507513-2111USA003726: US-009507513-2111USA003910: US-009507513-2111USA004109:
Rash- truncal- fine sandpaper textured.  Now on day #8 after vaccine administration and not resolved.  Prickly feeling and some pruritis.
she got "sick."; her body did NOT build up the titers.; This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, several months after receiving Hepatitis B vaccine, the patient experienced sickness and therapy non-responder. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the sickness to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination not reported. The patient report to herself  that many years ago she had  hepatitis B shot series.  She thought it was a 3 or a 4 shot series.  After Several months she got sick.  Her doctor checked her for titer but she stated, her body did not built up the titer. This case is one of 3 cases, reported by the same patient. GSK Note- since the patient was not sure, if she had 3 doses or 4 doses of Hepatitis B, only one Hepatitis B is coded without any dose number.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116458:Same reporter
Post vax, the patient complained of a sick feeling, very tired, loss of appetite, leg cramps and facial flush. These symptoms lasted 7 days.
Pt was to receive booster dose of 0.25ml instead, received full dose 0.50 ml Pt reports same symptoms as with previous two doses in series: fatigue, brain fog, nausea x's 3-4 days after vaccine, now recovered.
This spontaneous report as received from an office manager refers to three patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 16-AUG-2016 the patient's were inadvertently administered an expired dose of GARDASIL (dose details were not reported) (lot # J013324, expiry date 12-FEB-2016) (expired vaccine administered). The patients were each intended to receive GARDASIL 9,however the expired doses of GARDASIL were mistakenly administered instead. No adverse effect reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
On 10/7 had a few hives, by 10/8 went to ER covered with hives and itching, was treated with 60mg oral Prednisone, and oral Pepcid Was told to take 40 mg of Prednisone for the next 3 days alone with OTC Benadryl and Pepcid. No relief, the welts are large and itching. Some on my face around the eyes, both arms, back, chest, buttocks and thighs, back of head, ears.  Doing oatmeal soaks, hydrocortisone cream, gold bond powder, ice with no relief
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 17 year old male patient who developed slight redness at the injection site. The patient had received an unintentional dose of Prevnar that was administered subcutaneously. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 6/8/2005. Dose regimen was 1 dose subcutaneous. Concomitant therapy included unspecified product. A physician reported that on 6/8/2005 he gave a patient a dose of Prevnar, he intended to administer a dose of TB (drug dispensing error). The Prevnar was given subcutaneously (incorrect route of drug administration) (medication error). The patient developed slight redness at the injection site (injection site erythema). No additional adverse events were noted.
rash at the injection site; A spontaneous case report was received from  a consumer concerning himself  who experienced rash at the injection site.      The patient's past medical history included no adverse event.     The patient received first  of two planned doses of mRNA-1273 (Moderna COVID-19 Vaccine) intramuscularly on 1 Feb 2021 for the prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced rash at the injection site.  At the time of the report, the outcome of the event rash at the injection site had not resolved.     No treatment information was provided.   The action taken with mRNA-1273 in response to the event was unknown.
Initial unsolicited report received from a non-healthcare professional (Office staff) on 17-Jul-2017. This case involves a two patients (age and gender was not reported) who were vaccinated with dose of QUADRACEL and dose of PROQUAD (batch number, expiry date, route and site of administration were not reported for both vaccines) in same limb an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date following vaccination patients had large bumps (4-5" in diameter) each. It was reported that nurse could not remember patient initials or dates. She was willing to look, but said it would take some time. Reporter encouraged her also to call the home office to report. Reporter forgot to ask for the lot number. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
This case was reported by a physician and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject completed a 3 dose of TWINRIX (unknown). At an unspecified time after completion of the three dose series of TWINRIX, the subject was tested and titers were found to be negative. The subject had not responded to therapy. No additional details were reported.
11/16/2021 started to experience extreme fatigue, slight fever 99.7 higher than normal temperate and took Ibuprofen, 11/17/2021 this stomach issue was a re-occurrence since the second vaccination. Doctor had recommended over the counter medicines for care and treatment and they were not working. Stomach issue with bloating, constipation, fatigue hair breakage a couple weeks later. Then a new diabetes diagnosis after Dose 3 Metformin ER 500mg once a day and also a new diagnosis Cholesterol after Dose 2, Atorvastatin 20mg once a day, improving with stomach is not resolved.
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed/administered by a healthcare provider (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Chest and back pains; Chest and back pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 23Sep2022 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset 27Sep2022, outcome "not recovered" and all described as "Chest and back pains". The events "chest and back pains" required emergency room visit. It was unknown if therapeutic measures were taken as a result of chest pain, back pain.  Additional information: Other medical history reported as gurds. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had fever, swelling of both arms and feet, with itching. Some rash on lower (L) arm. Benadryl PO at home. Medrol dose pak given.
Breakthrough case admission after 2 vaccines ; Pfizer 7/31/21 Lot# FA7484;  Pfizer 8/21/21 Lot# FC3180
has allergy to Brazil nuts (maybe) and felt tongue was slightly tingling after vaccine. Provided Benadryl 50mg po. Patient tolerated well and denied ER treatment.
First dose of vaccine 1/7.  Had acupuncture on 1/26.  That evening began having migraine.  three days later and still having severe headache felt bumps on scalp.  three more days later still had headache and bumps in several places.  Forehead (hairline), eye brow, eyelid.   Went to emergency room in Fl.  The Dr. gave med a cocktail to get rid of headache and also diagnosed me with Shingles.   I don't know if this was the result of 1st dose vaccine or may have been triggered by the acupuncture.    I have not had Shingles before.
Intense pain in left shoulder - trapezious muscle atrophy - denervation - severe intrinsic constriction of spinal accessory nerve
pt recvd vax;started crying & having fever;apap given q 4 hrs;head hot but body cool to touch;mom took pt to MD;apap & motrin & cefaclartid given;
On Friday evening , pt had "bad swollen right arm of injection site" , itching. Was seen in ER 5ml Prelone x 3 doses and Benadryl
About a week after injection, I began experiencing hot flashes about 4 times per week.  They only last a few minutes.
Left deltoid edema/erythema, numbness/tingling/pain in the left arm, swelling down the arm to the hand.
Information has been received from a certified medical assistant concerning a 33 year old female nurse with drug hypersensitivity to DEMEROL and a flounder allergy who on 04-DEC-2007 administered a dose of Rotateq (lot# 657048/0909U) to an infant that spit the vaccine into the nurse's left eye.  The eye was immediately flushed with water but still irritated, stinging, itchy and felt like something was in it.  The nurse also experienced headache and she washed her face with alcohol.  The nurse sought medical attention in the physician's office.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested. 02/11/2010 Follow-up information from the reporting certified medical assistant indicated that upon administration to an infant (WAES# 0801USA0063) the 33 year old female nurse got a "spray" of ROTATEQ (lot# 657048/0909U) in her face and into her eyes (not sure how much). The patient experienced some irritation in the eye and stinging but was "fine after an hour or so." Additional information has been requested.
Possible adm. of only vial 1 was given to pt. not discovered until all 5 doses were adm. from the box. Unable to determine which patient did not get unmixed dose
About 4 hours after injection.  My heart started to race and it progressively increased to the point where the resting rate was anywhere from 130-160 beats per minute.  When I would move it would increase to the 180s.  As of today, the 21st, my resting heart rate has decreased to the 100s and when I move it increases to the 110s.
Parents got the packet from DCHD/OPS with instructions on how to get child vaccinated without a parent present. They sent in the consent forms as instructed to the school and planned on having their child vaccinated at school on the 12th. At some point before the 12th, the school nurse at Marrs or some other Marrs school representation told parents that they would have to bring their child to Marrs on Tuesdsay, Nov. 9th and that parents needed to be present. So, the parents took their child in-person to Marrs on Tuesday, November 9th and got them vaccinated. Then the child went to school on Friday, November 12th and got vaccinated again because they were in the school nurse's stack of consents of those needing to be vaccinated through the pilot.
Rash on neck, chest, under breast, abdomen, groin  - treated with hydrocortisone 1% - not yet resolved
Left deltoid red/swollen down to just above elbow. Rx Motrin, Benadryl and cool compress. ASA marked will be checked tomorrow.
Generalized achiness, sniffles, headache, insomnia.  Area around injection is reddened, hot, tender and firm to touch.
halo pink looking sore around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (halo pink looking sore around injection site) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (halo pink looking sore around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (halo pink looking sore around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   This case was linked to MOD-2021-013074 (Patient Link).
Sore arm at site of injection on 4/8/06, early AM (6:00). Soreness continued to spread up my left arm, across my shoulder to the back of my neck (brain base). I had a headache, my lymph glands under my chin (side of neck) was sore and my ear (both on the left side only) felt like I had cotton in my ear (muffled hearing). I could not turn my head to the left (a very stiff neck). These symptoms lasted for six days. I had no fever (that I was aware of). I took Advil all week. (I also had tinges of numbness in my jaw.)
Information has been received from a certified medical assistant concerning a 65 year old female who on 19-MAR-2007 was vaccinated, intramuscularly with a 0.5 mL dose of Pneumovax 23, (Lot #655500/1005F).  There was no concomitant medication.  On 20-MAR-2007 the patient developed injection site reaction that was red, swollen, and hot to touch, about one day after the Pneumovax 23 vaccination.  The patient sought unspecified medical attention.  The patient was treated with KEFLEX.  No other symptoms noted.  At the time of the report, the patient had recovered.  Additional information has been requested. Follow-up received 08/06/2008 reported patient is retired female. Vaccinated in left deltoid with first dose of PNEUMOVAX. At the time of the report it was unknown if the patient recovered. Additional information has been requested.