chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Our fridge being out of range on 02-Dec-2022 for one hour; No adverse event; 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened), PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened) and PRODUCT TEMPERATURE EXCURSION ISSUE (Our fridge being out of range on 02-Dec-2022 for one hour).    No concomitant medications were provided by the reporter.  HCP reported that 10 pediatric patients from 6 months to 5 years were vaccinated with monovalent Moderna COVID-19 Vaccine after an excursion happened. One patient was vaccinated on 09-Dec-2022 and 9 patients were vaccinated on 16-Dec-2022. Excursion happened on 02-Dec-2022 during 1 hour and minimum temperature reached was 1.2 A degree C.   No adverse events were reported.  No treatment medications were provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-695843, MODERNATX, INC.-MOD-2023-695862 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2023: Follow-up received contains non-significant information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-695862:Same reporter MODERNATX, INC.-MOD-2023-695843:Same reporter
Child developing vesicular circular rash, different shots on 04/25/05. pt had varicella vaccine 12/30/2003. Mom had clinical chicken pox x2.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JAN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician/MD at a medical facility/office, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-FEB-2015, the patient was treated by the same physician, at the medical facility/office for a blistering vesicular outbreak, which was diagnosed as shingles with post herpetic neuralgia, a condition which affects the nerve fibers and skin. The patient was prescribed gabapentin and PERCOCET for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for the 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Initial information was received on 19 August 2008 from a consumer (patient's mother).  A two and a half month old female patient with no reported medical history received an injection of ACTHIB (lot number not reported) intramuscularly on the left thigh on 11 August 2008.  Approximately three and a half hours after the vaccination the child woke up screaming, which lasted about 45 minutes.  During that time the child's legs became deep purple with deep red blotches.  The mother took the child to the ER.  By that time the child's legs were normal in color.  The patient had to rectal temperature of 99.6 degrees Fahrenheit.  The patient had recovered from the events.  Follow-up information was received from the patient's physician on 08 September 2008.  The ACTHIB lot number was reported as UF400AA (sanofi-pasteur SA lot number A0831-2).  Per the reporter, all symptoms had resolved by the time the patient arrived in the emergency room.  No treatment was needed.  The reporter noted that the patient's parent was "very anxious over vaccine use in general".
Red rash at/around injection site (R) upper arm: followed up w/PCP who prescribed prednisone.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/23/2021.
had high fever, turned blue, collapsed, sz activity w/in 60-90 min;hosp transferred to another hosp x 3 days;devel fine rash;no sequellae since that time;
Leg pain, temp 99.0, bruising on right. Vomited x 1.
Low fevers for 5 days in a row. Occasional vomiting. Gave ibuprofen every 6 hours to treat fever and cool her temperature. She was fussy, had no appetite, and would only drink a little bit of water. On the 6th day, she begun to have high fevers of 102.7. We continued with the same treatment. We also visited her pediatrician 3 times in the course of 7 days. Her ears, nose, and chest all seemed fine. She began to have a slight cough (day 6) that increased in congestion the following day. She is currently on her 9th day of consistent fevers.
generalized  tremors;not typical tonic-clonic or myoclonic;rapid, fine in nature, clenched teeth;alert throughout lasted 5 seconds;
pt recvd vax;30 mins later exp a ha;dizziness & was hot;addtl, exp pain at inject site; resolved;
within 2 weeks of receiving the covid vaccine patient became weak, stopped eating, more lethargic and became bedbound and was started on hospice. She died on 3/31/2021
get very very sick every time; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious social media case received from digital media via a consumer.   This case involves an unknown age patient who got very sick every time (illness), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient took a vaccine shot and got very very sick every time (illness), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Diarrhea after 1 hr of getting flu shot she didn't eat anything from night before and she got the shot around 3:00pm. Around 5:00 pm she started diarrhea.
On the 25th of September arm was swollen warm to touch and itching . it seems to be spreading .
Information has been received from a Licensed Practical nurse (LPN) referring to a pregnant female patient of unknown age. No other relevant medical history or concurrent conditions were reported. On 16-OCT-2012, the patient was vaccinated with her first dose of GARDASIL (lot# H010915, expiration date 13-FEB-2015, intramuscular, dose not reported). The second dose (lot# J007354, expiration date 20-FEB-2016; dose not reported) and third dose (lot# J010668, expiration date 29-APR-2016, dose not reported) were administered on 11-NOV-2013 (inappropriate schedule of drug administration) and 26-AUG-2014 (inappropriate schedule of drug administration) respectively. On 06-APR-2016 (also reported as 06-APR-2017), the patient was vaccinated with a "fourth" dose of GARDASIL 9 (lot # L019297, expiration date 18-AUG-2017, intramuscular) (captured in MARRS#1604USA010835). The nurse reported that the patient was pregnant when the GARDASIL 9 was administered on 06-APR-2016 (unspecified gestation) (maternal exposure before pregnancy). The pregnancy outcome was pending. This is one of two reports received from the same reporter. Additional information has been requested.
Case number PHEH2017US003444, is an initial spontaneous report received from a consumer on 01 Feb 2017. This report refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN prefilled syringe (PFS) (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 30 Jan 2017. After vaccination, that night, she took XANAX to help her sleep. She had problems sleeping throughout the night and she mentioned that reaction was strange because the XANAX usually allowed her to have hours of continual sleep. Patient stated that Monday and Tuesday combined, she had two hours of sleep and it happened 2 nights in a row. She also stated that the shot was the only thing different she had done. Patient believed that the FLUVIRIN had caused her abnormal sleeping patterns. The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as serious (disability and medically significant). The causality of the event was reported as suspected by the consumer.
Patient fainted for about 30 seconds. Recovered fine no issues.  Per patient normally happens after receiving vaccinations
PATIENT STATES HANDS TINGLING BUT WENT AWAY PATIENT HAD NOT INTERVENTIONS OR PROLONGED OBSERVATION
CARDIOPULMONARY ARREST 2 DAYS AFTER RECIEVING SECOND MODERNA DOSE
This spontaneous prospective pregnancy report as received from nurse refers to a currently 20 year old female patient. The patient's pertinent medical history was reported as none. No drug reactions/allergies were reported. The patient's concomitant medication was not reported. On 03-APR-2018 the patient was vaccinated with GARDASIL 9 injection (lot # N021571, expiry date: 29-APR-2020) (dose and frequency were not reported) intramuscularly for prophylaxis. On 10-APR-2018, pregnancy test revealed positive. It was unknown if the patient was pregnant at the time of administration of GARDASIL 9. It was unknown how long the patient had been pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) was unknown. It was reported that, the patient sought medical attention and reported pregnancy to immunization official. No product quality complaint was involved.
2/18/2021 Post menopausal bleeding LMP 7/2018. No significant gynecological history other than pregnancies/childbirth. No prior h/o abnormal vaginal bleeding, No known history of uterine fibroids. No h/o bleeding/coagulation disorder. 2/18/2021 Onset of vaginal bleeding began with light flow and gradually increased with use of pads and tampons. No clots. Menstrual period lasted until 2/23/2021. This appeared to be similar to menstrual periods in the past except that there was no cramping on the first day and in the past would have expected to end on 2/22) No further vaginal bleed or spotting since 2/23
Excessive crying and fussiness for > 12 hours along with decreased appetite. Treated with TYLENOL and warm compresses.
Limp, floppy, loss of coordination, loss of ability to eat, constant crying, couldn't hold her head up
I received the second dose of the vaccine on 1/30/2021. When i went to bed i had a headache but no other symptoms. I woke up around 5am the next day experiencing heat flashes, a migraine, and nausea. Throughout the day i had a migraine and nausea, and started throwing up around 6pm.
sides of my head also felt "hot" a few days after the second injection; sides of my head also felt "hot" a few days after the second injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 09:00 (Lot number: EN6203) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ulcerative colitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "psoriasis" (unspecified if ongoing); "meniere's disease" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; LISINOPRIL; HYDROCHLOROTHIAZIDE; PRAVASTATIN. Past drug history included: Ampicillin, reaction(s): "known allergies;ampicillian". Vaccination history included: Bnt162b2 (DOSE: 1st, Lot number: EL9269, Dose administration time=09:00, Vaccine location=Left arm), administration date: 19Feb2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: HEAD DISCOMFORT (non-serious), FEELING HOT (non-serious) all with onset 2021, outcome "unknown" and all described as "sides of my head also felt "hot" a few days after the second injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, feeling hot.  Additional information: Patient stated that sides of his head also felt "hot" a few days after the second injection. Patient stated that he called his gastroenterologist as he started taking Humira 6 weeks earlier, but was informed that Humira has no such side effects by his gastroenterologist, and patient continues taking Humira with no effects.
Varicella - Information has been received from a healthcare professional concerning a 5 year old male with strep at the time of vaccination who on 09 aug 1999 was vaccinated sc with one dose of varicella virus vaccine live lot 630675/0424J in the left arm.  Concomitant therapy included amoxicillin trihydrate (Amoxil).  On 10 mar 2000 thepatient developed a feer of 102 degrees F.  On 18 Mar 2000, he developed 3 pustules and one veasicle on his right cheek and chin. the patient was then afebrile.  The patient sought unspecified medical attention.  Follow up information received a healthcare professional indicated that the patient was seen in a physician's office on 20 mar 2000 and diagnosed with atypical varicella.  on an unspecified date the patient recovered.  No further information is available.
A pharmacist reported a 35 month old child (gender not specified) received an injection of Pnu-Imune 23 on 10/13/00. The child reported immunocompromised, but reporter "is unsure how". "Humoral immunity testing" showed the child only converted to serotypes 14, 19 and 23 but did not convert to serotypes 1, 3 and 51. The date and time of the humoral immunity testing was not specified and it was unclear whether the testing was done before or after vaccination. No further information was available at the date of this report.
SEVERE BAD ADVERSE REACTION AFTER THE INJECTION; WRONG ROUTE OF ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and anxiety.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown, expiry: Unknown) (Incorrect route of product administration and off label use) dose was not reported, 1 total, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUN-2021, post vaccination the patient experienced severe bad adverse reactions (unspecified) and was admitted to the hospital. The patient was kept overnight (one day) at the hospital and discharged on 03-JUN-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from off label use, wrong route of administration, and severe bad adverse reaction after the injection. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;20210607696-COVID-19 VACCINE AD26.COV2.S-severe bad adverse reactions . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event . V0 20210607696-COVID-19 VACCINE AD26.COV2.S-Wrong route of administration , off label use. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
About 2 weeks after getting my first Pfizer shot, I woke up with burning left-sided substernal chest pain that persisted for hours.  When I went to get up to use the bathroom that night, I passed out.  For the next 1-2 months, I had exertional left-sided chest pain that then resolved spontaneously.  I'm a 37-year-old male (was 36 at the time of symptoms), thin (BMI 23), exercise regularly, and take just one medication (the lowest dose of atorvastatin for mild dyslipidemia).  At the time I had these symptoms, the phenomenon of myocarditis after the Pfizer vaccine had not been widely reported, so it never occurred to me that my symptoms could have been due to this.  So I ended up receiving the second Pfizer vaccine about 3 weeks after the first dose.  My symptoms after the second dose were similar to others around me (24 hours of severe myalgias/chills/weakness followed by several days of not feeling like myself).   Now (6 months later), I feel essentially back to normal.
I gave an order for a Typhoid shot and she had already had one.  No adverse reaction noted.
This case was reported by a physician via a market research company and described the occurrence of convulsion in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included cold. Per the physician, the subject had a cold when they went to the emergency room. Concurrent vaccination included PEDIARIX (GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received 2nd dose of PEDIARIX for primary series ("standard dose", unknown details). Within 48 hours to 72 hours after vaccination with PEDIARIX, the subject experienced fever, convulsion, and urinary tract infection (U.T.I.). Per the physician, the subject had "fever and then develop[ed] short-term convulsion." The subject was "diagnosed with U.T.I.". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. Report received from a physician during market research. The physician reported another case with PEDIARIX. See case A1021890A for details on the other case.
received the first dose  / on February 1st 2020 / the second dose on May 13th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st february 2020).   On 13th May 2021, the patient received the 2nd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Batch number and expiry date was not reported. The follow-up was declined.
sl local irritation-erythema, 10mm nodule which had dec in size p/1wk-practically resolved;
Chills for 2-3 hours, followed by a headache and aching muscles.
Flu shot received 10/19/09.  C/o left arm soreness on 10/26/09, seen by physician who recommended rest, ice, ibuprofen and myoflex.  11/11/09 c/o left shoulder pain, seen by physician and referred to orthopedic surgeon for evaluation.  11/12/09 ortho dx: L rotator cuff tendonitis/bursitis.  Cortisone injection to L shoulder and therapeutic shoulder exercises.
This 67  year old white male received the Pfizer Covid shot on 2/23/21    and went to the ED on 3/22 /21     and was admitted  on 3/23/21 with the following diagnoses listed below.  Thrombocytopenia, unspecified
One day after vaccine arm became red and swollen,  no pain reported patient states is warm and swollen 5 days after shot. Patient is having no issues moving arm and any other issues. Told patient they should followup with md as well.
Fever & vomiting began about 12 hours after vaccinations. Anorexia [decrease in appetite] as well. TYLENOL alternating with ibuprofen did normalize fever. Fever to 104 degrees F. Questionable dysuria within 24 hours after vaccination.
had inadvertently been administered an expired dose of Daptacel with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional via Consumer/ Non-Healthcare Professional..  This case involves a 5 years old (unknown gender) patient who had inadvertently been administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) for prophylactic vaccination.  On 03-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5643BA, expiry date-17-July-2021 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency same day).  At the time of reporting, no adverse event was reported.   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. 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.
Mom called stating that when they arrived at cross country running practice Patient began profusely vomiting. Mom denies that Patient had been running yet and has otherwise been healthy. Patient complaining of severe abdominal pain with the vomiting. Denied, resp distress, hives or rash or other signs of possible allergic reaction. Due to severity of sx advised that Patient be seen in ER. Mom took her to ER where they gave Zofran and IVF.  Dx of possible gastroenteritis and discharged 4 hours later.