chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022; No adverse event; Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) and NO ADVERSE EVENT (No adverse event) in a 90-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022).    Concomitant product use was not provided by the reporter.   It was reported that, vial size was 2.5ml and it was initially stored in refrigerator on 13-Oct-2022.The vial had not undergone temperature excursion.  Treatment information was not reported.  This case contains information of second patient out of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-673303, US-MODERNATX, INC.-MOD-2022-673035, US-MODERNATX, INC.-MOD-2022-673345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673303:Same reporter US-MODERNATX, INC.-MOD-2022-673035:Same reporter US-MODERNATX, INC.-MOD-2022-673345:Same reporter
The patient reported having arrhythmia verified by echocardiogram the day following her second dose
severe nausea  severe vomiting  severe back ache  severe muscle pain  delirium  convulsions
Anaphylaxis; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be related.    This case contains information for the 1 of 21 patients described by the reporter. Vital signs were taken and physical examinations were performed before vaccine administration; however, results were not provided. No concomitant and treatment medications were reported. Patient had a first dose of vaccine between 17-Dec-2020 and 28-Feb-2021.  Company comment. This is a literature non  study case concerning a patient of an unknown age and gender with no medical history reported, who experienced the expected serious medically significant event of anaphylaxis reaction. The patient received a dose of mRNA-1273, reported as first dose of patient´s COVID  19 immunization schedule. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The patient fulfilled the Criteria of level 1 for the highest level of diagnostic certainty for anaphylaxis and the grade 3 severity. The patient was recommended to defer the second dose. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-610603, US-MODERNATX, INC.-MOD-2022-612775 (Linked Report).; Sender's Comments: This is a literature non  study case concerning a patient of an unknown age and gender with no medical history reported, who experienced the expected serious medically significant event of anaphylaxis reaction. The patient received a dose of mRNA-1273, reported as first dose of patient´s COVID  19 immunization schedule. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The patient fulfilled the Criteria of level 1 for the highest level of diagnostic certainty for anaphylaxis and the grade 3 severity. The patient was recommended to defer the second dose. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-612775:1 patient developed Uncontrolled urticaria US-MODERNATX, INC.-MOD-2022-610603:19 Patients with presumed allergic reactions
This spontaneous report as received from a physician via company representative refers to a 8 month old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. The physician reported that, the patient was vaccinated with ROTATEQ (dose unspecified) oral as follows: 24-JUL-2014, dose 1 (lot # K004620), on 30-SEP-2014, dose 2 (lot # K007444) and on 03-DEC-2014, dose 3 (lot # K010755) (the expiration dates were unknown). Concomitant therapies included PEDVAXHIB, PREVENAR 13 and PEDIARIX. On an unspecified date in approximately February 2015 (reported as "approximately 2 months after completion of the vaccine series"), the patient experienced eight episodes of diarrhea and then, on 04-FEB-2015, the patient went to physician for evaluation. It was reported that during the office visit, on 04-FEB-2015, the physician tested the patient for rotavirus and the results came back as positive on 06-FEB-2015. The outcome of the events was reported as recovered/resolved on an unspecified date in approximately February 2015. The relatedness between the event and the vaccination within oral, ROTATEQ was not provided. Additional information has been requested.
stated the second dose was not needed, DOB: 24-11-2019; stated the second dose was not needed, DOB: 24-11-2019; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st May 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 31st May 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the inappropriate schedule of vaccine administered to be related to Infanrix Pre-Filled Syringe Device. 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: 8-JUN-2022 Reporter's Comment: The patient received a second dose which was out of recommended schedule. The patient had already received a dose and the second dose was not needed, which led to overdose. Healthcare professional stated the dose was administered incorrectly then clarified it was not needed. The reporter consented to follow up. Additional Supportive Information: The patient had already received a dose and the second dose was not needed, which led to extra dose administered and inappropriate schedule of vaccine administered.
not feeling very great; I was exposed; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for himself that a 29-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 30Mar2021 (last Tuesday) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient was exposed, On 07Apr2021, not feeling very great. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on. On Friday 02Apr2021, and Monday 05Apr2021, I was exposed.  (At the point of this report) today, 07Apr2021, I am not feeling very great. We did buy rapid tests for our business here and I took two and they both came back negative. The clinical outcome of both events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complaint of painful sore left upper arm/shoulder pain for several weeks with movement.  Continues to have pain with internal rotation and abduction of the left shoulder which has not improved.   Seen by an MD on 4/22/19 and advised to use naproxen and a PT referral was made.
Provider attempted to administer the covid vaccine in the LD. Once the needle was inserted, as soon as the provider applied pressure to the plunger, the needle malfunctioned and sprayed solution on the patients arm while the needle was still inserted. Under 0.1ml of solution was actually injected into the patient. The needle was removed and the needle was put in a kidney tray. The provider called and told his supervisor. The supervisor talked to a doctor. The doctor said it was okay to administer a full dose into the RD.  The provider administered a full dose to the patients RD.
PATIENT HAS REDNESS AT INJECTION SITE, AND CIRCLE OF REDNESS CONTINUED TO GROW
Pt vaccinated with DTP/OPV then developed high pitch scream > 3 hrs after inject onset 5 hrs after inject. Duration 48-72 hrs.
It was probably a half of a tennis ball size welt- it was hot to touch and red exterior. It was a lump; very hard. It was a little bit painful. Doctor - at my facility that I work at -  told me to take Benadryl - after about three doses of Benadryl it started going down and it took a couple of days for it be resolved.
back pain; knee swollen; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache). At the time of the report, BACK PAIN (back pain), JOINT SWELLING (knee swollen) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: adverse events obtained via follow-up call
This spontaneous report was received from a medical assistant who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as 9009773, expiration date 20-SEP-2018 (dose and route of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 8.6 degrees Fahrenheit for 1 hour 10 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. It has been determined that lot number 9009773 is not valid for PROQUAD; Sender's Comments: US-009507513-1709USA006379:
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    The case was reported for 46th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-69612.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Severe headache, fever, spinal pain, limb pressure, numbness, tingling, weakness (both arms, both legs). Headache fever spine pain day of vaccination and next day, limb numbness tingling pressure and weakness day 3.
Unable to move the left side of her face 3 to 4 times a week; Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of REDUCED FACIAL EXPRESSION (Unable to move the left side of her face 3 to 4 times a week), PAIN (Pain) and CHILLS (Chills) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced REDUCED FACIAL EXPRESSION (Unable to move the left side of her face 3 to 4 times a week), PAIN (Pain) and CHILLS (Chills). At the time of the report, REDUCED FACIAL EXPRESSION (Unable to move the left side of her face 3 to 4 times a week), PAIN (Pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 01Apr2021 (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: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with Gardasil (lot # unknown) 0.5mL injection and developed a rash. Medical attention was sought. At the time of reporting it was unknown if the patient has recovered. One other patient also experienced a rash. Additional information has been requested.
expired dose of ACTHIB was inadvertently administered with no adverse event; Initial information was received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old female patient who experienced expired dose of acthib was inadvertently administered with no adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 17-Feb-2023, the patient received 0.5 ml dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot UJ740AAA,  Expiration Date: 11-Feb-2023), ( lot U74404BB,  expiry date 17-Aug-2023) (strength unknown) via intramuscular route in unknown administration site for Immunization.  On 17-Feb-2023 the patient developed a non-serious event of "expired dose of acthib was inadvertently administered with no adverse event" (expired product administered) same day following the administration of hib (prp/t) vaccine.  It was reported "Caller with question on whether dose is valid. Caller with question on whether titers could be done or whether it needs repeating.   Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of acthib was inadvertently administered with no adverse event.   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 guidelines. 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.
01/02/22 presents to ED for "shortness of breath". PMHx of "COPD, HTN, diverticulosis"
Extreme dizziness; Nausea; Vomiting lasting for multiple days and still has not gone away.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 11May2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not allergic to any medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 20Apr2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021, at 12:00,  the patient had extreme dizziness, nausea and vomiting lasting for multiple days and still has not gone away. It was reported that the patient would try to see a physician the following day. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events dizziness, nausea and vomiting were unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
red, localized around vaccine admin site (Rt) arm/raised, NT & soft ~ 1 1/2 in spread (Rt) upper arm
w/in 30mins the pt devel a red, itchy rash, became red & flushed & throat was itchy & tingled all over;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. This report was reported to the pharmacist by the patient's husband. "About 2 weeks ago", on approximately 03-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose and lot # not reported), subcutaneously. "Shortly after" the vaccination, in July 2014, the patient developed rash at the injection site, blurred vision and a tingling sensation in the hands and arms. No treatment was given. Lab tests were unspecified by the reporter. After a few days, in July 2014, the rash went away but the blurred vision and tingling were still present. Additional information has been requested.
5 hrs p/DTP/HIB injects jerking arms/legs, w/abormal eye, breathing for 30seconds; (-) fever
Information has been received from a physician concerning a 4 year old male patient who on an unknown date was vaccinated with a dose of MMR II. On 29-JAN-2010 the patient developed swollen lips, but the physician did not specify how long after getting the dose of MMR II this happened. The patient's outcome at the time of the report was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Pain and swelling in right upper arm where shot given within hour. Swelling resolved in 2-3 days but pain in upper arm persists, especially when raising arm.
27AUG92 pt was vaxed w/2nd dose of Hep B & 11 hrs following exp rash & hives; also noted swelling of hands; 30AUG92 presented to ER w/hives, elevated white cell count & elevated temp;
Nine year old Caucasian child received PPV 23 (lot#1007P) on 07-10/2006 in my office (left deltoid).  On 07-12/2006 the mother reported fever 101.5 F and swelling at the site of the injection. Has treated with Ibuprofen and saw family practice medical doctor, he treated her with KEFLEX and PREDNISONE.  On 07-17-2006 " the patient was better".  On 07/26/2006 the doctor called reported persistent induration at the site of injection 5" by 6" abscess formed, drained 5 cc, 15cc and 15cc pus on 3 different occasions.  No gas in the tissue.  Abscess packed.