chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in fridge longer than 30 days prior to administration; Vaccine was stored in fridge longer than 30 days prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 30-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in fridge longer than 30 days prior to administration) and PRODUCT STORAGE ERROR (Vaccine was stored in fridge longer than 30 days prior to administration) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Suspect route of administration and body site was reported as deltoid.  Concomitant product use was not provided by the reporter.  Unknown if the patient has ever been diagnosed with or tested positive for COVID-19.  Unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  Unknown if the patient had chronic or long-standing health conditions.  The vial was initially stored in the refrigerator on 27-May-2022.  The vial didn't undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600655:Master Case
shakes; couldn't walk/ "like a drunk person"; severe vertigo "like a drunk person; diarrhea; red bumps at injection site; sweats; steady/solid tinnitus; couldn't sleep; itching injection site; injection site started to swell; chills; vomiting; nausea; exhaution/fatigue; red bumps at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (steady/solid tinnitus), VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site) and HYPERHIDROSIS (sweats) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TINNITUS (steady/solid tinnitus), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site). On 30-Apr-2021, the patient experienced VERTIGO (severe vertigo "like a drunk person), TREMOR (shakes) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person"). On 04-May-2021, VERTIGO (severe vertigo "like a drunk person), DIARRHEA (diarrhea), VACCINATION SITE PAPULE (red bumps at injection site), HYPERHIDROSIS (sweats), TREMOR (shakes), INSOMNIA (couldn't sleep), VACCINATION SITE PRURITUS (itching injection site), VACCINATION SITE SWELLING (injection site started to swell), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (exhaution/fatigue) and VACCINATION SITE ERYTHEMA (red bumps at injection site) had resolved. At the time of the report, TINNITUS (steady/solid tinnitus) and GAIT DISTURBANCE (couldn't walk/ "like a drunk person") outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable  No relevant concomitant medications were reported  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt reported severe fatigue over the past week, noting new onset of bilateral facial weakness 2 days ago (Sunday), progressively worsening. All symptoms started bilaterally at the same time. Diagnosed with Cranial nerve VII palsy. Received IVIG x 2 days with no improvement. At follow-up visit 2 weeks later, pt reported 80% improvement in symptoms.
Swollen Lymph node under left armpit; shingle like rash about 6 inches in diameter between the tricep and bicep on the inner side of the left arm.
Child developed redness and warmth to site. DTAP given prior day. No tenderness, afebrile. Symptoms resolved the following am.
Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ALLERGY MEDICATION in 2019. Concurrent medical conditions included Drug allergy since 2017, Food allergy since 2017 and Pollen allergy (dirt allergy) since 2017.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On 04-Feb-2021, FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-002927 (Patient Link).
Hypotonic/hyporesponsive episode immed following shot; lasted 3 hrs, drowsy  rest of day;
Chills and night sweats started 2 days later; Chills and night sweats started 2 days later; Pain over left eye; Nausea; No appetite; This is a spontaneous report from a contactable consumer reported for herself. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, brand=Pfizer, lot number=EL3247) via unspecified route of administration at age of 46 years old on 21Jan2021 05:00 PM at single dose at left arm, for COVID-19 immunization. The patient medical history included patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other concomitant medications the patient received within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT 25mg), atorvastatin statin. It was reported patient experienced chills and night sweats started 2 days later. Pain over left eye, nausea, no appetite, can sleep at night. All the adverse events started on 23Jan2021 04:00 PM. It was reported case type non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Since the vaccination, the patient had been tested for COVID-19 on 27Jan2021: Nasal Swab (PCR): Negative. There was no treatment received for the adverse event. Outcome of events at the time of last observation was recovering.
Exhausted only after the second dose ("flat in the bed"); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhausted only after the second dose ("flat in the bed")) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient has multiple cancers.), Neuropathy since an unknown date, Shoulder dislocation (both shoulders dislocated) and Surgery (Patient had 10 heart surgeries (the 11th was cancelled by HCP because it was "too risky"),). Concurrent medical conditions included Diabetes (diabetic type 2) and Allergy (Patient has allergy to flu shots (last one was given on 1954).). Concomitant products included INSULIN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced FATIGUE (Exhausted only after the second dose ("flat in the bed")). On 26-Feb-2021, FATIGUE (Exhausted only after the second dose ("flat in the bed")) had resolved.            Concomitant medications reported include, Blood thinners.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR received and contains no new information.
Tingling, numbness of  forehead, left ear, left eye, tingling throughout arms, fingers & thighs. Received Benadryl  50 mg IM, monitored in the ED x 2 hours, EKG done.
Fever 103.8, muscle aches, pain, headache, chills, brain fog (confusion), extreme fatigue--all started about 6:00 PM, lasting through the night and all the next day. Friday, temp was normal, pain, fever and chills, were gone, but s; till had muscle aches and confusion Thursday, Friday, most of Saturday; am very tired today, Sunday.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 14-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 34 degrees Fahrenheit (1.111111111 degrees Celsius) (lowest recorded temperature) for 216 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
missed day of work; feeling sluggish or tired; left arm hurting; lower back tightness; sweating a lot; feeling spacey; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot), FEELING ABNORMAL (feeling spacey) and IMPAIRED WORK ABILITY (missed day of work) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) for an unknown indication.    The patient's past medical history included Anxiety.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), HYPERHIDROSIS (sweating a lot) and FEELING ABNORMAL (feeling spacey). 09-Mar-2021, the patient experienced FATIGUE (feeling sluggish or tired). On 10-Mar-2021, the patient experienced IMPAIRED WORK ABILITY (missed day of work). On 09-Mar-2021, HYPERHIDROSIS (sweating a lot) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (left arm hurting), MUSCLE TIGHTNESS (lower back tightness), FEELING ABNORMAL (feeling spacey), IMPAIRED WORK ABILITY (missed day of work) and FATIGUE (feeling sluggish or tired) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to MOD-2021-136100, MOD-2021-136100 (Patient Link).
This was a discovery that only 6 days had passed since patient's initial dose and not the recommended 4 weeks.  The Informed Consent for Immunization had been check "No" under Covid-19 Vaccine History.  The discovery was made upon later data entry into patient file. The patient was contacted within the hour.  No adverse effects.  The patient was contacted again the following day.  Only reported symptom was a sore arm.
Later that day: In PNEUMOVAX 23 arm, swelling (arm to elbow), redness, fever (100.2), induration, & muscle soreness. MD prescribed methylprednisolone and clindamycin the next day. By 2 days later, the patient noticed remarkable improvement. ER determined it was an infection at PNEUMOVAX 23 injection site.
"positive test result"  to COVID-19; This is a spontaneous report from a contactable Nurse. A 51-years-old female patient received First dose of BNT162B2 (pfizer-biontech covid-19 vaccine, solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on 11Jan2021 as single dose for covid-19 immunisation. Patients medical history and concomitant medication was not reported. The patient developed symptoms on 20Jan2021 and had a positive test result to COVID-19 on 22Jan2021. She mentioned her doctor prescribed her a treatment. The patient was taking antibiotics during the exchange. Patient was asking she passed the recommended 42 days of the ACIP, she restart the vaccination series. Patient wanted to know even get the second dose after getting an acute infection following the first dose. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
pt recv vax 10FEB97 & w/in 1wk exp muscle aches & scratchy throat;sx resolved w/o any prescription med;
Headache, Fever, NauseaVomiting,  CHILLS,, ABDOMEN "HOT TO TOUCH",LOSS OF APPETITE  Narrative:   Other Relevant History.
Took Benadryl 50mg prophylactically prior to vaccine. 5 min after shot experienced heart racing, mild air hunger and SOB. 15 min after symptoms started to subside. At 30-36 min later felt normal.
This spontaneous report was received from other health professional (licensed practical nurse) and refers to a unspecified multiple patients of unknown demographics. There was no information on patient's medical history, concurrent condition, concomitant medication and drug allergies/reactions. On an unknown date, unspecified multiple patients were vaccinated with improperly stored ROTATEQ via oral route for prophylaxis (dose, frequency, lot#, expiration date not provided). No adverse effects were reported. The vaccine was stored at temperature of 0.3 degree Celsius for 6 hours. Data logger was involved. There was no previous temperature excursions. No additional information provided. No product quality complaint was involved. No further information provided. This case has been linked with the 1709USA000855, 1709USA004998 and 1709USA004999 as same reporter link. Sender's Comments: US-009507513-1709USA000855: US-009507513-1709USA004998: US-009507513-1709USA004999.
Nurse states that yesterday she gave a flu vaccine that was last years that was expired on date: 30-JUN-2022 with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient to whom expired Influenza Quadrival A-B Multidose Vaccine [Fluzone] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2022, the patient received a 0.5 ml once dose of suspect Influenza Quadrival A-B Multidose Vaccine (lot number: UJ694AB, expiry date: 30-jun-2022) (Strength: standard) (formulation unknown) via intramuscular route in the left deltoid for Immunization which was last years expired with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is only 15 years 6 months old.  Was accompanied by parent.  No adverse reaction, just underage.  There was an error in the birthdate that was corrected, but she was not recognized as under age until entering vaccine into EHR/IIS.
throat & cheeks & neck swelled up like mumps or larger, very swollen & sore inside;also knee tendon now gets arthritis type flare ups;
Patient received 3 vaccines on 10-21-14 (FLUZONE HD, PNEUMOVAX 23 and ZOSTAVAX). On 10-24-14, patient reported to the pharmacist and store manager that she was unable to move her right arm. This was the arm where she got the ZOSTAVAX. Patient was advised to go to ER, where she was prescribed pain med and an antiinflammatory. Patient followed up with management after leaving the ER, but her phone # is disconnected.
Site swollen on injected (L) arm, beginning with 2 hours. Next morning, headache, slight fever, site hot and swollen to touch and episodes of syncope daily since Flu Shot - Rx ADVIL taken helps headache.
Joints are very painful; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 02May2021, the patient experienced that his joints were very painful. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joints were very painful was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
blood pressure shot up to over 200 and was sent to the ER and developed heart palpitations.  Narrative:
There was no adverse event except for patient was given the wrong dose/strength of COVID vaccine. Patient was  given the 3mcg strength instead of the 10 mcg strength of COVID Vaccine for his second dose.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter seems temperature excursions with her freezer in the facility where she works. It was happening for weeks since Apr-2022.  The storage condition at the time of the excursion was reported as frozen storage.  The affected batch lot numbers were reported as 065K21A and 045L21A.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9(-18.9) Fahrenheit degrees.  The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute.  The vials were stored frozen.  Visual inspection did not note any vaccine state change.  Treatment information was not provided.   This case was linked to MOD-2022-591989 (Patient Link).
About 3 hrs later, itching, red, painful, swollen right arm, radiating into right shoulder, neck and across top of right breast into middle of chest.