chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had an adverse event of greater than 36 days between primary series doses of the Moderna Covid-19 vaccine).    Concomitant medication not reported. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732792 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732792:Same patient
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose).    Concomitant medication not reported.   Dosage text for suspect product was reported as unknown.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732802:Same report
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 16Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 06Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 30Jul2022 as dose 4 (booster), single (Lot number: FP7150), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin, sulfur products, trazodone" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid treatment from 05Jul2023 to 09Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300249242 Same reporter/patient, different product/AE;
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis
Clinical narrative: I am overcoming a bad case of oral thrush; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization, reaction(s): "no adverse event". The following information was reported: ORAL CANDIDIASIS (non-serious), outcome "unknown", described as "I am overcoming a bad case of oral thrush". Additional information: The first one was fine, but the boosters were horrible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got sick even after vaccine/at the end of the day I still got sick; Got sick even after vaccine/at the end of the day I still got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got sick even after vaccine/at the end of the day I still got sick". Clinical course: Reporter's only only thoughts were that she should have never gotten the vaccine at all because at the end of the day she still got sick. The reporter considered that event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Madarosis
Clinical narrative: Eyelashes are almost gone; Hair thinning; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MADAROSIS (non-serious), outcome "unknown", described as "Eyelashes are almost gone"; ALOPECIA (non-serious), outcome "unknown", described as "Hair thinning".  Additional information: Patient just do not want to have the side effects she had with the other one. Eyelashes are almost gone and hair thinning. Reporter (patient) considered event caused by vaccine.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was so sick after all my shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was so sick after all my shots".  Additional information: Another shot. Not sure she can do it. She was so sick after all her shots. Reporter (patient) considered event caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: COVID; COVID; Very sick with vaccine and lasting symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID"; ILLNESS (non-serious), outcome "unknown", described as "Very sick with vaccine and lasting symptoms".  Clinical course: Patient stated that she felt very sick with COVID and the vaccine. She had lasting symptoms and did not know if she would ever vaccinate again. The reporter consider event as caused by suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ehlers-Danlos syndrome
Clinical narrative: Ehlers-Danlos syndrome; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EHLERS-DANLOS SYNDROME (non-serious), outcome "unknown".  Additional information : This nurse below reported to her today that she developed Ehlers-Danlos syndrome subsequent to receiving Pfizer's Covid vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Seizure
Clinical narrative: convulsions; enlarged heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as unknown dose number, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "convulsions"; CARDIOMEGALY (non-serious), outcome "unknown", described as "enlarged heart".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: I took the Pfizer covid vaccine series I recently developed a serious allergies to amoxicillin; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMOXICILLIN. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I took the Pfizer covid vaccine series I recently developed a serious allergies to amoxicillin".  Additional information: Clinical course: Patient took the Pfizer covid vaccine series and recently developed a serious allergies to amoxicillin which patient never had prior to vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: heavy and unusual period bleeding; her menstrual time schedule totaly chaged and became irregular; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "heavy and unusual period bleeding"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "her menstrual time schedule totaly chaged and became irregular". Therapeutic measures were taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information: After reporter's wife got last shot of COVID-19 vaccine, she had heavy and unusual period bleeding and her menstrual time schedule totally changed and became irregular. In the last two months her bleeding increased and was non-stop. It seemed very dangerous and hard situation to reporter. She took medicine but nothing changed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of Tenivac was administered to a patient, with no reported adverse event; Initial information was received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 9 years old female patient who reported that expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Tenivac) was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepa [hepatitis a vaccine]) for prophylactic vaccination; and polio vaccine (polio) for prophylactic vaccination.  On 10-Jul-2023, the patient received a dose of  0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult(Suspension for injection) (lot U7092AA, Expiry date: 24-Jun-2023) (strength was unknown) via intramuscular route in the left deltoid for Immunization.  On 10-Jul-2023 the patient administrated expired dose of tenivac was administered to a patient, with no reported adverse event (expired product administered) (latency : same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered to a patient, with no reported 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.
Age: 18.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: IPOL was administered as a TB skin test in error with no reported adverse event; patient received IPOL intradermally with no adverse event; Initial information received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old female patient to whom vaccine IPV (Vero) [IPOL] was administered as a tb skin test in error, intradermally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Jul-2023, the patient received 0.1 mL dose of suspect IPV (Vero), Suspension for injection (batch number: V1B891M) (expiry date: unknown) via intradermal route in the left forearm as TB skin test (Tuberculin test) in error with no reported adverse event (wrong product administered) (incorrect route of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of quadracel was administered to a patient today with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered an expired dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Jul-2023, the patient received an expired dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (batch number: C5916AA; expiry date: 06-Jul-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event an expired dose of quadracel was administered to a patient today with no reported 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.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Patient states that he has had a persistent itching in his arm since the day after he received the vaccine on06/28/2023
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: PATIENT CALLED THE PHARMACY TO REPORT, FEVER, SORE ARM, AND BODY ACHES STARTED IN THE MORNING ON JULY 13TH, 2023
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No patient side effects; HCP calling to report AE for MMRII and VARIVAX. MMRII was stored within recommended range. VARIVAX was improperly stored and experienced a supported temperature excursion. No patient side effects reported. HCP consent to contact obtained. No Addition; This spontaneous report was received from a medical assistant and to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-JUL-2023, the patient was vaccinated with a dose  of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # W016747, expiration date reported as 23-MAY-2024,  but upon internal review  stablished as 23-APR-2024) (dose, route of administration, anatomical location not provided) as prophylaxis, that was improperly stored and experienced a supported temperature excursion (product storage error) at 12.43 Fahrenheit (F) for 11 hours and 30 minutes, and at 18.43 F for 2 hours and 20 minutes, which was recorded by data logger. No side effects were reported for the patient. Additionally, it was also mentioned the vaccine measles, mumps, rubella virus vaccine live (M-M-R II) with lot # U039548, expiration date: 14-DEC-2023) but it was stated that it was stored within the recommended range.
Age: 1.83
Sex: F
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) which was also administered to a patie; This spontaneous report has been received from a medical assistant, regarding a 22-months-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 13-JUN-2023, the patient was vaccinated with an improperly storage dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, once at a dose of 0.5 milliliters in the left thigh as prophylaxis (lot number: W039033, which was determined to be valid for syringe formulation, with an expiration date on 01-OCT-2024) (strength and route of administration were not reported).  The administered dose underwent a temperature excursion of 49.1 degrees Fahrenheit (F) for 34 minutes (product use issue); with two previous excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes. No additional adverse event was reported.  No additional information was reported.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Rash
Clinical narrative: Pain at injection site lasting the last 2 days, unable to lift arm. Local rash about 8 inches in diameter
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Blood thyroid stimulating hormone normal, Brain fog, Cognitive disorder, Electrocardiogram abnormal
Clinical narrative: headache, cognitive change / brain fog, fatigue, word finding difficulties subacute onset headache now resolved cognitive change / brain fog continues to occur intermittently now over several years
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lipids abnormal, Low density lipoprotein increased, Magnetic resonance imaging head abnormal
Clinical narrative: headache, cognitive change / brain fog, fatigue, word finding difficulties subacute onset headache now resolved cognitive change / brain fog continues to occur intermittently now over several years
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test abnormal, Stress echocardiogram normal, Vitamin B12 normal
Clinical narrative: headache, cognitive change / brain fog, fatigue, word finding difficulties subacute onset headache now resolved cognitive change / brain fog continues to occur intermittently now over several years
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Multidose vial prepared, only one dose given however the volume of the vial was only half full. Staff reported no wastage of vaccine. Employee who prepared the vial is also the one who administered the single dose used. He reports preparation happened without issue and patient displayed no adverse reaction during or after receiving vaccine. Report being file due to  doses left to give not matching the quantity that should be available in the vial. Provider informed and states no further action needed. Patient guardian informed of event.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at the injection site with itchiness
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: 1. Patient was administered Pfizer monovalent covid 19 vaccine after the authorization for use expired April 18, 2023. 2. Patient was prescribed Pfizer Bivalent Covid 19 vaccine and received Pfizer monovalent in error.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, Wrong product administered
Clinical narrative: 1. Patient was administered Pfizer monovalent covid 19 vaccine after authorization for use expired April 18, 2023. 2. Patient was prescribed Pfizer Bivalent covid 19 vaccine and was administered Pfizer monovalent covid 19 vaccine in error.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Headache, Heart rate increased, Pain in extremity
Clinical narrative: 7/11/23  PATIENT SAID AFTER THE SHOT WHEN SHE GOT HOME HAD A HEADACHE, SHE TOOK HER BLOOD PRESURE AND HEART RATE.  BP AND HR (95) BOTH ELEVATED, ARM STARTED TO BECOME RED MAYBE 2X2 INCH AREA AND SORE .  TOOK BP AND HR LATER IN DAY HR REPORTED TO BE 93 BP ELEVEATED BUT NO NUMBERS AGAIN.  BY BEDTIME BP AND HR HAD RETURNED TO NORMAL.  DIDN'T BELIEVE SHE HAD A FEVER DURING THIS TIME.  NEXT DAY 7/12/23 WHEN SHE WOKE UP THE REDNESS ON ARM INCREASED TO AN AREA OF 6X2 INCHES AND WAS WARM, MAYBE SOME SWELLING AND SORE.  HR AND BP NORMAL. TODAY 7/13/23 WHEN CALLED AREA OF REDNESS A BIT SMALLER, NOT AS WARM BP AND HR NORMAL.  RECOMMENDED PAIN MED, COLD PACK TO ARM, CONTINUE TO MONITOR AREA THAT IS RED AND BP AND HR.  ALSO RECOMMENDED TO REACH OUT TO HER PCP
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: 7/11/23  PATIENT SAID AFTER THE SHOT WHEN SHE GOT HOME HAD A HEADACHE, SHE TOOK HER BLOOD PRESURE AND HEART RATE.  BP AND HR (95) BOTH ELEVATED, ARM STARTED TO BECOME RED MAYBE 2X2 INCH AREA AND SORE .  TOOK BP AND HR LATER IN DAY HR REPORTED TO BE 93 BP ELEVEATED BUT NO NUMBERS AGAIN.  BY BEDTIME BP AND HR HAD RETURNED TO NORMAL.  DIDN'T BELIEVE SHE HAD A FEVER DURING THIS TIME.  NEXT DAY 7/12/23 WHEN SHE WOKE UP THE REDNESS ON ARM INCREASED TO AN AREA OF 6X2 INCHES AND WAS WARM, MAYBE SOME SWELLING AND SORE.  HR AND BP NORMAL. TODAY 7/13/23 WHEN CALLED AREA OF REDNESS A BIT SMALLER, NOT AS WARM BP AND HR NORMAL.  RECOMMENDED PAIN MED, COLD PACK TO ARM, CONTINUE TO MONITOR AREA THAT IS RED AND BP AND HR.  ALSO RECOMMENDED TO REACH OUT TO HER PCP
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed rash, pain, swelling, and heat at injection site radiating down towards elbow.  Sought treatment at ER.  Was diagnosed with cellulitis.  Was given cephalexin 500mg QID for 7 days and discharged.  Infection responded to treatment and has completely resolved.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Break out Rash on forehead 2 days after Shingrix vaccine was given
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Muscle soreness did not go away after two weeks. Increased after 6 days and plateaued. Soreness and range of motion are effected.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Sinus tachycardia
Clinical narrative: fever, fatigue, body aches, ST, N/V
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Vomiting
Clinical narrative: fever, fatigue, body aches, ST, N/V
Age: 36.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram head, Electrocardiogram, Generalised tonic-clonic seizure, Laboratory test
Clinical narrative: tonic/clonic seizure
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The patient received a third booster dose on July 1, 2023 lot 065H22A expiration date June 13, 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a third booster dose on July 1, 2023 lot 065H22A expiration date June 13, 2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a third booster dose on July 1, 2023 lot 065H22A expiration date June 13, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received a third booster dose on July 1, 2023 lot 065H22A expiration date June 13, 2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (The patient received a third booster dose on July 1, 2023 lot 065H22A expiration date June 13, 2023).    No concomitant drug was reported.  On 20-May-2021, patient received first dose, lot 022B21A in left arm. No expiration date provided. No adverse reactions were reported.  On 22-Jun-2021, patient received second dose, lot 050C21A in left arm. Expiration date was unknown.  On 01-Jul-2023, patient received third dose (booster), lot 065H22A in left arm, expiration date 13-Jun-2023. The patient received expired Moderna Covid-19 vaccine. No other adverse reactions are reported.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732799 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732799:Same patient and different product (Monovalent dose)
Age: 1.25
Sex: M
Vaccine: PNC15, PNC15
Symptoms: Needle issue
Clinical narrative: No adverse event; A nurse called and reported a PQC and AE involving one VAXNEUVANCE syringe that leaked while it was being administered to a patient.; A nurse called and reported a PQC and AE involving one VAXNEUVANCE syringe that leaked while it was being administered to a patient; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history, concomitant medications, drug reactions and allergies were not reported.  On 09-JUN-2023, the patient received pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection, 0.5 ml once (lot #W039033, expiration date: 01-OCT-2024), administered as prophylaxis (route of administration was not provided).  On the same date, a nurse called and reported a product quality complaint (PQC) involving one pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe that leaked while it was being administered to a patient (Syringe issue / Poor quality device used). The caller said the syringe was discarded after the incident occurred, so no product was available for retrieval. The caller said the syringe was discarded after the incident occurred, so no product is available for retrieval. The caller did not have pictures, so no pictures were sent. The syringe needle was attached to the syringe tip securely before the leaking occurred. Leaking occurred from the tip of the syringe and between the syringe hub/Luer lock and syringe needle. The caller said no adverse effects (No adverse event) were reported with the patient after the incident occurred.  Follow-up information has been received from Other Health Professional on 06-JUL-2023.   The patient's demographics were updated, and it was reported that the report was regarding a 15-months-old male patient (case became valid).  The pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was administered intramuscularly.
Age: 1.25
Sex: M
Vaccine: PNC15, PNC15
Symptoms: No adverse event, Poor quality device used, Syringe issue
Clinical narrative: No adverse event; A nurse called and reported a PQC and AE involving one VAXNEUVANCE syringe that leaked while it was being administered to a patient.; A nurse called and reported a PQC and AE involving one VAXNEUVANCE syringe that leaked while it was being administered to a patient; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history, concomitant medications, drug reactions and allergies were not reported.  On 09-JUN-2023, the patient received pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection, 0.5 ml once (lot #W039033, expiration date: 01-OCT-2024), administered as prophylaxis (route of administration was not provided).  On the same date, a nurse called and reported a product quality complaint (PQC) involving one pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe that leaked while it was being administered to a patient (Syringe issue / Poor quality device used). The caller said the syringe was discarded after the incident occurred, so no product was available for retrieval. The caller said the syringe was discarded after the incident occurred, so no product is available for retrieval. The caller did not have pictures, so no pictures were sent. The syringe needle was attached to the syringe tip securely before the leaking occurred. Leaking occurred from the tip of the syringe and between the syringe hub/Luer lock and syringe needle. The caller said no adverse effects (No adverse event) were reported with the patient after the incident occurred.  Follow-up information has been received from Other Health Professional on 06-JUL-2023.   The patient's demographics were updated, and it was reported that the report was regarding a 15-months-old male patient (case became valid).  The pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was administered intramuscularly.
Sex: U
Vaccine: MMRV
Symptoms: Product expiration date issue, Product storage error
Clinical narrative: The vaccines were "short dated" and new expiration date of 6/30/2023 was given; had a temperature excursion 3/31/2023 / The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. / The products were labeled but still accidentally administered after the new short dated expiration date.; This spontaneous report has been received from an office manager referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 31-MAR-2023, a temperature excursion of 50 degrees Fahrenheit ocurred for a time frame of 6 degrees Fahrenheit up to 14 degrees Fahrenheit 4 hours 0 minutes; 14 degrees Fahrenheit up to 46 degrees Fahrenheit 4 hours 0 minutes ; 47 degrees Fahrenheit to 77 degrees Fahrenheit (50 F) 3 hours 57 minutes (TOTAL: 11 hours 57 minutes).   On 30-JUN-2023, the patient was accidentally vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA) subcutaneous Injection, at a dose of 0.5 ml, lot number W035470 that has been verified to be valid, the vaccine was "shor dated"and new expiration date was reported as 30-JUN-2023 but upon internal review established as 06-MAY-2024, for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of application were not provided). The vaccine was labeled but still accidentally administered after the new short-dated expiration date (Product expiration date issue and Improper storage of product in use).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE for inadvertent administration of PROQUAD following a TE.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information on the patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 12-JUN-2023, the patient inadvertently received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (rHA) (PROQUAD) 0.5 milliliter (strength and route not reported, lot # X011437, expiration date: 18-JUL-2024) for prophylaxis (product storage error). The vaccine was exposed to 6.4 degrees Celsius for 191 Hours 0 minutes 0 seconds. There was no prior excursion. No additional adverse events were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Embolism venous
Clinical narrative: Venous thromboembolism; This literature-non-study case was reported in a literature article and describes the occurrence of EMBOLISM VENOUS (Venous thromboembolism) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMBOLISM VENOUS (Venous thromboembolism) (seriousness criterion medically significant). At the time of the report, EMBOLISM VENOUS (Venous thromboembolism) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Author stated that there has been limited information regarding thrombosis development after receiving a messenger RNA (mRNA)-based vaccine. This case series highlights four different patients who received an mRNA-based COVID-19 vaccine and subsequently developed venous thromboembolism. Therefore, author hope that after reviewing this article, physicians will be more aware of thrombosis-related developments following mRNA vaccine administration for COVID-19. Fortunately, with early diagnosis and prompt treatment, patients can still expect full recovery from any vaccine thrombosis-associated complications, and the benefits of receiving an mRNA-based COVID-19 vaccine still outweigh the risks of post-vaccination complications.  Company comment: This is a literature non-study case concerning a 31-year-old female patient with No Medical History reported, who experienced the serious unexpected medically significant AESI embolism venous (reported as venous thromboembolism). The event occurred after receiving the second dose of mRNA-1273 vaccine (event and vaccine date was not provided). No treatment or concomitant medication was provided. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-732788 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732788:58-Y-M
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: TRANSIENT HYPOTENSION
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Nausea, Pain
Clinical narrative: Myalgia, Fever, NauseaVomiting, chills Narrative: 1/20 onset of quesy stomach. 1/21 subjective mild fever, body aches, chills, and nausea. 1/22 continued nausea, mild fever, body aches, chills, but has improved energy. 1/26 - employee reports all symptoms resolved as of later in the day on 1/22.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Myalgia, Fever, NauseaVomiting, chills Narrative: 1/20 onset of quesy stomach. 1/21 subjective mild fever, body aches, chills, and nausea. 1/22 continued nausea, mild fever, body aches, chills, but has improved energy. 1/26 - employee reports all symptoms resolved as of later in the day on 1/22.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 10/29/2022, 12/24/2022,  1/6/2022, 12/6/2022, 11/18/2022, 2/9/2023, 1/16/2023,  2/18/2023 -  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute coronary syndrome
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED
Age: 1.08
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: This rash is clearly distinct from the hand-foot-and-mouth rash that he had prior and mother sent pictures into chart.  The timing and characteristic of this rash appears consistent with an MMR vaccination rash which occurs in up to 5% of individuals after this injection. Another possibility that we discussed was heat rash which is the next item on the differential.  Mother was reassured in either case.  Plan on treat symptomatically with calamine lotion.  Return to clinic if symptoms persist or worsen
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Lacunar stroke, Subclavian steal syndrome
Clinical narrative: LEFT SUBCLAVIAN STEAL SYNDROME ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nauseous most of 2nd day;  Took Tylenol at onset of symptoms which resolved most nausea
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Mental status changes, Pneumonia
Clinical narrative: Hospitalization for altered mental status, multifocal pneumonia, and COVID-19 infection on dates 7/6/2023-7/13/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: PT parent reported. that 1 day after vaccines were given. the patient had a large, red rash where the vaccine was given. the parent described that the area was warm to touch, but unpainful to the child the rash has persited for 2-3 days and has not shrank.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Hypoxia, Pulmonary embolism, Pulmonary infarction
Clinical narrative: ACUTE DVT, UNSPECIFIED VEIN IATROGENIC PULMONARY EMBOLISM W INFARCTION HYPOXEMIA
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION ACUTE RESPIRATORY FAILURE 1/16/2023,  1/17/2023,  1/24/2023,  3/21/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 4 year old received a dose appropriate for a 5 year old.  Was this pt.'s first COVID-19 vaccine.  Is newly resettling and is  without health records.  Dose administered on 7/11/23.  Parents contacted 7/12/23 to review dose error, determine if child experiencing unanticipated effects of the vaccine, and review how to access care and have questions addressed.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypervolaemia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/30/2023 HYPERVOLEMIA
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Abnormal faeces, Diarrhoea, Dyschezia
Clinical narrative: 7/10/23 FOC, called this nurse to ask what company manufactured the RotaTeq vaccine his daughter received on 6/16/23. He explained his daughter had a "bad reaction" and was wanting to see if they could try a different rotavirus vaccine. RN asked about pts reaction and FOC reported his daughter had loose and sometimes "jelly-like" stools every day, usually multiple times for weeks, and is "just not starting to feel better" (approx. 1 month after vaccine). FOC talked to their pediatrician, but would also appreciate talking to the medical director of the clinic. This RN informed Dr. who called pt. Dr. emailed RN with this summary:  "I called him and we discussed his child at some length.  It turns out she was in quite a bit of pain when she had her diarrhea and so though they didn't see any blood the possibility of a spontaneous resolution of intussusception is a possibility.  I advised to discuss with their pediatrician Dr. and deferred the decision to further vaccinate with rotavirus to them."