chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-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) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date) 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 (They gave some Moderna vaccine on 12-Jun-2023 Monday, and they actually expired the end of May/12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12-JUN-2023 beyond MFG expiration date).    The case was for Patient 5 out of 12 Patients.  No concomitant medications were reported.   It was reported that the vial size was 2.5 ml. On 12-Jun-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The reporter asked to escalate the case to Tier-2 for a lot analysis.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Live Significant follow-up appended: Reporter added, Patient details updated, Suspect product details updated, Event verbatim updated and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Patient 1
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent ringing in the ears since 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Persistent ringing in the ears since 2nd shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21a) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine headache.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced TINNITUS (Persistent ringing in the ears since 2nd shot). At the time of the report, TINNITUS (Persistent ringing in the ears since 2nd shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (Adverse Event reported more than 35 days between the first dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (had a mild case of Covid in the middle of 2022.) in 2022.    On 12-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) 1 dosage form. On 12-Jun-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 (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023) 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 (received a Moderna vaccine on 12Jun2023 vaccine Lot 017H22A/it had the same LOT number as the dose he received on Oct2022/after researching they told him that lot expired on 29May2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient saw the card and it had the same lot number as the dose patient received on Oct-2022. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation) 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. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, 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 15-Jun-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 (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (if there was any flexibility in efficacy of Moderna bivalent if it was given three days after its manufacturer expiration date/HCP confirms this is an actual situation).    It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Individual vial was multi-dose vial. Vaccine was initially stored in the refrigerator on 15-Jun-2023. Vial did not undergo any temperature excursions. Suspect vaccine dosage text was reported as unknown. Expiry date of the suspect vaccine was 12-Jun-2023 reported as three days after its manufacturer expiration date.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-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) 1 dosage form. On 16-Jun-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 (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) 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 (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Dosage text was reported as unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information of 1st patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-729609, US-MODERNATX, INC.-MOD-2023-729611, US-MODERNATX, INC.-MOD-2023-729613, US-MODERNATX, INC.-MOD-2023-729614 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729613:(Pt 4 of 5) US-MODERNATX, INC.-MOD-2023-729611:(Pt 3 of 5) US-MODERNATX, INC.-MOD-2023-729609:(Pt 2 of 5) US-MODERNATX, INC.-MOD-2023-729614:(Pt 5 of 5)
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administerd expired vaccine/ Patient received the 6th dose (2nd bivalent) as an expired dose on 16Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administerd expired vaccine/ Patient received the 6th dose (2nd bivalent) as an expired dose on 16Jun2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     Patient did not report any relevant medical history, conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     On 16-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administerd expired vaccine/ Patient received the 6th dose (2nd bivalent) as an expired dose on 16Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administerd expired vaccine/ Patient received the 6th dose (2nd bivalent) as an expired dose on 16Jun2023) 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 (Administerd expired vaccine/ Patient received the 6th dose (2nd bivalent) as an expired dose on 16Jun2023).    No concomitant drug was reported.  Reporter wanted to know should the patient received another vaccine, or can they accept the dose given as a proper dose. Reporter did not provide previous dose administered.  No treatment drug was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2023: Live follow-up received: Additional reporter and suspect product information was updated.
Age: 95.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Wrong product administered
Clinical narrative: unknowm side effects due to the vaccine being administered today; Patient received bivalent vaccine as first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (unknowm side effects due to the vaccine being administered today) and WRONG PRODUCT ADMINISTERED (Patient received bivalent vaccine as first dose) in a 95-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     It was unknown if patient had any medical history, allergy, concomitant diseases and risk factor. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 19-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023, the patient experienced IMMUNISATION REACTION (unknowm side effects due to the vaccine being administered today) and WRONG PRODUCT ADMINISTERED (Patient received bivalent vaccine as first dose). At the time of the report, IMMUNISATION REACTION (unknowm side effects due to the vaccine being administered today) and WRONG PRODUCT ADMINISTERED (Patient received bivalent vaccine as first dose) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: the area became red, swollen, and painful; the area became red, swollen, and painful; the area became red, swollen, and painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), in Jun2023 as dose number unknown, single (Lot number: GN1897) at the age of 79 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Jun2023, outcome "recovering" and all described as "the area became red, swollen, and painful".  Additional information: Around 7 days after the shot, the area became red, swollen, and painful. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "tuberculosis" (unspecified if ongoing), notes: fully recovered 30 years ago; "uveitis" (unspecified if ongoing); "Known allergies" (unspecified if ongoing), notes: herpes zoster treatment. The patient's 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-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included: The patient previously receives a COVID-19 Vaccine and did not receive other medication in 2 weeks, then patient received treatment with Paxlovid for positive COVID-19 test from Oct2022 to Oct2022. The vaccine administration time was reported as 02:00 PM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary valve stenosis
Clinical narrative: Pulmonary stenosis; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PULMONARY VALVE STENOSIS (medically significant), outcome "unknown", described as "Pulmonary stenosis". It was unknown if therapeutic measures were taken as a result of pulmonary valve stenosis. Clinical course: Patient who was a nurse reported that she developed pulmonary stenosis following the Pfizer vaccine. It was unknown if other vaccine in four weeks, Other medications in two weeks, had covid prior vaccination and if covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event PULMONARY VALVE STENOSIS  and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Eosinophilic Esophagitis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (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 drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 30May2023 and stop date 04Jun2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300226396 same patient, different drug/AE;
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 as dose 6 (booster), single (Lot number: gj3268) at the age of 84 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Tricor, reaction(s): "Allergy to Tricor"; Celebrex, reaction(s): "Allergy to Celebrex"; Protonix, reaction(s): "Allergy to Protonix". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2023) negative; (07Jun2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 02Jun2023 and stop date 06Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300226561 Same patient, different drug and event;
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result= Positive; Covid test result= Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 at 12:00 as dose 1, single (Lot number: EP7543), in left arm, on 26Apr2021 at 12:00 as dose 2, single (Lot number: ER8729), in left arm and on 08Feb2022 at 12:00 as dose 3 (booster), single (Lot number: FK9729) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Surgery" (unspecified if ongoing), notes: Surgery at 14, otherwise perfectly healthy. Normal BMI, former college athlete.; "COVID-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid test result= Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Took 20 different ones. Clinical course: Patient did not received any other vaccine in four weeks, not received other medications in two weeks  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225413 Same patient/drug, different dose/events;
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: hive like reaction; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 14Jun2023 as dose 1, 0.5 ml single (Lot number: GF4142, Expiration Date: 30Aug2025) at the age of 18 years intramuscular, in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (medically significant) with onset 15Jun2023, outcome "unknown", described as "hive like reaction". The event "hive like reaction" required physician office visit. Therapeutic measures were taken as a result of urticaria. Clinical course: The patient got a hive like reaction on her chest, abdomen and back on 15Jun2023. Seriousness criteria was medically significant from a medical standpoint. Causality: directly related to the vaccine because after they did a whole health history there was not anything new except that regarding this first dose of the patient's Trumenba vaccine. Treatment: They recommended she take two different types of antihistamines and it was Benadryl as needed and Zyrtec every night at bedtime. For the time of administration of the Trumenba, caller states they put her vital signs in at 2:58pm so the vaccine would have been administered probably around 3:15pm and 3:30pm roughly. The patient has no drug allergies or food allergies or environmental allergies and has no history of any allergies.; Sender's Comments: Based on the close temporal relationship, the association between the event urticaria with TRUMENBA can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Oral discomfort, Taste disorder
Clinical narrative: hot mouth; Everything tastes spicy; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient 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: ORAL DISCOMFORT (non-serious), outcome "unknown", described as "hot mouth"; TASTE DISORDER (non-serious), outcome "unknown", described as "Everything tastes spicy". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash/non-urticarial not specified; Initial information received on 16-Jun-2023 regarding an unsolicited valid non-serious Courtesy case received from Pfizer via other health professional.  This case involves Adult and unknown gender patient who experienced rash/non-urticarial not specified while receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection in Pre-filled syringe (route,  administration site, lot number, strength, expiry date, dose not reported) as prophylactic vaccination.  On an unknown date the patient developed a non-serious rash/non-urticarial not specified (rash) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Erythema, Hypersensitivity, Injection site rash
Clinical narrative: allergic reaction to the Tdap; rash approximately 5 inches at and around the injection site; chills; muscle soreness; joint soreness and aches; swelling; erythema; Initial information received on 27-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old male patient who had allergic reaction to the tdap, chills, muscle soreness, joint soreness and aches, swelling, erythema and rash approximately 5 inches at and around the injection site while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-May-2022, the patient received a  fifth dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE , (lot:  U7271AA ; expiry date: not reported) via intramuscular route in the left deltoid for immunization.  On the same day,  the patient developed a non-serious event of  allergic reaction to the tdap (allergy to vaccine) , chills , muscle soreness (myalgia), joint soreness and aches (arthralgia), swelling, erythema, rash approximately 5 inches at and around the injection site (vaccination site rash)  following the fifth dose administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient's mother took him to urgent care on 25-May-2022 and they gave medications to soothe the symptoms  Action taken : not applicable for all the events.  The patient was treated with PARACETAMOL (TYLENOL),  DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) , LORATADINE (CLARITIN [LORATADINE])  and IBUPROFEN (IBUPROFEN) for Vaccination site rash, Allergy to vaccine, Chills, Myalgia, Arthralgia, Swelling and Erythema.  Outcome: not recovered for all the events
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Swelling
Clinical narrative: allergic reaction to the Tdap; rash approximately 5 inches at and around the injection site; chills; muscle soreness; joint soreness and aches; swelling; erythema; Initial information received on 27-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old male patient who had allergic reaction to the tdap, chills, muscle soreness, joint soreness and aches, swelling, erythema and rash approximately 5 inches at and around the injection site while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-May-2022, the patient received a  fifth dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE , (lot:  U7271AA ; expiry date: not reported) via intramuscular route in the left deltoid for immunization.  On the same day,  the patient developed a non-serious event of  allergic reaction to the tdap (allergy to vaccine) , chills , muscle soreness (myalgia), joint soreness and aches (arthralgia), swelling, erythema, rash approximately 5 inches at and around the injection site (vaccination site rash)  following the fifth dose administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient's mother took him to urgent care on 25-May-2022 and they gave medications to soothe the symptoms  Action taken : not applicable for all the events.  The patient was treated with PARACETAMOL (TYLENOL),  DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) , LORATADINE (CLARITIN [LORATADINE])  and IBUPROFEN (IBUPROFEN) for Vaccination site rash, Allergy to vaccine, Chills, Myalgia, Arthralgia, Swelling and Erythema.  Outcome: not recovered for all the events
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Induration, Injection site oedema, Injection site swelling, Vaccination site erythema
Clinical narrative: swelling at the injection site and edema measuring 13 cm x 10 cm;, of the right arm, after the adacel vaccine was administered subcutaneously; area is surrounded by an area of erythema; patientt received the vaccine to the back of arm subcutaneous instead of Intramuscular; Initial information received on 15-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 53 years old female patient who had swelling at the injection site and edema measuring 13 cm x 10 cm;, of the right arm, after the adacel vaccine was administered subcutaneously, area is surrounded by an area of erythema and patient received the vaccine to the back of arm subcutaneous instead of intramuscular after receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's family history included Cellulitis staphylococcal. The patient's past medical history, medical treatment(s), vaccination(s) was not provided.   On 11-Jun-2023, the patient received a 0.5 ml once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection, lot L17837AA, 25-Jul-2025 via subcutaneous route in the back of the right arm for Prophylactic Vaccination(immunisation).  On 11-Jun-2023 the patient developed a non-serious swelling at the injection site and edema measuring 13 cm x 10 cm; of the right arm, after the adacel vaccine was administered subcutaneously (vaccination site swelling), area is surrounded by an area of erythema (vaccination site erythema) and patient received the vaccine to the back of arm subcutaneous instead of intramuscular (incorrect route of product administration) (latency: same day).  The swelling is to the right arm; that the swelling is described as having hard tissue area measuring 5 cm x 6 cm and that area is surrounded by an area of erythema and edema measuring 13 cm x 10 cm.  Lab data was not reported.  Action taken was not applicable.  The patient was treated with DOXYCYCLINE (DOXYCYCLINE) for Vaccination site swelling.  Outcome: Recovering / Resolving for the event swelling at the injection site and edema measuring 13 cm x 10 cm;, of the right arm, after the adacel vaccine was administered subcutaneously, area is surrounded by an area of erythema and was Unknown for the event patientt received the vaccine to the back of arm subcutaneous instead of intramuscular.  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: MNQ
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was around 69 years old or 70 years old when patient received menactra dose with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a physician  This case involves Elderly (74-75 years of age) and unknown gender patient who received Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] dose when patient was around 69 years old or 70 years old with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (lot number, expiry date, dosage- not reported) via unknown route in unknown administration site for Immunization, when patient was around 69 years old or 70 years old with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Information on the batch number was requested  Reportedly, Doctor asking if MENACTRA is a life-long meningococcal vaccine? Doctor also asked if a patient received MENACTRA before, does the patient still need to get it or not? He also asked if less than 4 years have elapsed since the prior dose, can the patient still get another dose?  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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: F
Vaccine: TD
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccines exposed to reaching 24.7 degrees C for 2-hour 23 minutes and then 42.6 degrees C for 1-hour and 30-minutes due to a reason unknown with no reported adverse event; consumer received a dose of Tenivac after it was exposed to unsuitable temperatures with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 56 years old female patient who received a dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] after it was exposed to unsuitable temperature reaching 24.7 degrees C for 2-hour 23 minutes and then 42.6 degrees c for 1-hour and 30-minutes due to a reason unknown with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Jun-2023, the patient received 0.5 ml dose (strength: standard; frequency: once) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection of lot U7679AA and expiry: 25-Mar-2024 via intramuscular route in the right deltoid for immunization.  On an unknown date, it was reported that Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult vaccine was exposed to reaching 24.7 degrees C for 2-hour 23 minutes and then 42.6 degrees C for 1-hour and 30-minutes due to a reason unknown with no reported adverse event (product storage error) (unknown latency).  On 15-Jun-2023, the patient received a dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult vaccine after it was exposed to unsuitable temperatures with no reported adverse event (poor quality product administered) (latency: 1 day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both 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 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.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Flublok quadrivalent vaccine that was expired administered to a patient, with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who had flublok quadrivalent vaccine that was expired administered to a patient, with no reported adverse event after receiving vaccine influenza quadrivalent recombinant vaccine [flublok qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Jun-2023, the patient received a Booster dose, once of suspect influenza quadrivalent recombinant vaccine lot UJ891AA, 14-JUN-2023 via intramuscular route in the deltoid nos for Immunization.  On 15-JUN-2023 the patient developed a non-serious flublok quadrivalent vaccine that was expired administered to a patient, with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event flublok quadrivalent vaccine that was expired 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 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.
Age: 12.0
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: received two doses in 2017 and never received the third booster dose. They are a category risk 3 and require a booster dose due to travel with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA187322.  This case involves a 12 years old and unknown gender patient who, received two doses Of Rabies (Hdc) Vaccine [Imovax Rabies] in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient received two doses of suspect Rabies (Hdc) Vaccine (lot number: not reported, Expiry date: not reported) via unknown route in unknown administration site, indication: prophylactic vaccination) in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event (inappropriate schedule of product administration).  Action taken with Rabies Vaccine was not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Blood magnesium decreased, Blood potassium decreased, Blood test, Cardiac arrest
Clinical narrative: Was pregnant at time of vaccination. Only in 1st trimester, Maybe 6 weeks. After the shot I had extreme diarrhea till I was 16/17 weeks. Then I had a sever rash all over my face in the second trimester. All things I never experienced with my first pregnancy. I had extremely low potassium and magnesium to the point of needing medication at the ER. Delivered and she was 7.7 pounds. I was pregnant again, found out 1/20/2023 and went into cardiac arrest 1/21/2023. Confirmed non viable 2/9/2023 and took miscarriage medication 2/11/2023. I?ve never had a miscarriage before. Drs don?t know if I already had a PE on my lungs prior or from CPR my husband administered during my SCA. I?ve seen many drs and still cannot determine why this happened to me. I?m a perfectly healthy 30 year old with no family history of LQTS.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Cytogenetic analysis, Decreased embryo viability, Delivery, Diarrhoea
Clinical narrative: Was pregnant at time of vaccination. Only in 1st trimester, Maybe 6 weeks. After the shot I had extreme diarrhea till I was 16/17 weeks. Then I had a sever rash all over my face in the second trimester. All things I never experienced with my first pregnancy. I had extremely low potassium and magnesium to the point of needing medication at the ER. Delivered and she was 7.7 pounds. I was pregnant again, found out 1/20/2023 and went into cardiac arrest 1/21/2023. Confirmed non viable 2/9/2023 and took miscarriage medication 2/11/2023. I?ve never had a miscarriage before. Drs don?t know if I already had a PE on my lungs prior or from CPR my husband administered during my SCA. I?ve seen many drs and still cannot determine why this happened to me. I?m a perfectly healthy 30 year old with no family history of LQTS.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Implantable defibrillator insertion, Intensive care, Long QT syndrome, Magnetic resonance imaging
Clinical narrative: Was pregnant at time of vaccination. Only in 1st trimester, Maybe 6 weeks. After the shot I had extreme diarrhea till I was 16/17 weeks. Then I had a sever rash all over my face in the second trimester. All things I never experienced with my first pregnancy. I had extremely low potassium and magnesium to the point of needing medication at the ER. Delivered and she was 7.7 pounds. I was pregnant again, found out 1/20/2023 and went into cardiac arrest 1/21/2023. Confirmed non viable 2/9/2023 and took miscarriage medication 2/11/2023. I?ve never had a miscarriage before. Drs don?t know if I already had a PE on my lungs prior or from CPR my husband administered during my SCA. I?ve seen many drs and still cannot determine why this happened to me. I?m a perfectly healthy 30 year old with no family history of LQTS.