chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation error
Clinical narrative: supposed to receive PENTACEL yesterday, but was accidentally given the HIB component with no reported AE; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was supposed to receive pentacel yesterday, but was accidentally given the hib component with no reported ae while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 25-Oct-2022, the patient received 0.5 mL of dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot UJ684AAA) via intramuscular route in the intramuscular thigh for prophylactic vaccination.  On 25-Oct-2022, (latency: same day) the patient was supposed to receive pentacel yesterday, but was accidentally given the hib component with no reported ae (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was reported, a four month old baby was supposed to receive PENTACEL yesterday, but was accidentally given the HIB component mixed with sterile diluent instead of the DTAP and POLIO component.   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 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: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: eligible to receive the FLUZONE HIGH-DOSE QUADRIVALENT received the FLUZONE QIV NP because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event; eligible to receive the FLUZONE HIGH-DOSE QUADRIVALENT received the FLUZONE QIV NP because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves Elderly and unknown gender patient who was eligible to receive the fluzone high-dose quadrivalent received the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Influenza.  On an unknown date the patient eligible to receive the fluzone high-dose quadrivalent received the fluzone qiv np because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event (wrong product administered, product administered to patient of inappropriate age) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: Not applicable.  Outcome: Unknown for both 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 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: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 2 month old patient received the product FLUZONE QIV NP with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who received the product fluzone qiv np (INFLUENZA QUADRIVAL A-B VACCINE) 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 ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 26-Oct-2022, at 11 am, the patient received a first dose of 0.5ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UT7741JA, expiration date: 30-Jun-2023, via intramuscular route in the left thigh as Immunization.  On 26-OCT-2022, at 11 am, a 2 month old patient received the product fluzone qiv np with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient used the product for the first time and was not using the product now.  Action taken was 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   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: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to cases 2022SA446068(CLUSTER), 2022SA447057(CLUSTER), 2022SA447385(CLUSTER), 2022SA447853(CLUSTER), 2022SA448075(CLUSTER), 2022SA446195(CLUSTER), 2022SA447822(CLUSTER), 2022SA448121(CLUSTER) and 2022SA447057(CLUSTER).  This case involves a 59 years old female patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 18-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 18-Oct-2022 the patient developed a non-serious under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both 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 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: 23.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered FLUZONE HD QIV instead of the FLUZONE QIV. with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves a 23 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2022 the patient developed a non-serious event of administered fluzone hd qiv (dose: 0.7ml, 1X(once), intramuscularly in left deltoid, batch number: UT7729CA and expiry date: 30-Jun-2023 for Immunization) instead of the fluzone qiv. with no reported adverse event (wrong product administered) (Latency: same day).   Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves a 22 years old female patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 15-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a total dose of 0.7 ml once (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 15-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both 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 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: 35.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case is linked to cases 2022SA447057(CLUSTER) and 2022SA446385(CLUSTER).  This case involves a 35 years old male patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 04-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 04-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both 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 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: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: injecting expired ACTHIB on a patient/ActHIB was given after the expiration date of the diluent (with no reported adverse event); Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient who was injected expired acthib on a patient/acthib was given after the expiration date of the diluent (with no reported adverse event) while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported  (expiration date :17-Sep-2022 of powder and 15-Oct-2022  of diluent) at an unknown dose for via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date (latency: same day), the patient was injected  expired acthib on a patient/acthib was given after the expiration date of the diluent (with no reported adverse event) (expired product administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient that was under the age of 65 being administered FLUZONE HIGH DOSE QIV instead of the FLUZONE QIV at a flu clinic with no reported adverse event; patient that was under the age of 65 being administered FLUZONE HIGH DOSE QIV instead of the FLUZONE QIV at a flu clinic with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER), 2022SA446068(CLUSTER), 2022SA447385(CLUSTER), 2022SA447853(CLUSTER), 2022SA446195(CLUSTER), 2022SA447822(CLUSTER) and 2022SA448121(CLUSTER).  This case involves a 62 years old female patient who was under the age of 65 being administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the fluzone qiv at a flu clinic with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 04-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.7 ml total once(lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 04-Oct-2022 the patient under the age of 65 being administered fluzone high dose qiv instead of the fluzone qiv at a flu clinic with no reported adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: Not applicable.  Outcome: Unknown for both 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 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: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 1st dose April2022, 2nd July 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old male patient who received HAB (Twinrix) (batch number j477y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in April 2022).   On 12th July 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th July 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The pharmacist reported that the patient was late for the second dose of Twinrix. No adverse event was reported. No data provided for the first dose of Twinrix. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient ever tested positive or diagnosed with COVID-19.  Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] on 11-Oct-2022. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE]. Concurrent medical conditions included Penicillin allergy.    On 31-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022).    Concomitant drugs were not reported. Patient received Dose 1 of Moderna on 06-Jan-2021 lot number 012L20A. Patient received Dose 2 of Moderna on 03-Feb-2021 lot number 010M20A. Patient received Dose 3 of Moderna on 16-Nov-2021 lot number 077C21B.  The 2.5 ml individual vial was initially stored in refrigerator on 29-Sep-2022 and did not undergo any temperature excursion.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation reaction
Clinical narrative: did not feel that great after Covid vaccines; SHINGLES; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (SHINGLES) and IMMUNISATION REACTION (did not feel that great after Covid vaccines) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In May 2022, the patient experienced HERPES ZOSTER (SHINGLES). On an unknown date, the patient experienced IMMUNISATION REACTION (did not feel that great after Covid vaccines). At the time of the report, HERPES ZOSTER (SHINGLES) outcome was unknown and IMMUNISATION REACTION (did not feel that great after Covid vaccines) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  The reporter's causality for the event of Shingles and did not feel that great after Covid vaccines with Humira was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment medication was provided by the reporter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Inappropriate schedule of product administration, Peripheral coldness
Clinical narrative: Hand feeling cold; Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb; First dose on 01-Apr-2021 and second dose on 02-Feb-2022; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Hand feeling cold), CYANOSIS (Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01-Apr-2021 and second dose on 02-Feb-2022) in a 27-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Feb-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01-Apr-2021 and second dose on 02-Feb-2022). On 16-Sep-2022, the patient experienced PERIPHERAL COLDNESS (Hand feeling cold) and CYANOSIS (Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb). At the time of the report, PERIPHERAL COLDNESS (Hand feeling cold) and CYANOSIS (Pointer finger of both hands was turning blue from tip to first knuckle below nail bed/discoloration got worse/discoloration of thumb) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 01-Apr-2021 and second dose on 02-Feb-2022) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in COVID-19 vaccine Trial. The reporter causality for the event cold hands with cosuspect humira  was assessed as probable. The reporter causality for the event cyanosis peripheral with cosuspect humira drug was assessed as probable. No treatment medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Diabetes, Neuropathy, Blood pressure high and High cholesterol. Concomitant products included Telmisartan; Atorvastatin; Lantus; Lyrica; Finasteride; Tylenol with Codeine; Carbidopa/Levodopa; Baclofen; Aspirin [Acetylsalicylic Acid] for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2022-666611 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Ultrasound scan
Clinical narrative: lumps in the armpits, same arm of the injection, sometimes gets it in both; This spontaneous case was reported by a patient and describes the occurrence of AXILLARY MASS (lumps in the armpits, same arm of the injection, sometimes gets it in both) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 014C21A and 032B21A) for COVID-19 vaccination.     Patient had no medical history. Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included House dust mite allergy and Allergy to molds.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (lumps in the armpits, same arm of the injection, sometimes gets it in both). At the time of the report, AXILLARY MASS (lumps in the armpits, same arm of the injection, sometimes gets it in both) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: didn't turn out to be breast cancer.         Concomitant drugs were not reported. It was reported that patient had lump in armpit sometime in vaccination arm and sometime in both arm. Patient did not experience a similar event in the past and event happened repeatedly 5 times so far. Treatment medications were not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Loss of personal independence in daily activities, Myalgia, Nausea, Vomiting
Clinical narrative: Diarrhea; Couldn't function; Big wave of nausea; Vomiting; Severe body aches at night/had body aches; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't function), MYALGIA (Severe body aches at night/had body aches), NAUSEA (Big wave of nausea) and VOMITING (Vomiting) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051022A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (No hospitalization) on 28-Dec-2021. Previously administered products included for Product used for unknown indication: Pfizer (Primary Dose 1), Pfizer (Booster) and Pfizer (Primary Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Blood pressure high, Bone density abnormal (Bone density), Latex allergy and Penicillin allergy. Concomitant products included LISINOPRIL for Blood pressure high.    On 25-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Oct-2022, the patient experienced MYALGIA (Severe body aches at night/had body aches). On 26-Oct-2022, the patient experienced DIARRHOEA (Diarrhea), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't function), NAUSEA (Big wave of nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't function), MYALGIA (Severe body aches at night/had body aches), NAUSEA (Big wave of nausea) and VOMITING (Vomiting) had resolved.            Concomitant medication includes unspecified medication for Stomach acid and generic avista for bone density. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The AE didn't cause patient to seek medical. The patient did not experienced a similar event in the past. The symptoms had improved.   This case was linked to US-MODERNATX, INC.-MOD-2022-666766 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666766:Husband case
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Gait disturbance, Illness, Pain
Clinical narrative: Deathly sick; Thought she was going to die/ Amost died; Could barely walk; Could barely see; Could not breath; Had a great deal of pain; Urinary infection; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (Urinary infection), ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk) and VISUAL IMPAIRMENT (Could barely see) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (3 months ago). Concurrent medical conditions included Pollen allergy, Drug allergy (Codeine), Penicillin allergy, Drug allergy (Tramadol) and Thyroid disorder NOS.    On 20-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced URINARY TRACT INFECTION (Urinary infection). On 20-Oct-2022, the patient experienced ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk), VISUAL IMPAIRMENT (Could barely see), DYSPNOEA (Could not breath) and PAIN (Had a great deal of pain). At the time of the report, URINARY TRACT INFECTION (Urinary infection) outcome was unknown and ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk), VISUAL IMPAIRMENT (Could barely see), DYSPNOEA (Could not breath) and PAIN (Had a great deal of pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications included Thyroid medication and pain killers. Patient received first dose of Moderna COVID-19 vaccine on 10-Feb-2021 (Lot Number: 031L2BA), second dose on 09-Mar-2021 (Lot Number: 010A21A), 1st Booster Dose on 27-Oct-2022 (Lot Number: 939905). Patient received the Moderna COVID-19 bivalent vaccine on 20-Oct-2022 and patient almost died after this. Patient was so deathly sick. Patient stated that some hours after patient received the vaccine, patient could barely walk and see. Patient could not breath. Patient had a great deal of pain. Patient called her vaccination provider, and they said it would wear off. Patient thought she was going to die. After 4 days the symptoms subside. Patient also has a urinary infection last week. No treatment medications were reported.   This case was linked to MOD-2022-667037 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urinary tract infection, Visual impairment
Clinical narrative: Deathly sick; Thought she was going to die/ Amost died; Could barely walk; Could barely see; Could not breath; Had a great deal of pain; Urinary infection; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (Urinary infection), ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk) and VISUAL IMPAIRMENT (Could barely see) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (3 months ago). Concurrent medical conditions included Pollen allergy, Drug allergy (Codeine), Penicillin allergy, Drug allergy (Tramadol) and Thyroid disorder NOS.    On 20-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced URINARY TRACT INFECTION (Urinary infection). On 20-Oct-2022, the patient experienced ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk), VISUAL IMPAIRMENT (Could barely see), DYSPNOEA (Could not breath) and PAIN (Had a great deal of pain). At the time of the report, URINARY TRACT INFECTION (Urinary infection) outcome was unknown and ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk), VISUAL IMPAIRMENT (Could barely see), DYSPNOEA (Could not breath) and PAIN (Had a great deal of pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications included Thyroid medication and pain killers. Patient received first dose of Moderna COVID-19 vaccine on 10-Feb-2021 (Lot Number: 031L2BA), second dose on 09-Mar-2021 (Lot Number: 010A21A), 1st Booster Dose on 27-Oct-2022 (Lot Number: 939905). Patient received the Moderna COVID-19 bivalent vaccine on 20-Oct-2022 and patient almost died after this. Patient was so deathly sick. Patient stated that some hours after patient received the vaccine, patient could barely walk and see. Patient could not breath. Patient had a great deal of pain. Patient called her vaccination provider, and they said it would wear off. Patient thought she was going to die. After 4 days the symptoms subside. Patient also has a urinary infection last week. No treatment medications were reported.   This case was linked to MOD-2022-667037 (Patient Link).
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second bivalent dose and it was a Moderna Bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna Bivalent) and NO ADVERSE EVENT (No adverse event) in an 89-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 15-Oct-2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna Bivalent) 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 EXTRA DOSE ADMINISTERED (Patient received a second bivalent dose and it was a Moderna Bivalent).    No concomitant information was reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymphadenitis, Mammogram, Pain in extremity, Ultrasound breast
Clinical narrative: inflammed bilateral lymph nodes in both breasts; arm pain/arm was generally sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain/arm was generally sore) and LYMPHADENITIS (inflammed bilateral lymph nodes in both breasts) in a 65-year-old female 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.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Blood pressure high.   On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced PAIN IN EXTREMITY (arm pain/arm was generally sore). On 29-Oct-2022, the patient experienced LYMPHADENITIS (inflammed bilateral lymph nodes in both breasts). At the time of the report, PAIN IN EXTREMITY (arm pain/arm was generally sore) and LYMPHADENITIS (inflammed bilateral lymph nodes in both breasts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2022, Mammogram: The mammogram showed suspected cortical thickening involving bilateral axillary lymph nodes and possible intramammamry lymph nodes at bilateral upper outer quadrants warranting additional evaluation. On 29-Oct-2022, Ultrasound breast: several lymph nodes with 3 to 4 mm of thickness. The result showed conistencies with inflammed bilateral lymph nodes in both breasts 4 weeks after receiving the Moderna Covid-19 bivalent vaccine.         Patient was using high blood pressure medication as a concomitant medication. On 28-Jan-2021, the patient received first dose of Moderna COVID-19 Vaccine with lot number 007M20A on unknown arm. On 27-Feb-2021, received second dose of Moderna COVID-19 Vaccine with lot number 014M20A on unknown arm. On 15-Nov-2021, received third dose of Moderna COVID-19 Vaccine with lot number 026021A on left arm. On 18-Apr-2022, received fourth dose of Moderna COVID-19 Vaccine with lot number 066K21A on left arm. No treatment information was provided by the reporter.   This case was linked to MOD-2022-667014 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient had COVID positive test or diagnosis; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (patient had COVID positive test or diagnosis) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 031L2BA and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy, Drug allergy (codeine), Penicillin allergy, Drug allergy (tramadol), Thyroid disorder NOS and Pain.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (patient had COVID positive test or diagnosis). At the time of the report, COVID-19 (patient had COVID positive test or diagnosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.         Patient was concomitantly receiving Thyroid medication and pain killers. It was reported that 3 months ago, the patient had COVID positive test or diagnosis. No treatment drug was reported.   This case was linked to MOD-2022-666818 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold; Patient received 1st dose on May 2021 and 2nd dose on Aug 2021; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on May 2021 and 2nd dose on Aug 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on May 2021 and 2nd dose on Aug 2021). In October 2022, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on May 2021 and 2nd dose on Aug 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Tested for Covid twice and the results were negative.         No concomitant medications were reported. Patient had cold 2 weeks ago and it was almost 95 percent recovered. No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Moderna (had some shakiness and shivering, Dose 1, lot number 026L20A) on 07-Jan-2021, Moderna (Dose 2, Lot number 030L20A) on 04-Feb-2021, Moderna (Dose 3 and Lot number 058E21A) on 29-Oct-2021; for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Cold with Moderna; and No adverse event with Flu shot, Moderna and Moderna. Concurrent medical conditions included Heart disorder. Concomitant products included SACUBITRIL, VALSARTAN (ENTRESTO) and CARVEDILOL for Heart disorder.    On 27-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced COVID-19 (Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19). At the time of the report, COVID-19 (Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2022, SARS-CoV-2 test: Positive.     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.   Patient received the regular flu shot two weeks before the Moderna vaccine. Did not have additional information. Patient had some side effects after receiving the Bivalent Booster dose.  Patient was having normal cold symptoms, nothing terrible, a bit of a cold with cough and congestions.  Patient had an appointment scheduled for later the day. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-667350 (Patient Link).