chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Headache, Myalgia
Clinical narrative: Atrial fibrillation; Muscle aches; Headache; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2023AMR092037).   On 27-JUN-2023, the patient received the 2nd dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle aches) and headache (Verbatim: Headache). On 27-JUN-2023, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was not resolved and the outcome of the muscle pain and headache were unknown.   It was unknown if the reporter considered the atrial fibrillation, muscle pain and headache to be related to Shingrix.     It was unknown if the company considered the atrial fibrillation, muscle pain and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR092037   Additional Information: GSK Receipt date: 29-JUN-2023 The patient self-reported this case. The patient had headache and muscle aches but also stated he experienced atrial fibrillation that began one hour after the administration of Shingrix. The reporter stated that his diagnosis was confirmed as atrial fibrillation on 29th June 2023. The reporter stated that his cardiologist would perform a cardioversion on him soon.  The reporter consented to follow up. This case was linked with case US2023AMR092037 with Same patient.; Sender's Comments:  US-GSK-US2023AMR092037:Same patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered before recommended age for Shingrix; Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered before recommended age for Shingrix) and incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK receipt date: 29-JUN-2023 and 30-JUN-2023 The reporter mentioned patient was mid 40 years old but no exact age was reported. The pharmacist reported that patient had a first dose of Shingrix in approximately in 2020 and had not received a second dose yet. No exact details were reported about initials, vaccination date or vaccine information.  The reporter did not mentioned if patient was immunocompromised or not and a callback attempt was made being unable to contact hcp. The patient received 1st dose of Shingrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st October 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-JUN-2023 The reporter reported that patient got 1st dose of Shingrix on 31st October 2022 and never got the 2nd dose which led to incomplete course of vaccination. The reporter wanted to know if the patient needed to be revaccinated. The reporter consented to follow up via phone or fax.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number YA39L, expiry date 08-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 16-MAY-2023, the patient received the 2nd dose of Shingrix. On 16-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: early 2nd dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 29-JUN-2023 A pharmacist reported that a patient received the 2nd dose of Shingrix only 1 month and 3 days after the 1st dose which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Monocyte count increased
Clinical narrative: Elevated monocytes; This non-serious case was reported by a consumer via call center representative and described the occurrence of monocyte count increased in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-JUN-2023, the patient received the 2nd dose of Shingrix. On 29-JUN-2023, 3 days after receiving Shingrix, the patient experienced monocyte count increased (Verbatim: Elevated monocytes). The outcome of the monocyte count increased was unknown.   It was unknown if the reporter considered the monocyte count increased to be related to Shingrix.     It was unknown if the company considered the monocyte count increased to be related to Shingrix.   Additional Information: GSK Receipt date: 30-JUN-2023 A reporter reported about him self she received her second dose of SHINGRIX on Monday 26 June 2023 and the patient had routine blood work, in preparation for a physical on Thursday, 29 June 2023. The lab work showed elevated monocytes. The reporter wanted to knowcan Shingrix cause elevated monocyte levels. The reporter was consented to follow up. This case has been linked with case US2023090631 reported by same reporter.; Sender's Comments:  US-GSK-US2023090631:Same Reporter
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA934A, expiry date 30-JUN-2024) for prophylaxis.   On 29-JUN-2023, the patient received Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 30 Jun 2023: The nurse stated that patient was administered a dose of Menveo on 29th June 2023 that was reconstituted with a sterile diluent instead of the supplied liquid CYW-135 component. At the time of reporting, a repeat dose had not been administered. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient was administered a dose of Menveo that was reconstituted with a sterile diluent instead of the supplied liquid CYW-135 component which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number Y227N, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 30-JUN-2023, the patient received the 2nd dose of Shingrix. On 30-JUN-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date 30 Jun 2023: The pharmacist reported an early second dose of Shingrix was administered. The patient consented to follow up via email. The patient received early second dose of Shingrix which led to shortening of vaccination schedule.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: she had a high fever / low grade fever; arm was swollen after administration; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: arm was swollen after administration) and chills (Verbatim: chills). On 29-JUN-2023, the patient experienced fever (Verbatim: she had a high fever / low grade fever). The outcome of the fever was resolving and the outcome of the swelling arm and chills were unknown.   It was unknown if the reporter considered the fever, swelling arm and chills to be related to Shingrix.     It was unknown if the company considered the fever, swelling arm and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The patient self-reported this case. Less than a day after vaccination, the patient had fever. On the day of reporting, the patient stated her fever had decreased to a low-grade fever. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Visual impairment
Clinical narrative: Cramping behind the legs; Visual Changes/vision changed; This non-serious case was reported by a consumer via call center representative and described the occurrence of leg cramps in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced leg cramps (Verbatim: Cramping behind the legs) and visual disturbance (Verbatim: Visual Changes/vision changed). The outcome of the leg cramps and visual disturbance were not resolved.   It was unknown if the reporter considered the leg cramps and visual disturbance to be related to Shingrix.     It was unknown if the company considered the leg cramps and visual disturbance to be related to Shingrix.   Additional Information: GSK receipt date 30 Jun 2023: The patient was the reporter who desired to remain anonymous.  The patient would not release any information, except 5 days after taking her Shingrix vaccine her vision changed and her back of legs started cramping, this was ongoing. The patient asked if Shingrix caused these.
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 59 year old patient was inadvertently administered a Menveo 2 vial dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 59-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 29-JUN-2023, the patient received Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: A 59 year old patient was inadvertently administered a Menveo 2 vial dose ). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 03-JUL-2023 The reporter wanted to know how to proceed. The reporter asked as the patient need to be revaccinated with another age appropriate product. The reporter unable to provide full vaccine and patient details. The reporter did not consent to follow up. The patient received Menveo vaccine who was older than the indicated age which led to inappropriate age at vaccine administration.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number NC7GR, expiry date 17-JUL-2023) for prophylaxis.   On 03-JUL-2023, the patient received Havrix. On 03-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Havrix). The outcome of the expired vaccine used 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: 03-JUL-2023 The reporter consented to follow up by email. The reporter reported that a patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 21.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Inappropriate Age; Wrong vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-year-old female patient who received DTPa (Infanrix) (batch number Y42F9, expiry date 03-MAR-2024) for prophylaxis.   On 03-JUL-2023, the patient received Infanrix. On 03-JUL-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age) and wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 03-JUL-2023 The reporter was a medical assistant. The reporter called to inquire that how to proceed with series and what to look for in the patient or any side effects. The reporter mentioned that the Boostrix dose would have been a second Tdap for the patient. The reporter consented to follow up. The reporter reported that Infanrix dose was administered to a 21 year old patient at the time of reporting, when the patient was ordered to receive a Boostrix dose, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Rotarix - Administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number KX5XM, expiry date 01-JUL-2023) for prophylaxis.   On 03-JUL-2023, the patient received Rotarix lyophilized formulation. On 03-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Rotarix - Administration of expired dose). The outcome of the expired vaccine used 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: 3-Jul-2023 The vaccine coordinator asked if the patient had to be revaccinated. The reporter consented to follow-up. The patient received an expired dose of Rotarix, which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain, Nausea, Pyrexia
Clinical narrative: felt feverish; nausea that resolved the next day; she had fatigue; experienced injection site pain that lasted for several days; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 19-JUN-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: experienced injection site pain that lasted for several days), nausea (Verbatim: nausea that resolved the next day) and fatigue (Verbatim: she had fatigue). On an unknown date, the patient experienced fever (Verbatim: felt feverish). The patient was treated with ibuprofen (Motrin). On 20-JUN-2023, the outcome of the nausea was resolved.  On 22-JUN-2023, the outcome of the fatigue was resolved. The outcome of the injection site pain and fever were resolved.   It was unknown if the reporter considered the injection site pain, fever, nausea and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, nausea and fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The reporter was the patient.  The patient received her first Shingrix dose and immediately experienced injection site pain that lasted for several days. She treated the pain with Motrin.  The evening of the vaccination she had nausea that resolved the next day. Beginning on the date of vaccination she had fatigue and felt feverish, which both resolved. Nothing else was reported. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than Recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd January 2023).   On 01-MAY-2023, the patient received the 2nd dose of Twinrix. On 01-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than Recommended Interval). 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: 03-JUL-2023 The pharmacist would like to know how to proceed for the 3rd dose in the series. The reporter consented to follow up. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: diluent only administered; diluent only administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 15-month-old male patient who received MMR (Priorix) (batch number CT34G, expiry date 26-DEC-2025) for prophylaxis.   On 28-JUN-2023, the patient received Priorix. On 28-JUN-2023, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: diluent only administered) and inappropriate dose of vaccine administered (Verbatim: diluent only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 3-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient received only the diluent portion of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was 18 months of age at time of vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 31-MAY-2023, the patient received Kinrix. On 31-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient was 18 months of age at time of vaccination). The outcome of the inappropriate age at vaccine administration 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: 03-JUL-2023 The recommended dose schedule stated that Kinrix might be used for the fifth dose in the DTaP immunization series and the fourth dose in the IPV immunization series in children aged 4 through 6 years (prior to the seventh birthday)whose previous DTaP vaccine doses had been with Infanrix and/or Pediarix for the first 3 doses and Infanrix for the fourth dose.  The reporter called as a precautionary measure, seeking information on possible adverse events that might arise.  No adverse events had been reported by child's guardian as of present time. The reporter transferred to medical information. The reporter consented to follow up. The reporter reported that an 18 months of age patient received a dose of the Kinrix vaccine, which led to inappropriate age at vaccine administration.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia, Rhinorrhoea, Vaccination site pain
Clinical narrative: Flu like symptoms; sniffles; little warm temperature of 100 degrees Fahrenheit; injection site was warm to the touch; sore when pressed on; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site was warm to the touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles), VACCINATION SITE PAIN (sore when pressed on) and PYREXIA (little warm temperature of 100 degrees Fahrenheit) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A, 048B21A and 0314210) for COVID-19 prophylaxis.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE WARMTH (injection site was warm to the touch) and VACCINATION SITE PAIN (sore when pressed on). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles) and PYREXIA (little warm temperature of 100 degrees Fahrenheit). At the time of the report, VACCINATION SITE WARMTH (injection site was warm to the touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles), VACCINATION SITE PAIN (sore when pressed on) and PYREXIA (little warm temperature of 100 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported. The expiry date of the 1st dose was reported as  26-Sep-2021, 2nd dose was reported as 09-Oct-2021. It was reported that after both the 1st and second dose, the injection site was warm to the touch and sore when pressed on. After the booster dose, the patient had flu like symptoms, sniffles and a little warm temperature of 100 degrees Fahrenheit. The patient also took second booster dose on 22-Dec-2022 (lot:057M21A,expiry: 13-Aug-2022). No treatment medication was reported.   This case was linked to MOD-2023-730985 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Flu like symptoms; sniffles; little warm temperature of 100 degrees Fahrenheit; injection site was warm to the touch; sore when pressed on; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site was warm to the touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles), VACCINATION SITE PAIN (sore when pressed on) and PYREXIA (little warm temperature of 100 degrees Fahrenheit) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A, 048B21A and 0314210) for COVID-19 prophylaxis.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE WARMTH (injection site was warm to the touch) and VACCINATION SITE PAIN (sore when pressed on). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles) and PYREXIA (little warm temperature of 100 degrees Fahrenheit). At the time of the report, VACCINATION SITE WARMTH (injection site was warm to the touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), RHINORRHOEA (sniffles), VACCINATION SITE PAIN (sore when pressed on) and PYREXIA (little warm temperature of 100 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported. The expiry date of the 1st dose was reported as  26-Sep-2021, 2nd dose was reported as 09-Oct-2021. It was reported that after both the 1st and second dose, the injection site was warm to the touch and sore when pressed on. After the booster dose, the patient had flu like symptoms, sniffles and a little warm temperature of 100 degrees Fahrenheit. The patient also took second booster dose on 22-Dec-2022 (lot:057M21A,expiry: 13-Aug-2022). No treatment medication was reported.   This case was linked to MOD-2023-730985 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Same reporter (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 4th out of 10 infant patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    No concomitant medication was reported.  No treatment information was reported  This case contains information for patient 9 out of 10.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Wrong formulation to 10 patients. Patients 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. This case is reported for patient 10 out of 10 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Same reporter
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine adminitsred to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine adminitsred to patient) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-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 (Expired vaccine adminitsred to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine adminitsred to patient) 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 (Expired vaccine adminitsred to patient).    Patient have received first dose on 18-AUG-2021.  No concomitant medication was reported.  The vaccine been expired about 8 or more days. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731750 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731750:Same reporter
Age: 71.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired Moderna that was administered to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna that was administered to two patients) and NO ADVERSE EVENT (no adverse event) in a 71-year-old 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-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 (expired Moderna that was administered to two patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna that was administered to two patients) 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 (expired Moderna that was administered to two patients).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as 12-Jun-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731728 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731728:Patient 2
Age: 69.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination) and NO ADVERSE EVENT (No adverse event) in a 69-year-old 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. 045H22A) 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) .5 milliliter. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination) 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 (Inquire about the viability of expired Moderna that was administered to two patients and the validity of their vaccination).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as 12-Jun-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731716 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731716:Master case