chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen; pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number x723b, expiry date 08-DEC-2024) for prophylaxis.   Concurrent medical conditions included leukemia (was diagnosed before getting Arexvy).   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen) and inappropriate dose of vaccine administered (Verbatim: pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-SEP-2023 The patient was a physician. Pharmacist reported a pharmacy intern gave a dose of the Arexvy adjuvant to a patient, without reconstituting it with the antigen, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. Reporter noted a couple presented to receive doses of Arexvy. One patient received a fully reconstituted dose of Arexvy and the other patient received the adjuvant portion without being reconstituted with the antigen. The reporter was uncertain which patient received the full dose or which patient received the adjuvant only. The reporter consented to follow up. No other details were provided.
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: some of the vaccine leaked out during administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 71-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7594A, expiry date 23-JAN-2025) for prophylaxis.   On 15-SEP-2023, the patient received Arexvy. On 15-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: some of the vaccine leaked out during administration). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 19-SEP-2023 The pharmacy Intern reported that a patient was being administered a dose of Arexvy and some of the vaccine leaked out during administration.  The immunizer believed the patient received most of the dose.  At the time of reporting, no further dosing had been administered. The Vaccine Administration Facility was the same as Primary Reporter. Reporter did not want contact information stored in our database but agreed to follow-up by safety.  Email with contact information will be sent to Safety Team. The reporter consented to follow up. The patient received a dose of Arexvy and some leaked out during administration, which led to incomplete dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: does not think that he ever got his second dose of SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th August 2019).   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 social problem (Verbatim:does not think that he ever got his second dose of SHINGRIX).  The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 19-Sept-2023 The patient did not think that he ever got his second dose of Shingrix because it was right before the covid pandemic and when everything was shut down. Did not consent to follow-up. The patient did not receive the second dose of Shingrix due to covid pandemic, which led to social problem.
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: administration of Arexvy to a patient a portion of the vaccine sprayed out so, an incomplete dose was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 64-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7K545, expiry date 22-OCT-2024) for prophylaxis.   On 16-SEP-2023, the patient received Arexvy. On 16-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: administration of Arexvy to a patient a portion of the vaccine sprayed out so, an incomplete dose was given).  The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 19-Sept-2023 The pharmacist asked for recommendations on this situation. The reporter consented to follow-up. During the process of administration of Arexvy to a patient a portion of the vaccine sprayed out so, an incomplete dose was given, which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of this vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (completed the Shingrix series back in 2019).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: third dose of this vaccine).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The HCP (healthcare professional) was not aware of lot number, or exact date of administration, since administration occurred in a facility unknown to the HCP. The patient received the 3rd dose of Shingrix which led to extra dose administered. The reporter consented to follow up.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Accidental administration of Pediarix instead of Infanrix to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25-MAR-2024) for prophylaxis.   Concomitant products included POLIO VACCINE and HEPATITIS B VACCINE.   On 20-SEP-2023, the patient received Pediarix. On 20-SEP-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Accidental administration of Pediarix instead of Infanrix to a patient).  The outcome of the wrong vaccine administered 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: 20-SEP-2023 The reporter reported that the patient accidental received Pediarix instead of Infanrix, which led to wrong vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter stated that pediarix was the patient's 3rd dose of DTaP, Hepatitis B and IPV. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the 1st shot of shingrix then waits between 7 months - 12 months to receive the 2nd shot.; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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: Patient received the 1st shot of shingrix then waits between 7 months - 12 months to receive the 2nd shot.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter wanted to know if the patient received 1st dose of Shingrix vaccine then wait between 7 months to 12 months to receive the 2nd dose. The reporter asked the patient get the 2nd dose or does the patient need to get the 1st dose again then follow up with 2nd dose in the time frame recommended. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLUX, RVX
Symptoms: Pneumonia, Pulmonary embolism
Clinical narrative: pneumonia; pulmonary embolism; This serious case was reported by a physician via call center representative and described the occurrence of pneumonia in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included asthma and chronic obstructive pulmonary disease.   On an unknown date, the patient received RSV vaccine and Flu vaccine. On an unknown date, less than 2 weeks after receiving RSV vaccine and Flu vaccine, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria hospitalization and GSK medically significant) and pulmonary embolism (Verbatim: pulmonary embolism) (serious criteria GSK medically significant).  The outcome of the pneumonia and pulmonary embolism were unknown.   It was unknown if the reporter considered the pneumonia and pulmonary embolism to be related to RSV vaccine and Flu vaccine.     It was unknown if the company considered the pneumonia and pulmonary embolism to be related to RSV vaccine and Flu vaccine.   Additional Information: GSK receipt date: 21-SEP-2023 The Reporter was a GSK employee who was reporting on behalf of an HCP (MD).  The health care professional (HCP) had a patient who received dose of RSV vaccine unknown if Arexvy or Abrysvo.  Patient had a history of Chronic obstructive pulmonary disease (COPD) and asthma.  The patient received another vaccine at the same time as the RSV vaccine which was potentially a flu vaccine. 2 weeks after receiving the RSV vaccine, the patient was hospitalized with pneumonia, duration unknown.  The patient also recently present to the emergency room with pulmonary embolism. The reporter consented to follow up. Note: As vaccine was unknown if AREXVY or ABRYSVO but reported received dose of RSV vaccine so suspect coded as per generic name.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Swelling
Clinical narrative: Red bump; Red bump; Feels strange; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-SEP-2023, the patient received the 1st dose of Shingrix (right arm). On 21-SEP-2023, 1 days after receiving Shingrix, the patient experienced local swelling (Verbatim: Red bump), erythema (Verbatim: Red bump) and weird feeling (Verbatim: Feels strange). The outcome of the local swelling and erythema were resolving and the outcome of the weird feeling was unknown.   It was unknown if the reporter considered the local swelling, erythema and weird feeling to be related to Shingrix.     It was unknown if the company considered the local swelling, erythema and weird feeling to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter reported that the patient received Shingrix vaccine and felt strange. The reporter stated that he had one little red bump that appeared on his left arm opposite his elbow area that looks like it was going away now. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the adjuvant part only of Arexvy on September 20th 2023; patient received the adjuvant part only of Arexvy on September 20th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number T2SV9, expiry date 29-JAN-2025) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy. On 20-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient received the adjuvant part only of Arexvy on September 20th 2023) and inappropriate dose of vaccine administered (Verbatim: patient received the adjuvant part only of Arexvy on September 20th 2023).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-SEP-2023 The pharmacist (who remained anonymous) reported that patient received the adjuvant part only of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow-up.
Sex: U
Vaccine: UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Received a subcutaneous dose of Spikevax PFS instead of intramuscular; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Subcutaneous use) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Subcutaneous use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular).    No relevant concomitant medications were reported. It was unknown if patient had received any other vaccines in 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.
Sex: U
Vaccine: UNK
Symptoms: Polyuria
Clinical narrative: extreme increases in urine; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (extreme increases in urine) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 203e23a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 23-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced POLYURIA (extreme increases in urine). At the time of the report, POLYURIA (extreme increases in urine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741761:Same reporter, same product, different patient (spouse)
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Problems with autoimmune psoriasis (Psoriasis); This spontaneous case was reported by a patient family member or friend and describes the occurrence of PSORIASIS (Problems with autoimmune psoriasis (Psoriasis)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Problems with autoimmune psoriasis (Psoriasis)). At the time of the report, PSORIASIS (Problems with autoimmune psoriasis (Psoriasis)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: The caller informed that the side effects on him are not so adverse but would like to know if Moderna collects information about it.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The caller informed that the side effects on him are not so adverse but would like to know if Moderna collects information about it.) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced IMMUNISATION REACTION (The caller informed that the side effects on him are not so adverse but would like to know if Moderna collects information about it.). At the time of the report, IMMUNISATION REACTION (The caller informed that the side effects on him are not so adverse but would like to know if Moderna collects information about it.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient called to report on a potential adverse effect of the Moderna vaccine that he took on last Friday.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Irritability
Clinical narrative: she feels cranky; Her left arm injection site is a little sore; the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron; This spontaneous case was reported by a nurse practitioner and describes the occurrence of IRRITABILITY (she feels cranky), INJECTION SITE PAIN (Her left arm injection site is a little sore) and PRODUCT LABEL CONFUSION (the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABILITY (she feels cranky), INJECTION SITE PAIN (Her left arm injection site is a little sore) and PRODUCT LABEL CONFUSION (the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron). At the time of the report, IRRITABILITY (she feels cranky), INJECTION SITE PAIN (Her left arm injection site is a little sore) and PRODUCT LABEL CONFUSION (the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had received monovalent vaccine of Moderna vaccine in 2021.  Patient reported she received Spikevax 3030368 on 20-Sep-2023. Her left arm injection site was a little sore and she feels cranky. She further stated the local pharmacy gave her a fact sheet which in the title it states Bivalent and the foot note on page 3 states Spikevax original and Omicron. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-008609 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2023: Live follow up received on 22-Sep-2023, quality complaint number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-008609:Monovalent case
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes; Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes).    Concomitant medications were not reported.  None of the patients have reported any adverse reactions at this time.  Treatment medications were not reported.  This case contains information for patient 03 out of 06.   This case was linked to US-MODERNATX, INC.-MOD-2023-742028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742028:Patient 3 out of 6
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes; Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes).    Concomitant medications were not reported.  None of the patients have reported any adverse reactions at this time.  Treatment medications were not reported.  This case contains information for patient 04 out of 06.   This case was linked to US-MODERNATX, INC.-MOD-2023-742028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742028:Patient 4 out of 6
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes; Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes), POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (they had the Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion yesterday morning for 15 minutes) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Spikevax 2023-2024 single dose vials stored in the freezer that experienced a temperature excursion for 15 minutes).    Concomitant medications were not reported.  None of the patients have reported any adverse reactions at this time.  Treatment medications were not reported.  This case contains information for patient 05 out of 06.   This case was linked to US-MODERNATX, INC.-MOD-2023-742028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742028:Patient 5 out of 6
Age: 23.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Painful swollen fingers; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Painful swollen fingers) in a 23-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced PERIPHERAL SWELLING (Painful swollen fingers). At the time of the report, PERIPHERAL SWELLING (Painful swollen fingers) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had painful swollen fingers in same arm as vaccinations. Unclear if this was from spikevax or the flu vaccine. The patient did not experience any additional symptoms/events.  Treatment medications were not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Pneumonia
Clinical narrative: Pneumonia; Thought it was bronchitis; COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (Pneumonia), BRONCHITIS (Thought it was bronchitis) and COVID-19 (COVID) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), BRONCHITIS (Thought it was bronchitis) (seriousness criterion medically significant) and COVID-19 (COVID) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), BRONCHITIS (Thought it was bronchitis) and COVID-19 (COVID) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 70- year-old, male patient with a history of COVID-19, who experienced the serious (due to medically significant) unexpected events of Pneumonia, Bronchitis and COVID-19. The events occurred on an unknown date after a dose of mRNA-1273 (Spikevax) (date of administration, dose number, prior doses, if applicable, and onset date were not provided; hence, latency could not be estimated). Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the events was not reported. The events Pneumonia and Bronchitis were considered as not related to the vaccine due to lack of biological plausibility. The benefit-risk relationship of mRNA-1273 (Spikevax)  is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Had runny nose and dry cough/positive COVID-19 test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had runny nose and dry cough/positive COVID-19 test) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 001M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol and Overactive bladder (OA bladder). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR OD) for High cholesterol.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (Had runny nose and dry cough/positive COVID-19 test). At the time of the report, COVID-19 (Had runny nose and dry cough/positive COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: not below 96. On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Crestor on Z tab. Other Moderna covid-19 vaccination details were as follows: patient received fourth dose on 09-Oct-2022 with unknown batch number and fifth dose on 19-Sep-2023 with batch number 3030342. Patient's mild symptoms began after second shot of vaccination on Dec-2021 at Christmas time with runny nose and dry cough. Patient did not get hospitalized due to COVID-19. Patient did not have history of Myocarditis/pericarditis. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741466 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741466:Wife case
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: feeling of malaise; achy legs; mild fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling of malaise), PAIN IN EXTREMITY (achy legs) and PYREXIA (mild fever) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 007M20A, 023M20A, 012F21A and 065K21A) for COVID-19 prophylaxis.     No Known Allergies.  The patient's past medical history included COVID-19 (lasted 6 days, very mild, no symptoms) on 15-Apr-2022.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling of malaise), PAIN IN EXTREMITY (achy legs) and PYREXIA (mild fever). At the time of the report, MALAISE (feeling of malaise), PAIN IN EXTREMITY (achy legs) and PYREXIA (mild fever) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient said that the worst one was probably the 2nd dose of the first two where he had a feeling of malaise, achy legs, and mild fever, No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742282:New varient 2023-24
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Immunisation reaction, Malaise, Nausea
Clinical narrative: very bad reaction; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (very bad reaction) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced IMMUNISATION REACTION (very bad reaction) and NAUSEA (Nauseous). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Nauseous, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (very bad reaction) and NAUSEA (Nauseous) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had a very bad reaction. Patient was sick all day after taking the Spikevax. Patient asked her doctor if patient could take the Spikevax if patient was getting a shot on knee. Patient was also on an antibiotic. Patient reported that this was worse than what had in the past and what patient expected.   This case was linked to US-MODERNATX, INC.-MOD-2021-022622 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Sep-2023: Significant information received contains event and Reference ID added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022622:Spikevax 2023-2024 product case
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Caller stated that  stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that  stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that  stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that  stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that  stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months).    No concomitant medication was reported.  Caller's husband came on the line (added as a related contact to this case) and stated that the confusion happened when after he got his shot, the vaccination provider told him to schedule his next shot and to come back in 2 months. Caller then stated that after she got her shot, they figured out that they were looking at the incorrect dosing schedule of the previous vaccinations and that both of them did not need to come back in 2 months. Caller wants to confirm with Moderna whether they received the new Spikevax 2023-2024 formula or not. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741526 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741526:(Husband case)
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months).    Concomitant medication was not provided. Caller stated that there was an issue at their pharmacy where they received the new Spikevax 2023-2024 vaccine. Reporter wants to make sure that they have received the correct vaccine and provided the lot number. Caller's husband came on the line and stated that the confusion happened when he got his shot, the vaccination provider told him to schedule his next shot and to come back in 2 months. They figured out that they were looking at the incorrect dosing schedule of the previous vaccinations and that both of them did not need to come back in 2 months. Caller wants to confirm with Moderna whether they received the new Spikevax 2023-2024 formula or not.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741521 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741521:Wife case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: running nose; coughing; feverish; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (running nose), COUGH (coughing) and PYREXIA (feverish) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis.     No known allergies.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) since an unknown date, Pfizer (Dose 4) since an unknown date, Pfizer (Dose 3) since an unknown date and Pfizer (Dose 2) since an unknown date. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Blood pressure high (does take meds) and Heart disorder (statin for a heart preventative).    On 20-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced RHINORRHOEA (running nose), COUGH (coughing) and PYREXIA (feverish). At the time of the report, RHINORRHOEA (running nose), COUGH (coughing) and PYREXIA (feverish) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. She took their temperature a couple of times and the highest its been is 99 so not really feverish. No treatment medications were provided.