chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Temperature intolerance, Tinnitus, Ultrasound Doppler, Vision blurred
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Visual impairment, X-ray
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive result; positive result; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old patient received BNT162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0202), in left arm and on 17Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "anxiety/depression", start date: 2020 (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Feb2023, outcome "unknown" and all described as "positive result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Feb2023) positive. Clinical Course: Patient reported altered sense of smell since positive case. Both parents of the patient were having medical history of Coronary artery disease/Heart attack. Patient's mother was also having history of diabetes type 2.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300208833 Same patient & drug / different event and dose.;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Chronic obstructive pulmonary disease, Condition aggravated, Pneumonia
Clinical narrative: hair fall; This is a spontaneous report received from a Nurse from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have COPD" (ongoing), notes: I've always taking my vaccines. I have COPD.". The patient's concomitant medications were not reported.  The following information was reported: ALOPECIA (non-serious), outcome "recovering", described as "hair fall".  Clinical course: Patient stated that "I've had it every year since it came out, but, what I am noticing is that especially since I started taking it, every year that I take it my hair starts falling out, I can't even take a bath in my own tub because I have to put the strainer. If I didn't have (nationality) hair I wouldn't have any. I mean, it looks like it died". Patient stated she had a slight language barrier with the last agent, and didn't provide all of the information she is providing now. Patient was also unable to say how many vaccines she's had, she does not have her vaccination card. Patient stated, "I was a nurse, I am a pro vaccine-er. I've always taking my vaccines. I have COPD" Patient also stated, "I have seen some information like on (publisher name), nothing directly from Pfizer on any such thing, and it could be that people don't report some things.  [in audible]".  Patient also reported "I've had a medical condition for 30 years so, um, actually no 23, so this is definitely new. It's not related to any thing GI, it's not related to my lungs, it seems to be directly related to the vaccine". Patient added "she found information related to hair loss on (publisher name), hair loss related to covid vaccine. "It's not specific to one manufacturer. I just called Pfizer because I had/used Pfizer vaccine". Patient further mentioned "I don't mind my hair falling out due to chemo, I don't know if I want to keep doing this. When your hair falls out it's a blob of it, it's like a tennis ball and it just keeps coming through your fingers when it's wet. Patient then clarified that she is not on chemo and stated "I would have to be on chemo before I lost my hair, I would have to be on chemo before I'd take the risk of going bald. I've never been able to see my scalp". Patient further added "It is just now getting better, it seems to get better at the 6 months mark, after I've taken the vaccine... 6 to 9 Months, but with this, it's almost time to take it again".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: hair fall; This is a spontaneous report received from a Nurse from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have COPD" (ongoing), notes: I've always taking my vaccines. I have COPD.". The patient's concomitant medications were not reported.  The following information was reported: ALOPECIA (non-serious), outcome "recovering", described as "hair fall".  Clinical course: Patient stated that "I've had it every year since it came out, but, what I am noticing is that especially since I started taking it, every year that I take it my hair starts falling out, I can't even take a bath in my own tub because I have to put the strainer. If I didn't have (nationality) hair I wouldn't have any. I mean, it looks like it died". Patient stated she had a slight language barrier with the last agent, and didn't provide all of the information she is providing now. Patient was also unable to say how many vaccines she's had, she does not have her vaccination card. Patient stated, "I was a nurse, I am a pro vaccine-er. I've always taking my vaccines. I have COPD" Patient also stated, "I have seen some information like on (publisher name), nothing directly from Pfizer on any such thing, and it could be that people don't report some things.  [in audible]".  Patient also reported "I've had a medical condition for 30 years so, um, actually no 23, so this is definitely new. It's not related to any thing GI, it's not related to my lungs, it seems to be directly related to the vaccine". Patient added "she found information related to hair loss on (publisher name), hair loss related to covid vaccine. "It's not specific to one manufacturer. I just called Pfizer because I had/used Pfizer vaccine". Patient further mentioned "I don't mind my hair falling out due to chemo, I don't know if I want to keep doing this. When your hair falls out it's a blob of it, it's like a tennis ball and it just keeps coming through your fingers when it's wet. Patient then clarified that she is not on chemo and stated "I would have to be on chemo before I lost my hair, I would have to be on chemo before I'd take the risk of going bald. I've never been able to see my scalp". Patient further added "It is just now getting better, it seems to get better at the 6 months mark, after I've taken the vaccine... 6 to 9 Months, but with this, it's almost time to take it again".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 12-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 28-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 2-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 27-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 05-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 2-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 27-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 2-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 06-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 06-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 3-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 27-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 12-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 05-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 04-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.25
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 15-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 05-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.67
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 20-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 04-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 5-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 06-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 27-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.92
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 23-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 07-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 2-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 28-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 2-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 04-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.42
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 17-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 04-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.83
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 22-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 06-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 13-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 05-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 5-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 27-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 2-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 05-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.75
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 21-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 05-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 7.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a -year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 28-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 1.42
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 17-month-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 27-DEC-2023, the patient was vaccinated with mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, recombinant human albumin (rHA), (lot number X018574 has been verified to be a valid lot number, expiration date reported and validated as 05-JAN-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (product storage error) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a nurse and referred to a 4-year-old patient of unknown gender.  The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2023, the reporter arrived at work and the alarm of the freezer was going off. The vaccines were moved to another freezer, which was not suitable, and the vaccines were not kept frozen enough.  On 06-DEC-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number X006980 has been verified to be a valid lot number, expiration date was reported and validated as 07-MAR-2025), administered as prophylaxis after temperature excursions of 56.8 Fahrenheit degrees (F) for time frame of 253 hours and 48 minutes (which began on 01-DEC-2023) (strength, vaccination scheme, anatomical location and route of administration were not provided).  There were no additional adverse events.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 of Heplisav-B Given on 10/20/23 and 2nd Dose Given On 11/07/23; Initial report received on 28-Nov-2023  A certified medical assistant reported that a  patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 20-Oct-2023 and on 07-Nov-2023.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 20-Oct-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC # not reported, route, and site not reported). On 07-Nov-2023, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC # not reported, route, and site not reported) 18 days after having been vaccinated with the first dose of HEPLISAV-B.   No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received One Dose Of Heplisav-B Then A Dose of Twinrix; Initial report received on 04-Dec-2023  A registered pharmacist in the (Privacy) reported that a female patient (age, race, and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received TWINRIX.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 28-May-2023, the patient received one dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).  On 31-Jul-2023, 65 days after having been vaccinated with HEPLISAV-B, the patient received a dose of TWINRIX (no details provided). No additional side effects were reported by the patient.  No other information was available.   Company Comment:The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: 16 Year Old Received Heplisav-B As Their Second Dose; Received Engerix and then Heplisav-B; Initial report received on 03-Jan-2024.  A nurse in the (Privacy) reported that a 16-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as a second dose.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On an unknown date, the patient received ENGERIX-B as the first dose (Lot #, expiration date, NDC #, route, and injection site not reported) for hepatitis B immunization.   On 18-Dec-2023, after having been vaccinated with ENGERIX-B, the patient received HEPLISAV-B as the second dose (Lot # 944609, expiration date 29-Jan-2026, and NDC # 4352800301) intramuscularly in the right deltoid. No adverse side effects were reported by the patient.  The reporter stated that the patient's physician ordered HEPLISAV-B.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on Tuesday, 23Jan2024; Tested positive for COVID on Tuesday, 23Jan2024; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, on 22Sep2021 as dose 2, single (Lot number: EU0186) at the age of 53 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jan2024 at 05:00, outcome "recovering" and all described as "Tested positive for COVID on Tuesday, 23Jan2024". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jan2024) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient current age was reported as 54 years. No other vaccine was administered in four weeks. No covid prior vaccination. No known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: other students who suffer from alopecia; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "other students who suffer from alopecia". Additional information: 18 students who suffered from alopecia.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400009971 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 12:15 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm and on 07Aug2023 at 12:15 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Feb2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jan2024 at 13:15 as dose number unknown (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Jan2024 at 13:15, outcome "unknown", described as "Interchange of vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received paxlovid for COVID 19 Treatment since 19Jan2024 to 24Jan2024. Vaccine was received. No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400028717 Same patient, same drug, different event, different dose;
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: they received one that was a defective syringe that was broken; This is a spontaneous report received from a consumer. No patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (lot number: HR4393, expiration date: Mar2025) for immunisation, device lot number: HA3218, device expiration date: Mar2025. Relevant medical history and concomitant medications are not applicable. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "they received one that was a defective syringe that was broken".  Additional Information: The reporter called about Abrysvo RSV vaccine and stated that they received one that was a defective syringe that was broken and the reporter wanted to see if they can get a replacement sent. The reporter does not know where it is broken and does not know how broken or what it looks like in terms of being broken. The vaccine was not administered to any patient. A sample of the product is available to be returned, if requested. The reporter was made aware of prepaid mailer she may receive in 3-10 business days. Carton/box NDC number of Abrysvo: 00069034401. Diluent syringe NDC number: 00069025001. Antigen vial NDC number: 00069020701.  Causality for "they received one that was a defective syringe that was broken" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).