chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, PNC
Symptoms: Extra dose administered
Clinical narrative: A patient received PENTACEL and VAXELIS at the same time; This non-serious spontaneous safety report, with reference number 2023SA223707 was received by a partner on 20-JUL-2023 and forwarded to company on 23-JUL-2023 from a health professional.   Due to the nature of the event, the causality between the events "A patient received PENTACEL and VAXELIS at the same time" and Vaxelis was not applicable.  Further information is expected.   Significant follow-up information was received by company on 14-AUG-2023, from an HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported event " A patient received PENTACEL and VAXELIS at the same time "was assessed as Not applicable due to the nature of the event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP calling to report accidental vaccination of RECOMBIVAX in combination with VAXELIS for 6 month old male patient. No additional AE; This non-serious spontaneous safety report, with MSD case number 02437630 (Interaction number 02437615), was received by partner on 27-JUL-2023 and forwarded to company on 28-JUL-2023 from a health care professional.  The causal relationship between Vaxelis and the reported event "HCP calling to report accidental vaccination of RECOMBIVAX in combination with VAXELIS for 6 month old male patient. No additional AE" was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose?; accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose?; This non-serious spontaneous safety report, with company case number 2023SA234232, was received by partner on 31-JUL-2023 and forwarded to another company on 01-AUG-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose".  Further information is expected.  Significant follow-up information was received by UBC on 15-AUG-2023, from an HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported events " accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose? " was assessed as Not applicable due to the nature of the event.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, was received by the partner on 03-AUG-2023 and forwarded to agency on 04-AUG-2023, from a Health Professional. Additional information was received by partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023.  Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis is not applicable.   This case is linked to other temperature excursion cases: MCM-005126, MCM-005127, MCM-005136, MCM-005135, MCM-005138, MCM-005140, MCM-005142, MCM-005128.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HIBV, RV5
Symptoms: Extra dose administered
Clinical narrative: A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time;; Overdose; No reaction noted; This spontaneous safety report, with reference number 2023SA238061, was received by the partner on 03-AUG-2023 and forwarded to UBC on 04-AUG-2023, from a health care professional.  Due to the nature of the event, the causality between the events "A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time and Overdose" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 15-AUG-2022 and forwarded to company on the same day, from a physician. The case is maintained as non-serious.  Due to the nature of the event, the causality between the events "A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time and Overdose, Overdose, and No reaction noted" and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Product storage error
Clinical narrative: POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, with reference number 2023SA238007 (Inquiry #, Parent Inquiry #) was received by the partner on 03-AUG-2023 and forwarded to agency on 04-AUG-2023, from a health professional.    Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005127, MCM-005128,  MCM-005135, MCM-005136, MCM-005138, MCM-005140.   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered.; This spontaneous safety report,  was received by a partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a health care professional.  The causal relationship between Vaxelis and the reported event "She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered" was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, with reference number: 2023SA240546  (Inquiry number:01716271 ) was received by the partner on 03-AUG-2023 and forwarded on 07-AUG-2023, from a health professional.    Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005127, MCM-005135, MCM-005136, MCM-005138, MCM-005140.   Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Off label use
Clinical narrative: Dr wants to find out if VAXELIS can be given to a 5 year old pt,Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule,Sending due to off-label use as part of catchup schedule; Dr wants to find out if VAXELIS can be given to a 5 year old pt,Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule,Sending due to off-label use as part of catchup schedule; This non-serious spontaneous safety report with reference number #2023SA238033 (Inquiry #01714708) was received by a partner on 02-AUG-2023 and forwarded on 04-AUG-2023 from a health care professional.  This case was considered non-valid due to the lack of patient identifiers.   Due to the nature of the events, the causality between the events "Dr wants to find out if VAXELIS can be given to a 5 year old pt, Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule, Sending due to off-label use as part of catchup schedule" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 22-AUG-2023 and forwarded on the same day, from a physician. This case is maintained as non-serious.  This case was considered off-label due to use in unapproved age group.   Due to the nature of the events, the causality between the events "Dr wants to find out if VAXELIS can be given to a 5-year-old pt, Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule, Off label use in unapproved age group" and Vaxelis was not applicable.  Further information is expected.   Duplicate information was received by the partner on 25-AUG-2023 and forwarded on 25-AUG-2023, from a physician. This case is maintained as non-serious.  This case was considered off-label due to use in unapproved age group.   Due to the nature of the events, the causality between the events "Dr wants to find out if VAXELIS can be given to a 5-year-old pt, Physician reported child was ordered by another practitioner in the office to receive VAXELIS as part of catchup schedule, Off label use in unapproved age group" and Vaxelis was not applicable.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered.; This non serious spontaneous safety report,  was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, and additional information was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023 from a health professional.  The causal relationship between Vaxelis and reported event" She would like to find out if the vaccines involved in the previous excursion would need to be readministered. 31.5 degrees FAHRENHEIT. Vaxelis administered" was assessed as not applicable due to the nature of the event.  For reference purposes, the case is linked to MCM-005121, MCM-005126, MCM-005127, MCM--005141, MCM-005135, MCM-005138, MCM-005140, MCM-005128, MCM-005142  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, with reference number 2023SA240518 (Inquiry #) was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a nurse.  Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005126, MCM-005127, MCM-005128. MCM--005136, MCM-005135, and MCM-005140 (patient's twin).   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a nurse.   Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005126, MCM-005127, MCM-005128. MCM-005136, MCM-005135, and MCM-005138 (patient's twin).   Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15
Symptoms: Medication error, Product storage error
Clinical narrative: medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023; This spontaneous safety report, was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a health professional. Additional information was received by partner on 03-AUG-2023 and forwarded to agency on 09-AUG-2023.  Due to the nature of the event, the causality between the event "medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023" and Vaxelis was not applicable.   For reference purposes, the case is linked to MCM-005121, MCM-005126, MCM-005127, MCM--005136, MCM-005135, MCM-005138, MCM-005140, MCM-005128.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product use issue
Clinical narrative: HCP called to report a TE with PNEUMOVAX 23 PFS, GARDASIL 9, MMR II, VAXELIS PFS, ROTATEQ, VARIVAX. MMR was not supported and administered, and ROTATEQ was supported and also administered. No adverse effects reported. No additional AE.; This spontaneous safety report, with reference number 02450775 was received by the partner on 14-AUG-2023 and forwarded to company on 15-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "HCP called to report a TE with PNEUMOVAX 23 PFS, GARDASIL 9, MMR II, VAXELIS PFS, ROTATEQ, VARIVAX. MMR was not supported and administered, and ROTATEQ was supported and also administered. No adverse effects reported. No additional AE." and Vaxelis was not applicable.   No further information is expected. Specific country product was not administered.  Non-significant Follow-up information was received by the partner on 16-AUG-2023 and forwarded to company on 17-AUG-2023, from a health care professional. This case is maintained as non-serious.  Due to the nature of the event, the causality between the event "HCP called to report a TE with PNEUMOVAX 23 PFS, GARDASIL 9, MMR II, VAXELIS PFS, ROTATEQ, VARIVAX. MMR was not supported and administered, and ROTATEQ was supported and also administered. No adverse effects reported. No additional AE." and Vaxelis was not applicable.  No further information is expected. Specific country product was not administered.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: TE for unopen, unused QUADRACEL,DAPTACEL,VAXELIS, MENQUADFI,ADACEL,PENTACEL and IPOL.Excursion started when products were transferred.total time out of range is 39hrs with a min temp of negative 9.1 F.Reported as Medication error due to TE; This non-serious spontaneous safety report, with reference number 2023SA265316 (Inquiry number), was received by the partner on 30-AUG-2023 and forwarded to agency on 31-AUG-2023, from a health professional.  This case was considered non-valid due to no patient identifiers provided (temperature excursion only).  Due to the nature of the event, the causality between the event " TE for unopen, unused QUADRACEL, DAPTACEL, VAXELIS, MENQUADFI, ADACEL, PENTACEL and IPOL. Excursion started when products were transferred. Total time out of range is 39hrs with a min temp of negative 9.1 Reported as Medication error due to TE" and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Crying
Clinical narrative: The baby cried for two days straight; This non-serious spontaneous Safety Report, with reference number 02462961 (Interaction # 02462959), was received by partner on 30-AUG-2023 and forwarded to company on 31-AUG-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "The baby cried for two days straight".  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs; This spontaneous safety report, with reference number  (Case ID #: 02462671) was received by the partner on 30-AUG-2023 and forwarded to company on 31-AUG-2023, from a Physician.    This case was considered non-valid due to no patient identifiers (Temperature excursion only).  Due to the nature of the event, the causality between the event "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable.  Significant Follow-up information was received by the partner on 14-SEP-2023 and forwarded to company on 14-SEP-2023, from a health care professional. This case is maintained as non-serious.  Patient identifiers were received; therefore, the case is considered to be valid.  Due to the nature of the event, the causality between the event "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: receiving extra doses of Hib and Hepatitis B Vaccine; medication error due to a 4-year old male patient received VAXELIS instead of QUADRACEL; This non-serious spontaneous safety report, with reference number 2023SA268652, was received by the partner on 01-SEP-2023 and forwarded to company on 04-SEP-2023, from a health professional.     Due to the nature of the event, the causality between the events "receiving extra doses of Hib and Hepatitis B Vaccine" and "medication error due to a 4-year old male patient received VAXELIS instead of QUADRACEL" and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Allergy to vaccine, Infant irritability
Clinical narrative: Caller reports after patient received a dose of VAXELIS,she had increased irritability for few days,doctor thinks patient may be allergic to pertussis component of vaxelis.Reports they had patients in past allergic to Pertussis with similar reaction; This non-serious spontaneous safety report, with reference number 2023SA271433, was received by the partner on 05-SEP-2023 and forwarded to company on 06-SEP-2023, from a health professional.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Caller reports after patient received a dose of VAXELIS, she had increased irritability for few days, doctor thinks patient may be allergic to pertussis component of vaxelis. Reports they had patients in past allergic to Pertussis with similar reaction".  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs; This spontaneous safety report was received by the partner on 14-SEP-2023 and forwarded to company on 14-SEP-2023, from a health professional.   Due to the nature of the event, the causality between the event "VAXELIS was administered to a patient after experiencing a supported TE. HBP did not know the exact date of administration, between 8/18/2023 & 8/30/2023.No side effects reported.TE: 59.2 F,Time :7 hrs, 56 min,Previous TE:48.7F for 48 min,33.4F 10hrs" and Vaxelis was not applicable.   Companion Case: MCM-005216.  Further information is expected.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash papular
Clinical narrative: c/o diffuse red rash over bilateral arms .   Rash extends from elbow to hands.  No itching.  Areas of rash are raised.  Denies SOB, edema, fever or other symptoms.
Age: 44.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pruritus
Clinical narrative: patient received flublock (has a history of using fluzone). about an hour later patient returned to the pharmacy complaining of extreme itchiness. She stated on a scale of 1-10 that is was over a 10. Visual inspection showed some redness but hard to tell if caused by rubbing. No swelling noted. Patient stated that she was not experiencing any swelling or difficulty breathing.  An ice pack was applied and the patient stated after about 10 minutes the itching was down to a 4. She was offered diphenhydramine but declined due to the fact she was driving. She stated she had allegra at home and would take that when she got home. We discussed anaphylaxis symptoms and what to do. After 15 minutes patient was feeling better and wanted to go home. She was advised to reach out the us if any further concerns. I did leave a message at her provider's office mentioning what had occurred and asking for a call back to confirm they had received the message.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: muscle aching soreness, redness and swelling of upper arm and shoulder.  Subjective fever without measurable temperature elevation, dizziness, fatigue, headache.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: muscle aching soreness, redness and swelling of upper arm and shoulder.  Subjective fever without measurable temperature elevation, dizziness, fatigue, headache.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Myalgia, Vaccination site mass, Vaccination site pain
Clinical narrative: About 6 hours after administration, patient developed severe muscle pain, bone pain, soreness at sight of vaccine. She did not experience this with the first dose of Shingrix. Lasted for 3 to 4 days. Patient reports similar feelings on the skin as poison ivy pustules, but there were no visible pustules. She reports a hard lump still present in the area today 9/27/23, but is no longer hurting her.
Age: 47.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Somnolence
Clinical narrative: (Regarding Item #17, I do not know what flu shot I was given. I was just told it was the Covid+ Flu shot together).  Also, I caught Covid twice last year, so did not get a vaccine booster. My last Covid booster prior to this recent one was in October 2021. I had a headache (about a 7 on a scale of 1-10) for 2 days. Then when the headache went away, I have had pretty severe fatigue. It's been 5 days since and I'm still feeling fatigue. I have been taking a 1-2 hour nap each day and still sleeping 7-8 hours (normally) each night. If I walk more than 15 minutes I get very fatigued and barely make it up the 2 flights of stairs at our condo. Steps take an enormous amount of energy to climb. Prior to this, I lifted weights 3-4 times a week for about 45 minutes and ran or biked for 30-60 minutes  4-5 times a week. I am in fairly good shape. The side effects from this Covid shot have lasted 5 days so far, far longer than expected. In many ways, the symptoms feel like what I have experienced during Covid, only less severe and shorter. I have had extreme fatigue lasting 2-3 months each of the 3 times I've had Covid, so this may not be abnormal for my body, but it seems unorthodox for most people. My wife got the same sets of shots from the same place the same time as me and she only experienced mild symptoms for 1 day. I do not recall having fatigue like this after the Covid boosters before.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Below injection site, an area of tissue is painful, dark red, hot to touch,  and itchy, Approximate size  4 "X 4"
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I got shingles that lasted for6 weeks.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product administration error
Clinical narrative: Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients.; Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients.; This spontaneous safety report, was received by a partner on 14-SEP-2023 and forwarded to agency on 15-SEP-2023, from a health care professional.  Due to the nature of the event, the causality between the events "Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients." and Vaxelis was not applicable.  Further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration, Off label use, Product administration error, Product use issue
Clinical narrative: Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients.; product use in unapproved population; This non-serious spontaneous safety report, with Sanofi reference number 2023SA281679, was received by a partner on 14-SEP-2023 and forwarded to agency on 15-SEP-2023, from a HCP.   The reporter did not assess the causal relationship between Vaxelis and the events of "Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients" and "product use in unapproved population".  Due to the nature of the event, the causality between the events "Medical assistant called as she was advised by her supervisor to report a possible AE as she has incorrectly administered VAXELIS, ADACEL and Proquad to 2 of their patients" and "product use in unapproved population" and Vaxelis was not applicable.   This case is considered an off-label use, due to product use in unapproved population and Incorrect schedule of product administration.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: RN calls to report VAXELIS and ROTATEQ given during a TE. No further AE. No PQC; This spontaneous safety report, , was received by the partner on 18-SEP-2023 and forwarded to agency on 18-SEP-2023, from a health professional.  Due to the nature of the event, the causality between the event "RN calls to report VAXELIS and ROTATEQ given during a TE. No further AE. No PQC" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.,Temperature:8.74 C , Time frame:35min; This non-serious spontaneous safety report was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35 min." was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous non -serious safety report, with reference number  was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature :8.74C , time frame: 35min; This non-serious spontaneous safety report, with reference number 02475789, was received by a partner on 20-SEP-2023 and forwarded to agency on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.,Temperature :8.74 C ,Time frame:35 Min; This spontaneous non -serious safety report, with reference number 02475811, was received by a partner on 20-SEP-2023 and forwarded to company on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported., Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Cartilage injury, Muscle rupture
Clinical narrative: there is a muscle tear in the shoulder due to medication; labral tear; pain on the shoulder; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A 44-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left deltoid muscle for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE RUPTURE (medically significant), outcome "unknown", described as "there is a muscle tear in the shoulder due to medication"; CARTILAGE INJURY (medically significant), outcome "unknown", described as "labral tear"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain on the shoulder". Clinical course: the patient went back to the facility a week later complaining about pain in her shoulder. The patient called that there was a muscle tear in the shoulder due to medication. The patient had now a "labral tear".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of the administration with PREVNAR 20 in triggering the onset of Muscle tear in the shoulder and labral tear might not be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Gout, Pyrexia, Vaccination site pain
Clinical narrative: Low fever; injection site pain; gout pain in feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 14:45 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; FENOFIBRATE; LIPITOR; PANTOPRAZOLE. The following information was reported: PYREXIA (non-serious) with onset 20Sep2023 at 13:30, outcome "recovering", described as "Low fever"; GOUT (non-serious) with onset 20Sep2023 at 13:30, outcome "recovering", described as "gout pain in feet"; VACCINATION SITE PAIN (non-serious) with onset 20Sep2023 at 13:30, outcome "recovering", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, gout.  Additional information: The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Other medications in two weeks included allopurinol, Fenofibrate Lipitor and "pantorzole." The patient did not have any known allergies. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar is high/ blood sugar was at 400/ blood sugar is high and it was at 400 and she keeps pumping; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Lot number: HH7595, Expiration Date: 31Dec2024) at the age of 76 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (ongoing). Concomitant medication(s) included: SYNTHROID; BUPROPION; INSULIN ASPART. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar is high/ blood sugar was at 400/ blood sugar is high and it was at 400 and she keeps pumping". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional Information HCP called for patient who got the new Pfizer Covid-19 Vaccine and now her blood sugar is high and now caller is asking for recommendation. Pharmacist stated that a patient received the Comirnaty 2023-2024 Formula, NDC 00069-2362-10.  The patient has Type 1 diabetes and on a pump.  Her blood sugar was at 400 and she keeps pumping and it went down to 300.  Female patient; age=76 years old. DSU: E-transmitting possible duplicate. Response: Reviewed/Discussed per PI and attached SRD noting no specific warnings/precautions nor reports of blood sugar changes (searched: glucose, sugar, hyperglycaemia, hypoglycaemia).  It was not noted among common side effects.  Shared amount of sucrose per description section.  Will forward for further research on incidence, as requested.  Noted that we would not have specific recommendations and patient would be referred back to her provider for additional discussion.  When probed for medical conditions and concomitant medications: Reporter stated, "Synthroid, Bupropion she is on Insulin Aspart 100 unit per ml so, there is 90 unit in the pump." When probed for lab test: Reporter stated, "I cannot confirm if she has got any lab test although she did have an appointment last week. I see she does have another appointment." She wants to get most probably COVID vaccine to prevent COVID."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I am in peri-menopause and had not had a menstrual cycle in almost a year.  I starting menstruating  4 days after receiving the booster.  In hindsight, I realize this ALSO happened the last time I got; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "perimenopause" (unspecified if ongoing), notes: had not had a menstrual cycle in almost a year. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT: HF9275, Vaccine location: Left arm), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization, reaction(s): "Postmenopausal bleeding". The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "I am in peri-menopause and had not had a menstrual cycle in almost a year.  I starting menstruating  4 days after receiving the booster.  In hindsight, I realize this ALSO happened the last time I got". Therapeutic measures were not taken as a result of postmenopausal haemorrhage.  Clinical course: The patient was in perimenopause and had not had a menstrual cycle in almost a year. She started menstruating 4 days after receiving the booster. In hindsight, she realized this also happened the last time she got a booster shot. Adverse event start date: 21Sep2023. Adverse event start time: 6:00 AM. If AE treatment: No. If other vaccine in four weeks: No. If other medication in two weeks: No.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Muscle soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Known allergies: Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [FAMOTIDINE]. Vaccination history included: Covid-19 vaccine (DOSE 3; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Sep2023 at 06:00, outcome "recovering", described as "Muscle soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient had no covid prior vaccination and had no covid tested post vaccination. No other vaccine in four weeks. No other medical history.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain, Throat irritation
Clinical narrative: I never had the Pfizer vaccine. I only had the Moderna COVID-19 vaccines.; severe pain all night long; throat was scratchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose number unknown (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccines, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 2023, outcome "unknown", described as "I never had the Pfizer vaccine. I only had the Moderna COVID-19 vaccines."; PAIN (non-serious) with onset 2023, outcome "not recovered", described as "severe pain all night long"; THROAT IRRITATION (non-serious) with onset 2023, outcome "not recovered", described as "throat was scratchy".  Additional information: The patient only had the Moderna COVID-19 vaccines previously. She had a terrible reaction from Pfizer COVID-19 vaccine. She stated that she gave all her vaccination cards and she said she received Moderna previously but they still gave her Pfizer COVID-19 vaccine. She stated that she was in so much pain and as soon as she received the vaccine her throat was scratchy. It advanced to be bad and still scratchy at the time of reporting. She was in severe pain all night long.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Pain in extremity
Clinical narrative: sore left arm; increased menstrual cramps; increased menstrual bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Lot number: HF9275) at the age of 43 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2,SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 1,SINGLE), for covid-19 immunization.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 19Sep2023, outcome "not recovered", described as "increased menstrual bleeding"; DYSMENORRHOEA (non-serious) with onset 19Sep2023, outcome "not recovered", described as "increased menstrual cramps"; PAIN IN EXTREMITY (non-serious) with onset 19Sep2023, outcome "not recovered", described as "sore left arm". Therapeutic measures were not taken as a result of pain in extremity, dysmenorrhoea, heavy menstrual bleeding.  Additional information: The patient had no known allergies. No covid tested post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: having some numbness of my tongue and lips and a little of the tips of my fingers; having some numbness of my tongue and lips and a little of the tips of my fingers; also have a slight headache; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 21Sep2023, outcome "unknown", described as "also have a slight headache"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA (non-serious) all with onset 21Sep2023 at 13:30, outcome "unknown" and all described as "having some numbness of my tongue and lips and a little of the tips of my fingers".  Additional information: the patient (a physician) got the new Pfizer COVID vaccine 12 years of age and older on the morning of 21Sep2023 at 10 am on her left upper arm. Around 13:30, I started having some numbness of her tongue and lips and a little of the tips of her fingers. She also had a slight headache and stated that she was not sure if that's from being on the phones for 40 minutes or from the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia oral, Sensory disturbance
Clinical narrative: having some numbness of my tongue and lips and a little of the tips of my fingers; having some numbness of my tongue and lips and a little of the tips of my fingers; also have a slight headache; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 21Sep2023, outcome "unknown", described as "also have a slight headache"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA (non-serious) all with onset 21Sep2023 at 13:30, outcome "unknown" and all described as "having some numbness of my tongue and lips and a little of the tips of my fingers".  Additional information: the patient (a physician) got the new Pfizer COVID vaccine 12 years of age and older on the morning of 21Sep2023 at 10 am on her left upper arm. Around 13:30, I started having some numbness of her tongue and lips and a little of the tips of her fingers. She also had a slight headache and stated that she was not sure if that's from being on the phones for 40 minutes or from the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.