chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, FLU3, RSV
Symptoms: Erythema, Injection site rash, Rash erythematous
Clinical narrative: injection site rash; rash erythematous; erythema; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site rash in a 80-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) (batch number U8429CA) for prophylaxis and COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (batch number 6024MF013) for prophylaxis.   On 16-SEP-2024, the patient received Arexvy (intramuscular), Fluzone high dose (intramuscular) and Novavax COVID-19 Vaccine (intramuscular). On 17-SEP-2024, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: injection site rash), red rash (Verbatim: rash erythematous) and erythema (Verbatim: erythema). The outcome of the injection site rash, red rash and erythema were not resolved.   It was unknown if the reporter considered the injection site rash, red rash and erythema to be related to Arexvy.     It was unknown if the company considered the injection site rash, red rash and erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter reported that this involves a 80 years old male patient who had erythema, injection site rash and rash erythematous after receiving RSV vaccine subunit PREF3 (Arexvy), COVID 19 vaccine prot subunit NVX COV 2373, Novavax COVID 19 Vaccine and influenza USP trival A-B high dose subvirion vaccine fluzone high dose.  On 16th September 2024, the patient received unknown dose of suspect Arexvy (RSV vaccine prot. subunit PREF3) not produced by Sanofi Pasteur via intramuscular route in unknown administration site for prophylactic vaccination, unknown dose of COVID-19 vaccine prot. subunit not produced by Sanofi Pasteur via intramuscular route in unknown administration site for COVID-19 immunization and influenza USP trival A B high dose SUB VIRION vaccine Suspension for injection in prefilled syringe via intramuscular route in unknown administration site for prophylactic vaccination,  On 17th September 2024 the patient developed erythema, injection site rash and rash erythematous following the administration of RSV vaccine prot subunit PREF3, OVID-19 vaccine prot subunit and influenza USP trival A-B high dose vaccine. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was not recovered not resolved for all the events.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; This non-serious case was reported by a pharmacist via market research programs and described the occurrence of pain in arm in an unspecified number of patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and fever (Verbatim: fever). The outcome of the pain in arm and fever were resolved.   The reporter considered the pain in arm and fever to be related to Shingles vaccine.     The company considered the pain in arm and fever to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-DEC-2024 The case was reported for unspecified group of patients. The reporter reported that the patients received Shingles vaccine and experienced fever and sore arm. It was implied in conversation that the reporter had personally seen individuals experience these side effects. The adverse event start and stop date was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pain in extremity
Clinical narrative: local itching around the injection site; soreness on the arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site itching (Verbatim: local itching around the injection site) and pain in arm (Verbatim: soreness on the arm). The outcome of the injection site itching and pain in arm were unknown.   It was unknown if the reporter considered the injection site itching and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site itching and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-DEC-2024 The patient self-reported this case. The patient after receiving the first dose of Shingrix, she started experiencing soreness on the arm and local itching around the injection site.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: less than six month interval stated in the prescribing information; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 13-year-old female patient who received HAV (Havrix) (batch number 5JA57, expiry date 24-APR-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 10-DEC-2024, the patient received Havrix. On 10-DEC-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: less than six month interval stated in the prescribing information). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-DEC-2024 Nurse reported that a thirteen-year-old patient was administered a second dose of Havrix  (less than six month interval stated in the Prescribing information). Previous dose (first dose) was given in on 13-NOV-2024.  Nurse Practitioner wanted information about safety (adverse event) or what to expect.  Vaccination date, vaccine detail and patient demographics were retrieved from the Nurse Practitioner´s end in this call.  No further information was obtained during this call.  The patient received second dose (booster dose) of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laziness, Pain, Pyrexia
Clinical narrative: freezing and shaking, freezing that had never happened, body ache like you wouldn't believe; lazy; feeling "worn out"; one thing that she does not remember getting a strange headache; fever when she was in bed; This spontaneous case was reported by a patient and describes the occurrence of PAIN ( freezing and shaking, freezing that had never happened, body ache like you wouldn't believe), LAZINESS (lazy), FATIGUE (feeling "worn out"), PYREXIA (fever when she was in bed) and HEADACHE (one thing that she does not remember getting a strange headache) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043409) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: FLU on 28-Dec-2024 and Pfizer (all previous COVID-19 vaccines.). Past adverse reactions to the above products included No adverse effect with FLU and Pfizer.    On 31-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 31-Dec-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PYREXIA (fever when she was in bed). On an unknown date, the patient experienced PAIN ( freezing and shaking, freezing that had never happened, body ache like you wouldn't believe), LAZINESS (lazy), FATIGUE (feeling "worn out") and HEADACHE (one thing that she does not remember getting a strange headache). At the time of the report, PAIN ( freezing and shaking, freezing that had never happened, body ache like you wouldn't believe), LAZINESS (lazy), FATIGUE (feeling "worn out"), PYREXIA (fever when she was in bed) and HEADACHE (one thing that she does not remember getting a strange headache) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medications were reported.  The reporter stated that she woke up from taking a nap and did not take naps. The patient had symptoms from the COVID shot and she can't remember if that got bad last year and felt all those symptoms horribly when she got them.  The reporter stated that headache was not constant, and it was weird headache that comes and goes. The patient reported that she was feeling much better.  No treatment medications were reported.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: temp excursion on 7-23-2024. 3:59 am. Max 8.8 C, Low 4:35am 5.0 C; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-AUG-2024 and forwarded to agency on 26-AUG-2024 from other health professional.   This case was considered non-valid due to no patient identifiers provided (temperature excursion).  Due to the nature of the event, the causality between the event "Vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable.    Further information is expected.  NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 10-SEP-2024 and forwarded to agency on 11-SEP-2024 by a health care professional. The case is maintained as non-valid and non-serious.  Due to the nature of the event, the causality between the event "Vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable.  No further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 24-SEP-2024 and forwarded to agency on same day by a health care professional. The case is maintained as non-valid and non-serious.  Due to the nature of the event, the causality between the event "Vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable.  No further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024 by a health care professional. The case is now valid and non-serious.  Due to the nature of the event, the causality between the event "temp excursion on 7-23-2024. 3:59 am. Max 8.8 C, Low 4:35am 5.0 C" and Vaxelis was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: MA reports that she administered the VAXELIS to an 11-year-old patient; 11-year old male received VAXELIS in error instead of a flu vaccine; This non-serious spontaneous safety report, with reference number 2024SA278272, was received by partner on 25-SEP-2024 and forwarded to agency on 26-SEP-2024 from other health professional.  Due to the nature of the event, the causality between the event 'MA reports that she administered the VAXELIS to an 11-year-old patient', '11-year old male received VAXELIS in error instead of a flu vaccine' and Vaxelis was not applicable.  Off-label classification was added due to Vaxelis being administered to an 11-year-old patient.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP calling to report vaccines were administered after experiencing a temperature excursion; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-SEP-2024 and forwarded to agency on 26-SEP-2024 from a physician.   Due to the nature of the event, the causality between the event 'HCP calling to report vaccines were administered after experiencing a temperature excursion' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006896, MCM-006897.  Further information is expected.  Significant follow-up information was received by the partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024, from other health professional. The case is maintained as non-serious but became valid as patient identifiers were provided and route and site of product administration was provided along with dose number.  Due to the nature of the event, the causality between the event "HCP calling to report vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable.    No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP calling to report vaccines were administered after experiencing a temperature excursion.; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-SEP-2024 and forwarded to agency on 26-SEP-2024 from a physician.   Due to the nature of the event, the causality between the event 'HCP calling to report vaccines were administered after experiencing a temperature excursion' and Vaxelis was not applicable.  For reference purposes the case is linked to: MCM-006896, MCM-006898 and MCM-006827.  Further information is expected.  Significant follow-up information was received by the partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "HCP calling to report vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable.    No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP calling to report vaccines were administered after experiencing a temperature excursion.; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-SEP-2024 and forwarded to agency on 26-SEP-2024 from a physician.   Due to the nature of the event, the causality between the event 'HCP calling to report vaccines were administered after experiencing a temperature excursion' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-006896, MCM-006897.  Further information is expected.  Significant follow-up information was received by the partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024, from other health professional. The case is maintained as non-serious but became valid as patient identifiers were provided and route and site of product administration was provided along with dose number.  Due to the nature of the event, the causality between the event "HCP calling to report vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable.    No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS; a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS; a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS; This non-serious spontaneous safety report, with reference number 2024SA288921, was received by partner on 04-OCT-2024 and forwarded to agencyon 07-OCT-2024 from other health professional. Additional information was received on 04-OCT-2024 and forwarded to agency on 08-OCT-2024 from other health professional.  Due to the nature of the event, the causality between the event 'a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS', 'and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HBP calling to request temperature excursion evaluation for VAXELIS The vaccines were administered after the excursion. Temperature: 32.7F.; This spontaneous safety report, with reference number 02686879 (Interaction # 02686873), was received by the partner on 09-OCT-2024 and forwarded to agency on the same day from a consumer.   The reporter did not assess the causal relationship between Vaxelis and the reported event of "HBP calling to request temperature excursion evaluation for VAXELIS The vaccines were administered after the excursion. Temperature: 32.7F."  Due to the nature of the event, the causality between the event "HBP calling to request temperature excursion evaluation for VAXELIS The vaccines were administered after the excursion. Temperature: 32.7F." and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.; This non-serious spontaneous safety report, with reference number 02687975 (interaction number: 02687961), was received by partner on 10-OCT-2024 and forwarded to agency on 10-OCT-2024 from other 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 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.' and Vaxelis was not applicable.  Further information is expected.   FOLLOW-UP INFORMATION was forwarded to agency on 18-NOV-2024 from a health professional.  The case was considered valid due to patient identifiers reported.   Due to the nature of the event, the causality between the event 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.' and Vaxelis was not applicable.  Further information is  not expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaxelis administered to 5 year-old child; This non-serious spontaneous safety report, with reference number 2024SA311435 (inquiry number: 02280630), was received by partner on 25-OCT-2024 and forwarded to agency on 28-OCT-2024 from other health professional.  Off-label classification was added due to Vaxelis being administered to an 5-year-old patient.  Due to the nature of the event, the causality between the event and Vaxelis was not applicable.  Further information is expected.  Significant follow-up information was received by the HCP on 18-NOV-2024 and forwarded to agency on 18-NOV-2024. The case is maintained as non-serious and confirmed no adverse events were experienced.  Off-label classification was added due to Vaxelis being administered to an 5-year-old patient.  Due to the nature of the event, the causality between the event and Vaxelis was not applicable.  Further information is not expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered, Off label use
Clinical narrative: Patient received 4th dose of Vaxelis; Patient received 4th dose of Vaxelis; This non-serious spontaneous safety report, with the reference number: 02699483 was received by a partner on 31-OCT-2024 and forwarded to agency on 001-NOV-2024 from a healthcare professional.   This case is considered off-label use due to extra dose of Vaxelis administered to the patient.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Patient received 4th dose of Vaxelis".   Further information is expected
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Dark circles under eyes, Decreased activity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: She hasn't been playing like she usually does and she's had these bags of dark circles under her eyes too.; she's had these bags of dark circles under her eyes too.; Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm; Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm; Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm; Third dose in left thigh...spot that looked like a bug bite on her left thight, by the afternoon ...her leg was hurting her; This non-serious spontaneous safety report was received by agency on 04-NOV-2024 and forwarded to agency on 04-NOV-2024 with reference number # 02700418 from a consumer.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events: "Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm" and "She hasn't been playing like she usually does, and she's had these bags of dark circles under her eyes too".  No further information is expected.  Significant follow-up information was received by the partner on 11-NOV-2024 and forwarded to agency on 12-NOV-2024, from consumer. The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events: "Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm", "She hasn't been playing like she usually does, and she's had these bags of dark circles under her eyes too" and "Third dose in left thigh...spot that looked like a bug bite on her left thigh, by the afternoon...her leg was hurting her".  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Nurse ordered Fluzone and the Medical Assistant inadvertently gave Rotateq instead.; This non-serious spontaneous safety report, with reference number 02700153 (interaction number: 02700150), was received by partner on 01-NOV-2024 and forwarded to agency on 01-NOV-2024 from other health professional.   This case was considered non-valid due to wrong product administered (event does not concern Vaxelis).  Due to the nature of the event, the causality between the event and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by Fax from HCP on 02-DEC-2024. The case is maintained as non-serious.  This case was considered non-valid due to wrong product administered (event does not concern Vaxelis).  Due to the nature of the event, the causality between the event and Vaxelis was not applicable.  No further information is expected.  FOLLOW-UP INFORMATION was received, on 02-DEC-2024 and forwarded to agency on 04-DEC-2024 from a physician. The case is maintained as non-serious. The case becomes valid.  Due to the nature of the event, the causality between the event and Vaxelis was not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: a 6-month-old developed a high fever after receiving VAXELIS; This non-serious spontaneous safety report was received by MSD on 04-NOV-2024 and forwarded to agency on 07-NOV-2024 with Case ID: 02701884 from a field employee.   The reporter did not provide an assessment of the causal relationship between the reported events: "Fever" and Vaxelis.   Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: vaccines were administered following a temperature excursion; This non-serious spontaneous safety report with the reference number: 02705316 was received by a partner on 12-NOV-2024 and forwarded to agency on 12-NOV-2024 from a physician.  The reporter did not provide an assessment of the causal relationship between and Vaxelis and the reported events; "vaccines were administered following a temperature excursion"  Further information is expected.   FOLLOW-UP INFORMATION was received on 26-NOV-2024 from a physician. The case is now valid.   The reporter assessed the reported events; "vaccines were administered following a temperature excursion" as not related to Vaxelis.  Further information is not expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients; This non-serious spontaneous safety report, with reference number 02707692 (interaction number: 02707678), was received by partner on 15-NOV-2024 and forwarded to agency on 15-NOV-2024 from other health professional.   Due to the nature of the event, the causality between the event 'A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients' and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients; This non-serious spontaneous safety report, with reference number 02707685 (interaction number: 02707678), was received by partner on 15-NOV-2024 and forwarded to agency on 15-NOV-2024 from other health professional.   Due to the nature of the event, the causality between the event 'A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: No adverse event, Product storage error
Clinical narrative: There is no adverse event occurred with the use of this vaccine at all. The query was regarding temperature stability. No adverse event occurred to report at this time.; The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This non-serious spontaneous safety report was received by agency on 18-NOV-2024 and forwarded to agency on 18-NOV-2024 with case ID:  02708409 from a physician.  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 "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.    Further information is expected.  Non-significant follow-up information was received by the partner on 19-NOV-2024 and forwarded to agency on 20-NOV-2024, from a physician. The case is maintained as non-serious and non-valid.  Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.    Further information is expected.  Non-significant follow-up information was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. The case is maintained as non-serious and non-valid. Confirmed no adverse event.  Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C", "There is no adverse event occurred with the use of this vaccine at all. The query was regarding temperature stability. No adverse event occurred to report at this time." and Vaxelis was not applicable.    Further information is not expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients; This non-serious spontaneous safety report, with reference number 02707695 (interaction number: 02707678), was received by partner on 15-NOV-2024 and forwarded to agency on 18-NOV-2024 from other health professional.   Due to the nature of the event, the causality between the event 'A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.; This non-serious spontaneous safety report, with reference number 02687975 (interaction number: 02687961), was received by partner on 18-NOV-2024 and forwarded to agency on 18-NOV-2024 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided' and Vaxelis was not applicable.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.; This non-serious spontaneous safety report, with reference number 02687975 (interaction number: 02687961), was received by partner on 18-NOV-2024 and forwarded to agency on 18-NOV-2024 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided' and Vaxelis was not applicable.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; administered a VAXELIS on Nov 15th that expired on Nov 12th; This non-serious spontaneous safety report, with reference number 2024SA345002, was received by partner on 25-NOV-2024 and forwarded to agency on 26-NOV-2024 from other health professional.  Due to the nature of the event, the causality between the events 'administered a VAXELIS on Nov 15th that expired on Nov 12th' and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by email and duplicate follow-up information was received by fax on 12-DEC-2024 from other health professional. The case is maintained as non-serious.  Due to the nature of the events, the causality between the events 'administered a VAXELIS on Nov 15th that expired on Nov 12th' and 'no adverse event' and Vaxelis was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Product storage error
Clinical narrative: The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician.   Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007147.  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB, MMRV, PNC20
Symptoms: Product storage error
Clinical narrative: The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician.   Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007147.  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Product storage error
Clinical narrative: The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician.   Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007147.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician.   Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007147.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This non-serious spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician.   Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007147.  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician.   Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007147.  Further information is not expected.
Sex: U
Vaccine: DTPPVHBHPB, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Caller reported a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day. Date of administration unknown.; Caller reported a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day. Date of administration unknown.; This serious spontaneous safety report with MSD reference number #02715884 was received by the partner on 03-DEC-2024 and forwarded to agency on 03-DEC-2024, from a healthcare professional.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Caller reported a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day. Date of administration unknown".  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Incorrect dosage administered
Clinical narrative: Pt was given the incorrect dosage. The dosage ordered was l00mg/lmL and pt was administered 50mg/0.SmL; This non-serious spontaneous safety report was received by partner on 11-DEC-2024 with the following reference number: 2796962-1 and forwarded to agency on 12-DEC-2024 from a health professional   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event; "Pt was given the incorrect dosage. The dosage ordered was l00mg/lmL and pt was administered 50mg/0.SmL"  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, MEN, UNK
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VAXELIS was inadvertently administered to a 13 year old.; This non-serious spontaneous safety report was received by MSD on 12-DEC-2024 and forwarded to agency on 13-DEC-2024 with Case ID: 02721599 from a nurse.   Due to the nature of the event, the causality between the event "VAXELIS was inadvertently administered to a 13 year old" and Vaxelis was not applicable.   Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 13 years.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, MEN, MEN
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VAXELIS was inadvertently administered to a 16 year old. Patient also received MenQuadfi and Meningitis B vaccine. No other information provided; This non-serious spontaneous safety report was received by agency on 12-DEC-2024 and forwarded to agency on 13-DEC-2024 with Case ID: 02721564 from a nurse.   Due to the nature of the event, the causality between the event "VAXELIS was inadvertently administered to a 16 year old" and Vaxelis was not applicable.   Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 16 years.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: 2 month old inadvertently received both VAXELIS and RECOMBIVAX; 2 month old inadvertently received both VAXELIS and RECOMBIVAX; This non-serious spontaneous safety report was received by agency on 16-DEC-2024 and forwarded to agency on the same day with Case ID: 02723097 from a HCP.   Due to the nature of the event, the causality between the event "2 month old inadvertently received both VAXELIS and RECOMBIVAX" and Vaxelis was not applicable.    Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU3
Symptoms: Product storage error
Clinical narrative: VAXELIS was administered to 1 patient after temperature excursion with negative disposition.; This non-serious spontaneous safety report was received by Sanofi with GPV Number: 2024SA373698 on 18-DEC-2024 and forwarded on 17-DEC-2024 from an HCP.  Due to the nature of the event, the causality between the event "VAXELIS was administered to 1 patient after temperature excursion with negative disposition." and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported.; This spontaneous safety report, with reference number 02725276 (interaction number:02725238), was received by the partner on 19-DEC-2024 and forwarded to agency on the same day, from a physician.   Due to the nature of the event, the causality between the event "administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported." and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported.; This spontaneous safety report, with reference number 02725238 (interaction number:02725247), was received by the partner on 19-DEC-2024 and forwarded to agency on the same day, from a physician.   Due to the nature of the event, the causality between the event "administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported." and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Device leakage, Needle issue, Occupational exposure to product
Clinical narrative: the needle broke; It (Covid-19 vaccine) also splashed on the pharmacist; It (Covid-19 vaccine) also splashed on the pharmacist; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, 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: DEVICE LEAKAGE (non-serious), OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) all with onset 2024 and all described as "It (Covid-19 vaccine) also splashed on the pharmacist"; NEEDLE ISSUE (non-serious) with onset 2024, described as "the needle broke".  Causality for "the needle broke" and "it (covid-19 vaccine) also splashed on the pharmacist" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).  Additional information: When reporter got the shot (Clarified as Pfizer Covid-19 vaccine) and then the needle broke and then, what was in the needle splashed on reporter's face and it splashed on the reporter and it also splashed on the pharmacist and so when that happened the pharmacist said, she does not want to give the reporter another shot because she does not know how much went in reporter's arm before the needle broke.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400335023 Same reporter/event, different patient;; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Endometrial cancer, Vaginal haemorrhage
Clinical narrative: I was diagnosed as endometrial cancer; heavy and abnormal vagina bleeding; This is a spontaneous report received from an Other HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine on the same date. No other vaccine in four weeks. No other medications in two weeks. No known allergies. Patient was in good health before. No medical conditions. The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening) with onset 2021, 2 days after the suspect product(s) administration, outcome "recovering", described as "heavy and abnormal vagina bleeding"; ENDOMETRIAL CANCER described as "I was diagnosed as endometrial cancer". Therapeutic measures were taken as a result of vaginal haemorrhage includes: surgery, chemo and radiation. Clinical details: Patient experienced heavy and abnormal vagina bleeding 2 days post dosing which she never experienced before. I was diagnosed as endometrial cancer.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The event vaginal haemorrhage is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. As there is limited information in the case provided, the causal association between the event endometrial cancer and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  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.,Linked Report(s) : US-PFIZER INC-202500000306 same reporter/patient, partial same event, different dose;US-PFIZER INC-202500000312 same reporter/patient, partial same event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: heavy and abnormal vagina bleeding; This is a spontaneous report received from an Other HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient was in good health before. No medical conditions. Patient didn't have Known allergies. There were no concomitant medications. There was no other vaccine same date, no other vaccine in four weeks, no other medication in two weeks. Vaccination history included: Bnt162b2 (dose 1), administration date: 2021, for covid-19 immunisation, reaction(s): "heavy and abnormal vagina bleeding". The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening) with onset 2021, 2 days after the suspect product(s) administration, outcome "recovering", described as "heavy and abnormal vagina bleeding". Therapeutic measures were taken as a result of vaginal haemorrhage which included Surgery, Chemo and radiation. Clinical course: experienced heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The event vaginal haemorrhage is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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. ,Linked Report(s) : US-PFIZER INC-202500000306 same reporter/patient, partial same event, different dose;US-PFIZER INC-202500000311 same reporter/patient, partial same event, different dose;