chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness, Pyrexia
Clinical narrative: low grade fever; flu like symptoms; administered vaccine on 03/21/2023. which had expired on 03/11/2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (low grade fever), INFLUENZA LIKE ILLNESS (flu like symptoms) and EXPIRED PRODUCT ADMINISTERED (administered vaccine on 03/21/2023. which had expired on 03/11/2023) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 21-Mar-2023, the patient experienced PYREXIA (low grade fever), INFLUENZA LIKE ILLNESS (flu like symptoms) and EXPIRED PRODUCT ADMINISTERED (administered vaccine on 03/21/2023. which had expired on 03/11/2023). On 23-Mar-2023, PYREXIA (low grade fever) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine on 03/21/2023. which had expired on 03/11/2023) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     Relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.   On 28-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported.  No adverse events were reported.  No treatment medications were reported.  This case contains information for the 1st of 6th adult patients described by the reporter.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Accidentally administered with 3 different EXPIRED lot numbers; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ) and NO ADVERSE EVENT (No adverse event) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057B22A) for COVID-19 prophylaxis.     It was unknown if the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 16-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ).    Concomitant medication was not provided.  Pharmacist stated 6 patients were administered with 3 different lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 5 was vaccinated on 16-Feb-2023    Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717776 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717776:Master case
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine).    Reporter stated that relevant medical history conditions, allergy, concomitant diseases and risk factor were unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717776 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717776:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (Chronic urticaria) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA CHRONIC (Chronic urticaria). At the time of the report, URTICARIA CHRONIC (Chronic urticaria) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 29-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Concomitant drugs were not reported.  It was reported that the monovalent vial of 5.5 ml size was not exposed to temperature excursion. It was unknown when the vial was initially stored in refrigerator.  The fridge expiration date was reported as 03-Feb-2023, the website expiration date was 01-Apr-2023 and the pharmacy reported date was 30-Apr-2023.  Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy manager reports that an expired monovalent vaccine was inadvertently administered in one of their clinics).    No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 18-year-old patient received Monovalent 6-11 Booster only Moderna COVID-19 vaccine instead of Bivalent booster on 31MAR2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (18-year-old patient received Monovalent 6-11 Booster only Moderna COVID-19 vaccine instead of Bivalent booster on 31MAR2023) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1), PFIZER BIONTECH COVID-19 VACCINE (1st booster dose) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 31-Mar-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (18-year-old patient received Monovalent 6-11 Booster only Moderna COVID-19 vaccine instead of Bivalent booster on 31MAR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (18-year-old patient received Monovalent 6-11 Booster only Moderna COVID-19 vaccine instead of Bivalent booster on 31MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (18-year-old patient received Monovalent 6-11 Booster only Moderna COVID-19 vaccine instead of Bivalent booster on 31MAR2023).    No concomitant medications were reported.     No treatment medications were reported.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004407, MCM-004408, MCM-004409 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004407, MCM-004409 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004407 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004409 and MCM-004407 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
Age: 0.08
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product use issue
Clinical narrative: Physician called and reported that a patient was given Vaxelis earlier than recommended at 40 days old instead of 42 days (6 weeks old).; Physician called and reported that a patient was given Vaxelis earlier than recommended at 40 days old instead of 42 days (6 weeks old).; This spontaneous safety report, with reference number 02312186 (Interaction # 02312170), was received by the partner on 04-JAN-2023 and forwarded on 05-JAN-2023, from a physician.  The case was considered off label use due to Product use in unapproved population (40 days old infant).   Due to the nature of the event, the causality between the event "Physician called and reported that a patient was given Vaxelis earlier than recommended at 40 days old instead of 42 days (6 weeks old)." and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I gave patient Vaxelis and extra dose of Hepatitis B; I gave patient Vaxelis and extra dose of Hepatitis B; This case was retrieved during the  Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following:  I gave patient Vaxelis,and an extra dose of Hepatitis B. There were no adverse events other than the dose given twice. Mother of patient stated daughter was doing well. There was no redness on the area and baby is well. I did reach out to manufacture and to system to report the incident as well as to ask if there was harm, or what to look out for. Parent was notified as well.  Overdose event was added due to Hepatitis B vaccine being administered at the same time as Vaxelis.  The causality relationship between Vaxelis and the reported event "Extra dose administered" and "Overdose" is not applicable due to the nature of the event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLUX, MMR, PNC13, RV1, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received too many vaccines; This non-serious spontaneous safety report, with case number 02316824, was received by partner, on 12Jan2023 and forwarded on 12Jan2023 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Inappropriate schedule of product administration".  Further information is expected.  FOLLOW-UP information, with reference number 02316824 and reference number 2022SA508562, was received from the partner on 26-JAN-2023. The case is maintained as non-serious.   The partner confirmed that the initial receipt date was on 13-DEC-2023.  Due to the nature of the event, the causality between the event "The patient received too many vaccines" and Vaxelis was not applicable.  Further information is expected.  Non-significant follow-up information was received on 23-FEB-2023 from the consumer.  Due to the nature of the event, the causality between the event "The patient received too many vaccines" and Vaxelis was not applicable.  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB, RV1
Symptoms: Device power source issue, No adverse event, Product storage error
Clinical narrative: Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No adverse reactions have been reported.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following:  Staff administered vaccines that were declared spoiled per the manufacturer after a power outage event. No acute adverse reactions have been reported by the patient or guardian.  Due to the nature of the event, the causality between the events, "Expired product administered" and "Product storage error" and Vaxelis is not applicable.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "No adverse event".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following:  Patient is outside of the age range but was overdue to complete vaccination series. No other adverse reactions reported.  The case is classified as Off-Label Use (Product use in unapproved population).  Due to the nature of the event, the causality between the events, "Product storage error", "Product use in unapproved population" and "no adverse event" and Vaxelis is not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Full body hives noted within 10-15 minutes of receiving vaccines.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following:  Full body hives noted within 10-15 minutes of receiving vaccines. Pt still in the office so brought back to exam room for further evaluation. No wheezing, resp distress, vomiting, or diarrhea associated. Pulse ox 99%. Given Benadryl 0.5 mg/kg once. Observed for 1 hour following vaccines with improvement in hives noted. Did also have new formula on day of vaccine/hives.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event, "Urticaria".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: Vaxelis and Engerix-B administered on the same day.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following:  Vaxelis and Engerix-B administered on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis. Co-suspect products included VAXELIS for prophylaxis. Previously administered products included Engerix-B (The first dose was received on an unknown date). On 24th October 2022, the patient received the 2nd dose of Engerix-B (The first dose was received on an unknown date). On 24th October 2022, unknown after receiving Engerix B, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. Additional Information: GSK Receipt Date: 28-OCT-2022. Reporter's Comments: The medical assistant had reported that a child patient was given Vaxelis (manufacture-Sanofi) and a 2nd dose of Engerix-B on the same day 24th October 2022. The vaccine administration facility was the same as the primary reporter. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose of Engerix-B and Vaxelis on the same day, which had led to overdose of hepatitis B component.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event, "Overdose".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Urticaria; Injection site erythema; This case was retrieve during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following:  Mother reports that approximately 3 hours after vaccination she noticed severe redness on entire right thigh and several hives on infant's abdomen.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Urticaria", and "Injection site erythema".  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Circular ball like swelling on both thighs underneath fat; This case was retrieved during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following:  Circular ball like swelling on both thighs underneath fat, no redness or pain.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "injection site swelling",  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Abnormal faeces, Breast feeding, Diarrhoea, Eczema, Faeces discoloured
Clinical narrative: Abnormal faeces; Breast feeding; Eczema; Faeces discolored; Flatulence; Infant irritability; Infrequent bowel movements; Mucous stool; Pruritus; Skin laceration; Diarrhea; Sleep disorder; Injection site swelling; Injection site erythema; Pyrexia; Viral test negative; Stool analysis normal; Giardia test negative; This case was retrieve during the Reporting System monitoring on 12-JAN-2023.. The original narrative from the sender is the following:  Red swelling at site of left thigh injection (8/19/22 @ 6:15PM. Went away after a few hours).  Fever (8/19/22 @ 6:15PM. Administered 2.5mL Infant Tylenol. Went away after 12 hours. Awake every hour or so that night. Very fussy).  Eczema (Had not seen any signs of Eczema prior to 8/19/22 vaccines. On 8/24/22, I started noticing patches on both cheeks, all over belly, inside/outside elbows, outside legs/thighs, ankles. Seemed to be itchy. Was cutting cheeks & ankles by scratching a lot. Pediatrician said that it may be why he doesn't sleep as well now).  (Prior to 9/14/22 Sick visit: Used AVEENO Baby eczema therapy nighttime balm immediately after baths and throughout the day. Tried using Vaseline 100% pure petroleum jelly after baths and throughout the day. Tried using Lanolin Nipple Cream on areas during the day. It did not get worse, but nothing really helped).  (9/27/22 Applied light amounts of IC HYDROCORTISONE 2.5% Cream on cheeks & ankles (bad areas). This helped, but has not cured. The eczema will come back within a day if I don't apply the cream).  Chronic Diarrhea (Exclusively breastfed. My diet had not changed at all. I tried to cut back on soft cheeses and add more leafy greens, but did not change my son's diarrhea problem. No vomiting. He has continued to have a good appetite. Eats about 30oz of breast milk over 5-6 feedings in a 24 hour period).  (Prior to 8/19/22 vaccines: Small bowel movements 2-3 times a day. Bright mustard yellow, seedy, sweet smelling. Regularly slept through the night between 8:30/9PM-5:30/6AM).  (8/20/22-Present: Large blowout bowel movements once a day or once every 2-3 days. Dark yellow, bright yellow, or greenish, slimy, mucus, foam, or watery/runny. Smells bad, sour, rotten. Has more smelly gas. Regularly wakes up throughout the night and has to be fed between 2:30-4AM to get back to sleep).  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events Abnormal faeces, Breast feeding, Eczema, Faeces discoloured, Flatulence, Infant irritability, Infrequent bowel movements, Mucous stools, Pruritus, Skin laceration, Diarrhoea, Sleep disorder, Injection site swelling, Injection site erythema, and Pyrexia.  The causa relationship between Vaxelis and Viral test negative, Stool analysis normal, and Giardia test negative was assessed as not applicable, due to the nature of these events.  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Flatulence, Giardia test negative, Infant irritability, Infrequent bowel movements, Injection site erythema
Clinical narrative: Abnormal faeces; Breast feeding; Eczema; Faeces discolored; Flatulence; Infant irritability; Infrequent bowel movements; Mucous stool; Pruritus; Skin laceration; Diarrhea; Sleep disorder; Injection site swelling; Injection site erythema; Pyrexia; Viral test negative; Stool analysis normal; Giardia test negative; This case was retrieve during the Reporting System monitoring on 12-JAN-2023.. The original narrative from the sender is the following:  Red swelling at site of left thigh injection (8/19/22 @ 6:15PM. Went away after a few hours).  Fever (8/19/22 @ 6:15PM. Administered 2.5mL Infant Tylenol. Went away after 12 hours. Awake every hour or so that night. Very fussy).  Eczema (Had not seen any signs of Eczema prior to 8/19/22 vaccines. On 8/24/22, I started noticing patches on both cheeks, all over belly, inside/outside elbows, outside legs/thighs, ankles. Seemed to be itchy. Was cutting cheeks & ankles by scratching a lot. Pediatrician said that it may be why he doesn't sleep as well now).  (Prior to 9/14/22 Sick visit: Used AVEENO Baby eczema therapy nighttime balm immediately after baths and throughout the day. Tried using Vaseline 100% pure petroleum jelly after baths and throughout the day. Tried using Lanolin Nipple Cream on areas during the day. It did not get worse, but nothing really helped).  (9/27/22 Applied light amounts of IC HYDROCORTISONE 2.5% Cream on cheeks & ankles (bad areas). This helped, but has not cured. The eczema will come back within a day if I don't apply the cream).  Chronic Diarrhea (Exclusively breastfed. My diet had not changed at all. I tried to cut back on soft cheeses and add more leafy greens, but did not change my son's diarrhea problem. No vomiting. He has continued to have a good appetite. Eats about 30oz of breast milk over 5-6 feedings in a 24 hour period).  (Prior to 8/19/22 vaccines: Small bowel movements 2-3 times a day. Bright mustard yellow, seedy, sweet smelling. Regularly slept through the night between 8:30/9PM-5:30/6AM).  (8/20/22-Present: Large blowout bowel movements once a day or once every 2-3 days. Dark yellow, bright yellow, or greenish, slimy, mucus, foam, or watery/runny. Smells bad, sour, rotten. Has more smelly gas. Regularly wakes up throughout the night and has to be fed between 2:30-4AM to get back to sleep).  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events Abnormal faeces, Breast feeding, Eczema, Faeces discoloured, Flatulence, Infant irritability, Infrequent bowel movements, Mucous stools, Pruritus, Skin laceration, Diarrhoea, Sleep disorder, Injection site swelling, Injection site erythema, and Pyrexia.  The causa relationship between Vaxelis and Viral test negative, Stool analysis normal, and Giardia test negative was assessed as not applicable, due to the nature of these events.  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site swelling, Mucous stools, Pruritus, Pyrexia, Skin laceration
Clinical narrative: Abnormal faeces; Breast feeding; Eczema; Faeces discolored; Flatulence; Infant irritability; Infrequent bowel movements; Mucous stool; Pruritus; Skin laceration; Diarrhea; Sleep disorder; Injection site swelling; Injection site erythema; Pyrexia; Viral test negative; Stool analysis normal; Giardia test negative; This case was retrieve during the Reporting System monitoring on 12-JAN-2023.. The original narrative from the sender is the following:  Red swelling at site of left thigh injection (8/19/22 @ 6:15PM. Went away after a few hours).  Fever (8/19/22 @ 6:15PM. Administered 2.5mL Infant Tylenol. Went away after 12 hours. Awake every hour or so that night. Very fussy).  Eczema (Had not seen any signs of Eczema prior to 8/19/22 vaccines. On 8/24/22, I started noticing patches on both cheeks, all over belly, inside/outside elbows, outside legs/thighs, ankles. Seemed to be itchy. Was cutting cheeks & ankles by scratching a lot. Pediatrician said that it may be why he doesn't sleep as well now).  (Prior to 9/14/22 Sick visit: Used AVEENO Baby eczema therapy nighttime balm immediately after baths and throughout the day. Tried using Vaseline 100% pure petroleum jelly after baths and throughout the day. Tried using Lanolin Nipple Cream on areas during the day. It did not get worse, but nothing really helped).  (9/27/22 Applied light amounts of IC HYDROCORTISONE 2.5% Cream on cheeks & ankles (bad areas). This helped, but has not cured. The eczema will come back within a day if I don't apply the cream).  Chronic Diarrhea (Exclusively breastfed. My diet had not changed at all. I tried to cut back on soft cheeses and add more leafy greens, but did not change my son's diarrhea problem. No vomiting. He has continued to have a good appetite. Eats about 30oz of breast milk over 5-6 feedings in a 24 hour period).  (Prior to 8/19/22 vaccines: Small bowel movements 2-3 times a day. Bright mustard yellow, seedy, sweet smelling. Regularly slept through the night between 8:30/9PM-5:30/6AM).  (8/20/22-Present: Large blowout bowel movements once a day or once every 2-3 days. Dark yellow, bright yellow, or greenish, slimy, mucus, foam, or watery/runny. Smells bad, sour, rotten. Has more smelly gas. Regularly wakes up throughout the night and has to be fed between 2:30-4AM to get back to sleep).  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events Abnormal faeces, Breast feeding, Eczema, Faeces discoloured, Flatulence, Infant irritability, Infrequent bowel movements, Mucous stools, Pruritus, Skin laceration, Diarrhoea, Sleep disorder, Injection site swelling, Injection site erythema, and Pyrexia.  The causa relationship between Vaxelis and Viral test negative, Stool analysis normal, and Giardia test negative was assessed as not applicable, due to the nature of these events.  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Sleep disorder, Stool analysis normal, Viral test negative
Clinical narrative: Abnormal faeces; Breast feeding; Eczema; Faeces discolored; Flatulence; Infant irritability; Infrequent bowel movements; Mucous stool; Pruritus; Skin laceration; Diarrhea; Sleep disorder; Injection site swelling; Injection site erythema; Pyrexia; Viral test negative; Stool analysis normal; Giardia test negative; This case was retrieve during the Reporting System monitoring on 12-JAN-2023.. The original narrative from the sender is the following:  Red swelling at site of left thigh injection (8/19/22 @ 6:15PM. Went away after a few hours).  Fever (8/19/22 @ 6:15PM. Administered 2.5mL Infant Tylenol. Went away after 12 hours. Awake every hour or so that night. Very fussy).  Eczema (Had not seen any signs of Eczema prior to 8/19/22 vaccines. On 8/24/22, I started noticing patches on both cheeks, all over belly, inside/outside elbows, outside legs/thighs, ankles. Seemed to be itchy. Was cutting cheeks & ankles by scratching a lot. Pediatrician said that it may be why he doesn't sleep as well now).  (Prior to 9/14/22 Sick visit: Used AVEENO Baby eczema therapy nighttime balm immediately after baths and throughout the day. Tried using Vaseline 100% pure petroleum jelly after baths and throughout the day. Tried using Lanolin Nipple Cream on areas during the day. It did not get worse, but nothing really helped).  (9/27/22 Applied light amounts of IC HYDROCORTISONE 2.5% Cream on cheeks & ankles (bad areas). This helped, but has not cured. The eczema will come back within a day if I don't apply the cream).  Chronic Diarrhea (Exclusively breastfed. My diet had not changed at all. I tried to cut back on soft cheeses and add more leafy greens, but did not change my son's diarrhea problem. No vomiting. He has continued to have a good appetite. Eats about 30oz of breast milk over 5-6 feedings in a 24 hour period).  (Prior to 8/19/22 vaccines: Small bowel movements 2-3 times a day. Bright mustard yellow, seedy, sweet smelling. Regularly slept through the night between 8:30/9PM-5:30/6AM).  (8/20/22-Present: Large blowout bowel movements once a day or once every 2-3 days. Dark yellow, bright yellow, or greenish, slimy, mucus, foam, or watery/runny. Smells bad, sour, rotten. Has more smelly gas. Regularly wakes up throughout the night and has to be fed between 2:30-4AM to get back to sleep).  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events Abnormal faeces, Breast feeding, Eczema, Faeces discoloured, Flatulence, Infant irritability, Infrequent bowel movements, Mucous stools, Pruritus, Skin laceration, Diarrhoea, Sleep disorder, Injection site swelling, Injection site erythema, and Pyrexia.  The causa relationship between Vaxelis and Viral test negative, Stool analysis normal, and Giardia test negative was assessed as not applicable, due to the nature of these events.  No further information is expected
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Crying, Infant irritability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme fussiness and unconsolable; Tenderness from the knee to the thigh; after receiving VAXELIS swelling at the injection site on the thigh and fever; Fever/ Pt reported a 100.9 temp; Redness & swelling at the site where vaccine was given/ from knee to the thigh; This non-serious spontaneous safety report with reference number 02320717 was received by a partner on 19-JAN-2023 and forwarded on 20-JAN-2023 from a health care professional.  This case was considered non-valid given that no patient identifiers were provided (the reporter was not sure of the patient's age).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the event "after receiving VAXELIS swelling at the injection site on the thigh and fever".   Further information is expected.  FOLLOW-UP Information was received by partner on 25-JAN-2023 and forwarded on 26-JAN-2023 from a health care professional.  The case is considered valid (Patient identifiers provided).  The reporter assessed the events, "after receiving VAXELIS swelling at the injection site on the thigh", "Redness & swelling at the site where vaccine was given/ from knee to the thigh" and fever/ Pt reported a 100.9 temp" as related to Vaxelis. The reporter did not provide an assessment of the causal relationship between Vaxelis and the events, "Extreme fussiness and unconsolable" and "Tenderness from the knee to the thigh".  Follow up information is not expected.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Extreme fussiness and unconsolable; Tenderness from the knee to the thigh; after receiving VAXELIS swelling at the injection site on the thigh and fever; Fever/ Pt reported a 100.9 temp; Redness & swelling at the site where vaccine was given/ from knee to the thigh; This non-serious spontaneous safety report with reference number 02320717 was received by a partner on 19-JAN-2023 and forwarded on 20-JAN-2023 from a health care professional.  This case was considered non-valid given that no patient identifiers were provided (the reporter was not sure of the patient's age).  The reporter did not provide an assessment of the causal relationship between Vaxelis and the event "after receiving VAXELIS swelling at the injection site on the thigh and fever".   Further information is expected.  FOLLOW-UP Information was received by partner on 25-JAN-2023 and forwarded on 26-JAN-2023 from a health care professional.  The case is considered valid (Patient identifiers provided).  The reporter assessed the events, "after receiving VAXELIS swelling at the injection site on the thigh", "Redness & swelling at the site where vaccine was given/ from knee to the thigh" and fever/ Pt reported a 100.9 temp" as related to Vaxelis. The reporter did not provide an assessment of the causal relationship between Vaxelis and the events, "Extreme fussiness and unconsolable" and "Tenderness from the knee to the thigh".  Follow up information is not expected.
Sex: F
Vaccine: DTPPVHBHPB, MMR, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination.; This non-serious spontaneous safety report with reference number # 2023SA031533 (Inquiry # 01465069) was received by a partner on 26-JAN-2023 and forwarded on 27-JAN-2023 from a health care professional.  Due to the nature of the event, the causality between the event "Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination." and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received from the health care professional, by Fax, on 24-FEB-2023.  No adverse event was reported.   Due to the nature of the event, the causal relationship between Vaxelis and the event "Caller reported VAXELIS was administered instead of the intended VARICELLA vaccination" was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: A patient had 2 doses of VAXELIS so far and developed fever after the 1st dose and the 2nd dose; This non-serious spontaneous safety report, reference number 02329597, was received by a partner on 02-FEB-2023 and forwarded on 03-FEB-2023, from a non-health professional.   The reporter did not assess the causal relationship between Vaxelis and the reported event "A patient had 2 doses of VAXELIS so far and developed fever after the 1st dose and the 2nd dose".  No further information is expected given that the reporter did not give consent to be contacted.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: Vaxelis was accidentally administered to an adult patient; The caller states that the physician ordered a Tdap vaccine and the MA administered Vaxelis.; Caller with medical facility called to report that Vaxelis was accidentally administered to an adult patient. Patient was 28 weeks and 1 day pregnant; This non-serious spontaneous safety report, with reference number 2023SA049850/ Inquiry# 01487665 was received by a partner on 10-FEB-2023 and forwarded on 13-FEB-2023 from a non-health professional.   Due to the nature of the event, the causality between the events "Vaxelis was accidentally administered to an adult patient", "the caller states that the physician ordered a Tdap vaccine and the MA administered Vaxelis" and "Caller with medical facility called to report that Vaxelis was accidentally administered to an adult patient. Patient was 28 weeks and 1 day pregnant" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, RV5
Symptoms: Product storage error
Clinical narrative: VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion.  Temperature: Above 9°C; This non-serious spontaneous safety report, with reference number 02335318, was received by a partner on 13-FEB-2023 and forwarded on 14-FEB-2023, from a non-HCP.  Due to the nature of the event the causal relationship between Vaxelis and "VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion. Temperature: Above 9°C." was not applicable.    Further information is expected.  FOLLOW-UP INFORMATION, with reference number 02335318, was received by a partner on 16-FEB-2023 and forwarded on 17-FEB-2023, from a non-HCP. The case is maintained as non-serious.  It was reported that VARIVAX and PROQUAD might have been also administered to the patient post-excursion (yet to be confirmed).  Due to the nature of the event the causal relationship between Vaxelis and the reported event "VAXELIS and ROTATEQ were administered on 2/13/2023 after a temperature excursion. Temperature: Above 9°C" remained not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product dose omission issue
Clinical narrative: a 3 month old patient missed their 2 dose of VAXELIS in the series; This non-serious spontaneous safety report, with reference number 2023SA055146 (and inquiry number 01494959), was received by a partner on 16-FEB-2023 and forwarded on 17-FEB-2023, from a non-HCP.  Due to the nature of the event the causal relationship between Vaxelis and "a 3 month old patient missed their 2 dose of VAXELIS in the series" was not applicable.    Further information is expected.