chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Wrong product administered
Clinical narrative: Only diluent was given to patient; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2639746-1. The original narrative from the sender is the following:  "only diluent was given to patient".  The causal relationship between Vaxelis and the event "only diluent was given to patient" was assessed as not applicable due to the nature of this reported event.  It should be noted that it is unclear to which vaccines this event is associated. However, the case was databased to mirror what was reported in VAERS.  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Product preparation error
Clinical narrative: Only diluent was given to patient; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2639746-1. The original narrative from the sender is the following:  "only diluent was given to patient".  The causal relationship between Vaxelis and the event "only diluent was given to patient" was assessed as not applicable due to the nature of this reported event.  It should be noted that it is unclear to which vaccines this event is associated. However, the case was databased to mirror what was reported in VAERS.  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15
Symptoms: Wrong product administered
Clinical narrative: Patient came to received pneumococcal vaccine and was given Vaxelis (DTaP+IPV+Hib+HepB) instead; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2642353-1. The original narrative from the sender is the following:  "Patient came in the office to receive pneumococcal vaccine and was given Vaxelis (DTaP+IPV+Hib+HepB) instead. Once realized, parent and PCP were informed. Patient was then given the correct vaccine, PCV15".  The causal relationship between Vaxelis and the event "Patient came to received pneumococcal vaccine and was given Vaxelis (DTaP+IPV+Hib+HepB) instead" was assessed as not applicable due to the nature of this reported event.  No further information is expected
Sex: F
Vaccine: DTPPVHBHPB, PPV, RV1, DTPPVHBHPB, PPV, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was mistakenly administered Pneumovax23 which is not recommended for children under 2 years; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2642961-1. The original narrative from the sender is the following:  "The patient was mistakenly administered Pneumovax23 which is not recommended for children under 2 years. Attempts have been made to contact parents, but I have not been able to reach them, so it is unknown if there has been an adverse effect".   The causal relationship between Vaxelis and the event "Patient was mistakenly administered Pneumovax23 which is not recommended for children under 2 years" was assessed as not applicable due to the nature of this event.  Of note, these events do not concern Vaxelis, but rather Pneumovax23 vaccine. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Injection site rash
Clinical narrative: patient developed a rash on the thigh at the site where she was given Vaxelis; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2644045-1. The original narrative from the sender is the following:  "Mom reported that patient developed a rash on the thigh at the site where she was given Vaxelis".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "patient developed a rash on the thigh at the site where she was given Vaxelis".  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Administration site erythema, Administration site swelling, Swelling
Clinical narrative: Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; This non-serious spontaneous safety report with reference number # 2307USA011814 (VAERS ID 2644679-1) was received by a partner on 25-JUL-2023 and forwarded to company on 27-JUL-2023 from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh".  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh; This non-serious spontaneous safety report with reference number # 2307USA011814 (VAERS ID 2644679-1) was received by a partner on 25-JUL-2023 and forwarded to company on 27-JUL-2023 from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Localized swelling,redness within hours of administration not directly at the site given but on the inner thigh".  Further information is not expected.
Sex: F
Vaccine: COVID19-2, DTPPVHBHPB, FLU4, PNC15, DTPPVHBHPB
Symptoms: Crying, Hypophagia, Incorrect product formulation administered, Injection site induration, Pyrexia
Clinical narrative: Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; She states that her food intake has been minimal for 24-hours; It appears to be like heat rash and it not raised or bumpy; It appears to be like heat rash and it not raised or bumpy; Childs left leg is hard to the touch but does not appear read or swollen; It appears to be like heat rash and it not raised or bumpy; She thinks she was febrile but did not take her temperature; She cried and was inconsolable for the entire night; This spontaneous safety report, with reference number 2645370-1, was received by the partner on 25-JUL-2023 and forwarded to UBC on 24-AUG-2023, from a consumer.  Due to the nature of the event, the causality between the events "She states that her food intake has been minimal for 24-hours, it appears to be like heat rash and it not raised or bumpy, Childs left leg is hard to the touch but does not appear read or swollen, she thinks she was febrile but did not take her temperature and she cried and was inconsolable for the entire night" and Vaxelis was related.  The event "Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation" and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: COVID19-2, DTPPVHBHPB, FLU4, PNC15, DTPPVHBHPB
Symptoms: Rash, Rash erythematous, Rash macular, Underdose
Clinical narrative: Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; She states that her food intake has been minimal for 24-hours; It appears to be like heat rash and it not raised or bumpy; It appears to be like heat rash and it not raised or bumpy; Childs left leg is hard to the touch but does not appear read or swollen; It appears to be like heat rash and it not raised or bumpy; She thinks she was febrile but did not take her temperature; She cried and was inconsolable for the entire night; This spontaneous safety report, with reference number 2645370-1, was received by the partner on 25-JUL-2023 and forwarded to UBC on 24-AUG-2023, from a consumer.  Due to the nature of the event, the causality between the events "She states that her food intake has been minimal for 24-hours, it appears to be like heat rash and it not raised or bumpy, Childs left leg is hard to the touch but does not appear read or swollen, she thinks she was febrile but did not take her temperature and she cried and was inconsolable for the entire night" and Vaxelis was related.  The event "Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation" and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: COVID19-2, DTPPVHBHPB, FLU4, PNC15, DTPPVHBHPB
Symptoms: Crying, Hypophagia, Incorrect product formulation administered, Injection site induration, Miliaria
Clinical narrative: Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; She states that her food intake has been minimal for 24-hours; It appears to be like heat rash and it not raised or bumpy; It appears to be like heat rash and it not raised or bumpy; Childs left leg is hard to the touch but does not appear read or swollen; It appears to be like heat rash and it not raised or bumpy; She thinks she was febrile but did not take her temperature; She cried and was inconsolable for the entire night; This spontaneous safety report, with reference number 2645370-1, was received by the partner on 25-JUL-2023 and forwarded to UBC on 24-AUG-2023, from a consumer.  Due to the nature of the event, the causality between the events "She states that her food intake has been minimal for 24-hours, it appears to be like heat rash and it not raised or bumpy, Childs left leg is hard to the touch but does not appear read or swollen, she thinks she was febrile but did not take her temperature and she cried and was inconsolable for the entire night" and Vaxelis was related.  The event "Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation" and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: COVID19-2, DTPPVHBHPB, FLU4, PNC15, DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation; She states that her food intake has been minimal for 24-hours; It appears to be like heat rash and it not raised or bumpy; It appears to be like heat rash and it not raised or bumpy; Childs left leg is hard to the touch but does not appear read or swollen; It appears to be like heat rash and it not raised or bumpy; She thinks she was febrile but did not take her temperature; She cried and was inconsolable for the entire night; This spontaneous safety report, with reference number 2645370-1, was received by the partner on 25-JUL-2023 and forwarded to UBC on 24-AUG-2023, from a consumer.  Due to the nature of the event, the causality between the events "She states that her food intake has been minimal for 24-hours, it appears to be like heat rash and it not raised or bumpy, Childs left leg is hard to the touch but does not appear read or swollen, she thinks she was febrile but did not take her temperature and she cried and was inconsolable for the entire night" and Vaxelis was related.  The event "Wrong Moderna formulation given, should have been 0.25 mg/ug but gave 0.2 mg/ug formulation" and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake; Almost certain that Vaxelis was given orally by mistake; No adverse reaction as of 6/19/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2646972-1. The original narrative from the sender is the following:  "Patient was given either Vaxelis or Vaxnevance orally along with Rotavirus by mistake. After mistake was made aware, went through sharps container to identify that Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake, but wanted to report for both as possible outcomes. No adverse reaction as of 6/19/2023".  The causal relationship between Vaxelis and the events "Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake" and "No adverse reaction as of 6/19/2023" was assessed as not applicable due to the nature of these reported events.  No further information is expected.  Non-significant follow up information with reference number # 2646972 was received by the partner on 25-JUL-2023 and forwarded to agency on 28-JUL-2023 from a health professional.  The causal relationship between Vaxelis and the events "Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake" and "No adverse reaction as of 6/19/2023" was assessed as not applicable due to the nature of these reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: Incorrect route of product administration, No adverse event, Product administration error
Clinical narrative: Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake; Almost certain that Vaxelis was given orally by mistake; No adverse reaction as of 6/19/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2646972-1. The original narrative from the sender is the following:  "Patient was given either Vaxelis or Vaxnevance orally along with Rotavirus by mistake. After mistake was made aware, went through sharps container to identify that Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake, but wanted to report for both as possible outcomes. No adverse reaction as of 6/19/2023".  The causal relationship between Vaxelis and the events "Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake" and "No adverse reaction as of 6/19/2023" was assessed as not applicable due to the nature of these reported events.  No further information is expected.  Non-significant follow up information with reference number # 2646972 was received by the partner on 25-JUL-2023 and forwarded to agency on 28-JUL-2023 from a health professional.  The causal relationship between Vaxelis and the events "Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake" and "No adverse reaction as of 6/19/2023" was assessed as not applicable due to the nature of these reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15, PNC15, RV1, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake; Almost certain that Vaxelis was given orally by mistake; No adverse reaction as of 6/19/2023; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2646972-1. The original narrative from the sender is the following:  "Patient was given either Vaxelis or Vaxnevance orally along with Rotavirus by mistake. After mistake was made aware, went through sharps container to identify that Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake, but wanted to report for both as possible outcomes. No adverse reaction as of 6/19/2023".  The causal relationship between Vaxelis and the events "Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake" and "No adverse reaction as of 6/19/2023" was assessed as not applicable due to the nature of these reported events.  No further information is expected.  Non-significant follow up information with reference number # 2646972 was received by the partner on 25-JUL-2023 and forwarded to agency on 28-JUL-2023 from a health professional.  The causal relationship between Vaxelis and the events "Vaxelis did not have needle attached and almost certain that Vaxelis was given orally by mistake" and "No adverse reaction as of 6/19/2023" was assessed as not applicable due to the nature of these reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, DTPPVHBHPB, PNC13
Symptoms: Wrong product administered
Clinical narrative: Vaccines were pulled for a different patient and were mistakenly given to this patient; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2647341-1. The original narrative from the sender is the following:  " Vaccines were pulled for a different patient and were mistakenly given to this patient".  The causal relationship between Vaxelis and the event "Vaccines were pulled for a different patient and were mistakenly given to this patient" was assessed as not applicable due to the nature of the reported event.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV1, DTPPVHBHPB, PNC15, RVX
Symptoms: Crying, Dyskinesia
Clinical narrative: Crying involuntary movement; Crying involuntary movement; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2647999-1. The original narrative from the sender is the following:  Concomitant medications include acetaminophen.  "Crying Involuntary movement".  The reporter did not provide the causal relationship between Vaxelis and the events, "Crying Involuntary movement".  Non-significant follow up information received from partner with reference number #2647999 on 25-JUL-2023 and forwarded to agency on 28-JUL-2023 from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of "Crying involuntary movement".  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Crying, Musculoskeletal stiffness, Opisthotonus, Screaming
Clinical narrative: Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2648473-1. The original narrative from the sender is the following:  "Child became very stiff and unable to console at times. He would ball his hands and fists tightly and just scream while arching his back. As parents we could not do anything to help him during these moments he would just scream until he fell asleep. This lasted for several weeks post vaccine".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event, " Child became very stiff and unable to console at times. He would ball his hands and fists tightly and just scream while arching his back".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Crying, Musculoskeletal stiffness, Screaming
Clinical narrative: Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; Child became stiff and unable to console at times. He would ball his hands and fist tightly and just scream while arching his back; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2648473-1. The original narrative from the sender is the following:  "Child became very stiff and unable to console at times. He would ball his hands and fists tightly and just scream while arching his back. As parents we could not do anything to help him during these moments he would just scream until he fell asleep. This lasted for several weeks post vaccine".  The reporter did not provide an assessment of causal relationship between Vaxelis and the event, " Child became very stiff and unable to console at times. He would ball his hands and fists tightly and just scream while arching his back".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Patient was given vaxelis vaccine instead of the Tdap vaccine that was ordered.; product use in unapproved population; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2648886-1 The original narrative from the sender is the following:  "Patient was given vaxelis vaccine instead of the Tdap vaccine that was ordered.".  The causal relationship between Vaxelis and the events "Patient was given vaxelis vaccine instead of the Tdap vaccine that was ordered and product use issue " was assessed as not applicable due to the nature of these reported events.  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given vaxelis vaccine instead of the Tdap vaccine that was ordered.; product use in unapproved population; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2648886-1 The original narrative from the sender is the following:  "Patient was given vaxelis vaccine instead of the Tdap vaccine that was ordered.".  The causal relationship between Vaxelis and the events "Patient was given vaxelis vaccine instead of the Tdap vaccine that was ordered and product use issue " was assessed as not applicable due to the nature of these reported events.  No further information is expected
Sex: F
Vaccine: DTPPVHBHPB, HEPA, DTPPVHBHPB, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years.; PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years.; PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years; Mother verbalized no adverse reaction to vaccine administration; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2649300-1. The original narrative from the sender is the following:  "PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years. Clinic aware of error and clinic notified Regional Director, and Immunization Program nurse of the error. Per nurset, the dose can be considered valid with no revaccination necessary. On 6/7/23, Patient's mother was contacted by PHN and notified of error. Mother verbalized no adverse reaction to vaccine administration".  The causal relationship between Vaxelis and the events, " PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years" and "Mother verbalized no adverse reaction to vaccine administration" was assessed as not applicable due to the nature of the reported events.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, HEPA, DTPPVHBHPB, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years.; PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years.; PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years; Mother verbalized no adverse reaction to vaccine administration; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2649300-1. The original narrative from the sender is the following:  "PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years. Clinic aware of error and clinic notified Regional Director, and Immunization Program nurse of the error. Per nurset, the dose can be considered valid with no revaccination necessary. On 6/7/23, Patient's mother was contacted by PHN and notified of error. Mother verbalized no adverse reaction to vaccine administration".  The causal relationship between Vaxelis and the events, " PHN administered Vaxelis as a 4th dose of DTaP to a 5 year old patient. Vaxelis is not approved for 4th dose of DTaP or children over the age of 5 years" and "Mother verbalized no adverse reaction to vaccine administration" was assessed as not applicable due to the nature of the reported events.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15
Symptoms: Dyskinesia, Febrile convulsion, Pyrexia
Clinical narrative: jerking movements of arms and legs lasting less than 1 min; Patient developed febrile seizure at 12 midnight on 2/7/23; tactile fever; This non-serious spontaneous safety report with reference number # 2649564 (VAERS ID-2649564-1) was received by a partner on 25-JUL-2023 and forwarded to agency on 28-JUL-2023 from a health care professional  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "jerking movements of arms and legs lasting less than 1 min, Patient developed febrile seizure at 12 midnight on 2/7/23 and tactile fever".  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Urticaria
Clinical narrative: Hives about 2 hours after vaccine administration; This non-serious spontaneous safety report with the VAERS ID: #2652699-1 was received by a partner on 18-AUG-2023 and forwarded to agency on 22-AUG-2023 from a health care professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Hives about 2 hours after vaccine administration".  Further information is not expected.
Age: 0.33
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was due for her 4 month old vaccines during visit 8/28/23. Medical Assistant failed to verify vaccines and accidentally administered HPV, instead of Pneumococcal 15 vaccine.
Age: 0.33
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Patient was due for her 4 month old vaccines during visit 8/28/23. Medical Assistant failed to verify vaccines and accidentally administered HPV, instead of Pneumococcal 15 vaccine.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Ataxia, Chills, Confusional state, Fatigue
Clinical narrative: couldn't walk very well; arm pain; muscles adversely effected; sleeping; fever; tired; joints hurt; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt) had not resolved and SOMNOLENCE (sleeping) outcome was unknown.            The dosage text was reported as unknown. No concomitant medication was reported. The patient had a serious bad reaction to it with fever, sleeping, tired, muscles adversely effected, couldn't walk very well, and his joints hurt. The patient was nearly better, and hopes to fully better by the next day. The patient still had some arm pain and it hurts to lift or touch it. The patient hopes to be better. Essentially no reactions to any prior doses but the patient had taken all doses available to him.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: couldn't walk very well; arm pain; muscles adversely effected; sleeping; fever; tired; joints hurt; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt) had not resolved and SOMNOLENCE (sleeping) outcome was unknown.            The dosage text was reported as unknown. No concomitant medication was reported. The patient had a serious bad reaction to it with fever, sleeping, tired, muscles adversely effected, couldn't walk very well, and his joints hurt. The patient was nearly better, and hopes to fully better by the next day. The patient still had some arm pain and it hurts to lift or touch it. The patient hopes to be better. Essentially no reactions to any prior doses but the patient had taken all doses available to him.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue, Gait disturbance, Hyperaesthesia, Muscle discomfort
Clinical narrative: couldn't walk very well; arm pain; muscles adversely effected; sleeping; fever; tired; joints hurt; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt) had not resolved and SOMNOLENCE (sleeping) outcome was unknown.            The dosage text was reported as unknown. No concomitant medication was reported. The patient had a serious bad reaction to it with fever, sleeping, tired, muscles adversely effected, couldn't walk very well, and his joints hurt. The patient was nearly better, and hopes to fully better by the next day. The patient still had some arm pain and it hurts to lift or touch it. The patient hopes to be better. Essentially no reactions to any prior doses but the patient had taken all doses available to him.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: couldn't walk very well; arm pain; muscles adversely effected; sleeping; fever; tired; joints hurt; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 202F23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), SOMNOLENCE (sleeping), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk very well), PAIN IN EXTREMITY (arm pain), MUSCLE DISCOMFORT (muscles adversely effected), PYREXIA (fever), FATIGUE (tired) and ARTHRALGIA (joints hurt) had not resolved and SOMNOLENCE (sleeping) outcome was unknown.            The dosage text was reported as unknown. No concomitant medication was reported. The patient had a serious bad reaction to it with fever, sleeping, tired, muscles adversely effected, couldn't walk very well, and his joints hurt. The patient was nearly better, and hopes to fully better by the next day. The patient still had some arm pain and it hurts to lift or touch it. The patient hopes to be better. Essentially no reactions to any prior doses but the patient had taken all doses available to him.
Age: 55.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Administration of RECOMBIVAX HB to a patient on 28-AUG-2023 after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 55-year-old patient. Patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.    On 28-AUG-2023, inadvertently the patient was vaccinated with an improper storage dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # W036194, expiration date 29-SEP-2025 for prophylaxis (dose and route were not reported) (product storage error). The vaccine was exposed to -1.1 Celsius (C) for 5 minutes. There was no previous temperature excursion.  No additional adverse event and nor product quality complain were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient who received an expired dose of PNEUMOVAX 23 (pre-filled syringe) with no prior TEs.; This spontaneous report was received from a licensed practical nurse (LPN) concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-SEP-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered as prophylaxis (strength, and route of administration were not provided) (Expired product administered).  It was reported that the vaccine did not have any prior temperature excursions. No symptoms or additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no side effect; HCP calling to report AE for PROQUAD. Improperly stored vaccine was administered. No side effects reported. No other medical information known. HCP permission to contact obtained. See additional AE cases 02477408, 02477522, 02477532, and 02477561. No; This spontaneous report was received from Other Health Professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X005166, expiry date 15-AUG-2024 (conflicting information)) subcutaneous injection (strength, route of administration, and indication were not provided). No side effects reported. No other medical information was known.   The temperature excursion was at 6 degrees C during a time frame of 7 hours. No previous temperature excursion was reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, COVID-19, Computerised tomogram head, Computerised tomogram neck, Tinnitus
Clinical narrative: Tinnitus. My ears have been ringing non-stop since September 2022. It got worse after contracting Covid-19 in November 2022.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Albumin globulin ratio normal, Angiogram cerebral normal, Anion gap
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphasia, Aspartate aminotransferase normal, Bacterial test negative, Basophil percentage decreased, Bilirubin urine
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood albumin normal, Blood alcohol normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood chloride normal, Blood cholesterol normal, Blood creatinine normal, Blood glucose normal, Blood lactic acid
Clinical narrative: From about 6PM to 10PM (on the day vaccinated), I visited neighbors to watch college football on TV. I drank 3 or 4 beers and consumed a BBQ dinner. I went to bed about 10:30PM and was awoken about mid-night by the worst splitting headache I have ever had. It was so bad that I could not lie down. I sat on the edge of the bed for some slight relief, but it was still extremely painful. I tried to sleep sitting up, but wasn't very successful. My spouse woke up about 7AM and I tried to tell her about my condition, but all my words were a jumbled jiberish that was totally uncomprehensible. We realized the symptons were that of a potential stroke, so my spouse drove me to the Hospital emergency room. The staff immediately began tests and scans and blood work for a potential stroke. They concluded my diagnosis was TIA (transient ischemic attack) Primary, (code G45.9), Cerebrovascular accident (CVA), unspecified mechanism (HCC) (code I63.9), and Dysphasia (code R47.02). As time went by my symptoms decreased and I gradually was able to gain my speech and increase my vocabulary such that I was again understandable. They gave me one aspirin (325mg) each day I was in the hospital and a B-1 injection on my last day in the hospital. I did not take my daily medications on Saturday night, Sunday morning and night, and Monday morning. The hospital doctor changed my daily prescriptions for 30 days to add an 81mg aspirin 1/day, add 80mg atorvastatin 1/day, and stop taking simvastatin 40mg. They recommended follow-up appointments with my primary care physician (PCP) and a neurologist. My headache dissapated daily while in the hospital and has nearly ceased today.