chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: leg cramps /severe leg cramps; joint pain all over /joint pain; headache; Covid arm; Discomfort; Itching at injection site; Large swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (leg cramps /severe leg cramps), IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Large swelling at injection site) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Large swelling at injection site). On 19-Nov-2022, the patient experienced MUSCLE SPASMS (leg cramps /severe leg cramps), ARTHRALGIA (joint pain all over /joint pain) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (leg cramps /severe leg cramps), IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Large swelling at injection site), ARTHRALGIA (joint pain all over /joint pain) and HEADACHE (headache) outcome was unknown.            No concomitant information provided. Patient took the offered four doses Covid Moderna vaccine, at the appropriate times.  Patient was in relatively good health and patient had O negative blood. Patient had no fever or life threatening issues.  It was reported that patient had previously received different vaccines, that did nothing of the sort. Patient had a general doctor appointment coming up and would report this.   This case was linked to MOD-2022-675368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Live Follow-up Significant information which includes Events added
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022; No adverse event; Received Moderna Covid 19 Bivalent Booster after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Nov-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 21-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent Booster after 30 Day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10Oct2022 and was administered to patient on 21Nov2022).    No concomitant information provided. The vial did not undergo any temperature excursions. Vaccine was initially stored in refrigerator on 10-Oct-2022. No treatment information provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; A patient was accidently administered VARIVAX via intramuscular route; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patients' concurrent conditions, medical history, concomitant therapies and historical drug were not provided.  On 25-OCT-2012, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U019903, expiration date: 24-JUN-2023, administered intramuscularly (Incorrect route of product administration) for prophylaxis (strength, dosage not reported was not provided).  No additional adverse events were reported.
Age: 0.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARIVAX that had undergone temperature excursion; This spontaneous report has been received from a registered nurse concerning a 11-month-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX), in a timeframe of 1 hour and 45 minutes. A previous temperature excursion was also reported.  On 15-SEP-2022, the patient received a vaccine dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U039726, expiration date: 15-DEC-2023) (dose, route of administration and anatomical location were not provided) as prophylaxis (product storage error). No additional events were reported (no adverse event).
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: she received the first dose towards the end of June, 2019. She did not get the second dose due to COVID starting.; No additional AE's reported.; This spontaneous report was received from a pharmacist and referred to a currently 19-year-old female patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  Towards the end of June 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not reported) for prophylaxis. She did not get the second dose due to coronavirus disease (COVID) starting (inappropriate schedule of product administration). The patient was wanting her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the pharmacy.The pharmacist would like to know if the series should be restarted or if they could continue with the second dose and count the first? No additional adverse events were reported (no adverse event). No other information known.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; an improperly stored vaccine was administered to a patient; This spontaneous report was received from an other health professional and refers to a 4 year-old female patient with drug hypersensitivity for penicillin (PCN), slow transit constipation, asthma and non-seasonal allergic rhinitis due to pollen. The patient's medical history included exercise induced bronchospasm and acute cystitis without hematuria. The patient was also a premature newborn (36 weeks, 2381 gram birth weight) and had 1 sibling.  On 18-OCT-2022 the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (recombinant human albumin) (PROQUAD) (lot # W024548, expiration date: 31-JAN-2024),0.5 milliliter, subcutaneous in the right vastus lateralis for prophylaxis (product storage error). The same day the patient was also vaccinated with influenza vaccine (manufacturer GSK) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).  Administered doses of vaccines experienced the temperature excursion of 10.8 degrees Fahrenheit for 18 hours 30 minutes. There was no previous temperature excursion.  There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2211USA004005: US-009507513-2211USA004003: US-009507513-2211USA004004: US-009507513-2211USA008242:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Caller is an HCP reporting an expired dose of MMR II (Lot: T033814, Expiration Date: 5OCT2022) was accidently administered to a patient.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date in October 2022, the patient was accidently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (0.5 milliliter (ml) /once, strength, anatomical site of vaccination and route of administration were not reported, lot #T033814, expiration date was reported and validated as 05-OCT-2022) for prophylaxis (expired product administered). No additional clarifying statements or details were provided.  This is one of two reports from same reporter.; Sender's Comments:  US-009507513-2211USA005029:MSD
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; A patient received a 2nd dose of PROQUAD in error before 4 years of age. Patient was supposed to receive the 2nd dose when she was 4 years old. Patient is 2 years of age now and received a 2nd dose today (11/16/2022).; This spontaneous report was received from a medical assistant regarding a 2-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered for prophylaxis.  On 16-NOV-2022, the patient was vaccinated in error with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, product quantity 1, lot #W024548, expiration date: 31-JAN-2024 (strength, anatomical location, and route of administration were not provided) administered for prophylaxis, before 4 years of age (Product administered to patient of inappropriate age).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose was administered after expiration; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) intramuscular injection, lot #T032918, expiration date: 12-NOV-2022 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). No additional adverse events were reported.
Sex: M
Vaccine: PPV
Symptoms: Contusion, Peripheral swelling, Rash, Skin discolouration
Clinical narrative: Patient experienced swelling of his arm, an arm rash and bruise-like discoloration of whole arm, not just the injection site; bruise-like discoloration of whole arm; Patient experienced swelling of his arm, an arm rash and bruise-like discoloration of whole arm, not just the injection site; Patient experienced swelling of his arm, an arm rash and bruise-like discoloration of whole arm, not just the injection site; This spontaneous report has been received from a pharmacist referring a 79-year-old male patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 17-NOV-2022, the patient was vaccinated with the first dose of pneumococcal vaccine (+) polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0,5 milliliter, lot number W021636 with expiration date 01-OCT-2023, administered intramuscularly for prophylaxis (strength, vaccination scheme and anatomical site of application were not provided).   On an unknown date in November in 2022, the patient experienced swelling of his arm (arm unspecified by health care professional) (peripheral swelling), an arm rash (rash) and bruise-like discoloration of whole arm (contusion, skin discolouration), not just the injection site. At time of reporting, the patient was recovering from the events.   The causal relationship between the events and pneumococcal vaccine (+) polyvalent (23-valent) (PNEUMOVAX23) was not reported.   This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2211USA007016:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's were reported; An office manager called to report and evaluate an expired dose of VAQTA that was administered to a patient.  The office manager put a nurse on the phone to receive the evaluation results.  No additional AE's and no PQC's were reported.; This spontaneous report has been received from an officer manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-NOV-2022, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection as prophylaxis (lot number: U026792, which was determined to be valid, with an expiration date on 28-OCT-2022) (strength, dose, scheme, route and anatomical location of administration were not reported) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported expired vaccine administered.  No additional information provided.  No additional AEs or PQC reported.; Caller reported expired vaccine administered.  No additional information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 26-OCT-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter administered intramuscularly (IM) in the right (Rt) deltoid (vaccination scheme frequency was not provided; valid lot number T036820, with an expiration date of 01-JUL-2022) administered as prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Multiple Patients were administered Improperly Stored; This spontaneous report has been received from a registered nurse to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On unknown date in October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 10-OCT-2022, 11-OCT-2022, 12-OCT-2022, and 13-OCT-2022) the patient was vaccinated with improperly storage dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number: W010874, expiration date on 12-OCT-2024, lot number: W006721, expiration date on 12-OCT-2024). All of the vaccines were administered as prophylaxis (strengths, doses, routes of administration, and anatomical sites of injection were not reported).   The administered doses of the vaccines were stored on 25-JUL-2022, at a temperature of -47.5 degrees Fahrenheit (F), during a time frame of 5 minutes. (Product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.  This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Multiple Patients were administered Improperly Stored; This spontaneous report has been received from a registered nurse to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On unknown date in  October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 10-OCT-2022, 11-OCT-2022, 12-OCT-2022, and 13-OCT-2022) the patient was vaccinated with improperly storage dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number: W010874, expiration date on 12-OCT-2024, lot number: W006721, expiration date on 12-OCT-2024). All of the vaccines were administered as prophylaxis (strengths, doses, routes of administration, and anatomical sites of injection were not reported).   The administered doses of the vaccines were stored on 25-JUL-2022, at a temperature of -47.5 degrees Fahrenheit (F), during a time frame of 5 minutes. (Product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.  This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE; Multiple Patients were administered Improperly Stored; This spontaneous report has been received from a registered nurse to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On unknown date in  October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 10-OCT-2022, 11-OCT-2022, 12-OCT-2022, and 13-OCT-2022) the patient was vaccinated with improperly storage dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number: W010874, expiration date on 12-OCT-2024, lot number: W006721, expiration date on 12-OCT-2024). All of the vaccines were administered as prophylaxis (strengths, doses, routes of administration, and anatomical sites of injection were not reported).   The administered doses of the vaccines were stored on 25-JUL-2022, at a temperature of -47.5 degrees Fahrenheit (F), during a time frame of 5 minutes. (Product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.  This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278:
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly; Case reference number US-BN-2022-001860 is a spontaneous case report initially received from a healthcare professional on 09-Aug-2022 and concerns a patient of unknown demographics (first out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  This case is linked to cases no. US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001863, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.  Additional information was received on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients, information about needle, local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a healthcare professional on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. Inappropriate route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. Inappropriate route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly; Case reference number US-BN-2022-001861 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (second out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001862, US-BN-2022-001863, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly; Case reference number US-BN-2022-001862 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (third out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001863, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, the patient did not experience any negative effects due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly; Case reference number US-BN-2022-001863 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (fourth out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001864, and US-BN-2022-001865 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. No associated adverse events were reported with the reported medication error. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. No associated adverse events were reported with the reported medication error. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly; Case reference number US-BN-2022-001864 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (fifth out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from the Bavarian Nordic on 15-Aug-2022, included local BN case ID.  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001863, and US-BN-2022-001865 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intramuscularly; Case reference number US-BN-2022-001865 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (sixth out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001863, and US-BN-2022-001864 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Jynneos vaccine was administered 21 days after the first dose; Case reference number US-BN-2022-002579 is a spontaneous case report initially received on 20-Sep-2022 from a nurse via Company (reference number: USBAV22-1470) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 25-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown), at an unknown dose, route or site of administration, for monkeypox prophylaxis.  On an unspecified date, 21 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown), at an unknown dose, route or site of administration, for monkeypox prophylaxis (explicitly coded as 'inappropriate schedule of product administration').  It was reported that no treatment was given to the patient due to adverse event and no laboratory tests have been performed.  At the time of this report, no adverse reaction was reported.  Additional information received from Bavarian Nordic on 21-Sep-2022 included the local BN case ID.  No further information was provided.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine, at an unknown dose, route or site of administration, for monkeypox prophylaxis, on the day 21 after the first dose, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine, at an unknown dose, route or site of administration, for monkeypox prophylaxis, on the day 21 after the first dose, which is considered as inappropriate schedule of product administration. No associated adverse events have been reported. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product administration error, Product storage error
Clinical narrative: Jynneos that had been punctured for at least eight hours was administered; Jynneos was administered intradermally with a vial that had been punctured for at least eight hours; Jynneos was administered intradermally; Case reference number US-BN-2022-002658 is a spontaneous case report initially received on 21-Sep-2022 from other health professional via Agency (reference number: USBAV22-1488) and concerns a male patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On 20-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose of 0.1 ml, administered intradermally at an unknown site of administration for monkeypox prophylaxis. The vaccine was administered with a vial that had been punctured for at least eight hours (explicitly coded as 'product storage error ', 'product administration error' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 22-Sep-2022 included local BN case ID.; Reporter's Comments: A male patient of an unknown age was vaccinated with the first dose of Jynneos, administered intradermally at an unknown site of administration for monkeypox prophylaxis. The vaccine was administered with a vial that had been punctured for at least eight hours, which is considered as a product storage error and product administration error. No associated adverse events were reported. Intradermal injection, product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of an unknown age was vaccinated with the first dose of Jynneos, administered intradermally at an unknown site of administration for monkeypox prophylaxis. The vaccine was administered with a vial that had been punctured for at least eight hours, which is considered as a product storage error and product administration error. No associated adverse events were reported. Intradermal injection, product storage error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection, product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos was administered intradermally instead of subcutaneously; Case reference number US-BN-2022-003166 is a spontaneous case report initially received from a consumer via Company (reference number: USBAV22-1499) on 22-Sep-2022 and concerns an elderly male patient.  The patient's medical history and concomitant medication details were not provided.  The patient's concomitant vaccine included Pfizer BioNTech COVID-19 vaccine (tozinameran).  On 23-Aug-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: not provided), administered intradermally (explicitly coded as 'intradermal injection'), at an unknown dose or site of administration, for monkeypox prophylaxis.   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Additional information received from Bavarian Nordic on 23-Sep-2022 included the local BN case ID.; Reporter's Comments: An elderly male patient was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as intradermal injection, at an unknown dose or site of administration, for monkeypox prophylaxis. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. The event of intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, and concomitant vaccine included Pfizer BioNTech COVID-19 vaccine. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An elderly male patient was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as intradermal injection, at an unknown dose or site of administration, for monkeypox prophylaxis. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. The event of intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, and concomitant vaccine included Pfizer BioNTech COVID-19 vaccine. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Jynneos vaccine administered intramuscularly; Case reference number US-BN-2022-003207 is a spontaneous case report initially received on 15-Sep-2022 from a nurse via Bavarian Nordic and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose, route or site of administration, for monkeypox prophylaxis.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown), at an unknown dose or site of administration, administered intramuscularly (explicitly coded as 'incorrect route of product administration'). After the vaccination, the patient was observed for approximately 20 minutes and no adverse event occurred.  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received from Company on 15-Sep-2022 included Company ID and indication for Jynneos, and is blended in the case narrative.  This case is linked with the case US-BN-2022-003208 (same reporter).; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos vaccine intramuscularly, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. No associated adverse events have been reported. Inappropriate route of vaccination has been considered not related to the suspect product. The case is non-serious.