chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Cerebrovascular accident, Dizziness, Influenza virus test negative, Malaise
Clinical narrative: Took flu shot at 6pm Friday  Got sick Saturday - around morning or noon  Started getting dizzy and lost balance on Sunday around 5pm (likely had a stroke) Called EMS at 2:30am that night
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Troponin T normal
Clinical narrative: Took flu shot at 6pm Friday  Got sick Saturday - around morning or noon  Started getting dizzy and lost balance on Sunday around 5pm (likely had a stroke) Called EMS at 2:30am that night
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: first symptoms were low grade fever and achy and fatigue.  That was the first day and 2 days after. My arm became more and more inflamed, swollen and hot. The fourth morning I woke up very dizzy but it passed. I continued ot have the other symptoms. Fifth morning I woke up dizzy and then had several bowel movements and started to vomit to the eventual point of dry heaves.my arm was hot and inflamed almost to my elbow and the inner arm was also swollen, inflamed and hot.  I then to a car service to the urgent care. at urgent care my blood pressure was very high
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Frequent bowel movements, Hypertension, Inflammation, Pain, Peripheral swelling
Clinical narrative: first symptoms were low grade fever and achy and fatigue.  That was the first day and 2 days after. My arm became more and more inflamed, swollen and hot. The fourth morning I woke up very dizzy but it passed. I continued ot have the other symptoms. Fifth morning I woke up dizzy and then had several bowel movements and started to vomit to the eventual point of dry heaves.my arm was hot and inflamed almost to my elbow and the inner arm was also swollen, inflamed and hot.  I then to a car service to the urgent care. at urgent care my blood pressure was very high
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Retching, Skin warm, Vomiting
Clinical narrative: first symptoms were low grade fever and achy and fatigue.  That was the first day and 2 days after. My arm became more and more inflamed, swollen and hot. The fourth morning I woke up very dizzy but it passed. I continued ot have the other symptoms. Fifth morning I woke up dizzy and then had several bowel movements and started to vomit to the eventual point of dry heaves.my arm was hot and inflamed almost to my elbow and the inner arm was also swollen, inflamed and hot.  I then to a car service to the urgent care. at urgent care my blood pressure was very high
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Headache, Nausea
Clinical narrative: 2-3  hours after the injection I developed a slightly elevated temperature, a headache and severe nausea which resolved approximately 4 hours later.  There was no vomiting.  12 hours later there was still a slight headache.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine administered during temperature excursion; No additional AEs; This spontaneous report was received from a Medical Assistant concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 07-NOV-2022, the patient was vaccinated with an improperly storage dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Recombinant Human albumin (rHA) (PROQUAD) 0.5 ml administered subcutaneously (SQ) as prophylaxis, lot number W017571 with expiration date 29-NOV-2023. The vaccine underwent a temperature excursion of 7.8 F for 1 hours and 30 minutes with no previous temperature excursions (Product storage error). No additional adverse events were reported (No adverse event).
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; MMR II got administered to a patient via Intramuscular route instead of Subcutaneous route; This spontaneous report has been received from a medical assistant, referring to a 5-year-old female patient. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 09-NOV-2022, the patient was administered with measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter (mL) subcutaneous injection (0.5 mL, lot# U039907, expiration date 16-DEC-2023, therapy type: rHA, frequency and anatomical location were unknown) for prophylaxis via intramuscular route instead of subcutaneous route (Incorrect route of product administration). No additional adverse event (AE) was reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant reporting VARIVAX was administered after expiration.; This spontaneous report was received from a Medical Assistant concerning to a patient of unspecified age and gender. The patient's medical history, drug reactions and allergies, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #T037642, expiration date: 06-NOV-2022 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (expired product administered).  No temperature excursion or additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE/PQC reported at time of call.; Caller states a patient who is currently "in her 30's" has received 2 doses outside of the dosing schedule recommended in product prescribing information.; This spontaneous report was received from a nurse and refers to a female patient "in her 30's". The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date in 2002 (also reported as approximately 10 years ago "back in college"), the patient was vaccinated with human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, administered for prophylaxis (strength, anatomical location, lot #, expiry date, and route of administration were not provided), but she did not finish the series at that time. Then on an unspecified date in 2022, she was vaccinated with the second dose of the vaccine, receiving 2 doses outside of the dosing schedule recommended in product prescribing information. Additional information or adverse event was not provided.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant reporting that a dose of PNEUMOVAX23 with a labeled expiry of 6/22/2022 was inadvertently administered to a patient on 11/14/2022. Caller reports no temperature excursion involved. No additional information provided. No additional A; This spontaneous report was received from a medical assistant and referred to a 58-year-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 14-NOV-2022, the patient was inadvertently administered with a labeled expiry of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0,5 milliliters (lot number: T034630 and expiration date: 22-JUN-2022) for prophylaxis (strength and route of administration were not provided). No temperature excursion was involved. No additional information provided. No additional adverse event was reported at the reporting time.
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no additional AE reported; Medical assistant calling to report that a 4 month old patient was inadvertently administered PROQUAD. No additional information was provided. Caller reports no additional AE reported. No PQC.; This spontaneous report has been received from a medical assistant, concerning a 4-month-old patient of unknown gender. The patient's concomitant medications included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). The patient's medical history, concurrent conditions, previous drug reactions and allergies were not provided.   On 15-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (product administered to patient of inappropriate age) subcutaneous injection, at a dose of 0.5 milliliters (ml) (lot number W010063 has been verified to be valid; expiration date reported and established as 20-SEP-2023) (strength, frequency, vaccination scheme, route of administration, and anatomical locations were not provided).
Sex: U
Vaccine: HIBV, UNK
Symptoms: Medication error, No adverse event, Product packaging confusion
Clinical narrative: Always confuse the PEDVAXHIB and DILUENT because their boxes look the same; Always confuse the PEDVAXHIB and DILUENT because their boxes look the same; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient reported to confuse the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered as prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided); with the sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose, frequency, lot #, expiry date, route of administration, and indication were not provided) as their boxes looked the same (product packaging confusion).  The patient did not provide additional information to clarify if the confusion had ever led to a medical error (circumstance or information capable of leading to medication error).  No additional adverse events were reported (no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal
Clinical narrative: Crohn's Disease; the patients Hepatitis B titers were low; This spontaneous report was received from a nurse and refers to a female of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown dates in 2013, the patient received 2 doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #0569AA, expiration date: 01-NOV-2013, lot # 0893AA, expiration date: 17-MAY-2022, administered for prevention of hepatitis B (strength, exact dose and route of administration were not provided).  On an unknown date, the patient was seen by an allergy and immunology doctor, who said the patient's hepatitis B titers were low and they recommended she received another manufacturer's hepatitis B vaccine. The patient was being seen by a gastrointestinal (GI) doctor as well and it was also reported that "nobody really knew what's going on with her, but that her doctors seemed to think she might have Crohn's Disease."   At the time of reporting, the outcome of the events was not known.  The causal relationship between the events and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.   Upon internal review, the event of Crohn's Disease was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP is reporting an expired dose of VAQTA (Lot: U031911, Expiration Date 11NOV2022) was administered to a patient.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided.  On 17-NOV-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliters (mL) once (valid lot number U031911 with an expiration date on 11-NOV-2022) (strength, frequency, route of administration and anatomical injection site were not provided) for prophylaxis (expired product administered).  No additional adverse event (AE) was reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; Nurse called and reported that a patient's vaccine schedule was interrupted.  The patient received the first dose of GARDASIL 9 in 2015 (unknown lot and expiry), second dose in 2/2022 (unknown lot and expiry), and third dose (w006229  9/15/2024) tod; This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On an unknown date in 2015, the patient was vaccinated with dose 1 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose description, lot #, expiry date, and route of administration were not provided). On an unknown date  in February 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose description, lot #, expiry date, and route of administration were not provided). On 17-NOV-2022, the patient was vaccinated with dose 3 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #W006229, expiration date: 15-SEP-2024 (dose description, and route of administration were not provided) all 3 doses as prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse event were reported.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Caller reports that lot expired on 10/22/22 and was administered to adult patient on 11/18/22.; This spontaneous report was received from a medical assistant and refers to a 28-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 18-NOV-2022, the patient was vaccinated with a expired lot of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter, lot #U024378, expiration date: 22-OCT-2022, administered for prophylaxis (strength and route of administration were not provided). No additional adverse event was provided.
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Repoter called on behalf of the customer to report an AE for GARDASIL 9. The customer was not on the line. The customer reported she administered GARDASIL 9 to an 11 year old patient, and the patient had syncope 1 minute after receiving the dose. The cus; the patient did bump her head during the episode of syncope; Information has been received from a nurse via a company representative referring to a 11 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-NOV-2022, 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) (lot #, expiration date, anatomical location and administration route) for prophylaxis.       On the same date (16-NOV-2022), 1 minute after receiving the dose, the patient had a syncope. The reporter stated that the patient did bump her head during the episode of syncope. The nurse said the doctor examined the patient, and the patient recovered the same day (on 16-NOV-2022). The outcome of syncope was reported as recovered and for the head injury was unknown.  The causality assessment between the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not provided.    Upon internal review, the syncope was considered as a medically significant event.
Sex: F
Vaccine: SMALLMNK
Symptoms: Accidental exposure to product, No adverse event, Product container issue
Clinical narrative: Nurse got the Jynneos vaccine in her eye; The entire metal and cap came off from Jynneos vaccine; Case reference number US-BN-2022-001646 is a spontaneous case report initially received on 22-Jul-2022 from other health care professional via Agency (reference number: USBAV22-0640) and concerns a 26-year-old female patient.   *The patient had no relevant medical history and was not taking any concomitant medication.*  On 20-Jul-2022, one of the nurses got the Jynneos vaccine ((Smallpox and Monkeypox Vaccine, Live, Nonreplicating); batch number: BNFDP00004; expiration date 31-Aug-2023) in her eye (explicitly coded as 'accidental occupational exposure to product'). She pulled the cap off and the entire metal and cap came off and it splashed in her eyes (explicitly coded as 'product container issue').  *It was confirmed that the patient did not experience any adverse event due to Jynneos vaccine.*  Additional information received on 25-Jul-2022 from Bavarian Nordic included local BN case ID and attached PQC information (PQC number: QE-001752).  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a nurse via Bavarian Nordic on 17-Aug-2022: New information included information that the patient did not have any medical history, was not taking any concomitant medication and did not experience any adverse event due to Jynneos.; Reporter's Comments: A 26-year-old female nurse got the Jynneos vaccine in her eye which is considered as accidental occupational exposure to product. When she pulled the cap, the entire metal and cape came off and splashed in her eyes which is considered as product container issue. Accidental exposure to product  and product container issue are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccine. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 26-year-old female nurse got the Jynneos vaccine in her eye which is considered as accidental occupational exposure to product. When she pulled the cap, the entire metal and cape came off and splashed in her eyes which is considered as product container issue. Accidental exposure to product  and product container issue are both considered listed per company conventions. It was confirmed that the patient did not experience any adverse event due to Jynneos vaccine. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001687 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns *37-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 37-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001688 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *23-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 23-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001689 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *21-years-old (as reported) female patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples. At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 21-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 21-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001690 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *23-year-old female patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 23-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 23-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001691 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *41-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *right deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 41-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 41-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001692 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *39-year-old male patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *right deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 39-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 39-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001693 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *51-year-old female patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *right deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 51-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 51-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001694 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional via Communication (reference number: USBAV22-0690) and concerns a *29-years-old female patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at *right deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to the Jynneos vaccination.  This case is linked with case no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number. 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  on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 29-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 29-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos administered intramuscularly; Case reference number US-BN-2022-001695 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional (reference number: USBAV22-0690) and concerns a *35-years-old male patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at the *left deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to Jynneos vaccination.  This case is linked with case no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from Bavarian Nordic on 29-Jul-2022 included an additional reference number.  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 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 35-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the left deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 35-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at the left deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.