chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Urticaria
Clinical narrative: red rash; developed hives/break out in hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID (ongoing); FLU VACCINE VII taken for immunisation, on 13Oct2022 as dose 1, single. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0150), administration date: 02Apr2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EW0170), administration date: 23Apr2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FF2587), administration date: 23Nov2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4, SINGLE, Lot: FK9894), administration date: 19May2022, when the patient was 72-year-old, for COVID-19 immunization.  The following information was reported: URTICARIA (medically significant) with onset 02Nov2022, outcome "not recovered", described as "developed hives/break out in hives"; RASH ERYTHEMATOUS (medically significant) with onset 05Nov2022, outcome "not recovered", described as "red rash". The event "developed hives/break out in hives" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Clinical course: This was her fifth dose; She was now on prednisone, how long she would be on that. Caller reports she has never had reaction to previous doses of Covid vaccination. Other Conditions: No. Investigations: No. Caller states she was calling about her fifth Booster Dose for the Covid 19 Bivalent Pfizer BioNTech Covid 19 Vaccine. prescribed Prednisone 2 20mg daily for 5 days and she was still taking Allegra with it and it seems to be helping. Complete if a 3rd or Subsequent dose was administered as booster Dose. Vaccine Administered at Facility: No. Family Medical History Relevant to Adverse Events (AEs): None. Relevant Tests: None.
Age: 73.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: red rash; developed hives/break out in hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID (ongoing); FLU VACCINE VII taken for immunisation, on 13Oct2022 as dose 1, single. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0150), administration date: 02Apr2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EW0170), administration date: 23Apr2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: FF2587), administration date: 23Nov2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4, SINGLE, Lot: FK9894), administration date: 19May2022, when the patient was 72-year-old, for COVID-19 immunization.  The following information was reported: URTICARIA (medically significant) with onset 02Nov2022, outcome "not recovered", described as "developed hives/break out in hives"; RASH ERYTHEMATOUS (medically significant) with onset 05Nov2022, outcome "not recovered", described as "red rash". The event "developed hives/break out in hives" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Clinical course: This was her fifth dose; She was now on prednisone, how long she would be on that. Caller reports she has never had reaction to previous doses of Covid vaccination. Other Conditions: No. Investigations: No. Caller states she was calling about her fifth Booster Dose for the Covid 19 Bivalent Pfizer BioNTech Covid 19 Vaccine. prescribed Prednisone 2 20mg daily for 5 days and she was still taking Allegra with it and it seems to be helping. Complete if a 3rd or Subsequent dose was administered as booster Dose. Vaccine Administered at Facility: No. Family Medical History Relevant to Adverse Events (AEs): None. Relevant Tests: None.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Blindness transient, Blood test, Cerebrovascular accident, Computerised tomogram, Echocardiogram
Clinical narrative: The patient developed a sudden loss of vision both eyes while he was exercising on the treadmill. He stopped and sat down.  After a few moments, left sided vision returned, but right vision loss persisted. In hospital, patient was evaluated and diagnosed with acute central retinal artery occlusion.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Magnetic resonance imaging, Thrombosis, Ultrasound scan, Vision blurred
Clinical narrative: The patient developed a sudden loss of vision both eyes while he was exercising on the treadmill. He stopped and sat down.  After a few moments, left sided vision returned, but right vision loss persisted. In hospital, patient was evaluated and diagnosed with acute central retinal artery occlusion.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Angiogram cerebral, Arteriogram carotid, Blindness, Blood test, C-reactive protein
Clinical narrative: The patient developed a sudden loss of vision both eyes while he was exercising on the treadmill. He stopped and sat down.  After a few moments, left sided vision returned, but right vision loss persisted. In hospital, patient was evaluated and diagnosed with acute central retinal artery occlusion.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Full blood count, Glycosylated haemoglobin
Clinical narrative: The patient developed a sudden loss of vision both eyes while he was exercising on the treadmill. He stopped and sat down.  After a few moments, left sided vision returned, but right vision loss persisted. In hospital, patient was evaluated and diagnosed with acute central retinal artery occlusion.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Magnetic resonance imaging head, Metabolic function test, Retinal artery occlusion, SARS-CoV-2 test, Troponin I
Clinical narrative: The patient developed a sudden loss of vision both eyes while he was exercising on the treadmill. He stopped and sat down.  After a few moments, left sided vision returned, but right vision loss persisted. In hospital, patient was evaluated and diagnosed with acute central retinal artery occlusion.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: People got sick after receiving the booster dose; got COVID afterwards; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (People got sick after receiving the booster dose) and COVID-19 (got COVID afterwards) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (People got sick after receiving the booster dose) and COVID-19 (got COVID afterwards). At the time of the report, ILLNESS (People got sick after receiving the booster dose) and COVID-19 (got COVID afterwards) outcome was unknown.            No concomitant medications were provided. Reporter states that she knows some people who got sick after receiving the booster dose. No further details were provided. patient know several people that got the booster. They got COVID afterwards. No treatment medication was provided.  On 17-Nov-2022, the case ID MOD-2022-672866 was processed as invalid as it contains no patient identifiers.(multiple patients with no patient identifiers)   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2022: Significant follow-up received, updated Event and Narrative. On 18-Nov-2022: Non-significant follow-up received QE ID added.
Sex: U
Vaccine: HEPA, IPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE; patient who inadvertently received an extra dose of VAQTA; extra dose of VAQTA on 10/21/2022 / The caller said the patient received 1 dose of a hepatitis A (brand name and manufacturer unknown by reporter) vaccine in 2001, and the patient received a second dose in 2022; This spontaneous report was received from a Registered Nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  Patient was previously vaccinated with 4 doses of a polio vaccine (manufacturer unknown), 2 doses on an unknown date in 1984, 1 dose on an unknown date in 1985 and 1 dose on an unknown date in 1989.   On an unknown date in 2001, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided) (also reported as Hepatitis A vaccine, manufacturer unknown). On 21-OCT-2022, the patient was vaccinated with an extra dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided) (Extra dose administered). On the same date, the patient also received an extra dose of a polio vaccine (manufacturer unknown) (Inappropriate schedule of product administration). The reporter did not know the patient had received both of these vaccines in the past. No other adverse events occurred (No adverse event).
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no ae; second dose of PROQUAD was administered to a patient who is 2 years old instead of at the recommended minnimum age of 4 years old.; This spontaneous report was received from medical assistant and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications was not reported.   On 25-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, unk, lot #W019625, expiration date: 19-DEC-2023, administered for prophylaxis (strength and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: GARDASIL 9 series was delayed a month; 9 series was delayed a month for her second dose due to COVID. Caller refused demographics. No additional AE details or PQC.  First dose: 05/06/2022 Second dose: 08/01/2022; This spontaneous report was received from a consumer referring to a 32 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 06-MAY-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) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On 01-AUG-2022, the patient received the second dose, and the series was delayed a month due to COVID (inappropriate schedule of product administration). The outcome of COVID was reported as recovered. The causality assessment was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; HCP reporting a patient was administered PNEUMOVAX 23 today 9NOV2022. The PNEUMOVAX 23 expired on 11SEP2022.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-NOV-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (expiration date 11-SEP-2022) (strength, dose, frequency, route of administration, and lot number were not provided) indicated as prophylaxis (expired product administered).  No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional Ae; HCP calling in to report that an expired dose of VARIVAX was administered on 11/11/2022.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) subcutaneous injection (VARIVAX) (lot number T037642 has been verified to be a valid lot number, expiry date 06-NOV-2022) (strength, dose, and frequency were not provided) indicated for prophylaxis (expired product administered) indicated as prophylaxis.  No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Facial paralysis, Herpes zoster, Hypoacusis, Post herpetic neuralgia
Clinical narrative: Facial paralysis; Herpes zoster; Hearing problems; Balance problems; Post herpetic neuralgia; This spontaneous report has been received from a lawyer referring to a female patient (pt) of unknown age. The pt's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles. On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the pt experienced herpes zoster, facial paralysis, hearing problems, balance problems and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX) vaccine, her symptoms had resulted in physical limitations not present prior. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt sustained severe, serious, progressive, incurable, and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was assessed as not recovered. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of facial paralysis was determined to be medically significant, and all the events were considered as disabling due to "severe and permanent injuries".
Sex: M
Vaccine: SMALLMNK
Symptoms: Rash
Clinical narrative: Poison ivy like rash on his wrist (a few inches away from injection site). He has two other instances of rash in the same area; Case reference number US-BN-2022-004002 is a spontaneous case report initially received on 10-Oct-2022 from a consumer via agency (reference number: USBAV22-1671) and concerns a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, unknown route of administration, for monkeypox prophylaxis.  As reported, the patient was vaccinated against monkeypox two weeks ago and developed a poison ivy like rash on his wrist (a few inches away from injection site). He had two other instances of rash in the same area. He was not exposed to monkeypox.  At the time of this report, the event outcome was unknown.  The reporter did not provide seriousness criteria and a causality assessment.  No further information was provided.; Reporter's Comments: A male patient of unknown age experienced the non-serious event of rash, on an unspecified date following vaccination with the first dose of Jynneos, applied at an unknown dose, unknown route of administration, for monkeypox prophylaxis. Rash is listed per the agency but unlisted per the agency 2 for Jynneos. The patient's medical history and concomitant medications were not provided. Reportedly, the patient had not been exposed to monkeypox. Based on the known safety profile and the suggestive temporal relationship, the event of rash is assessed as related to Jynneos.; Sender's Comments: A male patient of unknown age experienced the non-serious event of rash, on an unspecified date following vaccination with the first dose of Jynneos, applied at an unknown dose, unknown route of administration, for monkeypox prophylaxis. Rash is listed per the agency but unlisted per the agency 2 for Jynneos. The patient's medical history and concomitant medications were not provided. Reportedly, the patient had not been exposed to monkeypox. Based on the known safety profile and the suggestive temporal relationship, the event of rash is assessed as related to Jynneos.
Sex: U
Vaccine: SMALLMNK
Symptoms: Wrong technique in product usage process
Clinical narrative: Jynneos administrated intradermally; Case reference number US-BN-2022-004063 is a spontaneous case report initially received on 17-Oct-22 from a nurse via agency (reference number: USBAV22-1723) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00019), at an unknown dose, administrated intradermally, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event.  This case is linked with the case US-BN-2022-004064 (same reporter).  Additional information received from Bavarian Nordic on 18-Oct-2022 included the local BN case ID.  Non-significant case correction received on 08-Nov-2022 from agency included new reference number.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine on unspecified date. The dose was unknown, but the vaccine was administered intradermally for monkeypox prophylaxis, which is coded as intradermal injection. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos vaccine on unspecified date. The dose was unknown, but the vaccine was administered intradermally for monkeypox prophylaxis, which is coded as intradermal injection. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos administrated intradermally; The vaccine was opened for 23 hours, refrigerated, then given to a patient; Case reference number US-BN-2022-004064 is a spontaneous case report initially received on 17-Oct-22 from a nurse (reference number: USBAV22-1723) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00019), at an unknown dose, administrated intradermally, for monkeypox prophylaxis (explicitly coded as 'intradermal injection'). As reported, the vaccine was opened 23 hours before, it was also given to another patient, afterwards refrigerated, and then given to this patient the following day (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event.  This case is linked with the case US-BN-2022-004063 (same reporter).  No further information was provided.  Non-significant case correction performed for information received on 21-Oct-2022 from Bavarian Nordic included local case ID.  Non-significant case correction received on 08-Nov-2022 included new reference number.; Reporter's Comments: A patient of unknown demographics was vaccinated on an unspecified date with Jynneos vaccine. The vaccine was administered intradermally which is considered intradermal injection. Reportedly, the vaccine was opened 23 hours before, it was also given to another patient, afterwards refrigerated, and then given to this patient the following day which is considered expired vaccine used. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired vaccine used are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated on an unspecified date with Jynneos vaccine. The vaccine was administered intradermally which is considered intradermal injection. Reportedly, the vaccine was opened 23 hours before, it was also given to another patient, afterwards refrigerated, and then given to this patient the following day which is considered expired vaccine used. Both events are listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection and expired vaccine used are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Expired Jynneous vaccine administered beyond use date.; Case reference number US-BN-2022-004177 is a spontaneous case report initially received on 24-Oct-2022 from a health professional via Agency (reference number: USBAV22-1761) and concerns a patient of unknown gender or age.  The patient's medical history and concomitant medication details were not provided.  On a 19-Oct-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and monkeypox vaccine (live modified vaccinia virus Ankara; batch number: FDP00014) at unknown dose, at an unknown route or site of administration, for active immunization against Monkeypox.  On a 19-Oct-2022, as reported, the patient received Jynneos vaccine with beyond use date of 15-Oct-2022 (explicitly coded as 'Expired product administered').   At the time of this report, it was unknown if the patient experienced any adverse event.  No further information is provided.  Non-significant case correction performed for information received on 24-Oct-2022 from Bavarian Nordic included local BN case ID; Reporter's Comments: A patient of unknown gender or age was vaccinated with the first dose of Jynneos vaccine for active immunization against Monkeypox. Reportedly, the patient received vaccine with beyond use date of 15-Oct-22 on a 19-Oct-22, which is considered as expired product administered. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown gender or age was vaccinated with the first dose of Jynneos vaccine for active immunization against Monkeypox. Reportedly, the patient received vaccine with beyond use date of 15-Oct-22 on a 19-Oct-22, which is considered as expired product administered. The event is listed per the Company conventions. Patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: dose of expired Jynneos administered; Case reference number US-BN-2022-004183 is a spontaneous case report initially received on 12-Oct-2022 from Other Health Professional (reference number: USBAV22-1691) and concerns a patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose, at an unknown route or site of administration, for an unknown indication.  As reported, the vaccine that was administered to the patient had expired two days prior to vaccination (explicitly coded as 'expired product administered').  At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos.  Additional information received from Bavarian Nordic on 12-Oct-2022 included the local case ID.; Reporter's Comments: The patient of unknown age or gender was vaccinated with the Jynneos vaccine on an unspecified date at an unknown dose, route or site of administration. Reportedly, the vaccine that was administered to the patient had expired two days prior to vaccination which is considered expired product administered. The event is considered listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: The patient of unknown age or gender was vaccinated with the Jynneos vaccine on an unspecified date at an unknown dose, route or site of administration. Reportedly, the vaccine that was administered to the patient had expired two days prior to vaccination which is considered expired product administered. The event is considered listed per the Company conventions. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse events following vaccination. Expired product administered is assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos was administered beyond expiration date; Jynneos vaccines went beyond the 8 weeks in the refrigerator; Jynneos was administered beyond expiration date; Case reference number US-BN-2022-004198 is a spontaneous case report initially received on 12-Oct-2022 from other health care professional via Communication (reference number: USBAV22-1694) and concerns one patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 26-Sep-2022, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) was administered 8 weeks beyond the expiration date and the eight weeks for refrigerating (explicitly coded as 'expired vaccine used', 'product storage error' and 'product administration error').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 12-Oct-2022 included local case ID.  The case is linked with US-BN-2022-004197 and US-BN-2022-004198.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos vaccine was administered beyond expiration date; Jynneos vaccines went beyond the 8 weeks in the refrigerator; Jynneos vaccine was administered beyond expiration date; Case reference number US-BN-2022-004198 is a spontaneous case report initially received on 12-Oct-2022 from other health care professional via Communication (reference number: USBAV22-1694) and concerns one patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 26-Sep-2022, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) was administered beyond the expiration date and the eight weeks for refrigerating (explicitly coded as 'expired vaccine used', 'product storage error' and 'product administration error').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-004198 and US-BN-2022-004196.  Non-significant case correction performed for information received 28-Oct-2022 to include local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Jynneos vaccine was administered beyond expiration date; Jynneos vaccines went beyond the 8 weeks in the refrigerator; Jynneos vaccine was administered beyond expiration date; Case reference number US-BN-2022-004198 is a spontaneous case report initially received on 12-Oct-2022 from other health care professional via Communication (reference number: USBAV22-1694) and concerns one patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 26-Sep-2022, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) was administered beyond the expiration date and the eight weeks for refrigerating (explicitly coded as 'expired vaccine used', 'product storage error' and 'product administration error').   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-004197 and US-BN-2022-004196.  Non-significant case correction performed for information received on 28-Oct-2022 to include local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos (at an unknown dose, via unknown route or site of administration), after Jynneos had been kept in a refrigerator for 8 weeks, past the expiration date (which is considered product storage error, expired vaccine used and product administration error). No associated adverse events were reported with the reported medication error. Product storage error, expired vaccine used and product administration error are considered listed per company conventions. The patient's medical history and concomitant medications were unknown. Product storage error, expired vaccine used and product administration error are considered not related to Jynneos, but to human error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Product storage error, Wrong technique in product usage process
Clinical narrative: Jynneos vaccine was administrated intradermally; The patient was administered with Jynneos vaccine that was supposed to be discarded after 8 weeks being refrigerated; The patient was administered with Jynneos vaccine that was supposed to be discarded after 8 weeks being refrigerated; Case reference number US-BN-2022-004217 is a spontaneous case report initially received on 20-Oct-2022 from nurse via Communication (reference number: USBAV22-1748) and concerns a patient of unknown gender and age.  The patient's medical history and concomitant medication details were not provided.  On 19-Oct-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00002), at a dose reported as 0.1 mL, administered intradermally (explicitly coded as 'Intradermal injection') at unknown site of administration, indicated for Monkeypox Prophylaxis.  As reported, the patient was administered with Jynneos vaccine that was supposed to be discarded after 8 weeks being refrigerated (explicitly coded as 'Expired vaccine used' and 'Product storage error').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 20-Oct-2022 from included the local ID number.; Reporter's Comments: A patient of unknown age or gender was vaccinated with the first dose of Jynneos vaccine on 19-Oct-22. The vaccine was administered intradermally, at a dose reported as 0.1ml for monkeypox prophylaxis which is coded as intradermal injection. Reportedly, the patient was administered with Jynneos vaccine that was supposed to be discarded after 8 weeks being refrigerated which is considered expired vaccine used and product storage error. All events are listed per the Company conventions. The patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection, expired vaccine used and product storage error are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age or gender was vaccinated with the first dose of Jynneos vaccine on 19-Oct-22. The vaccine was administered intradermally, at a dose reported as 0.1ml for monkeypox prophylaxis which is coded as intradermal injection. Reportedly, the patient was administered with Jynneos vaccine that was supposed to be discarded after 8 weeks being refrigerated which is considered expired vaccine used and product storage error. All events are listed per the Company conventions. The patient's medical history and concomitant medications were unknown. It was unknown if the patient experienced any adverse events following vaccination. Intradermal injection, expired vaccine used and product storage error are assessed as not related to the suspect vaccine, but related to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: By error the nurse took the box that had a beyound use date of October 18, 2022 and administrated 6 doses to patients; Case reference number US-BN-2022-004306 is a spontaneous case received from other health care professional on 24-Oct-2022 via agency (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, the patient vaccinated with Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept-2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  It was stated that, by error the nurse took the box that had a beyond use date of 18-Oct-2022 and administrated six doses to patients (explicitly coded as 'Expired vaccine used'). Vials were not punctured prior to administration.  At time of this report, the patients did not experience any adverse events as a result of Jynneos vaccination.  The reporter assessed causality between 'Expired vaccine used' and Jynneos as possibly related.  This case is linked with the cases US-BN-2022-004307, US-BN-2022-004308, US-BN-2022-004309, US-BN-2022-004310 and US-BN-2022-004311 (same reporter).  Additional information received on 24-Oct-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: By error the nurse took the box that had a beyound use date of October 18, 2022 and administrated 6 doses to patients; Case reference number US-BN-2022-004307 is a spontaneous case received from other health care professional on 24-Oct-2022 (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, the patient was vaccinated with Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept-2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  It was stated that, by error the nurse took the box that had a beyond use date of 18-Oct-2022 and administrated six doses to patients (explicitly coded as 'Expired vaccine used'). Vials were not punctured prior to administration.  At time of this report, the patients did not experience any adverse events as a result of Jynneos vaccination.  The reporter assessed causality between 'Expired vaccine used' and Jynneos as possibly related.  This case is linked with the cases US-BN-2022-004306, US-BN-2022-004308, US-BN-2022-004309, US-BN-2022-004310 and US-BN-2022-004311 (same reporter).  Additional information received on 24-Oct-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: By error the nurse administered Jynneos vaccine beyond use date to 6 patients; Case reference number US-BN-2022-004308 is a spontaneous case report initially received on 24-Oct-22 from health care professional via Communications (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, six patients were vaccinated with an unknown dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept,2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  On the same day, as reported by error, the nurse took the box that had a beyond use date of October 18, 2022, and administrated six doses to patients, (explicitly coded as 'Expired product administered'). Vials were not punctured prior to administration.  As reported, patients have not reported any adverse events.  The Reporter did not assess the event per seriousness criteria and assessed causality between the event and Jynneos as possible related.  This case is linked with the case US-BN-2022-004306, US-BN-2022-004307, US-BN-2022-004309, US-BN-2022-004310 and US-BN-2022-004311 (same reporter).  Additional information received from on 31-Oct-2022 included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: By error the nurse administered Jynneos vaccine beyond use date to 6 patients; Case reference number US-BN-2022-004309 is a spontaneous case report initially received on 24-Oct-22 from health care professional (reference: USBAV22-1762) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On 21-Oct-2022, six patients were vaccinated with an unknown dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00013, Expiration date: Sept,2024) at an unknown dose, through unknown route of administration, at unknown anatomical location, for monkeypox prophylaxis.  On the same day, as reported by error, the nurse took the box that had a beyond use date of October 18, 2022, and administrated six doses to patients, (explicitly coded as 'Expired product administered'). Vials were not punctured prior to administration.  As reported, patients have not reported any adverse events.  The Reporter did not assess the event per seriousness criteria and assessed causality between the event and Jynneos as possible related.  This case is linked with the case US-BN-2022-004306, US-BN-2022-004307, US-BN-2022-004308, US-BN-2022-004310 and US-BN-2022-004311 (same reporter).  Additional information received from Bavarian Nordic on 31-Oct-2022 included local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with vials of Jynneos which were 3 days past the beyond-use date, which is considered expired product administered. No adverse events were reported. Expired product administered is considered listed per company convention. No medical history or concomitant medications information was reported. The event is considered not related to Jynneos, but to human error. The case is non-serious.