chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: SMALLMNK
Symptoms: Product administration error, Product storage error
Clinical narrative: Jynneos vaccine was drawn up into the syringe 35 minutes before it was administrated to the patient.; Jynneos vaccine was drawn up into the syringe 35 minutes before it was administrated to the patient.; Case reference number US-BN-2022-002247 is a spontaneous case report initially received on 01-Sep-2022 from a pharmacist (reference number: USBAV22-1249), and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient received Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) that was drawn up into the syringe 35 minutes before the administration at an unknown dose, route, or site of administration, for smallpox/ monkeypox (explicitly coded as ' Product storage error', 'Product administration error ').  At the time of this report, it was unknown which dose this was, or whether the patient experienced any adverse events due to Jynneos.  Additional information received on 05-Sep-2022 from Bavarian Nordic included local case ID.  This case is linked with US-BN-2022-002245 and US-BN-2022-002246 concerning the same reporter; Reporter's Comments: A patient of unknown age and gender received the Jynneos vaccine that was drawn up into the syringe 35 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/monkeypox, which is considered as product storage error and product administration error. At this point, it was unknown which dose this was, or whether the patient experienced any adverse events due to Jynneos. Product storage error and product administration error are both considered listed per company. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender received the Jynneos vaccine that was drawn up into the syringe 35 minutes before the administration, at an unknown dose, route, or site of administration, for smallpox/monkeypox, which is considered as product storage error and product administration error. At this point, it was unknown which dose this was, or whether the patient experienced any adverse events due to Jynneos. Product storage error and product administration error are both considered listed per company. The patient's medical history and concomitant medication details were not reported. Product storage error and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: Jynneos vaccine was administered intradermally; Case reference number US-BN-2022-002263 is a spontaneous case report initially received from a pharmacy student via Communication (reference number: USBAV22-1276) on 06-Sep-2022 and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medication details were not provided.  On 02-Sep-2022, also reported as in the afternoon, Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating) was drawn up and accidentally left in the fridge over the weekend, however, the vaccine was stored correctly, as reported.  On 06-Sep-2022, the patient was vaccinated with the first dose of Jynneos (batch number not provided), administered intradermally (explicitly coded as 'inappropriate route of vaccination') at an unknown dose or site of administration, for unknown indication.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.   Non-significant case correction performed for information received from Bavarian Nordic on 06-Sep-2022 to include the local BN case ID.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as inappropriate route of vaccination, at an unknown dose or site of administration, for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is no-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with the first dose of Jynneos, administered intradermally, which is considered as inappropriate route of vaccination, at an unknown dose or site of administration, for unknown indication. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is no-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: The patient received the first dose of Jynneos intramuscularly instead of subcutaneously; Case reference number US-BN-2022-002270 is a spontaneous case report initially received on 06-Sep-2022 from a consumer via Communication (reference number: USBAV22-1289) and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, administered intramuscularly, at an unknown site, for monkeypox prophylaxis (explicitly coded as 'inappropriate route of vaccination').  On an unspecified date, after unknown amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: unknown) at an unknown dose, administered subcutaneously at an unknown site, for monkeypox prophylaxis.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 06-Sep-2022 included local BN case ID.; Reporter's Comments: A male patient of unknown age received the first dose of Jynneos vaccine at an unknown dose, administered intramuscularly at an unknown site, for monkeypox prophylaxis (which is considered inappropriate route of vaccination). An unknown amount of time following the first dose, the patient received the second dose of Jynneos vaccine, at an unknown dose, administered subcutaneously at an unknown site, for monkeypox prophylaxis. Inappropriate route of vaccination is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Inappropriate route of vaccination is considered not related to the suspect product, but to human factor. No associated adverse events have been reported with the reported medication error.; Sender's Comments: A male patient of unknown age received the first dose of Jynneos vaccine at an unknown dose, administered intramuscularly at an unknown site, for monkeypox prophylaxis (which is considered inappropriate route of vaccination). An unknown amount of time following the first dose, the patient received the second dose of Jynneos vaccine, at an unknown dose, administered subcutaneously at an unknown site, for monkeypox prophylaxis. Inappropriate route of vaccination is considered listed per company convention. The patient's relevant medical history and concomitant medications were not reported. Inappropriate route of vaccination is considered not related to the suspect product, but to human factor. No associated adverse events have been reported with the reported medication error.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Underdose
Clinical narrative: Jynneos vaccine administered at a dose of 0.1 mL; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-002283 is a spontaneous case report initially received on 07-Sep-2022 from other healthcare professional via Communication (reference number: USBAV22-1300) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at a dose of 0.1 mL (explicitly coded as 'vaccine underdose'), intradermally (explicitly coded as 'inappropriate route of vaccination'), at an unknown site, for monkeypox prophylaxis. As reported, the patient did not have a bubble under the skin after being administered with Jynneos vaccine.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 08-Sep-2022 included local BN case ID number.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at a dose of 0.1 mL, which is considered as vaccine underdose, intradermally, which is considered as inappropriate route of vaccination, at an unknown site, for monkeypox prophylaxis. As reported, the patient did not have a bubble under the skin after being administered with Jynneos vaccine. No associated adverse events have been reported with the reported medication error. Underdose and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at a dose of 0.1 mL, which is considered as vaccine underdose, intradermally, which is considered as inappropriate route of vaccination, at an unknown site, for monkeypox prophylaxis. As reported, the patient did not have a bubble under the skin after being administered with Jynneos vaccine. No associated adverse events have been reported with the reported medication error. Underdose and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received first dose of Jynneos intradermally; Case reference number US-BN-2022-002629 is a spontaneous case report initially received from other health care professional (reference number: USBAV22-1451) on 01-Sep-2022 and concerns a male patient of unknown age.  The patient's past medical drug included ACAM2000 (smallpox vaccine).   The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) administered intradermally (explicitly coded as 'intradermal injection') at an unknown dose or site of administration for unknown indication.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos   Additional information received from Bavarian Nordic on 20-Sep-2022 included local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, the vaccine was administered intradermally, and this is coded as intradermal injection. The event is considered listed as per the Company. The patient's past medical drug included ACAM2000 (smallpox vaccine) and patient's concomitant medications were not provided. It's unknown if the patient experienced any adverse events following vaccination. Case is non-serious. Based on information provided, causality is assessed as not related to the suspect vaccine, but to a human action.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos vaccine, the vaccine was administered intradermally, and this is coded as intradermal injection. The event is considered listed as per the Company. The patient's past medical drug included ACAM2000 (smallpox vaccine) and patient's concomitant medications were not provided. It's unknown if the patient experienced any adverse events following vaccination. Case is non-serious. Based on information provided, causality is assessed as not related to the suspect vaccine, but to a human action.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: Jynneos administrated intradermally at a dose of 0.1 ml; A vial was thawed for 10 minutes a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer.; Case reference number US-BN-2022-004435 is a spontaneous case report initially received on 28-Oct-22 from other health care professional (reference number: USBAV22-1806) and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, as reported four weeks ago, the patient was vaccinated with a dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FPD00016, expiration date: 31-Oct-2024) at a dose of 0.1 ml intradermally, (explicitly coded as 'intradermal injection'), at unknown anatomical location, for monkeypox prophylaxis.  As reported, a vial was thawed for ten minutes, a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer, instead of being refrigerated after being thawed, (explicitly coded as 'product storage error').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 28-Oct-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A patient of unknown age and gender was vaccinated with Jynneos at a dose of 0.1 ml (at unknown anatomical location), administered intradermally (considered as intradermal injection) for monkeypox prophylaxis. Reportedly, a vial was thawed for ten minutes, a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer, instead of being refrigerated after being thawed, which is considered as product storage error. Injection and product storage error are both considered listed per company conventions. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medications were not reported. Injection and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with Jynneos at a dose of 0.1 ml (at unknown anatomical location), administered intradermally (considered as intradermal injection) for monkeypox prophylaxis. Reportedly, a vial was thawed for ten minutes, a 0.1 ml dose was taken from this vial then the vial was placed back in the freezer, instead of being refrigerated after being thawed, which is considered as product storage error. Injection and product storage error are both considered listed per company conventions. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos vaccination. The patient's relevant medical history and concomitant medications were not reported. Injection and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: temperature 101.5 - 100, elevated; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 2nd dose of Shingrix. In November 2022, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK receipt date: 13-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received 2nd Shingrix vaccine 24 hours prior to the reporting.  The patient elevated temperature 101.5 to 100 degree F. The patient was asking for other than Tylenol or ibuprofen what else could take.  The patient was asking approximately how long does an elevated temperature last from the vaccine. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: kicked my ass; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporters comment: This case was reported by a consumer via  interactive digital media. The patient received second dose of Shingles vaccine yesterday (day before reporting) and he/she stated that it kicked his/her butt for about 24 hrs. Additional Supportive information: The duration of the event was 24 hours. As per narrative it kicked my ass for this conservatively event coded as feeling bad.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Irritability, Mental disorder
Clinical narrative: mild mental issues; Normal side effects, feeling of anxiety; Mild mental issues, irritation; This case was reported by a consumer via interactive digital media and described the occurrence of mental disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced mental disorder, feeling anxious and irritability. On an unknown date, the outcome of the mental disorder, feeling anxious and irritability were unknown.   It was unknown if the reporter considered the mental disorder, feeling anxious and irritability to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comments: The case was reported via (Shingrix GSK) interactive digital media. The patient was received his or her Shingrix shot on Friday and experienced the normal side effects. The patient also seemed to had mild mental issues, feeling of anxiety, irritation.  The patient was asked as could this sometimes happen.
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: aching in arm; aching in neck; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-NOV-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The patient reported that he or she had aching in his/her arm and neck 3 weeks after receiving 2nd shingles shot. The patient asked it was normal or not.  Additional Supportive Information:The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 11th October 2022, the patient received the 1st dose of Shingrix. On 11th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter. Additional Supportive Information: The patients received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022168220:same reporter US-GSK-US2022AMR169910:same reporter US-GSK-US2022AMR169911:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2022) for prophylaxis.   On 17th October 2022, the patient received the 1st dose of Shingrix. On 17th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter. Additional Supportive Information: The patients received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022AMR169909:same reporter US-GSK-US2022AMR169911:same reporter US-GSK-US2022168220:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant portion; administered only the adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14 NOV 2022 Reporter's comment: This case was reported by nurse. The nurse stated that the patient was administered only the adjuvant portion of Shingrix. The vaccine administration facility is the same as primary reporter. Additional supportive information: As patient received only the adjuvant portion of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 26th October 2022, the patient received the 1st dose of Shingrix. On 26th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. Additional Supportive Information: The patient was received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with US2022AMR169910, US2022AMR169911, US2022AMR169909 same reporter.; Sender's Comments:  US-GSK-US2022AMR169909:same reporter US-GSK-US2022AMR169910:same reporter US-GSK-US2022AMR169911:same reporter
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo was administered before reconstitution with only the diluent portion; Menveo was administered before reconstitution with only the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) for prophylaxis.   On 1st August 2022, the patient received Menveo. On 1st August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment:  The patient received the menveo vaccine before reconstitution with only the diluent portion. The health care professional reported that after vaccination of 5 patients they became aware one of them was administered only the diluent of menveo without the lyophilized part but did not know which patient was. The reporter consent to follow-up. Additional Supportive information: Till the time of reporting,the patient received the menveo vaccine before reconstitution with only the diluent portion which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This case has been linked to the cases US2022168204,US2022168209, US2022168203, US2022168210 reported by the same reporter.; Sender's Comments:  US-GSK-US2022168204:Same reporter US-GSK-US2022168209:Same reporter US-GSK-US2022168203:Same reporter US-GSK-US2022168210:Same reporter
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on SEP, didn´t received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comments: The reporter called to inquire about how to proceed with Series. Pharmacist reported a patient received the first dose of Engerix B on 10th September 2022. Adult patient would like to continue with the series but it had over a month since the first dose.  The reporter confirmed first dose was administered in their facility.  The reporter was unable to provide any patient details.  The reporter did not consent to follow-up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Aug2020, 2nd 12Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 49EL9, expiry date 7th February 2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   On 12th November 2022, the patient received the 2nd dose of Shingrix. On 12th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's comment: Pharmacist reported that the patient got a late second dose of Shingrix on 12th November 2022 after the first dose was in August 2020 (no specific day information available). The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,01 total, administered to the right arm on 31-MAR-2021 for covid-19 prophylaxis. The patient experienced felt light headed for 15 mins when treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received additional dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered to left arm on 04-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 38 years old. No concomitant medications were reported. On an unspecified date in JUL-2022, patient had symptoms after patient tested positive (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (Dose number in series 2), after the husband got covid-19 when came back from traveling. Patient did not saw a physician when patient got covid-19. This is the only time patient got sick after getting the covid vaccine and booster (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221134142. This report was associated with product quality complaint: 90000259271.; Sender's Comments: V0: 20221135292- confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cerebrovascular accident, Death, Red blood cell abnormality
Clinical narrative: DEATH; STROKE; CARDIAC; PROBLEM WITH RED BLOOD CELLS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced death, stroke, cardiac, and problem with red blood cells. On an unspecified date, the patient died from stroke, cardiac, and unknown cause of death. It was unknown whether autopsy was performed or not. It was reported as "Then 4 months later my brother had problem with his red blood cells found dead at home presumably for a cardiac/stroke. He also have J&J vaccine." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of problem with red blood cells was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221135762.; Sender's Comments: V0: 20221135799-Death, Cardiac, stroke. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable; Reported Cause(s) of Death: STROKE; CARDIAC; UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via media via a company representative concerned a patient of an unspecified age, sex, race and ethic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported administrated for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed. The reporter stated that "You killed my friend with your clot shot" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221139927-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: CANCER; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cancer. It was reported that "My boyfriend and best friend, both developed 2 different cancers after receiving the shot. Weird, Coincidence. Or is the shot what some say it is. It sure wasn't tested long after it was made". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cancer was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221146108.; Sender's Comments: V0:20221143605-Cancer. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Cerebrovascular accident
Clinical narrative: STROKE LIKE SYMPTOMS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative through social media (J and J Corporate account) concerned a male of unspecified age, race and ethnicity.   The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received 2 doses with covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number and expiry date were not reported), dose was not reported (dose number in series 1), for covid-19 prophylaxis. It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer (dose number in series 1). The patient received third dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced stroke like symptoms (dose number in series 2). It was reported as "my husband had stroke like symptoms after his 3rd shot this year". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke like symptoms and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221145286-Stroke like symptoms. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Injection site area was slightly sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B228) for COVID-19 prophylaxis. The patient's past medical history included Chemotherapy, Radiation therapy, Lumpectomy in 2007 and Lymphadenectomy (all of the lymph nodes on her left side were removed). Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 2) and Pfizer vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Type 1 diabetes mellitus since 1987, Breast cancer female (Left, cancer was 2 Centimeters in diameter - left breast has been larger/perkier than right breast) since 2007, Hypertension and Graves' disease. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), ATORVASTATIN, LISINOPRIL, METOPROLOL SUCCINATE, ALENDRONATE SODIUM (ALENDRONATE), AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site area was slightly sore). At the time of the report, VACCINATION SITE PAIN (Injection site area was slightly sore) outcome was unknown. The patient received a Moderna monovalent vaccine as a booster dose, expiration date was not known. Patient received vaccine in her left arm. Injection site area was slightly sore. No treatment information was provided by the reporter. This case was linked to MOD-2022-674650, MOD-2022-674648 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Sweats; Covid 19 immnunization; Interchange of vaccine products; Dizziness; Nausea; Fatigue; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweats), COVID-19 IMMUNISATION (Covid 19 immnunization), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051f21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient was plenty healthy. Her auto immune markers have diminished.  The patient's past medical history included Walker user (had to use back in 2016 when she first came down with autoimmune issues) in 2016, Lyme disease (She was pretty healthy until she got what considered to be Lyme disease on 2015) in 2015 and Near death experience (she really was dying in 2016 and had to be hospitalized for a month) in 2016. Previously administered products included for Product used for unknown indication: J and J (Lot#1805025 and first dose) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Asthma, Pollen allergy (allergic to tree pollen), Allergy to molds and Antiphospholipid syndrome (complex of autoimmune disorders back in 2016, a serious heart autoimmune disorder or a blood autoimmune disorder called APS antiphospholipid syndrome) since 2016.    On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), COVID-19 IMMUNISATION (Covid 19 immnunization), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved and COVID-19 IMMUNISATION (Covid 19 immnunization) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            No concomitant medications were reported.   It was reported that patient experienced life threatening adverse reaction to Moderna's Boosters.  Following vaccination with the 1st Moderna booster patient experienced adverse reaction of nausea, fatigue, fever, sweats, chills, dizziness and it went away by the 3rd day.  Patient did not had COVID positive test or diagnosis and never had symptoms for COVID.   No treatment medication was provided.   This case was linked to MOD-2022-674780, MOD-2022-674779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Follow-up received included added.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Nausea, Pyrexia
Clinical narrative: Sweats; Covid 19 immnunization; Interchange of vaccine products; Dizziness; Nausea; Fatigue; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweats), COVID-19 IMMUNISATION (Covid 19 immnunization), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051f21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient was plenty healthy. Her auto immune markers have diminished.  The patient's past medical history included Walker user (had to use back in 2016 when she first came down with autoimmune issues) in 2016, Lyme disease (She was pretty healthy until she got what considered to be Lyme disease on 2015) in 2015 and Near death experience (she really was dying in 2016 and had to be hospitalized for a month) in 2016. Previously administered products included for Product used for unknown indication: J and J (Lot#1805025 and first dose) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Asthma, Pollen allergy (allergic to tree pollen), Allergy to molds and Antiphospholipid syndrome (complex of autoimmune disorders back in 2016, a serious heart autoimmune disorder or a blood autoimmune disorder called APS antiphospholipid syndrome) since 2016.    On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats), COVID-19 IMMUNISATION (Covid 19 immnunization), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats), DIZZINESS (Dizziness), NAUSEA (Nausea), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved and COVID-19 IMMUNISATION (Covid 19 immnunization) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            No concomitant medications were reported.   It was reported that patient experienced life threatening adverse reaction to Moderna's Boosters.  Following vaccination with the 1st Moderna booster patient experienced adverse reaction of nausea, fatigue, fever, sweats, chills, dizziness and it went away by the 3rd day.  Patient did not had COVID positive test or diagnosis and never had symptoms for COVID.   No treatment medication was provided.   This case was linked to MOD-2022-674780, MOD-2022-674779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Follow-up received included added.