chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses; A spontaneous report was received from a nurse on 26OCT2022. It described a 34-years-old male patient who "forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses" (PT: Incomplete course of vaccination). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. On 15OCT2022, the patient received the first dose of Vivotif, followed by the second dose on 17OCT2022. However, the patient forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses. Reportedly, the patient did not experience any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses (incomplete course of vaccination. Considering the nature of the event, the causality of incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses (incomplete course of vaccination. Considering the nature of the event, the causality of incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed the 3rd dose and took it late; A spontaneous report was received from a caregiver on 31OCT2022. It described a male patient of unknown age who "missed the 3rd dose and took it late" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported that the patient missed his third dose of Vivotif which was to be administered on Friday (as per the reporting) and took it on 31OCT2022 (today- as per reporting). The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient missed the 3rd dose and took it late (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient missed the 3rd dose and took it late (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; A spontaneous report was received from a nurse on 03NOV2022. It described a 57-years-old male patient who had "severe diarrhea" (PT: Diarrhoea) following administration of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient received the second dose of Vivotif on 02NOV2022. On an unknown date in NOV2022, following the second dose of Vivotif the patient had severe diarrhea. The outcome of the reported event was unknown, at the time of this report.  Action taken with Vivotif with respect to the reported event was unknown.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif for immunisation and he had severe diarrhea (diarrhoea). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took Vivotif for immunisation and he had severe diarrhea (diarrhoea). Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of diarrhoea is assessed as possible. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Lip disorder, Maternal exposure during breast feeding, Oral disorder, Secondary transmission
Clinical narrative: Breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas; Breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas; This literature case, derived from a full-text article, was received on 02NOV2022.  Literature citation:   A five-month-old "breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas" (PT: Vaccinia virus infection and Infection transmission via personal contact) who apparently developed the infection from the father who had been vaccinated with ACAM2000 (smallpox vaccine, live).  Case report: A five-month-old, breastfed infant acquired a vaccinia lesion on her upper lip, tongue, and cheek after her mother developed vaccinia lesions on both areolas. The mother's infection apparently originated from the father who had been vaccinated about 10 days prior.  Author's comment: Persons who received smallpox vaccine during pregnancy or breastfeeding should avoid breastfeeding and handling any baby for at least 3-4 weeks until the vaccination scab has separated from the vaccination site. The breasts can be pumped to maintain the milk supply, but the milk should be discarded. Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination.   Smallpox (vaccinia) vaccine should not be used during nursing.  Based on the available information in the article, two individual case safety reports 22000256 (baby) and 22000257 (mother) were created and cross-linked in the database.  Company comment:  A breastfed infant acquired a vaccinia lesion after mother developed vaccinia lesions on both areolas from close contact with recently vaccinated husband (Secondary transmission).  No additional medical history was captured. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection through close contact. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of vaccinia virus infection and infection transmission via personal contact is assessed as possible. According to literature infants are at low risk of harm while nursing.  However, the case is considered serious due to medical significance of vaccinia virus infection.; Sender's Comments: A breastfed infant acquired a vaccinia lesion after mother developed vaccinia lesions on both areolas from close contact with recently vaccinated husband (Secondary transmission).  No additional medical history was captured. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection through close contact. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of vaccinia virus infection and infection transmission via personal contact is assessed as possible. According to literature infants are at low risk of harm while nursing.  However, the case is considered serious due to medical significance of vaccinia virus infection.
Sex: F
Vaccine: SMALL
Symptoms: Skin lesion, Tongue disorder, Vaccinia virus infection
Clinical narrative: Breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas; Breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas; This literature case, derived from a full-text article, was received on 02NOV2022.  Literature citation:   A five-month-old "breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas" (PT: Vaccinia virus infection and Infection transmission via personal contact) who apparently developed the infection from the father who had been vaccinated with ACAM2000 (smallpox vaccine, live).  Case report: A five-month-old, breastfed infant acquired a vaccinia lesion on her upper lip, tongue, and cheek after her mother developed vaccinia lesions on both areolas. The mother's infection apparently originated from the father who had been vaccinated about 10 days prior.  Author's comment: Persons who received smallpox vaccine during pregnancy or breastfeeding should avoid breastfeeding and handling any baby for at least 3-4 weeks until the vaccination scab has separated from the vaccination site. The breasts can be pumped to maintain the milk supply, but the milk should be discarded. Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination.   Smallpox (vaccinia) vaccine should not be used during nursing.  Based on the available information in the article, two individual case safety reports 22000256 (baby) and 22000257 (mother) were created and cross-linked in the database.  Company comment:  A breastfed infant acquired a vaccinia lesion after mother developed vaccinia lesions on both areolas from close contact with recently vaccinated husband (Secondary transmission).  No additional medical history was captured. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection through close contact. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of vaccinia virus infection and infection transmission via personal contact is assessed as possible. According to literature infants are at low risk of harm while nursing.  However, the case is considered serious due to medical significance of vaccinia virus infection.; Sender's Comments: A breastfed infant acquired a vaccinia lesion after mother developed vaccinia lesions on both areolas from close contact with recently vaccinated husband (Secondary transmission).  No additional medical history was captured. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection through close contact. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of vaccinia virus infection and infection transmission via personal contact is assessed as possible. According to literature infants are at low risk of harm while nursing.  However, the case is considered serious due to medical significance of vaccinia virus infection.
Sex: F
Vaccine: SMALL
Symptoms: Breast feeding, Nipple disorder, Secondary transmission, Skin lesion, Vaccinia virus infection
Clinical narrative: Developed vaccinia lesions on both areolas; Patient's infection apparently originated from the father who had been vaccinated about 10 days prior; This literature case, derived from a full-text article, was received on 02NOV2022.  Literature citation:  It described a female patient (a mother of unknown age) who "developed vaccinia lesions on both areolas" (PT: Vaccinia virus infection) and "the infection apparently originated from the father who had been vaccinated about 10 days prior" with ACAM2000 (smallpox vaccine, live) (PT: Secondary transmission).  Case report: A 5-month-old breastfed infant acquired a vaccinia lesion on her upper lip, tongue, and cheek after her mother developed vaccinia lesions on both areolas. The mother's infection apparently originated from the father who had been vaccinated about 10 days prior. The exact mechanism of transmission was not apparent.  Author's comment: Persons who received smallpox vaccine during pregnancy or breastfeeding should avoid breastfeeding and handling any baby for at least 3-4 weeks until the vaccination scab has separated from the vaccination site. The breasts can be pumped to maintain the milk supply, but the milk should be discarded. Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination. Smallpox (vaccinia) vaccine should not be used during nursing.  Based on the available information in the article, two individual case safety reports 22000256 (baby) and 22000257 (mother) were created and cross-linked in the database.  Company comment: A female patient developed vaccinia lesions on both areolas (vaccinia virus infection) from husband recently vaccinated with ACAM2000 (secondary transmission). ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccine. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of the events vaccinia virus infection and secondary transmission are assessed as possible with ACAM2000. Secondary transmission and vaccinia virus have been noted within the agency. The case is considered serious due to medical significance of vaccinia virus infection.; Sender's Comments: A female patient developed vaccinia lesions on both areolas (vaccinia virus infection) from husband recently vaccinated with ACAM2000 (secondary transmission). ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccine. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of the events vaccinia virus infection and secondary transmission are assessed as possible with ACAM2000. Secondary transmission and vaccinia virus have been noted within the agency. The case is considered serious due to medical significance of vaccinia virus infection.
Sex: M
Vaccine: TYP
Symptoms: Wrong technique in product usage process
Clinical narrative: Patient had coffee in the nothing by mouth duration; A spontaneous report was received from a nurse practitioner on 03NOV2022. It described a 41-year-old male patient who "had coffee in the nothing by mouth duration" (PT: Wrong technique in product usage process). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient consumed coffee during the duration after administering a dose of Vivotif but could not confirm the timeframe of when he had coffee after taking Vivotif. Additionally, it was reported that the patient completed the course of Vivotif on 27OCT2022 and did not experience any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient had coffee in the nothing by mouth duration (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient had coffee in the nothing by mouth duration (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had one shot of Shingrix and then I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingrix and then he/she got shingles. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling in under arms; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th November 2022, the patient received the 1st dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-NOV-2022 Reporter's Comments: The case was reported via interactive digital media. The patient received his/her 1st Shingles vaccine yesterday and experiencing swelling in under arms.  The patient asked as was that normal. Additional Supportive Information: Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: it gave me that reaction with the 2nd dose, injection is painful but it's worth it; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Nov-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient said thank god, as he/she had already been vaccinated, that injection was painful but it was worth it. It gave the patient that reaction with the 2nd dose. Additional supportive information: The follow-up could not be possible as no contact detail were available.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: So sick from quadruple senior vax; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that he/she was so sick from quadruple senior vaccine. The patient asked could it be taken as two half doses. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2022, the patient received Shingrix. In November 2022, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingrix vaccine Friday and had hives 2 days later. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Hep A vaccine administered; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received Hepatitis A vaccine (batch number unknown, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Hepatitis A vaccine. On 3rd November 2022, unknown after receiving Hepatitis A vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: This case was reported by a reporter via interactive digital media. The reporter asked could GlaxoSmithKline give him/her the proper steps to take when mistakenly administered Hep A vaccine that was expired on 9th August 2022. The reporter also asked would patient need to be revaccinated and if so how many days should wait before doing so. Additional supportive information: The patient received a dose of Hepatitis A vaccine which was already expired, which led to expired vaccine used. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Severe shaking; This case was reported by a consumer via interactive digital media and described the occurrence of tremor in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 24 hrs after receiving Shingles vaccine, the patient experienced tremor. On an unknown date, the outcome of the tremor was unknown.   It was unknown if the reporter considered the tremor to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via  interactive digital media. The patient received a dose of Shingles vaccine and 24 hours after experienced severe shaking. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5E43J, expiry date 30th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 4th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comments: A pharmacist called to ask for information about the administration of an expired dose of Boostrix to the patient.  The reporter asked whether the patient had to be re-vaccinated.  The reporter did not consent to follow-up. Additional Supportive information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The expired Havrix was administered to the patient. No adverse reactions were reported. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email. Additional Supportive Information: The expired Havrix was administered to the patient, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix was administer; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The reporter called to report a third dose of Shingrix was administered to a patient. The reporter did not have any information about the event, said he was out of office.  The reporter agreed to follow up to gather information. The reporter consented to follow up. Additional Supportive Information: The reporter called to report a third dose of Shingrix was administered to a patient, which led to extra dose administered.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Feeling abnormal, Injection site swelling, Pain in extremity
Clinical narrative: Patient felt terrible/patient felt really really bad; Weakness; Disorientated; Sore arm; Swelling in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt terrible/patient felt really really bad), ASTHENIA (Weakness), DISORIENTATION (Disorientated), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE SWELLING (Swelling in the site of injection) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041F22A) for COVID-19 vaccination.     It was reported that patient never had COVID + test or diagnosis.  It was reported that there was no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Thyroid operation (thyroid  replacement). Concurrent medical conditions included Allergy (x-ray dye allergy), Drug allergy (statins allergy), Kidney failure and Blood pressure high.    On 04-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Nov-2022, the patient experienced FEELING ABNORMAL (Patient felt terrible/patient felt really really bad), ASTHENIA (Weakness), DISORIENTATION (Disorientated), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE SWELLING (Swelling in the site of injection). On 09-Nov-2022, FEELING ABNORMAL (Patient felt terrible/patient felt really really bad), ASTHENIA (Weakness), DISORIENTATION (Disorientated), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE SWELLING (Swelling in the site of injection) had resolved.            Patient mentioned she was under treatment for high blood pressure and also medicine for thyroid replacement, but did not remember the names.  It was reported that there was no recent change in status such as improvement or worsening.  AE did not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The patient had not experienced a similar event in the past.  No treatment was given. No concomitant medication was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, Rash pruritic, SARS-CoV-2 test, Vaccination site reaction
Clinical narrative: got COVID; rash on my arm; She had the rash for a few days after the last booster. It was itchy.; COVID arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (COVID arm), COVID-19 (got COVID), RASH (rash on my arm) and RASH PRURITIC (She had the rash for a few days after the last booster. It was itchy.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On 23-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE REACTION (COVID arm), RASH (rash on my arm) and RASH PRURITIC (She had the rash for a few days after the last booster. It was itchy.). On 25-Jul-2022, the patient experienced COVID-19 (got COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID arm), RASH (rash on my arm) and RASH PRURITIC (She had the rash for a few days after the last booster. It was itchy.) had resolved and COVID-19 (got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2022, SARS-CoV-2 test: Positive.         Patient had no allergies.  She had preliminary shots and 2 boosters, She was wondering how it was different from the vaccines. She has gotten COVID arm, rash on her arm after all 4 shots. She had the rash for a few days after the last booster. It was itchy. She was not hardly sick.  Patient received Flu vaccine on 09-Sep-2022.  The AE did not cause patient to seek medical care.   This case was linked to MOD-2022-670562, MOD-2022-670500 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet).    No concomitant medication were reported.  Pharmacist states that they have a patient who had their 1st dose of the Moderna vaccine on 21Jun2022 and is now at their store for the 2nd dose. Pharmacist wanted to know if they can give them the 2nd dose. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscular weakness, Vaccination site anaesthesia, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: uncontrollable spasms in her left arm; arm became weak/  weaker than her right arm; left arm was numb up to her shoulder; Left arm was tingling; Patients left arm was sore; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (uncontrollable spasms in her left arm), MUSCULAR WEAKNESS (arm became weak/  weaker than her right arm), VACCINATION SITE ANAESTHESIA (left arm was numb up to her shoulder), VACCINATION SITE PARAESTHESIA (Left arm was tingling) and VACCINATION SITE PAIN (Patients left arm was sore) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (first booster dose.) and Pfizer doses (primary series). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer doses.    On 04-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022, the patient experienced MUSCLE SPASMS (uncontrollable spasms in her left arm), MUSCULAR WEAKNESS (arm became weak/  weaker than her right arm), VACCINATION SITE ANAESTHESIA (left arm was numb up to her shoulder), VACCINATION SITE PARAESTHESIA (Left arm was tingling) and VACCINATION SITE PAIN (Patients left arm was sore). At the time of the report, MUSCLE SPASMS (uncontrollable spasms in her left arm), MUSCULAR WEAKNESS (arm became weak/  weaker than her right arm), VACCINATION SITE ANAESTHESIA (left arm was numb up to her shoulder), VACCINATION SITE PARAESTHESIA (Left arm was tingling) and VACCINATION SITE PAIN (Patients left arm was sore) was resolving.            No concomitant information provided On 10-NOV-2022 the patient's arm felt better however was still sore, tingling, and weaker than her right arm. No treatment information provided
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot number: EL3247. .) on 28-Jan-2021, Pfizer (Dose 2, Lot number: EN5318.) on 18-Feb-2021, Pfizer (1st booster and Lot number:FC3183.) on 29-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced FATIGUE (I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.). At the time of the report, FATIGUE (I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.) had resolved.            No concomitant medication information was provided. End date of event felt worn out and fatigued for about 12-15 hours was Oct 2022. No treatment medication were provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Outside of the arm hurting; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Outside of the arm hurting) and PYREXIA (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 939909, 001B21A and 024M20A) for COVID-19 vaccination.     Patient had not tested or diagnosed positive for covid-19.  Previously administered products included for Drug use for unknown indication: Prevnar (perhaps 1-2 months ago) in 2022. Past adverse reactions to the above products included No adverse event with Prevnar.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Outside of the arm hurting) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Outside of the arm hurting) and PYREXIA (fever) outcome was unknown.            No concomitant medications was reported.  No treatment medications was reported.   This case was linked to MOD-2022-670586 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient administered vaccine more than 12 hours post puncture of the vial; No adverse event; Patient administered vaccine more than 12 hours post puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022 at 3:25 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022 at 3:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial), PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine more than 12 hours post puncture of the vial) and PRODUCT STORAGE ERROR (Patient administered vaccine more than 12 hours post puncture of the vial).    No concomitant medications were reported.  The patient received first dose on 24-Feb-2021 lot number 030M20A and expiration date were not known in left arm, received 2nd dose on 24-Mar-2021 lot number 048A21A and received 3rd dose on 5-Jun-2022 lot number 017B22A in right arm.  Vial size was reported as 2.5ml. The vial was initially stored in the refrigerator on 8-Nov-2022. The vial was first punctured on 9-Nov-2022 at 12 noon. The vial was stored post puncture at room temperature. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Tachycardia
Clinical narrative: sore arm; body aches; Tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Tachycardia), PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia) and MYALGIA (body aches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Tachycardia), PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient experienced the event Tachycardia and body aches started 4-8 hours after receiving each dose and lasted 12-24 hours. Patient was concerned with an allergic reaction.   This case was linked to MOD-2022-670602 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction; Got expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got expired vaccine) and NO ADVERSE EVENT (No adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got expired vaccine) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Got expired vaccine).    Concomitant medication was not reported.  Patient and her husband received expired vaccine. They did not experience any side effects. Treatment details were not reported.   This case was linked to MODERNATX, INC.-MOD-2022-662400 (E2B Linked Report).
Age: 16.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient was administered flublok for immunization with no reported adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2022SA457603(CLUSTER).  This case involves a 16 years old male patient who was administered influenza quadrivalent recombinant vaccine [flublok] for immunization with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2022, the patient received an unknown dose once total of suspect influenza quadrivalent recombinant vaccine (lot: QFAA2231; expiry date: 30-Jun-2023; strength: standard) via intramuscular route in the left deltoid for prophylactic vaccination.  On 26-Oct-2022, a 16 year old patient was administered flublok for immunization with no reported adverse event (product administered to patient of inappropriate age).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The reporter was an anonymous chat visitor. The reporter reported that patient received three doses of Shingrix vaccine. The reporter was identified as healthcare professional on the chat session, but chat was ended when asked for contact information. No further details were able to be obtained before chat session was terminated by visitor. Additional supportive information: The patient received extra dose of Shingrix, which led to extra dose administered. Follow-up would not possible as no contact details were available.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck mass, Neck pain
Clinical narrative: It popped up. It was on his neck on the right side. It wasn't there before the shot; It's sore; lymph node swelled up really quick; This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (It popped up. It was on his neck on the right side. It wasn't there before the shot), NECK PAIN (It's sore) and LYMPHADENOPATHY (lymph node swelled up really quick) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     Allergies and past history was not reported. Patient had not tested or diagnosed positive for covid-19.  Previously administered products included for Prophylaxis: Prevnar (perhaps 1-2 months ago (Pneumonia prophylaxis)) in 2022. Past adverse reactions to the above products included No adverse event with Prevnar.    On 16-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced LYMPHADENOPATHY (lymph node swelled up really quick). On an unknown date, the patient experienced NECK MASS (It popped up. It was on his neck on the right side. It wasn't there before the shot) and NECK PAIN (It's sore). At the time of the report, NECK MASS (It popped up. It was on his neck on the right side. It wasn't there before the shot) and NECK PAIN (It's sore) outcome was unknown and LYMPHADENOPATHY (lymph node swelled up really quick) had not resolved.            No concomitant medications were reported.  On 03-Mar-2021, patient received the 1st dose of Moderna COVID-19 vaccine (lot number: 024M20A). On 01-Apr-2021, patient received the 2nd dose of Moderna COVID-19 vaccine (lot number: 001B21A). On 24-Nov-2021, patient received the 1st booster dose of Moderna COVID-19 vaccine (lot number: 939909). On 11-Jun-2022, patient received the 2nd booster dose of Moderna COVID-19 vaccine (lot number: 054A22A). On 16-Oct-2022, patient received the booster dose of Moderna COVID-19 vaccine, Bivalent. It was reported that a day and a half later, his lymph node swelled up really quick. The patient would have a examination with his doctor on 11-Nov-2022.  No treatment medications provided.   This case was linked to MOD-2022-670592 (Patient Link).