chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first Shingrix dose more than 6 months ago; Mild case of shingles in August 2022; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. In August 2022, more than 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: The reporter was the patient.  She received her first Shingrix dose more than 6 months ago from reporting (date was unknown to the patient).  The patient had developed a mild case of shingles, which was recovered.  She had nothing else to report. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: maladministration of a Havrix vaccine, in which an adolescent was given an adult dose; maladministration of a Havrix vaccine, in which an adolescent was given an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a adolescent patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult use of a child product. On an unknown date, the outcome of the overdose and adult use of a child product were 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 Reporters comment: The pharmacist reported that patient received a maladministration of a Havrix vaccine, in which an adolescent was given an adult dose. During the recollection of the event the reporter mentioned that no information could be relayed as they did not have any on hand. The reporter consent to follow-up. Additional Supportive information: The adolescent patient was given an adult dose, which led to overdose and adult use of child product
Age: 13.0
Sex: M
Vaccine: HEPAB
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 13 YO got Twinrix administered to a pediatric patient; 13 YO got Twinrix administered to a pediatric patient; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th November 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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: 8-Nov-2022 Reporter's comment: The pharmacist called to reported that an adult dose of Twinrix had been administered to a pediatric patient, given at the same site and by a different pharmacist than the one giving the report. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: An adult dose of Twinrix had been administered to a pediatric patient, which led to overdose and adult product administered to child.
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: 1st dose 2017-2018, 2nd not yet, vaccine shortage; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2017 or 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The patient's wife reported that the patient received his first Shingrix dose but had not yet received the second dose. The patient attributes the delay to vaccine shortage.  Nothing else was reported. The reporter declined to provide date of birth. The reporter did not consent to follow up. This is report 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient did not receive second dose of Shingrix due to vaccine shortage, which led to product supply issue.; Sender's Comments:  US-GSK-US2022163649:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incomplete course of vaccination, Myalgia, Nausea, Pain
Clinical narrative: 1st dose 2018, 2nd not yet; muscle aches; pain, soreness of the rotator cuff; headaches; nausea; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles and allergy to insect sting.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced muscle pain, pain, headache, nausea and incomplete course of vaccination. On an unknown date, the outcome of the muscle pain, pain, headache and nausea were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the muscle pain, pain, headache and nausea to be related to Shingrix.     Additional Information: GSK receipt date: 8-Nov-2022 Reporter's comment: The patient received his first dose of Shingrix in 2018 but never received his second dose. The patient stated that when he received this dose he experienced muscle aches, pain, headaches, nausea and soreness in his rotator cuff.  The patient stated that these started day after the administration and continued for four days. The patient stated that he plan to get the second dose as soon as possible. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular administration of Rotarix.; This case was reported by a other health professional via call center representative and described the occurrence of wrong route of administration in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number Z5R33, expiry date 23rd February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 8th November 2022, the patient received the 2nd dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 8th November 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration 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: 8-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow-up by safety team. The reporter consented to follow-up. Additional supportive information: The patient received Rotarix vaccine intramuscularly instead of orally, which led to wrong route of administration.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2020, 2nd dose in 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose in 2020).   On 8th November 2022, the patient received the 2nd dose of Shingrix. On 8th 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: 8-Nov-2022 Reporter's comment: No other information reported to the agent by the patient. The reporter did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received Havrix that had expired; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, 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: 08-NOV-2022 Reporter's Comment: The physician reported that a patient (no identifiers available) received a dose each of Havrix (no lot number available) that had expired on 30th September 2022.  The reporter wanted to know was the dose valid. The reporter consent to follow up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. This case is linked to the case US2022AMR164695, US2022AMR163547 and US2022AMR163515 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR164695:same reporter US-GSK-US2022AMR163515:same reporter US-GSK-US2022AMR163547:same reporter
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in Nov2020, 2nd on 05Nov2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 2J82N, expiry date 6th October 2023) for prophylaxis.   Previously administered products included Shingrix (received first dose in November 2020).   On 5th November 2022, the patient received the 2nd dose of Shingrix. On 5th 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: 9-Nov-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received his first dose of SHINGRIX one year ago and never received his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 09-Nov-2022 Reporter's comment: The reporter was the Health-care professional (pharmacist) who was reporting on behalf of a patient.  She stated that the patient received his first dose of Shingrix one year ago and had never received his second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of SHINGRIX; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number JH25S, expiry date 4th November 2022) for prophylaxis.   On 9th November 2022, the patient received Shingrix. On 9th November 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-Nov-2022 Reporter's comment: The reporter was a physician. The patient received Shingrix vaccine in left arm.   The Physician reported that the patient received an expired dose of Shingrix. The adverse event was filed. The consent to follow-up was granted. Additional Supportive Information: The patient received expired dose of Shingrix, which led to expired vaccine used.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo reconstituted with sterile water; received Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva701a, expiry date 28th February 2023) for prophylaxis.   On 24th October 2022, the patient received Menveo. On 24th October 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's comment: The medial assistant reported that the patient received a dose of Menveo powder reconstituted with sterile diluent from Merck for live vaccine (sterile water).  The reporter consented to follow up. Additional supportive information: The patient received dose of Menveo powder reconstituted with sterile diluent (sterile water), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 4 MONTH OLD WAS GIVEN KINRIX; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 10-NOV-2022 Reporter's comment: The medical assistant reported that the four months old patient received a dose of Kinrix. The reporter consented to follow up.   Additional supportive information: The four month's old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 14.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered to a 14 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 10-NOV-2022 Reporter's comments: The health care professional reported that the 14 years old patient received a dose of Twinrix. At the time of reporting, lot number and expiry date were not available. The reporter consented to follow up by postal. Additional supportive information: The 14 years old patient received a dose of Twinrix, which led to inappropriate age at vaccine administration.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant; received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number H9LL4, expiry date 24th November 2023) for prophylaxis.   On 10th November 2022, the patient received Shingrix. On 10th November 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: 10-NOV-2022 Reporter's comment: The nurse reported that the patient received only the adjuvant of Shingrix.  The reporter consented to follow up. Additional supportive information: The patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erysipelas, Periorbital swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash classified as Erysipelas; Itching rash in scalp and forehead; red rash in scalp and forehead; Warm to touch; Pustular rash in scalp and forehead; Swelling around forehead and reyes; scarring; open sores; crusted; This case was reported by a other health professional via call center representative and described the occurrence of erysipelas in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7BC47, expiry date unknown) for prophylaxis.   On 28th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erysipelas (serious criteria GSK medically significant), itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust. On 18th October 2022, the outcome of the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, skin ulcer and crust were recovered/resolved. On an unknown date, the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter was medical assistant, reporting on behalf of patient.  The reporter reported that, patient received Shingrix at a pharmacy.  The reporter reported that, patient stated rash appeared a couple of days after receipt of dose.  The reporter reported that, rash was located on the patient's scalp and forehead. The reporter reported that, patient's rash was itchy, red, contained pustules and was warm to the touch.  The reporter reported that, patient experienced swelling around the forehead and eyes.  The reporter reported that, pustules turned into open sores, crusted and left scarring.  The reporter reported that, patient's rash was classified as erysipelas, which was a skin infection involving the dermis layer of the skin.  The reporter reported all symptoms were resolved as of 18th October 2022, at patient's last visit.  The reporter reported that, the patient had scarring remaining from the pustules. The reporter worked at a dermatology office, where patient went to receive treatment for rash. In 2022, less than 2 months after receiving Shingrix, the patient experienced facial swelling, scar, skin ulcer and crust. The patient did not receive Shingrix dose at dermatology office.  The reporter did not have contact information where patient received dose of Shingrix. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular, Scab, Scar, Skin infection, Skin ulcer
Clinical narrative: rash classified as Erysipelas; Itching rash in scalp and forehead; red rash in scalp and forehead; Warm to touch; Pustular rash in scalp and forehead; Swelling around forehead and reyes; scarring; open sores; crusted; This case was reported by a other health professional via call center representative and described the occurrence of erysipelas in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7BC47, expiry date unknown) for prophylaxis.   On 28th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erysipelas (serious criteria GSK medically significant), itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust. On 18th October 2022, the outcome of the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, skin ulcer and crust were recovered/resolved. On an unknown date, the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter was medical assistant, reporting on behalf of patient.  The reporter reported that, patient received Shingrix at a pharmacy.  The reporter reported that, patient stated rash appeared a couple of days after receipt of dose.  The reporter reported that, rash was located on the patient's scalp and forehead. The reporter reported that, patient's rash was itchy, red, contained pustules and was warm to the touch.  The reporter reported that, patient experienced swelling around the forehead and eyes.  The reporter reported that, pustules turned into open sores, crusted and left scarring.  The reporter reported that, patient's rash was classified as erysipelas, which was a skin infection involving the dermis layer of the skin.  The reporter reported all symptoms were resolved as of 18th October 2022, at patient's last visit.  The reporter reported that, the patient had scarring remaining from the pustules. The reporter worked at a dermatology office, where patient went to receive treatment for rash. In 2022, less than 2 months after receiving Shingrix, the patient experienced facial swelling, scar, skin ulcer and crust. The patient did not receive Shingrix dose at dermatology office.  The reporter did not have contact information where patient received dose of Shingrix. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Swelling face
Clinical narrative: rash classified as Erysipelas; Itching rash in scalp and forehead; red rash in scalp and forehead; Warm to touch; Pustular rash in scalp and forehead; Swelling around forehead and reyes; scarring; open sores; crusted; This case was reported by a other health professional via call center representative and described the occurrence of erysipelas in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7BC47, expiry date unknown) for prophylaxis.   On 28th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erysipelas (serious criteria GSK medically significant), itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust. On 18th October 2022, the outcome of the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, skin ulcer and crust were recovered/resolved. On an unknown date, the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the erysipelas, itchy rash, red rash, skin warm, pustular rash, facial swelling, scar, skin ulcer and crust to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter was medical assistant, reporting on behalf of patient.  The reporter reported that, patient received Shingrix at a pharmacy.  The reporter reported that, patient stated rash appeared a couple of days after receipt of dose.  The reporter reported that, rash was located on the patient's scalp and forehead. The reporter reported that, patient's rash was itchy, red, contained pustules and was warm to the touch.  The reporter reported that, patient experienced swelling around the forehead and eyes.  The reporter reported that, pustules turned into open sores, crusted and left scarring.  The reporter reported that, patient's rash was classified as erysipelas, which was a skin infection involving the dermis layer of the skin.  The reporter reported all symptoms were resolved as of 18th October 2022, at patient's last visit.  The reporter reported that, the patient had scarring remaining from the pustules. The reporter worked at a dermatology office, where patient went to receive treatment for rash. In 2022, less than 2 months after receiving Shingrix, the patient experienced facial swelling, scar, skin ulcer and crust. The patient did not receive Shingrix dose at dermatology office.  The reporter did not have contact information where patient received dose of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a consumer concerned multiple patients. 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, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus was not reported. This report was non-serious. This case, from the same reporter is linked to 20221135750.
Sex: U
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: suddenly started sneezing; This spontaneous case was reported by a patient and describes the occurrence of SNEEZING (suddenly started sneezing) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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. In November 2022, the patient experienced SNEEZING (suddenly started sneezing). At the time of the report, SNEEZING (suddenly started sneezing) outcome was unknown.            No concomitant medications were reported. Patient received  Moderna booster and suddenly started sneezing. The patient wanted to know if it was a side effect of vaccine or if the patient had a cold. No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Did not get the second dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Did not get the second dose of the primary series).    The concomitant medication was not reported by reporter. It was reported that patient came for a booster and all they had was a Bivalent booster now. Caller knew you must have the first entire series to get the Bivalent booster. Caller enquired that do we have information on anyone getting the bivalent booster if they just got the first dose of Moderna. HCP reported a patient got the first dose in 2021 and did not get the second dose of the primary series but needed to have a booster to be able to start a job on Friday.  HCP was unsure why the patient did not get the second dose of the primary series. The treatment medication was not reported by reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (History of Heart) and Stroke. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacy gave Moderna Bivalent dose to a patient who never had any covid-19 vaccines).    Concomitant medication included Blood pressure medication.  The reporter who was infection preventionist reported that the patient had a health history of heart and stroke and was concerned.  No treatment details were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site reaction
Clinical narrative: arm turned red and splotchy; covid arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (arm turned red and splotchy) and VACCINATION SITE REACTION (covid arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 037F21A, 011M20A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-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 ERYTHEMA (arm turned red and splotchy) and VACCINATION SITE REACTION (covid arm). At the time of the report, ERYTHEMA (arm turned red and splotchy) and VACCINATION SITE REACTION (covid arm) had resolved.            Patient had no known prior health conditions  No concomitant medication was provided.  Patient was given a steroid shot which cleared it up in a day.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received a regular booster instead of a bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a regular booster instead of a bivalent booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a regular booster instead of a bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a regular booster instead of a bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information provided No treatment information provided
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired vaccine/Moderna COVID-19 vaccines by injection on 10NOV2022 (expiration date listed as 20MAY2022); This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine/Moderna COVID-19 vaccines by injection on 10NOV2022 (expiration date listed as 20MAY2022)) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (previous dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.    On 10-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine/Moderna COVID-19 vaccines by injection on 10NOV2022 (expiration date listed as 20MAY2022)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine/Moderna COVID-19 vaccines by injection on 10NOV2022 (expiration date listed as 20MAY2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not provided. Patient received previous dose of the Pfizer COVID-19 vaccines and has received a dose of the Moderna COVID-19 vaccines by injection. The expiration date listed on patient's vaccination card is before administration date  No reported symptoms.  Treatment information was not provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Pain in extremity
Clinical narrative: Sore arm; Administration error, half of a dose administered of Moderna bivalent; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ACCIDENTAL UNDERDOSE (Administration error, half of a dose administered of Moderna bivalent) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     Patient had no allergies. It was reported that patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included High cholesterol (No improvement or worsening.), Seizures (No improvement or worsening.) and Epilepsy (No improvement or worsening.). Concomitant products included PRAVASTATIN, SERTRALINE and LEVETIRACETAM for an unknown indication.    On 12-Sep-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. On 12-Sep-2022, the patient experienced PAIN IN EXTREMITY (Sore arm) and ACCIDENTAL UNDERDOSE (Administration error, half of a dose administered of Moderna bivalent). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and ACCIDENTAL UNDERDOSE (Administration error, half of a dose administered of Moderna bivalent) outcome was unknown.            No medical care took by the patient.  First dose of Moderna COVID-19 Vaccine was administered on 02-Mar-2021; lot number: 012A21A; expiration date: 17-Aug-2021. Second dose on 30-Mar-2021; lot number: 021B21A. First booster on 25-Oct-2021; lot number: 27C21A. Second booster on 01-Apr-2022; lot number: 002M21A.  No treatment medication details was reported.   This case was linked to MOD-2022-672848 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy
Clinical narrative: patient reports that he recently contracted Bells Palsey; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (patient reports that he recently contracted Bells Palsey) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (patient reports that he recently contracted Bells Palsey) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (patient reports that he recently contracted Bells Palsey) outcome was unknown.            No concomitant medications were reported.  The patient reported that he received COVID-19 vaccinations primary series and booster doses The patient has had the Moderna Primary Series and has had two Moderna Booster dose. The patient reported that he recently contracted Bells Palsey.  No treatment medications were reported.  Company comment. This spontaneous case concerns a male patient (unknown age), with no medical history reported, who received a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the expected, serious (medically significant) of Bell's palsy. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The patient reported he recently contracted Bell´s palsy. The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The patient previously received a primary schedule and booster doses with mRNA - 1273. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient (unknown age), with no medical history reported, who received a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the expected, serious (medically significant) of Bell's palsy. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The patient reported he recently contracted Bell´s palsy. The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The patient previously received a primary schedule and booster doses with mRNA - 1273. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: minor one day reaction/minor one day reaction (unknown related to which vaccine); This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (minor one day reaction/minor one day reaction (unknown related to which vaccine)) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 27C21A, 021B21A and 012A21A) for COVID-19 prophylaxis.     Patient has not tested positive for COVID-19.  Concurrent medical conditions included Coronary artery disease, Hypertension, Sleep apnea and Drug allergy (ophthalmic drops for pupils dilatation). Concomitant products included APIXABAN (ELIQUIS), LATANOPROST, SPIRONOLACTONE, LOSARTAN POTASSIUM, CHLORTALIDONE (CHLORTHALIDONE) and ATORVASTATIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNISATION REACTION (minor one day reaction/minor one day reaction (unknown related to which vaccine)). On 01-Apr-2022, IMMUNISATION REACTION (minor one day reaction/minor one day reaction (unknown related to which vaccine)) had resolved.            No concomitant medications were reported. Caller mentioned he experienced a minor one day reaction after the 2nd booster Patient did not take any treatment for the symptoms.   This case was linked to MOD-2022-672872 (Patient Link).