chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Perhaps my immune system still weak; still tired; sinus symptoms; Cellulitis due to Lymphedema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Uterine cancer", start date: 14Sep2011, stop date: 14Sep2011; "Surgery", start date: 14Sep2011, stop date: 14Sep2011, notes: Surgery only, No other treatment, uterine cancer surgery in 2011; "Lymphedema", start date: 2014 (ongoing); "13 Lymph nodes in pelvic region removed" (unspecified if ongoing), notes: 13 Lymph nodes in pelvic region removed; "hysterectomy", start date: 14Sep2011 (unspecified if ongoing), notes: Complete hysterectomy lumpectomy of 13 lymph nodes 14Sep2011; "hysterectomy", start date: 14Sep2011 (unspecified if ongoing), notes: Complete hysterectomy lumpectomy of 13 lymph nodes 14Sep2011. There were no concomitant medications. Vaccination history included: Moderna (Dose: 1st Moderna), for COVID-19 immunization; Moderna (Dose: 2nd Moderna), for COVID-19 immunization; Moderna (Dose: 3rd Moderna), for COVID-19 immunization; Covid-19 vaccine (4th Dose, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CELLULITIS (medically significant) with onset 18Jan2023, outcome "recovered" (25Jan2023), described as "Cellulitis due to Lymphedema"; SINUS DISORDER (non-serious) with onset 02Mar2023, outcome "not recovered", described as "sinus symptoms"; FATIGUE (non-serious) with onset 02Mar2023, outcome "not recovered", described as "still tired"; IMMUNE SYSTEM DISORDER (non-serious), outcome "not recovered", described as "Perhaps my immune system still weak". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Positive, notes: Positive covid home test. Therapeutic measures were taken as a result of cellulitis.  Clinical course: It was reported that the patient had issue after use of a Pfizer product. On 23Sep2022 the patient received fifth dose of bivalent vaccine and on 18Jan2023 the patient experienced Cellulitis due to Lymphedema for which the patient received the treatment with antibiotics and was recovered on 25Jan2023. No relevant tests. The patient further stated that she didn't have any other acute illness at the time she got covid but did have a cellulitis infection on 18Jan2023 and was put on antibiotics for 7 days. She get cellulitis. Sometime due to lymphedema in legs from uterine cancer surgery in 2011. Perhaps her immune system still weak from cellulitis. 02Mar2023 still tired and some sinus symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Immune system disorder, SARS-CoV-2 test, Sinus disorder
Clinical narrative: Perhaps my immune system still weak; still tired; sinus symptoms; Cellulitis due to Lymphedema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Uterine cancer", start date: 14Sep2011, stop date: 14Sep2011; "Surgery", start date: 14Sep2011, stop date: 14Sep2011, notes: Surgery only, No other treatment, uterine cancer surgery in 2011; "Lymphedema", start date: 2014 (ongoing); "13 Lymph nodes in pelvic region removed" (unspecified if ongoing), notes: 13 Lymph nodes in pelvic region removed; "hysterectomy", start date: 14Sep2011 (unspecified if ongoing), notes: Complete hysterectomy lumpectomy of 13 lymph nodes 14Sep2011; "hysterectomy", start date: 14Sep2011 (unspecified if ongoing), notes: Complete hysterectomy lumpectomy of 13 lymph nodes 14Sep2011. There were no concomitant medications. Vaccination history included: Moderna (Dose: 1st Moderna), for COVID-19 immunization; Moderna (Dose: 2nd Moderna), for COVID-19 immunization; Moderna (Dose: 3rd Moderna), for COVID-19 immunization; Covid-19 vaccine (4th Dose, Manufacturer unknown), for COVID-19 immunization. The following information was reported: CELLULITIS (medically significant) with onset 18Jan2023, outcome "recovered" (25Jan2023), described as "Cellulitis due to Lymphedema"; SINUS DISORDER (non-serious) with onset 02Mar2023, outcome "not recovered", described as "sinus symptoms"; FATIGUE (non-serious) with onset 02Mar2023, outcome "not recovered", described as "still tired"; IMMUNE SYSTEM DISORDER (non-serious), outcome "not recovered", described as "Perhaps my immune system still weak". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Positive, notes: Positive covid home test. Therapeutic measures were taken as a result of cellulitis.  Clinical course: It was reported that the patient had issue after use of a Pfizer product. On 23Sep2022 the patient received fifth dose of bivalent vaccine and on 18Jan2023 the patient experienced Cellulitis due to Lymphedema for which the patient received the treatment with antibiotics and was recovered on 25Jan2023. No relevant tests. The patient further stated that she didn't have any other acute illness at the time she got covid but did have a cellulitis infection on 18Jan2023 and was put on antibiotics for 7 days. She get cellulitis. Sometime due to lymphedema in legs from uterine cancer surgery in 2011. Perhaps her immune system still weak from cellulitis. 02Mar2023 still tired and some sinus symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Tingling when lifts arm; The right arm muscle was sore to the touch/ became more severe; Soreness radiates down his right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The first dose was received in the right arm in 2022).   In JAN-2023, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tingling (Verbatim: Tingling when lifts arm), myalgia upper extremities (Verbatim: The right arm muscle was sore to the touch/ became more severe) and radiating pain (Verbatim: Soreness radiates down his right arm). The outcome of the tingling, myalgia upper extremities and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the tingling, myalgia upper extremities and radiating pain to be related to Shingrix.     It was unknown if the company considered the tingling, myalgia upper extremities and radiating pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2023 The patient stated that, he received his second Shingrix vaccine shot in January 2023 in the right arm. The patient said, a few days after he received the second Shingrix dose, the right arm muscle was sore to the touch. The patient said a 3 to 4 days after this sore feeling, the sore feeling became more severe. The patient said that when he lifts his arm at the day of reporting, he had experienced a tingling down his right arm. He said the soreness radiates down his right arm. The patient did not know about the lot number or expiration date of the Shingrix vaccines that, he took.  The patient did not consent to follow-up.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Tingling when lifts arm; The right arm muscle was sore to the touch/ became more severe; Soreness radiates down his right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The first dose was received in the right arm in 2022).   In JAN-2023, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tingling (Verbatim: Tingling when lifts arm), myalgia upper extremities (Verbatim: The right arm muscle was sore to the touch/ became more severe) and radiating pain (Verbatim: Soreness radiates down his right arm). The outcome of the tingling, myalgia upper extremities and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the tingling, myalgia upper extremities and radiating pain to be related to Shingrix.     It was unknown if the company considered the tingling, myalgia upper extremities and radiating pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2023 The patient stated that, he received his second Shingrix vaccine shot in January 2023 in the right arm. The patient said, a few days after he received the second Shingrix dose, the right arm muscle was sore to the touch. The patient said a 3 to 4 days after this sore feeling, the sore feeling became more severe. The patient said that when he lifts his arm at the day of reporting, he had experienced a tingling down his right arm. He said the soreness radiates down his right arm. The patient did not know about the lot number or expiration date of the Shingrix vaccines that, he took.  The patient did not consent to follow-up.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Peripheral swelling, Pruritus, Rash, Swollen tongue
Clinical narrative: swollen fingers; itchy fingers; swollen tongue; swollen parts of face; full body rash; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: pfizer coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FD8448), administration date: 19Aug2021, when the patient was 23-year-old, for Covid-19 Immunization; pfizer coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0170), administration date: 29Jul2021, when the patient was 23-year-old, for Covid-19 Immunization. The following information was reported: RASH (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "full body rash"; URTICARIA (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "hives"; PRURITUS (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "itchy fingers"; PERIPHERAL SWELLING (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen fingers"; SWELLING FACE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen parts of face"; SWOLLEN TONGUE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae". The patient was hospitalized for peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria (hospitalization duration: 2 day(s)). The events "swollen fingers", "itchy fingers", "swollen tongue", "swollen parts of face", "full body rash" and "hives" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Apr2021) Positive; (Nov2021) Negative. Therapeutic measures were taken as a result of peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria with EpiPen, Steroids and Allergic medication.  Clinical Course: The patient did not take other vaccines in 4 weeks prior to vaccination. The patient did not take other medications within 2 weeks of vaccination. The adverse events initially started as swollen/ itchy fingers, progressed to swollen tongue, swollen parts of face, full body rash and hives. It was reported that the patient recovered with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent test for COVID-19 post vaccination.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: swollen fingers; itchy fingers; swollen tongue; swollen parts of face; full body rash; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: pfizer coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FD8448), administration date: 19Aug2021, when the patient was 23-year-old, for Covid-19 Immunization; pfizer coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0170), administration date: 29Jul2021, when the patient was 23-year-old, for Covid-19 Immunization. The following information was reported: RASH (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "full body rash"; URTICARIA (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "hives"; PRURITUS (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "itchy fingers"; PERIPHERAL SWELLING (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen fingers"; SWELLING FACE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen parts of face"; SWOLLEN TONGUE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae". The patient was hospitalized for peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria (hospitalization duration: 2 day(s)). The events "swollen fingers", "itchy fingers", "swollen tongue", "swollen parts of face", "full body rash" and "hives" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Apr2021) Positive; (Nov2021) Negative. Therapeutic measures were taken as a result of peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria with EpiPen, Steroids and Allergic medication.  Clinical Course: The patient did not take other vaccines in 4 weeks prior to vaccination. The patient did not take other medications within 2 weeks of vaccination. The adverse events initially started as swollen/ itchy fingers, progressed to swollen tongue, swollen parts of face, full body rash and hives. It was reported that the patient recovered with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent test for COVID-19 post vaccination.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, SARS-CoV-2 test, Swelling face
Clinical narrative: swollen fingers; itchy fingers; swollen tongue; swollen parts of face; full body rash; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: pfizer coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FD8448), administration date: 19Aug2021, when the patient was 23-year-old, for Covid-19 Immunization; pfizer coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0170), administration date: 29Jul2021, when the patient was 23-year-old, for Covid-19 Immunization. The following information was reported: RASH (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "full body rash"; URTICARIA (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "hives"; PRURITUS (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "itchy fingers"; PERIPHERAL SWELLING (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen fingers"; SWELLING FACE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen parts of face"; SWOLLEN TONGUE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae". The patient was hospitalized for peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria (hospitalization duration: 2 day(s)). The events "swollen fingers", "itchy fingers", "swollen tongue", "swollen parts of face", "full body rash" and "hives" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Apr2021) Positive; (Nov2021) Negative. Therapeutic measures were taken as a result of peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria with EpiPen, Steroids and Allergic medication.  Clinical Course: The patient did not take other vaccines in 4 weeks prior to vaccination. The patient did not take other medications within 2 weeks of vaccination. The adverse events initially started as swollen/ itchy fingers, progressed to swollen tongue, swollen parts of face, full body rash and hives. It was reported that the patient recovered with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent test for COVID-19 post vaccination.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: swollen fingers; itchy fingers; swollen tongue; swollen parts of face; full body rash; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: pfizer coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FD8448), administration date: 19Aug2021, when the patient was 23-year-old, for Covid-19 Immunization; pfizer coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0170), administration date: 29Jul2021, when the patient was 23-year-old, for Covid-19 Immunization. The following information was reported: RASH (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "full body rash"; URTICARIA (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "hives"; PRURITUS (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "itchy fingers"; PERIPHERAL SWELLING (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen fingers"; SWELLING FACE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen parts of face"; SWOLLEN TONGUE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae". The patient was hospitalized for peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria (hospitalization duration: 2 day(s)). The events "swollen fingers", "itchy fingers", "swollen tongue", "swollen parts of face", "full body rash" and "hives" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Apr2021) Positive; (Nov2021) Negative. Therapeutic measures were taken as a result of peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria with EpiPen, Steroids and Allergic medication.  Clinical Course: The patient did not take other vaccines in 4 weeks prior to vaccination. The patient did not take other medications within 2 weeks of vaccination. The adverse events initially started as swollen/ itchy fingers, progressed to swollen tongue, swollen parts of face, full body rash and hives. It was reported that the patient recovered with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent test for COVID-19 post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Date: 11Oct2022 / Moderna, Date:06Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: 6J6665) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 030B21A), in left arm, on 29Apr2021 as dose 2, single (Lot number: 021C21A), in left arm, on 03Dec2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 06Jul2022 as dose 4 (booster), single (Lot number: 954A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Minimal allergy to peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Oct2022, outcome "unknown", described as "Pfizer, Date: 11Oct2022 / Moderna, Date:06Jul2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Mar2023 to 06Mar2023.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Date: 11Oct2022 / Moderna, Date:06Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: 6J6665) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 030B21A), in left arm, on 29Apr2021 as dose 2, single (Lot number: 021C21A), in left arm, on 03Dec2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm and on 06Jul2022 as dose 4 (booster), single (Lot number: 954A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Minimal allergy to peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Oct2022, outcome "unknown", described as "Pfizer, Date: 11Oct2022 / Moderna, Date:06Jul2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Mar2023 to 06Mar2023.
Sex: U
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient did not have any adverse events after administration of GARDASIL 9; The first dose was administered on 11/6/2020/ The second dose was administered on 12/4/2020; The caller said a patient received a fourth dose of GARDASIL 9 on 12/1/2022; This spontaneous report refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 06-NOV-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #s020254, expiration date not reported, but established as: 09-DEC-2021, administered for prophylaxis (strength, and route of administration were not provided). On 04-DEC-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (inappropriate schedule of product administration), lot #1687292, expiration date not reported, but established as: 25-AUG-2022, administered for prophylaxis (strength, and route of administration were not provided). On 06-APR-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #t024831, expiration date not reported, but established as: 18-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided). On 01-DEC-2022, the patient was vaccinated with the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (extra dose administered), lot #1780878, expiration date not reported, but established as: 02-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided). No further information was provided. No other adverse event reported.
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Laboratory test abnormal, Neutropenia, Platelet count decreased, Thrombocytopenia, Wrong product administered
Clinical narrative: neutropenia; thombocytopenia/low platelets; Patient's lab work had stopped 'growing and restarted 'growing'.; concomitantly administered STERILE DILUENT Reconstituted PROQUAD instead of the Intended MMRII; Accidental overdose; This spontaneous report was received from a physician referring to a 15-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 28-SEP-2022, the patient was meant to be administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection for prophylaxis (strength, dose, lot #, expiration date and route of administration were not provided) but the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (therapy type: rHA, lot #W004029, expiration date was unknown, but upon internal validation established as: 02-AUG-2023) for prophylaxis (strength, dose and route of administration were not provided) with concomitantly administered sterile diluent (manufacturer unknown) solution for injection/infusion (strength, dose, frequency, indication, lot# and expiration date and route of administration were not provided) instead of the intended measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). On the same date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U039722, expiration date: 15-DEC-2023) for prophylaxis (dose, strength, and route of administration were not provided) with concomitantly administered sterile diluent (manufacturer unknown) solution for injection/infusion (strength, dose, frequency, indication, lot# and expiration date and route of administration were not provided) (accidental overdose).  On unknown dates, the patient's lab work had stopped "growing" and restarted "growing" (laboratory test abnormal). On unknown dates, the patient experienced neutropenia and thombocytopenia/low platelets (thrombocytopenia). The outcome of all events was not reported. The action taken with all suspect therapies was not reported.  The causal relationship between all events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent (manufacturer unknown) was not reported. The causal relationship between events of laboratory test abnormal, neutropenia and thrombocytopenia and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not related.   Upon internal review, the events neutropenia and thrombocytopenia were determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reporting an inadvertently administered MMR-II that was expired.; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 10-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, (lot number U007684 which has been verified to be valid, expiration date reported and validated and expiration date as 09-MAR-2023) (dose, strength, route of administration, and anatomical sites of injection were unknown by the reporter). in combination with sterile diluent (dose, strength, route of administration, anatomical sites of injection,  lot number and expiration date were unknown by the reporter).  No additional side effects were reported in the patient.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; vaccine expired on 03/06/2023 and was administered to the patient on 03/10/2023.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-MAR-2023, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, 0.5 milliliter once, lot #W002894, expiration date: 06-MAR-2023 (lot number has been verified as valid for VAQTA) (strength, and route of administration were not provided) as prophylaxis (expired product administered). No adverse event was reported.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE reported. No PQC; PNEUMOVAX 23 was administered to one patient during an ongoing temperature excursion; 49-year-old patient received PNEUMOVAX 23; This spontaneous report was received from a physician and refers to a 49-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-MAR-2023, the patient was vaccinated an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter once, lot #W007035, expiration date: 20-OCT-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis (product storage error, product administered to patient of inappropriate age). The reporter informed that the vaccine underwent a temperature excursion of 60 Fahrenheit degrees for 24 hours previous the administration. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/new vaccine I got it, got on my face throat ear eye and was vaccinated; Got on my eye and was vaccinated; Got on my face throat ear and was vaccinated; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/new vaccine I got it, got on my face throat ear eye and was vaccinated) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Got on my eye and was vaccinated) (serious criteria GSK medically significant) and shingles (Verbatim: Got on my face throat ear and was vaccinated). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that not fun.  The patient was vaccinated and got them on face, throat, ear, eye. When they came out with new vaccine got them in a hurry and said once that had them more prone to get them again.  The vaccine kept the patient from getting them so bad being treated soon was very important. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Renal impairment
Clinical narrative: felt like his kidneys were gonna stop functioning; This serious case was reported by a consumer via interactive digital media and described the occurrence of renal function abnormal in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced renal function abnormal (Verbatim: felt like his kidneys were gonna stop functioning) (serious criteria GSK medically significant). The outcome of the renal function abnormal was not reported.   It was unknown if the reporter considered the renal function abnormal to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the renal function abnormal to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 02-Mar-2023 This case was reported by patient's friend via interactive digital media. The reaction the reports friend got from the 2 regimens Scared me because he felt like his kidneys were gonna stop functioning and he almost went to the emergency room. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain of skin, Pemphigoid
Clinical narrative: Bullous pemphigoid; his body is reflecting his skin. Very painful.; no longer Walk without assistance; This serious case was reported by a consumer via interactive digital media and described the occurrence of bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bullous pemphigoid (Verbatim: Bullous pemphigoid) (serious criteria GSK medically significant), skin pain (Verbatim: his body is reflecting his skin. Very painful.) and walking difficulty (Verbatim: no longer Walk without assistance). The patient was treated with steroids nos (Steroids). The outcome of the bullous pemphigoid and skin pain were not reported and the outcome of the walking difficulty was not recovered/not resolved.   It was unknown if the reporter considered the bullous pemphigoid, skin pain and walking difficulty to be related to Shingrix.     It was unknown if the company considered the bullous pemphigoid, skin pain and walking difficulty to be related to Shingrix.   Additional Information: GSK Receipt date: 02-Mar-2023. This serious case was reported by a consumer via interactive digital media. The reporter was patient's wife. It was reported that after receiving the 2nd Shingrix vaccine, 2 1/2 years ago, her husband had been suffering with Bullous Pemphigoid. Basically, his body was reflecting his skin. Very painful. Treatment requires high doses of steroids and anti-rejection drugs.  They live isolated because he could not receive the Covid vaccine. The patient could no longer walk without assistance. Apparently this was not rare. Check it out and be very cautious with this vaccination. Follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine, had shingles/Suspected vaccination failure; Shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine, had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles 3 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 and 07-MAR-2023 The case  was received from the patient via interactive digital media. The patient got the Shingles vaccine and had shingles 3 times afterwards.  The patient stated that apparently, the vaccine could trigger outbreaks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, COVID-19, Herpes zoster, Scratch, Skin haemorrhage
Clinical narrative: Up to date on all vaccines, got shingles/suspected vaccination failure; I was in recovery of shingles broke out; Was in recovery of covid; In addition to the already blisters; Scratched so hard my skin bled; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Up to date on all vaccines, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I was in recovery of shingles broke out), covid-19 (Verbatim: Was in recovery of covid), blister (Verbatim: In addition to the already blisters) and scratch (Verbatim: Scratched so hard my skin bled). The patient was treated with topical steroid nos (Steroid Cream). The outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were recovering/resolving and the outcome of the blister and scratch were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, blister and scratch to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, covid-19, blister and scratch to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that same with him/her. The patient was in recovery of covid and shingles broke out.  The patient scratched so hard his/her skin bled in addition to the already blisters and 2 different rounds of steroid topical cream.  The patient stated that yes, he/she was up to date on all vaccines. The patient was never thought this dreadful shingles would get him/her.  No one was immune. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Up to date on all vaccines, got shingles/suspected vaccination failure; I was in recovery of shingles broke out; Was in recovery of covid; In addition to the already blisters; Scratched so hard my skin bled; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Up to date on all vaccines, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I was in recovery of shingles broke out), covid-19 (Verbatim: Was in recovery of covid), blister (Verbatim: In addition to the already blisters) and scratch (Verbatim: Scratched so hard my skin bled). The patient was treated with topical steroid nos (Steroid Cream). The outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were recovering/resolving and the outcome of the blister and scratch were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, blister and scratch to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, covid-19, blister and scratch to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that same with him/her. The patient was in recovery of covid and shingles broke out.  The patient scratched so hard his/her skin bled in addition to the already blisters and 2 different rounds of steroid topical cream.  The patient stated that yes, he/she was up to date on all vaccines. The patient was never thought this dreadful shingles would get him/her.  No one was immune. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired gastric emptying, Vaccination failure
Clinical narrative: Had the shingles shot and I got shingles/ suspected vaccination failure; Gastroperesis; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included chickenpox (patient's 4 boys and granddaughter had chickenpox).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shingles shot and I got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), gastroparesis (Verbatim: Gastroperesis) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the gastroparesis and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, gastroparesis and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, gastroparesis and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-Mar-2023 The case was received from the patient via interactive digital media.  The patient had the shingles shot 2 and half years ago and got shingles while in the hospital for gastroperisis. The patient asked that he/she was supposed to get 2 shots or something and he/she never had chickenpox, even after taking care of his/her 4 boys and granddaughter while they had it. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was not clear whether the patient was hospitalized for gastroperisis or not was just visit for follow-up, therefore, only emergency visit was tick considering that the patient was not hospitalized.