chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sick for a year and 2 months/was a little sick on first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0168) at the age of 50 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "stressor" (unspecified if ongoing), notes: is a stressor and is horrible; "She is old and has to get her glasses" (unspecified if ongoing), notes: She is old and has to get her glasses; "she had surgery" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shots (Caller said did not hurt and did not feel like anything and the flu shots hurt worse and she won't get the flu shot anymore.), for Immunization, reaction(s): "flu shots hurt worse". The following information was reported: ILLNESS (medically significant), outcome "unknown", described as "sick for a year and 2 months/was a little sick on first vaccine". Clinical course: Caller confirmed she received first and second vaccine and was a little sick on first vaccine and the second vaccine through her over the edge and she said there was a class action and she said the worst thing is she feels like a jerk. The patient received the second shot on 01Jul2021. It was reported that patient was 50 years old at the time of onset of reaction and time of vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201182051 same reporter/product, different event. PFIZER INC-202200463772 same reporter/product, different event.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: sick for a year and 2 months/was a little sick on first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0168) at the age of 50 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "stressor" (unspecified if ongoing), notes: is a stressor and is horrible; "She is old and has to get her glasses" (unspecified if ongoing), notes: She is old and has to get her glasses; "she had surgery" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shots (Caller said did not hurt and did not feel like anything and the flu shots hurt worse and she won't get the flu shot anymore.), for Immunization, reaction(s): "flu shots hurt worse". The following information was reported: ILLNESS (medically significant), outcome "unknown", described as "sick for a year and 2 months/was a little sick on first vaccine". Clinical course: Caller confirmed she received first and second vaccine and was a little sick on first vaccine and the second vaccine through her over the edge and she said there was a class action and she said the worst thing is she feels like a jerk. The patient received the second shot on 01Jul2021. It was reported that patient was 50 years old at the time of onset of reaction and time of vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201182051 same reporter/product, different event. PFIZER INC-202200463772 same reporter/product, different event.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Gait inability, Mobility decreased, Neuralgia, Pain
Clinical narrative: Extreme muscle pain, neuropathy and inability to control muscle function.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Muscle disorder, Myalgia, Neuropathy peripheral
Clinical narrative: Extreme muscle pain, neuropathy and inability to control muscle function.
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm pain; unable to use arm; This spontaneous report was received from a nurse practitioner referring to a 43-year-old female patient. The patient had no pertinent medical history, or drug reactions or allergies. Concomitant medications included desogestrel, rizatriptan benzoate (MAXALT), spironolactone (ALDACTONE) and escitalopram oxalate (LEXAPRO).  On 09-AUG-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # 1775827, expiration date was 27-JUN-2024, serial number was reported as 17006-4121-01; strength and dose were not reported) administered intramuscularly through left deltoid for prophylaxis. The patient had previously vaccinated 2 doses.  On 12-AUG-2022, the patient had presented with arm pain, and she was having a hard time using arm because of pain. The arm pain had persisted for more than 2 weeks. Lab/diagnostic tests were not performed. The reporter was unable to confirm if the patient was administered ibuprofen prior to or at current call time. The outcome of the events was reported as unknown.   The causality between the events and the suspect vaccine was reported as related.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HCP called in and reported that the improperly stored vaccine was administered on 08/26/22. No further information was provided. Consent to contact HCP was provided. No additional AEs/no PQCs.   Include in the Description (cut and paste with response; This spontaneous report was received from a registered nurse and refers to a patient of unspecified gender and age. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 26-AUG-2022, the patient was administered with improperly stored dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #T029522, expiration date: 13-MAR-2023 (exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis (Product storage error). The vaccine underwent excursion in -39.8 Fahrenheit degrees (F) in a time frame of 3 hours 27 minutes. No previous temperature excursions were reported. No additional adverse events were reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; A patient received improperly stored vaccine; This spontaneous report was received from a healthcare worker and refers to a 4-month-old patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 19-AUG-2022, the patient was vaccinated with 1 dose of improperly stored (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (exact dose and frequency were not reported) as prophylaxis. The patient received only 1 dose, but the healthcare worker did not specify which lot (of the following two) the patient actually received: lot number W002562 and expiration date 12-OCT-2023 or lot number W004504 and expiration date 16-JUN-2023. The suspect vaccine was improperly stored for 34 minutes in temperature of 11.3 degrees Celsius. No additional adverse events were reported, no further information provided.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; A patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 8-week-old patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 23-AUG-2022, the patient was vaccinated with 1 dose of improperly stored (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (exact dose and frequency were not reported) as prophylaxis. The patient received only 1 dose, but the healthcare worker did not specify which lot (of the following two) the patient actually received: lot number W002562 and expiration date 12-OCT-2023 or lot number W004504 and expiration date 16-JUN-2023. The suspect vaccine was improperly stored for 34 minutes in temperature of 11.3 degrees Celsius. No additional adverse events were reported, no further information provided.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse AEs; HCP administered expired dose of MMR II.; route of administration IM; This spontaneous report has been received from a physician via company representative, concerning to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 02-SEP-2022, the health care professional (HCP) administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose was unknown by the reporter; strength, vaccination scheme frequency, route of administration and anatomical site of application and lot number were not provided, expiration date reported as on 01-SEP-2022) administered for prophylaxis (expired product administered).  No additional adverse event (AE) was reported (no adverse event).  This report was considered non-valid due to the lack of patient's identifiers.  Follow-up information has been received on 20-SEP-2022.  Report was regarding a 12 month-old male patient, who was vaccinated on 02-SEP-2022 with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA) (M-M-R II) lot number T029550 intramuscularly (subcutaneous injection formulation administered by other route).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information reported.; Nurse reporting administration of improperly stored VARIVAX. See  02240320. No additional AE information reported. No PQC reported.     ?    Names of vaccines involved (including lot/exp): VARIVAX (W012167 and 04/12/2024)         ?    Temperatu; This spontaneous report was received from a nurse and refers to a patient of unspecified gender and age. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 02-SEP-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one dose, lot #W012167, expiration date: 12-APR-2024 (exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis. The vaccine underwent temperature excursion in -11.6 Celsius degrees (C) during a time frame of 25 minutes. No additional adverse event information was reported.
Sex: U
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Chills, Extra dose administered
Clinical narrative: By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.; felt really sick; I was in misery; headaches; joint pain; fever; chills; throw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills) and VOMITING (throw up). On 22-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.). At the time of the report, ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), VOMITING (throw up) and ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.) outcome was unknown.            No concomitant medications were reported. Patient went for vaccination on 22-Sep-2022. Instead of receiving Moderna Covid-19 vaccine and a flu shot there was medication error and got two Moderna Covid-19 vaccine on each arm. Patient felt like 24 hours in misery. No treatment information was reported.
Sex: U
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Fear, Headache, Vomiting
Clinical narrative: By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.; felt really sick; I was in misery; headaches; joint pain; fever; chills; throw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills) and VOMITING (throw up). On 22-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.). At the time of the report, ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), VOMITING (throw up) and ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.) outcome was unknown.            No concomitant medications were reported. Patient went for vaccination on 22-Sep-2022. Instead of receiving Moderna Covid-19 vaccine and a flu shot there was medication error and got two Moderna Covid-19 vaccine on each arm. Patient felt like 24 hours in misery. No treatment information was reported.
Sex: U
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.; felt really sick; I was in misery; headaches; joint pain; fever; chills; throw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills) and VOMITING (throw up). On 22-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.). At the time of the report, ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), VOMITING (throw up) and ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.) outcome was unknown.            No concomitant medications were reported. Patient went for vaccination on 22-Sep-2022. Instead of receiving Moderna Covid-19 vaccine and a flu shot there was medication error and got two Moderna Covid-19 vaccine on each arm. Patient felt like 24 hours in misery. No treatment information was reported.
Sex: U
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Accidental overdose, Arthralgia, Chills, Feeling abnormal, Headache
Clinical narrative: By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.; felt really sick; I was in misery; headaches; joint pain; fever; chills; throw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills) and VOMITING (throw up). On 22-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.). At the time of the report, ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), VOMITING (throw up) and ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.) outcome was unknown.            No concomitant medications were reported. Patient went for vaccination on 22-Sep-2022. Instead of receiving Moderna Covid-19 vaccine and a flu shot there was medication error and got two Moderna Covid-19 vaccine on each arm. Patient felt like 24 hours in misery. No treatment information was reported.
Sex: U
Vaccine: COVID19, COVID19, COVID19-2, COVID19-2, COVID19-2, COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.; felt really sick; I was in misery; headaches; joint pain; fever; chills; throw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills) and VOMITING (throw up). On 22-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.). At the time of the report, ILLNESS (felt really sick), FEELING ABNORMAL (I was in misery), HEADACHE (headaches), ARTHRALGIA (joint pain), PYREXIA (fever), CHILLS (chills), VOMITING (throw up) and ACCIDENTAL OVERDOSE (By mistake Two Moderna Covid-19 vaccines administered on each arm on the same day.) outcome was unknown.            No concomitant medications were reported. Patient went for vaccination on 22-Sep-2022. Instead of receiving Moderna Covid-19 vaccine and a flu shot there was medication error and got two Moderna Covid-19 vaccine on each arm. Patient felt like 24 hours in misery. No treatment information was reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The area of the shot was red, swollen, hot to the touch. I had a low fever (never above 99.5) for two days after the vaccine, including the night of the vaccine. Starting the same afternoon that I received the vaccine, my body ached, as if I had the flu. My head hurt, the shot site REALLY hurt, and I had no energy for six days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: The area of the shot was red, swollen, hot to the touch. I had a low fever (never above 99.5) for two days after the vaccine, including the night of the vaccine. Starting the same afternoon that I received the vaccine, my body ached, as if I had the flu. My head hurt, the shot site REALLY hurt, and I had no energy for six days.
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 22.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt came in for a second dose of the Moderna primary series, and we gave her the Pfizer bivalent booster.  No adverse events, already reported to Pfizer safety department.
Age: 22.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt came in for a second dose of the Moderna primary series, and we gave her the Pfizer bivalent booster.  No adverse events, already reported to Pfizer safety department.
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Sore throat (started about 3 hours after vaccination), fatigue, body ache, generally feeling unwell.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood culture negative, Blood lactic acid normal, Full blood count, Headache
Clinical narrative: Patient  presented 1 day after vaccine for continued fever that  she was unable to control at home with associated headache and body aches and tachycardia.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pain, Procalcitonin increased, Protein urine present, Pyrexia
Clinical narrative: Patient  presented 1 day after vaccine for continued fever that  she was unable to control at home with associated headache and body aches and tachycardia.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Patient  presented 1 day after vaccine for continued fever that  she was unable to control at home with associated headache and body aches and tachycardia.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after BUD of 72 days. No adverse reaction noted during 15 minute observation time
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Condition aggravated, Feeding disorder, Sleep disorder, Urticaria
Clinical narrative: I've just been living with servere hives got blexten from doctor But it made them worse now I'm getting help from natropath 100 times worse after vaccines.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Catheterisation cardiac normal, Echocardiogram normal, Troponin increased
Clinical narrative: Admit to hospital for NSTEMI on 9/24/2022  Normal echo and Normal left heart cath.  No PCI indicated
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report was received from a nurse regarding a patient of unknown gender an age.    There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   Since 15-NOV-2021, a temperature excursion occurred (until reporting time). On 28-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (formulation, strength, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U015678 which had been verified to be valid, expiration date reported and validated as 18-MAY-2023), as prophylaxis (Improper storage of product in use). The vaccine administered was stored at temperature of 51 degrees Fahrenheit (F) for an unknown time frame. There was no previous temperature excursion. No additional AE details were reported. It was unknown if a data logger was used.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Caller confirmed that the improperly stored dose of VARIVAX was administrated; This spontaneous report was received from a nurse regarding a patient of unknown gender and age.    There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 15-NOV-2021, a temperature excursion occurred (until reporting time). On 17-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (formulation, strength, route of administration, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U015678 which had been verified to be valid, expiration date reported and validated as 18-MAY-2023), as prophylaxis (Improper storage of product in use). The vaccine administered was stored at temperature of 51 degrees Fahrenheit (F) for an unknown time frame. There was no previous temperature excursion. It was unknown if a data logger was used. No additional AE details were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The office manager in a physician's office reported that unknown number of patients received improperly stored vaccines.; No additional AEs were reported; This spontaneous report has been received from an office manager concerning an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patients were vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # u037810, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 28-MAR-2023) (dose, anatomical location and route of administration were not reported) for prophylaxis. The vaccine was stored at a temperature of Fahrenheit (F) during 6 hours and 59 minutes (Product storage error). The vaccine did not suffer previous temperature excursions.  No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other issues or concerns noted.; Medical assistant calling to report that a adult was given a pediatric dose vs the adult dose. Patient is almost 30 years of age. Admin on 9/20/2022 VAQTA:  LOT: U012007 EXP: JAN 18, 2023 NO PQC No other issues or concerns noted.; Medical assistant calling to report that a adult was given a pediatric dose vs the adult dose. Patient is almost 30 years of age; This spontaneous report was received from a medical assistant and refers to an adult (almost 30 years old) patient of unknown gender. The patient's medical history, concurrent conditions concomitant therapies were not reported.  On 20-SEP-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, intramuscular injection, lot number U012007, expiration date: 18-JAN-2023, administered for prophylaxis (dose, strength, and route of administration were not provided). The patient was given pediatric dose instead of the adult one (product administered to patient of inappropriate age, incorrect dose administered). No other issues or concerns were noted (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: Accidental underdose, No adverse event, Product preparation issue
Clinical narrative: No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-SEP-2022, the patient was going to receive the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #W002453, expiration date: 24-JUN-2024, strength, dose, frequency and route were unknown) for prophylaxis. During the preparation, the vaccine was diluted with sodium chloride (NORMAL SALINE) 0.5 milliliter (ml) (strength, lot #, expiry date, route of administration, and indication were not provided) and then drawn up 0.5 ml of the mixed solution and administered it to this patient (vaccine preparation error, accidental underdose). No additional adverse events were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2209USA007866: US-009507513-2209USA007891: US-009507513-2209USA007893: US-009507513-2209USA007924: US-009507513-2209USA008037: US-009507513-2209USA008058: US-009507513-2209USA008125: US-009507513-2209USA008249: US-009507513-2209USA008273: US-009507513-2209USA008275:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE; Caller is a medical assistant who reports a dose of ROTATEQ which expired on 10Sep2022 was given 22Sep2022. The patient had no symptoms or adverse effects after administration. The ROTATEQ had no temperature excursions. Potency was supported by Post-; This spontaneous report was received from medical assistant and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, once, lot number U005994, expiration date: 10-SEP-2022, administered orally for prophylaxis (exact dose, and strength were not provided) (expired product administered). It was reported that there was no temperature excursion. No other adverse event was reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old male patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819, expiration date reported as 24-FEB-2004 but upon internal validation was set as  02-FEB-2024, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008838: US-009507513-2209USA008836: US-009507513-2209USA008837:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old female patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819 expiration date reported as 24-FEB-2022 but upon internal validation was set as 02-FEB-2022, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008835:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old female patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819, expiration date: reported as 24-FEB-2022 but upon internal validation was set as 02-FEB-2024, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008835:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from Other Health Professional and refers to a 1-year-old male patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W011624, expiration date: reported as 24-FEB-2022 but upon internal validation was set as 06-APR-2024, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008835:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: no other AE occurred; the product was administered on 9/23/2022 and the dose was expired.; This spontaneous report was received from a registered nurse (RN), concerning a patient of unknown age and gender.   Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On 23-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1742465, expiration date: 21-SEP-2022, (dose, route of administration, and anatomical location were not provided) administered orally for prophylaxis (expired product administered).
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not take the fourth dose of Vivotif as per the schedule; A spontaneous report was received from the nurse on 07SEP2022. It described a 39-year-old female patient who "did not take the fourth dose of Vivotif as per the schedule" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took her first three doses of Vivotif correctly (every other day). Reportedly, the patient took her third dose of Vivotif on 02SEP2022 however did not take the fourth dose until 06SEP2022. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer did not take the fourth dose of Vivotif as per the schedule (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer did not take the fourth dose of Vivotif as per the schedule (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both shots and have had them/Suspected vaccination failure; Have had them about 5 times; This 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.   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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media The reporter reported that the patient received Shingles vaccine. The reporter stated that after received Shingrix vaccine the patient experienced shingles 5 times. The reporter stated that the vaccines are not 100 percentage effective in his case. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Developed shingles after vaccine/ took the shingles shot, had tiny dot of it in hairline/suspected Vaccination failure; Developed shingles/ had tiny dot of it in hairline; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received the shingles shot and later patient had tiny dot of it in her hairline. Her doctor was able to give medication and it helped. At least she had not had a full blown case. The reporter considered the events might had been to be related to Shingrix. Additional supportive information: 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: Incomplete course of vaccination
Clinical narrative: 1st shot on Oct2019, did not receive 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had 1st shot of shingles vaccine in October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 17-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient apparently did not have a second shot of shingles vaccine.  The reporter wanted to know if he/she should get one now. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: my left arm was very sore for days; I can not even lift up; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMONIA VACCINE for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-SEP--2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient he/she received the shingles vaccine shot and pneumonia shot and experienced sore arm for days and he/she did not lift up. The patient stated that he/she would receive second dose in November. Additional Supportive information: It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Pneumonia vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Redness at the injection site; Swelling at the injection site; Low grade fever; Extreme fatigue; Very sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, fever, fatigue and pain in arm. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, fatigue and pain in arm were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, fatigue and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got his/her first shingles vaccine on Thursday (date unspecified).  The patient had redness and swelling at the injection site, a very sore arm, low grade fever and extreme fatigue the next day.  The patient was not looking forward to taking the second dose. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: pain on the left side only; rash; This case was reported by a consumer via interactive digital media and described the occurrence of pain localized in a 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain localized and rash. On an unknown date, the outcome of the pain localized and rash were unknown.   It was unknown if the reporter considered the pain localized and rash to be related to Shingles vaccine and Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR134386   Additional Information: GSK Receipt Date: 18-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had rash and pain on the left side only.  The patient wanted to know if it was common. Additional Supportive Information: The follow up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR134386:Same reporter